chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive with Corona Virus; lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of CORONAVIRUS TEST POSITIVE (tested positive with Corona Virus) and DRUG INEFFECTIVE (lack of drug effect) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced CORONAVIRUS TEST POSITIVE (tested positive with Corona Virus) and DRUG INEFFECTIVE (lack of drug effect). At the time of the report, CORONAVIRUS TEST POSITIVE (tested positive with Corona Virus) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, Coronavirus test positive: positive (Positive) Positive with Corona Virus.         Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-294138 (Patient Link).; Sender's Comments: Based on the mechanism of action of mRNA-1273, causal association between the event  Coronavirus test positive and mRNA-1273 is assessed as not applicable.
Pt received Moderna for 1st dose of COVID-19 vaccine, and today received Pfizer for 2nd dose. Pt informed and educated.
heart attack; Bell's Palsy; other zoster related injuries; other zoster related injuries; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 31-MAR-2017 (61 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by healthcare providers and physicians for the following injuries resulting from zoster vaccine live (ZOSTAVAX): heart attack, Bell's Palsy and other zoster related injuries. The outcome of these events was unknown.  Upon internal review, heart attack and Bell's Palsy were determined to be medically significant.
Patient given Tdap, HAV, MMR when 2 wks pregnant. Patient informed to discuss with her OB doctor. Pt had a positive HCG (Pregnancy test on 10/30/06.  MMR was given 10/12/06.  Pt may have been pregnant at the time MMR was given.  Pt's OB Dr. was informed. RN.
patient was 17 years old when receiving vaccine indicated for 18 and older. No adverse reaction occurred. Reporting due to age restriction guideline violation
Weight Loss; This case was reported by a other health professional via call center representative and described the occurrence of weight loss in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced weight loss. On an unknown date, the outcome of the weight loss was unknown.   It was unknown if the reporter considered the weight loss to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient experienced weight loss after the first dose of Shingles vaccine. The reporter was asked about what are the side effects of Shingrix vaccine for Shingles and dose it cause weight loss in elderly people. The reporter did not consent to follow up.
Pt got her vaccine @ 0823, at end of 15 min monitoring, pt c/o headache.  @ 0842 BP 140/90, HR 70 & regular.  Denied visual disturbances or dizziness.  @ 0852 BP taken again and remains same.  Pt reported she also has allergies.  Last dosage of BP meds last evening.  Then stated she was fine, declined further monitoring.
Patient returned to clinic next day complained of headache, muscle aches to entire body and temp not responding to Motrin (103.9F)
Pt recv vax on 10/23/98; on same day pt exp eye pressure, nausea, dizzy
Fever; He is not feeling well.; This is a spontaneous report from a Pfizer- sponsored program received from a contactable consumer (patient). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number: not reported) as SINGLE DOSE, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After getting the first dose of the vaccine, on an unspecified dose, the patient experienced fever and a lot of symptoms. The patient also mentioned that he was not feeling well. The patient would like to know whether he can still be infected with the virus even after getting the first dose. The outcome was unknown for the reported events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Site: Pain at Injection Site-Mild, Additional Details: Patient reports pain in left arm at the injection site that has persisted ever since getting the Pfizer booster vaccine on 10/27/2022. "Dull muscle pain"
No additional adverse event (AE); HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report was received from a medical assistant and refers to a unknown age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 06-OCT-2022, the patient was vaccinated with a improperly storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) lot number W023868, expiration date: 24-JAN-2024 (upon internal review, had been verified to be a valid number) administered for prophylaxis (strength, dose, anatomical site of injection and route of administration were not provided). The vaccine underwent a temperature of 10.8 degrees Fahrenheit with a time frame of 1 hour, 39 minutes and 0 seconds. There was no previous temperature excursion.; Sender's Comments:  US-009507513-2210USA002259: US-009507513-2210USA002344:
Patient received flu & pneumonia shots. About 10 minutes after vaccination patient felt dizziness, weak, & began having seizures. Blood pressure & pulse were low. Patient rested & applied cool compresses to help with sweats/other symptoms.
