chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received a contactable consumer, the patient. A 53-year-old adult [non-pregnant] female received the second dose of BNT162B2 (solution for injection; Lot provided as unknown and expiry information not reported) via unspecified route in the right arm on 18Mar2021 at 12:00 (at 53-years-old), for COVID-19 immunization. Relevant medical history included hypothyroid, Chiari malformation, hemicrania continua, depression, allergic rhinitis, sulfonamide allergy, and food allergy (pineapple and hot peppers). Concomitant medications included riboflavin (VITAMIN B 2), cetirizine hydrochloride (ZYRTEC ALLERGY), levothyroxine, fluoxetine hydrochloride (PROZAC), and indomethacin (INDOMETHACIN). The patient previously received COVID-19 immunization with the first dose of BNT162b2 (Lot unknown) in the right arm on 25Feb2021 at 11:30 (at 53-years-old). The patient previously received treatment for unspecified indications with codeine, morphine, and capsaicin and experienced allergy with each. The denied being diagnosed with COVID-19 prior to the vaccine, the patient was not pregnant at time of vaccination, and the patient denied receiving any other vaccine within four weeks of this vaccine. On 25Mar2021 at 16:30 the patient developed swollen right inside of throat, joint pain entire body, nausea, chills, diarrhea, and headache; which the reporter considered non-serious. The patient denied being tested for COVID-19 since the vaccine. There was no treatment received for the events. The outcome of the events, swollen right inside of throat, joint pain entire body, nausea, chills, diarrhea, and headache, was recovering. No follow-up attempts are possible; information about lot number cannot be obtained.
Pt recv 1 & 2nd dose vax 24Nov1997 & 20Feb98. 21Feb98 pt exp "burning,itching,redness,tenderness & swelling inj site". There was no rash. "It felt like a bee sting".
Pharmacist called in to report patients received an expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist called in to report patients received an expired dose of the Moderna vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist called in to report patients received an expired dose of the Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist called in to report patients received an expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
WHILE STILL IN CLINIC, CHILD DEVELOPED BLOTCHY RED RASH ON FACE FIRST, THEN ON CHEST AND STOMACH AREAS, AND AT INJECTION SITES. BENEDRYL 1 TSP PO WAS GIVEN AT 9:43 A.M.  RASH HAD ALREADY STARTED TO FADE ON FACE, AND RASH WAS TOTALLY GONE FROM BODY WITHIN 20 MINUTES.
Rash & pain. Swelling  present after 1 week and itchy. Redness.
very fatigued; body very sore; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very fatigued) and MYALGIA (body very sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced FATIGUE (very fatigued) and MYALGIA (body very sore). At the time of the report, FATIGUE (very fatigued) and MYALGIA (body very sore) outcome was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-024394 (Patient Link).
Evening of 2/15, area sore.  The next morning symptoms of dry mouth, loss of appetite, fatigue, weakness, and chills begain.  By late afternoon on 2/16, low grade fever and nausea started.
15 minutes after Patient had his COVID booster, he had a tonic seizure at his home where he had gotten the vaccination.  He has a history of seizures and gets one once a month.  No record of having a seizure after his other 2 Moderna vaccinations.  He seized for a minute to a minute and a half and vomited during the seizure.  Caretaker was there to witness and observe as well as me and a nursing student who is an ER nurse.
This initial spontaneous case was received from other non-health care professional on 09-Nov-2017, concerning a 21-year-old patient. The patient's concomitant medication included meloxicam for unknown indication. On 09-Nov-2017, the patient was administer with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 166003 (as reported), expiry date: Apr-2017). It was reported that, the patient had no reactions after administration of the vaccine. The reporter assessed the case as non-serious.
