chrisvoncsefalvay/vaers-outcomes huggingface dataset:
never received a second dose during the 6 month window; patient developed shingles afterhis first dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 7th April 2021, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details was reported as follows: The age at vaccination was not applicable for 2nd dose. The patient received 1st dose of Shingrix and experienced shingles.  Till the time of reporting, patient did not received 2nd dose which led to incomplete course of vaccination. The patient received 1st dose at a different pharmacy so no lot or expiry date was available. The reporter consented to follow up via postal.
@ inj site lt deltoid: swelling, redness, c/o tingling in arm;
Rash; Multiform erythema (predominately torso) x 10 days contin.; GI distress; fever w/rash.
Arm swelled up at injection site on first day, by Friday 10/20, swelling had moved to lower part of arm, red itchy patch that was warm to touch.
04/16/2009 Mother called and spoke to call center who then called our office. Child received MMR and VARIVAX today, rash developed on face, and arm according to call center. I then asked the call center to find out if there was difficulty breathing, upon hearing that there was, I advised them to tell mom to immediately cal 911. Dr. informed.   See attached.
In and out of consciousness; feeling faint, fainted briefly/Passed out multiple times; Couldn't stand up; Flu-like symptoms; Fever with a temperature of 103 degress; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (In and out of consciousness) and SYNCOPE (feeling faint, fainted briefly/Passed out multiple times) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010N120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included AMITRIPTYLINE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (In and out of consciousness) (seriousness criteria hospitalization and medically significant), SYNCOPE (feeling faint, fainted briefly/Passed out multiple times) (seriousness criteria hospitalization and medically significant), DYSSTASIA (Couldn't stand up) and INFLUENZA LIKE ILLNESS (Flu-like symptoms). 24-Mar-2021, the patient experienced PYREXIA (Fever with a temperature of 103 degress). At the time of the report, LOSS OF CONSCIOUSNESS (In and out of consciousness), SYNCOPE (feeling faint, fainted briefly/Passed out multiple times), DYSSTASIA (Couldn't stand up), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PYREXIA (Fever with a temperature of 103 degress) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 103 High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received treatment medication included Tylenol, to alleviate the symptoms.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Twitching, eye shutting,reduced control of facial muscles and some bdy muscles, low calcium
-Sore in area of vaccination (since 7pm day of vaccination) -Weakness/Slight aching from the waist down to feet (since 11pm)
Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The reporter report that, shingles was tough. but he/she got medication and she/he got through it. No vaccine for her/him. The reporter stated that, do we know the long term side effects. is it like the Covid jab and you will get Covid anyway. The reporter know a lot of people that got the shingles vaccine and got really sick. So reporter don't know which was worse. yes it was pain and no fun for about a week. But reporter got through it.  Every one needs to make the decision what was best for them.  The reporter medication worked, Warm baths with epsom salt were perfect. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender with no pertinent medical history reported. On 22-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot number reported as 1502AA and expiration date of 19-MAY-2013) (dose and route not specified). No other suspect therapies or concomitant medications were reported. The reporter stated that the patient was administered PNEUMOVAX23 from an expired vial. No adverse events were reported. The medical assistant reported that other three patients were administered with PNEUMOVAX23 from an expired vial (MARRS 1308USA004971 MARRS 1308USA005804 MARRS 1308USA005805) This is one from several reports from the same reporter. Additional information has been requested.
1:45 PM - shot administered. 5 PM - throat sore. 6 PM - trouble breathing 1 BENADRYL taken. 7 PM - notified pharmacy additional BENADRYL and advised to go to ER.
This spontaneous report was received from a 88 years old female patient with allergies to sephalasporin. The patient was subcutaneously vaccinated with ZOSTAVAX (lot # 00008496341 MSD) on 14-JAN-2013 to prevent shingles. No other co-suspects were reported. Concomitant medications included: ZYRTEC, "ACIPHEX" and "WELLBUTRIN". On the same day, the patient experienced a hard knot and warmth at the injection site on her right arm. She also stated that she was experiencing itching all over. No treatment information was reported. She was going to the pharmacist. The outcome of AEs were unknown. Additional information has been requested.
