chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dry heaves; Chills/My teeth just chattered and very tired; My teeth just chattered and very tired; Headache; Wasn't really able to eat anything; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), administration date 07Mar2021 (Batch/Lot number: unknown) at the age of 81 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Rapid Heart beat" (unspecified if ongoing), notes: Rapid Heart beat; "blood thinner" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; BUMETANIDE; BUFFERIN taken for anticoagulant therapy; SIMVASTATIN. The following information was reported: RETCHING (non-serious) with onset 08Mar2021, outcome "unknown", described as "Dry heaves"; CHILLS (non-serious) with onset 08Mar2021, outcome "unknown", described as "Chills/My teeth just chattered and very tired"; FATIGUE (non-serious) with onset 08Mar2021, outcome "unknown", described as "My teeth just chattered and very tired"; HEADACHE (non-serious) with onset 08Mar2021, outcome "unknown", described as "Headache"; FEEDING DISORDER (non-serious) with onset 08Mar2021, outcome "unknown", described as "Wasn't really able to eat anything". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of retching, chills, fatigue, headache, feeding disorder. Additional information: Consumer stated, she saw her doctor because she thought she was having some side effects from the Covid Pfizer BioNTech (Covid Vaccine). Patient had the shot this was the first one and she had it on Sunday afternoon probably going on 4 PM. Everything was fine, everything was fine all over the night. But the next morning she started having dry heaves and chills. Her teeth just chattered and very tired. She had a friend who took her to see the doctor and she had headache, wasn't really able to eat anything and he looked at the information that she got when she received the shot. Now the second day which was yesterday I felt better but not so much in the morning, but she ate something at noon. The consumer mentioned that events would have been started on 08Mar2021. Consumer stated, she thinks concomitant product was generic form of Claritin Sinus (Not clarified). The patient takes lot of vitamins. When she don't feel good because she couldn't eat. Patient took the heart medicine and all that but not the vitamins so on.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had coughing and a high fever of around 101.0. The coughing went away after 2 days. I had very little congestion. I was just achy for a total of 5 days with fatigue. I took DAYQUIL and NYQUIL as needed. It took a total of 6 days for all the symptoms to resolve. I tested positive for 10 days, so I remained in isolation for that time frame. I have since completely recovered.
had Shingles but had shot as well / suspected vaccination failure; had shingles, suffers alot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter stated that, his/her partner (patient) had shingles a number of times but had shot as well and patient suffered a lot. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/5/2023 ATHEROSCLEROSIS OF AORTA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/5/2023 CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/5/2023 PREOP EXAM
numbness in hands, pain in hands, numbness in toes & feet;referred to neuro & dx w/acute polyradiculoneuropathy;hosp 19NOV96 to 26NOV96 & tx w/steroids;
pt recv vax & devel a swollen, red, painful & itchy arm, 2 days p/vax;inj site rxn lasted 7 days;pt has a med hx of chronic bronchitis;pt has recovered;
Vaccine Administration given in wrong site.  It was delivered Sub Q Am I vaccinated?  Do I need another dose.  Large Hot red Spot 4 inches above elbow.  Missed Deltoid by 3-4 inches
Case number PHHY2011US03780, is an initial spontaneous report received from a nurse on 07 Sep 2011: This report refers to multiple patient. One or two patients were administered only the MENVEO (batch number unknown) without being reconstituted with the MenA conjugate component, intramuscularly. No adverse event occurred following this administration.
Approximately 10 minutes after injection, patient became stiff and was unable to speak. She was responsive with head nods and shakes.  Breathing and pulse remained WNL. Patient was taken to the hospital via EMS.