weakness in legs, myalgia, headache, chest discomfort, neck pain, hyporeflexic 8/4, improved reflexor 8/5
SYNCOPAL EPISODE ~30 SECONDS RESP RATE - 18 PULSE - 92 SP02 - 99 BP - 122/86 GCS - 15
Information had been received on 14-JUN-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient (age unknown) was inoculated with ZOSTAVAX on or about 12-NOV-2014 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-MAY-2016, patient was treated at a healthcare facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster. On or about 28-MAY-2016, patient was treated at the same facility for ongoing and worsening symptoms, at which time the patient was diagnosed with post-herpetic neuralgia, a chronic condition of nerve damage and residual pain secondary to shingles. Patient was prescribed gabapentin, amitriptyline (ELAVIL), acetaminophen/hydrocodone (NORCO), fentanyl patches and amitriptyline for management of his excruciating symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Chills, shaking, sweating, body aches, headache, ringing in ears
Information has been received from a registered nurse concerning a 26 year old female with no past medical history and no known allergies who on 08/27/2001 was vaccinated with a dose of varicella vaccine in the left arm SC. On 09/12/2001, the pt reported symptoms of joint pain in arms and shoulder, injection site tenderness and few bumps. The pt sought unspecified medical attention. Follow-up info reported tha the pt was not seen after her reaction and did not return for the second dose. No further info is expected.
pt recvd vax & devel low grade fever & skin rash approx 1 wk,generalized morbiliform & measles facies;
Patient went to the doctor because of large redness around the area and felt hot. Doctor prescribed CIPRO and asked patient to return for lab CBC next day. Doctor told patient it was cellulitis.
Minutes after receiving Tdap, HPV and MCV4 vaccinations, patient had difficulty walking out to car and had to sit down due to lightheadedness, nausea, and felt like he was going to faint. We immediately took him back into the doctor's office where he had to lay down for about 30 minutes and was monitored by doctor and nurses due to low blood pressure. At one point he was at 82/52 BP.
Fever and myalgias persistent 48 hours after vaccination, no SOB, no cough, no abdominal pain, no loss of smell. treated with tylenol.
little discomfort at site of the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (little discomfort at site of the shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Hives. Concurrent medical conditions included Drug allergy (Allergic to niacin, causes hives/rash all over), Hypercholesterolemia since 2012, Meningioma since 2018, GERD and Migraine. Concomitant products included PANTOPRAZOLE for GERD, SIMVASTATIN for Hypercholesterolemia, TOPIRAMATE and UBIDECARENONE (COQ10 [UBIDECARENONE]) for Migraine, RIZATRIPTAN for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (little discomfort at site of the shot). On 19-Mar-2021, VACCINATION SITE DISCOMFORT (little discomfort at site of the shot) had resolved.            Treatment information for the first dose event was not reported.   This case was linked to INC.-MOD-2021-075083 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information received on 3-May-2021 contains medical history and pt. demographics.; Sender's Comments:  INC.-MOD-2021-075083:for 2nd dose
I experienced flares at the site of eczema (neck, cheeks, fold of arms, armpits) following the booster shot, as I had following my second vaccine. Similarly to my first two doses of the vaccine, I am currently experiencing persistent swelling in my lower abdominal area, independent of my menstrual cycle. While the eczema reaction and lymph swelling in my left armpit has subsided, my lower abdomen remains swollen/protruding.   While there has not been pain resulting in hospitalization, it is troubling to have my stomach distended in this manner for such a protracted period of time.
The patient was given Pfizer Covid vaccine and was the 1st dose in series. The patient walked to observation chair after receiving  vaccine.  He fell from chair to the floor and appeared to have a seizure with arm movements and became aware soon after.  Ems was called.  Patient had some water and disclosed that he had not eaten yet.  He then had OJ while awaiting EMS.  He did not go with EMS.
Vertigo starting within 24 hours and continuing through today 1/3/2022. Was severe on Day 3 post vaccine and has improved gradually but I continue to be unable to put my head down below my waist without initiating vertigo. This symptom was present with the first two vaccines but has worsened with each additional vaccine.
Patient presents to the emergency department due to concern for stroke. Patient denies chest pain, shortness of breath, fever or chills. No abdominal pain, nausea, vomiting or diarrhea. No dysarthria or aphasia.
I woke up at 1 am and needed to urinate. I did but then immediately felt the urge to go again but I could only go a small amount. This continued on for every 5 to 10 minute until 2am. My urine was tinged pink and then continued to get worse. By 2am, it was the color of tomato juice with several clots. I went the the emergency room and was given 1 liter of IV solution and an IV antibiotic. I was released around 4am and returned home. I was prescribed a 7 day regimen of oral antibiotics. I did not feel any pain, only the discomfort from the urge to urinate which lasted about 18 hours. By 9am, my urine was clear and in normal amounts. I have never had a UTI in my life which is why I am reporting this.
