chrisvoncsefalvay/vaers-outcomes huggingface dataset:
problems with her thyroid / her thyroid is all messed up right now; gets nervous usually; Consumer did not receive the second dose of the vaccine, and it has been past 36 days since her first dose.; Arm sore; Arm swollen; Arm red; arm itchy; Warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), PRURITUS (arm itchy) and FEELING HOT (Warm to touch) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Graves' disease, COPD, Anemia and Drug allergy (contrast dye). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A), VITAMIN D3, FOLIC ACID and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), PRURITUS (arm itchy) and FEELING HOT (Warm to touch). On an unknown date, the patient experienced THYROID DISORDER (problems with her thyroid / her thyroid is all messed up right now), NERVOUSNESS (gets nervous usually) and PRODUCT DOSE OMISSION ISSUE (Consumer did not receive the second dose of the vaccine, and it has been past 36 days since her first dose.). At the time of the report, PAIN IN EXTREMITY (Arm sore), PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), PRURITUS (arm itchy), FEELING HOT (Warm to touch), THYROID DISORDER (problems with her thyroid / her thyroid is all messed up right now) and NERVOUSNESS (gets nervous usually) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Consumer did not receive the second dose of the vaccine, and it has been past 36 days since her first dose.) 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.   Other Concomitant medication includes injections for anemia, inhaler (trelogy) for copd, medication for acid reflux added. No Treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant follow up appended-. Reporter contact details and new events -problems with her thyroid / her thyroid is all messed up right now(thyroid disorder),get nervous usually(nervousness) and the event (missed dose) added. On 16-Aug-2021: Significant follow up
This case was reported by a physician via sales rep and described the occurrence of pain in a adult patient who received SHINGRIX. Previously administered products included SHINGRIX (1st dose received and experienced events (refer case US2018GSK093084)). On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional heard report from another provider who was asking about trends in adverse reported with SHINGRIX doses. With this dose of SHINGRIX, the patient was worried about flu like symptoms again but had reported pain only. The health professional stated this was not her patient and did not want to report adverse events. This case was linked with US2018GSK093084, reported by the same reporter for the same patient and US2018GSK092161, reported by the same reported.
Worsening abdominal pain and distention on 3/2/21 which progressed to include shortness of breath for which he did not seek medical care. He was found unresponsive on the couch on 3/11/21 and resuscitation was unsuccessful.
I had my flu shot on October 6, 2008.  We held an onsite flu clinic for all staff.  Five weeks later I still have pain in my arm.  It hurts when I reach up or lay on the arm.  The pain is a shooting or jabbing pain.  On a scale of 1  5, it is a 3 (last week it was a 5).  The shot site has no redness or swelling.  Basically I am experiencing muscle pain.
This spontaneous report as received from a registered nurse via company representative refers to a 8 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB (lot number: K010216, dose, frequency, expiry date were not reported) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA003706:
Right arm with 5cmX5cm and Left arm with 5cmX6cm areas that are red, painful, firm, warm. No fever or other symptoms. Immunization given on 6/11/07 reaction started 6/12/07 and got progessivly worse. Seen in office 6/14/07. RX cool compresses, Benadryl, Keflex 250/5 1 1/2 tsp BID X 10 days
.5-1hr post vax developed reddness below where needle entered skin - area hard; affected area inc size daily until mo took to MD; Described now as size of a half dollar; Lt upper leg area swelling, also pt has t99ax, ear infect per mom;
pt mom called reporting that site of Hep B vax had become swollen red & puffy; no fever lt leg had localized pain;
3 days late for their 2nd dose for post exposure; Case reference number US-BN-2021-002397 is a spontaneous case report initially received from other health care professional via Agency (reference number USBAV21-0556) on 02-Nov-2021 and concerns a male patient of unspecified date.  The patient's medical history and concomitant medication details were not provided.  On 27-Oct-2021, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus vaccine; batch number was not provided), at a dose described as one vaccine per dose, adminsitered intramuscularly, for post exposure.  On an unspecified date in 2021, the patient was coming for the second dose of RabAvert (inactivated rabies virus vaccine; batch number was not provided) and was about three days late for the dose (explicitly coded as 'Inappropriate schedule of vaccine administered').    At the time of this report, it was unknown whether the patient received the second dose or if the patient experienced any adverse event.  Significant correction (amendment) identified on 12-Nov-2021, for the information received on 02-Nov-2021 included removal of the event 'Product dose omission issue'.  No further information was provided.; Reporter's Comments: The male patient was vaccinated with the first dose of RabAvert for post exposure. On an unspecified date, reported as about three days late for the second dose, the patient was coming for the second dose of RabAvert, which is considered as inappropriate schedule of product administration. It was unknown whether the patient received the second dose. No associated adverse events have been reported with the reported medication error. The event of inappropriate schedule of product administration is considered listed per convention. The patient's medical history and concomitant medication details were not provided. The event of inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human action. This case is considered non-serious.; Sender's Comments: The male patient was vaccinated with the first dose of RabAvert for post exposure. On an unspecified date, reported as about three days late for the second dose, the patient was coming for the second dose of RabAvert, which is considered as inappropriate schedule of product administration. It was unknown whether the patient received the second dose. No associated adverse events have been reported with the reported medication error. The event of inappropriate schedule of product administration is considered listed per convention. The patient's medical history and concomitant medication details were not provided. The event of inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human action. This case is considered non-serious.
