chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingrix was giving with another diluent; Shingrix was giving with another diluent; This case was reported by a nurse and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) (batch number M972X, expiry date 9th October 2022) for prophylaxis.   On 9th December 2020, the patient received Shingrix. On 9th December 2020, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  The Shingrix was giving with another diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The NP found only a vial and she is looking which of the 3 patients who received Shingrix on that day is involved in this situation. The HCP needs time to look the information. The reporter consent to follow up.
DIZZINESS; TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tired, and had not recovered from dizziness. This report was non-serious.
Chest pain, was found to have perimyocarditis based on EKG and troponin and was transferred to Hospital for higher level of care on 6/7/21.
6 days post vaccination, pt presented to clinic with scattered rash on lower legs. Relates rash is pruritic but not exudative. Pt given Allegra 180mg every day.
Flushing /redness of face starting 50 minutes after vaccine  Hot feeling of face & mouth & slight tingling in mouth that lasted 3-4 hours Low grade fever 99.4 about 3-4 hours after vaccine  All resolved within  5-6 hours
Patient had some problems; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient had some problems) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient had some problems). At the time of the report, IMMUNISATION REACTION (Patient had some problems) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that patient started treatment on an unspecified date with Moderna COVID-19 Vaccine at an unspecified dose and frequency for COVID-19 vaccination. Reportedly, the patient had some problems.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Circle size of a baseball at the site of vaccine, really hot and bright red, itchy, hard, and swollen.
This currently 35 year old male patient started Gardasil 9 on 26Nov2020; On 02Mar2020 the caller woke up and had difficulty seeing out of his right eye/They suspected that he had multiple sclerosis at one time during his visit, but he was eventually given the diagnosis of optic neuritis/his vision is getting worse; the patient also developed hearing loss in his right ear/He explains that it feels as if he bas water in his right ear; This spontaneous report was received from a 35 years old male patient referring to himself. The patient's medical history, concurrent condition, concomitant therapies and drug allergies were not provided.  On an unknown date (reported as 26-NOV-2020), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose detail, route, lot# and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). On 28-JAN-2020, the patient received his second injection of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose detail, route, lot# and expiration date were not provided).   On 02-MAR-2020, the patient woke up and had difficulty seeing out of his right eye. The patient went to the emergency department on the same day. He had a brain magnatic resonance imaging (MRI) and a lumber spinal tap, which suspected that he had multiple sclerosis at one time during his visit, but he was eventually given the diagnosis of optic neuritis. From 02-MAR-2020 to 06-MAR-2020, the patient had been to the emergency department every day. The patient received methylprednisolone sodium succinate (SOLU-MEDROL) injections from 04-MAR-2020 to 06-MAR-2020 for treatment, but these did not improve his vision in fact his vision seemed to be getting worse. He stated that he only had peripheral vision in his right eye and be only had 10 percent of his vision in that eye as well. On an unknown date of March 2020 (also reported as some point of time this last week), the patient also developed hearing loss in his right ear. He explained that he did not notice at first, because of his vision issue, but this was an issue when listening to music. He explained that it felt as if he had water in his right ear. He explained that his vision was getting worse and he would be visiting a neurologist in the future. Medical attention had been sought.  The outcome of optic neuritis and hearing loss was reported as not recovered. The causality between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) and optic neuritis, hearing loss was not provided.  Upon internal review, optic neuritis and hearing loss in right ear were determined to be medically significant.; Sender's Comments:  US-009507513-2003USA004150: US-009507513-2003USA003782:
passing out; really bad reaction; This is a spontaneous report received from contactable female consumer (wife) on behalf of her husband 80-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on 29Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.   On 29Mar2021, the reporter stated that patient had a really bad reaction last night and had to go to the emergency room, she stated that overnight her husband kept passing out and states that when he would come to, he would say it's the medicine, the medicine. The reporter thought he was talking about his blood pressure medication because she states she checked and he hadn't taken it yet, but when she asked if what medicine he was talking about, her husband would say the one in my arm. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Fever, extreme joint pain, bruising at injection site, arm fever at injection site, week and then mobile for a day.
Small itchy inflamed spot at injection site; Small itchy inflamed spot at injection site; Dull manageable headaches; This is a spontaneous report from a contactable consumer, the patient. A 33-years old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the right arm on 18Mar2021 at 14:15 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. It was reported that the patient had known multiple allergies. Concomitant medications included norethindrone acetate (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), cetirizine (MANUFACTURER UNKNOWN) all for an unknown indication from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 12:00, patient experienced small itchy inflamed spot at injection site, comparable to a medium sized mosquito bite and dull manageable headaches for the last few days, but could be from seasonal allergies. No treatment was received for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events small itchy inflamed spot at injection site, dull manageable headaches was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
On February 12th I had the biopsy showed two cancerous masses in my breast.  I had a mastectomy done.  I also had headaches, left arm pain and total body aches.
