chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received 2nd Shingrix vaccine on Thursday, June 2, 2022. 3-4 days after 2ndShingrix dose, patient's mouth became sore, and ulcers developed all along her gum lines, into the cheeks, and under the tongue. Gums are red and inflamed. Pt presented to pharmacy 8 days after vaccination with complaints of ulcers and pain. Pharmacist recommended orajel (benzocaine), ibuprofen, warm salt water gargle and to contact dentist. Pt contacted dentist, magic mouthwash with benadryl, maalox, lidocaine called in. Pt following up with dentist Monday morning (6/13/2022).
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. No treatment drug information was provided. 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live significant follow-up received contains age group added and updated narrative.
About 2 hours after, I developed a sore arm. At 6:30am the following day, I woke up with a 102 degree fever, chills, a headache, and the sweats. They went away with tylenol and fluids.
Varivax given on 02/01/2000. Had chicken pox on 06/24/2004
Approximately a few months after my 2nd dose I experienced the following: Fatigue for a week straight and fortunately I have an appointment with my cardiologist - and it was found that I have some problems with my heart (heart was racing). Then I went to the hospital and they performed a heart shock by the use of the machine. I was prescribed with Eliquis (Xarelto), Metoprolol Tartrate. As of today I am feeling much better but I still feel a bit fatigued, I am going back to my cardiologist by the end of the month.
9 days, post vax, pt's temperature shot up to 104F. Called ER and they recommended rotating Motrin and Tylenol but not necessary to bring in. 12 hours later, temperature was down but saw MD with sore throat, rash "temperature too high for sore throat" and was prescribed Amoxicillin and now she is fine; no problems.
This spontaneous report was received from a pharmacist via a company representative referring to a female patient currently in her 80's years of age. The patient's medical history and concurrent condition were not reported. The patient was vaccinated with ZOSTAVAX (strength, dose, lot# and route unknown) when she was in her late 70's years of age (date unspecified). Concomitant therapy was unknown. After getting the ZOSTAVAX vaccine, the patient lost her ability to taste and her sense of taste on an unknown date. The patient sought medical attention by contacting the pharmacist. The outcome of the event was reported as not recovered. The reporter considered the event to be significant disability. Additional information has been requested.
Arm became sore on the left arm - I had a lump and my whole arm was like one giant bruise. That lasted about three weeks. I still have a lump but it isn't bruised looking anymore. The incident I went to medical care for - I saw the doctor on 4/2/2021 and he diagnosed I have shingles on my right leg. I thought it was spider bites. I did have the shingles vaccine. It is inflamed and I get nerve pain down my leg. It is very, very sore to the touch. Right now it is kind of dry - like blisters on it. It's a mild case. Doctor put me on Valacyclovir. He put me on it for one week and I have two more days after today.
The day after vaccination (01/16/2021), patient was a bit cranky and had slight tenderness around injection site. Stayed with Maternal Aunt on the night of 01/16/2021; she reported that he felt warm, but mostly otherwise okay.  Mild redness (5x5cm of splotchy pink skin over left thigh), Left leg swelling (2cm larger than 'normal' right side), "babying" his left leg  by favoring to walk on right leg more (easily walks back and forth across room for sucker candy) starting on 01/17/2021 (2 days after vaccination). No pain detected on exam, even with direct palpation of left thigh. Patient left office with same signs and symptoms as before coming into the office.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2022 at 1:54 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In December 2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date). On 05-Feb-2022 at 1:54 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  This vaccine was administered up until its manufacturer expiry date of 04-Apr-2022.  No treatment medication was provided.
Pentacel was ordered on the patient. MA drew up the Hib portion of the vaccine with a sterile dilutant instead of the DTap-IPV portion of the vaccine. The patient only received the Hib portion of the medication.
Pain/swelling/redness 11 x12 cm at site of injection. No Tx self treated.
Patient reported episode of lightheadness.her vital signs are stable BP 110/78,P 80,Resp 19,02Sat100%, Patient kept on close Observation, reports feeling better,left Vaccination site ambulatory accompanied by her friend.
On April 4/13/2023 at 6:40 pm, patient, came in to see Dr. for a Well Child Check visit. Patient was seen by the doctor at 6:50 pm. Following the visit by the doctor, I was given instructions to administer vaccines; Dtap vaccine, Hepatitis A vaccine, and Covid Vaccine. My understanding was that we would be administering Covid vaccine 1st and 2nd dose. This was a mistake on my part, we are only giving Covid vaccine booster and not the 1st and 2nd dose. These vaccines were administered at 7:29 pm. The patient received the  Dtap vaccine on his left thigh, Hepatitis A Vaccine on his left thigh, and Covid vaccine booster on his right thigh. The patient was given instructions to wait 15 minutes after to see if he would have any side effect or reaction, but he did not have either and went home.
