chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tenderness at the injection site; Redness at the injection site; Fatigue; muscle weakness; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bone marrow transplant (received in 2016). Previously administered products included Immunosupressive drugs (were stopped a couple of years prior to getting the Shingrix vaccine).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). In January 2019, 2 weeks after receiving Shingrix, the patient experienced muscle weakness. On 29th December 2019, the patient experienced fatigue. On an unknown date, the patient experienced injection site tenderness and injection site erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fatigue was not recovered/not resolved and the outcome of the muscle weakness, injection site tenderness and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the fatigue, muscle weakness, injection site tenderness and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix intramuscularly and experienced muscle weakness and fatigue after one week. He experienced tenderness and redness at the injection.  The reporter consented to follow up. For tolerances of 1st dose, refer case US2020009048, reported by same reporter for the same patient.
a lot of people had loss of taste and smell; a lot of people had loss of taste and smell; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (a lot of people had loss of taste and smell) and ANOSMIA (a lot of people had loss of taste and smell) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced AGEUSIA (a lot of people had loss of taste and smell) and ANOSMIA (a lot of people had loss of taste and smell). At the time of the report, AGEUSIA (a lot of people had loss of taste and smell) and ANOSMIA (a lot of people had loss of taste and smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.  This case concerns a patient of an unknown age and gender, with no reported relevant medical history, who experienced the non-serious unexpected events of AGEUSIA and ANOSMIA. The events occurred on an unknown date, after the administration of a dose of Moderna COVID-19 Vaccine. The re-challenge was not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no reported relevant medical history, who experienced the non-serious unexpected events of AGEUSIA and ANOSMIA. The events occurred on an unknown date, after the administration of a dose of Moderna COVID-19 Vaccine. The re-challenge was not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Heart palpitations occurring 5-10 times a minute with sinus rhythm but irregular heart beat; Heart palpitations occurring 5-10 times a minute with sinus rhythm but irregular heart beat; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration on the left arm on 23Dec2020 09:00 at a single dose for COVID-19 immunization. The patient's medical history included allergies to dust mites, sinusitis, depression. The patient was not pregnant. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR), fluticasone propionate (FLONASE), and lamotrigine (LAMICTAL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 24Dec2020 23:00, the patient experienced heart palpitations occurring 5-10 times a minute with sinus rhythm but irregular heart beat. There is no history of any cardiovascular diseases or abnormal findings. No caffeine or alcohol intake on the day of the occurrence. No treatment was received for the adverse events. Outcome of the irregular heart beat was not recovered while of the remaining event was recovered on 25Dec2020 23:00. The events were considered non-serious.
Received complaint call 2/19/21 from patient regarding administration site being anterior arm for 1st dose of Covid-19 vaccine on 2/16/21. Submitted photos with band-aid placement towards anterior mid-upper arm.  Complaints of pain/discomfort to arm (whole arm) also in shoulder area.  Discussed that arm discomfort can come with vaccination as an expected outcome.  Describes that she did not have pain in arm during injection when administered.  Clients concern is regarding administration and if administered in tissues versus muscle if vaccine will still be absorbed by body and be effective.  Consulted with "medical professionals" regarding technique and was encouraged to call vaccine administration site.
mom reports t98 of 104.4 p/vax;a/that had lower temp ;mom gave motrin;pt did not eat or play during this time;vomited x 1;occ diarrhea
Site of DTaP vaccine (right deltoid) became red, warm to touch and swollen approximately 2 days after vaccine was administered. Pt was started on Keflex 250 mg/5cc 2 tsp po BID on 8/27/03 at approx 8:30 PM. Redness and swelling have improved.
Pain in deltoid; This case was reported by a other health professional via call center representative and described the occurrence of localized muscle pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th December 2019, the patient received Shingrix. On 10th December 2019, less than a day after receiving Shingrix, the patient experienced localized muscle pain. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the localized muscle pain was unknown.   It was unknown if the reporter considered the localized muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain in deltoid after receiving Shingrix. The patient was treated with icepack and Tylenol, with some relief. The reporter consented to follow up. This case has been linked with case US2019226007 reported by the same reporter.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 77-year-old female patient who received SHINGRIX. On 2nd May 2018, the patient received SHINGRIX. On 3rd May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, insomnia, injection site itching, injection site swelling, injection site warmth and discomfort. On an unknown date, the outcome of the injection site erythema, insomnia, injection site itching, injection site swelling, injection site warmth and discomfort were not recovered/not resolved. The reporter considered the injection site erythema, insomnia, injection site itching, injection site swelling and injection site warmth to be related to SHINGRIX. It was unknown if the reporter considered the discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine on last Wednesday. The patient had experienced redness at the injection site which was the size of a baseball, swollen at the injection site, hot at the injection site and itches at the injection site. The patient stated, she did not sleep because it was so uncomfortable. The patient started having these side effects the day after the vaccination and she still had the symptoms persisted at the time of reporting.
