chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from the patient's mother referring to her daughter; a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 08-JUN-2017, the patient was scheduled to receive GARDASIL, but that day, after the administration of the vaccine a nurse indicated to the reporter that the patient was vaccinated with Hepatitis A vaccine (manufacturer unknown). However, after a lot verification it was confirmed that the patient was vaccinated with GARDASIL 9 (dose, route and expiration date were not reported) (lot # M040412) for prophylaxis. Additional information has been requested.
falls; This is a spontaneous report from a contactable consumer. The consumer reported similar event for two patients, this is the second of two reports.  A patient with unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was in a nursing home due to falls after receiving the vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021424414 same reporter/drug/event, different patient
Took off band aid that evening.  Started to hurt.  Next day - red, itchy, bump last few days.  Wk later it was still visible.  Red & bruised.
With 1st vaccine on 1-9-21 I had severe chest pain, the NP diagnosed it as pleurisity, told to take Tylenol, on second vaccine 2-6-21 I had a very bad headache that went down my neck and right shoulder, and lower back, NP said it was arthritis, go to sports med. since that time the pain has covered all my joints, muscle spasms to the point of not being able to walk, completely bedridden at this time, severe pain, headache, insomnia
606 doses were given after expiration date; Vial refrigerated after expiry date of product; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial refrigerated after expiry date of product) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial refrigerated after expiry date of product). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial refrigerated after expiry date of product) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. The vaccine was placed in refrigerator on 25 Nov 2021. The vaccine did not go any temperature excursion and does not experience adverse event. No treatment information was provided.
VACCINE DID NOT WORK; COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a white and not Hispanic/Latino male of an unspecified age. 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: 1805022, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 19-MAR-2021 for prophylactic vaccination to left arm. No concomitant medications were reported.  On 18-JUL-2021, the patient tested positive for COVID-19 rapid POC test through the nostril (covid-19 test positive). It was also reported that, the vaccine did not work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 test positive and vaccine did not work was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186473. The suspected product quality complaint has been confirmed to be not voided (meet product quality complaint (PQC) criteria) based on the product quality complaint (PQC) evaluation/investigation performed.; Sender's Comments: V0: 20210741048-Covid-19 vaccine ad26.cov2.s-Vaccine did not work. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Pt had 3rd GARDASIL Injection and was diagnosed with transverse myelitis and is being treated with steroids. Pt has LE weakness.  7/17/09 Medical records received DOS 6/25/09. Assessment: Skin sensation disturb, toxic effect venom, cervicalgia. Patient presents with entire left side numb, neck pain and trunk area tingling X 3 days. Not able to sleep because of neck pain, paresthesias. Decreased ROM of cervical spine.   7/23/09 Hospital records received DOS 6/30/09. Diagnosis: tranverse myelitis, hypertension, anxiety, constipation, urinary retention. Patient presented with worsening neck pain and weakness below the waist. Numbness left side of neck, shoulder, arm. Babinski (+) No patellar reflex on right. Tremor in hands. Weakness, paresthesias, brisk tendon reflexes, clonus ankles, alterations in temperature and vibration sense. Neck stiffness.
pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hepatitis c and shingles (25 years before reporting date). Concurrent medical conditions included autoimmune disorder (IGE autoimmune disease).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was resolved with sequelae.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but could be 66 or 67 years. The patient received a dose of Shingrix and experienced pain at the injection site that only lasted for 1 night, then resolved. The patient did not consent to follow up. This case has been linked to US2020017554, reported by the same reporter.
p/vax pt exp varicella w/4-5 confirmed lesions & some itchiness;pt sought unspecified medical attention & was given DPH for rash;
the same symptoms of COVID all over again; the same symptoms of COVID all over again; bad fever; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. The consumer reported same events for 2 patients. This is a first of two reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history included COVID-19 (not ongoing). Concomitant medications were not reported. The patient experienced symptoms of COVID-19 all over again and bad fever all on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date.  The information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107798 Same reporter/product/event, different patient
On approximately 6/22/99, the pt received the first dose of Lymerix for prevention of Lyme disease.  Subsequently on 6/22/99, the pt experienced muscle pains and fatigue. These symptoms resolved after ten days.  The most recent information, received on 7/19/99 reports the condition of the pt is resolved.
severe weakness, muscle aches, probably every lymph node. worse was shortness of breath. could not even walk a few feet without trying to catch my breath
ill; Initial information was received on 30-Sep-2021 regarding an unsolicited valid Social Media non-serious case received from a Consumer.  This case involves a male patient (unknown age) who was ill (illness) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I won't be getting my flu shot. I never have and have had no reason to have it. My dad had it and was I'll and he never took it again either".  It is unknown if the patient experienced any additional symptoms/events.  Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
Pt received Menactra ACYW-135 0.5 ml when should have received Menomune d/t over age 65 yrs. No adverse effects noted.