Right deltoid area erythematous (5 x 5 cm) w/area of induration, tender to palpation and warm to palpation. Dx: Cellulitis us reaction Tx: Cephalexin QID x 5 days.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates since 11-FEB-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L043213, expiration date: 28-AUG-2017, and lot # L048459, expiration date: 22-FEB-2018; dose and route were not provided). The vaccine underwent a temperature excursion in range between 30 degrees Fahrenheit and 53.2 degrees Fahrenheit for an undetermined amount of time, which was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
mom states lt arm has erythema size of silver dollar w/some swelling (sl) area is warm to touch;mom did not put ice on or give APAP since vax was given-was re-instructed to do so & return 13OCT95 for re-check;
Given flu vaccine R deltoid. Immediate spasm of deltoid, swelling and pain. No anaphylaxis.
Rash on both arms, rash on chest, rash on buttocks, rash on both legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on both arms, rash on chest, rash on buttocks, rash on both legs) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced RASH (Rash on both arms, rash on chest, rash on buttocks, rash on both legs). The patient was treated with HYDROCORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash on both arms, rash on chest, rash on buttocks, rash on both legs) outcome was unknown.     No relevant concomitant medications were reported.   This case was linked to MOD-2021-024119 (Patient Link).
Pt. had pain, redness and swelling at the site, By  the afternoon he had a fever, aches, chills and headache. This lasted a few days I called the pediatrician she said it was normal. He had the same issues over the weekend.  I called the ER.  They said to continue to monitor him. He never really got better, He had fevers off and on, headaches, pain  and nausea for weeks. I took him back in to the pediatrician and they ran tests on him and couldn't find anything wrong. I then found him laying facedown, unconscious in our backyard. He started having petite mal seizures during the day and seizures at night and tachycardia like symptoms. He had to be taken out of school.
the day p/vax 17NOV93 pt noticed generalized joint & muscle pain, no fever, felt fine otherwise, became progressivley more painful, peaked on 22NOV93 required medication to sleep;
Recieved Tdap in L deltoid on 08/29/09.  She noted swelling at injection site on 08/29/09.  Reported to Employee Health on 08/31/09 via phone.  She was seen on 09/01/09 by a nurse practitioner, with noted redness and pain at site.
Pt recvd 1st dose of recomb in AUG90 recvd 2nd dose & exp joint pains & sx of arthritis in several joints, including neck & elbows; @ the time of the report pts sx persisted;
Only the adjuvant (liquid) portion of the vaccine was administered: the reconstitution step was mistakenly skipped.
Presented to ED w/COVID symptoms x 1 wk; SOB & hypoxic on arrival; admitted for COVID-19 PNA and acute on chronic resp failure w/hypoxia;10/27 -  tx w/ steroids, zin, pulmicort & bronchodilator nebs;10/28 - added zinc; 10/29 - added remdesivir; pt was O2 dependent on 2L/NC prior to arrival and was weaned down to 2L at discharge.
At 5:30PM, PHN was called to check on client at place of employment. Client was found in an office with on site paramedics checking her vital signs. Client was shaky and seemed anxious. Her forearms and hands were mottled, and there was no visible swelling. VS 205/127mmHg, 116 BPM, O2 sats >92%. Client denied difficulty to breathe and stated she felt lightheaded. PHN encouraged client to go to the hospital to control her BP. Client was taken by ambulance to nearest hospital at 6PM.
Patient requested to receive a 2nd dose of the covid vaccine. Patient was then given a consent form to fill. Patient stated that she had received a 1st dose of the vaccine from a different provider. She stated that she had received the Moderna vaccine. Patient was then administered the 2nd dose of the Moderna vaccine. Patient was then asked for her vaccine card which she handed to me. While filling out the information paterning to her 2nd dose I then realized that pateint has received the Pfizer vaccine.
Received pneumonia vaccine at 1015 on 10/6/10. Today, patient reports that the evening of 10/6/10 he became ill - nausea, vomiting, body aches, shaking all over. No increased temp.
She is part of a trial study for Moderna flu shot.  She got the vaccine, she is bleeding every day vaginally, some days worse than others.  She did contact them regarding that, and said that they don't care.  They only want to know if you are congested, if the arm hurts, or having flu-like symptoms.  She has gone to her PCP and they don't know what is happening and wanting to do invasive female probing.  The bleeding has continued since then . She has had a lot of blood work, she is anemic due to this and was not prior to this vaccine.  They want her to take iron supplements due to the bleeding.    With her third Pfizer shot she really did bleed out, and did not go to the ER.  That bleeding lasted about a week, really intense.    The bleeding she is having now since the vaccine is not as bad, but still continuing.  She does have more doctor appointments coming up.