COVID-19; MATERNAL EXPOSURE DURING PREGNANCY; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) and MATERNAL EXPOSURE DURING PREGNANCY (MATERNAL EXPOSURE DURING PREGNANCY) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Caffeine consumption (caffeinated beverages less than 3 per day), Alcohol use (1 to 9 drinks per week), Non-smoker (smoke cigarettes- no) and Non-tobacco user. Concomitant products included SERTRALINE, ASCORBIC ACID, CALCIUM, CHOLECALCIFEROL, CYANOCOBALAMIN, FERROUS FUMARATE, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, THIAMINE, VITAMIN A NOS, VITAMIN E NOS, ZINC OXIDE and PANTOPRAZOLE for an unknown indication.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (MATERNAL EXPOSURE DURING PREGNANCY). In 2022, the patient experienced COVID-19 (COVID-19). The delivery occurred  on 12-Oct-2021, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. In 2021, MATERNAL EXPOSURE DURING PREGNANCY (MATERNAL EXPOSURE DURING PREGNANCY) had resolved. At the time of the report, COVID-19 (COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Patient had symptoms and was tested to see she was currently infected.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient did not needed to be hospitalized because of COVID-19 infection. Patient didn't consumed marijuana or recreational drugs since your last questionnaire.  Treatment medication was not provided. Company Comment: This retrospective spontaneous case of maternal exposure during pregnancy concerns an unknown-year-old female patient with no relevant medical history who experienced the unexpected events of COVID-19 and maternal exposure during pregnancy unknown days after a dose of mRNA-1273.  In 2022, SARS-CoV-2 test Positive At the time of the report, COVID-19 (COVID-19) outcome was unknown The benefit-risk relationship of product is not affected by this report   This case was linked to (Patient Link). Sender's Comments: This retrospective spontaneous case of maternal exposure during pregnancy concerns an unknown-year-old female patient with no relevant medical history who experienced the unexpected events of COVID-19 and maternal exposure during pregnancy unknown days after a dose of mRNA-1273.  In 2022, SARS-CoV-2 test Positive At the time of the report, COVID-19 (COVID-19) outcome was unknown The benefit-risk relationship of product is not affected by this report
vial placed into the refrigerator 11/01/2021. used beyond 31 days.
pt recv vax 4JAN99 & 9JAN99 pt exp a fever ranging from 99-100.5;abd pain in rt to central lower quadrant, dehydration & vomiting;pt seen by MD to r/o appendicitis;pt hosp
Information has been received from a registered nurse (RN) concerning her 19 year old daughter who on 30-JUL-2007 was vaccinated with her first dose of GARDASIL (lot, route and site not reported).  On 05-OCT-2007 she was vaccinated with her second dose of GARDASIL (lot, route and site not reported) and on 08-FEB-2008 was vaccinated with her third dose of GARDASIL (lot, route and site not reported).  Concomitant therapy included hepatitis A virus vaccine (unspecified) (manufacturer unknown) on 30-JUL-2007 and a booster of hepatitis A virus vaccine (unspecified) (manufacturer unknown) on 08-FEB-2008, meningococcal vaccine (unspecified) on 30-JUL-2007, influenza virus vaccine (unspecified) on 05-OCT-2007, and fexofenadine hydrochloride (ALLEGRA), pseudoephedrine HC1 (SUDAFED) and hormonal contraceptives (unspecified).  The nurse stated that after completing the series, on 23-FEB-2008 her daughter developed a sore throat, arthralgia, coughing, runny nose, hand numbness and tingling.  The patient contacted the physician on an unspecified date.  A test for strep throat (date not reported) was negative.  The patient's liver and spleen were within normal limits.  Also, the patient's complete blood count, thyroid stimulating hormone, glucose, and erythrocyte sedimentation rate were within normal limits.  At the time of reporting the patient had not recovered.  No other information was available.  Sore throat, arthralgia, coughing, runny nose, hand numbness and tingling were considered to be disabling by the reporter.  Additional information has been requested.
Temperature excursion; No Adverse event; Patient received these vaccines post excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion).    No concomitant medications were reported. The nurse reported that, there was temperature excursion on 01-Nov-2022 in the refrigerator. At the time of excursion, the vials were in refrigerated storage. It was individual vials and vial size was unknown. The maximum or minimum temperatures reached at time of excursion was minimum 34.8 F (Fahrenheit) and maximum at 42.49 F  for 14 Minutes duration. The vials were moved from freezer to refrigerator in less than 30 days. On visual inspection vials were in normal state. The patient received the vaccine post excursion and remaining vials were discarded.   No treatment medications were reported.
Information has been received from a physician concerning a female who was vaccinated with a dos of GARDASIL, and subsequently was being treated for generalized body pain and muscle spasms. The patient was not recovered. The patient sought medical attention by an office visit. Additional information has been requested.
