chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bright yellow feces; extreme tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FAECES DISCOLOURED (bright yellow feces) and FATIGUE (extreme tiredness) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FAECES DISCOLOURED (bright yellow feces) and FATIGUE (extreme tiredness). At the time of the report, FAECES DISCOLOURED (bright yellow feces) and FATIGUE (extreme tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Diarrhea 6+/day for three days, fever >100 for two days, abdominal cramping and dehydration. Diarrhea 4/day for 18 days.
A few hours after the vaccine was administered patient had severe malaise. She laid in bed for approximately 20 hours. She got up the morning after the vaccine and had a headache. She went to take Tylenol but syncopated while standing in her bathroom. She continued to experience episodes of lightheadedness and brain fog.  ECG and 3-day Holter monitor were unremarkable. Echocardiogram showed depressed ejection fraction (43%) and wall motion abnormalities. Coronary angiogram showed no coronary artery disease to explained these findings. Cardiac MRI showed improved ejection fraction and improving (although not fully normal) wall motion.  Patient has experienced an improvement in her symptoms, but not full return to normal. This episode and imaging findings are suspicious for stress induced (Takotsubo) cardiomyopathy. Patient will get a repeat echocardiogram in 3 months to ensure resolution of wall motion abnormalities.
7 days following vaccine the patient developed a fever of 102.5, runny nose and approximately 20 erythematous papular lesions, some with centriole vesicles on trunk and lower extremities.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired product administered) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired product administered) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  There was an excursion from their freezer on 01 Oct 2021.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: follow-up received on 15-NOV-2021 includes  patient details was updated
Started feeling really bad heartburn down into stomach. Had hot and cold flashes and then vomiting and diarrhea. Felt dizzy and weak. All of this lasted until about 8 pm.
Pt recvd vax & following the 1st inject had elevated liver function tests; pt was seen by a MD;
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M001152 (dose, expiration date and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Swollen, red, itchy, painful rash around injection site. 2 inches in diameter.
WARM FIRM ERYTHEMATOUS EDEMATOUS AREA APPROX 2" DIAMETER ON RIGHT LATERAL UPPER THIGH AT INJECTION SITE.
Felt crummy; Flu like symptoms; No energy; She had bumps (could not see but could feel) on face; Shingles; Information has been downloaded from Agency (US-CHIRONMA-PHHY2013US000834).  This spontaneous report was received from an other health professional referring to a 69 years old female patient. The patient's concurrent condition included bladder infection. The patient's medical history and drug allergy or reactions were not reported. Concomitant therapies included amlodipine besylate (+) hydrochlorothiazide (+) olmesartan medoxomil (TRIBENZOR), gemfibrozil, atenolol, pravastatin and nitrofurantoin (MACROBID).       On 18-SEP-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), 1 dosage form, subcutaneously (lot # 0073AC is an invalid lot number for zoster vaccine live (ZOSTAVAX), expiration date was not reported) and influenza virus sag 3v vaccine inactivated (FLUVIRIN 2012/2013) 1 dosage form, intramuscularly (lot #1204701, expiration date was not reported) for immunisation (strength, exact dose and dose number were not reported for both vaccine).   On an unknown date, the patient experienced felt crummy, flu like symptoms, no energy, she had bumps (could not see but could feel) on face and shingles. The outcome of the events was reported as not recovered. The causality between the events and zoster vaccine live (ZOSTAVAX) was not reported. The causality between the event flu like symptoms and influenza virus sag 3v vaccine inactivated (FLUVIRIN 2012/2013) was reported as not assessable; the causality between other events and influenza virus sag 3v vaccine inactivated (FLUVIRIN 2012/2013) was reported as suspected.  The events felt crummy, flu like symptoms, no energy, she had bumps (could not see but could feel) on face and shingles were considered to be medically significant by the reporter.
10 minutes after receiving injection felt body heating up like blood was boiling, sweating eventually passed out.   8 weeks later still low energy levels and llengthy sleeping times
Injection site (both shots given in left arm) remains painful and feels like muscle mass is impacted. It hurts without lifting when I lay on my side to sleep in the bed -and in a counter clockwise motion.
This case was reported by a healthcare professional and described the occurrence of rash in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 November 2008, the subject received a dose of FLULAVAL (unknown). In November 2008, more than 48 hours after vaccination with FLULAVAL, the subject experienced rash. The healthcare professional reported a female subject experienced a rash (not at the injection site) after receiving FLULAVAL. The rash occurred more than 48 hours after receiving the vaccine. The reporting healthcare professional did not believe the rash was related to the FLULAVAL vaccination. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was not related to vaccination with FLULAVAL. The healthcare professional reported five other subjects adverse events with FLULAVAL. See cases, A0759344A, A0759348A - A059351A. Follow-up information received on 06 January 2009 indicated that the subject was 53 years of age. She received FLULAVAL in the left deltoid on 06 November 2008 and within 48 hours, on 08 November 2009, developed a rash and hives on her upper chest, neck and ears which lasted about three weeks and received by 29 November 2008. It was reported that the subject has many allergies and take an unspecified antihistamine concurrently. She treated the rash and hives with Benadryl and Claritin and was advised by her physician to stop those treatments and only continue her regular antihistamine. The subject has received previous flu shots with no reactions. In the reporter's opinion, the events were possibly related to treatment with FLULAVAL. Three weeks after the vaccination, the reporting nurse saw the subject. The subject had what looked like an intermittent rash on her upper chest. The nurse reported that the subject's employer informed the reporter that the subject was allergic to everything after this happened.
