chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it burnt when the injection went in; huge bruise at the injection site; could not move her arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site burning in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 14th September 2020, the patient received the 1st dose of Shingrix. On 14th September 2020, immediately after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site burning. In September 2020, the patient experienced injection site bruising and injected limb mobility decreased. On an unknown date, the outcome of the injection site burning was unknown and the outcome of the injection site bruising was not recovered/not resolved and the outcome of the injected limb mobility decreased was recovered/resolved.   It was unknown if the reporter considered the injection site burning, injection site bruising and injected limb mobility decreased to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported, but the patient was in her 50's. On 14th September 2020, the patient received Shingrix vaccine at left arm and reported that it burnt when the injection went in, which led to injection site burning and on the same day, the patient also received the flu shot and did not experienced pain, redness or swelling at the injection site, right arm. Patient also reported that she could not move her arm for several days, which led to injected limb mobility decreased . Pharmacist reported that five days later the patient had a huge bruise at the injection site and the vaccine appeared to had been administered higher up the left arm upper deltoid muscle, which led to injection site bruising. The reporter did not consented to follow-up.
Returned to office 1hr after injection with petechial rash on left face and neck slowly already to right side. Itching developed while in office. No other symptoms. Gave ED precautions and recommended Benadryl for itching. Scheduled follow up in 2 days.
PATIENT REPORTED RASH AT SITE OF INJECTION 2 DAYS AFTER RECEIVING FIRST DOSE; ON THIRD DAY, PATIENT REPORTED RASH ON CHIN (SEPARATE-NOT CONTINUOUS)
Pt reports Receiving shot on Monday, being extremely tired the day after receiving the shot on Tuesday, and then experiencing full body itching on Wednesday, which lasted for 3 to 4 days resolving some time on saturday. Pt reports self administering benadryl q 6 hours during that time to alleviate the itching. has had no additional itching since then,
01/20/22 presents to ED as  transfer from facility "Dyspnea, Mental Status Change" "intracranial bleed". PMHx of "DM, HTN"
Developed left sided facial rash 50 minutes after receiving 1st dose of Pfizer vaccine. No swelling, itching, pain. No respiratory symptoms. Seen by clinic on day 2 of symptoms; symptoms unchanged. Erythematous, coalescing papular rash on left cheek, scattered on chin, and few lesion on upper chest.
Severe and prolonged Migraines lasting every day for 5 weeks; severe fatigue
This spontaneous report has been received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent condition, drug reactions/allergies and concomitant medication were not reported. On 01-FEB-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection (lot # M009378; expiry date: 23-APR-2018) (dosing details were not reported) for prophylaxis. Nurse reported that the vaccine was exposed at >46 F but <77 F for 2 hours 36 minutes. There were no previous temperature excursions. Data Logger was involved. No adverse effects were reported. Additional information has been requested.
headache; This is a spontaneous report received from a contactable consumer (Patient). A 72-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: ER87347), via an unspecified route of administration in Arm Left on 08Apr2021(age t vaccination: 72-years-old) as first dose, single dose for covid-19 immunization. (Vaccination Facility Name: Hospital hosted the event). Medical history included cardiac pacemaker insertion from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing. Concomitant medication was not reported. It was reported on 08Apr2021 after first dose of the vaccine she experienced headache for 8 days now, first started half an hour after getting vaccinated and it just has not stopped. patient asked for treatment recommendations. She has a question about her headache. She was asking is there anything she can do to stop the headache. She has had a headache every day for 40 years. But this headache was different. She normally gets migraines, but she has not had any lately. Patient did not require ER and physician office visit. The outcome of the event was Not resolved.  No follow-up attempts are needed. No further information is expected.
Patient was administered dose of the Moderna COVID-19 vaccine from an expired vial.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered dose of the Moderna COVID-19 vaccine from an expired vial.) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0J1021A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered dose of the Moderna COVID-19 vaccine from an expired vial.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered dose of the Moderna COVID-19 vaccine from an expired vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.