Asymptomatic Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (Asymptomatic Covid-19) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced ASYMPTOMATIC COVID-19 (Asymptomatic Covid-19). At the time of the report, ASYMPTOMATIC COVID-19 (Asymptomatic Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test positive: Positive.     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.; Sender's Comments: Based on the mechanism of action of mRNA -1273 vaccine, the event is assessed as unlikely related to mRNA-1273.
About 2 hours after the injection patient experience arm pain that led to such pain he was unable to move it. This resolved overnight and he is now only slightly tender 2 days later. About 4 hours after the injection patient experienced shortness of breath that persisted until he fell asleep that night. He states that he was unable to pull a full breath and was forced to lay prone with his feet elevated to even get a breath in.
Severe dizziness within five minutes of injection. I had to lie down at the clinic; the bed felt like it was spinning. Lasted approx. 5 min.
Information has been received from a physician concerning a male (age not reported) who on an unspecified date was vaccinated with COMVAX (lot # 657380/0377U).  A day after receiving the vaccine, the patient experienced a knot, the size of a thumbnail, under the skin where the injection was given.  Medical attention was sought.  The physician reported that the knot was slowly going away.  At the time of reporting, the patient was recovering.  Additional information has been requested.
Patient received: 1st dose of Moderna Lot 028L20A on 1/17/2021. 2nd dose of Moderna Lot 031L20A on 2/11/2021. Had exposure to COVID+ person on 4/10/2021.  Developed mild symptoms (cough, congestion, sneezing) on 4/12/2021 and tested +COVID via rapid testing and PCR on 4/14/2021.
Very nauseous and dizzy for 2 days; Very nauseous and dizzy for 2 days; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6199) via unspecified route of administration in the left arm on 05Mar2021 01:00 PM (age at the time of vaccination 39 year). as a single dose for COVID-19 immunisation. Medical history included Ehlers Danlos syndrome, compromised immune system. Patient allergies include Penicillin allergy. She has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination she was not diagnosed with COVID-19. Since the vaccination she has not been tested for COVID-19. Concomitant medications reported included Gabepentin, Vyvanse, Cymbalta, quintepine, rosarum all taken for unknown indication on unknown date. On 15Mar2021, the patient experienced very nauseous and dizzy for 2 days. Patient not received treatment for the reported events. The clinical outcome of the events Very nauseous and dizzy for 2 days was not recovered and is ongoing. No follow-up attempts are possible. No further information is expected.
No adverse event; Nurse reports administration of ROTATEQ to a 9 month male patient; This spontaneous report was received from a nurse referring to a 9-month-old male patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 09-MAR-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #W026137, expiration date: 05-FEB-2024, administered orally for prophylaxis (strength was not provided) at the age of 9-month-old (Product administered to patient of inappropriate age). No additional adverse event was reported (no adverse event).
DEATH; This spontaneous report received from a company representative concerned 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: Unknown and expiry date: Unknown) dose, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died after getting Janssen vaccine. The patient died from an unknown cause of death. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210507041-covid-19 vaccine ad26.cov2.s-Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Ataxia; This spontaneous report was received from a physician via a company representative refers to a 13 year old female patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On an unknown date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. On an unknown date, (reported as: approximately 5 days after vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the patient experienced ataxia. The outcome of ataxia was reported as recovered/resolved, on an unknown date. The causality of event was not reported.
Shortly after receiving the shot, the patient was was waiting the 15 minutes monitoring period in the store. She was standing/walking and told her parents that she was feeling dizzy and needed to urgently sit down to prevent herself from falling. I was notified that a patient was having an event. I encountered Pt who was sitting on the floor. She was conscience but seemed lethargic. I attempted a BP measurement with a machine x 2 with no result then obtained a manual pressure of 115/65. I obtained a radial pulse rate of 65. Forehead Temp was 97.4. We placed patient in a chair and encouraged water and bit of orange juice. I took a follow up vital set BP 115/61, HR 65, T 97.2. Patient recovered spontaneously and was observed for approximately 15 minutes and then left store with parents. I followed up with a phone call at 0915 on 7/31/21 and the parents reported a full recovery.
