chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Beginning 4 hours after second injection: body aches and chills that lasted 48 hours. These were not responsive to Tylenol or ibuprofen. On day two fever that got as high as 101 degrees was observed. Severe headaches lasted from 4 hours after second injection until 48 hours after second injection. Beginning at about 48 hours post second injection painful tender lymphadenopathy observed in axillary area of  left arm.  I am now 96 hours post second injection and the lymph nodes in that left arm are still swollen and tender and painful.
104 degrees F fever; flu-like symptoms; shaky hands; pain at injection site; shots given 10/16/13 and patient reported 10/18/13 treatment not pursued per patient.
pt recv vax 23OCT95 & exp inject site pain which still persists;pt stated couldn't lift arm over head or move it side to side & remains in constant pain;exp swelling @ noc;
This spontaneous report as received from a pharmacist refers to a 19 year old male patient. The patient's concurrent conditions and medical history were not reported. On an unspecified date the patient was administered GARDASIL 9 (dose, lot number and expiration date not reported). No adverse effects were reported. Additional information has been requested.
There is an enlarged area under left arm. Area of swelling is approximately 8 cm in diameter. I first noticed the enlargement at 3:00 pm 10/21/2021. This morning at 8:00 am on 10/22/2021 the area of swelling has gotten even larger. Pain down the left arm persists.
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium
2 days s/p vaccination; aching with flu-like sx. 5 days s/p vaccination: fever, blurred vision, dizziness, HA, fatigue.
DID NOT TAKE VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case report (PVX2019-2743) was received from a nurse on 05-Nov-2019. It described a female consumer who "did not take Vivotif according to schedule" (PT: Inappropriate schedule of product administration). She was receiving oral Vivotif for typhoid fever.  Case report: The consumer did not take Vivotif according to schedule. The doses were taken on 29-Oct-2019, 31-Oct-2019, 03-Nov-2019, and 05-Nov-2019.   Action taken with Vivotif with respect to reported event was not applicable.  The outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.
Ischemic Stroke on January 3 2022. Patient has fully recovered but had speech issues during and after the stroke.
Patient complained of a tingling in her tongue. Has a history of allergic reactions to other medications and foods. Vital signs taken and remained stable throughout time.  Patient was given Benadryl 25 mg po at 12:45 and states relief. Stated that symptoms were lessening/improving. Patient was discharged with daughter to be driven home in personal vehicle.
3 out of 13 pts who recvd 3 doses of Engerix-B failed to convert; titers were tested 6 months p/last dose of vax;
patient started to get dizzy and said he was going to faint. we called 911. as patient was being placed on the floor he regained consciousness but then vomited. paramedics took vitals and said they were all normal. they said most likely he is dehydrated and could drink water slowly. he waited to regain strength in his legs and said he felt ok to go home.
Pts father stated that pt developed flat round disc shaped lesion 6 days post MMR & Hib adm.  Lesions nickel sized on hand + leg.
Vaccine use by 12/12/2021; vaccinated 12/13/2021.
Has fainted immediately during the HPV vaccination. Legs kept high, didn't fall on the floor. Kept him on the table, he became pale, eyes rolling backward. NO seizure activity last for 10-15 seconds, recovered fully.
Moderna shot - first dose Flu like symptoms: achy, headache, fatigue. Then 8 days later "covid arm".  Area hot to touch and itchy, alittle swollen
Patient states about a week to 10 days out from vaccine he has had trouble with his left arm, not particularly the left shoulder but the upper arm. He says he has pain in the arm to the degree that he can not put his pants or a belt on. He was seen by his physician and given tramadol with no relief. He says that he also has pain in the right shoulder as well. He does not believe that the pain is related to the vaccination, but that he just doesn't know. I gave him some biofreeze to rub on the arm and followed up with him today and he said that the biofreeze seems to help, but after that wears off, the pain returns.  I have asked him to keep us informed as to how his pain is progressing.
pt recv vax 15SEP95 & 20SEP95 approx 5 days following vax pt devel a rash all over;no further details were provided;
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-FEB-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0869AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
About 7-10 minutes after receiving covid vaccine, I  was just talking with other nurses and suddenly felt a rush came over me. Felt lightheaded and dizzy. My pulse and blood pressure spiked. After about 5 more minutes, my forehead became numb. My pulse and BP had come back down. Later on that evening and into the next day my palms of my hands were bright red and itchy.
Exactly 3 weeks after my first shot (2/9/21) I had severe arthritis pain and was unable to walk for a number of days. Exactly 3 weeks after my second shot (3/1/21) I had a reaction of being dizzy and nauseous and unable to get out of bed for 3 days. Both times I just waited it out.
Cardiac arrest, followed by seizure and death.  Pt was hospitalized, undetermined cause of death, case send to a medical examiner.  Case was noted upon chart review by reporter.
