chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ATE GRAPES 30 MINUTES AFTER TAKING FIRST DOSE OF VIVOTIF; This spontaneous case report (PVX2019-2925) was received from a consumer on 27-Nov-2019. It described a female consumer who "ate grapes 30 minutes after taking first dose of Vivotif" (PT: Product administration error). She was receiving oral Vivotif (lot number: 3003296) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 27-Nov-2019 and after 30 minutes she ate grapes.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "ate grapes 30 minutes after taking first dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "ate grapes 30 minutes after taking first dose of Vivotif" was considered as not applicable.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported but could be 71 or 72 years old. The patient's husband could not remember the vaccination date for the 1st dose of SHINGRIX. The reporter's wife experienced injection site pain for a day after vaccination. This case was linked with case US2018GSK181366 (2nd dose), reported by the same reporter for the same patient.
Information has been received from a consumer concerning her friend's 15 year old daughter who was vaccinated with two doses of GARDASIL. After getting two doses of GARDASIL the patient experienced seizures. Upon internal review, seizures was determined to be an other important medical event. No further information was available.
Skin cellulitis treated with Ceftriaxone 1 gm IM & oral antibiotics. Arm soreness.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 14-MAY-2013 the patient was vaccinated with a dose of VAQTA 50/1.0 U/ML lot # 0628AE, expiration 26-JUN-2015 (dose and route unknown). The Healthcare worker reported that VAQTA had multiple excursions from 20-FEB-2013 to 13-MAY-2013. The lowest temperature the vaccines reached was 24F. The total time of hours for the excursions was 253 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
29 yr old student who was preparing to go to  School.  Pt did not want the vaccine and reported being bullied, threatened and coerced into getting it  in order to progress in her career. Pt was vaccinated with J&J on 30 April, 2021 and had an acute onset of symptoms within 24 hrs.  Pt had severe fatigue, all over body aches, muscle pain, erratic, elevated resting heart rates, easy, unprovoked bruising all over her body, chest pain and difficulty breathing.  Pt was subsequently diagnosed with new onset murmur, mitral regurg, PITUITARY BRAIN TUMOR, MULTINODULAR THYROID, AMENORRHEA x 5 months.  Pt has NOT recovered to pre-vaccination physical functioning or health.  SM had extensive lab and physical exam prior to vaccination in preparation for  School and was the PICTURE OF HEALTH and fitness.
This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and drug reactions or allergies was provided. Between 01-JUN-2017 and 05-SEP-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # M044022 with expiration date 01-MAY-2018 (albumin status: recombinant human albumin (rHA)) and lot# N000336 with expiration date 03-JUL-2018 (also reported as 02-JUL-2018) (albumin status: recombinant human albumin (rHA)) (dose and route of administration were not reported) reconstituted with sterile diluent (manufacturer unknown). The temperature excursion ranged from minus 14 to minus 10 degrees Celsius for 630 minutes and from minus 9 to plus 8 degrees Celsius for 3 hours. No adverse effects were reported. There was no previous temperature excursion. Digital data logger was used. Product quality complaint was not involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA002044.
Started w/ headache 15 minutes after shot was given. Progressed to face and neck burning and itching 10 minutes later. Soon progressed to throat and tongue swelling. 50 minutes later her toes started turning purple. She was given (2) ibuprofen 200mg and 25mg benadryl. 911 was called and she was taken to the ER.
L arm red, swollen and warm to the touch.  Swelling increased to elbow two days after shot given.  No fever.
Person giving shot gave it to high on my arm, and made it extremely sore.  Shots should be given 2 fingers widths below the acromion    process.  This will keep the arm from beaning  sore after the shot.
9cm by 9cm area left deltoid; raised, hot to touch, pruritic topical steroids mupirocin to minor excoriations from itching zyrtec 10 mg qd benadryl prn cool compresses
The patient was given a varicella vaccine in clinic without incident. She returned home with mom. was given a snack and then placed in a warm bath for comfort.  Mom was nearby in another room and heard grandmother yelling out pt.'s name.  She appeared to be awake but not responsive and the left side of her body became still. This lasted for approximately one minute. Mom proceeded to call EMS.  When they arrived, they evaluated her and she appeared to be completely recovered. Mom declined the ER and was seen by her Pediatrician at the same office where the child was given the vaccine. She was afebrile before, during and after the incident.
