chrisvoncsefalvay/vaers-outcomes huggingface dataset:
loss of appetite; Anxiety; extreme thirst; On and off GI problem; Gas; Stomach loudly numbling; eye twitching; Both toes have been tingling, feet and claves tingling; Both toes have been twitching, feet and calves began twitching; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Both toes have been tingling, feet and claves tingling), MUSCLE TWITCHING (Both toes have been twitching, feet and calves began twitching), DECREASED APPETITE (loss of appetite), ANXIETY (Anxiety) and THIRST (extreme thirst) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 28-Mar-2021, the patient experienced PARAESTHESIA (Both toes have been tingling, feet and claves tingling) and MUSCLE TWITCHING (Both toes have been twitching, feet and calves began twitching). On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite), ANXIETY (Anxiety), THIRST (extreme thirst), GASTROINTESTINAL DISORDER (On and off GI problem), FLATULENCE (Gas), ABDOMINAL DISCOMFORT (Stomach loudly numbling) and BLEPHAROSPASM (eye twitching). At the time of the report, PARAESTHESIA (Both toes have been tingling, feet and claves tingling), MUSCLE TWITCHING (Both toes have been twitching, feet and calves began twitching), DECREASED APPETITE (loss of appetite), ANXIETY (Anxiety), THIRST (extreme thirst), GASTROINTESTINAL DISORDER (On and off GI problem), FLATULENCE (Gas), ABDOMINAL DISCOMFORT (Stomach loudly numbling) and BLEPHAROSPASM (eye twitching) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (UNKNOWN ROUTE), the reporter did not provide any causality assessments. Concomitant product is not provided. treatment is not provided.       Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: ADR appended
Pt received Rotavirus vaccine on 4/06/09. Pt had ER visit with Dx intussusception on 4/08/09. pt c/o vomiting/rectal bleeding, low grade fever. Moc + PPD, taking INH/Vit B-12.  6/8/09 Medical records received DOS 4/6/09 to 4/20/09. FINAL DIAGNOSIS: Reduction of Intussusception. Post vaccination presented with fever, emesis, crying and arching back. R TN obscured. Diarrhea. Referred to hospital for evaluation, reduction of intussusception.  6/15/09 Received hospital medical records for 4/8-4/15/2009. FINAL DX: intussusception, open reduction w/appendectomy Records reveal patient experienced vomiting, decreased appetite, irritable, lethargic, bloody stools, cramping, abdominal pain, low grade fever x 1 day.  Attempted enema reduction unsuccessful. Surgical consult done.  To OR for difficulty manual reduction.  Bowel noted to have edema & hemorrhage but no frank necrosis.  Developed cough & fever postoperatively which resolved by d/c to home.
Patient reported extreme arm soreness in his right arm where the Tdap vaccine was given compared to his left arm.
Medical assistant gave an initial Covid vaccination to her patient. While he was waiting his 15 minutes post vaccination to monitor for reactions, she noticed he was staring blankly at her. She asked if he was ok. Site Lead overheard her ask the patient and came into the room. RN noticed that he was slumped over and having a seizure. RN picked him up and placed him on the floor on his side. RN told MA to get an onsite MD and advised another RN in the room to call 911. Patient continued to seize. Blood pressure, oxygen level, and glucose levels were checked. All were within normal limits. Patient awoke and told RN he has a history of seizures but has not had his medication for a couple months. He stated that he has seizures when he gets nervous or upset. His last seizure that he could recall was a month ago. He then went into another seizure. EMS was on the scene. He came out of that seizure quickly. They placed oxygen on the patient. He wanted to sit up. RN helped him to sit up and helped him walk to the stretcher. He was awake, alert and oriented to person, place and time when he left the clinic. He was transported to Hospital per his request.
Sore arm only; Arm discomfort only; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 17Mar2021 08:30 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Mar2021, outcome "recovering", described as "Sore arm only"; LIMB DISCOMFORT (non-serious) with onset 17Mar2021, outcome "recovering", described as "Arm discomfort only". Therapeutic measures were not taken as a result of pain in extremity, limb discomfort.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient did not have COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with thyroid issues, migraines and dexamethasone (manufacturer unknown) allergy. On 21-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX, vial (dose and route unspecified) for shingles prevention. Concomitant therapies included levothyroxine sodium (manufacturer unknown), sumatriptan, naproxen sodium, TREXIMET and estrogens, PREMARIN. On an unspecified date the patient developed hives around her back and stomach. Patient saw an unspecified physician who prescribed an unspecified antihistamine on an unspecified date. Patient was fully recovered on an unspecified date. Additional information has been requested.
