chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu-like symptoms started 1-2 day later.  Symptoms included: cold, aches, sneezing, sore throat, and mouth was sore so couldn't brush teeth.  Developed cold sores on lips which has never happened before. Flu-like symptoms lasted about 1 week and still has some residual cough.  Patient has been using hydrogen peroxide mouthwash to help with the cold sores. Sores not improving yet and still has them now.  Patient noted that he received the Flu-HD last year with no problem.  Patient called pharmacy today to let them know the symptoms.   Yesterday patient contacted doctor and has appointment scheduled for follow-up.  Patient is concerned about the mouth sores as had not had herpes before or possible exposure.
No further AE; temperature excursion; This spontaneous report was received from a practice manager and 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-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Initial pain in chest, significant loss of cardiac output, shortness of breath, dizziness, loss of vision immediately following end of exercise routine. Continued pain in chest for 72 hours following initial episode, along with notable shortness of breath. Blood pressure of 137/89 at doctors appointment 3 days after onset of symptoms. 1000mg of Acetaminophen alleviated the chest pain to a manageable level. As time went on, the persistent pain resolved, but I continue to experience noteable shortness of breath and chest pressure upon even light physical activity.
Initial report received from a healthcare professional (Consumer) on 20 September 2013. A 23-year-old female patient, who had no medical history and concomitant medications was not reported, received intramuscular dose of FLUZONE QIV in left deltoid (lot number: U4756BA) on 20 September 2013. On 20 September 2013, within 15 minutes of vaccination, patient developed symptoms of swelling, burning, redness and rash at the left deltoid which was the site of vaccine injection and patient developed a low grade temp and her face and neck were blotchy. No laboratory investigations were done and the patient had received ZYRTEC and BENADRYL as a corrective treatment. The patient had not recovered from the events. List of documents held by sender: None.
Pneumonia; Left arm was sore; vaccination failure; This spontaneous report was received as other company letter from (manufacturer control number: 21K-163-4165505-00) reported by a female consumer of 63-year-old referring to herself.   The patient's medical history included chicken pox (all over the body including the mouth). Information regarding concomitant therapies was not provided.   On an unspecified date, the patient had pneumonia and was hospitalized on 23-SEP-2021, until 06-OCT-2021. It was reported that, unspecified injections of medications were given on 18-OCT-2021, and 23-OCT-2021. On 10-NOV-2021, she started adalimumab (HUMIRA) solution for injection in prefilled pen, strength 40 mg/ 0.8 mL, at a dose of 40 mg (1 in 2-2), subcutaneously, for moderate to severe rheumatoid arthritis, and arthropathic psoriasis (unspecified).  On 15-NOV-2021, she was vaccinated with pneumococcal vaccine (manufacturer unknown), and with an unspecified influenza vaccine; both as prophylaxis.  On an unknown date in 2021, the patient experienced pneumonia (vaccination failure) and was hospitalized due to this event. On an unspecified date in November 2021, she experienced left arm sore (pain in extremity) which was considered as non-serious adverse event by the reporter. On 24-NOV-2021, the last reported dose of adalimumab (HUMIRA) was given to the patient. Later, this medication was discontinued. At the time of the report, the outcomes of the events and the action taken with the suspect therapies were unknown.   The causality assessment between pneumococcal vaccine (manufacturer unknown) and unspecified influenza vaccine with the events pneumonia and pain in extremity was reported as unknown. The reporter considered adalimumab (HUMIRA) to be probable related (reported as reasonable possibility) to pneumonia, but to be not related to pain in extremity (conflicting information also reported as unknown).
Patient complained of being nauseous, dizzy, weak and fatigued immediately after immunization. Patient checked out by EMS, began feeling better shortly thereafter. Patient advised to call 911 or go to the nearest emergency room for any additional issues as needed. Also advised to sign up for v-safe. Patient left site stating she already feeling better.
Initial information received on 20 October 2006 from the patient.  A 63-year-old female patient, with a history of allergies and hypertension, had received a left deltoid injection of Fluzone SV, lot number unknown, on 06 October 2006.  The reporter believes that she had also received an injection of Pneumovax, manufacturer Merck, lot number unknown, on 06 October 2006.  Immediately post-vaccination, the patient felt warm and itchy all over.  Three days later, she began self treating with Benadryl.  Seven days post-vaccination, the patient experienced shortness of breath, and redness in her skin all over.  She was examined in an emergency room and treated with epinephrine.  She is currently taking a methylprednisolone dose pack.  The patient continues to experience itchiness and redness. On 19 October 2006, the patient was examined by an allergist.  Findings of that visit were not provided.  At the time of this report, the patient had not recovered.