FEELING COLD/HOT SENSATIONS IN LEFT ARM; RASH ON ARM; NAUSEA; REALLY BAD STOMACH ACHE; DEHYDRATION; NERVE PAIN; FELT COLD RUSH DOWN HER LEFT ARM/ FEEL NUMB FOR A MINUTE/ NUMBNESS FIZZLED OUT; EXTREME ARM PAIN/ BURNING ARM PAIN/ FELT LIKE A REALLY BAD SUNBURN/ ARM SORENESS / ARM BEGAN TO SHAKE/ INNER ARM AND ARMPITS SORE/ FEELING WARM, FUZZY PAIN IN LEFT ARM; INJECTION SITE SORENESS; CHILLS; HIGH FEVER; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included born with cleft palate, non alcohol user, non smoker, pollen allergy, and mild cat allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced felt cold rush down her left arm/ feel numb for a minute/ numbness fizzled out. On 31-MAR-2021, the subject experienced extreme arm pain/ burning arm pain/ felt like a really bad sunburn/ arm soreness / arm began to shake/ inner arm and armpits sore/ feeling warm, fuzzy pain in left arm. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced high fever. On 31-MAR-2021, the subject experienced injection site soreness. On 01-APR-2021, the subject experienced nerve pain. On 07-APR-2021, the subject experienced dehydration. On 10-APR-2021, the subject experienced really bad stomach ache. On 10-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced feeling cold/hot sensations in left arm, and rash on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt cold rush down her left arm/ feel numb for a minute/ numbness fizzled out on 31-MAR-2021, rash on arm, chills on 01-APR-2021, and high fever on 02-APR-2021, was recovering from injection site soreness, had not recovered from nerve pain, and extreme arm pain/ burning arm pain/ felt like a really bad sunburn/ arm soreness / arm began to shake/ inner arm and armpits sore/ feeling warm, fuzzy pain in left arm, and the outcome of dehydration, really bad stomach ache, nausea and feeling cold/hot sensations in left arm was not reported. This report was non-serious.; Sender's Comments: V0 Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
One week after injection noted itchy raised papules at sight of injection  1.5 x1 inch).  After 48 hours the area spread (2x3)  inches but flattened and continued to itch.
Missed dose; extreme pain on her backside from her left to right; pain was extreme as she could not get out of bed; pain was extreme as she could not get out of bed; Couldn't move her neck, arm, head and shoulders; Couldn't move her neck, arm, head and shoulders; Couldn't move her neck, arm, head and shoulders; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed dose), MUSCULOSKELETAL DISCOMFORT (Couldn't move her neck, arm, head and shoulders), LIMB DISCOMFORT (Couldn't move her neck, arm, head and shoulders), HEAD DISCOMFORT (Couldn't move her neck, arm, head and shoulders) and BACK PAIN (extreme pain on her backside from her left to right) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Couldn't move her neck, arm, head and shoulders), LIMB DISCOMFORT (Couldn't move her neck, arm, head and shoulders) and HEAD DISCOMFORT (Couldn't move her neck, arm, head and shoulders). On 29-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose), BACK PAIN (extreme pain on her backside from her left to right), MUSCLE DISCOMFORT (pain was extreme as she could not get out of bed) and PAIN (pain was extreme as she could not get out of bed). On 29-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved. On 05-Apr-2021, MUSCULOSKELETAL DISCOMFORT (Couldn't move her neck, arm, head and shoulders), LIMB DISCOMFORT (Couldn't move her neck, arm, head and shoulders), HEAD DISCOMFORT (Couldn't move her neck, arm, head and shoulders), BACK PAIN (extreme pain on her backside from her left to right), MUSCLE DISCOMFORT (pain was extreme as she could not get out of bed) and PAIN (pain was extreme as she could not get out of bed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the listed events included Bengay (menthol) cream and use of a heating pad.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up received on 06-Apr-2021, Contains significant information, Updated Outcome of events. (Recovered/Resolved)
No adverse effects were reported; one dose of expired VARIVAX (lot N012487 exp 4/20/2019) was administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.  On 05-JUL-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot number N012487 and expiration date on 20-APR-2019, 1 dose for prophylaxis (frequency, route of administration and anatomical injection site were not reported) (expired product administered). The suspect vaccine was stored properly through the date of administration and the sterile diluent used was not expired and it was stored properly. No adverse effects were reported.
Numbness beginning in left shoulder blade, later entire left side from top of head to knee. Lasted one and a half days,  went away, then returned a week later. Now, the numbness is random and sporadic. Nerve pain in left hand finger tips.