Information has been received from physician concerning a 14 year old female who was vaccinated the first dose of with GARDASIL on an unspecified date. Subsequently the patient experienced abnormal wart growth on the inside of her thigh. She was not given any further doses or medication to treat the wart. Additional information has been requested.
Gave patient expired dose of vaccine; Product storage error; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave patient expired dose of vaccine) and PRODUCT STORAGE ERROR (Product storage error) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave patient expired dose of vaccine) and PRODUCT STORAGE ERROR (Product storage error). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Gave patient expired dose of vaccine) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   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.  The pharmacist stated that the patient did not express experiencing any side effects.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up was received on 04-aug-2021 and contains significant information. Added patient demographics, updated action taken and event outcome.
Patient has received annual influenza vaccines recorded in electronic immunization records between 2008 and 2011, as well as the monovalent H1N1 flu vaccine in Dec 2009. Denies AEFI with vaccines until she received the Flu vaccine on 25 Aug 2011 (Sanofi Pasteur, # UH453AC). Patient reports developed of fever, (did not measure temperature and does not recall what her temperature was when she went on sick call), headaches (pain intensity rated as 4-5/10 using VAS), nasal congestion alternating with rhinorrhea, sore throat, and cough. Denies chest pain, shortness of breath, wheezing, and body aches. After 1 week, she lost her voice. Patient sought evaluation on sick call. Although not feeling well, she was able to function at work. Patient has a history of exercise induced asthma and allergic rhinitis, but denies symptoms exacerbation in temporal association to vaccine receipt. Denies exposure to sick contacts; reports neighbor experienced similar symptoms (sore throat, stuffy nose) within days of receiving her flu vaccine. Patient reports symptoms persisted for about 3 weeks.
This case was reported by a nurse and described a 26 year old female who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. On 6/18/02, the pt received her first injection of Engerix B. On 7/18/02, the pt received her second injection of Engerix B. On 12/17/02, the pt received her third injection of Engerix B. Lot numbers for this series were not provided. On 8/25/03, serology for hep B surface antigen was "negative." The reporter considered this to represent a lack of response to immunization. On 9/11/03, the pt received a booster injection of Engerix B.
Received the vaccine Friday around 11:40 am. Arm was sore and had joint/body aches that evening.  Saturday 2/20, 24 hours after getting the vaccine my tongue started to swell up/ was splotchy/ had bumps allong the side and my throat was scratchy. My breathing/asthma was also triggered and I increased use of my albuterol.  I took benadryl with minimum results, but symptoms did not get severe enough to go to the ER.   The next day, Sunday 2/21 my tongue was still swollen and my jaw/ face were also sore and had inflammation. This was in addition to the sore arm/joints.
Patient called 10/22/2010 and complained of Sore Throat and Headache.  Then added her arm hurt the day of shot, was sore; then said that Throat was sore and had gotten worse, then that she had Itchy Chills on her back, then said that soreness in throat was accompanied by cough, and that cough had settled in her chest and was spitting up phlegm and continued hoarseness; started on Monday 10/18/2010 and has gotten worse over last 3 days and reported first time to us on 10/22/2010
Narrative: COVID infection following COVID vaccine series 03/03, Pfizer, dose #1 03/24, Pfizer, dose #2 10/21, Pfizer, dose #3 09/17 COVID swab, result: detected 10/11/ COVID swab, result: NOT detected 09/17 pt cc: cough, headache, myalgias, rhinorrhea exposure: unknown
Itching and hives on inner arm - same arm as vaccination, but not at vaccination site.   No other known exposures to substances that could have caused this reaction.  No prior hive reactions.  Taking OTC loratadine to allieviate symptoms.
pt recv vax 15MAR96 & 7NOV96 pt devel a chickenpox rash consisting of 40 lesions & red spots all over body;more lesions were appearing;
muscle fiber twitching; This case was reported by a consumer via call center representative and described the occurrence of muscle twitching in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 5th November 2019, 21 days after receiving Shingrix, the patient experienced muscle twitching. On an unknown date, the outcome of the muscle twitching was not recovered/not resolved.   It was unknown if the reporter considered the muscle twitching to be related to Shingrix.  Additional details were reported as follows: The patient planned to follow-up with a neurologist. Reporter consented to follow up.
