chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse (R.N.), referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 13-SEP-2016, the patient was vaccinated with GARDASIL 9 (lot# reported as L040054, expiration date 26-DEC-2017, intramuscular; dose and dose number were not reported) which had been exposed to a temperature excursion (25 Fahrenheit, 1 hour, on 12-SEP-2016) (incorrect product storage). No known adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
THE PT RECIEVED A SINGLE DOSE OF FLUZONE FROM A MULTIDOSE VIAL USING THE NEW PHARMAJET NEEDLE-FREE MACHINE ON FRIDAY SEPTEMBER 9, 2011 AND BY SATURDAY HIS ARM HAD A LARGE HOT RED RASH FROM ABOVE THE SHOULDER TO ABOUT 7 INCHES DOWN AND IT WAS PAINFUL AND THE INJECTION SITE HAD A ROUND HARD LUMP ABOUT A CENTIMETER IN DIAMETER.  THE RASH WAS GONE BY MONDAY BUT THE HARD LUMP WAS STILL PRESENT AT THE INJECTION SITE AND THE AREA WAS STILL HOT.
Scratchy throat and post nasal drip developed within 15 mins of vaccine administration. VS remained stable. 1700 Diphenydramine 25mg IM administered. 1723 Epineprine 1 mg  IM administered.  Patient monitored, VS remained stable. Symptoms improved. Patient discharges at 1743. Patient was driven home.
This case was reported by a nurse and described the occurrence of injection site redness in subjects of unspecified age and gender who were vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of KINRIX (unknown route, arm and batch number). At an unspecified time after vaccination with KINRIX, the subjects experienced redness and swelling, both at the injection site. The nurse mentioned to the field representative she had noticed these adverse events more lately. The representative stated it was more than one subjects and the nurse did not state how many subject have these adverse events. These subjects did not receive any other vaccines in the same arm on the same day. At the time of reporting, the events were resolved. The nurse considered the events were probably related to vaccination with KINRIX.
No additional AE reported; VARIVAX was administered to patient after a temperature excursion; This spontaneous report was received from a medical assistant and referred to a patient of unknown age or gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reaction/allergies were not reported.   On 23-JUN-2023, the patient received vaccination with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, once, lot #W008904, expiration date: 15-MAR-2024, administered for prophylaxis (strength, dose and route of administration were not provided) after a temperature excursion (Product storage error). Administered dose of suspect vaccine experienced the temperature excursion of 23 degree Fahrenheit for 2 hours 17 minutes. There was no temperature excursion occurred previously. No additional adverse event reported.
Information has been received from a physician, via a company representative, concerning a 22 year old female patient, who on 14-MAR-2007 was vaccinated with the first dose, 0.5ml, IM, of Gardasil. On 17-MAR-2007 the patient experienced "pain in lower right leg (down from the knee), aching" and reported a problem with sleeping. At the time of this report, the leg pain, aching and problem with sleeping had not resolved. The patient sought unspecified medical attention. Additional information has been requested.
Headache, arm ache & joint aches started within 5 hours of shot. By morning (8 AM) day after shot temperature up to 99.8 (usually 97-ish), nausea by noon that day which lasted until after 10 PM of 2nd day, by 6 PM the 2nd day temperature 100.2. Temperature down to 98.2 by midnight of 2nd day and aches gone.
Initial misuse report received from healthcare professional on 22 October 2013. The cases were received on 21 March 2014. A 08-month-old patient received 0.5 ml dose of FLUZONE (no other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
On 02/11/2023 I tested negative for COVID-19. On 02/12/2023 tested positive for COVID-19 and I had a fever of 102. It felt like a bad cold, coughing, running nose, congestion, fatigue. I reached out to the local clinic, health system nursing line and they advised me to isolate. 02/13/2023 lost of smell and taste and still have fever of over 100.4. On 02/14/2023 fever did broke and I was still testing positive. On 02/17/2023 symptoms were improving. On 02/18/2023 tested negative for COVID-19.
total relief of pre-existing vertigo since receiving the 3rd full dose; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (total relief of pre-existing vertigo since receiving the 3rd full dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (total relief of pre-existing vertigo since receiving the 3rd full dose). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (total relief of pre-existing vertigo since receiving the 3rd full dose) had resolved.            Concomitant medications were not reported Treatment information was not reported
Systemic: Seizure-Severe, Additional Details: Patient experienced 5 seizures that evening after having the vaccine.  Patient does suffer from seizures
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L043213, expiration date 28-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. No product quality issue was involved. Administered dose of vaccine experienced the temperature excursion of low -28 degrees Fahrenheit for 5 hours on 22-APR-2016. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Day 8 woke up with an itchy quarter-sized rash on upper left arm about an inch from the injection site.  Redness has faded somewhat but the rash has spread to about 3 inches in diameter as of today.  Just sporadic itching, no other symptoms - feeling fine.
