chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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. The patient's healthcare provider, a pharmacist, recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-JUN-2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). Later in 2015, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 62 years old female patient with thyroid and cholesterol. The patients medical history included post breast cancer. On 29-JAN-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number was reported as H018510, expiry date was 15-JAN-2014, route was not reported) in the left arm. Concomitant medications included LEXAPRO, metformin, WELLBUTRIN, LUNESTA, simvastatin, SYNTHROID and XANAX. On 01-Feb-2013, the patient had called the pharmacy to reported that approximately on an unknown date in 2013, she has red, circular itchy rash at the injection site of left arm and it is hot to touch. The patient sought medical attention (had called the pharmacy). The pharmacist reported that he would follow-up with her healthcare provider. The pharmacist also stated that the patients husband was a physician. The outcome of all the reported events was not recovered/not resolved.
***Soreness of Injection Site Arm (Began approximately 30 minutes after the injection.  Pain increased and lasted for about 3 days.  It was treated with Tylenol as needed.)  -- MILD TO MODERATE DISCOMFORT  ***Fever (Began approximately 3 hours after injection.  Fever lasted for 3 days.  It typically stayed between 99.9 - 101.0 F.  It did reach 102.2 F, but that was lowered with Tylenol.  I stayed hydrated by drinking water and Pedialyte.) -- MILD TO MODERATE FEVER  *** Swelling and Itchiness of Injection Site (Began approximately 3 hours after injection.  The swelling lasted about 48 hours, as did the itchiness) --- MILD SWELLING AND ITCHINESS  *** Nausea and Vomiting (Nausea began about 3 hours after injection.  Vomiting began about 36 hours after injection.  Treated with Dramamine and Zofran) -- MODERATE NAUSEA / MILD VOMITING  *** Headache (Began approximately 16 hours after injection.  Treated with Toradol, as I regularly get migraines) -- MODERATE MIGRAINE HEADACHE
Patient was in waiting area of monkeypox vaccine clinic waiting for the observation period after the vaccine. He had itching and slight erythema about 15 minutes after intradermal injection of the JYNNEOS monkeypox vaccine. Then the injection site wheal began to spread. It was marked by nurse and the maximum size was about the size of a quarter in diameter and about 1/4 cm high. I was called to the vaccine clinic to evaluate patient. When I saw the patient, the erythema had disappeared and the swelling remained the same size. Patient did not have any SOB or generalized rash. Vitals were stable at T 98, P-58, R-16, BP 128/96, 99% O2 saturation. Physical exam was pertinent for lung exam with no wheezes and heart exam normal and no generalized skin rash noted. Patient was observed for an hour after the injection and had no other complaints.  Patient was discharged with  instructions to return to the ED if needed for any  SOB or any other symptoms. As far as I know - he has not had any other Doctor's visit for this issue.
On June 5th, I developed what I thought I was laryngitis for the first time in my life.  I went to an ENT doctor and he diagnosed it as a paralyzed vocal cord.  I have seen an article where this has happened to other people as well.  This is unacceptable and is going to cost me a fortune to fix.
p/vax 1wk later the appearance of macular-papular rash w/pustules ro rt inner thighs-self-limited x 1wk;did not seek medical attention;10/22/99 adm to hosp w/atrial fibrillation & probable myocarditis dilated cardiomyopathy;
PATIENT CALLED 10/25/2010 AM C/O SINCE TAKING FLU/PNU VACCINE, SHE STAYS SLEEPY; QUESTIONED REGARDING CHANGE IN HOME MEDS; DENIES ANY.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) on 09-Mar-2021 for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 25-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On 25 July 2014, the subject received unspecified dose of BOOSTRIX (.5 ml, intramuscular, unknown injection site). The subject's last menstrual period was on 06 January 2014 and estimated date of delivery was on 13 October 2014. The type of conception was normal. The subject was exposed to the vaccine during the 3rd trimester. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 10 October 2014 from nurse: The VAERS details and some of the patient's details were provided. Follow-up information received on 30 October 2014 from nurse: No new infor provided.
