chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HPI: Cough began 12/7/08 then persisted with worsening symptoms, including post tussive emesis x 1. PMHx: has had rare episode of RAD in past - last episode remote from FLUMIST administration on 11/11/2008. Acute symptoms. Have not had f up assessment as of yet.
1st Shingrix shot on 11-25-2019 - no adverse reaction.  2nd Shingrix shot on 2-18-2021.   Late in the evening of 2-21-21, left eye was scratchy & irritated.  Condition worsened by morning with redness and a crusty discharge.   Went to Urgent Care morning of 2-22-21.  Initial diagnosis was possible bacterial infection. Rx for Ciprofloxacin.  No improvement so returned to Urgent Care 2-24-21.  Slit-lamp exam revealed dendritic lesion on cornea - diagnosis of dendritic keratitis. Referred to ophthalmologist. Saw ophthalmologist afternoon of 2-24-21.  Image taken of anterior segment. Assessment:  Dendritic keratitis of left eye due to herpes simplex virus.  Artificial tears recommended. RX for valACYclovier HCl-1 - 1 gm oral tablet. RX for Zirgan 0.l1% ophthalmic gel was not approved by insurance company.  Rx for Trifluridine added several days later.  Follow-ups with ophthalmologist on 2-26-21 and 3-3-21.  Advised lesion was gone and no scar tissue was visible.  Condition slowly improved over the next week but irritation upon awakening continued for an additional week or so.  The event was extremely stressful as I feared I would suffer with permanent scar tissue resulting in impaired vision.  NOTE:  I had shingles under my eye (thought it was under my right eye, but one of the ophthalmologists said it was likely under my left eye) when I was between 11-14 years old.  PCP does not think the dendritic keratitis was a reaction to the Shingrix vaccine but the timing is very suspect.
9/22/10 2AM Mother states child "running 102 degree F plus temperature and rash all over body".
24 HOURS AFTER VACCINE INJECTION, EXPERIENCED DIARREA, RUNNY NOSE AND CHILLS - NONE WERE MAJOR ISSUES
8 DAYS ONGOING, NAUSEA, BODY ACHES, NECK MUSCLE TIGHTNESS, LOW GRADE FEVER, DIAPHRESIS, HEADACHES
3/2/17: Had well child check up - received Hep A #1, MMR #1, Varicella #1 at 10 AM. Approx 10 PM, was in carseat - started making strange facial expression; appeared "stiff"; hands shaking, had some spitting up and frothy sputum, suspect febrile seizure - went to ER.
Pt vax /w Recombivax 1-6 hrs post inject.of 3rd dose experienced near collapse, w/severe headache,fever,muscle & joint pain. Persisted 5 days, 4wks later episode of muscle & joint pain /w tongue, clonic contractions. Muscle pain since 1/89
Pt arrived for Pfizer COVID vaccine around 8pm 8/25/21. Directly after giving vaccine, pt fainted forward, was caught (did not hit the floor), pt was feeling nauseous, and slightly throwing up. No EpiPen was administered, ambulance was consulted but felt no need in coming as pt was communicating and breathing normally. Gave water, supervised pt for 15-25 min, felt comfortable enoguht to walk on his own.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions.  Subsequent to patient's inoculation, patient was treated by a healthcare provide for shingles.  As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The outcome of shingles was reported as not recovered.   The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Extreme swelling and joint pain in all joints of arm shot was given, shoulder, elbow, wrist, knuckles. Continued joint pain to date of filing form.