This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 55-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 27th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 28th March 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, general body pain, fever, vomiting, nausea and headache. In March 2018, the outcome of the muscle pain, general body pain, fever, vomiting, nausea and headache were recovered/resolved. The reporter considered the muscle pain, general body pain, fever, vomiting, nausea and headache to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The registered pharmacist reported adverse events to VAERS. This case is 1 of 4 cases reported by same reporter.
Developed chest pain, extreme fatigue and short of breath when I got up 6 days after first shot of Pfizer.  Right after shot developed fatigue, headache and nausea, but recovered two days after from initial side effects. But still have tightness in my chest once in while. Note, on day I did heavy weight lifting as usually do on Sunday for 4-5 hours, plus 6 miles power walk.
I never got the flu until the 2 time I took the flu shot, I got the worst case of the flu that I have event had; Initial information regarding an unsolicited valid non-serious case from a consumer (patient) via social media on 08-Dec-2020.  This case involved a patient of unknown age and gender who never got the flu until the 2 time patient took the flu shot, patient got the worst case of the flu that he/she have event had (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported for prophylactic vaccination.  On an unknown date, latency unknown, it was reported patient never got the flu until the 2 time patient took the flu shot, patient got the worst case of the flu that he/she have event had (influenza).   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown for influenza.  There will be no information available on the batch number for this case.
Initial report was received from a patient on 21 September 2011. A 69-year-old female patient had received an intramuscular FLUZONE HIGH-DOSE in left deltoid (lot number not reported) on 19 September 2011. On the same day of the injection, the patient developed swelling in her left upper arm, redness covering one in a half inches around the injection site, warm to touch, very tired, achy all over, hard time lifting arm and doesn't feel like herself. The patient has reported the events to her physician. No further information was available at the time of the report. The patient outcome was not recovered/not resolved. Documents held by sender: none.
Severe Pain on shoulder / neck on side of injection site.  Did not regain full motion without pain for over a week.  Treated neck and shoulder with ice.
45 minutes post-observation, the patient returned to the site reporting redness on the back. Redness on the upper back and chest. No visible rash or hives were noted. VS within normal range. The patient denied chest tightness, or elephant on the chest, SOB, numbness, and difficulty breathing. Patient alert and oriented X4. No medication was given. Symptoms resolved within 30 minutes. Left the site accompanied by parents with stable condition.
Chills, I took 2 extra strength Tylenol and chills started back within 6 hours.  Lasted a day and a half.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP7538), on 12Apr2022 as dose 2, single (Lot number: EP7538) and on 02Nov2021 as dose 3 (booster), single (Lot number: FH8020), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Mildly high cholesterol." (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Jun2012, stop date: 31May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19".  No follow-up attempts are possible. No further information is expected.
Patient had vaccine Friday afternoon then on Saturday morning she woke up with pain and low temperature (96.0).  She took ibuprofen and took a nap.  When she woke up from her nap she felt better. On Saturday evening she noticed redness about the size of her hand and swelling at the injection site , she stated site not painful unless she touched it and applied pressure.   When she called me Sunday after at 2:00pm to report all this she stated it is starting to be less red and less swollen. Patient reports no shortness of breath, no tightness in chest, or no tightness in throat.
Pfizer-BioNTech Covid-19 Vaccine EUA: Hives on upper torso and arms. Hives ranges between penny and quarter sized spots. Occurred once per day for the next three days (14, 15 and 16th). Took Benadryl and oatmeal bath to relieve itching. Hives did not come back after April 17th.
Severe Myalgia, Joint tenderness, Nausea, Fever, Lumbar tenderness  All resolved after 36hrs
Invalid vaccine as the incorrect expiration date was documented. Vaccine expired on 12.06.2021 and was administered on 12.09.2021
24 hours post vaccination with 1/2 dose of fluzone, child developed fever of 103F. Could not keep Tylenol down. Required visit to ER. Parents refused remaining booster dose of vaccine.