lmpropely stored vaccine administered; route: IM; This spontaneous report was received from a licensed practical nurse referring to a 15 months old (reported as 16 months old) male patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.    On 11-AUG-2021 the patient was vaccinated with improperly stored of varicella virus vaccine live (oka/merck)(VARIVAX) (strength and dose were not reported, dose number: 1 (reported as previous doses number was 0), lot # T002847, expiration date: 23-JAN-2022) intramuscularly in the left thigh for prophylaxis (product storage error and incorrect route of product administration). The digital data logger was involved to capture the temperature excursion.       This is one of several report reported by the same reporter.; Sender's Comments:  US-009507513-2108USA006311:
tested positive for covid; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (tested positive for covid) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included SLE.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 Year. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced COVID-19 (tested positive for covid). At the time of the report, COVID-19 (tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Body temperature: 101.6-103.2 (High) Fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to MOD-2021-028818 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-028818:Mother
A nurse reported that a 24 year old female sustained a puncture wound to her hand and received an injection of TD Toxoids Adsorbed, Purogenated on 5/27/00 as part of wound management. On 5/29/00, the pt developed a fever of 103F, hives on the back of her legs, nausea and vomiting, and a "severe" injection site reaction characterized by redness, swelling and itching. The pt was seen by the physician and treated with IM diphenhydramine and oral prednisone. This is 1 of 3 pts from this facility who had an adverse experience following receipt of this vaccine, lot 470536.
I was super tired and warn out shortly after the first shot, sleeping for most of the next two days with lot of arm pain, dizziness, and nausea. Than in the early morning on 04/19/2021 I became absolutely horribly ill with severer vomiting and the inability to keep anything down, sipping water made me vomit immediately. I had horrendous heart burn but the vomiting was so bad I couldn't even finish chewing a tum before it came up. I had body aches, chills, was over heating, and had lots of horrible pain from heart burn and vomiting. I couldn't keep fluids down end till 3:30 in the afternoon, I wasn't able to eat anything end till the next day.
19 hours later I got cold and started Wheezing  20 hours later slight chest pressure after taking ventolin inhaler
Shot gave me lightheadedness, hot, and muscle spasms also pain from my left shoulder all the way to my hand
Started with B leg achiness and pain the day after vaccination. She was having difficulty walking. the second day began having arm pain L>R to the point she could not lift her left arm. Also has severe headache unable to be treated by otc medicine, chest tightness and some difficulty breathing.
I'm feeling like I'm going to throw up; Nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (I'm feeling like I'm going to throw up) and NAUSEA (Nausea) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (I'm feeling like I'm going to throw up) and NAUSEA (Nausea). At the time of the report, VOMITING (I'm feeling like I'm going to throw up) and NAUSEA (Nausea) outcome was unknown.            no concomitant and treatment medication reported.
Within 4 hours I experience chills, fatigue and a headache.  Within 8 hours I had a fever and slept for the next 24 hours.  I broke out in buckets of night sweats.  The following 2 days I was generally fatigued and had sniffles.  After that I was fine, until Monday night (Day 10). I suddenly experienced a sudden onset of a painful and raised red rash at the base of my spine on my lower back. Within hours it migrated up to my head, face and then to the front of my torso. My eyes and throat closed. I took benadryl with no relief.  I called Dr. on Demand and they urged me if the symptoms got worse to head to urgent care/ER.  The next day (Tuesday 4.13) I went to the ER where they gave me a steroid shot, and prescribed me predisone and Prilosec to block the histimines.  I am still having rash symptoms,itchiness and burning.  While I have a history of seasonal allergies they've always been stuffy nose at the most. We had no new dietary introductions or new habits.
Vaccine found to be compromised by elevated refrigerator temperature to 62 degrees. Patient tolerated well without adverse effect but it unclear for how long temperature excursion occurred.
pressure in head and back; left maxillary sinus infection; Felt like a brain freeze; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (left maxillary sinus infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history was not reported .     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced SINUSITIS (left maxillary sinus infection). The patient was treated with AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency. At the time of the report, SINUSITIS (left maxillary sinus infection) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Magnetic resonance imaging: abnormal (abnormal) MRI that showed the left maxillary sinus infection..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
pt aunt reported pt had red knot & swelling w/tenderness rt arm on 22NOV98;pt aunt states noticed rxn this AM;
Reports have urticarial on right neck, bilateral forearm and lower abdomen the next morning after receiving the MMR injection. No reaction at the actual vaccine site.
Dizziness; Weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202, Expiry Date: unknown) via an unspecified route of administration administered in upper left arm on 23Feb2021 11:00 (at the age of 75-years) as single dose for covid-19 immunization. The patient medical history included ongoing chronic obstructive pulmonary disease she was diagnosed years ago and she was just now receiving since Jun2020 oxygen at night, ongoing cardiac disorder states it was years ago. There was no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received the first dose of bnt162b2 (Lot Number: EM9810) via an unspecified route of administration administered in upper left arm on 02Feb2021 11:00 (at the age of 75-year-old) as single dose for COVID-19 immunization. Patient stated that she had no side effects with the first shot. On 23Feb2021 13:30 after the second dose of vaccination, the patient experienced dizziness and weakness started after that on same day for 24hours. Patient stated the dizziness hit her first and then the weakness came after but started that same day. Patient not sure if she should even report the weakness as when you're dizzy you usually feel week. Patient clarified that the weakness and dizziness stopped on 24Feb2021. Patient stated she had the vaccine card and it said COVID 19 PFIZER BIONTECH. Patient stated she did not see a dose listed for either shot. There was no any relevant tests performed. AE's dose not resulted in physician office and emergency room visit. As for treatment she sat down, pretty much moved from chair to chair and couldn't do much of anything. Outcome of events was recovered on 24Feb2021.  No follow-up attempts are possible. No further information is expected.
