chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open.  (headache is not uncommon for me but the extreme drowsiness is).   I slept solid through the night (unusual) and the puppy woke me around 5am. (ususal)  I felt that i had a heavy? head.  My thoughts seemed clear but my head had a fullness to it.  Its difficult to describe.  I was not stuffy.  I had trouble staying awake, to the point I was nodding off at times I should have been able to stay awake.  I did not feel safe to work and felt obligated to call in.  I slept solidly for the next 5 hours.  Later in the day, my affected arm began to have pain radiate from the injection site to my wrist.  (probably not unusual).  600mg of Ibuprofen did not seem to help much.  By the time I went to bed last night (24+ hrs after receiving the vaccine) I noticed my axillary nymph nodes were extremely tender to the touch and remain so this morning.  The pain in my arm still continues to radiate to my wrist but not as intense.
Following the vax, the pt experienced a hard, red, raised area on the right arm at the site of injection. This was hot to the touch and tender. The pt also experienced intermittent fever and chills. On exam on 6/19/00, the area remains hard, red, and tender. Measures 5 1/2 x 3 1/2.
This is a spontaneous report from a contactable physician. An 18-year-old patient of an unspecified gender received TRUMENBA, via an unspecified route of administration on 26Jun2017 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was pale, shaky, and had fever of 101.7 on 26Jun2017, an hour later after vaccination. There was no rash, no hives , and no shortness of breath. Outcome of the events was unknown. Follow-up activities are possible and information on the batch number has been requested.
Information has been received from a physician concerning an 18 year old female who was vaccinated with the third dose of GARDASIL vaccine (yeast). One week later, the patient experienced diffuse bruising over entire body. Patient outcome was unknown. No further information is available.
I got cills; low grade fever; achy; arm is still is red; arm is still /swollen; 1st dose given subcutaneously; I did get diarrhea / (have had that for two days); This case was reported by a other health professional and described the occurrence of erythema of extremities in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 2nd dose of Shingrix (subcutaneous). In December 2020, less than a week after receiving Shingrix, the patient experienced erythema of extremities, swelling arm, pain, diarrhea and intramuscular formulation administered by other route. On 19th December 2020, the patient experienced chills and low grade fever. On an unknown date, the outcome of the erythema of extremities and swelling arm were not recovered/not resolved and the outcome of the chills, low grade fever, pain and intramuscular formulation administered by other route were unknown and the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm, chills, low grade fever, pain and diarrhea to be related to Shingrix.  Additional details were reported as follows: The reporter was an office supervisor. The reporter stated, they found the massage about the patient who got the Shingrix shot subcutaneously instead of intramuscular route, which led to intramuscular formulation administered by other route. On 21st December 2020, the patient contacted through patient satisfaction survey and stated that, the nurse gave Shingrix dose in the back side of arm and said it needed to be in a fatty part of arm and not in the muscle. The patient added, she never got a shot there. The patient searched about this and got to know that, the shingles shot needs to be given in the arm muscle. The patient asked if this shot remain effective since it was not given in the muscle. The patient had side effects like her arm was still red and swollen. On Saturday, she got chills and a low grade fever and was achy. She got diarrhea for two days. The patient stated it might be due to the shot was working.
Continuing after the first dose, when I received the second dose it made the current arthritis flare up worse. When I saw my rheumatologist on 09/20/2021, he saw that I was in a flare up and had recommended some new meds for me. I did not change the meds, and I was supposed to come back on 11/23/2021. I saw him and he thought my hands "looked the worst they have been in forever" and recommended to follow up in a few months and if its still bad, then he would insist to switch meds. By about January, the flare up had subsided and the swelling was reduced. I have not followed up since due to another issue going on. I have an appointment for 03/16. I had the flu shot at some point between the 2nd shot and the booster. On 10/25/2021, I saw my dermatologist who said my skin looked bad (psoriasis flare up).
severe toothache; my toothache is better now but my face is swollen up a bit; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (severe toothache) and SWELLING FACE (my toothache is better now but my face is swollen up a bit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced TOOTHACHE (severe toothache) and SWELLING FACE (my toothache is better now but my face is swollen up a bit). At the time of the report, TOOTHACHE (severe toothache) and SWELLING FACE (my toothache is better now but my face is swollen up a bit) outcome was unknown.            No treatment information was reported.