Employee received vaccine at 11:38 AM. At 12:48 PM she returned complaining of feeling flushed, headache, nausea, and sweating. Noted cool clammy skin & flushed appearance. Vital Signs 12:49 PM, BP 102/72, HR 88. Employee denies SOB, dysphagia, dizziness. Employee given cold drink and remained in nurses care for 30 minutes. 1:05 PM Vital signs, BP 110/72, HR 72. Refused offer to call 911 stating she felt somewhat better with lessening of headache. Referred employee to primary care phsycian.
Felt as though I was burning on all over on my skin, hurt to touch skin, clothing hurt, when I gave myself insulin shot - it burned.  Clammy feeling all over.  Lasted about 24 hours.  Took advil around the clock - did not alleviate burning sensation
pt recv vax 17AUG95 & 6AUG96 pt devel breakthrough chickenpox;
Vaccination site red, itchy, warm to touch. About 5x5in area in size. Tried taking Zyrtec and put hydrocortisone on it. Put some Hydrocortisone on it. Areas is about 5x5 cm.
Patient received the TdaP vaccine, given by the MA in the Internal Medicine Clinic. The MA left the room. When walking by the room a few minutes later, heard a thud. Entered the room and found the patient on the ground, tremulous, awake, generally feeling poorly. Patient reported falling off their chair, hitting their head during the fall. A rapid response was called. BP normal, fingerstick glucose normal. Patient remained alert, generally tremulous, and reporting feeling unwell. Send to the ED for further evaluation given head trauma during the fall.
red swollen arm, chills, low-grade fever, weak, tired, Headache, diarrhea, cough, muscle pain
Fully vaccinated with J&J, not boosted.   Symptomatic COVID infection with inpatient stay on general medical unit.
This spontaneous report as received from a pharmacist via a field representative refers to a female patient of unknown age. It was possibly a senior patient. Relevant medical history and concomitant medication were not provided. On an unknown date the patient developed pain in the shoulder that received the vaccine. The pain lasted for 5 days and was said to be very severe to the point that the patient was unable to lift the arm. The patient was recommended to use a cold compress. The outcome of developed pain in the shoulder that received the vaccine was reported as recovered/resolved on an unknown date. The reporter causality was unknown. Additional information has been requested.
Woke up at 2am with sweating followed by vomiting, fever of 101F, joint/ muscle pain, lightheadedness.  Later the next day lymphadenitis in left axilla (same arm vx was given) fatigue, general malaise, inappetance, persistent fever.
Rash, red, generalized, raised and swollen at injection site with generalized edema. Symptoms began 2 days after injection. Fever, muscle pain, nausea, headache and fatigue.
RECALL FROM MANUFACTURER REGARDING PRODUCT STABILITY INFORMATION. PATIENT HAS NOT REPORTED ANY ADVERSE REACTIONS
Information has been received from a certified medical assistant (CMA) regarding a patient of unknown age and gender who on 30-JUL-2013 was vaccinated with an improperly stored dose of GARDASIL exposed to 20F and 30 F. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Left arm puffed up about an inch from the injection site; Feverish underneath the injection site; Redness underneath the injection site; Swollen hurting for about 5-6 days underneath the injection site; Red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), VACCINATION SITE SWELLING (Left arm puffed up about an inch from the injection site), PYREXIA (Feverish underneath the injection site), VACCINATION SITE ERYTHEMA (Redness underneath the injection site) and VACCINATION SITE PAIN (Swollen hurting for about 5-6 days underneath the injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red rash). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Left arm puffed up about an inch from the injection site), PYREXIA (Feverish underneath the injection site), VACCINATION SITE ERYTHEMA (Redness underneath the injection site) and VACCINATION SITE PAIN (Swollen hurting for about 5-6 days underneath the injection site). At the time of the report, RASH ERYTHEMATOUS (Red rash), VACCINATION SITE SWELLING (Left arm puffed up about an inch from the injection site), PYREXIA (Feverish underneath the injection site), VACCINATION SITE ERYTHEMA (Redness underneath the injection site) and VACCINATION SITE PAIN (Swollen hurting for about 5-6 days underneath the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
2 days after vaccine lost sense of taste badly Lasting loss for now Unable to enjoy food Some loss of smell too Mild : tired , can't sleep; 2 days after vaccine lost sense of taste badly Lasting loss for now Unable to enjoy food Some loss of smell too Mild : tired , can't sleep; 2 days after vaccine lost sense of taste badly Lasting loss for now Unable to enjoy food Some loss of smell too Mild : tired , can't sleep; 2 days after vaccine lost sense of taste badly Lasting loss for now Unable to enjoy food Some loss of smell too Mild : tired , can't sleep; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 54-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 22Mar2021 14:00 (at the age of 54 years) (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included no from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021, 2 days after vaccine, the patient experienced lost sense of taste badly Lasting loss for now Unable to enjoy food Some loss of smell too Mild: tired, can't sleep. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was not recovered at the time of report.  Information about lot/batch number has been requested.