Started have allergic reactions to nuts , swelling of face, eyes, etc and my body was covered in hives.  This was finally diagnosed as an autoimmune disorder and I now have to get treatments (xolair injections) for continous hives every 4-6 weeks.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 08-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 2-year-old female patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 11-OCT-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage). On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes.There was no previous temperature excursion. The call was due to digital data logger.   No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567:
pt devel arthralgia of the shoulder & elbow in the evening of the day vax recvd;
CBC obtained 3 days post influenza vaccine, demonstrated neutropenia (ANC 650) and mild thrombocytopenia (plt 150). Patient otherwise well and asymptomatic. There is a possibility results may be spurious.
Child lost consciousness for < 1 min. after receiving vaccines. Required monitoring, laying supine, cool compresses, and a popsicle. Blood pressure was low. Child required approx. 30 mins. to recover fully, blood pressure to return to normal.
Rash, went to Urgent Care per office advice.    prescribed Prednisone for 3 day course.  PCP follow up on 1/13.  No work capacity until then.
Raised, itchy, spotty rash starting at ankles. Covered trunk and torso within 24 hours. No headache. No fever.
Information has been received from a physician through the Merck Pregnancy Registry concerning a 19 year old female with anxiety, depression, chronic fatigue and drug allergy to acetaminophen who on 22-JAN-2008 was vaccinated IM with a 0.5 mL dose of Gardasil (Lot# unknown).  Concomitant therapy included clonazepam and buspirone HCl.  On 31-JAN-2008 the patient began experiencing tremors, fatigue, lightheadedness, a faint feeling, heart palpitations and blurred vision.  She reported that "complete bloodwork" was done (results not reported).  At the time of the report, the patient had not recovered.  Additional information has been requested.
Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 25Feb2021 at 10:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified relevant medical history and had unspecified allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Feb2021 at 11:00, the patient had diarrhoea and at the time of this report patient had 3 days of diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event diarrhea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Around 10AM on 01-14-21 I felt fever, my temperature was 99.8, later on it went up to 100F. 01-15-21 my temperature was about 99.8 and I felt tiered.   Previously on 12-24-21 after my Covid shot on 12-23-21 my temperature rose to 103F. The next day it went down to 100F.
nausea; vomiting; severely tired; achy joints; This spontaneous case was reported by a pharmacist and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting), FATIGUE (severely tired) and ARTHRALGIA (achy joints) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea), VOMITING (vomiting), FATIGUE (severely tired) and ARTHRALGIA (achy joints). At the time of the report, NAUSEA (nausea), VOMITING (vomiting), FATIGUE (severely tired) and ARTHRALGIA (achy joints) outcome was unknown.        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.   Concomitant medication was not provided.  Treatment information was not provided.
This spontaneous report was received from the Vaccine Coordinator referring to a 3 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 14-DEC-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Flu-like symptoms; sick whole weekend; awake in and out of it; didnt eat or drink anything; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), ILLNESS (sick whole weekend), SLEEP DISORDER (awake in and out of it) and EATING DISORDER (didnt eat or drink anything) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), ILLNESS (sick whole weekend), SLEEP DISORDER (awake in and out of it) and EATING DISORDER (didnt eat or drink anything). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), ILLNESS (sick whole weekend), SLEEP DISORDER (awake in and out of it) and EATING DISORDER (didnt eat or drink anything) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  no concomitant medications were provided.  no treatment medications were  provided.
Case number PHEH2015US019626, is an initial spontaneous report received from a physician via sales representative on 29 Sep 2015. This report refers to a 10 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: X14136, expiry date: 31 Oct 2017) in right arm on 12 Sep 2015. The patient was also vaccinated with BOOSTRIX and Varicella in the left arm on 12 Sep 2015. On an unknown date after vaccination, she experienced redness and swollen in the right arm within a 3-4 inch diameter of where the MENVEO vaccine was given. Upon follow up it was reported that swelling and redness had reduced to the size of a mosquito. The outcome of the events was reported as condition improving. Seriousness and causality of the events were not reported. No further information was reported.