Approximately two weeks post vax the pt developed CNS symptoms. The physician noted child's symptoms started as weakness in the legs. The weakness became worse and the child could no longer walk due to the loss of balance. Ataxia was diagnosed. The pts symptoms increased and the pt could no longer use his left arm. At the time of reporting the pt had regained the use of his arm, however, he still could not walk. An EEG was performed which was found to be normal. A pediatric neurologist was consulted and does not believe the pt has Guillain-Barre. Additional information has been requested. Follow up information from a physician reported that the pts EEG has changes and the pt has become progressively weaker. The pts pediatric neurologist feels that the pt may have some type of metabolic disorder. The physician has not completely ruled out the vaccinations as causative factors in the pt experience, however, it was looking less likely that the pts experience was in any way related to the vaccinations.
On September 30th, it was severe ovulation pain. I've never had that before. It lasted a few days. But it began to get worse the following month from October 24th to 28th. I took Acetaminophen about 500 mg or Ibuprofen about 200 mg. I have an appointment in December to see my doctor and all I've done is talk to someone through an application.
Patient reported scratch and tightness in throat. Vital signs obtained, 124/82, 62, 92%, 18. Patient reports no. nausea, vomiting, rash, difficulty breathing, or other symptom. Patient lung sounds clear. Administered 25mg PO Benadryl and apple juice. Patient monitored. Symptoms resolved. Vital signs rechecked, 122/82, 72, 18, 96%. Patient monitored for a total of 30 minutes past onset of symptoms.
Subsequent to receiving one dose of varicella virus vaccine live on 7/13/95, the pt developed atypical chickenpox on 4/1/99.
4/1: Woke up very sick fatigued, dizzy, sweaty, in bed for 24 hours.   4/2: aforementioned symptoms improved and could get out of bed but dizzy and ?off? feeling persisted  4/6: increased dizziness throughout day to point fell when walking out of work (did not follow up with blood pressure or anything at this point).   4/16: Dizziness and ?off? feeling continued to progress over past 10 days snd fell when bringing in the groceries.   4/17: woke up feeling heart palpitations when at rest in much. Also much more dizzy to point where could not walk also. Husband recommended taking BP which measure 178. Called PCP who recommended go to hospital. Admitted to hospital and BP erratic. Performed nuclear stress test which was negative and prescribed losartan 25 MG did a nuclear stress test  4/18: discharged from hospital and proceeded to take BP three times a day. Values continued to be erratic also still feeling dizzy (to a lesser extent thought)   Approx 5/3: called the doctor to inform of continued erratic BP. He prescribed a new blood pressure medicine- LISINOPRIL 10 MG?s. Despite medication change Bp remained erratic and dizziness persisted   5/18: dizzy woke up on dizzy similar to presentation 4/17 blood pressure 159/98. Proceeded to work and dizziness progressed to point where almost passed out and had to lay head on desk. EMS was called and BP measuring 169. Admitted to hospital took off BP medication and Echocardiogram, CT and MRI of brain all performed- all negative. BP running lower than normal at certain points during hospitalization (as low as 109). Cardiologist prescribed medication for low blood pressure and dizziness (have not filled this medication)   5/20- 5/22: (discharged from hospital) dizziness still more than normal and BP still up and down but better than prior to hospitalization   5/23- current: dizziness but not limiting function and BP remains erratic but still lower than prior
LUMP UNDER ARM; SWOLLEN ARM; FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (LUMP UNDER ARM), PERIPHERAL SWELLING (SWOLLEN ARM) and FATIGUE (FATIGUE) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 25288185) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (LUMP UNDER ARM), PERIPHERAL SWELLING (SWOLLEN ARM) and FATIGUE (FATIGUE). At the time of the report, AXILLARY MASS (LUMP UNDER ARM) and FATIGUE (FATIGUE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
was sick / He was laying in bed; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of sickness in a child male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than 4 months after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced sickness and flu-like symptoms. On an unknown date, the outcome of the sickness and flu-like symptoms were recovered/resolved.   It was unknown if the reporter considered the sickness and flu-like symptoms to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were reported as follows: The case was reported by patient's mother. The age at vaccination was not reported. The reporter reported that the patient was sick for 2 days with Flu like symptoms which lasted 36 hours in 2018 after receiving the flu vaccine manufacturer unknown. The patient was lying in the bed saying that he had to went to the hospital. The reporter consented to follow up.
patient had no past history of headaches or migraines but started experiencing headaches within 24 hr of receiving her first pfizer dose. headache has been occurring intermittently since then up through today. ~3 weeks. patient reports the pain is in the lower back of the head. has taken medication (not specified) to help alleviate the pain
DEVELOPED BODY ACHES, FEVER, CHILLS, AND HEADACHE LASTING 24 HOURS.