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient appeared to have short (<1min) seizure approximately 5 minutes after having COVID vaccine administered. She woke up, eventually alert and oriented. EMS was called and responded to call. She refused ER visit stating she was feeling fine, just a little shook up.
After 7 days my right arm was red and irritant around the injection site. This is the second day.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 07-MAY-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-NOV-2016, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient was prescribed valacyclovir and hydrocodone for management of his painful symptoms and chronic pain. 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 is unknown. Additional information has been requested.
The pharmacist told me that he would only give 1/2 of this Booster injection because I got really sick with the 1st two vaccines. The injection sight became swollen about the size of an orange. About a week later I came down with Shingles.
Sick & weak in left arm, have seen a doctor & orthopedic, MRI & X-rays still unable to use my left arm in some positions.
shortness of breath; This serious case was reported by a physician via sales rep and described the occurrence of shortness of breath in a 95-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included alzheimer's disease.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced shortness of breath (Verbatim: shortness of breath) (serious criteria hospitalization). The outcome of the shortness of breath was unknown.   It was unknown if the reporter considered the shortness of breath to be related to Arexvy.     It was unknown if the company considered the shortness of breath to be related to Arexvy.   Additional Information: GSK receipt date: 07-NOV-2023 The reporter was a physician who stated that a female patient with alzheimer who received Arexvy vaccine had to be admitted in the hospital due to shortness of breath. No other information provided regarding this event. The reporter did not want to be contacted by GlaxoSmithKline.
According the patient:  Red, fever, tender area on 12/7/11 at injection site. On the following day 12/8/11 it was the size of the palm of her hand and more tender.  By the morning of 12/9/11 it was swollen from her armpit to her elbow and was hard.  She was seen by a medical professional and told it was infected.  They gave her prescriptions for doxycycline and prednisone.
Patient was given an adult dose instead of a pediatric dose.   Side effects: sore arm,  chills,  fever,  achyness, tired,  fatigue
My upper right side was completely in pain and stiff. The pain was shooting up my neck and reaching underneath my right breast. Soon afterward, I started catching the chills, a came down with a fever. My head was booming and I felt overly weak and nauseous. The pain in my arm was completely paralyzing to the point where even when I moved my head and was completely in pain. I had covid before in April and this experience was worse.
Requested #2 - Her HCP told her to take it if desired - Benadryl 25mg given pre vaccine = c/o H/A Sweats, Fever, Chills bodyaches, (0 Blisters as of 2/10/21) had blisters after 1st dose - H/Ax4days
difficulty lifting her arm; sore arm; Stated that she received the booster at 4pm on 19 Nov; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 19Nov2021 16:00 (Lot number: FD0809, Expiration Date: 22Jan2022) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot: EP6955  , Expiration date: 30Jun2021, Route: Intramuscular), administration date: 20Mar2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (Second dose, Lot: EP6955 , Expiration date: 30Jun2021, Route: Intramuscular), administration date: 10Apr2021, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 16:00, outcome "unknown", described as "Stated that she received the booster at 4pm on 19 Nov"; MOBILITY DECREASED (non-serious) with onset 20Nov2021, outcome "recovering", described as "difficulty lifting her arm"; PAIN IN EXTREMITY (non-serious) with onset 19Nov2021 21:00, outcome "recovering", described as "sore arm". Therapeutic measures were taken as a result of mobility decreased, pain in extremity.  Additional information: There was no patient history. It was reported that the patient could lift her arm more easily last night and that she took Tylenol on 19Nov2021 and she iced her arm on Saturday.  No follow-up attempts are possible. No further information is expected.