Severe headache for 5 days continuously.  I took a Rizatriptan 2 times and i took several doses of ibuprofen or Excedrin over the 5 days.  The pain of the headache caused nausea and vomiting.  I treated myself and did not see a doctor.
VACCINE ADMINISTERED AT 1425.  10 MINUTES LATER IN OBSERVATION AREA @ 1435, CLIENT C/O FEELING, "WARM RUSH, LIGHT-HEADED, AND PULSE BEATING OUTSIDE OF MY NECK." VITALS: 212/107 (R WRIST), 115, 96% O2 SAT, RR16. CLIENT STATED THAT HE, "PARTIED ALOT FOR MY BIRTHDAY YESTERDAY"... I.E. DRANK EXCESSIVE ALCOHOL.  HE ALSO STATES THAT HE HAS 3-4 WHISKEY DRINKS/WEEK. OCCASSIONAL SMOKER (CIGARS) ONCE/MONTH.  CLIENT DENIES A HX OF HEART DISEASE, RESPIRATORY ILLNESS, OR ANY SIGNIFICANT HEALTH HISTORY. HE CLAIM TO BE ALLERGIC TO AMOXICILLIN. MATERNAL HX OF HTN AND PATERNAL HX OF DM.  ENCOURAGED CLIENT TO ALLOW TO BE TRANSFERRED TO HOSPITAL FOR ELEVATED BP AND HR. HE AGREED AND EMS WAS CALLED AT 1445 AND ARRIVED AT 1450. CLIENT TRANSPORTED TO UNIVERSITY HOSPITAL.  CLIENT HESITATED TO ALLOW FOR TRANSPORT DUE TO NOT HAVING INSURANCE BUT WAS ENCOURAGED BY NURSE AND HE COMPLIED.
Itchy armpits, and then cyst developed under left armpit.  The cyst is about an inch in diameter. I'm having it removed this week.
pt work in the morning 2 weeks after second shot with L facial paralysis without evidence of CVA, diagnosed with Bells Palsy
NO MAJOR ADVERSE EVENT REPORTED BY PATIENT. In this case, Comirnaty (mono-valent) covid vaccine was administered instead of Bi-valent vaccine that was due.She was due for a booster and a previous moderna Bi-Valent dose on 12/17/22. Patient reported a sore arm for a day or two and feeling slightly feverish the next day. I contacted the patient regarding  the immunization and we will schedule a Bi-Valent covid vaccine in the future per timing protocol.
Pain, tingling and muscle weakness in legs. Went to the ER, stayed overnight while they ran a CT scan, MRI, blood work, and a lumbar tap. All tests came back negative.
About 12-14 hours following my second vaccine, I began to experience intense, widespread nerve pain.  I experienced pain all over my body for almost 12 hours, with some relief from Tylenol, Advil, bio-freeze and warm baths.  It felt like the tissue holding my skin to my musculoskeletal system was on fire.
pt recv vax 23APR96 & pt learned was pregnant;LPM 20MAR96;MD noted that the pt was warned about the risk of vax during pregnancy & did not mention that menstrual period was late;16MAY96 pt underwent elective abortion
constipation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 21Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONSTIPATION (non-serious) with onset Apr2021, outcome "unknown", described as "constipation".  Additional information: Reporter: Sister. NDC number: Not Provided. Reason for no lot number: Caller unwilling to complete the report. Caller stated her sister was experiencing constipation since getting her Pfizer Covid Vaccine. Verified with caller that her sister did receive the Pfizer Covid Vaccine. Caller verified she received it on 21Apr2021. Caller declines to complete report for sister; therefore, no further details obtained.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4-5 days post flu shot client c/o migraine headaches and pain behind eyes. Per client stated PCP said it was due to the flu shot. Went to ophthalmologist and was told nothing wrong with her eyes.
