chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician and refers to a 67-year-old female patient. The patient did not have any known drug reactions and allergies and none pertinent medical history. On an unknown date in January 2018, the patient received a dose of VARIVAX for prevention of varicella (dose, route of administration, anatomical location, lot# and expiration date were not reported) with STERILE DILUENT (dose, route of administration, lot# and expiration date were not reported). Concomitant therapies included ampicillin, ceftriaxone, vancomycin and acyclovir. On 29-JAN-2018, the patient the began to experience an unspecified change in mental status. On the same day, she was diagnosed with a urinary tract infection by a healthcare provider at an emergency room and was prescribed an unspecified antibiotics as a treatment. On 02-FEB-2018, the patient was admitted to hospital with an unspecified change in mental status. During hospitalization, she had Magnetic Resonance Imaging (MRI) performed (results unspecified) (onset date in approximately February 2018). On an unknown date, the patient was diagnosed with hydrocephalus and on an unknown date, had external ventricular drain placed in an unspecified location (details were not provided). In approximately February 2018, the patient was placed on placed on a ventilator for an unspecified reason. The outcome of the events was reported as not recovered. The relatedness between the events and VARIVAX and STERILE DILUENT was not reported. Upon internal review the event of hydrocephalus was determined to be medically significant. Upon internal review the unspecified reason was determined to be medically significant due to ventilator placement.
Information has been received from a physician concerning a 77-year-old female with no allergies, diabetes, hypertension, hyperthyroidism and hypercholesterolaemia who on 23-MAR-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included SYNTHROID, LIPITOR, LOPRESSOR and "meformin". On 09-APR-2007 the patient developed shingles. Unspecified medical attention was sought and it was reported that the physician did not want the rash analyzed. The physician reported that she drew blood blood to detect herpes simplex virus on 12-APR-2007. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
This report was received  from Sanofi Pasteur Inc. and was assigned manufacturer report number 72782, concerning a 29 year old female with no illness at time of vaccination or pre existing physician diagnosed allergies who on 19-JUN-2012 (at 8:10 am) was vaccinated with the 3rd dose of (Lot#672781/1706AA) IM in left deltoid. Concomitant therapy included EFFEXOR. The patient began with headache, dizziness and nausea 1.5 hours after receiving vaccine. No vomit or diarrhoea happened. At the time of reporting, the patient's outcome was unknown. The patient was seen "6 degree" after vaccine, she appeared fine. No other vaccinations within 4 weeks were used. No adverse event happened following prior vaccination. This was originally reported by a certified registered nurse practitioner. Additional information has been requested.
felt like a pill is stuck in chest between trachea and lower wind pipe but haven't taken any pills.; It's very annoying; slightly pain; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 11May2021 at 15:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication 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 vaccines within four weeks prior to the vaccination. On 12May2021, from the day after the vaccine, and now a week later the patient felt like a pill was stuck in the patient's chest between her trachea and lower windpipe but had not taken any pills and it happens more in the later part of the day or after exercising. At the time of the report happened in the morning which was very annoying and slightly painful. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of events felt like a pill was stuck in the chest between the trachea and lower windpipe, annoying and slightly painful were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
patient received a dose of expired Menactra / no AE; Initial information received on 14-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 18 year old male patient who was vaccinated with expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6207AB and Expiry date 25-May-2020) via intramuscular route in the left deltoid on 14-Jul-2020 for Prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used.  At a time of reporting no adverse event 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 and Module VI of the 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.
Local Reaction @ injection site, right deltoid area. Redness, Swelling 45mm, painful to touch and fever x 3 days.
This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 55-year-old male patient who received BOOSTRIX (batch number AG7KY, expiry date 20th May 2016). On 12th September 2015, the patient received BOOSTRIX .5 ml. On 26th September 2015, 14 days after receiving BOOSTRIX, the patient experienced nerve pain and numbness in fingers. On an unknown date, the outcome of the nerve pain and numbness in fingers were not recovered/not resolved. The reporter considered the nerve pain and numbness in fingers to be possibly related to BOOSTRIX. Additional details were received as follows: This case was previously reported to a doctor. On 26th September 2015, two weeks after vaccination, the patient experienced left arm nerve pain in forearm, elbow and shoulder and left hand numbness in thumb, index and middle fingers.
Patient felt dizzy and fainted after receiving IPV, TDaP and HBV shots. Father and I supported patient while at the same time, providing ammonia inhalant. Once patient recovered, he felt nauseated and vomited. I applied cold pack to patients neck and offered apple juice. I asked for assistance and patient was transported to Area 3 via wheelchair to lay on the examination bed and to continuously monitor patient and his vital signs.