Narrative: rash to face felt like band was around throat. Pt. reports that she had a "bit of a reaction" to first dose of Covid Vaccine. Did go to Local Urgent Care and was given Benadryl which was effective. Veteran calls to report she did to urgent care yesterday for follow up of symptoms after first Covid vaccine. She reports feeling much better today, has been taking Benadryl q 4 hours, reports throat is much better, itching is improved. She reports that they also have arranged for her to have lab work and testing to see which component of the vaccine she had an allergic reaction.
Tingling in mouth and throat.   No rash, sob, nausea.   Very well appearing, observed for 1.5 hours, symptoms completely subsided, and released to home.
Interchange of vaccine products (1st dose of Janssen COVID-19 Vaccine and 2nd dose of  Moderna); Covid-19 infection; Congestion in ear clogged; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 infection), EAR DISCOMFORT (Congestion in ear clogged) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products (1st dose of Janssen COVID-19 Vaccine and 2nd dose of  Moderna)) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 03-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2022, the patient experienced COVID-19 (Covid-19 infection) and EAR DISCOMFORT (Congestion in ear clogged). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products (1st dose of Janssen COVID-19 Vaccine and 2nd dose of  Moderna)). At the time of the report, COVID-19 (Covid-19 infection) was resolving and EAR DISCOMFORT (Congestion in ear clogged) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products (1st dose of Janssen COVID-19 Vaccine and 2nd dose of  Moderna)) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.         No treatment details reported. Company comment: This case concerns a 45 year old female patient with prior vaccination with COVID-19 vaccine NRVV AD26, who experienced the unexpected non serious AESI event of Covid 19 1 month 28 days after receiving a dose of mRNA-1273 Vaccine. Current pandemic of Covid 19 can be a risk factor. Covid 19 rapid test was reported to be positive. Interchange of vaccine products also noted in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 45 year old female patient with prior vaccination with COVID-19 vaccine NRVV AD26, who experienced the unexpected non serious AESI event of Covid 19 1 month 28 days after receiving a dose of mRNA-1273 Vaccine. Current pandemic of Covid 19 can be a risk factor. Covid 19 rapid test was reported to be positive. Interchange of vaccine products also noted in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient requested flu vaccine and after administration, we realized that the patient had previously received a flu vaccine at Pharmacy on 10/01/22. Patient has felt fine after administration of the second flu vaccine as of 11/05/22.
Developed arm tingling/pain of Right arm. Pain increased for a few days and then small blister rashes began on 8/25.21. Diagnosed with varicella zoster (shingles) on 8.26.21. Given acyclovir PO for 7 days, gabapentin for 20 days. Rash progressed to encompass Right arm from shoulder to middle fingertip with ~100 blisters. Rash dried/crusted on day 10. Pain remains at date of filing.
No adverse symptoms.  Administered Pediatric COVID19 bivalent booster instead of Pediatric COVID19 vaccine.
01/29/2022 Sore arm, fever of 100.3 F, chills and body ache. 01/30/2022 Sore arm, fever of 102.4 F, chills and body ache. Fever broke around 10 pm. 01/31/2022 Sore arm. 02/01/2022 Sore arm, shortness of breath and rapid heart beat (as high as 125 beats per minute, started at 8 pm).  It dropped to 92 beats per minute after 10 pm. Resting heart rate is usually 68 beats per minute.
pt was born 22-33wks gestation; Discharged on 7JAN94 dx listed are prematurity, ROS vs TTN w/resp failure, hyperbilinbinemia, apnea &bradycardia, chalasia,  suspected small lt intercranial hemorrhage w/mild ventriculomegaly;
10 sec generalized tonic clonic sz witnessed by parents approx 5 hrs p/vax;
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 11/15/2021 CHF EXACERBATION, UNSPECIFIED J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/15/2021 CHF EXACERBATION, UNSPECIFIED
No adverse event occurred, but incorrect vaccine was given.  Pt. had not received initial monovalent COVID booster series and was given the bivalent COVID vaccine as a first dose as the ordering provider,  APN, was unaware.