Information has been received from a nurse concerning a female patient who in May 2009, was vaccinated with a first dose of GARDASIL (lot # not reported). In May 2009, after received the first dose of vaccine the patient experienced sinus problems and fever. The patient did not sought medical attention. Additional information has been requested.
Ears started itching with thicken of throat She feels like something in back of throat. Was given Steroid & Benadryl by EMT BP 145/90 P=99 O2 = 100%
Child received influenza vaccine at approx 10AM and after 1 day, the site was red with induration of approx. 3"diameter that lasted for 48 hours. No treatment was prescribed. Child has history of allergies to amoxicillin and ceftin.
4 year old female patient developed injection site inflammation after receiving Daptacel, in the left leg on 08/11/2005.  The patient also received IPOL, in the right leg on the same day.  On 08/19/2005, she had swelling leg, tenderness and redness.  She did not have a fever.  She was seen by doctor on 08/14/2005 and was still found with swelling.  She was treated with Tylenol.  At the time of reporting, the patient did not recover. Follow up information received on 09/12/2005.  The gender of the patient has been corrected to male.  He had no illness at the time of vaccination.  The patient recovered.  No further information is expected.
1st dose on 2019, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received Shingrix first dose in 2019.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comments: The reporter stated that a patient who received Shingrix first dose on 2019 and never got second dose. The reporter gave consent to follow up. Additional Supportive Information: The patient never got second dose which leads to incomplete course of vaccination.
This spontaneous report as received from a nurse refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 12-NOV-2014, the patient was vaccinated with a dose of ROTATEQ injection administered orally at dose 2 ml (strength, indication, lot# and expiry date unspecified), that underwent a temperature excursion. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Patient fainted twice after vaccines received, diaphoretic, cool, clammy, and blurred vision.
Bilateral tinnitus began the next morning after the booster at the same time that I experienced the other Covid booster side effects of headache, malaise, and fatigue. The other side effects ended in approximately 24 hrs., but I still have bilateral tinnitus as of 9/16/22.
CHIEF COMPLAINT:   Pt sent from nursing home with sudden onset of right sided weakness and aphagia at 1300 today.  pt has dementia but at baseline is verbal and can answer most questions accuratly.  pt arrived with snoring respirations   HISTORY OF PRESENT ILLNESS:     90-year-old female with a history of prior CVA, atrial fibrillation, dementia presenting for evaluation of acute onset mental status change.  Patient is a resident of a nursing facility.  She has dementia at baseline but is reportedly ambulatory with fluent speech at baseline.  Today while at physical therapy, the patient had a acute onset of word finding difficulty and confusion.  Her last known well was 1 PM this afternoon.  She does have a history of prior stroke.  EMS was called to the scene where the patient was found with stable vital signs and a normal BGL was brought to the ED for evaluation.   On arrival here, the patient is significantly aphasic and unable to provide further history.   Further history was obtained from the patient's daughter who does report the patient has a history of prior CVA, she does not report any history of intracranial neoplasm, intracranial bleed, recent GI bleed, or major surgery.   Per chart review, patient does take aspirin and Plavix.
I had my jaw rewired 20 years ago.  The jaw, teeth started to hurt  about a week after first dose.  Then 3 days after second dose,  I got a big cold sore with several clusters. I NEVER get cold sore in warm months. If I do get one, it?s in the winter and just a small one. I use abreva at the first sign, and it goes away next day. But this cold sore, it is going the full blown 2 week recovery despite abreva.  One week after my second dose, I got skin rash on my face cheeks, kinda like rosacea. I never had this before. All symptoms are still as of May 23.
This spontaneous report as received from a nurse refers to a 10 months 24 days old male patient. No concurrent condition, medical history or allergy/drug reaction were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) oral, ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Large burden of DVT/PEs; Large burden of DVT/PEs; Associated acute kidney injury and fevers; Associated acute kidney injury and fevers; This is a spontaneous report from a contactable physician. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication included drospirenone, ethinylestradiol (YASMIN) taken as birth control pills, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient diagnosed with COVID-19 prior to vaccination. The patient experienced large burden of DVT/PEs noticed approximately 1 month after vaccination in Jun2021 and associated acute kidney injury and fevers. Events resulted in visit to Doctor or other healthcare professional office/clinic and Emergency room/department or urgent care. Patient was hospitalized for the events. Treatment received included anticoagulation + IVC Filter. Outcome of the events was recovering. The patient had not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported events cannot be excluded.  The impacts of this report on the benefit/risk profile of the product and on the conduct of the study are evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concerns identified as part of this review, as well as any appropriate actions in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from a health professional concerning a 6 month old male who on 21 Sep 2006 was vaccinated with a dose of Rotateq (human bovine) (Lot# 654970/0777F). Additional information has been requested.
