chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT HAD SYNCOPE AFTER RECEVING THE AFLURIA INJECTION INTRAMUSCULARY. PATIENT REPORTED HOT FLASHES, VISUAL DISTURBANCES, AND ALMOST FAINTED. PATIENT WAS ASKED TO SIT IN THE CHAIR, AFTER ABOUT 10 MINUTES , HE REPORTED CLEARING VISION, RESTORED SKIN COLOR. PATIENT WAS ASKED TO LAY DOWN IN RELAXED POSITION FOR ABOUT 1 HOUR , BEFORE HE REPORTED RECOVERY FROM THE EPISODE.
serious daily diarrhea; This is a spontaneous report form a contactable consumer (patient). A 56-years-old female patient received second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine, solution for injection, batch/lot number: EW0170, expiry date: 31Aug2021), via intramuscular route of administration, in arm, on 11Jun2021 (at the age of 56-years-old) as single dose for COVID-19 immunisation. The patient medical history was Eosinophilic esophagitis (EOE) in 2019 which was ongoing. EOE confirmed by multiple biopsies of oesophagus. Concomitant medication included Estradiol (Estrogen), Hydroxyprogesterone Caproate (Hydroxyprogesterone), PROGESTERONE and testosterone; all were taken as bioidentical hormone therapy from an unknown date and ongoing. The patient received first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine, solution for injection, batch/lot number: EW161RA, expiry date: 31Jul2021), via an unspecified route of administration, in arm, on 21May2021 (at the age of 56-years-old) as historical vaccination as single dose for COVID-19 immunisation and experienced severe headaches with outcome recovered 28May21 and serious daily diarrhoea with outcome not recovered. Vaccine facility type was reported as clinic (Site). There was no prior vaccinations within 4 weeks. On 11Jun2021, the patient experienced serious daily diarrhoea. The outcome of the adverse event was not recovered.  Follow-up attempts are completed. No further information is expected.
Felt a little fatigue and little tired. It was lymphadenopathy - super clavicle area - above clavicle and neck (above collarbone area) - painful lymph node inflammation - and tender, marble size inflammation. Gradually subsided within four weeks. Today it is very small size now but almost back to normal. I had consulted with a physician because in this area it can be a cancer concern and he said to watch and wait.
she experienced a bad taste in her mouth "like she has medicine" and is fatigued. She has soreness experienced a bad taste in her mouth "like she has medicine".; fatigue; soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (she experienced a bad taste in her mouth "like she has medicine" and is fatigued. She has soreness experienced a bad taste in her mouth "like she has medicine".), FATIGUE (fatigue) and VACCINATION SITE PAIN (soreness in her arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced TASTE DISORDER (she experienced a bad taste in her mouth "like she has medicine" and is fatigued. She has soreness experienced a bad taste in her mouth "like she has medicine".), FATIGUE (fatigue) and VACCINATION SITE PAIN (soreness in her arm). At the time of the report, TASTE DISORDER (she experienced a bad taste in her mouth "like she has medicine" and is fatigued. She has soreness experienced a bad taste in her mouth "like she has medicine".), FATIGUE (fatigue) and VACCINATION SITE PAIN (soreness in her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Approximately 8-10 hours after receiving Influenza vaccine, patient noted multiple "hives" on various body locations including legs, knee, ankles, arms, wrist, and total trunk. Positive pruristis, no pain. No fever, chills, N/U, chest pain, shortness of breath. Patient was given Benadryl and experienced symptomatic improvement. The next day fingers swollen, but "hives" had improved. Currently, still experiencing mild symptoms.
pt recvd vax & exp neck stiffness & pain & musculoskeletal sx; seen by MD; treated w/heat & anti imflammatory meds;
left arm pain; inability to lift her arm over her head; Initial information received on 23-Dec-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 77 years old female patient who experienced left arm pain (pain in extremity) and inability to lift her arm over her head (injected limb mobility decreased), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Oct-2019, the patient received a dose of0.5 ml suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Prefilled syringe) lot UJ285AB and expiry date 02-Jun-2020 via intramuscular route in the left arm.  On 06-Nov-2019, the patient experienced a non-serious left arm pain (pain in extremity) and inability to lift her arm over her head (injected limb mobility decreased) 15 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  The HCP prescribed heating and stretching. Because the pain was more in bicep than then the deltoid, the HCP believes that the arm pain is not related to the Fluzone High dose vaccine.  (Other relevant tests included No lab data.)  Final diagnosis was inability to lift her arm over her head and left arm pain.  It was not reported if the patient received a corrective treatment.  The outcome was reported as unknown for both the events.