Arm was slightly sore 6-8 hrs after injection...for 3 days, then totally gone. Which seemed normal. BUT one week after that injection (Friday 1/22) I noticed my arm getting very sore, swollen and hot in the same injection site and several inches below?about the size of my palm. It continued to get more swollen and hotter for a couple of days, then a mild red rash appeared covering the whole affected skin surface by Sunday 1/24  & then it all had slowly, basically, disappeared by Wed 1/27 night.
chest tightness similar to symptom of bronchospasm; chest tightness similar to symptom of bronchospasm; This is a spontaneous report from a contactable physician. A 64-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 intramuscular, administered in Arm Left on 22Apr2021 15:30 (Batch/Lot number was not reported) as dose 1, single (age at vaccination 64-year-old) for covid-19 immunisation. Medical history included asthma and gluten sensitivity from an unknown date. Concomitant medications included fluticasone propionate, salmeterol xinafoate (WIXELA INHUB); montelukast sodium (SINGULAIR); fexofenadine hydrochloride (ALLEGRA); pravastatin (PRAVASTATIN); ezetimibe (ZETIA) and bupropion. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced chest tightness similar to symptom of bronchospasm on 22Apr2021 15:45 with outcome of recovered. Therapeutic measures were taken as a result of chest tightness similar to symptom of bronchospasm includes inhaled albuterol. The outcome of the events was recovered on an unknown date in Apr2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
numbness & tingling of legs starting about noon, 19OCT95;next day, 19OCT95 very noticable;seen 20OCT95 no motor deficit;DTR nl;muscle strength nl;paresthesia extends toes to buttocks bilat;
blurred vision; little spots on the inside of her eyelids; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot number and expiry date were unknown), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. Medical history included eyeglasses wearer (reported as with her glasses). The patient's concomitant medications were not reported. The patient is experiencing symptoms from the COVID-19 vaccine received on 18Dec2020. She began to have blurred vision that night, and it worsened over the following weekend. She saw the eye doctor on 22Dec2020, and they stated her vision had changed even with her glasses. Now she has little spots on the inside of her eyelids that were also noticed on the eye examination in Dec2020. She has already reported these symptoms to the V-safe program. She mentioned that she is not the only nurse in the workplace that has experienced blurry vision. She asked if she should receive the second dose on 08Jan2021. It was still blurry, but it was better than it was a week ago. It still affected her reading and seeing at a distance. It scared her to get the second one because she doesn't want to go blind. She went to the eye doctor for visit on Tuesday. The outcome of the event blurred vision was recovering, while for the other event was unknown. The reporter considered blurred vision as serious due to being medically significant.  Information about lot/batch number has been requested.; Sender's Comments: There is not a reasonable possibility that the reported event vision blurred and eyelid disorder related to the suspect product event most likely due to patient underlying contributory factors
Rash at injection site and muscle aches.  Was achy on the morning of 1/28/2021 with 'bumps' on the chest area. Achiness resolved on 1/29/2021 but rash continued affecting her abdomen as well.
Patient described hives developed on trunk, scalp & neck, around 4 pm on 11/9/10. Contacted doctor on call & was advised to take BENADRYL. She took 50 mg & sx resolved 1-2 hrs later.
Pt recvd 1st dose of vax on 11MAR92 & w/in 24 hrs following vax devel hives @ inject site & involvement of lymph nodes; that evening also exp tightness in chest; some itching;
On 11/23/99, the pt experienced breakthrough varicella. Subsequently, the pt recovered from the varicella.
Irregular menstrual cycle/ First cycle after the first dose was a 40 day cycle; extreme fatigue; arm soreness; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 16:00 (Batch/Lot Number: ER2613) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had 23-MAR-2021 19:00, Irregular menstrual cycle. First cycle after the first dose was a 40 day cycle. My cycle is typically 26-28 days and VERY heavy lasting about 5 days. Unknown when it will end. she usually very regular. After getting the vaccine I have no idea when her period is coming. Also, immediately after the first vaccine she experienced extreme fatigue and arm soreness the night of the 1st dose on 23-MAR-2021. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 26Mar2021 Nasal Swab. The outcome of the events was Resolved with Sequel.  Additional information has been requested.
Employee came to employee Health Dept complaining of nausea, hives and tongue feels swollen. Ambulated to Emergency dept with Employee Health staff.
Pt reported left arm pain and tingling, chest pain and left leg pain and tingling. Vital signs were normal, pulse ox 99, HR in 90s. No hypotension. 911 was called and EMS transported the patient to the nearest ED.
