chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child arrived from another country 3 weeks before arriving to clinic for school entry vaccines. Family are refugees with no obtainable vaccine records. Vaccines were given on 01/09/2017. A rash started to the upper chest on 01/16/2017. The rash progressed to the upper back, and two lesions on the face (right forehead and medial right eyebrow regions) over the next two days. Student was seen in the clinic on 01/18/2017 for stomach rash and history of fever. There were approximately 10 lesions on the upper chest and 10 lesions on the upper back. The lesions appeared as small macules, papules, and scabbed lesions. There were no fluid filled vesicles noted. The student was restricted from school entrance for 7 days. Epidemiology (County)was contacted and provided the timeline symptoms, history etc. They concurred and the child remained in isolation at home. The mother appeared to the clinic without the child on 01/20/2017 stating that there was swelling and redness around the right eye. The mother was instructed to take the child to the ER at Medical Center (two blocks away from clinic) for R/O periorbital cellulitis. The mother returned to the school on 01/24/2017 with an ER note confirming the Varicella diagnosis and asking to be checked prior to school entrance by clinic NP. There was one lesion on the left that was not fully scabbed and the child was restricted 24 hours more for school entry. The child was evaluated on 01/25/2017 and all lesions were scabbed. The child had approximately 40-50 scabbed lesion to chest, abdomen, back both arms, and legs without sequelae.
Child dvlped itchy bumps on arms w/i hrs of receiving Hep B vax. School nurse reported that the symptoms lasted through the evening but were gone when child returned to school the next day.
Sever vertigo,was admitted to hospital on March 25,2021,still am dizzy undergoing PT now.$/9-?
Pt reported pain lasting several days and got worse causing nausea and vomiting. Pt reported reduced mobility causing her to miss a day of work after vaccination. Prolonged pain, tingling, etc. Reported that immunizer standing while the patient was sitting could've contributed to pain.
About 12 days after first shot, louder noises on TV hurt my ears. An hour later, I started feeling fullness in both ears. The next morning the feeling of fullness was mostly in the right ear, and noises coming from the right-side sounded like they were coming from the left. Visit to otolaryngologist confirmed conductive hearing loss in right ear with no signs of fluid or other problems. There was also some discomfort in the lower skull area. Seems like the right ear may have slightly improved at this point, although that hasn't been confirmed. After 2nd shot, it initially seemed like there was little reaction other than painful swelling under left arm (the one the shot was given in). Since then, there has been gradual increasing fullness/pain in left ear, mostly the left lower-side of my skull. 3 weeks after the second dose, the feeling in the left ear, and surrounding area, has gone from fullness to pain. Apparently ear doctors are seeing an uptick in cases of sudden hearing loss, etc., but this reaction is not on the official reportable side effect list.
After getting his first Covid- 19 immunization, pt noticed his heart racing. Here was no SOB, chest pain or dizziness. Vitals were b/p 123/73, pulse 67 and SaO2 98%. He felt better after eating and drinking. He was monitored and discharged stable Tachycardia
Pregnant as of 08MAR2021; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant as of 08MAR2021) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 10-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant as of 08MAR2021). On 10-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant as of 08MAR2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information not provided.  08-Mar-2021, pregnancy results positive
I got the shot on a Saturday afternoon.  Overnight Monday, I got an enormous and painful cold sore on my lip, which extended an inch onto my face.
Moderna Booster given - Sore Arm -  Panic attack the next morning with sweating, light headedness and diarrhea.  Followed by nausea, chills, weakness and extreme exhaustion.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with a compliance improvement plan and has been reinstated vaccination privileges.
Rash on legs- 1 wk no itching more like red spots headache 1 week - Took TYLENOL. Tingling around mouth.
No second dose of the Moderna Covid19 Vaccine after 8 weeks; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (No second dose of the Moderna Covid19 Vaccine after 8 weeks) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (No second dose of the Moderna Covid19 Vaccine after 8 weeks). At the time of the report, PRODUCT DOSE OMISSION ISSUE (No second dose of the Moderna Covid19 Vaccine after 8 weeks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Female patient (soon-to-be 71y/o) who is a retired ICU nurse called for her and her husband (soon-to-be 73y/o) who were prescribed PAXLOVID. Reporter stated that she had side effects and provide feedback about PAXLOVID. Also stated that she was not going to recommend other people to take it. Completed her 5-day course but her husband stopped after 3 doses, because it was too nasty. Stated that they would not do it gain. Mentioned that they also had the Pfizer vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the reported events and suspect cannot be excluded .BNT162B2.The case will be reviewed further with FU information., Linked Report(s) : US-PFIZER INC-202201095005 Same product and event, different patient;
severe muscle cramps; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (severe muscle cramps) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 05-Apr-2021, the patient experienced MUSCLE SPASMS (severe muscle cramps). At the time of the report, MUSCLE SPASMS (severe muscle cramps) outcome was unknown. Not Provided          Concomitant medication is not provided.