Quality check noticed that Moderna vials were stored in a box in the refrigerator that only had an expiration date and no accompanying BUD information. After reviewing inventory in database, it was discovered that 1 of the 5 vials in the box had expired beyond its BUD. Because all vials were stored in the same box, it could not be determined if an expired dose was given. After the team consulted with the manufacturer, manufacturer gave the guidance to have the individual re-vaccinated. The patient was notified. No symptoms noted by the patient.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: cellulitis
Day 2, evening, had mild itching in many places on my body.  (not injection site).  The itching increased for two more days and my neck and ear canals swelled up.  The 3rd night was worst--I would wake up scratching and ear canals were swelled closed.  On Day 4 morning, I observed rashes all over my body and intense itching.  (not the injection site).  I went to doc who said this was an unusual and serious allergic reaction to the vaccine.  I intend to visit an allergist prior to 2nd shot. I am very worried about the severity of the inflammation that I experienced.
Two days after flu vaccine he started having significant joint pain in both of his arms and both of his legs. The pain is worse at night. He is having problems raising both arms and legs.  He first inquired at the pharmacy if his symptoms could be from the flu vaccine on 10/5/2022.  He said at the time he was slowly getting better, but I advised he contact his physician to be seen.  On 10/8/22 we followed up with him, and he had not contacted the doctor but was still having ongoing symptoms.  He will contact them on 10/10/2022.
Lips blue, face swollen. went to the Dr. put on medication, did know know the name.
Seizures, lethargy, high fever, aspiration, weakened muscles, stopped breathing.
Severe headache and weakness 4 days post vaccination with the 2nd dose; Severe headache and weakness 4 days post vaccination with the 2nd dose; This is a spontaneous report received from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe headache and weakness 4 days post vaccination with the 2nd dose. The outcome of the events were unknown.  The information on the lot/batch number has been requested
This spontaneous report as received from a registered nurse and refers to a 12 month old male patient. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 05-SEP-2017, the patient was inadvertently vaccinated with RECOMBIVAX HB 4th dose, lot # M042322 with an expiration date 21-FEB-2019, intramuscular in the right arm instead of a dose of VAQTA for prophylaxis. Concomitant therapies included M-M-R II and VARIVAX administered at the same office visit. According to the reporter, "the nurse thought she grabbed VAQTA and it was not until after the dose of RECOMBIVAX HB was administered she realized she grabbed the wrong vial". On an unknown date, the nurse had contacted the patient's mother, however the mother did not provide any information in regard to whether or not the patient had any adverse reactions.
Severe lower back muscle spasms and weakness when getting off bed. Faded off in 1/2 hr, but returned next day and getting worse.
Exceptionally heavy period, very unusual for me... both in terms of amount of blood and solid matter passed. Event remains in effect... I never have more than a single day of heavy flow and I'm several days in, still soaking pad after pad. I hope that researchers start to take some of the period-related changes occurring in women post-vaccine seriously, as I'd like to know what's going on.  I have not yet alerted the healthcare provider listed, but I will be doing so within a few days if this volume doesn't decrease and will let her know regardless the next time I have a well-visit or otherwise touch base.
Patient received COVID-19 dose #3 too early. Dose 1 given 7-26-22, Dose 2 given 8-16-22; Maroon vial 0.2ml dose No symptoms noted.
Chills; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Slight fever) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and PYREXIA (Slight fever). At the time of the report, CHILLS (Chills) and PYREXIA (Slight fever) had resolved. Not Provided          Treatment included Tylenol   This case was linked to MOD-2021-028937 (Patient Link).   Reporter did not allow further contact
AREA MOUTH  BLISSER,INVOLING TEETH,TONGUE,PELLING OF SKIN IN HER MOUTH WITCH STARTS BLEEDING,PAIN IN HER HOLD BODY. PRESENTS  DIARRIA,VOMITING FEVER IN HER HOLD BODY.
Patient is 25wks pregnant with estimated delivery date of august 11, 2021. The adverse event was an elevated heart rate beginning 10 hrs after administration of vaccine dose and lasting approx 24hrs. Elevated heart rate base was 100bpm and fluctuated up to 135bpm. During the 24hr period the heart rate did not fall below the baseline of 100bpm.   This was in conjunction with severe body aches, headache, sore throat, runny nose and fever of 99.7F.
Patient stated that he had on going pain for 21 days , starting day after covid shot.  He has neck muscle tightness ( 7 on scale 1-10).   He gets knots in the neck.  His driving is limited due to pain in the neck when turning.   He has to take OTC Advil for his constant pain when in it is unbearable, happens later part of the day.  He has headache toward the back of his head.
Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC) for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced NAUSEA (Nausea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency. On 18-Apr-2021, NAUSEA (Nausea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Extreme swollen lymph node to lt axilla, approximately size of a baseball. Chills and significant fatigue.
CONFIRMED COVID-19 INFECTION; FEVER; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included alcohol use, and cigarette smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: UNKNOWN) dose was not reported, administered on 13-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-JUN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 16-JUN-2021, the subject experienced fever. On 17-JUN-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) positive. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of confirmed covid-19 infection was not reported. This report was non-serious. The product quality complaint number was assigned to this case as 90000183353.