I had Covid in Late March 2021 and recovered with symptoms by April 1st.  On April 19th, I woke up with chest pains and went to Hospital Emergency Room.  Was diagnosed with Pericarditis after many tests and being in hospital for 3 days.  Took Colchicine Tab 1/day and ibuprofen for 2 months and was fully recovered.  July 2nd had visit with Cardiology and was told I could stop all medicine and could get Covid Vaccine.  On July 20th, I had 1st dose of Maderna, On July 21st I had full Covid symptoms of extreme tiredness, fever of 100.5 deg F, and chills, which lasted until July 22nd.  On 7/26, I began having symtoms that felt like Pericarditis, so I went to my family doctor.  Blood work showed CRP of 4, then on 7/29, I had blood work again that showed CRP of 43.1 and had heart discomfort.  Had blood work again on   8/10 and CRP was down to 1.5 level.  As of 8/16, I am still having Pericarditis symptoms when I do any exercise.
Information has been received from a Registered Nurse concerning a 16 year old female who was vaccinated intramuscularly with her third dose of GARDASIL. Subsequently the patient developed a rash on her arm and a blotchy rash on her nose shortly after receiving the vaccine. Lot numbers not available. The patient sought unspecified medial attention. Additional information has been requested.
My back became red and itchy approximately 8 hours after the injection. By the next morning, my chest was red and hives were starting. By Wednesday morning, it had also moved to the injection site.  I sought out medical attention on Wednesday. Both Dr and I think it had to do with the vaccine, especially since the injection site showed irritation. I had allergy testing done on Friday, so Dr wants me to talk to the allergist to see if that could have sensitized my system. He also wants to know if I should get the second dose and if so, pre load my system with steroids and antihistamines.
Patient was to receive DTaP, Pediarix given causing extra dose of polio and hep b. No adverse reactions noted.
Gradual loss of hearing acuity. Realized tv was at highest audio and couldn't decipher dialogue
Patient came into the pharmacy on 9/21/17 with his arm in a sling complaining of immense pain. Patient claims that the needle hit the bone causing blood to pool in his joints because he is on blood thinners. The patient claims that the pooled blood was pushing against the bone causing it to separate. Patient got the following prescriptions on the following days: Oxycodone/APAP 5/325mg #10 on 9/21/17, Oxycodone/APAP 5/325mg #20 on 9/22/17, Oxycodone/APAP 5/325mg #15 on 9/25/17, and Oxycodone/APAP 5/325mg #30 on 9/28/17 all from different doctors from different practices.
Vaginal bleeding that started after injection. Period is not due for 2 weeks. I?m very regular.
Severe altered mental in a healthy 16 year old; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 15Jun2021 at 09:30 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and was reported to be healthy. The patient did not receive any medication within two weeks of vaccination. The patient previously took amoxicillin and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 26May2021 at 09:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. 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 20Jun2021 at 13:00, the patient experienced severe altered mental for a healthy 16-year-old. The event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event severe altered mental was not resolved at the time of report.
Went to bed for three days straight; Teary eyes; Runny nose; Swelling in lymph nodes and neck; Little bit of confusion 3-4 days ago; Muscle and joints swelled up; Night terrors about 3 times; Stuffy nose; Dizziness; Painful swelling; Cold chills; Fever of 99.9F; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Went to bed for three days straight), LACRIMATION INCREASED (Teary eyes), RHINORRHOEA (Runny nose), SWELLING (Swelling in lymph nodes and neck) and MUSCLE SWELLING (Muscle and joints swelled up) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia and Lupus syndrome.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced SOMNOLENCE (Went to bed for three days straight), LACRIMATION INCREASED (Teary eyes), RHINORRHOEA (Runny nose), SWELLING (Swelling in lymph nodes and neck), MUSCLE SWELLING (Muscle and joints swelled up), PAIN (Painful swelling), CHILLS (Cold chills), SLEEP TERROR (Night terrors about 3 times), NASAL CONGESTION (Stuffy nose), DIZZINESS (Dizziness), CONFUSIONAL STATE (Little bit of confusion 3-4 days ago), PYREXIA (Fever of 99.9F), NAUSEA (Nausea) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, SOMNOLENCE (Went to bed for three days straight), LACRIMATION INCREASED (Teary eyes), RHINORRHOEA (Runny nose), SWELLING (Swelling in lymph nodes and neck), MUSCLE SWELLING (Muscle and joints swelled up), PAIN (Painful swelling), CHILLS (Cold chills), SLEEP TERROR (Night terrors about 3 times), NASAL CONGESTION (Stuffy nose), DIZZINESS (Dizziness), CONFUSIONAL STATE (Little bit of confusion 3-4 days ago), PYREXIA (Fever of 99.9F), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 (Inconclusive) 99.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported
expired Daptacel vaccine was administered to a child/No AE; Initial information was received on 18-Feb-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 5-year-old female patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included IPV, MMR and Varicella vaccine.  On 17-Feb-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C5367AA, expiry date: 30-Jan-2020] via an intramuscular route at the right side for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  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.