I could barely walk because my pain in my hip; am still limping a little bit now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset 13Oct2023, outcome "not recovered", described as "I could barely walk because my pain in my hip"; GAIT DISTURBANCE (non-serious) with onset 13Oct2023, outcome "not recovered", described as "am still limping a little bit now". Therapeutic measures were taken as a result of arthralgia, gait disturbance.  Additional information: Patient could barely walk because patient's pain in the hip and that went all night when patient finally took a muscles relaxer (Intent: Treatment). Patient asked if that is one of the side effects. Patient was still limping a little bit now.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (sore arm after 3 doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 037K20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, 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 experienced PAIN IN EXTREMITY (sore arm after 3 doses). At the time of the report, PAIN IN EXTREMITY (sore arm after 3 doses) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided. This case was linked to MOD-2021-420889, MOD-2021-420839 (Patient Link).
One to two hours, post vax of Recombinant vaccination, the pt states that she had difficulty breathing, wheezing, weakness, irritability, nausea and that her heart was racing. She reported this at the time of her 2nd vaccination appt. She sought no medical attention at the time of the event. Did not receive her subsequent vaccines per her physician's orders.
Pt received PNEUMOVAX 0.5mL in left deltoid on 6/18/08. Shortly thereafter, pt developed neuropathic pain in that same arm. Paresthesia and neuropathic pain as only unilateral in left arm and appeared to be temporarily related to the vaccination. Pt went to private neurologist for further testing and physical evaluation. Was treated with GABAPENTIN and the pain remitted after 2 weeks of treatment. GABAPENTIN was subsequently discontinued and pt has been pain free.
Pt calling stating that she is having bad pain in left arm. Pt states that site of injection is warm, hard swollen and painful. Pt states that it was itchy all night. Pt denies SOB, fever. She then went to see Primary Care Doctor 10/30/15 at 10am. Patient reporting severe left arm pain, swelling and itchiness. Started last night. Reports was in GI clinic yesterday and received flu and Pneumovax. One in each arm. Afterwards started noticing swelling and pain in left arm. Became very severe and almost went to ER but could no leave her child at home. Associated with subjective fevers. Review of records received pneumovax on left deltoid. Denies previous reactions to flu shot. First time having the Pneumovax. Denies airway symptoms stridor, or SOB. Very concerned about her symptoms. BP 113/75 mmHg | Pulse 95 | Temp(Src) 98.2 °F (36.8 °C) | Wt 69.9 kg | SpO2 100% Physical Exam  Constitutional: Uncomfortable appearing. Pulmonary/Chest: No respiratory distress. No wheezes or rhonchi. Musculoskeletal: Left upper arm significant swelling and erythema, appears to be one large hive, excoriations noted, warm to touch, tender to touch, radial pulses palpable, full ROM. Assessment and Plan: Patient with significant left arm swelling, erythema and itchiness. Appears to be reaction to pneumovax. No airway involvement. Urticaria adverse reaction to pneumovax. Given subjective fevers and warmth will empirically treat for cellulitis. Benadryl (25mg, 2 capsules every 6 hours as neded for itching), Famotidine 20mg (1 tablet BID) cold packs (PRN) Keflex (250mg, 2 capsules BID x 5 days). Return to clinic in 1 week.
This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received DTaP vaccine. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and pertussis were unknown. It was unknown if the reporter considered the vaccination failure and pertussis to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, in 2014, there was an outbreak of Pertussis in 5 individuals. The reporter stated that they had all been vaccinated. The patient tested positive, but had no symptoms to minimum symptoms with less coughing. When tested the patient's were pertactin lacking. The reporter was not sure which brand of DTap that was provided. This case was considered as the suspected vaccination failure since the details regarding basic immunization schedule, time to onset for the event were not reported. This case is 1 of the 5 cases which was reported by same reporter.
A patient was inadvertently administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was inadvertently administered from an expired vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was inadvertently administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was inadvertently administered from an expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided.  2 patients had administered from expired vaccines (beyond use by date). HCP does not have that information but states the Use by date was on 07 Mar 2022. Date(s) of administration of vaccine, 1st patient on 07 Mar 2022 at 2:30 pm and 2nd patient on 09 Mar 2022 at 11:30 am. The vial did not undergo any temperature excursions.  No treatment details were provided.   This case was linked to MOD-2022-508368 (Patient Link).