Following 1st dose of vax developed "knot" w/itching @ inject site, rash that spread fr inject site to his shoulder;
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 06-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (route, lot#, expiration date and anatomical location were not reported) to prevent shingles. Co-suspect therapy or concomitant medications were not provided. The pharmacist reported that after vaccination, the patient experienced an injection site reaction of a rash with redness and a bump. The patient sought medical attention by returning to pharmacy. It was unspecified if the patient received treatment for the adverse events. The outcome of injection site mass, injection site erythema and injection site rash was reported as recovering. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Breakthrough case admission after 2 Janssen vaccines  Janssen 5/10/21 Lot# 205A21A;  Janssen 11/9/21 Lot# 1822811
pt states later the night after getting the vaccine her left arm started swelling and turned red.  The next day she started feeling confused.  She bouts of confusion and dizziness.  She felt very strange and her mind was not working normal.  She went out to eat and the food tasted really salty.  She also drank a margarita.  She was not feeling well.  She went home and the next thing she remembered she was being escorted from her home by paramedics.  Her husband found her having an episode so he had her son come over who could not wake her up either.  She was having a seizure that lasted about 20 minutes.  She was taken to Hospital.  She had blood work, MRI, chest xray , EEG, CT.  Everything test was negative.  The only thing out of the normal was the sodium lever which was 127.  She was admitted for test.  Her sodium ranged from 127-140 levels.  She was given drip during her stay at the hospital.  She was released and followed up with Nephrologist Dr..  She had more blood work which came out fine.  She also went to her Thyroid specialist Dr. and her thyroid function was normal.  She is going to a Neurologist Specialist Dr. for a second opinion.
Client was in clinic on 1-25-05 for 12 month immunizations.  Client returned to clinic on 2/4/05 with rash on torso, arms, and legs.  Rash consisted of red flat and raised bumps.  No vesicles.  Advised patient's mom to call her doctor. Spoke with mom today, 2-07-05.  She states "the rash only lasted two days, no itching or blisters developed.  The rash is now completely gone and her daugther is fine".  Mom had called daughter's MD, informed him that she had received her immunizations including varicella, but MD did not see her, simply advised that if she had chicken pox she would be contagious for two weeks and to keep her away from others.
Patient states she received flu shot from the clinic at an off-site location from employee health. Unable to tell from chart which vaccine she was given (or lot #, etc). This is a 36-year-old female with a history of multiple drug allergies. Yesterday morning she was given an injection of a flu shot into her left deltoid. She developed swelling and hives in her left upper extremity across her left chest. She was referred to hospital ER she was given pills of prednisone and sent home. When she went home she developed a cough difficulty breathing and chest tightness. She was not given IV SOLU-MEDROL and she states she has a severe allergy to BENADRYL. Allergy to BENADRYL in the past and her description sounds like anaphylaxis.
Information has been received from a medical assistant concerning a 19 year old female, who on 09-APR-2008 was vaccinated with a 0.5mL first dose of Gardasil.  Subsequently, the patient was pregnant.  It was reported that the office did not conduct a pregnancy test prior to the vaccination.  The patient called the office to report that she experienced a miscarriage on 21-APR-2008.  The patient went to see the physician.  A total serum human chorionic gonadotropin test was performed and did not show that the patient was pregnant.  On 09-APR-2008 the patient experienced received first dose while pregnant.  At the time of the report, the outcome of the patient was unknown.  Upon internal review miscarriage was considered to be an other important medical event.  Additional information has been requested.
Took 2 shots at noon, around 6 p.m. Severe chills for about an hour or so. Severe stomach issues and a high fever during sleep, very little sleep.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Diabetes.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 12-Jan-2021, DIARRHOEA (Diarrhea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included unspecified  diabetic pills, blood thinners and high blood pressure pills. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient received her first dose of the Pfizer COVID-19 vaccine and during the post-vaccination wait period she stated that she felt tingling, numbness and itching on the front part of her tongue. She has a history of allergies and is allergic to eggs, cats, pollen and Benadryl. During examination by the nurse, she stated that she felt ?sweaty? and her neck was itching. She however stated that she did not want the EMT called, but would wait and let us know if the symptoms were getting worse. She waited for half an hour and stated that she was feeling better and was ready to leave. She was asked to call ?911? if the symptoms returned and she voiced understanding.