Mom came to office with patient today stating that site ((R) arm subq) where VARIVAX was given on 04-19-2011 became red, hot & swollen the evening of vaccination. Mom took patient to ER on 04-21-2011 and was told patient "has an infection in the arm" and was given KEFLEX. Today area of site is red around injection site & slightly warm.
myalgia; pain at the injection site, painful during the injection; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site, painful during the injection) and MYALGIA (myalgia) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jun-2022, the patient experienced VACCINATION SITE PAIN (pain at the injection site, painful during the injection). On 28-Jun-2022, the patient experienced MYALGIA (myalgia). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (pain at the injection site, painful during the injection) outcome was unknown and MYALGIA (myalgia) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  It was reported that it was painful during the injection  It was reported that reporter was awaiting a callback from the pediatrician
None- vaccine given 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
I don't know for sure that my symptoms were a result of the vaccine but  they started soon after and lasted 4 weeks!  I had a rancid taste in my mouth...coming up from my throat!  Tasted like something went inside me and died! I didn't lose my sense of taste or smell.  I was in contact with my doctor I was not tested.  I just waited it out and thankfully it cleared up!  Thought I should report it in case it's helpful?  This happened after my 2nd dose of the same vaccine.  I didn't have any reactions to the 1st one.
Woke up day after shot around 9:30am with a localized pain, left of center, on my left glute muscle.  Other side effects are normal... arm very sore shortly after shot and still sore the next day,  by 8pm on the following day, feeling lethargic with upper body muscle aches and a headache.
This spontaneous report was received from a medical assistant refers to a 2 year old female patient. The patients' pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On 24-APR-2018, the patient was vaccinated with improperly stored dose of VARIVAX lot # N022980, expiration date on 23-AUG-2019 for prophylaxis (strength, dose and route of administration were not reported). A sterile diluent (MERCK) was used to reconstitute vaccines. Vaccines were improperly stored at a temperature between 6°F to 14°F (8.5°F) for 38 minutes. No previous temperature excursions neither adverse effects were reported. The call was because of a data logger. The outcome was supported. Sender's Comments: US-009507513-1805USA000900.
Death, code blue at home, received COVID vaccine 5/20/21.  No known health issues
Client informed RN that he gets lightheaded after getting vaccination because he is afraid of needles. He received the vaccination and started to feel light headed at 1:10 pm. Client was placed on the floor with legs higher.
Report received from a registered nurse on 20-Nov-2009. A female patient received H1N1 (brand unknown) for immunization on an unknown date. The patient has a medical history of allergies to Penicillin, Sulfa and other non-drug items. No concomitant medication was provided. On the date of vaccine administration, the patient immediately experienced weakness, SOB (shortness of breath) and muscle aches. Her reaction did subside a few hours after receiving the vaccination. Additional information has been requested. The company assessed the event causality as possibly due to the suspect drug. Information derived from this AE report does not change the safety profile of the product.
chills; Low grade fever and next day fever of 101.5; feeling fatigue; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received second dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: 0172) via an unspecified route of administration in the left arm on 24Apr2021 at 1700, as a single dose for COVID-19 immunisation. It was reported that patient had no medical history. Concomitant medication included flonase nasal steroid (MANUFACTURER UNKNOWN) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 25Apr2021, the patient experienced fatigue. On 26Apr2021, the patient had low grade fever and on 28Apr2021, the patient had fever of 101.5 and chills. On 29Apr2021, the patient started to experience fatigue and fever again. The clinical outcome of the events fatigue, fever and chills were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
No additional AE reported; 2-dose series of GARDAIL-9. The first dose was administered 4/12/2021 and the second dose was administered 8/27/2021; This spontaneous report was received from a nurse and refers to a 11-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 12-APR-2021, the patient was vaccinated with first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot # T025369, expiration date 01-DEC-2022 (route of administration and anatomical location were not provided). On 27-AUG-2021, they received the second dose in 2-dose series of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot # T025369, expiration date 01-DEC-2022 (route of administration and anatomical location were not provided) (inappropriate schedule of vaccine administered). Both doses were administered for prophylaxis. There was no additional adverse event reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T025369; expirationdate: 01-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Awoke on 6APR91 w/rt hip, im area of inject red, swollen, & heat; To MD that evening was told to use cold pack & DPH, was told was allergic rxn 8APR91 swelling dec 9APR91 just a bruise @ inject site;