On 12/19/19 pt contacted the office stating that she was having left upper arm pain 2 days after receiving the FLU vaccine in our office on 12/09/19,  then few days after the pain was radiating to left upper shoulder including shoulder blade, then few days later she started having severe left upper back spasms with bilateral legs tingling sensation on and off. Stated the pain was so severe that she asked her neighbor to take her to the closest ED for evaluation. ED referred her to a neurologist. Stated she was seen by a neurologist on 12/19/19 who told her that her symptoms were probably  a reaction to the FLU vaccine and to reporter it to the clinic where she received the vaccine.  Seqirus, INC was contacted to report vaccine reaction and find out if similar reactions had been reported by others but was told that they did not have that information available.
Pain to the touch of her arm, armpit all the way to her collar bone area; Injection site pain; Redness widespread from site of injection to her arm, arm pit and collar bone; Injection site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain to the touch of her arm, armpit all the way to her collar bone area), INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (Redness widespread from site of injection to her arm, arm pit and collar bone) and INJECTION SITE PAIN (Injection site tenderness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain to the touch of her arm, armpit all the way to her collar bone area), INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (Redness widespread from site of injection to her arm, arm pit and collar bone) and INJECTION SITE PAIN (Injection site tenderness). At the time of the report, PAIN (Pain to the touch of her arm, armpit all the way to her collar bone area), INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (Redness widespread from site of injection to her arm, arm pit and collar bone) and INJECTION SITE PAIN (Injection site tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-017087 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: No specific follow-up information recorded.
Muscle aches - 14 hours Numbness - 14 hours Lightheaded - 12 hours Sinus pressure - 12 hours Headache - 12 hours
vaccines with temperature excursions were administered; No additional AE/PQC reported; This spontaneous report was received from a nurse practitioner referring to a 5 years old patient of unknown gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with the second dose of an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S020961 with an expiration date on 07-JUL-2021) for prophylaxis (strength, dose, anatomical location and route of administration were not reported) (product storage error).  The dose administered experienced a temperature excursión of -58 degrees Fahrenheit (°F) and +46°F (-50 Celsius degrees (°C) to +8°C): above 46°F (46.73°F) for 46 hours and 5 minutes and 0 seconds recorded by a data logger.  There was no previous temperature excursión.  No additional adverse events or product quality complaint were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA002066: US-009507513-2104USA002067:
gave a Flublok vaccine to an 11 year-old child/no AE; gave a Flublok vaccine to an 11 year-old child/no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 11 years old patient received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant therapy was received.  On 15-Oct-2019, the patient received a single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot 2FAA1933 via intramuscular route in the left deltoid.  It was of actual medication error due to Inappropriate age at vaccine administration and overdose.  It was unknown whether adverse event was occurred or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Second dose increased stiffness in left leg, mostly left calf; all over muscle soreness; then by day 3 puffy left leg plus neuralgia at site of past shingles left shoulder blade; then by day 3 puffy left leg plus neuralgia at site of past shingles left shoulder blade; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 74-years-old female patient  received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EW0158, EW0175) as DOSE 2 SINGLE for covid-19 immunization(Age at vaccination 74 years). The patient past Medical history included blood pressure measurement from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing and known allergies codeine. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. On an unspecified date after the administration of second dose of vaccine the patient experienced increased stiffness in left leg, mostly left calf, all over muscle soreness, then by day 3 puffy left leg plus neuralgia at site of past shingles left shoulder blade, and general adverse reaction perhaps related to shingles sensitivity when experiencing immune storm. The event outcome was Not recovered.  No follow-up attempts needed. No further information is expected.
Burning pain in right calf.  Felt like a burn or scratch but no wound on the skin.
I am a practicing physician and the patient.  I can assure you of the clinical accuracy.  I developed shingles/zoster reactivation on my left hand/forearm.
Felt flushed/hot about 30-60 minutes after shot. Muscle pain at site of injection and throughout upper arm - painful throughout the night. Pain dissipated somewhat 26-28 hours out from shot. Ran low-grade fever about 29 hours out from shot. Nausea, just general malaise throughout the day.
pt recv vax & mom stated awaken by raspy respiration, arched stiff body, glassy eyes, frothing noted lasting about 4min @ about 0300AM 31AUG96;
She received her flu vaccine in November 2020. Patient called on March 29, 2021 stating that she was still having pain on her left arm but our record states that she was given the vaccine on her right side.  No other specific details were given to me by the patient.