Paresthesia, radiculopathy  in left arm since second shot. I received first Covid vaccine in ?Left? arm on 01/02/2021 via drive through at Church with local discomfort, myalgia and arthralgias that resolved. After second shot ?right? arm this time, I developed discomfort about 10-15 minutes later in the injection site of the first shot which has persisted intermittently throughout each day since that time. Discomfort is radicular in nature and characterized as numbness. Motor strength thus far has not been effected. I take extra strength Tylenol on occasion when it gets worse, along with use of salonpas patch locally with some relief.
This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 20-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012691 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Received doses from vials that had exceeded the 30 day refrigeration limit; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received doses from vials that had exceeded the 30 day refrigeration limit) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received doses from vials that had exceeded the 30 day refrigeration limit). On 25-May-2021, EXPIRED PRODUCT ADMINISTERED (Received doses from vials that had exceeded the 30 day refrigeration limit) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable  The vials were placed in the refrigerator on 21-Apr-2021 and stayed in the same location until their administration date on 25-May-2021.
Due to physician oversight (myself), pt inadvertently received an extra dose of Menactra today. After nnk you. shot given, noticed it was given in Nov of 2005. There were no reactions. However inadvertent extra vaccine dose was given ( patient had menactra a year ago.) Per National Immunization Program representive, I was told I need to send a vares form to describe error. Tha
"Healthy 13 yo female with no significant PMH. No problem with the Pfizer vaccine dose #1. Today, 7 minutes after she received the Pfizer vaccine, she c/o dizziness. She was pale and sweaty.  BP 96/61, HR 82, RR 16 -- > 102/62, 78, 16 She was supported by the nurses.  She was alert with her eyes closed.  Pt was given water.  Pt stable, dizziness resolved.  She is at baseline and verbalized readiness to go home.  Pt stable and released from the vaccination site with her father."
severe pain in the left arm; unable to move the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in the left arm) and MOVEMENT DISORDER (unable to move the left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (severe pain in the left arm) and MOVEMENT DISORDER (unable to move the left arm). On 19-Mar-2021, MOVEMENT DISORDER (unable to move the left arm) had resolved. At the time of the report, PAIN IN EXTREMITY (severe pain in the left arm) outcome was unknown. Not Provided      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.
Pt received flu injection in R arm and pneumovax in L arm at office appointment the morning of 10/13/2021.  By the evening, she had severe R shoulder pain with decreased range of motion.   She came in for evaluation on 10/19/2021 and had some mild improvement in pain and range of motion, but still extremely limited.
Severe shaking to the point I could barely walk, talk, or function in general. In fact, had to end work conference call due to effects.  In desperation, I have my wife help me into a hot shower where I continued to shake violently for about 25 minutes.  My wife continued to monitor me to make sure I didn't collapse or pass out and continually ask if we should go to the ER.  However, after about 25 minutes the shaking subsided and I was left exhausted with some minor muscle pain due to shaking.  It was very difficult to breath during the incident, noticed my hands turning blue so I focused on deep breaths and staying calm to eventually stop it.
Patient received flu vaccine (Aventis) and developed shingles on the face 16 days later.  Treated with Acyclovir 1000mg tid. Trigeminal nerve dermatone- intense redness, itching, pain, swelling.
got shingles after we had the vaccine/Suspect vaccination failure; got shingles after we had the vaccine.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male 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 details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and got shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown. This case has been linked with US2021AMR106617, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR106617:Same reporter .
This case was reported by a nurse via sales rep and described the occurrence of enlargement of lymph nodes in a 57-year-old female patient who received SHINGRIX (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis. On 12th February 2019, the patient received the 2nd dose of SHINGRIX. On 12th February 2019, less than a day after receiving SHINGRIX, the patient experienced enlargement of lymph nodes. In February 2019, the patient experienced malaise and influenza-like symptoms. On an unknown date, the outcome of the enlargement of lymph nodes was unknown and the outcome of the malaise and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the enlargement of lymph nodes, malaise and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. Swollen lymph node under her left arm noticed on the night of the day of vaccination and the patient called on 13th February 2019. Office could not reach the patient until 14th February 2019. The patient told to monitor and come back, all malaise and flu like symptoms got resolved.
Left thigh developed 8cm X 8cm firm and red area of induration. Treated empirically with Augmentin X 10 days and warm compresses.
Information has been received via litigation article regarding a case in litigation concerning a female who was vaccinated with RECOMBIVAX HB. Subsequently the patient experienced juvenile dermatomyositis. The outcome of juvenile dermatomyositis was not reported. Additional information has been requested.
NO ADVERSE AFFECT-VACCINE ERROR.GIVEN TOO  EARLY. PT IS NOT 16