Patient is a 68 y.o. female admitted to the hospital on 10/19/2022 for with nausea, poor p.o. intake and worsening renal function on blood work.   Discharge Diagnosis and Associated Hospital Course   AKI on CKD3b None anion gap metabolic acidosis Kidney transplant Secondary to ongoing GI losses and diarrhea known h/o ESRD s/p renal transplant 1.5yrs ago. Follows with Dr.  -Baseline SCR appears to be around 1.2 -Tacrolimus level stable -UA negative renal US nonacute -stool PCR negative, COVID-19 positive.   -Continue Myfortic 540 mg q12h, Bactrim DS daily. Hold Chlorthalidone, tacrolimus. -Dexamethasone for Immunosuppression while off tacrolimus now restarting tacrolimus so stopped dexamethasone -IV fluid stopped as diarrhea better and eating better    Infectious diarrhea-improving COVID-19 infection Hypokalemia Ongoing diarrhea likely secondary to COVID-19 infection as well as Myfortic. -Maintained on room air, no indication for dexamethasone or remdesivir at this time. -S/p monoclonal antibody treatment 10/21 -Continue aggressive potassium replacement -nursing state diarrhea significantly improve,   Acute on chronic anemia Likely due to ongoing infection, AKI.  No blood loss noted. -Chronic component due to iron deficiency, recently started on iron. -Hgb around 8 on admission.  Hgb 6.3 on 10/21.  S/p 1 unit PRBC -Continue transfusion for Hgb <7 today 8   NIDDM2 with ckd3b -A1c 7.0% on 1/22/22. BG at goal.  Appears to be diet controlled -Continue sensitive corrective scale while inpatient. HTN Known history. Patient reports BP low normal with HR ~50 at home recently; she holds Procardia and Coreg for SBP<150. -Hypertensive on admission. -Continue home Procardia XL 60 mg q12h, Coreg 12.5 mg q12h. Hold home Chlorthalidone 25 mg qhs due to AKI.   HLD: Continue statin. Resume home Crestor 20 mg qhs on discharge. GERD: Continue home Pepcid. COPD: Not in exacerbation. Continue home Breo Ellipta.  OSA:Continue BiPAP while inpatient. Major recurrentDepression: Continue home Zoloft 50 mg qhs.  RLS: Continue home Requip 0.5 mg qhs.  Gout: Continue home Allopurinol 100 mg qhs.
pt recv vax 23OCT95 & 20MAY97 pt devel gen rash on face & neck;
Received vaccine at 8:45am. Face felt hot and developed hives at 11:15am. Took Benadryl 25mg at 1pm. Continued to work. Two Pepcid and ice at 2:30pm. Had little improvement. Took Claritin at 4:30pm then Benadryl 50mg. Symptoms resolved that am - no further issues.
mom states baby felt warm, but had not checked the babies temp, after checking Mom reported it being 99.9
Positive PPD skin test/Skin test flaring and still growing 5 days after administered; Positive PPD skin test/Skin test flaring and still growing 5 days after administered; This is a spontaneous report from a non-contactable nurse. A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), intramuscular (left arm) first dose on 21Jan2021 12:00 at single dose for Covid-19 immunization.  The patient's medical history includes PPD skin test positive from 21Jan2021 3 hours prior Pfizer covid 19 vaccine injection. The patient's concomitant medications were not reported.  On 21Jan2021, PPD skin test done 3 hours prior Pfizer covid 19 vaccine injection on same left arm, Positive PPD skin test with clear x-ray with no history of positive PPD skin test. The patient had a separate negative PPD skin test in 2018 with negative results. On 23Jan2021 12:00, the patient skin test flaring and still growing 5 days after administered. Again the patient got the skin test the same day as the vaccine and have no history of a positive PPD skin test. The patient did not received treatment for the event. The outcome of the event was recovering.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained. No further information is expected
Patient reports feeling fever and chills as well as mental status changes 2 hours after receiving vaccine. Since then, patient reports intermittent chills with or without fever that correspond with worsening daytime fatigue and a sense of sleepiness, as well as cold sweats and flushing. These symptoms have continued for almost 4 months, with the patient noting persistence of symptoms at 3 separate emergency department visits and 3 separate primary care visits. Most recently, this reaction has been described as a severe urticarial reaction by her primary care physician. Patient reporting that these symptoms are threatening every day life, that they are too much on her system, she can only sleep, and cannot get anything done. Patient has been counseled multiple times that symptoms will resolve with time, but patient continues to have symptoms almost 4 months since vaccination.