after receiving the shingrix vaccination the patient began to fell light headed. i asked the patient if wanted some water and replied yes. i went to get some water and the patient had fainted.
Vaccine received at 12:30 Physical shakes/chills from 7-9 pm Woke up next morning with a splitting headache
Out of PF 6-35 month prefilled FLUZONE. FLUZONE QUADRIVALENT 6 month and older 0.5ml given to 7 month old patient as a second dose of flu vaccine.
pt noticed redness p/a shower 8PM;redness & soreness have diminished but itching & hardness in area persist;
I had a mild fever Saturday morning, fatigue, and my arm was sore for a few days at the site of injection.
Information has been received from a medical assistant referring to a 6 month old female patient. No relevant medical history or concurrent conditions were reported. On 08-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
SORE THROAT; SNIFFLES; COUGH; BODY ACHES; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180502 and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced sore throat. On 12-MAR-2021, the subject experienced sniffles. On 12-MAR-2021, the subject experienced cough. On 12-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on MAR-2021, and had not recovered from sore throat, sniffles, and cough. This report was non-serious.
fever, chills, body/joint aches, nausea, weakness/fatigue. Fever started 7 hours after the injection and lasted about 24 hrs, the rest of the symptoms are still present 48 hrs after the injection.
Mom states patient had 2 minute seizure and then another one a little bit later that lasted about 5 minutes. She states she hasn't had a seizure for about 4 to 5 months. Took her into ER per ambulance at 2:30am. Left ER 5:30am. Called ambulance again when she had a 35 minute seizure around 9:30am. Had chest x-ray earlier which was clear. Her Trilepta dosage was increased and she was sent home again.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 83-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional case details were reported as follows: The age at vaccination was not reported. The pharmacist did not know if the patient had a history of shingles. It was unknown whether when the patient received the dose at reporter's facility or the patient got it somewhere. The patient was getting over shingles now. The pharmacist did not know how long the patient waited between having the SHINGRIX shot and developing shingles.
Armpit swelling and pain lasting longer than 24hours. Advil providing relief.  Chest and upper back pain and tightness. No relief from standard otc medicine like Advil or NyQuil.   Coughing when trying to take deep breaths.
Information has been received from a 64 year old female consumer with an allergy to sulfa products and no pertinent medical hx who recently, in approximately November 2003, was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. It was reported that her arm began to swell around the injection site. Her arm got really swollen, the lump got as big as her hands and it was hard as a rock and warm to touch. It was also very painful. The reporter indicated that on 07NOV2003 it seemed a little abated an the swelling was going down. Unspecified medical attention was sought. the pt does not have a physician. No product quality complaint was involved. It was reported that the pt was recovering with sequalea. Additional information has been requested.
red around injection site; swollen around injection site; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE ERYTHEMA (red around injection site) and VACCINATION SITE SWELLING (swollen around injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Oral thrush from 01-Feb-2021 to 06-Feb-2021. Concurrent medical conditions included Allergy to antibiotic (Macrodantin) and Hypothyroidism since 1992. Concomitant products included TIMOLOL and LATANOPROST for Glaucoma, LEVOTHYROXINE for Hypothyroidism.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, 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 VACCINATION SITE ERYTHEMA (red around injection site) and VACCINATION SITE SWELLING (swollen around injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red around injection site) and VACCINATION SITE SWELLING (swollen around injection site) had resolved.            Medical History of oral thrush -was prescribed clotrimazole tablets Treatment medication not provided.   This case was linked to MOD-2021-025395 (Patient Link).
Pt seen by doctor 2 days after injection and pt had swelling, redness, and tenderness to palpation at site in diam about 5 cm diam from center. Pt was started on Kelfex po for possible cellulitis.  24 hour rechcek showed resolution of swelling and inflammation.