All symptoms lasted 4 days, except fever: Severe headache (8/10 on pain scale) nonstop. Fever ~100.6 F x 3 days. Body and muscle aches (8/10). Extreme fatigue (8/10).
Within two weeks of receiving the Pfizer booster I noticed a lump in my neck when I was shaving.  My Primary Care physician referred me to an ENT.  After CAT scans, Ultrasounds and Biopsies, I am scheduled for surgery on March 28th to remove the complete thyroid
headache, muscle pain, severe swelling and redness at site, fever,nausea,shivering, very tired  since then
This spontaneous report as received from a medical assistant refers to a 11 week old female patient. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 09-OCT-2017 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M016238 and expiration date: 07-DEC-2017), (dosing regimen and frequency unknown) orally for prophylaxis. The ROTATEQ vaccines were stored between 44 Fahrenheit degrees (F) and 77 F for 45 minutes. There was no previous temperature excursion. There was no previous temperature excursion. The medical assistant also stated that a data logger was involved on 23-OCT-2017 that prompted her to call the company. This is one of the many reports from the same source. Sender's Comments: US-009507513-1710USA012197: US-009507513-1805USA007926: US-009507513-1805USA007927: US-009507513-1805USA007928: US-009507513-1805USA007929.
3 days after my 2nd shot on 3/26/2021 I broke out with hives legs arms and face, the sensation was burning and itching.  Allegra seem to it go away for avout 6 to 12 hours.  My doctor gave me a steriod shot and prescription medicine ( can't remember the medicine name).  After 6 days of prescription medicine the hives have disappeared.
Patient received a dose of Shingrix first at Drs office 7/2022 that pharmacy did not know about.  Patient received 2 and last dose of series 11/2022 but pharmacy saw this as first dose and called pt to remind about second dose.  Patient thought she was done with Shingrix but our records only showed the one vaccine so another Shingrix dose was given which was number 3 for patient in 2/2023 Next  day after 3 shot patient had severe body aches and fatigue reaction
felt discomfort in the arm, a little sore; felt discomfort in the arm, a little sore; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0150), via an unspecified route of administration at Left Arm on 30Mar2021 (at age of 75 years old) as single dose for COVID-19 immunization. The patient medical history included: Cholesterol abnormal, Blood pressure abnormal. Concomitant medication(s) included atorvastatin for Cholesterol; lisinopril for Blood pressure. Caller clarifies he received the first dose of the vaccine on 30Mar2021 between 1415PM and 1430PM in the left arm. The first shot patient felt discomfort in the arm, a little sore, but it went away. No Emergency Room visit, no Physician Office visit. The outcome of the events was recovered in 2021.
spiked fever of 102°F within hours; she didn't feel quite right; uncontrollable shaking; she felt burning shot down her arm; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   In March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than a day after receiving Shingrix, the patient experienced fever, feeling unwell, tremor and injection site burning. On an unknown date, the outcome of the fever, feeling unwell, tremor and injection site burning were recovered/resolved.   It was unknown if the reporter considered the fever, feeling unwell, tremor and injection site burning to be related to Shingrix.  Additional details were provided as follow: The age at the vaccination was not reported. The patient experienced severe reactions. A few seconds after she received the dose, she felt burning shot down her arm. Within hours she didn't feel quite right. There was uncontrollable shaking and spiked fever of 102 degree F within hours. The patient went in to emergency room because fever was not breaking.  At the time of the call no vaccine details were provided because the reporter was driving. The reporter did not consent to follow up nor declined.
Patient stated that she is having problems out of her right ear. She has loss hearing in her right ear. Hearing improved after a VAC that was inserted in her ear but lost hearing again. Was diagnosed auto immune inner ear disease.