Bilaterally swollen lower legs that were noticed after work while taking a shower and discomfort/pain due to the pressure of the edema. I never had swollen legs in the past. Swelling came completely 2 days after and some discomfort was still felt id standing too long. On 4th day I went to run (I am a runner) and I initially something had bit me on my lower leg then the pain started to get worse such as if I had shin splints all over my lower legs. I could not run any longer and this is something I did not have before. I felt the legs off but after stopping the run I was fine so I took my regular salsa dancing class a few hours later and they pain started again but worst, it felt as if I had bruises all over and just
Pt states it started as a 15cm "lump" and continued to spread. Today, pt has a 60mm X 60mm red, raised circle, warm to touch. PA examined pt's circle area with pen and instructed to RTC on 1/5/01 for evaluation. Pt to apply ice prn and take Benadryl as directed.
Reviewed.  3/23/2021 @ 10 am patient received Pfizer boost vaccination administered in  Provider Room.  Patient was monitored in waiting area for 15 minutes with no reported side effects.    At about 1:45 pm  patient was in waiting area and had just finished eating a sandwich with tomato when she started feeling SOB and itchy.  A rapid response was called and the patient was transported to the ED by wheelchair. Patient has documented allergy to tomatoes.  In ED patient and IV was started and the patient was medicated with methylprednisolone 125 mg x1 IVP, Diphenhydramine 25 mg IVP, Lorazepam 1 mg IVP and Famotidine 20 mg IVP.
The mix of vaccine, dental anesthesia and Amoxicillin caused an enduring flu-like symptoms and tingling/pressure on left side of head where tooth was treated.
tinnitus in both ears; low energy; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus in both ears) and ASTHENIA (low energy) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced TINNITUS (tinnitus in both ears) and ASTHENIA (low energy). At the time of the report, TINNITUS (tinnitus in both ears) and ASTHENIA (low energy) outcome was unknown.            No concomitant medication was reported. Treatment medication was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Patient was vaccinated on 3/15/21, tested positive for COVID 19 on 9/23/23 .  She was admitted to our facility on 10/5/23, was made comfort measures and expired 10/18/23.
MOTHER OF PATIENT STATES CHILD WOKE UP THE DAY AFTER RECEIVING VACCINE WITH SWELLING AT VACCINE SITE AND REDNESS THAT EXTENDED TO JUST BELOW THE ELBOW OF HIS LEFT ARM. MOTHER TOOK CHILD TO LOCAL ER WHERE HE WAS GIVEN MEDICATIONS TO TREAT. POSSIBLY A STEROID AND BENADRYL. REDNESS BEGAN TO RESOLVE, AND NOW DECREASED TO LOCAL AREA OF VACCINE ADMINISTRATION SITE.
This spontaneous report as received from a registered nurse refers to a patient of unknown gender aged between 12 months old who on 17-JUL-2014, the patient was vaccinated at the same time with PROQUAD (Merck) (Lot # K007155 expiration date 12-NOV-2015) (dose not provided), subcutaneous and VARIVAX (Merck) (Lot # J014129 expiration date 07-NOV-2015) (dose and route not provided) at the same office visit. No adverse effects reported. No further information is available at this time. This is one of several reports from same source. Additional information has been requested.
MOTHER STATED THAT CHILD HAD NO REACTION TO PREVIOUS VACCINES. PATIENT INSTRUCTED TO WAIT 15 MINUTES, PER MANUF. INSTRUCTIONS. AFTER 15 MINUTES, CLIENT C/O ITCHING THROUGHOUT BODY. NO VISIBLE RASH, DENIED DIFFICULTY BREATHING OR SWALLOWING. SUPERVISOR NOTIFIED. HE SPOKE WITH MOTHER AND INSTRUCTED ME TO GIVE 25 MG. BENADRYL PO. THIS WAS GIVEN AT 9:30 AM. CLIENT WAS OBSERVED FOR 30 MINUTES. SHE STATED THAT SHE FELT BETTER. MOM WAS INSTRUCTED TO OBSERVE PATIENT TODAY AND IF SYMPTOMS INCREASE, TO CALL FOR MEDICAL HELP.
Shivering, rapid heart rate, dizziness, night sweats, aches, sore arm (all occurred over 3 days after vaccination, sore arm persisted for more than a week), took Tylenol for pain, rash appeared on arm approximately 2 weeks after, remained for several more weeks, treated rash with triamcinolone acetonide 0.1 % cream.