Hives.  Patches of hives appearing bilaterally in the same places.  ie-  right hip and left hip, right inner thigh and left inner thigh,  behind right knee and left knee.
Rashes and itchiness on both shins; Rashes and itchiness on both shins; a few red dots/spots on my chest and face; a few red dots/spots on my chest and face; itching in my ears (around the antihelix and canal); redness around the helix; some respiratory symptoms; pins and needles in my left hand for half a day; debilitating fatigue; This is a spontaneous report from a contactable consumer (reported for herself). A 39-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL3249/ Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 11Feb2021 at 14:45 (at the age of 39-years-old) as dose 2, single for covid-19 immunisation at other. Medical history included spinal osteoarthritis from an unknown date and unknown if ongoing (Only chronic cervical spine issues). Concomitant medication(s) included toradol (KETOROLAC TROMETHAMINE) taken for an unspecified indication, start and stop date were not reported and cyclobenzaprine (CYCLOBENZAPRINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL3248/ Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 21Jan2021 at 10:00 (at the age of 39-years-old) as dose 1, single for covid-19 immunisation at other. On 12Feb2021, the consumer experienced rashes and itchiness on both shins, a few red dots/spots on my chest and face, itching in my ears (around the antihelix and canal) and redness around the helix, some respiratory symptoms, pins and needles in my left hand for half a day and debilitating fatigue. Therapeutic measures were taken as a result of events included treatment with Claritin and Benadryl. The outcome of the events was not resolved.  Follow-up attempts completed. No further information expected.
Varicella Information has been received from a physician concerning a 47 month old male who on 31-COT-2002 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (Oka/Merck). On 01-OCT-2005, the patient developed break through chickenpox. He had approximately 10 lesions and did not have a fever. Unspecified medical attention was sought. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested. Body temp 10/01/05 afebrile.
Admitted for AMS, weakness not hypoxic.  Received monoclonal antibody 9/22/20212
R arm swollen, red, hot over entire arm;  developed within 24 hours after vaccine.
Patient reported itching and swelling localized to injection area.  She showed me a picture of how her arm looked yesterday.  There was a approx 2-3" raised red area around site.   She denied trouble breathing or swallowing and denied any other issues.  Today the site is much smaller.  I instructed her to apply a cool compress.
After prolonged motionless time, uncomfortable, slight pain in joints (legs and arms). Additional arthritis-like pain on hand joints which prevented daily activities that required hand strength (e.g. twist open a cap)
Extreme terrible itching red rash all over both arms,  across chest, tops of legs, occurring over a week.  Visited Dermatologist, who prescribed  benedryl   an dTriancinolone   actonide cream      Problem has not resolved- Need help
Headache, Myalgia, NauseaVomiting, CHILLS, FATIGUE Narrative:
Post Vaccine patient complained of having an itchy back. Pt transferred to med obs. Pt back appears red with no noticeable rashes/ bumps or hives .  Pt reports his skin is no longer itching, and skin remains free from rash.  Vitals obtained and monitored.  Onsite  physician sent patient home with PO Benadryl. Pt instructed by physician to take Benadryl once home if itching returns and to seek medical attention if symptoms were worst.  Pt released at 1200  1140 BP 160/93 HR 100 RR 20 SPO2 96 1150 BP 143/90 HR 102 RR 20  SPO2 97 1155 BP 132/95 HR 102 RR 20 SPO2 97
severe muscle ache and muscle weakness (left arm above elbow) headache; tiredness; slight fever -- all at the same time.  Muscle ache and slight headache  lasted about 30 hours
Inadvertently gave 6m-4y formulation. Mom does not plan to revaccinate at this time.