Nerve pain all over the body. Nerve pan relieved by Tylenol short term,
The pt was presented with a complaint of swelling of lips, chest and throat tightness, dyspnea for 30 minutes. Treated with epinephrine, Benadryl, Solumedrol and Albuterol.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 13-JUN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # N035171 exp date 09-JUN-2019) (dose and route not provided). The vaccine was reconstituted with properly stored sterile diluent. Data digital logger was reported. The vaccine was exposed to a temperature of 6 °F to 14 °F for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1806USA006387: US-009507513-1806USA006474: US-009507513-1806USA006476: US-009507513-1806USA006477: US-009507513-1806USA006478: US-009507513-1806USA006479.
Onset January 7.,2021 of nausea, diarrhea, chills and body aches that lasted about 18 hours. Noticed on vaccination arm an area of about 2x2 inches that looked like red petechial hemorrhage that is sore to palpation.
On day 3 post vaccination, patient noted itching in left palm of hand, then the next day noted erythematous blisters appeared that worsened over a 24 hour period.  Blisters are now stable and slowly improving without treatment.
Case previously recorded as MA2009-3744. Initial case report received from a physician on 05 NOV 2009. A patient 18-year-old female was vaccinated into the deltoid with FLUVIRIN (batch no. 102041P1) i.m. on 05 NOV 2009. Vaccine sprayed from the end the needle onto the patient's arm. No adverse event was reported.
Received full dose of booster instead of half dose and unsure if they are immunocompromised; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Received full dose of booster instead of half dose and unsure if they are immunocompromised) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Received full dose of booster instead of half dose and unsure if they are immunocompromised). At the time of the report, ACCIDENTAL OVERDOSE (Received full dose of booster instead of half dose and unsure if they are immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment informations were reported.
Patient reported a severe headache on one side of his head. Also described "scalp" pain. Resolved in 3 to 5 days. Self-treated with Tylenol.
Irregular menses, period has always been very regular and same amount of days every month. After getting the 2nd dose of the COVID-19 vaccine my menses has been extremely irregular and painful. October 22, 2021 I started my menses which was a day late, and lasted three days. I had intolerable cramping. Ended October 24, 2021. November 17 I started my menses on the 17 and it lasted until November 21st. This was a total of five days earlier than my normal regular menses and was a day longer  than my normal menses. Again I had intolerable cramping and lots of small blood clots.
Temp. 101.8, headache, chills. Not reported to facility until 08/13/2013 at 4:30PM. Per patient, patient sought medical attention from own private medical doctor who prescribed Tylenol and rest.
This spontaneous report was received from a registered nurse concerning an unknown number of patient of unknown age and gender that were vaccinated with a dose of VARIVAX (Merck) (dose, dose number, lot number, expiration date and route were not reported), that was improperly stored. No adverse effect reported. Medical history and concurrent conditions were not reported. Co-suspect and concomitant therapies were not reported. This is one (1) of eight (8) reports from the same reporter. Additional information has been requested.
Case received on 15 April 2014 from a healthcare professional (physician). A 41 year old female was vaccinated intradermally with FLUZONE Intradermal batch UT4721BA, site not reported on 23 October 2013. The patient denied being ill at the time of vaccination. The patient has a history of diabetes type 2 and hyperlipidemia. On 11 April 2014, the patient had a rapid flu test for A and B only and tested positive for influenza A with a Rapid Test. It is unknown if the A strain is H1N1. The patient is being treated with TAMIFLU. The patient outcome is not recovered. This reporter also reported another adverse event which is captured in case number 2014SA049822 same product and same reporter. Documents held by sender: None.