Mild cellulitis of arm. 3/3/09 MR received from reporter including vax rec (no lot #s). Pt presented 1/26/09 with c/o increasing redness around SP vaccination site. DX:  Cellulitis of L arm.  Adverse effect of drug therapy vaccines Smallpox. Tx:  Keflex. Pt presented several days with productive cough and chest congestion. DX:  URI.  Injection site erythema has receded
flu like symptoms body ache fatigue mild fever  felt like my nerve endings on my arm were sensitive ,,chills.....its been 48 hours seems to have gotten better   just a little worn out
frequent urination; Injection site pain; mild fatigue; mild chills; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 15:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 52 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for influenza immunisation, on 30Aug2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Sep2023 at 09:00, outcome "recovering", described as "Injection site pain"; POLLAKIURIA (non-serious) with onset 23Sep2023 at 09:00, outcome "recovering", described as "frequent urination"; HEADACHE (non-serious) with onset 23Sep2023 at 09:00, outcome "recovering"; CHILLS (non-serious) with onset 23Sep2023 at 09:00, outcome "recovering", described as "mild chills"; FATIGUE (non-serious) with onset 23Sep2023 at 09:00, outcome "recovering", described as "mild fatigue". Therapeutic measures were not taken as a result of pollakiuria, vaccination site pain, fatigue, chills, headache.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Red puffy and itchy eyes. Slight tightening of the throat and slightly itchy skin. Took 2 Sudafed sp?
All events occurred 1 day after vaccine: 1:00am- severe chills, slightly elevated body temperature (99.2 degrees F) 1:30pm - hives on right wrist (itching, red/puffy, and raised), lasted 30-45 minutes, treated with over-the-counter lotion; 10:00pm - hives covering entire body, (itching, red/puffy, and raised), lasted approximately 1 hour; No symptoms after.
3 days after receiving Covid 19 vaccine I experienced shortness of breath, chest pain, light headedness, and fatigue. Symptoms lasted 6 days.
Diarrhea; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and DIARRHOEA in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 01-Mar-2021, the patient experienced DIARRHOEA. On 01-Mar-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. On 02-Mar-2021, DIARRHOEA had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment details were provided.
10 days after injection red rash, swollen upper arm, hot, itchy 4inches by 2 inches appeared around injection site.
leg @ site turned red, raised, hot, feverish (entire leg from groin to just ablve feet) w/scarring post event, temp, leg swelled, fever;
16 year old patient vaccinated; A spontaneous report was received from a consumer concerning a 16-year-old female patient who received both doses,  The patient's medical history was not provided.    Concomitant product use was not provided by the reporter.  On unknown date, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  The patient received both doses and is only 16-years old. She forgot when she got vaccinated.   Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   The outcome for the event was considered resolved.; Reporter's Comments: This case concerns a 16 year old female who received her second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of  product administered to patient of inappropriate age who received both doses.
PATIENT DIAGNOSED WITH SHINGLES 7 DAYS AFTER VACCINE --  THEN EMERGENCY ROOM VISIT FEB. 16TH OR 17TH DUE TO HYPERGLYCEMIA, VERTIGO , DEHYDRATION AND ELEVATED BLOOD PRESSURE/HEART RATE
This is a spontaneous report from a contactable physician. This physician reported that a 57-year-old female patient, with a medical history of rheumatoid arthritis, had an allergic reaction following administration of pneumococcal vaccine (TRADE NAME UNKNOWN). At the time of reporting, no other information was provided.
Patient became paralyzed and could not move legs for several hours. She had continued pain. This was her third Lymerix vaccine. The 60 day follow-up states that the pt developed severe arthritis in knees since the vaccine. After being treated by several doctors, they feel the damage has already been done. Also, she developed hypertension.
Patient woke day after injection with a tennis ball size swelling at the injection site. It was firm, red, hot, and tender to the slightest touch. He applied heat only. Did not seek medical care. Patient was seen 3 days after injection with a little improvement. On day 4 the swelling and redness is resolving.
Adult HEP A given to pediatric patients. A new public health nurse and back-up RN pulled from a wrong bin.
Patient became diaphoretic,  vomited clear liquids, Patient placed in wheelchair and moved to room and placed on cot. VS remained normal throughout event. patient observed for 35 minutes. patient left after stating she feels normal and will drive myself home. Patient advised to call PCP or 9/11 if need arises.