chrisvoncsefalvay/vaers-outcomes huggingface dataset:
encephalitis; This case was reported by a physician via sales rep and described the occurrence of encephalitis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced encephalitis (serious criteria GSK medically significant). On an unknown date, the outcome of the encephalitis was unknown.   It was unknown if the reporter considered the encephalitis to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's friend. The age group was not reported, but was selected adult as per vaccine indication. Shortly after vaccination, the patient experienced encephalitis. The reporter would be happy to provide further details, if helpful. This case has been linked with case US2019AMR114835, reported by the same reporter (pharma case).
APPROXIMATELY THREE DAYS POST VACCINATION; DEVELOPED SPOTS; LESIONS; AND SORES ON RIGHT MIDDLE FINGER; RIGHT INDEX FINGER; TOP OF RIGHT FOOT; AND GROIN; WHICH SPREAD TO LEFT THIGH. WENT TO URGENT CARE ON 2/1/21. HAD MD FOLLOW UP ON 2/8/21. BIOPSY OF LEFT THIGHT DOWN AND LABS DRAWN. ACCORDING TO HER, THE DOCTOR THINKS IT MAY BE RELATED TO UNDERLYING LIVER DISEASE. AS OF THIS TIME IT IS NOT RESOLVED.
Within a few days my ears clogged up - it was hard to hear. I felt at times as if I was in a swimming pool. By approximately day 13, I experienced severe congestion, nausea, difficulty breathing, occasional worsening of the clogged ears, fatigue, feeling feverish (but no fever), brief sore throat. I thought it was allergies to cats or pollen- but it kept worsening once those allergens were not in the environment.  It took almost two weeks to fully recover.  As of this report, my ears are not fully back to normal and I cough about once a day.
After second HPV child fell down off exam table and hit head on floor. Cut under left eye right below the brow. Child lost consciousness momentarily, ambulance was called and child was alert and active heading to the ER.
client received 3 doses of moderna and was to receive her second booster dose but she received Pfizer instead
allergic reaction; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced allergic reaction in Feb2021. Patient was told not to get the second dose of vaccine and wonders what her options are. It was unknown if treatment received. The outcome was unknown.    No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Pt developed an arthritis reaction and an injection site reaction characterized by swelling, tightness and pain after receiving a tetanus toxoid injection in 1991.
Pain in the left shoulder and gradually spreading to the neck and right shoulder area in 3 days. Flulike symptoms, severe headache, but no fever. On 6th day, the pain on the right side slowed down, but the pain on the left side is lingering.
Patient reported itching, felt hot, presented with axillary rash, redness to face and head, swelling of lips
Experienced a 100% occluded right coronary artery causing ST elevation myocardial infarction
Pt has a stable seizure disorder.  1. Seizure, 'one', tonic clonic about 40 hours post vaccination.  2. Moderately severe local reaction with swelling, erythema RUE.
On 13-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 VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE PRURITUS (arm is itchy), VACCINATION SITE ERYTHEMA (arm is red) and VACCINATION SITE SWELLING (arm is swelling). At the time of the report, VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE PRURITUS (arm is itchy), VACCINATION SITE ERYTHEMA (arm is red) and VACCINATION SITE SWELLING (arm is swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI
This spontaneous report was received from a consumer refers to an approximately 65 year old male patient, concerning himself. The patient had no medical history, concurrent conditions or drug reactions/allergies. The patient was taking unspecified medication for blood pressure. In approximately 2017 (reported as "approximately one year ago"), the patient was vaccinated with ZOSTAVAX for shingles prevention. The vaccine was reconstituted with MERCK STERILE DILUENT (reported as "DILUENT")(dose, route of administration, frequency, lot number and expiration date were not provided). In approximately October 2017 (reported as "3 months ago") the patient started noticing that he was experiencing "blurry vision." Patient said for example when he watched television that sometimes his vision becomes blurry. The patient did not receive treatment for the event. At the time of this report, he had not recovered from the event. The patient did not seek medical attention. Causality assessment was not provided.