Covid vaccine kicked his butt; This is a spontaneous report from a contactable consumer, the patient.  A 33-year-old male patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that the covid vaccine kicked his butt. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Uncontrollable shivering and teeth chattering despite feeling very warm, appx 16 hrs after shot, lasted 3 hrs. Very sore injection site/shoulder x 3 days, extremely sore day after shot. General malaise and lethargy x48 hrs post vaccine.
Initial case received from a consumer, who is also the patient, via another manufacturer under reference number 20800281403USA013674 on 15 April 2014. A 64-year-old female patient received tetanus toxoid vaccine (manufacturer and lot number not reported) on an unspecified date, and later experienced the reaction of "paralyze from top waist for ten days". The consumer reported this reaction as an allergy to tetanus. No additional information was reported, and outcome was unknown. Of note, the primary reporter (consumer) did not provide any contact information; as a result, no follow-up requests will be sent. The other manufacturer (Merck) has agreed to forward any additional information received. Documents held by sender: None.
I tested positive for COVID-19 on December 18, 2022. I had a mild cough and a temperature that ranged from 99.9-degrees to 101.8-degrees. I had a slightly runny nose and some nasal congestion. He prescribed molnupiravir because I was not a candidate for PAXLOVID. I tested positive for COVID-19 for a full week. On the 9th day, I tested negative for COVID-19.
took nap-woke up almost non-responsive wouldn't move legs-pale-BP 120/70, 1/2 hrs unconsolable cry=when left ER color pink;
Information has been received from a physician concerning a 21 year old female who was vaccinated with 3 doses of GARDASIL more than 3 years ago. In June 2010, the patient experienced low grade squamous intraepithelial lesion (LGSIL). On 20-JUN-2010 papanicolaou smear was performed and revealed HR HPV positive. At the time of the report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sore arm after the 1st dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after the 1st dose of the Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after the 1st dose of the Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Sore arm after the 1st dose of the Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication provided.  No treatment drugs were provided.
A report has been received from a Health Professional concerning a 1 year old, Male subject, who had been received Nasal FLUMIST QUADRIVALENT (intranasal) 0.2 Millilitres. FLUMIST QUADRIVALENT (intranasal) started on 09-Nov-2015. Reporter stated that 18 month old boy was inadvertently administered FLUMIST. The outcome of the event (s) of inadvertent administration to 18 month old is unknown. The reporter's description of the event(s) was as follows: Boy has some slight asthma but he was given an inhaler a year ago and hasn't really needed it ever since then. The report was considered to be non-serious.
After injection of Gardasil vaccine 0.5 ml, Pt was sitting talking to her mother. She became pale and passed out for a few minutes. She was revived and walked to exam table. After lying down for 15-20 min.-left the office doing well.
Pt developed redden rash, itching, and whelps to arms and face. Pt also c/o throat feeling funny. Pt was given Benadryl and Epi IM and transferred to hospital per EMS. Spoke patient the following day 5/11/21 states she was home feeling better. Denied any problems at that time
Local 4x6 cm pink mildly pruritic rash at injection site left deltoid within 15 minutes.  Resolved completely within several hours.
Received 1st dose on 3/4/99 and pt does not recall any adverse reactions. Received 2nd dose on 4/7/99 and had body aches, pain all over, flu-like symptoms and continues to have pain in lower back, hips, knees, hands, feet and toes. Knees swollen and muscle aches.
