chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had shingles twice, had shingles shot / suspected Vaccination failure; Shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comments: This case was reported by a patient via interactive digital media. The reporter suggested to go to the doctor immediately and get a drug called Valtrex and if doctor said there would nothing that would help, find a another doctor. The patient stated that, he/she had shingles twice and had his/her shingles shot. Follow-up would not possible as no contact details were available. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Patient presented to the ED with acute coronary syndrome and was subsequently hospitalized, diagnosed with NSTEMI. This was within 6 weeks of receiving COVID vaccination.
Rec'd flu vaccine 1/29 seen in our office 1/31 immun site on (L) arm 3x4cm area of erythema just inferior to injection site. Temp 102 - no streaking. Dx cellulitis prescribed clindamycin x 10 days.
Covid 19 infection.  fever, cough, congestion, fatigue. Started June 19th 2022.  Fatigue persisted though July 6th.  Paxlovid was taken for 5 days beginning June 21st.  Otherwise, symptomatic treatment with Naproxen and tylenol.
patient with unprovoked large left lower extremity DVT and bilateral PE with moderate/high clot burden.  Platelet count was normal.  Hemoglobin was still low at 9 but improving with iron supplementation over the last month.    She does not have a previous history of blood clot or family history of blood clot or hypercoagulable state.
Menveo 1 vial plus administration to 4 yo patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA91A, expiry date 08-FEB-2025) for prophylaxis.   On 22-JUN-2023, the patient received Menveo. On 22-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Menveo 1 vial plus administration to 4 yo patient). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 23-JUN-2023 Office manager reported that she left a voicemail with the incorrect administration of a vaccines (no data apart from this one ) on June 22nd 2023. Today (June 23rd 2026) reported that 4 years old patient received a dose of one vial Menveo by mistake (it is approved until the patient is 10 years of age), which led to Inappropriate age of vaccine administration. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
instead of receiving a pediatric dose, the patient received an adult dose; received the 3rd dose of Engerix-B, but instead of receiving a pediatric dose, the patient received an adult dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 5-year-old female patient who received HBV (Engerix B adult) (batch number NJG23) for prophylaxis.   On 14-AUG-2023, the patient received the 3rd dose of Engerix B adult. On 14-AUG-2023, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: instead of receiving a pediatric dose, the patient received an adult dose) and adult product administered to child (Verbatim: received the 3rd dose of Engerix-B, but instead of receiving a pediatric dose, the patient received an adult dose). The outcome of the overdose and adult product administered to child were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt Date: 15-AUG-2023 A nurse practitioner called to inform that a 5-year-old patient received the 3rd dose of Engerix-B, but instead of receiving a pediatric dose, the patient received an adult dose, which led to overdose and adult product administered to child. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
29JUL97 pt c/o swelling & knot around inj site;white around inj site w/redness to surrounding area;site itches;no pain;MD visit 29JUL97 dx allerg rxn/infect;rx ATB, DPH for itch;rash around inj site;
Approximately 4 weeks after first dose of Moderna vaccine, patient began to experience constant whooshing sound in left ear that wakes her from sleep and is extremely distracting and disruptive to daily life activities.  The symptoms are consistent with tinnitus. The patient went to see an ENT specialist who she sees for ongoing care. She had visited the provider in 2020 and had  her hearing screened. Her hearing was normal at the time in both ears. The patient visited her ENT in early April 2021 for the ear symptoms. The provider found no causes of the symptoms during her examination (ie: ear wax, issues with ear drums, etc) in either ear and scheduled a follow up MRI to assess whether the patient may have a brain tumor. Additionally, the provider conducted a hearing test and discovered that the patient's hearing acuity in her left ear is 10% below normal. So it has degraded since the visit in 2020.  The patient has additional specialist follow up scheduled with a otolaryngologist to assess alternate causes of the symptoms, which have not abated and which are extremely distressing to the patient. The constant sound in the patient's left ear has continued for approximately 10 weeks at this point, and she frequently experiences a feeling of distracting pressure in her left ear as well.
Headache; It continues to grow; red, warm, itchy spot; red, warm, itchy spot; red, warm, itchy spot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (red, warm, itchy spot), CONDITION AGGRAVATED (It continues to grow), VACCINATION SITE PRURITUS (red, warm, itchy spot), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (red, warm, itchy spot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031AZ1A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).  On 26-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 VACCINATION SITE WARMTH (red, warm, itchy spot), VACCINATION SITE PRURITUS (red, warm, itchy spot) and VACCINATION SITE ERYTHEMA (red, warm, itchy spot). On 01-Apr-2021, the patient experienced CONDITION AGGRAVATED (It continues to grow). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, VACCINATION SITE WARMTH (red, warm, itchy spot), CONDITION AGGRAVATED (It continues to grow), VACCINATION SITE PRURITUS (red, warm, itchy spot) and VACCINATION SITE ERYTHEMA (red, warm, itchy spot) had not resolved and HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medication reported. Spot went away on 29 Mar 2021 and returned on 01 Apr 2021, larger in size. The patient reported it continued to grow. Treatment included Tylenol and Ibuprofen.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Vax given at well child visit. Rxn occurred post vax, rash, itching. Given Benadryl elixer orally.  Resolved.