Pt. received 2 doses of the Pfizer COVID vaccine: 12/21/2020 and 1/11/2021.  Pt. reports COVID symptoms of Loss of taste and smell, cough, sneezing, fever, headache and fatigue starting 7/5/21. Pt. tested COVID positive on 7/8/21 at  Health Clinic, unknown test type.
I had slight chills and body aches at 7pm on 3/19/21.  Chills worsened, had vigorous body shaking, body aches worsened by 10pm. Developed fever of 102 degrees Celsius. Vomited around 11 pm, Took DayQuil, had a fever, sweating and body aches all night. Temperature went down to 98 by 7am the next morning.  Had a very intense headache, took Tylenol and had caffeine. Still had a slight headache until 7pm.  The next few days, I felt a little dizzy at times, tired,  and out of breath climbing steps. Felt normal by 3/22/21.
11/14/2003: Dacrosteno, ? Viral illness.  Per mom-not himself, grunting resp.  Sent to ER-chest x-ray, streaky infiltrate right middlel lob. Treated with Rocephin 11/15/2003.
2 month old vaccines were administered at 3:00p.m. After 15 minutes the nurse assessed patient and noticed that patient had a reddened macular rash to the abdomen/chest/back/groin T=98.9F, HR=158, RR=36, )2 Sat=100%. No respiratory distress noted. Patient was assessed by doctor. No treatment rendered other than close observation. At 5:00 p.m. rash appeared to be resolving, as evidenced by decreased redness to all areas affected. Patient appears to be sleeping with no symptoms of distress at this time. Patient had also been taking Omnicef prior to clinic visit for treatment of UTI; antibiotic now to be changed to Bactrim per doctor. Patient then to be sent home per MD.
12 hours after receiving my second dose of the Pfizer vaccine I experienced the start of chills. Within a few hours after that I woke up with severe chills,  body aches, joint pain, and a very swollen and painful lymph node in my left axilla.  By the 24 hour mark everything improved but I am now experiencing some nausea and bloating.
Stiffness, soee, low grade pain in neck, back and left sid extending to upper arm
Development of severe verbal and physical tics after the first shot.  The tics worsened after the second shot on 4/20/2021.  She is still suffering from verbal and physical tics.
Blood pressure dropped; Pulse dropped; Became very weak; Sleeping most of the time; Chills; Fever; Nausea; Fatigue; This spontaneous case was received on 29-Oct-2020 from other health professional (nurse) via Health Authority (reference number: SEQW20-04448) and concerned a 74-year-old, male patient.   The patient's concurrent conditions included diabetic (not on medication) and renal cancer. The patient's past medical history included bypass surgery (two and a half years ago) and mini stroke one year ago. The patient's concomitant medications included Opdivo (nivolumab) used for renal cancer, metoprolol, lisinopril and Eliquis (apixaban), all used for an unreported indication. The patient's historical vaccine included unspecified influenza virus vaccine with no adverse reaction.  On 26-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On the same day, four to five hours after receiving Fluad Quadrivalent, the patient became very weak. He developed chills, fever which was on and off for the next days, nausea and fatigue. His pulse and blood pressure dropped, and he was sleeping most of the time. He was treated with Tylenol (paracetamol) at unknown dosage regimen.   On an unspecified day in Oct-2020, the patient recovered from event fever.   At the time of initial reporting on 29-Oct-2020, the patient had not recovered from event 'weakness' and was recovering from all other events as it was reported that he was feeling better.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  The case is linked to 202005979 (due to same reporter).  Company comment: The patient experienced blood pressure decreased, heart rate decreased, asthenia, somnolence, chills, pyrexia, nausea and fatigue after administration of Fluad Quadrivalent. Causality is highly confounded with reported medical history (renal cancer) and chemotherapy with Opdivo even though temporal association is suggestive. Causality is assessed as not related for all events.; Sender's Comments: The patient experienced blood pressure decreased, heart rate decreased, asthenia, somnolence, chills, pyrexia, nausea and fatigue after administration of Fluad Quadrivalent. Causality is highly confounded with reported medical history (renal cancer) and chemotherapy with Opdivo even though temporal association is suggestive. Causality is assessed as not related for all events.