5 hours after receiving the vaccines, the patient was unable to walk due to leg pain. He could no longer stand/walk, even when taking Tylenol. The patient was crying whenever he tried to put any weight on his legs. The next morning, the patient was still experiencing pain. 24 hours after vaccination, he was able to walk, but still limping, moving slower than normal, and needing to take Tylenol to alleviate pain.
After pt receive Pfizer first dose, pt admitted to receiving Sinovac full series to nurse. RN previously screened pt if they have gotten a different COVID vaccine before and pt stated "no". RN notified proper agency.
Headache (Tylenol didn't help, sumatriptan  was taken) triggered 2 days migraine Chills muscle pain nausea pain in the arm (shot) dizziness
mild headache next day; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2021, the patient received Shingles vaccine. In November 2021, 1 day after receiving Shingles vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient. The age at vaccination was not reported. The patient received her dose of Shingles vaccine, last week of reporting date. The patient got mild headache next day of vaccination. The reporter did not consent to follow-up.
Cognitive, behavioral, psychiatric within 1-2 hours.  Adult left home and wandered for over 22 hours before being found by police in heat no phone keys etc.  required filing a missing persons report.  Still doing neuro work up.
The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022; Administered with vaccine that is past beyond the 30 day use; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2022 at 8:30 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2022 at 8:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date vaccine removed from freezer to refrigerator 27-Apr-2022 1020. Date vaccine administered to patient 28-May-2022 0830. No adverse events have been reported by the 7 patients at the time of the call. No treatment information was reported.
On the afternoon of 1/23/21, I began having achiness and fatigue, which lasted through 1/26/21. Headache, nausea, and fever ranging from 99.1-100.9 also experienced with onset on 1/24/21 through 1/25/21.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of Sore arm in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced Sore arm. At the time of the report, Sore arm outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
severe anxiety; depression; circadian rhythm dysfunction; feeling tired in the middle of the day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 12:00 (Lot number: EP6955) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Feb2021 (unspecified if ongoing), notes: I had COVID in mid february(mild case). Concomitant medication(s) included: PANTOPRAZOLE; ROSUVASTATIN. Vaccination history included: Bnt162b2 (Covid vaccine details: Product COVID 19, Brand Pfizer, Lot number 6205, Lot unknown False, Administration date 27Feb2021, Administration time 12:00 PM, Vaccine location Left arm, Dose number 1), administration date: 27Feb2021, when the patient was 34 years old, for Covid-19 Immunization, reaction(s): "Sleeplessness", "tingling burning in arms", "tingling burning in arms". The following information was reported: CIRCADIAN RHYTHM SLEEP DISORDER (non-serious) with onset 22Mar2021, outcome "not recovered", described as "circadian rhythm dysfunction"; FATIGUE (non-serious) with onset 22Mar2021, outcome "not recovered", described as "feeling tired in the middle of the day"; ANXIETY (non-serious) with onset 24Mar2021, outcome "not recovered", described as "severe anxiety"; DEPRESSION (non-serious) with onset 24Mar2021, outcome "not recovered", described as "depression". The events "circadian rhythm dysfunction", "feeling tired in the middle of the day", "severe anxiety" and "depression" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of circadian rhythm sleep disorder, fatigue, anxiety, depression.  Additional information: Facility type of vaccine was noted as other MA (unspecified) mass vaccination site. The patient had no other medical history and had no known allergies. Prior to vaccination, patient was diagnosed with covid-19 and post vaccination, patient had not been tested for covid-19. Patient have not received other vaccine in four weeks. It was reported 2 days after (on 22Mar2021) getting the shot, patient developed circadian rythym disfunction that lead patient to have continuous sleep pattern disruption, feeling tired in the middle of the day, unable to fall asleep or stay asleep, and then 2 days after that (captured as on 24Mar2021) developing severe anxiety and depression that came in waves. Patient never had anxiety or depression before this.  No follow-up attempts are possible. No further information is expected.
Patient received first SHINGRIX vaccine a little over 2 months ago. Patient had had a "funny bone like pain" in his arm he received the shot ever since. This occurs with pressure or when he applies pressure to something else with his arm. Goes all the way down his arm.