8MAR93 & 9MAR93 inc t103 had fine red rash all over body; vomiting & rash on 9MAR94; 10MAR94 t102 had sz, rash seen by MD dx roseola; MD recommend ped DT:
This case was reported by a healthcare professional and described the occurrence of non-seroconversion in a 20-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On unspecified dates (as a child) the subject received three doses of ENGERIX B to complete the three dose series. Years later, as a 20 year old adult, the subject was tested and found to not have seroconverting antibody titer referred to as 'lack of expected effect.' This was non-seroconversion. No other information was provided.
I started having headaches every day and they didn't start from any particular thing. Sometimes they would last 15-20 minutes and sometimes they lasted 8-20 seconds and they were mostly over my left eye/left temporal region. Eventually I just stopped having them. I did talk to my Doctor and I did go to urgent care and they drew a COVID Test and a bunch of lab work. They also did an MRI of brain and they found nothing structural or obvious. It didn't feel like tension headaches, they were sharp pains behind eyes. I went to eye doctor and got prescription for my glasses changed but it wasn't in that eye. Sometimes they were disturbing enough to stop me from doing what I was doing.  This lasted about six weeks. I have recovered from the headaches. I did have itchiness and swelling in L arm from both vaccines. I didn't have anything else happen.
Pt tollerated vaccine well in clinic and was driven home by mom. Pt's mom called in around 1330 state pt has a headache, she is in tears, and she feels like she can hardly move due to the pain and mom states she is currently bringing pt to ED. Reporter attempted to collect further information through mom, to which pt yelled at mom. PCP advised to take 600mg ibuprofen and drink water, if no better in an hour or 2, but mom would like to bring pt to ED. Pt is currently at ED.
Patient experienced sudden hearing loss in his left ear exactly 10 days after receiving 3rd dose. He went to his personal physician and he diagnosed it as COVID-19 related.
dose 1 06May2021; dose 2 06May2021; hurting on top of my foot/gravitated to my big toe and then to the ball of my foot and now back to the top; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 02:00 (Lot number: ER8737) at the age of 42 years as dose 1, single and administered in arm left, administration date 06May2021 (Lot number: EW0187) as dose 2, single for covid-19 immunisation. Relevant medical history included: "stroke", start date: Feb2018 (unspecified if ongoing); "cardiomyopathy" (unspecified if ongoing); "narcolepsy" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "Hypertension" (unspecified if ongoing), notes: high blood pressure; "full hysterectomy", start date: Apr2019 (unspecified if ongoing); "gastric sleeve", start date: Feb2020 (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25May2021, outcome "not recovered", described as "hurting on top of my foot/gravitated to my big toe and then to the ball of my foot and now back to the top"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "dose 1 06May2021; dose 2 06May2021". The event "hurting on top of my foot/gravitated to my big toe and then to the ball of my foot and now back to the top" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient did not receive any other vaccination within 4 weeks of Covid-19 vaccine. The patient received other medications within 2 weeks of covid-19 vaccine. There were no known allergies. It was unknown if patient had covid prior to vaccination. The patient has not been tested for covid post vaccination.    Follow-up attempts are completed. No further information is expected.
Red papules on back and one on face in clusters. May be fluid filled. Fevers x 48 hours, very irritable. Rash not itching.
Left arm became very sore on 8/11/14, right after BOOSTRIX given to left deltoid. That night, left deltoid became swollen and hard, his skin was red and hot to touch. Mom calls our office 8/15/14 to let us know his left arm is much better. No longer red or hot, but is still warm and muscle is still hard. ROM is back fully.
Dizziness; Severe vertigo; Fell in yoga class; Lethargic; Feel run down; Nausea; A spontaneous report was received from other healthcare professional, concerning a 48 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced dizziness, severe vertigo (vertigo), fell in yoga class (fall), nausea, lethargic (lethargy), feel run down (depressed mood), and nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Feb 2021, prior to the onset of events, the patient received the second of planned doses of mRNA-1273 (Batch number: 13M20A), intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 03 Feb 2021, same day, the patient experienced nausea, dizziness, severe vertigo, having a fall in yoga class, lethargy, & feels run down. The patient went to urgent care, and then the emergency room (ER). An electrocardiogram (EKG) and a computerised tomography (CT) scan were done with no results provided. The patient was given ondansetron and meclizine.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.  The outcome of the events, dizziness, severe vertigo, fell in yoga class, nausea, lethargic, feel run down, and nausea were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient stated  on Saturday afternoon she could feel the vaccine traveling to her head.  Described the Headache as a severe Hangover feeling.  She reported she stayed in bed all day Sunday.  On Sunday the HA moved over her right eye, described as a "dull pain"  She also reported her arm to be "very" sore.
