chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Roth spot on her eye; Indication:had a pap smear that showed I have HPV high risk strain, showed ASCUS"; This spontaneous report as received from a consumer refers to a 39-year-old female patient, no pregnnat nad  with no present medical history. Current conditions include:  allergy to Erythromycin reported as Arythomicin. Historical vaccine include a vaccination of COVID (manufacturer unknown), on an unknown date, reported as over 3 months.   Concomitant therapies included docosahexaenoic acid, eicosapentaenoic acid(VEGETARIAN OMEGA 3), cyanocobalamin(B12-VITAMIN) and colecalciferol(VITAMIN D3).    On 12-DEC-2022 and 13-MAR-2023, the patient was vaccinated with a first and second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscular (strengths, lot #s and expiration dates were not provided) respectively,  for high risk HPV strain, because the patient had a pap smear that showed "ASCUS", date unspecified (Product use issue).  The caller reported she went to the eye doctor on 29-APR-2023, and the doctor found a Roth spot (Retinal exudates) on her eye. The caller said her doctor told her this could be caused by COVID, chronic high blood pressure or leukemia, but all of these had been ruled out as causes for this patient. The caller also said they mentioned it could be from a COVID vaccine, but the caller said she has not had a COVID vaccine in over 3 months (date unknown). The caller said they checked her complete blood count, on an unknown date  and confirmed she did  not have leukemia.  The outcome of retinal exudates was reported as not recovered/not resolved. Causality for retinal exudates and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was unspecified.  Upon internal review retinal exudates was considered to be medically significant.
28APR94 knee joint had swelling & pain gradually it went away then next day arms from shoulder down to elbow joints & in the hands became painful hard to open & close hands & have general weakness & a lot of numbness & pins & needles;
had balance issues for 4 months after her 2nd sho/If she turned a certain way, you could tell; This spontaneous case was reported by a nurse and describes the occurrence of BALANCE DISORDER (had balance issues for 4 months after her 2nd sho/If she turned a certain way, you could tell) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (had balance issues for 4 months after her 2nd sho/If she turned a certain way, you could tell). At the time of the report, BALANCE DISORDER (had balance issues for 4 months after her 2nd sho/If she turned a certain way, you could tell) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported No treatment Drug was reported
From telephone contact with reporting physician it was stated that a 19-month-old male patient received an ActHIB and an Engerix Hepatitis B vaccination on June 25, 2001. The next morning the patient developed a large local reaction, red and hard, warm area at the injection site (site not specified). Patient was seen in physician's office on June 27, 2001. The reaction completely resolved.
Patient got Pfizer vaccine 1:53pm and reported that her throat felt kind of tight and-  she sat down had some water and after 5 minutes she said she was fine.  we had her wait 30 minutes on site.  I later followed up with her at 5:30pm that day and all was well.  She was told she should go to the clinic, and she said she didn't want to.  Her Epi pen was expired and recommended she get new Rx. immediately.
High fever, excruciating headache, nausea, vomiting, pain in arms and legs. Two emergency room visits required. IV Saline, Toradol and Zofran administered on both visits.
Pharmacist (reporter) accidentally gave 2 doses of the COVID bivalent vaccine in separate IM locations (deltoids). Realized mistake after administration. Patient tolerated vaccine ok and showed no adverse events directly after. Told patient to monitor herself for severe reaction.
Both vaccines given in left arm. Patient states that she is unable to move her left arm up all the way to dress herself and is only able to lift her arm to mid body level without discomfort and muscle soreness. She states that she has been feeling the muscle soreness and inability to raise left arm fully shortly after vaccine and for about two weeks now. She has visited the doctor's office and has been given a medrol dose pack to see if this helps her improve her mobility.
-Mom gave Tylenol before office visit -2 Hours after vaccines administered, baby was difficult to arouse from sleep -had difficulty feeding baby-took 2 ounces, slept, then projectile vomiting -rectal temp 105.3 -tongue 'flopping' in mouth, body jerking -called E.D. and was instructed to manage on own, they did not know what to tell her -used cooling baths and repeat doses of tylenol until fever decreased
Moderna COVID-19 Vaccine   All day fatigue, nausea, body aches, injection site pain, chills
Subsequently post vax, the pt developed an injection site reaction characterized by redness, swelling, and pain. The symptoms resolved within 4 to 5 days.