I got covid after my first dose on april 6,.; and I still havent gotten second dose. When should i get the second dose? (35 days have crossed); 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 COVID-19 (I got covid after my first dose on april 6,.) and PRODUCT DOSE OMISSION ISSUE (and I still havent gotten second dose. When should i get the second dose? (35 days have crossed)) 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 06-Apr-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 COVID-19 (I got covid after my first dose on april 6,.) and PRODUCT DOSE OMISSION ISSUE (and I still havent gotten second dose. When should i get the second dose? (35 days have crossed)). At the time of the report, COVID-19 (I got covid after my first dose on april 6,.) and PRODUCT DOSE OMISSION ISSUE (and I still havent gotten second dose. When should i get the second dose? (35 days have crossed)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided  No treatment medications provided   Reporter did not allow further contact
redness at the injection site; itching; blisters; pain; got both Shingrix vaccines, and shingles/suspected vaccination failure; shingles; whole right arm had muscle pain and weakness for about 2 days; whole right arm had muscle pain and weakness for about 2 days; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic kidney disease stage 4.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and the 1st dose of Shingrix (intramuscular) .5 ml. On 4th September 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced injection site erythema, myalgia upper extremities, weakness of arms, pruritus, blister and pain. On an unknown date, the outcome of the vaccination failure, pruritus, blister and pain were unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the injection site erythema, myalgia upper extremities and weakness of arms were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, injection site erythema, pruritus, blister and pain to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, myalgia upper extremities, weakness of arms, pruritus, blister and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-SEP-2022 Reporter's Comment: The case was self-reported by the patient. The patient received both of the Shingrix doses in 2019 into right arm and got both times patient had a site reaction. After the first dose of Shingrix her whole right arm had muscle pain and weakness for about 2 days. After the second dose of Shingrix, she only had some redness at the injection site for a few days.  The patient also reporting that she currently had shingles and she also experienced itching, blisters, and pain with shingles. The reporter did not consent to follow up. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles was unknown at the time of reporting.
Redness/rash occurring at and around injection site.  Did not start until a few days after injection.  Itching starting one week after injection around injection site.
Information has been received from a nurse practitioner concerning a 24 year old female who on 08-NOV-2007 was vaccinated IM in the gluteal region with 0.5 mL dose of GARDASIL (lot # 659437/1266U). Concomitant therapy included RELPAX as needed and YAZ. On 12-NOV-2007 the patient fainted receiving a concussion. The patient called the office on 20-Mar-2008 to report the fainting and concussion that occurred in November of 2007. The patient did not want to continue the vaccination series. The patient recovered. There was no product quality control involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Information has been received from a nurse practitioner concerning a 24 year old female who on 08-NOV-2007 was vaccinated IM in the gluteal region with the first 0.5 mL dose of GARDASIL (lot # 659437/1266U). Concomitant therapy included RELPAX as needed and YAZ, for birth control. Four days post vaccinatin, on 12-NOV-2007, the fainted receiving a concussion. The patient called the office on 20-MAR-2008 to report the fainting and concussion that occurred in November of 2007. The patient did not want to continue the vaccination series. On an unspecified date, the patient recovered. There was no product quality complaint involved. Follow up information has been received from a physician. It was reported tht 4 days after the vaccine was administered, the patient was seen in a emergency room for syncopal episode. There were no illness at time of vaccinationand ther were no known drug allergies reported. Additional information is not expected.
Caused an increased pulse over 150.  Went to see his doctor and ended up needing a procedure to correct the issue
Pt reported dizziness/. BP  8548. wet & clammy. waited 30 minutes to leave, no dizziness or clammy BP 104/66 hr80
high heart rate; high blood pressure; shortness of breath; bilateral pulmonary emboli; This is a spontaneous report from the patient. This 49-year-old non-pregnant female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9269) via an unspecified route of administration in the right arm on 04Feb2021 at 08:30 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient's known allergies included morphine, hydromorphone (DILAUDID), sulfas, and coconut. The patient did not have COVID prior to vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9269) via unspecified route in the right arm on 14Jan2021 as a single dose for COVID-19 immunization. Concomitant medications were not reported. On 19Apr2021, the patient was having high heart rate, high blood pressure and shortness of breath. She was hospitalized and diagnosed with bilateral pulmonary emboli. The events resulted in emergency room/department or urgent care and hospitalization for 3 days. The patient stated that she doubts this was vaccine related but wanted to report it. The patient was treated with intravenous heparin, then oral rivaroxaban (XARELTO). The clinical outcome of the events high heart rate, high blood pressure and shortness of breath, and bilateral pulmonary emboli was recovering. The patient was tested for COVID post vaccination via nasal swab on 19Apr2021 with result of negative.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Investigators, as appropriate.
Patient returns to the clinic with hives at the site of the Tdap injection (right deltoid) approximately 11:20am. No respiratory symptoms. Upon exam, alert in no apparent distress. Chest CTA. BENADRYL Allergy liquid suspension 5 mL given to patient at 11:29am, by 11:45am hives are less noticeable and less redness.