Patient reports difficulty breathing several hours after receiving Shingles vaccine, and that symptoms continued for 4 days after vaccination.  Patient reports that she did not contact her physician, nor seek any other medical care, and that the symptoms have since resolved.
Heart beating hard, normal heart rate, just felt it was beating hard.(4 hrs after receiving shot). 16 hours after receiving 2nd vaccine shot: Fatigue  Severe headache  Fever Body aches Sore arm (left arm received vaccine in). Nausea  Loss of appetite
Red macular rash including "sunburn" type coloring to Left Arm.  No hives, no itching, no respiratory distress.  Slight chest blotching. White fair skin, red hair, states sensitive skin and sunburns easily.  History of acne including chest and arms. States mother received first dose COVID vaccine (Pfizer) one week prior with same localized reaction.  Resolved with no treatment. No treatment administered, observed for >45 minutes.  Medical Director of site consulted including picture sent.  Rash was resolving upon discharge from observation area.  Advised to proceed with second dose per medical director in 21 days with observation period of 45 minutes to 1 hour.  Patient will report to PCP or local ED for any emergency should it occur later today.
Information has been received from a certified medical assistant concerning multiple patients' (unknown number) who were vaccinated with a dose of Gardasil. Subsequently the patients' complained of pain while and after receiving vaccinations of Gardasil. It was reported that all of their patients' complain of the pain. It was also reported that vaccinations are given via intramuscular route using two inch needles. The needles do not completely penetrate nor do the staff want to "force it." It was also reported that for all patients' the symptoms resolved. No product quality complaint was involved. Attempts are being made to obtain additional identifying to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
wheezing; severe dry cough/coughs so much that she is on the brink of vomiting; chest tightness; arm soreness; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm soreness), CHEST DISCOMFORT (chest tightness), WHEEZING (wheezing), COUGH (severe dry cough/coughs so much that she is on the brink of vomiting) and FATIGUE (fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Asthma.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and FATIGUE (fatigue). On 22-Apr-2021, the patient experienced CHEST DISCOMFORT (chest tightness). On an unknown date, the patient experienced WHEEZING (wheezing) and COUGH (severe dry cough/coughs so much that she is on the brink of vomiting). The patient was treated with AMOXICILLIN SODIUM, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANIC ACID]) at a dose of 875 mg and METHYLPREDNISOLONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm soreness), CHEST DISCOMFORT (chest tightness), WHEEZING (wheezing), COUGH (severe dry cough/coughs so much that she is on the brink of vomiting) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
have had head aches on left side of head only feels likes getting shocked last any where from 10 to 45 seconds then goes away happens 5 to 6 times a day, doctor prescribed gabapentin
approx 2hr p//vax became SOB leading to not being ble to breath @ all;was then taken to hosp ER;
Large red and raised spot at injection site. Growing hotter and bigger daily; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 17May2021 at 13:30 (at the age of 36-year-old) as a single dose for COVID-19immunisation. Medical history and concomitant medications were not reported. The patient previously took penicillin (MANUFACTURER UNKNOWN), ketorolac tromethamine (TORADOL) and prochlorperazine edisylate (COMPAZINE) for unknown indication on an unknown date. 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 vaccines within four weeks prior to the vaccination. On 18May2021 the patient experienced large red and raised spot at injection site, growing hotter and bigger daily. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event large red and raised spot at injection site, growing hotter and bigger daily was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
A ZOMBIE FOR 10 HOUR WORK DAY; SLEPT A LOT THAT WHOLE WEEKEND; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, 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 experienced a zombie for 10 hour work day, and slept a lot that whole weekend. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a zombie for 10 hour work day and slept a lot that whole weekend was not reported. This report was non-serious.
Colleague notified me of adverse events following second dose of Pfizer vaccine given at a school campus.  Colleague described severe headache within hours of receiving second dose and then; muscle ache; fatigue; fever; This is a spontaneous report from a contactable consumer. A adult male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 22Mar2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose number unknown on unspecified date as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. On 22Mar2021 the patient experienced severe headache within hours of receiving second dose and then, muscle ache, fatigue, fever. It was reported that colleague notified me of adverse events following second dose of Pfizer vaccine given at school campus. Colleague described severe headache within hours of receiving second dose and then muscle ache, fatigue, feeling fever, and headache the following morning. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be requested.
Information has been received from a physician concerning a female who on approximately 06-SEP-2007 was vaccinated with a 0.5 ml second dose of Gardasil. Subsequently the patient experienced hives and unspecified burning sensation. The patient called the physician. At the time of the report the patient's outcome was unknown. Additional information has been requested.
body pain; temperature of 99.4 °F; This is a spontaneous report received from a Pfizer sponsored program COVAX Support. A contactable consumer (patient) reported for himself that a male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Mar2021 for covid-19 immunisation. Patient had his first dose on 21Mar2021 and his second dose on 11Apr2021. However, he started to experience mild symptoms such as body pain and a temperature of 99.4 °F in Apr2021. He wanted to know if he can take paracetamol (TYLENOL). Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Red, hot and swollen 3" circle at injection site of right thigh, put on Keflex