Menstrual cycle was late - period was delayed by 28 days and had a period with more PMS symptoms than normal
Case number PHEH2015US017620 is an initial spontaneous report received from a pharmacist on 08 Sep 2015. This report refers to a 54 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 157021) intramuscularly on an unknown date. She also received ZOSTAVAX (other manufacturer, batch number: not reported) along with FLUVIRIN. On 24 Aug 2015, the patient experienced bronchitis. The events outcome was unknown. The seriousness of the events was not reported, but the event bronchitis was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Subject reported the following to this study RN today. He had been experiencing muscle pain equally in both arms and had been seeing his PCP for this problem. The pain is worse in the mornings upon rising to where it is painful to raise his arms up. He is able to continue with his ADLs and does not take pain meds. He stated that the pain began over a month after his first GARDASIL injection (Day 1=3/12/2008) and after his doctor had changed his ARV regimen, and before his second GARDASIL injection. He started new HIV medication regimen on 3/25/08. His doctor (PCP) told him that his arm pain was a side effect of one of his new HIV medications such as TRUVADA and did not think it was caused by the GARDASIL vaccine. The pain did not subside so his physician switched the TRUVADA out for INTELENCE one month ago to see if his arm pain will subside. The arm pain continues, so one of the other HIV medications will be switched out to see if the symptoms improve. The subject states that he is otherwise well and that it is "not a big deal," yet agrees that it will be good to be rid of the arm pain. (The subject never reported this arm muscle pain on his report cards and stated that he tolerated the injections well without problem.)
Pain L deltoid, anti - inflammatories, ice, darvocet N-100 prn break through pain.
AFTER BOTH SHOTS, IN 2-3 MINTUES, PT EXPERIENCED FAINTING SENSATION AND SWEATING, BLURRED VISION AND ALMOST COLLAPSED, IMMEDIATLY CALLED 911 AND CREW ARRIVED IN  LESS TAHN 3 MINUTES, DURING THAT TIME, PT RECOVERED VISION AND FEELING BETTER
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from  other health professional.  This case is linked to cases 2023SA057733 and 2023SA057309.  This case involves adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.  It was unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (latency: unknown)  (poor quality product administered) (latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It was unknown if the patient experienced any additional symptoms/events   It was unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events  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 the guidelines. 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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Devel redness & swelling evening 22AUG91; mom took pt to ER & was told to apply heat to elevated leg & if no improvement to seek med attn next day pt brought to clinic w/redness & swelling from site of inject down thigh; dx cellulitis;
Burning at injection site. Loss of movement in arm, left. Dr diagnosis of Reflex Sympathetic Dystrophy (RSD). Referred to pain mgmt dr for nere block, dr, not certain of long term damage.
This spontaneous report was received from a physician regarding a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with GARDASIL lot #, dosing details and route unknown. Concomitant medications were not reported. On an unknown date the patient experienced syncope episode while in car driving home from physician's office. The physician reported that the patient's mother sought medical attention for the patient. The physician reported that the patient was monitored at emergency room as treatment. No treatment medication was given to the adverse event. It was reported that the patient's mother brought emergency room bill to physicians' office for implied payment. The outcome of syncope episode was unknown. Product quality complaint (PQC) was not filed. Causality assessment was not provided. Additional information has been requested.
I woke up 3:00AM, and was very nauseated. I wanted to throw up. I had really bad stomach cramp. I called the doctor's office in the  morning because of the bad stomach pain. It just had to work itself out. It lasted most of that next day 12-14 hours. I felt fine after that.
Rash and soreness to left arm where vaccines were given, denies any itching. Was noted through telehealth appt so area was not measured.
Fever for at least 18 hours most of which was a temperature of 101-102.3. Chills and muscle aches. Headache that led to nausea. Sinus pressure/ocular migraine. Soreness at injection site.
Menstrual cycle was 3 weeks. Blood tests confirmed  TSH was high and further confirmed hashimotos. Thyroid was normal in the fall of 2021 prior to December.
Tachycardia 140- 125; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at 13:00 at single dose in left arm for COVID-19 immunisation at the age of 70-year-old. Lot number was EL1284. Medical history included myocardial infarction (MI), diabetic diet controlled, open heart surgery, cardiac stents, allergy. The patient experienced tachycardia 140-125 on 17Jan2021 at 06:00. The patient was not treated due to the event. The patient recovered from the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.