PT INJECTION SITE BECAME WARM AND SWOLLEN, TOOK ONE DOSE OF BENADRYL, TRAVELLED DOWN TOWARD INSIDE OF ARM. CURRENTLY APPEARED FLUID FILLED AND RED/SWOLLEN ENTIRE LEFT INNER ARM TO JUST BELOW THE ELBOW WHERE SWELLING WAS THE WORST. PT C/O SOME ACHINESS AND SWOLLEN AREA
01/08/2020 2:00AM extreme pain in arm at injection site ; 11:00AM chills, jaw pain, fever 103. 2, Tylenol reduced fever to 100.8, body aches and joints, slight cough
Information has been received from a healthcare worker referring to a 5 month old male patient. The patient's concurrent condition included congenital heart disease. The patient's medical history included 2 heart surgeries. The patient did not have drug reactions/allergies. On 24-JUN-2015 the patient was administered the first dose in the series of PEDVAXHIB (lot# L030868 with expiration date of 09-JUN-2018, 0.5 ml, intramuscular) in the right thigh. Concomitant therapies included amoxicillin, PULMICORT, XOPENEX and MYCOSTATIN. The patient developed a pus-filled abscess on the right thigh at the injection site on 22-SEP-2015. Then on 04-NOV-2015, the same patient was administered the second dose in the series of PEDVAXHIB (lot# L030868 with expiration date of 09-JUN-2018, 0.5 ml, intramuscular) in the left thigh. On 06-NOV-2015 (2 days later) the patient's mother called the physician's office to report "a bump broke out" at the injection site. It was reported that on an unspecified date "several weeks later" that the "bump turned to a blister and popped." The patient was recovering, but not yet completely healed. The healthcare worker also reported another AE for a different patient after administration of this same lot of PEDVAXHIB in SR#I-14178158106 (MARRS#1512USA010129). Additional information has been requested.
Partial facial Paralysis--eye wont close; eyebrow unaligned with other, eye tearing; side of mouth distorted, cant smile, drooling from side of mouth
Her symptoms included the development of a rash down her back, neck, chest, belly, and R forearm.  The symptoms began within 4 hrs of receiving the vaccine and included intense itching.  She described the itching similar to poison ivy.  No fever, pain, aches, SOB, etc. was elicited.  All symptoms have resolved at this time.
Was having trouble not hearing especially when I attended church services. Also was noticing that certain voices on the television were distorted or uncomfortable to listen to.
No adverse event has occurred. Patient was administered 2 flu shots on 9/24/21 and 10/18/21
Hives on rt arm inside. Bumps  on  lower arm outside swelling,large red circle midway down arm. Pain and itching. Called Dr office told to put some anti itch cream on. If gets worse go to er. Sunday. Still itching and just large red circle still present. No more hives or bumps. Still alittle pain. Monday better still redness on arm. Still alittle pain.
hard time walking; Muscle aches so bad that they had a hard time walking; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of hard time walking, Muscle aches so bad that they had a hard time walking, and Fever in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced hard time walking, Muscle aches so bad that they had a hard time walking, and Fever. At the time of the report, hard time walking, Muscle aches so bad that they had a hard time walking, and Fever outcome was unknown.            No concomitant medications and treatment medication were reported.  The reporter stated two doctors that she knows just had a sore arm from the first dose but after the second dose they had fever and muscle aches so bad that they had a hard time walking.   This case was linked to MOD-2021-019765.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 22-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided It was reported that first shipment was received on 15-March2021, and since they didn't know it was refrozen, they used it beyond April 14th
Moderate abdominal cramping about 30 mins following the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Aug2021 (at the age of 31-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 receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (TIROSINT), vitamin D NOS (MANUFACTURER UNKNOWN), prenatal (MANUFACTURER UNKNOWN) and biotin (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. On 24Aug2021, about 30 minutes following the vaccine, the patient experienced moderate abdominal cramping, lasting about 30 minutes where the patient had to lay day and it was bad. The moderate abdominal cramping did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event moderate abdominal cramping was resolved an unknown date in Aug2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Subsequent to receiving vax, the pt developed a local reaction. No further information was available at the date of this report. The reporter was unable to specify the number of pts who experienced this event. Additional reports will be generated when identifying information is provided
Within 1-2 minutes after receiving Hep B vaccine and Pneumococcal-23 vaccine, patient develop red rash, swelling, warmth and itching at both right and left ante-cubital area of each arm. Rash approximately 4 in diameter. Swelling approx 2 in diameter. Itching moved down arms. Pt c/o mild left sided headache but has been having headaches recently. Pt was monitored for 45 minutes with resolution of symptoms. No medications were given to treat symptoms. Pt was discharged to home.