12/19 1000 developed chills, 1230-body aches, nausea, and headache, fever 101.5 (self reported), 1300 fever increased to 102 (self reported), fever then increased to 106 (self reported).  Pt reported dizziness.  Visited ER.  Fever 100.8 on arrival.  Patient reports taking PO advil, tylenol, and benadryl.  Used ice packs at home to decrease fever.  TX in ER with IVF, tylenol, and zofran.  D/c from ER.  OHN f/u 12/20-patient feeling better, resting at home, denies fever.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 14-AUG-2012 the patient was vaccinated with GARDASIL dose 1 (route and lot number not provided) and would receive her second dose on 02-AUG-2013. There were no adverse effect reported. Additional information has been requested.
Upper arm muscles at site of injection sore.  Could not lift affected arm above shoulder level or move arm behind back.  Could not sleep on left side because of pain.
pt recvd vax; upper arm where shot given goes up into shoulder like tooth ache;
Child experiencing generalized malaise, temp 101.2, nausea and vomiting, rash top of foot red raised non pruritic.
Pt had outbreak of hives while in store on 23NOV91; Had severe itching some wheezing; taken to Hosp ER; given DPH
a couple of weeks after taking the vaccine her right arm was so sore it was almost paralyzed.  It was bruised then turned red and painful.  The pain is like a burning sensation.  It was sore from elbow to shoulder blade.  She has been applying hot packs and seems to help.   She says her symptoms are getting better.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 14-NOV-2013 the patient was vaccinated with a dose of unknown age and gender. On 14-NOV-2013 the patient was vaccinated with a dose of GARDASIL (lot number H017698, 02-JUL-2013) 0.5 ml, (dosing regimen and frequency unknown) intramuscularly that was exposed to 31 degree Fahrenheit for 10 hours. No adverse event was reported. No product quality issue was reported. Additional information has been requested.
101-102 fever for 48 hours, body aches, ankle pain, very swollen left armpit lymph node (same side as vaccine injection), exhaustion, significant drop in blood pressure, dizzy, weak. Everything lasted 48-52 hours. The only remaining symptom is the swollen, painful left armpit lymph node (60 hours since shot)
mistakenly received a third dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2021) and Shingrix (2nd dose was given in early 2022). Concomitant products included amoxicillin + clavulanic acid (Augmentin).   On 25-AUG-2023, the patient received the 3rd dose of Shingrix (intramuscular, unknown deltoid) .5 ml. On 25-AUG-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: mistakenly received a third dose of Shingrix).The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 25-AUG-2023 The reporter mistakenly received a third dose of Shingrix at the time of reporting (extra dose), which led to extra dose administered. The third dose was given because the patient did not know if she would already receive her second Shingrix dose and when the pharmacist checked the Vaccine Registry he only noticed one previous dose. When the immunization record was printed, after the third dose had been given, it was noted that two doses were previously given.  Nothing else was reported. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up.
approx 4 1/2hr p/vax pt got chills which escalated into numbness of fingers & toes w/excessive, shaking throughout body inside & out;(very unnerving & painful);heated temp, sweats & chills & aching;T102;
Did not feel very good after her first booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Verbatim: two doses of the Covid Vaccine, Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization; Flu vaccine (Verbatim: Sick as a dog after flu vaccine States that she had one flu shot), for Flu, reaction(s): "Sick". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Did not feel very good after her first booster".  Additional information: Caller states that she is 70 years old and sometimes weighs 100 pounds, but is usually a few pounds under that. States she does not understand why she would take the same dose of the Covid Vaccine that a 500 pound man takes. Caller states that she has had two doses of the Covid Vaccine and then the booster. She wants to get the second booster and talked to her doctor about getting the child's dose. Caller states that her doctor prescribed it for her, but her vaccination provider would not give it to her, that provider gave her the phone number for Pfizer. Caller states that she did not feel very good after her first booster. Caller mentions that she has been a vegetarian for about 50 years. States that she had one flu shot in her life when they first came out when she was in high school and it made her sick as a dog. Caller states that she is not an anti-vaxxer, but she is cautious. States that the flu vaccine might have been a live vaccine back then, or egg based, and she doesn't eat eggs. Caller declines to complete safety report, states she does not think it matters. Caller also declines to provide last name and phone number, states it is not relevant.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Local reaction to DTaP warm redness. Treatment cool compresses, Ibuprofen and BENADRYL.
Nausea, Headache, Migraine-like symptoms sensitive to light and noises; headache meds ineffective, quiet/dark room ineffective; departed work early to seek respite at home. 2nd day occurrence started at 3:00 AM with severe nausea, body aches, and extreme light-headedness.
Injection left deltoid, 1 hour later pain down left leg, multiple body aches about 17-18 hrs later fever, arm swollen to hand, unable to touch (pain) at 72 hours, arm sore, swollen total body aches, fever.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Dr stated that the patient experienced mild muscle aches after receiving the flu sot on 1/19/13. The aches were relieved 24-36 hours later. She also experienced a mild temperature of 99.7 degrees F & had a sore deltoid muscle where the vaccine was administered. The Dr then stated that after consulting her notes, the patient's sore arm felt better after a couple of weeks, then began to hurt again. She saw the Dr on 2/1/13 w/ limited range of motion & terrible arm pain requiring pain medication (unknown what kind) & NSAIDS.