Patient reported to the administering pharmacist today that he has been experiencing dyspnea and shortness of breath, which began approximately two days prior to date and time that the event was reported (i.e. beginning on or around July 4th, 2021).  Patient states that he has been experiencing dyspnea and shortness of breath both upon exertion (and, even upon minimal exertion ? for example, when walking from car in parking lot into the pharmacy today) and also while at rest.  Patient states that he has no known history of dyspnea or shortness of breath similar to the symptoms he is currently experiencing. After contacting the patient?s primary care physician?s office and discussing the signs and symptoms the patient was experiencing with the medical office personnel, the patient was advised by the pharmacist to seek immediate medical attention and report to the nearest hospital emergency department. The patient stated that he would seek immediate medical attention at the local hospital emergency department, as his primary care physician did not have any appointment availability to be able to see him in office today.
Foreign body sensation in throat. Symptoms resolved and patient was discharged from ED after Benadryl and oral steriods
red dots around injection site; kinda bumpy; itchy;  A spontaneous report was received from a Consumer concerning a 2021- Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, red dots around injection site, kinda bumpy, itchy. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, the patient experienced the events, red dots around injection site. kinda bumpy, itchy. No treatment information was provided. Action taken with mRNA-1273 in response to the events, red dots around injection site, kinda bumpy, itchy was not reported.   On an unknown date the outcome of events include, red dots around injection site, kinda bumpy, itchy was not reported.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-AUG-2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-SEP-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 03-OCT-2016, she was treated again for ongoing and uncontrolled pain and worsening herpes zoster outbreaks. On or about 29-MAR-2017 the patient received treatment for worsening symptoms and extreme discomfort which was then diagnosed as post-herpetic nervous system involvement and post-herpetic neuralgia, which are chronic conditions of residual pain and nerve damage caused secondary to zoster infections. On or about 24-APR-2017, she was treated for uncontrolled and increasing post-herpetic pain. On or about 23-MAY-2017 she received treatment for post herpetic neuralgia with increasing nervous system involvement. On or about 23-JUN-2017 she sought treatment for her post herpetic neuralgia at which time she was diagnosed with chronic pain syndrome. The patient continues to experience uncontrolled symptoms and excruciating daily pain which has not been successfully eased or resolved by medication or pain management therapies. The patient has been prescribed ZORIVAX, PERCOCET, fentanyl patches, DURAGESIC patches and oxycodone for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding patient's medical history, concurrent conditions, drug reactions or allergies, concomitant medications and past therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N022856, expiry date: 23-AUG-2019) for prophylaxis whose dose and route of administration were not reported. It was reported that the vaccine administered was reconstituted with properly stored Merck sterile diluent) whose lot number and expiry date were reported as unknown. No adverse effects were reported. VARIVAX administered was subjected to a temperature excursion of 6 degree F to 14 degree F for a duration of 432 hours which was noted from a data logger. It was reported that VARIVAX administered was subjected to a previous temperature excursion of 6 degree F to 14 degree F for a time frame of 24 hours. There was no product quality complaint (PQC) involved.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 at 12:00 as dose 1, single (Lot number: EN6205), in right arm, on 03Apr2021 at 14:00 as dose 2, single (Lot number: ER8733), in left arm, on 28Oct2021 at 16:30 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 12Apr2022 at 12:45 as dose 4 (booster), single (Lot number: FJ4991) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cerebral aneurysm" (unspecified if ongoing); "Pituitary gland microadenoma" (unspecified if ongoing), notes: Pituitary gland microadenoma. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL], start date: Jan2011. Past drug history included: Morphine, reaction(s): "known_allergies Morphine", notes: known_allergies Morphine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Jul2022, outcome "recovered" (18Aug2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2022) Positive; (18Aug2022) Negative; (31Jul2022) Positive; (07Aug2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: COVID 19 Treatment included the patient COVID-19 PCR test was positive on 31Jul2022. The nurse practitioner at # prescribed me Paxlovid for 5 days which she completed the regime on 05Aug2022. On 07Aug2022, She took another COVID-19 PCR test, the result was negative. On 12Aug2022 she took another covid (antigen) and tested positive, so she had a rebound event. She primary care doctor prescribed me a 2nd round of Paxlovid for 5 more days. On 18Aug2022 I took another COVID (antigen) test and tested negative. 2nd round of Paxlovid treatment was received for the adverse event.
The injection for the flu vaccine was improper administered. The injection was given on top of the left shoulder and not on the upper arm side. This caused a 2" diam. hematoma. Continued bleeding for one day and I have continued pain on side of neck, all the way down to left arm.