Left arm, near injection site; swellings, itchy red rash; 7-9 days; benadryl
Initially I experience some right sided numbness, headaches, joint pain, weight loss, anemia, right eye dropping and uneven pupil dialation, low grade fevers. Today I still have joint pain right sided flank pain, Gi problems, muscle spasms, hematuria, syncope, low blood pressure. I have been hospitalized 4 times in 2 years with cellulitis infections, have decreased c3-c4 compliments, iron abnormalities, neuropathy. Additional Info: Dose #2 Lymerix 9/2/99 LY116A2, Dose #3 Lymerix 08/30/00. As per follow up report I am currently receiving therapy to try an drepair nerve damage. I am taking Florinef to raise my blood pressure to reduce vagal phase episodes.
diarrhea; fever; leg pain; arm swollen; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included neuropathy peripheral.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced diarrhea, fever, leg pain and swelling arm. On an unknown date, the outcome of the diarrhea, fever, leg pain and swelling arm were recovered/resolved.   It was unknown if the reporter considered the diarrhea, fever, leg pain and swelling arm to be related to Shingrix.  Additional details were reported as follows: The age at the vaccination was not reported. The patient received vaccine and experienced fever, diarrhea, leg pain and swollen arm. The reporter did not consent to follow up. This case has been linked with US2020AMR074112, reported by same reporter.
Patient received a flu shot today. I told him and his dad to stay near the pharmacy for next 15-20 minutes. They went for shopping and after about 15 minutes I was notified by the store manager that patient passed out at the customer service desk. I immediately went there and by that time he was conscious and responding to my questions. 911 was already dialed before and paramedics arrived in few minutes. He was lying down and seemed ok. He was given IV hydration by paramedics and then he was taken to the hospital
Report of racing heartbeat  HR 120 Alert   Vitals obtained and client stable  Discharged to home  Follow up call feeling much better
Information has been received from a doctor of pharmacy concerning a female patient, who in approximately June 2009, "one and a half years ago" (also reported as last summer), was vaccinated with a dose of GARDASIL (Lot # not reported). The pharmacist stated that his niece was experiencing abdominal cramping. He stated that she was going to be seen by the physician the next day. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
I started getting symptoms of fatigue, chest congestion, and difficult cough. I also had headaches as well. I did have leg pains like a Charlie horse which is leg cramps. I had a low grade fever. On 6/20/2022 I took a COVID-19 test that was negative. On 6/21/2022 I took another COVID-19 test which was positive. I called my doctor and was scheduled a PCR test that was positive. I had a telehealth visit after was scheduled an antibody infusion. On 6/23/2022, I had the antibody infusion which I feel that helped with my symptoms. My symptoms lasted for about 7 days. I still have lingering symptoms of cough and minor sinus congestion as well as the leg cramps.
extreme pain at injection site & traveling down entire arm including fingers.  Pain moved on to all muscles i ncluding my back & right arm.  Extreme fatigue. loss of appetite.  This was a booster shot.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe
2 year and 11-month patient came in for second dose Pfizer Maroon top Monovalent vaccine, Orange top Pedi Pfizer Monovalent vaccine given to patient. Patient came in today for visit and parent stated patient only had fever on that day of the vaccine and was ok days after. Today patient was informed of incorrect vaccine given by provider.
Information has been received from a physician and the father of a consumer concerning a 19 year old female patient with drug hypersensitivity, seasonal allergy hay fever and allergic to codeine who on 27-JUN-2007 was vaccinated IM with a first dose of Gardasil lot #657621/0387U. Concomitant therapy included unspecified birth control pill. The physician reported that on 27-JUN-2007 the patient developed muscle pain in her neck and the patient experienced neck muscle pain on the left side of her neck. The reporter mentioned that on 27-JUN-2007 his daughter experienced injection site pain at neck. On 28-JUN-2007 the patient awakened with pain on her left side of her body, with difficulty moving left arm and leg, and she could not throw her neck and head. Her doctor was notified and said to take her to the Emergency Room. The patient has not recovered. Additional information has been requested.