PATIENT DID NOT HAVE AN ADVERSE REACTION TO THE VACCINE. HOWEVER, WHEN SHE CAME IN ONE MONTH LATER TO GET HER BOOSTER, IT WAS DISCOVERED THAT SHE RECEIVED THE PEDIATRIC DOSE OF ENGERIX B INSTEAD OF THE ADULT DOSE (10MCG INSTEAD OF 20MCG).
Rash surrounding a large area of injection sight with persistent itching and lasting 3 weeks.
pt recv vax 16SEP96 & on 17SEP96 pt exp pain & erythema @ the inj site & a rash;
Information has been received from a pharmacist concerning a female patient of unknown age. Pertinent medical history or drug reactions/allergies were unknown. On 24-JUN-2015 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneous, lot number L006392). The reporting pharmacist could not confirm the expiration date for the vaccine. On 26-JU-2015, the patient experienced a rash and a lump at the injection site. The patient sought medical attention by calling the pharmacy. There was no treatment were given for the adverse events. At the time of reporting, the patient was not recovered from the adverse event. The causality was not provided. This is one of two reports received from the same reporter. Additional information has been requested. Lot number L006392 has been verified to be a valid lot number for ZOSTAVAX.
I did not observe the adverse event happen, but patient reported that a rash developed a few days after receiving the shingles (ZOSTAVAX) vaccine. He came back into pharmacy on 11-28-16 and reported the possible adverse reaction and showed the rash. It had small red bumps in the armpit area. It was all over that area plus a few inches further. Patient was not reporting any other effect or issue.
This spontaneous report was received from a licensed vocational nurse refers to a patient of unknown age and gender. On an unspecified date in 2007, the patient received first dose of GARDASIL 2007 and second dose in March 2015 (dose, route of administration and lot number were not reported). No adverse effects reported. Additional information has been requested.
extreme chills; body ache; slight fever; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included covid-19 and spent two weeks in the hospital battling the virus , lung carcinoma cell type unspecified stage iv I also have stage 4 lung cancer which I take Alectinib from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took alectinib. On an unspecified date, the patient experienced extreme chills, body ache, slight fever. It was further reported that does anyone else have similar reporting of these side effects as it might make my decision as to take the second dose of Pfizer vaccine or not easier. The clinical outcome for all the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
COVID-19; Respiratory Problems; Panic attacks; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), RESPIRATORY DISORDER (Respiratory Problems) and PANIC ATTACK (Panic attacks) in a 67-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.  Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.  No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In 2022, the patient experienced COVID-19 (COVID-19), RESPIRATORY DISORDER (Respiratory Problems) and PANIC ATTACK (Panic attacks). At the time of the report, COVID-19 (COVID-19), RESPIRATORY DISORDER (Respiratory Problems) and PANIC ATTACK (Panic attacks) was resolving. Not provided.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: positive (Positive) Patient had COVID.  The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.  No concomitant medication was reported. Patient was on an inhaler, and it helped him a lot and it came from the effects of the COVID. It was unknown if patient was enrolled in a COVID 19 Vaccine Trial. The reporter's causality for the event of COVID with SKYRIZI (RISANKIZUMAB) was no reasonable possibility. The reporter's causality for the event of respiratory problems and panic attacks with SKYRIZI (RISANKIZUMAB) was not provided.  Company comment: This is a spontaneous case concerning a 67-year-old, male patient with no relevant medical history, who experienced the unexpected non serious of COVID-19 and other non serious events such as respiratory disorder and panic attack. Patient test positive for SARS-CoV-2. It is unknow timeframe between the event and the administration of a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 67-year-old, male patient with no relevant medical history, who experienced the unexpected non serious of COVID-19 and other non serious events such as respiratory disorder and panic attack. Patient test positive for SARS-CoV-2. It is unknow timeframe between the event and the administration of a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient presents blurred vision and fainting 10 minutes after vaccine administration. Patient was pale and diaphoretic. Initial Vital sign BP: 90/50 mmHg, HR:76 bpm, RR: 18 rpm 1 minutes  Vital sign BP : 100/65 mmHg, HR: 74 bpm, RR 16 rpm Patient was under observation 15 minutes after last vital sign check. Patient denies dizziness, blurred vision or headache. Patient and parent was oriented about vaccine adverse reactions and  recommended  further medical evaluation by her primary care physician. Patient and parent refers understand instructions and recommendations. Patient recived all vaccine documentation. Patient was call to follow up primary care physician visit.
Pt given 5-11yo dose instead of 12 and up dose; no adverse event, just incorrect vaccine given
Pt with syncope episode and jerking motions lasting <10 seconds upon standing approx 2 min after vaccination with 3 vaccines.