Severe and persistent Upper Left Arm pain.    Cannot lift my left arm above shoulder height since the date of the injection.     Still present after 3 weeks!
Headache, Myalgia, Arthralgia, Fever & Diarrhea Narrative: day 1 chills. day2 4am throbbing headaches, continued chills, moderate fever, intense muscle pain throughout my entire body, sore throat/congestion, and diarrhea. These sideeffects lasted around 16-20 hrs
Pain in arm; This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced pain in arm. The patient was treated with ibuprofen and non-drug therapy, non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the pain in arm was recovered/resolved.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that things were going well with arm and next day had pain and more pain. The patient quickly took two Ibuprofen, iced my arm, and decided not to go back for the second shot. The reporter did not consent to follow up.
Pt visit to office for diaper rash & bruising easy. Labs result of platelet 17. Pt was transported to hospital.
This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever and shivering. On an unknown date, the outcome of the fever and shivering were recovered/resolved. The reporter considered the fever and shivering to be related to Shingrix. Additional details were provided as follows: The reporter was a friend of the patient. This case was not previously reported to anyone. The age at vaccination was not reported. The patient received the vaccine on an unknown arm. The reporter stated that the patient experienced chills, shivering, and a fever of 102 degree F. The reporter stated that the patient's symptoms resolved after 1 day. The reporter had limited information at the time of reporting. The reporter also had limited details regarding the patient's healthcare professional information. Lab Comments: On an unknown date, the lab test was performed.
experiencing changing temperatures between hot and cold; I had chills; nauseated; my body just felt so cold; swollen lymph nodes in his clavicle area; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 COVID-19 immunization.  In this case it was reported that, after he received his second dose on 10Mar2021, he developed swollen lymph nodes in his clavicle area on 14Mar2021 and they were still there. They have improved some. After the first dose, he did not have any reports of side effects at all. After his second dose, he also started experiencing changing temperatures between hot and cold. he had chills, he was nauseated, and his body just felt so cold. On the 14Mar2021, that was when he noticed the swelling of the lymph nodes in the clavicle on his left side. Since then, it has shrunk in size, but he could still feel it. Some of his colleagues had swollen lymph nodes under the armpit, for him just happened to be in the clavicle. He pressed on it and barely felt it. He did not think it was any cause of concern. The patient experienced swollen lymph nodes in his clavicle area on 14Mar2021 and changing temperatures between hot and cold, i had chills, nauseated and my body just felt so cold on an unspecified date. The patient underwent lab tests and procedures which included physical examination on Dec2020: Everything checked out fine. Outcome of the event swollen lymph nodes in his clavicle area was recovering and unknown for other events.
On 3/24/21, pain in right leg. On 3/30/21, pulse dropped to 37 and she passed out and was unable to recover, so called 911
Guillian Barre Syndrome requiring intubation. Pt is still in hosp as of 10Dec90, Developed weakness on 28Nov90
24 hours after patient received vaccines (2) she got really red, bright red on face, neck, chest, shoulder area. Patient started taking BENADRYL and ZYRTEC for the hives/redness.
COVID?19 Vaccine EUA. I have hives on my right chest and under right arm that started day of vaccine 1/19 and are still with me 1/23. I did not have systemic allergic reaction. I have used cortizone, tylenol, claratin and cold pack to manage symptoms.
Started at 5:00am on 5/5/21.  Started with full body aches (even down to individual toes on feet) and throbbing  arm pain at site of injection.  8:00AM -6pm on 5/5 fever of 100.7, and on 5/5 and 5/6, extremely swollen lymph node under armpit of arm that got the shot.   Treated fever and body aches with Tylenol, ice packs at site of injection and armpit.  On 5/6 primary symptom is swollen lymph node (visibly swollen) and painful under arm with injection site.  Some residual arm pain at injection site.