no additional AE; HCP reported VARIVAX was administered after a temperature excursion to a patient. VARIVAX was administered on Jul 29, 2022. No further information provided.; This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and drug allergies were not provided.   On 29-JUL-2022, the patient was vaccinated with improper storage varicella virus vaccine live (Oka/Merck) (VARIVAX) once as prophylaxis (lot number W011625 had been verified to be a valid number; expiration date reported and established as: 06-APR-2024; dose, route of administration, and anatomical location were not provided).   The vaccine experienced a temperature excursion of minus 8.1 Celsius degrees with a time frame of 1 hour 58 minutes and 0 seconds. It was stated that no previous temperature excursion occurred.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA002433: US-009507513-2208USA002737: US-009507513-2208USA002739: US-009507513-2208USA003187:
Rash/itchiness began about 3 days after vaccination.  Gradually became more severe. Startedd with ears and then moved to scalp and face. Then finally moved to neck, upper back and then arms and legs. It became very severe starting a week or so and is still extremely itchy and persistent rash. Resembled allergic reaction but antihistamine and topical hydrocortisone do not alleviate symptoms much.
patient described having a metallic taste in mouth after receiving the vaccine; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (COVID-19, Pfizer, solution for injection), via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as 1st dose, single dose for Covid-19 immunization. The patient medical history included known allergies: Yes. The patient concomitant medications were not reported. It was unknown if the patient was pregnant. It was unknown if the patient had other vaccine in four weeks or other medications in two weeks. No Covid prior vaccination and no Covid tested post vaccination. On 28Jan2021, the patient described having a metallic taste in mouth after receiving the vaccine. The outcome of the event was reported as recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
02/06/04: Noticed bumps under skin arms, legs and back.  Fells them more than sees them.  Itchy at times.  Taking Benadryl occasionally.  02/09/04: Saw MD, bumps still present-given Claritin to take daily for 7 days.
I felt tired and then after 5 days I had a rash on my breast and it lasted for almost 3 weeks.  I went to Urgent Care.
had an allergic reaction; heart palpitations; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A female patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for immunization. Medical history included chronic diabetes and allergies. The patient's concomitant medications were not reported. The patient had an allergic reaction and heart palpitations on an unspecified date. It was reported that the patient experienced heart palpitations and was rushed to the emergency room 2 hours after getting her Pneumonia shots. It turns out that there were ingredients of the vaccine that she had an allergic reaction with. She also has chronic diabetes, and given these medical conditions, she is considering getting the Pfizer BioNTech Covid-19 Vaccine. She states she had an allergic reaction to a pneumonia vaccine. She doesn't know which kind she got. The vaccine gave her heart palpitations. She ended up in the ER. She wanted to take the Covid vaccine, but she is afraid of it. She wanted to know if there is any way she could get ingredient information and compare them to the pneumonia vaccine and make sure that it is safe for her. Clarified with the patient that she was referring to Pfizer Covid-19 vaccine. She is afraid because she has a lot of allergies. She wanted to know if Pfizer also makes the pneumonia vaccine. She doesn't know the brand, but she knows there are two different kinds. She doesn't know which kind she took. It was several years ago. Her doctor said if she's allergic she probably shouldn't take it. She wanted to compare pneumonia vaccine ingredients with Covid vaccine ingredients. She may see an allergist so she can get all the info. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Patient express felt a sudden dizzy spell and lightheaded, post 8mins. of administration of the shot, and began to feel anxious/concern. Patient verbalized is Diabetic at this time -non-fasting, at home self -accu-check with a reading of 107, am medication dose taken. Also notified, had trouble sleeping and was nervous because was debating to take the COVID shot.  Patient was escorted to an examination room for close monitoring. Denies any other chronic or acute medical condition. Patient ambulating with normal gait. Good general appearance -V/S: BP 128/82, P 92, R 14 non-labored with O2Sats 98%, administered O2 @ 2L x 15 minutes. 9:40am -Patient express that the mentioned symptoms -have subsided. Patient was given instructions and recommendations before discharge. Reassurance given, patient verbalized understanding.   Dizzyness Lightheaded Headache
This spontaneous report as received from a pharmacist refers to a 61 year old female patient. On approximately 17-MAY-2013, reported as about 6 weeks ago, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported). Concomitant therapy was not reported. It was reported that recently, in 2013, the patient developed stinging and burning in her scalp and felt it was affecting her hearing. The patient sought medical attention by contact the pharmacy and no treatment was given for the adverse events. At the time of the report, the patient's outcome was reported as not recovered. Upon internal review the adverse event affecting her hearing was considered an other important medical event. Additional information has been requested.