Within 2-3 hours after injection, client noted slight redness and c/o pain at left arm injection site.  No fever.  Still c/o soreness and "lumps" about the size of a dime under injection site. States it now feels itchy.
11-5-08  injection approx 1 pm, 6pm low grade fever, chills, 8 pm muscle aches, rigors fever 10:40 took Tylenol fever improved 11-6-2008 2 am fever 104, rigors, dizziness headaches, muscle pain 11-06-08 pm all symptoms resolved > all reported by patient.
Rash. Dehydration. Yellow projectile vomiting 3 times within 4 hours. Irritable. Lethargic.
FLULAVAL 0.5ml given IM to 17 y/o. Vaccine is approved for 18 years and above only. No data on children's group.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M010480, expiry date: 01-MAR-2018) (route: subcutaneous) (incorrect product storage). The vaccine was stored at a temperature of 49 F for 2 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. The outcome of the events was unknown. Additional information is not expected.
Vaginal bleeding. My menstruation ended 3 days ago. Today, about 24 hours after receiving my first dose, I started bleeding again.
hives; rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and RASH (rash) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was provided.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced URTICARIA (hives) and RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 UNK. At the time of the report, URTICARIA (hives) and RASH (rash) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable Concomitant medications include eye drops
Patient reported having sores in his mouth. He was advised that this is not a likely side effect of this vaccine, but he was positive that it was the only change in the last week, so we reported it just in case.
10JUN94 onset of fever, sore throat, swollen glands 13JUN94; not takes liquids & food OK; occasional low grade fever (once today) glands still swollen & tender
No adverse affects reported; a improperly stored dose of ROTATEQ was administered; This spontaneous report as received from a license practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 23-AUG-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # R035369, expiration date 10-OCT-2020, orally, for prophylaxis (dosage schedule was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 50 degrees Fahrenheit for 49 minutes. Data logger was involved. There were no previous excursions reported.
Vomiting, diarrhea, fever, headache, fell to the floor with weakness for about ten minutes. 911 was called and said all normal side effects of the vaccine.  Slowly subsided in a couple of hours. Rested for a few days and was fine.  I'm scared to get the second shot.
Approximately 04/27/21, I started getting a sharp pain above my right ear, eye, forehead and right temple. I went to Urgent Care and was diagnosed with Shingles. The sores began to irritate my right eye, so I saw my Eye Dr who also diagnosed me with Shingles. ( My R eye and vision all checked out ok ). Except for Shingles. I then saw my Primary Care Dr. who also diagnosed me with shingles. All three doctors diagnosed Shingles due to the possibility of a low immune system caused by the vaccine. To this date, I am still suffering from the nerve pain above my right eye and forehead area. I broke out twice within this period which is unusual.
DEVELOPED TACHYCARDIA, LIMB NUMBNESS, VISION LOSS, WARM FEELING IN BODY WITHIN 30 MINUTES OF VACCINE
Pt experienced continuous screaming fr 245PM unt 315PM; Screaming was loud & high pitched, swelling of inject site  RT reported; t102R;
6 hours after shot my throat closed a bit and had trouble swallowing. . . I took 2 benedryl and drove to ER at Hosp. . . They said it wasn't too bad. Observed me for 2 hours . . I went home . . I asked for Epipen script.
Began Seizure activity on 03/01/02. There was no treatment other than nebulizer treatment and PCN for OM on that day.
his reflux was aggravated; had regurgitation in the back of his throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 2-year-old male patient received BNT162b2 (BNT162B2), as dose 2 (maroon cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "reflux infant" (not ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1 (MAROON CAP), SINGLE, Batch/lot number: FT9142, Expiration date: 31Dec2022), for COVID-19 immunization, reaction(s): "his reflux was aggravated", "fatigue", "his reflux was aggravated", "had regurgitation in the back of his throat". The following information was reported: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "his reflux was aggravated"; REGURGITATION (non-serious), outcome "unknown", described as "had regurgitation in the back of his throat".  Additional information: Mother of patient reported that her son is a "reflux infant" so has a history of reflux but has resolved. She reported that every time he got the vaccine (has received 3 doses), it aggravated his reflux or it started acting up again. This same thing happened with his first two doses in his primary series.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300102461 same patient different dose/drug/event;US-PFIZER INC-202300102439 same patient different dose/drug/event;