2 days after injection (2nd of series). Presents with swelling, erythema, warmth and itching at injection site. Treatment: BENADRYL, KEFLEX. Rechecked 12/19 with now complete resolution of symptoms.
REDNESS SWELLING AND PAIN AT SITE OF INJECTION LARGE WEAL MEASURING 7X 8CM AT SITE OF INJECTION NAUSEA VOMITING FEVER AND CHILLS
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients (couple). This is the first of two reports. An elderly male patient of unspecified ethnicity and age (reported as over 65 years) received PREVNAR 13 via unspecified route of administration on unspecified date at single dose for immunization. Patient medical history and concomitant medications were not reported. The patient experienced soreness, coughing and low grade fever on unspecified date. The patient complained and thought that he was going to get pneumonia after getting the shot a day after. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2017472129 same drug/event, different patient.
Difficulty breathing/trouble breathing; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficulty breathing/trouble breathing) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 044A21A) for COVID-19 vaccination.     Concomitant products included EVOLOCUMAB (REPATHA) for Hypercholesteraemia, LOSARTAN for Hypertension, PRASUGREL and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing/trouble breathing) and FATIGUE (Tired). At the time of the report, DYSPNOEA (Difficulty breathing/trouble breathing) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal.         Patient reported on 22-APR-2021, breathing trouble  increased, but was not gasping for air, Consumer saw her cardiologist on Friday. Consumer reported that she had a heart test on 19-MAY-2021 and got 2 stents. Consumer reported that her breathing is better after the stents were put in, but not perfect. patient was in cardiac rehab and has not returned back to work.  Treatment information in response to events was not provided.  Company Comment: 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. However, based on the available data previously undiagnosed cardiac disorder may be at least partially responsible for the reported events. After the stent placement the patient reported improvement.   This case was linked to MOD-2021-227938 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received on 07-Jul-2021 contains no new information.; 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. However, based on the available data previously undiagnosed cardiac disorder may be at least partially responsible for the reported events. After the stent placement the patient reported improvement.
After IZ HBV injection child had breath holding episode that required mouth to mouth resuscitation.
felt light headed and dizziness the next day after the injection.; This is a spontaneous report from a contactable consumer. A 16-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in May2021(at the age of 16-years-old) as a single dose and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Jun2021(at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and patient had known allergy (unspecified). It was not known whether the patient had other medications within two weeks of 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. It was not known whether the patient received any other vaccines within four weeks prior to the vaccination. On an unknown date in May2021, the patient felt light headed and dizziness the next day after the injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the event felt light headed and dizziness the next day after the injection was resolved on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client reported almost immediate severe pain at injection site (approx. 11:15 a.m.).  Was monitored by RN.  At 11:18 BP was 140/90, HR 82.  Injection slightly warm to touch.  No redness or edema noted.  Client denied dizziness, nausea, SOB or other symptoms.  At 11:30 BP was 130/92, HR 72.    At 11: 35 BP 122/92.  No further progression of symptoms.  Pt reported she felt fine and was allowed to leave site and instructed to monitor symptoms, report to her provider if pain persists or other symptoms develop.
Patient c/o palpitations after receiving 2nd COVID vaccine. Her HR was 140-160. No CP, no SOB or dizziness. Went down to 86 and she felt better and left the clinic. she returned to the clinic 20 minutes later c/o  palpitations again. Her HR was then 112.  Transported to ED for eval and treatment.
HE HAD CONVULSIONS FOR A DURATION OF ABOUT 20 SECONDS; HE DOESN'T REMEMBER ANY OF THAT TIME; HE WAS EXTREMELY PALE; THIS WAS ABOUT 15 MINUTES AFTER THE SHOT WAS ADMINISTERED AND HE HAD LEFT THE DR OFFICE AND WAS IN THE TRUCK WITH HIS FATHER LEAVING WHEN THE CONVULSIONS STARTED AND HIS DAD TURNED AROUND AND DROVE HIM BACK TO THE OFFICE WHERE HE LAID DOWN FOR ABOUT 30 MINUTES UNTIL HIS COLOR RETURNED. THE OFFICE INDICATED THEY FEEL HE JUST FAINTED.  PATIENT'S DAD WITNESSED THE TIGHTENING UP OF THE ENIRE BODY AND THE FLAILING AROUND OF HIS HEAD AND ARMS.  BY THE TIME THE OFFICE WAS INVOLVED PATIENT HAD COME OUT OF THAT PORTION AND WAS JUST PALE AND WEAK.
Narrative: Symptoms: HYPOtension, Bradycardia & Diaphoresis Treatment:
Large swollen armpit lymph node on the same arm that received the shot. Size of baseball. Painful/tender.
Violent headache, dizziness, cold sweats when standing, vomited, some mild lower back pain, all these symptoms lasting until evening about 9:30 PM.  NO FEVER. No illness the next day.