On 12/24- vomiting, severe chills, diarrhea  On 12/26- woke up with head cold symptoms- stuffy nose, sinus pressure, fatigue.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 4:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 4:07 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 24.43 for dose administered on 15-Apr-2021.  No concomitant medications were reported.  Vial was moved to fridge on 06-Apr-2021. Product moved to clinic on 15-Apr-2021. Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. Beyond use date for the vial was reported as 09-May-2021. 18 vials from this batch were sent to the clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous report as received from an allergist refers to a 73 years old female patient with penicillin allergy, hypertension and hyperlipidemia. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on 04-JUN-2012. No other co-suspect were reported. No concomitant medications were reported. The allergist was attending the patient for pruritus two days after receiving the vaccination on 06-JUN-2012. The patient was experiencing itching bilaterally on her mid back and on her popliteal region and the itching was responding to antihistamine therapy. The allergist stated that the patient was taking cetirizine, diphenhydramine and SINGULAIR (related case # 1208USA011923) in unspecified dosages. The outcome of pruritus/itching bilaterally on her mid back and no her popliteal region was reported as not recovered. The relatedness for pruritus/itching bilaterally on her mid back and no her popliteal region was not provided for ZOSTAVAX. Additional information has been requested.
dizziness, coughing , and headaches    visit ER and got  prescribed  medicine to stop coughing
Frequent thirst, frequent urination, bed-wetting after a year of sleeping through the night.
Painful, sore, itchy rash (only on the site of injection) tried to call doctor - weekend unable to reach her.
Patient came to Clinic on 2/19/22 for c/o agioedema/difficulty swallowing and chest/left arm and neck pain. Patient received a prescription for Epi pen for use as needed due to history of angioedema and current complaints. EMS was activated and transported patient to ED. Per patient report, she was discharged home on oral steroids after ruling out cardiopulmonary abnormalities.
After vaccine headaches, nausea, muscle pain, after 45 days significant change of behavior later child has been diagnosed with Autism.
Information has been received from a physician concerning a 75 year old female with no allergies who on 17-SEP-2007 was vaccinated with a single dose series of Zostavax (lot # 658211/0884U). Concomitant therapy included unspecified therapies. There was no illness at the time of vaccination. On 20-SEP-2007 the patient developed "irothemas" rash that started in the webbing of the patient's fingers. The rash was also at the injection site and then went from the patient's arm, legs, palms and lips. The physician treated with patient with ZYRTEC. A product quality complaint was not involved. Additional information has been received from a physician who stated that the patient was diagnosed with erythema multiforme and was referred to a dermatologist. At the time of report the patient had recovered. The patient's experience was considered to be an other important medical event by the reporter. Additional information has been requested.
A third Shingrix dose was accidentally administered to the patient. She completed a two-dose series on 05/2018. At the time of this writing, no adverse reactions have been reported. I informed patient about the extra dose and then I contacted the manufacturer, GSK and spoke with their medical information team. They provided me with some literature about the safety of 3 doses of Shingrix, specifically in immunocompromised individuals and that no serious complications from third doses were reported. I contacted patient and informed her of this information.
Fever above 101 degrees Fahrenheit for approximately 16 hours. Fever reached 102.6 degrees Fahrenheit at 1:00 pm.
Dizziness, stiff neck, ears clogged, headaches.  Treatments: physical therapy, vestibular therapy.  Improved from worse symptoms, but still have recurring flare-ups.