Woke up really fatigued. Within one hour  January 6  - 10:00 and 10:45 here are all the symptoms that showed up in that 45 minutes. I was in the middle of treating a PT. Scratchy throat; mild cough; persistent moderate headache; runny nose; diarrhea; very pale. Never had a fever. I had weird neurological side affects (didn't lose taste or smell  ) issues with facial recognition - didn't recognize my own face and finding words for every day objects and making sentences was difficult . I was easily winded and had tightness in my lungs. I called Public Health office - and asked them what to do. She told me to go home. Dr  (telehealth visit) told me to take a test in the parking lot that day for COVID January 6. Treatment  - none. All o f my symptoms lasted until Friday January 8 except being winded and fatigued. Those last two symptoms lasted until January 19.  Verbal issues also lasted until the 19th of January. Facial recognition came back around January 12.  On January 27 I had second dose.
Mother states all his toe nails fell off after chickenpox vaccine. This was within days. Also happened to daughter toe nails turned black and fell off.
Patient received an expired dose of Pfizer COVID-19 vaccine. Vaccine expired on 10/21/2021.  Nurse in clinic confused over the expiration date, which extended to November 30th (if frozen).  She did not understand the 30-day expiration once refrigerated.
Right upper arm: red, hot, mildly indurated area 18cm x 15cm, no fever, no constitional 5x's. Began 06/05, immunizations given 06/04. Recommended: cool compress, Benadryl.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # L015282 with expiration date 30-APR-2017, lot# M002419 with expiration date 12-JAN-2018 and lot # L039613 with expiration date 08-OCT-2017 (dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 11.8 degrees Celsius for 1 hour 3 minutes. Data logger was involved. There was previous excursion of 10.2 Celsius for 1 hour 3 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Pt developed hives on bilateral arms, wrist and hands. Vital signs stable, no other complaints of tongue or throat swelling. No other s/s of anaphylaxis. Pt given Benadryl 50 mg po and observed for 60 minutes. Hives resolved and patient sent home.
given a double dose of the Fluzone Quadrivalent, first dose given on 09Nov2020 and second dose given 06Jan2021 with no adverse event; Initial information regarding an unsolicited valid non-serious case received on 06-Jan-2021 from other health professional (Nurse) via call center.  This case involved a 71 year old male patient who received a 0.5 ml first dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number- UJ476AA and expiry date- 30-Jun-2021), via unknown route at unknown administration site, on 09-Nov-2020 and second dose given 06-Jan-2021 (Extra dose administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error given a double dose of the Fluzone Quadrivalent, first dose given on 09-Nov-2020 and second dose given 06-Jan-2021 (Extra dose administered)..    At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
taking positive/COVID-19; taking positive/COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative Colitis" (unspecified if ongoing). Date of last menstrual period: 01Dec2021. The patient was 17 weeks pregnant at the time of exposure to BNT162b2. The patient is expected to deliver a baby(s) on 07Sep2022. Concomitant medication(s) included: HUMIRA; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]; LEVOTHYROXINE; NASACORT. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "taking positive/COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested negative 6 days after taking positive; Negative, notes: Tested negative 6 days after taking positive; Positive, notes: tested positive on day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19 dated from 08May2022 to 12May2022 with Anti-viral.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
First I had no period when it was due. Now I have been bleeding heavily for two weeks with no sign of easing up.
1st dose on 11th Dec 2021, 2nd dose not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th December 2021).   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: 21-Sep-2022 Reporter's comment: The patient had a chat with pharmacist. The reporter would like to know what was the protocol for the 2nd dose of Shingrix for a patient that had passed the 6 month interval. The reporter had a patient that got their first dose at a pharmacy and asked him/her to give them their second dose, but it had past the 6 month interval. 11th December 2021 was to be exact date. The reporter wanted the follow up via postal. The consent to follow up was granted. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
FIRST REACTION BUT NOT BOTHERSOME WAS SLIGHT SORE ARM. WITHIN 22 HRS OF RECEIVING THE SHOT, I STARTED WITH. A  SLIGHT FEVER 99.9  FATIGUE & CHILLS. FOR THE NEXT 36 HRS, MY TEMP STAYED IN THE RANGE OF 100.3 TO 102.1.  I TOOK TYLENOL EVERY 6 HRS.  FINALLY TEMP WENT BACK TO NORMAL & CHILLS STOPPED.  HOWEVER , THE TIREDNESS/FATIGUE LASTED ANOTHER 24 HRS. TODAY 4/9, I FEEL FINE  WITH NO SIDE EFFECTS. THANK YOU FOR LISTENING.
3 hours after immunizations, had fever to 104 degrees and cried all night. Had 2nd fever to 104 degrees then went to 98 degrees without further complications.
Breakthrough Covid case: very mild cold like symptoms including slight headache, slight runny nose, low grade fever(highest was 99.9) Symptoms started on Wednesday June 29 and ended on Friday July 1.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN5318), in left arm, on 29Mar2021 as dose 2, single (Lot number: EN6199), in left arm, on 19Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 11May2022 as dose 4 (booster), single (Lot number: FH8028) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "propylene glycol allergy" (unspecified if ongoing). Concomitant medications included: ZOLOFT oral; BUSPIRONE HCL oral. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.