Bell's Palsy with symptoms starting 3/14/2021 with mouth issues and facial problems from eye to mouth drooping. Recognized pain behind left ear the night before but didn't think about it until other systems. All symptoms on left side of face. Contacted Dr. and was referred immediately to the ER for diagnosis and to rule out stroke. Morning visit to ER and diagnosis was not stroke but Bell's Palsy. Treatment of predniSone 20mg taken three at a time each morning for five days and Valcyclovir 1 gram taken three times per day for 7 days. Dr. was the ER doctor performing the diagnosis.
Patient c/o feeling dizzy/lightheaded and her face was warm.  Reported feeling anxious. Facial flushing noted.  Patient taken to private room for further observation via w/c.  Patient reports SOB and chest pressure 9/10 BP 204/85 hr 71 spo2 99%.  Nitroglycerin 0.4 mg SL given.  Pt continues to appear flushed, and c/o h/a and chest pressureEKG completed and handed to doctor at bedside. FM replaced with O2 2LNC.     Patient's facial flushing, redness to upper extremities and tremors, has subsided notably and pt is reports feeling better.  Continues to deny chest pain.  Pt's affect improving and she is able to smile when she answers questions.  BP 144/53  HR 88 Spo2 100%.    Pt discharged via w/c with family in stable condition as per doctor.  Patient aware allergy department will be following up on her reaction and she will be provided with further instructions regarding second dose of moderna covid vaccine.
After patient received 1st dose of COVID vaccine, voiced complaints of CHF exacerbation.  Was admitted for diuresis and symptom management.
Miscarriage. Exact time n dates is unknown. I have no previous history of miscarriage and I have a perfectly healthy 1yr old son from previous pregnancy unvaccinated.
I started getting arm pain about 3 hours after the shot. It was worse than the first 2 doses. By about 12am, was at an 8/10. It lasted about 3 days before it started getting better. I got a fever about 7 hours after the shot. The highest temp I recorded was 102.5. I had a loss of appetite and sluggishness as well. I experienced breakthrough bleeding 16 hours after the shot. I was 5 days before my period but had bleeding for the 5 days leading up. This was abnormal for me. I called the doctor regarding the pain in my arm which was due to a swollen lymph node. The doctor advised to come in if it did not begin to go away. It did go away. It is currently still present but resolving. I also experienced headaches as well.
Pt recv vax on 3/25/98; on 3/26/98 pt exp erythema of 5-6 ins.-a large local reaction progressed to the upper thigh; area was slightly tender & indurated.  On 6/27/98 redness had become larger.
ever since she is sick; cold; Chills; burning in skin; fever; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ever since she is sick), NASOPHARYNGITIS (cold), CHILLS (Chills), SKIN BURNING SENSATION (burning in skin) and PYREXIA (fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (ever since she is sick), NASOPHARYNGITIS (cold), CHILLS (Chills), SKIN BURNING SENSATION (burning in skin), PYREXIA (fever) and DECREASED APPETITE (no appetite).            Reporter did not allow further contact
Rash on arm of injection  and neck problems Date of Onset: approximately 10 days ago: 01/10/2021 -reported due to late onset rash
Complex febrile seizure requiring multiple meds (Versed, Phenobarbital, Dilantin) and intubation for airway protection ( < 24 hrs.). Fever persisted to 3/2/14. On 3/5/14 (R) mild otitis seen (had 2 doses Ceftriaxone in hosp).