Oblong area of about 6 cm on the left arm with redness, itching, swelling and pain since the 3rd day of vaccination -04/09/2021 and  lasted till today 04/19/2021.  I thought that it will go away after few days as they said, but it continues till  now (10 days).
I woke up with the chills, every bone hurt, and every muscle aches for 24 hours. I stayed in bed!
Terrible cramps diarrhea nausea vomiting constipation a high fever of a 103 or more Muscle aches sore skin joint ache Worse than the flu
Vaccine was not administered properly in the deltoid muscle but rather halfway between her elbowand shoulder; Rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was not administered properly in the deltoid muscle but rather halfway between her elbowand shoulder) and VACCINATION SITE RASH (Rash around the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was not administered properly in the deltoid muscle but rather halfway between her elbowand shoulder) and VACCINATION SITE RASH (Rash around the injection site). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was not administered properly in the deltoid muscle but rather halfway between her elbowand shoulder) and VACCINATION SITE RASH (Rash around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided.
Symptoms of oral blisters and sore, red areas with white striae  in buccal mucosa began approximately 2 weeks after Moderna Booster in Nov. 2021. Diagnosed with Oral Lichen Planus in Jan. 2022 by local ENT physician.  Treatment with topical Clobetasol Ointment is ongoing. If not resolved, plan is to treat with systemic steroids or Tacrolimus.
Adult dose administered to 8 YO.; Adult dose administered to 8 YO.; This case was reported by a physician via call center representative and described the occurrence of overdose in a 8-year-old female patient who received HAV (Havrix adult) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th January 2023, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 18th January 2023, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-Jan-2023 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received an adult dose of Havrix, which led to underdose and adult product administered to child.
significant local reaction; I have a Flublok given SQ not IM; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a female patient who experienced significant local reaction (local reaction), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via subcutaneous route.  On an unknown date, The patient developed a non-serious significant local reaction (local reaction) Unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was of actual medication error case due to Inappropriate route of vaccination.  No lab test reported.  Final diagnosis was significant local reaction.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for significant local reaction.  Information on the batch number was request.  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.
I have twins that were given their 2 month vaccinations. About a week later, both babies starting having seizures. They were diagnosed with infantile spasms. One was diagnosed with a cortical dysplasia as well.
Feeling like getting the flu again; Body aches and pain; Body aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feeling like getting the flu again), PAIN (Body aches and pain) and MYALGIA (Body aches and pains) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 immunisation.     The patient's past medical history included Breast cancer. Concurrent medical conditions included Cholesterol.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feeling like getting the flu again), PAIN (Body aches and pain) and MYALGIA (Body aches and pains). At the time of the report, INFLUENZA LIKE ILLNESS (Feeling like getting the flu again), PAIN (Body aches and pain) and MYALGIA (Body aches and pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.
11/20/09 developed angioedema. 12/1/09 Medical records and discharge summary received for DOS  11/20/09. Final DX: Acute angioedema, diabetes, elevated cholesterol Reaction to azithromycin.  tongue swelling.  Concern for patent airway. Improved w/tx. Concomitant URI.
The vaccine was administered way too high into my rotator cuff, not in the deltoid muscle belly. The injection hurt and felt like she hit a tendon or nerve and hasn?t stopped hurting.
This spontaneous report was received from a nurse practitioner and referred to a patient of unknown age, race and sex. On 18-JUL-2016, the patient was inadvertently administered an expired dose of VARIVAX, (lot # K009759, expiration date: 09-JUL-2016) subcutaneous. No adverse effect was reported. Additional information has been requested.