Entire arm became very hot to the touch.  Then entire arm became swollen.  Child developed hives.  Child began screaming and screamed for four hours until she fell asleep.  Woke up the next morning and spent the entire day of awake time rolling on the ground screaming.  This cycle continued for approximately three days.  Child had a developmental test the week before and tested in the normal range in all areas, child has just been tested and tested behind in 3 of the 5 areas.
patient said she was feeling lightheaded and dizzy - I instructed her to remain seated and got a her a chilled bottle of water- she then remained seated and drank her water. I checked in on her every 5 minutes or so and after she drank her water she said she felt better and left
feeling dizzy; sick; feeling tired; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling dizzy), MALAISE (sick), FATIGUE (feeling tired) and NAUSEA (nauseous) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (feeling dizzy), MALAISE (sick), FATIGUE (feeling tired) and NAUSEA (nauseous). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. At the time of the report, DIZZINESS (feeling dizzy), MALAISE (sick), FATIGUE (feeling tired) and NAUSEA (nauseous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: The follow up received were the outcome of the event was updated.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9265), in left arm, on 24Feb2021 as dose 2, single (Lot number: EN6198), in left arm, on 02Nov2021 as dose 3 (booster), single (Lot number: FF259), in left arm and on 12Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Irritable bladder" (unspecified if ongoing). Concomitant medication(s) included: MYRBETRIQ, start date: 01Sep2021; PRAVASTATIN, start date: 01Jun2019. Past drug history included: Tetracycline, reaction(s): "known allergies:Tetracycline", notes: known allergies:Tetracycline; Erythromycin, reaction(s): "known allergies:erythromycin", notes: known allergies:erythromycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course included: Patient received COVID 19 treatment with Paxlovid on 21Jun2022 and stopped on 25Jun2022.
The COVID-19 vaccine administered June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
Patient had her first covid vaccine on Wed 1/6. She injected her orencia that following Sat and reports getting a migraine. Patient slept for 16 hours and woke up feeling better. Her 2nd covid vaccine was Friday 2/15. she injected orencia on Sat and reports a migraine once again. She medicated with excedrin and was feeling slightly better by Sunday. Patient has a hx of migraines with her lupus. She is doing well now and no issues with migraines or her RA.
Patient started noticing sinus drainage and flu-like symptoms initially. As the weekend progressed the patient reported a rash on the inside of his forearms and back of the hands that began to worsen. By Monday the patient had a rash all over his arms, headache, joint pain, and injection site soreness. Saw PCP 10/08/18 and given steroids. Out of work Friday-Tuesday.
Severe tremors, muscle twitches, occasional  blurred vision, sudden weakness, light headed, foggy clouded mind, difficulty concentrating, and migraines.
Bells Palsey; This is a spontaneous report from a contactable other health care professional (patient himself). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. Unknown if other vaccine in four weeks. It was reported that, patient developed Bells Palsey 4 days after second shot. No treatment for adverse event. It was unknown prior to vaccination, whether the patient diagnosed with COVID-19. It was unknown since the vaccination, if the patient been tested for COVID-19. The outcome for the event was reported as not resolved.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Bell's Palsy and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
The pt was vaccinated with vaccinia and it was later determined that she was pregnant. LNMP: 1/31/03
p/vax pt dizzy feeling like being drunk;dizziness lasted through the noc approx 8hr total;8/19/99 no further dx reported;
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An 82-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FK9893) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Feb2021 as dose 1, single (Lot number: 010M20A), on 11Mar2021 as dose 2, single (Lot number: 027A21A) and on 01Nov2021 as dose 3 (booster), single (Lot number: 939906) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. Concomitant medication(s) included: AMLODIPINE; ATORVASTATIN; GABAPENTIN; IRBESARTAN; TRIAMTERENE & HCTZ; ZOLPIDEM. Past drug history included: Sulfadiazine, reaction(s): "Known allergies: sulfadiazine". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received anti-viral treatment via oral route from 22Jun2022 till 27Jun2022 for COVID-19. Patient experienced rebound covid symptoms; about 10 days after paxlovid treatment started.  Patient symptoms was improving at the time of this report. AE resulted in none of the above (details unspecified).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.
Developed severe nosebleed 23 hours and 30 minutes after receiving vaccine.  Bleeding time OK but platelet count on the low side (165,000)
whole body was experiencing muscle and joint pain.; whole body was experiencing muscle and joint pain.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (whole body was experiencing muscle and joint pain.) and ARTHRALGIA (whole body was experiencing muscle and joint pain.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 096B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced MYALGIA (whole body was experiencing muscle and joint pain.) and ARTHRALGIA (whole body was experiencing muscle and joint pain.). At the time of the report, MYALGIA (whole body was experiencing muscle and joint pain.) and ARTHRALGIA (whole body was experiencing muscle and joint pain.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Pt's R/arm had hard area size of baseball to grapefruit.  Hot to touch, red, fever, tenderness to touch, felt weak, reaction lasted for 1 week.  Took aspirin.