Information has been received from a physician concerning her 18 year old daughter with a history of HPV and acne who at the beginning of October 2006, was vaccinated with a dose of HPV vaccine. Concomitant therapy included Yasmin and Minocin. One week later, the patient developed a urinary tract infection. Two weeks after vaccination, she had an acute onset of arthritis. She had significant swelling of her finger joints and generalized myalgia. She had blood work to include viral antibody titers which were positive for parvo virus, Epstein Barr and Cytomegalovirus. The patient was treated with steroids and anti inflammatory drugs. At the time of the report she had not recovered. The reporter considered the events to be disabling and other important medical events (OMIC). Additional information has been requested.
A few days after the first vaccine I had chest tightness, especially on the left side and middle of my chest that came out of nowhere (no runny nose or anything). It felt like my lungs were irritated and I was short of breath, very tired. Worried it might be covid I went to get tested and it came back negative. Monocytes were high and the doctor suspected early pneumonia. Chest x ray came back without signs of pneumonia (but I continued the antibiotics for 10 days just in case it had been too early to show on the X-ray). Chest discomfort especially on left side, especially with deep inhale and when moving or laying on my side persisted.  Lungs felt better but still left side chest discomfort. Followed up with a chest CT after three weeks and it showed pericardial effusion and splenomegaly in addition to micro nodules in left lung. Pulmonologist cleared me for lung issues, infectious disease tested many things all came back negative. The source of the random chest pain especially on inhaling, shortness of breathe, etc has not been solidly determined and all symptoms started after getting the first moderna shot. After the second shot I felt extremely unwell with high fever for many days. Chest CT was done after the second shot so it is hard to know if the pericardial effusion and splenomegaly came from both shots.
itchy rash on her lower abdomen and back which has gotten progressively worse; rash is now itching and burning, 12 inches wide by 10 inches hight from side of stomach to lower back with some spots down wtowards bikini line and other parts of torso; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (itchy rash on her lower abdomen and back which has gotten progressively worse) and BURNING SENSATION (rash is now itching and burning, 12 inches wide by 10 inches hight from side of stomach to lower back with some spots down wtowards bikini line and other parts of torso) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced RASH PRURITIC (itchy rash on her lower abdomen and back which has gotten progressively worse). 23-Apr-2021, the patient experienced BURNING SENSATION (rash is now itching and burning, 12 inches wide by 10 inches hight from side of stomach to lower back with some spots down wtowards bikini line and other parts of torso). At the time of the report, RASH PRURITIC (itchy rash on her lower abdomen and back which has gotten progressively worse) and BURNING SENSATION (rash is now itching and burning, 12 inches wide by 10 inches hight from side of stomach to lower back with some spots down wtowards bikini line and other parts of torso) had not resolved.            Her HCP prescribed prednisone and an unspecified ointment for the rash. She has also been self-treating by applying ice.
Weakness; Feeling shaky; This is a spontaneous report received from a contactable consumer (the patient) from a female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 16Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the COVID-19 vaccine on 16Apr2021, and she has been experiencing weakness and feeling shaky (from an unspecified date). The outcome of the events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported that the vaccine was stored in refrigerator on 22-Sep-2021, there was no temperature excursion and The patient did not experience any adverse event.  No treatment medications were provided.
Frequent heart palpitations one month after vaccine.  Lasted about a month off and on.
Aching arm shortly after injection on shot 1 and 2. Chills, body aches, fever for 12 hours following 2nd dose beginning about 12 hours after receiving 2nd dose. Fatigue lasting several days. These reactions have left. BUT  I have worsening ringing in my ears with increased volume that has been pronounced and long lasting. I still have the increased ringing in my ears as of 7/27/2021
Felt fatigue; chills; 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 FATIGUE (Felt fatigue) and CHILLS (chills) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Felt fatigue) and CHILLS (chills). At the time of the report, FATIGUE (Felt fatigue) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
This spontaneous report as received from a medical assistant (also reported as "nurse") refers to an unspecified numer of  patients of unknown age. On unknown date the patients were vaccinated with improperly stored doses of VAQTA ((lot M038572, expiration 11-MAR-2018; lot N003194, expiration 28-OCT-2017). There was no adverse events. The doses of vaccines experienced temperature excursion of 47 to 77 degrees Fahrenheit for 15 minutes. There was no previous temperature excursions. Digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA006990: US-009507513-1707USA008737:
Red/discolored skin about 2-3 inches in diameter. Painful with and without touching within 24 hours of 2nd dose. Lump formed below redness. The lump and redness/rash became itchy about 72 hours after injection with continued soreness and tenderness.
Approx 24-36 hrs after seasonal FLUMIST vaccine given Pt c/o feeling very tired with onset of nasal congestion, headache and sore throat and weakness.
Patient came to pharmacy on 7/26/18. Her arm had a noticeable large red area that was warm to the touch per patient. It was not painful.
On 01/30/2023, he started with a fever that day and also had runny nose and right ear pain. He tested negative for COVID-19. We took him to the doctor, he had an ear infection and took antibiotics. He is better.
Red swollen arm - about size of baseball, hot tender. Started 1day after shot and lasted 4-5 days.