Admission Date: 6/7/2022 Discharge Date: Jun 8, 2022  PRESENTING PROBLEM: COVID-19    HOSPITAL COURSE: 66-year-old female with a past medical history significant for CML as well as self-reported history of asthma and previous COVID-19 vaccination who presents due to complaints of generalized weakness as well as headache and neck pain.   Patient states he has been at her baseline state of health up until the morning of 06/06/2022.  She states he has been feeling well has had no complaints that she thought were related to infection.  However, after awakening 06/06/2022, she complained of generalized weakness.  She states that while she normally ambulates around the house with no assistive devices although she does use a cane and walker outside the house, she felt like her legs at home today were much weaker than usual.  She had no numbness or tingling.  She did report a headache with some neck pain but she had no visual changes and no photophobia.  With her symptoms she was concerned that she may have had a stroke and because of this, she presented to the emergency department.   In the emergency department the patient was hemodynamically stable and afebrile.  Low suspicion was had for a stroke based on the patient's clinical exam and she did undergo CT angiography of the head and neck as well as CT of the head unenhanced.  No acute pathology was seen on imaging.  However, the patient did test positive for COVID-19 and with ambulation, her oxygen saturation would drop to the mid 80% range and she would become quite tachycardic.  Because of this, she was thought to warrant observation in the hospital and she was started on dexamethasone by the ER provider.   in-house:  patient presented with generalized weakness as well as headache and neck pain, she was admitted for acute hypoxemic respiratory failure secondary to what was suspected to be a COVID-19 mediated asthma exacerbation. patient was started on prednisone (she was given a dose of dexamethasone in the ED) and nebulizers; micro studies were sent were sent as well. a CXR was obtained and steroids were switched to dexamethasone, procalcitonin and the rest of her 'COVID labs' (d-dimer, ESR, and troponin) were unremarkable. pulmonary rehab saw her and set her up with home oxygen, suspect a component of her hypoxemia (if not all of it) is related to underlying lung disease. patient was arranged to be followed by 'Transition to Home' service. at the time of discharge patient was in good spirits and eager to leave. she said she felt slightly weak (ambulated the halls fine) and head her usual daily morning SOB. all questions and concerns addressed, all meds and follow-ups reviewed.
Rash, rough to the touch, from head to toe; Developed a fever; Chills; Headache; Chest was hurting (clarified as pressure on his chest); Hard to breathe; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest was hurting (clarified as pressure on his chest)), DYSPNOEA (Hard to breathe), BACK PAIN (Back pain), RASH (Rash, rough to the touch, from head to toe) and PYREXIA (Developed a fever) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced CHEST DISCOMFORT (Chest was hurting (clarified as pressure on his chest)), DYSPNOEA (Hard to breathe), BACK PAIN (Back pain), PYREXIA (Developed a fever), CHILLS (Chills) and HEADACHE (Headache). On 23-Apr-2021, the patient experienced RASH (Rash, rough to the touch, from head to toe). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 22-Apr-2021, CHEST DISCOMFORT (Chest was hurting (clarified as pressure on his chest)), DYSPNOEA (Hard to breathe), BACK PAIN (Back pain), PYREXIA (Developed a fever), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, RASH (Rash, rough to the touch, from head to toe) was resolving.            No concomitant medications were reported.  At the time of follow up report, patient was doing fine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up information received and updated the outcome of event (rash) from unknown to recovering and updated narrative.
when she administered the product the medication leaked out/ no adverse event; medication leaked out on consumer's arm/ no adverse event; she only received about 0.1 ml dose of FLUZONE HIGH-DOSE QUADRIVALENT/ no adverse event; Initial information was received on 19-Oct-2021 regarding an unsolicited valid non-serious case from a other healthcare professional and physician via  Media Information  (under reference: 00818407) in a specific country.  This case involves a 71 years old female patient who when administered the product the medication leaked out on consumer's arm, that she only received about 0.1 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (syringe issue, exposure via skin contact, underdose).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included COVID-19 VACCINE for prophylactic vaccination.  On 17-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (total, once, lot number: UJ764AC and expiry date: 30-JUN-2022) via an intramuscular route in the right deltoid for prophylactic vaccination.  This case was a special situation due to (syringe leak, exposure via skin contact, vaccine underdose) (latency: same day).  It was reported "Caller stated that when she administered the product the medication leaked out on consumer's arm. She believes it came out of the glass part. She stated that she only saw about 0.1 ml was actually administered into the patient. Caller wanted to know if there was any data on if the consumer should be revaccinated."  At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported event.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On or about 03-MAY-2012, the patient was inoculated with ZOSTAVAX (strength, dose, route, lot # and expiry date were not provided) by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions. On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 11-JUN-2015, the patient was treated for shingles. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
Headache-TYLENOL, red, puffy left arm- ice to arm, nausea-PHERGAN administered by mom.
Per RN on site - pt received the Moderna vaccine and immediately c/o L arm tingling and pain from injection site to forearm. Symptoms not relieved with range of motion exercises. Within 10 minutes, patient reported lip tingling. RN noted that lips and face were swollen. Patient then developed difficulty breathing and inability to produce saliva. Pt began retching without vomiting. CMO notified and 911 called. Pt developed labored breathing and HR was 135. APRN on site administered an EpiPen through patient's pants to the left thigh. After about 3 minutes, patient's breathing improved, but her lips and face remained swollen, HR decreased to 100. Left arm weakness observed. Patient was transferred via EMS to the local hospital.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-JAN-2017, the patient was vaccinated with expired dose of the VAQTA lot#L030442, expiry date 19-DEC-2016 (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild
Severe muscle aches, headache, chills for @ 24 hours, then weakness, malaise for next 24 hours
Nausea, headache, achy, general malaise, injection site tender and sore.
Pfizer 3/8/21, 3/31/21, 8/19/21. Positive on 1/20/22