He received the vaccine in the L arm and noted no symptoms until about 45 minutes when he developed upper lip swelling. He took acetaminophen and used ice on his lip with eventual resolution after 3 days. He denied swelling anywhere else or any other rash during the time. At the time of the injection, he was taking Lisinopril/HCTZ 20mg/25mg daily and Amlodipine 5mg daily which he started in Feb 2021.  In July 2021, he had a recurrence of lip swelling that lasted for 3 days. He had not changed medications or received any immunization. He treated the swelling as above with acetaminophen and ice with eventual resolution. He did not use an H1 blocker to treat the swelling
Pain at injection site; Swelling at injection site; Joint pain; Body aches; Upset stomach; Fatigue; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2019, the patient received the 1st dose of Shingrix. In September 2019, 10 hrs after receiving Shingrix, the patient experienced injection site pain, injection site swelling, joint pain, general body pain, upset stomach, fatigue and headache. On an unknown date, the outcome of the injection site pain, injection site swelling, joint pain, general body pain, upset stomach, fatigue and headache were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, joint pain, general body pain, upset stomach, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 70 or 71 years. The patient experienced pain at injection site, swelling at injection site, joint pain, body aches, upset stomach, fatigue and headache about 10 hours after the dose. The reporter asked to remain anonymous and did not provide demographics. This case has been linked with US2019161261, reported by same reporter.
Information has been received from a consumer concerning his daughter who on an unspecified date was vaccinated with a dose of ROTATEQ (lot # not reported). Subsequently the patient vomited. The outcome of vomiting was unknown. It was unknown if the patient seek medical attention. No further information is available.
Pt recvd 3 doses of Engerix-B & exp no adverse rxn; HBSAB neg p/completing the series; recvd a booster dose of Engerix-B on 6NOV91 had pos HBSAB p/booster dose;
Varicella rash, Benadryl prn, Tylenol prn
FLUMIST was given to patient 8 days after expired. Vaccine was still in refrigerator and had been stored under proper conditions.
Immediately after HPV vaccine was given while pt is in sitting position-- > pt fainted per LVN and "entire body jerked for a few seconds"  per older sister who witness episode.  Pt remembers the vaccination but does not remember slumping over.  Pt reports feeling normal  and had reassuring exam when I returned to room with blood glucouse 94.  BP96/61.  HR 80.
Mother states the child had a fever of 102, redness, soreness, inflammation and warmth to the left deltoid area. The pt has received Tylenol and ice packs to the area.
I am 69 and received the second/booster Shingles vaccine which had very intense side effects that began on the 2nd day and lasted through the 4th day.  You are stating vague, inaccurate, and safe descriptions of the side effects and you are sugarcoating the most likely reactions which can lead to misunderstandings and unmet expectations it would be more helpful if you included the words   ?intense?, ? most likely?, and ?possibly not able to go to work?.   It is essential to convey the intensity of these side effects when discussing the vaccine's potential reactions. You need to give better explanations to each individual vaccine for instance the shingles shot usually has a very intense reaction.  I had extreme body aches much longer than you give. This went on for over 24 hours and was the most intense for 9 hours.  ibuprofen, Tylenol, or any of those pain relievers wouldn?t even touch it for 8 hours this is ridiculous that you hold back this information. I live in a retirement community and had a discussion this morning with FIVE neighbors None of them had experienced such severe side effects before, and they felt that the CDC, along with doctors are sloppy in not informing you when you get this Shingle vaccine. I asked neighbors if they reported it to CDC and none of them did.  You are very inaccurate when you claim the percentage of people's side effects and extreme aches and I believe you know it.  DO YOUR HOMEWORK and improve the vaccine AND It is crucial to offer a truthful warning that the Shingles vaccine often results in intense side effects of severe body aches, so that individuals can make informed decisions about their vaccinations.  And YES, the vaccine is still better than Shingles, thank you, please CDC be truthful of the vaccine reaction.