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient was unresponsive for 5 minutes. Pharmacy called 911 and the EMT took her out of the building.
Pts entire body started to ache. Facial swelling and hard time breathing went to ED-given 2 doses of epinephrine.
Immediately following the administration of the vaccine the patient stated that they felt like they were going to vomit. A receptacle was provided to the patient and he began to vomit. Water was retrieved for the patient and his vital signs were taken. BP 130/100, HR 85. Once the patient finished his emetic episode he stated that he felt okay. The patient was told to finish their 15 minute post-vaccination waiting period and then they could leave if they continued to feel well-enough to go.  The patient's father remained with the patient and escorted him out to their vehicle once the 15 minutes time frame was over.
Infanrix was given to an 11-year-old patient that was supposed to receive Boostrix; 11 year old received Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number 3M9Y7, expiry date 03-MAR-2024) for prophylaxis.   On 28-JUL-2023, the patient received Infanrix. On 28-JUL-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix was given to an 11-year-old patient that was supposed to receive Boostrix) and inappropriate age at vaccine administration (Verbatim: 11 year old received Infanrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Jul-2023 The reporter consented to follow-up via email. The patient was supposed to receive Boostrix but received Infanrix at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Patient reported to pharmacy one week after receiving Moderna CV-19 dose. She said she had a red, itchy rash on her forearms and her stomach has started itching as well. She reported this began 3 days after receiving the immunization. I will call her PCP to follow up.
I went in for a routine mammogram where they found something on my right breast. My doctor ordered an MRI of my breast to get a better look at what had been seen on the mammogram. The MRI came back showing DCIF, grade 1 invasive, I had biopsies, my lymph nodes under my right arm have been removed, and two weeks of radiation. At this point in time, I do not need chemotherapy.
Tdap given by RN. After 4 wk developed itchiness, red raised fine rash approx 2cm at injection site.
The vaccines listed above were given on 1/16 and 2/6.  One week after the first vaccine, shoulders, arms and hands became weak, painful and stiff.  These symptoms have remained since them and have worsened.
Morning after vaccination Woke up with fever of 100.7, body chills.  Had symptoms of fatigue all day. Fever stopped by noon.
Nine days after my initial shot I noticed a big red rash on my arm, 3x3, very itchy and warm to the touch. The next day it looked a little bigger and today its even bigger. Not itchy today but very sore. Sent my doctor an email and doctor said it sounds like COVID arm.
left arm became swollen; left arm is itching; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm became swollen) and PRURITUS (left arm is itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included COPD and Shoulder deformity NOS.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PERIPHERAL SWELLING (left arm became swollen) and PRURITUS (left arm is itching). At the time of the report, PERIPHERAL SWELLING (left arm became swollen) and PRURITUS (left arm is itching) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient received ProQuad MMRV vaccine at 10:30, within about 3-5 minutes, patient was unsteady on feet and then vomited, patient was laid on exam table, patient became extremely diaphoretic and disoriented, hives began appearing on right side of face, arms were very flushed, small hives began appearing on trunk. Patient was very tremulous, awake but not responding to questions. Oxygen Saturation was noted to 97%, unable to obtain BP at that time due to position. Paramedics arrived within about ten minutes, they obtained blood pressure at which time they noted patient was hypotensive. They proceeded to give epinephrine, and possibly IM benadryl (unsure). Patient was awake and alert with symptoms subsiding within a few minutes, Paramedics took patient to Emergency Department.
pt devel varicella as secondary transmission from sibling;on 23SEP97 pt exp severe case of varicella @ the same time as sibling who recv vax (WAES97102089);