All ok on 3/16, then awoke 6:30am 3/17 with very sore left arm at injection site with swelling, pain and swelling increased throughout the day, site and surrounding area becoming swollen and turning red/bruised. Can't raise left arm due to pain, migrating to left neck and upper back scapula area. No recourse at this time, attempting to get some sleep while immobilizing left arm. Hoping for positive results tomorrow and consult from you.
Three days after I received the first vaccine. It felt like I had to a constant urge to urinate. No matter how many times I went to the bathroom it still felt like I had to go. It started to wane about three weeks later. This returned immediately after I received the second vaccine and did not let up until mid October.
8 1/2hr p/vax pt devel sl nausea, followed by uncontrollable shaking & teeth chattering;p/a period of rest pt devel a fever;T max 102 orally;had one other episode of violent shaking w/in the next 12hr;temp remained elevated for 36hr;
I am having a feeling like I am in shock; I woke up last night not feeling right and this; Irregular heartbeat/Pulse 112/Pulse 108/went to 112; checked blood pressure, the lower number was high, upper number lower than what it usually is/130/96/then 110/78; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL3247) via an unspecified route of administration on 21Jan2021 10:00 am at single dose in left arm for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medication included ongoing atenolol for high blood pressure, ongoing amlodipine for high blood pressure, ongoing lisinopril for high blood pressure. The patient received the Pfizer COVID-19 vaccine at 10 am yesterday, her symptoms started last night and came on suddenly. She went and checked her blood pressure on 25Jan2021, the lower number was high, upper number lower than what it usually is, it was exactly: 130/96, Pulse 112, then 110/78 Pulse 108, after taking her medication. Her pulse went to 112, it does that when it gets irregular, it did get better after blood pressure medication atenolol. She woke up last night not feeling right and this morning, she was having a feeling like she was in shock. She developed an irregular heart beat last night on 25Jan2021. It is still bothering her. She had her first shot on Thursday of this past week. She is unsure if this is a side effect. Received the vaccine on 21Jan2021. She says it feels like it is right before you pass out. No treatment received. She is supposed to take blood pressure medication but she is being cautious right now. Her blood pressure medications are: Atenolol, Amlodipine, Lisinopril. She did not take them this morning, all have taken for years. Event outcome of irregular heartbeat was not recovered, while for others was unknown.
NO ADVERSE REACTION REPORTED. A PFIZER VACCINE WAS ADMISNISTERED TO A PATIENT AFTER BUD OF 7/22/22. PATIENT, RECIEVED A PFIZER BOOSTER SHOT 5 DAYS AFTER BUD. The medical/safety team at Pfizer WAS CONTACTED AND indicated THE DISCOVERING PHARMACIST they do have stability but not efficacy data on the adult Pfizer vaccine beyond 72 days when stored in a refrigerator. They recommended that our rph contacts the CDC and inquires about repeating doses for these patients. Speaking with the CDC employees, our rph was given the same information as above and referred to the immunization division at the DOH.  Our rph contacted the DOH in the state, but she was asked to confer with either Medical Doctor or the standing order physician. Our rph was able to interact with the latter, and she was given the guidance of re-vaccinating . In the context of the guidance from the standing order physician, the patient will need to repeat the dose. Regular schedules for series completion/booster doses will be observed if/when warranted.
This spontaneous prospective pregnancy report was received from a medical assistant concerning a 21 year old female patient. The patient's medical history included syndactyly, low grade squamous intraepithelial lesion (LGSIL), cervical dysplasia (CIN 1) and CIN 2. On 16-NOV-2017, the patient was vaccinated with GARDASIL 9 lot # N012093 dose 1 for prophylaxis (dose, route of administration and expiration date were not reported). Concomitant therapies included nitrofurantoin(manufacturer unknown) for urinary tract infection (UTI). The patient became pregnant with last menstrual period (LMP) of 20-OCT-2017, and estimated date of delivery (EDD) of 27-JUL-2018. Initial exposure to GARDASIL 9 was at 4 week(s). On 16-NOV-2017, the patient experienced exposure during pregnancy (first trimester of pregnancy). On 12-DEC-2017 an ultrasound was performed, results were not provided.
pt recv vax 14JUL97 & 17JUL97 pt exp h/a, joint pain, vomiting & worsening diarrhea;also exp rt upper quadrant pain in & around the liver area @ the base of the rib cage, that worsened when eating or drinking;24JUL97 chest pain;