Uncontrollable shaking for 3 hours as if having a very high fever. But, I never have a fever.  I took Tylenol every 4 hours and would start sweating an hour after taking it.
general listlesness; R arm soreness approx. 12-36 hours post-dose; fatigue; DOSE 3 (BOOSTER), SINGLE; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection), administered in arm right, administration date 08Nov2021 (Lot number: FF8841) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU, administration date 23Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 16Feb2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Nov2021, outcome unknown, described as DOSE 3 (BOOSTER), SINGLE; LISTLESS (non-serious) with onset 09Nov2021, outcome recovered(2021), described as general listlesness; VACCINATION SITE PAIN (non-serious) with onset 09Nov2021, outcome recovered(2021), described as R arm soreness approx. 12-36 hours post-dose; FATIGUE (non-serious) with onset 09Nov2021, outcome recovered(2021), described as fatigue. Therapeutic measures were not taken as a result of listless, vaccination site pain, fatigue.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. List of any other medications the patient received within 2 weeks of vaccination: no. Known allergies were reported as No. The patient received Flu vaccine as other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.
Two days after receiving my booster shot I came down with vomiting, diarrhea, high fever, headache, weakness, chills, inability to eat.  The diarrhea and vomiting pursued for several hours.  The fever persisted for another day and a half.  At a day and a half after the onset, i feel like I'm recovering.  I might have thought it was food poisoning,  but there were 3 other people who ate the same things the day prior to onset.  I had mild symptoms of fatigue and soreness with the first Pfizer shot, no symptoms with the second.
Chest tightness; BPs 131/84 (pulse 92), 133/88 (pulse 87). Given water and crackers.
Erythema, swelling, tenderness on 2/3 of arm below injection.
Information has been received from a physician concerning a around 25 year old female with drug allergy of TYLENOL and ibuprofen and with no other pertinent medical history who in January 2010, was vaccinated with a dose of MMR II post partum. In January 2010, 7 days post vaccination, the patient developed generalized papular rash. No labs were performed. The patient's generalized papular rash persisted. The patient sought medical attention by calling the physician. Additional information has been requested.
Came down with COVID / Tested positive; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Came down with COVID / Tested positive) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and second dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Came down with COVID / Tested positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Came down with COVID / Tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medication was reported.  Reportedly, the patient had primary doses of AstraZeneca and came down with COVID and was taking Paxlovid. Patient tested positive and confirmed had COVID prior to taking Paxlovid.  Patient had a total of 5 doses. All of patient's doses were AstraZeneca and Moderna.
Immediate swelling red and itchy at injection site, headache within 2 hours, upper arm, shoulder and neck pain within 4 hours Applied alternate heat and cold therapy at injection site, OTC pain relievers every 6-8 hours UTI within 48 hours - pain and frequency urge with no flow, unusual low back pain, low grade fever
The patient received an expired vaccine (12/31/21). The patient is not reporting any adverse events at this time.
Dose Number:3; Heart palpitations 4days after second and third mrna vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 12:00 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hbp" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 01May2021, when the patient was 58 years old, for COVID-19 immunization, reaction(s): "Heart palpitations 4days after second and third mrna vaccination"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 01Apr2021, when the patient was 58 years old, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: IMMUNISATION (medically significant) with onset 01Dec2021 12:00, outcome "unknown", described as "Dose Number:3"; PALPITATIONS (medically significant) with onset Dec2021, outcome "not recovered", described as "Heart palpitations 4days after second and third mrna vaccination". The event "heart palpitations 4days after second and third mrna vaccination" was evaluated at the emergency room visit. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of palpitations. Treatment included: Beta blocker's. Mag. Device Date: 24Dec2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red, itchy rash occurring all over body in skin folds. Began about 48hrs after vaccination, no change in lotions/body care items/detergents or medications for 3 months prior.
Possible secondary infection ie) scratching forearm, itching with vaccinations.  Redness, warmth and 1-2+ swelling of L arm, mid upper arm, elbow, and lower arm (started 12-13-07).  Injection sites not red.  Treatment: 1) ibuprofen 100 mg/5 ml 7.5 ml Q 6-8 hrs., 2) Dephenhist 1-2 tsp. TID.