This spontaneous report as received from a Registered Nurse concerning a 6 month old patient who on 11-NOV-2013 was vaccinated with an expired dose of ROTATEQ lot # 0579AE, exp date reported 27-OCT-2013, oral (dose not provided). No adverse effect was observed. This is one of several reports received from the same source. Additional information has been requested.
Night of vaccine: fever, chills, body aches for 24 hours. Fatigue, mental fog, dizzy spells, vertigo still persisting after 12 days.
Itchy red bumps appeared on left side of upper back. Applied hydrocortisone lotion for relief. Some minor muscle pain experienced on previous days. Rash spread and inflamed with increased pain and itch. Continued treating with calamine & hydrocortisone. Dermatologist visit confirmed shingles on 10/24/2014.
The patient was given the SHINGRIX with the diluent of sterile Diluent instead of the Adjuvant suspention component to form the SHINGRIX given on 9/17/2018 in Right Deltoid. This was the patients #2 vaccine. This was discovered on 09/24/2018 when their was an extra Adjuvant suspention component left in the box. The was a message left for the patient to call back to the clinic. For us to notify the patient what had happen. He had not reported any adverse reaction at this time. On 9/24/2018 I had contacted the immunization program to verify what had happen and how soon the patient could get the corrected dose.
Brachial plexus neuritis - severe shoulder & upper arm pain in the not-injected limb, progressing to tingling & intermittent numbness in left hand in June/July.
Within 30 minutes of receiving my first Pfizer Covid-19 shot, I developed tinnitus.
7/12/small pox, 7/21-developed redness pain left deltoid 7/22-erythema approx 4" surrounding site positive lymph nodes. Treated with Levaquin
This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and malaise. On an unknown date, the outcome of the fever and malaise were recovered/resolved. It was unknown if the reporter considered the fever and malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The physician casually reported that, they heard of a patient who experienced more severe symptoms of fever and malaise which lasted for 3 to 4 days. The healthcare professional wondered the occurrence of systemic adverse events and provided general statements of what he had heard in terms of patient experiences but did not had an adverse event to directly report. This case has been linked with US2018GSK181365, reported by the same reporter.
Throat felt tight, flushing/sweating. Used patient home inhaler albuterol 2 puffs 5 minutes after symptom onset. BP 138/67, HR 89, RR20, O2 99%. Upon discharge, BP 133/70 P77 RR20 O2 96%, lungs clear bilaterall, no respiratory distress.
Constant itching on legs, arms, torso.  Eruptions that scale and peel off.  Started right after vaccination and persists today.  Have seen family physician, 2 different dermatologists, one PA.  Stopped when I received a cortisone shot from my physician but it didn't last.  He also took a biopsy with no actionable results.  All 3 doctors prescribed Triamcinolone Acetonide Cream.  Last dermatologist said to take Zyrtec and use Cera Ve Anti-Itch Cream.  His last diagnosis was Eruption of immunosenescence, maybe puritus.
Discomfort; tickle in throat; minimal mild cough that is not constant; slight runny nose; This is a spontaneous report from a contactable other health care professional (patient). A 41-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in arm left on 01Feb2021 at 15:00 as single dose for COVID-19 immunisation. The patient medical history included COVID. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no known allergies. On 02Feb2021, the patient experienced discomfort, tickle in throat, minimal mild cough that is not constant and slight runny nose not constant just brief episode. Therapeutic measures were taken as a result of events included cough drop. The outcome of all the events was unknown.  Follow-up attempts completed. No further information expected.
Vaccine was expired, no temperature excursions occurred and moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".  Patient reported no adverse reactions.
Within 18 hours of vaccine I had chills and fever, nausea, severe headache, began shaking uncontrollably, rash and itching developed on legs, palpitations/rapid heartrate, became delirious and confused, weakness, fatigue, blurred vision.  I was unable to speak clearly, felt impaired, passed out.  I woke up with severe nausea and vomiting, diarrhea and my temperature was 104.  Treated with advil, excedrin, zofran, fluids and ice packs.  Within 36 hours the symptoms improved