BLOOD CLOTS IN HEART; BLOOD CLOTS IN LUNGS; BLOOD CLOTS IN LEGS; CHILLS; SORE ARM; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1808982 expiry: unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  It was reported by patient that on 06-APR-2021 patient experienced sore arm and on 07-APR-2021 patient had experienced chill. The patient stated that on 27-MAY-2021, the patient experienced chest pain which led to him hospitalization on an unspecified date. While hospitalized they discovered that he had blood clots in the heart and lungs (also reported as blood clots in the legs). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and chills, and the outcome of blood clots in heart, blood clots in lungs and blood clots in legs was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210557848-covid-19 vaccine ad26.cov2.s-Blood clots in heart, Blood clots in lungs, Blood clots in legs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
A non-serious spontaneous report of inadvertently gave two patients expired FLUMIST was received from a physician concerning a 14-year-old female. Neither medical history nor concomitant medication was reported for this patient. The product expired on 12-Dec-2010. On 15-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information received on 10-Mar-2011 and incorporated into case: no late occurring adverse events.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 09-OCT-2015, the patient was vaccinated inadvertently with the first dose in GARDASIL immunization series (lot number H020901 and expiration date 05-JUL-2015) (dose and route of administration were not reported) which was expired. Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
aches; 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 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling and redness right thigh about 8 x 6cm. Not well demarcated.
Within 2 hours I couldn't move my arm and was crying out in pain for 12 hours. I contacted my doctor after 1 week due to the level pain and limited range of motion in my left arm. I can not raise my arm higher than a 45° in any direction. I was able to get in to see him on April 26th. He prescribed Diclofenac Sodium and Tramadol. He gave me an order to start physical therapy.
CBC blood count reading--all counts low, including very low hemoglobin (9.3)
Patient given 2 IPV immunz 1 single dose and 1 combo with Hep B which was not needed.
admitted on 4/1/21 for respiratory failure, COVID positive after completing 2 dose vaccine series, requiring ICU cares. expired in the ICU.
patient had redness, swelling, and warm to the touch of injection site and pain that went up into her neck. Patient was prescribed Pepcid, Prednisone, and Clindamycin. Patient should be taking steroids for the next 7 days. Patient was also given Methylprednisolone at time of visit before she left.
Had an issue with my toe nails on 6 of my 10 nails,I had the moderna booster anw my toenails are clearing up; This spontaneous case was reported by an other health care professional and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Had an issue with my toe nails on 6 of my 10 nails,I had the moderna booster anw my toenails are clearing up) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Nail discomfort.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Had an issue with my toe nails on 6 of my 10 nails,I had the moderna booster anw my toenails are clearing up). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Had an issue with my toe nails on 6 of my 10 nails,I had the moderna booster anw my toenails are clearing up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment details were provided.  Patient had an issue with her toe nails, on 6 of 10 nails and tried everything without any luck. Patient reported that her toenails are clearing up after having booster dose.
Bruising at the injection site; Swollen, unspecified lymph nodes; Bruising underneath the arm; fever; could not lift arm for 1 week; This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injected limb mobility decreased, injection site bruising, enlargement of lymph nodes, bruising of arm and fever. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved and the outcome of the injection site bruising, enlargement of lymph nodes, bruising of arm and fever were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, injection site bruising, enlargement of lymph nodes, bruising of arm and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix about 3 months ago at a different pharmacy and had experienced bruising at the injection site of the arm, and underneath the arm. The patient noted swollen, unspecified lymph nodes.  The patient also reported fever.   No other details were known about the patient, as there was no pharmacy profile. The reporter did not consent to follow up.
Patient developed a rash on 07/05/2019, within ~48 hours of vaccine.  Diagnosed in clinic with zoster rash on 07/08/2019. Per Dr.'s notes dated 07/08/2019: Diagnosis #1 Shingles: Reports rash, noticed on Friday, after administering Shingrix vaccination on Wednesday. States rash appeared one day later vaccination; had burning, itching and tingling sensation before rash appeared. Has pain and itching, treated with Tecnu thinking it was Poison Ivy rash, was not beneficial. Reports increase in size, blisters and discharge. States there are breakouts all over her body. Informs pain resolves occasionally. History of shingles in the past. -Crusted vesicles over right inner arm, in a nerve distribution consistent with shingles. -Cautioned to avoid contact with newborn until lesions healed ( 4 mo grandchild)
Symptoms felt at 8p on day of vaccination (6 hours after dose): Pain  Swelling  Symptoms beginning Tuesday, 3/23/2021, one day after dose: Rash  Symptoms beginning Thursday, 3/25/2021: Itching