Child was given an undiluted dose of Pediatric Pfizer vaccine.  Discussed situation with Health Department's medical director - determination was that no medical intervention was necessary.  PHN supervisor contact the parent via phone call, parent advised of administration of undiluted Pfizer pediatric vaccine.  Parent advised that no medical intervention was needed, reviewed when to contact emergency care if needed.  Parent reported that child was experiencing no adverse events after vaccination.
experiencing extremely heavy longer periods (monthly menstruations) with violent painful cramps/It is atrocious; experiencing extremely heavy longer periods (monthly menstruations) with violent painful cramps/It is atrocious; experiencing extremely heavy longer periods (monthly menstruations) with violent painful cramps/It is atrocious; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18May2021 (Lot number: ER8731) at the age of 30 years as dose 1, single and administration date 08Jun2021 14:30 (Lot number: ER8731) as dose 2, single for covid-19 immunisation. Relevant medical history included: "chipotle sauce/flavoring any brand" (unspecified if ongoing); "fever" (unspecified if ongoing). Concomitant medication(s) included: ALEVE taken for pyrexia. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), OLIGOMENORRHOEA (non-serious), DYSMENORRHOEA (non-serious) all with onset 18May2021 14:30, outcome "not recovered" and all described as "experiencing extremely heavy longer periods (monthly menstruations) with violent painful cramps/It is atrocious". Therapeutic measures were not taken as a result of heavy menstrual bleeding, oligomenorrhoea, dysmenorrhoea.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not diagnosed with COVID-19. The patient received other medications within two weeks was Aleve for fever after the vaccination. It was reported that ever since patient had the vaccinations. Patient was experiencing extremely heavy longer periods (monthly menstruations) with violent painful cramps that patient never had prior to the vaccinations. It is atrocious!!! Patient using two boxes 36 count ever since her cycle was that was not normal for her.    No follow-up attempts are possible. No further information is expected.
Right arm, 4cm length welt inferior to deltoid, tender, no discharge. Fever 99.2F documented. Headache, myalgias and arthralgias. Started 11 days, post vax. Evaluated 13 days, post vax.
Initial event was unusual sudden release of pressure during injection. Felt discomfort at inj site in evening, could not sleep on left side due to shoulder pain. Could not abduct Left arm more than 6 inch away from body for 3 days.  Interfered with household tasks and ball toss when serving at tennis. Was no swelling, fever or other reaction (as with a flu shot), only pain. Dr advised using heating pad but was no help. Movement improved slowly over the following 6 months.  Still have some movement restriction and occasional pain, now 7 months after event. (I have been exercising to improve surrounding muscles to help situation). Nurse was standing while I was sitting - have read this may be a factor in the injury.  Hesitate to check Permanent Disability box below not knowing how long the issue will last.
cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (cough). The patient was treated with CHLORPHENAMINE MALEATE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (XL 3) ongoing since an unknown date for Cough, at a dose of 1 dosage form. At the time of the report, COUGH (cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication included XL3 for cough.  The Patient was due for her second dose of Moderna on 26-MAR-2021
severe chest pains; shortness of breath start a little and seemed to be getting worse; shortness of breath start a little and seemed to be getting worse; EF factor was 35; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 (Lot number: EW0168) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Barrett's esophagus" (unspecified if ongoing); "Heart attack 2018", start date: 2018 (unspecified if ongoing). No known allergies. Concomitant medication(s) included: DILANTIN [PHENYTOIN SODIUM]; ENTRESTO; NEXIUM [ESOMEPRAZOLE MAGNESIUM]; ANORO inhaler; ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Bnt162b2 (Dose Number: 1 Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 15Apr2021, when the patient was 59 years old, for COVID-19 Immunization. The patient had not received any other vaccine in four weeks prior to vaccination. Patient had no COVID infection prior vaccination. The following information was reported: CHEST PAIN (hospitalization, disability, life threatening) with onset 06May2021, outcome "not recovered", described as "severe chest pains"; DYSPNOEA (hospitalization, disability, life threatening), CONDITION AGGRAVATED (hospitalization, disability, life threatening) all with onset 06May2021, outcome "not recovered" and all described as "shortness of breath start a little and seemed to be getting worse"; EJECTION FRACTION DECREASED (hospitalization, disability, life threatening) with onset 06May2021, outcome "not recovered", described as "EF factor was 35"; The patient was hospitalized for chest pain, dyspnoea, condition aggravated, ejection fraction decreased (hospitalization duration: 3 day(s)). The events "severe chest pains", "shortness of breath start a little and seemed to be getting worse", "shortness of breath start a little and seemed to be getting worse", "EF factor was 35" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: ejection fraction: (06May2021) 35; sars-cov-2 test: (11Nov2021) negative; (23Nov2021) negative. It was unknown if therapeutic measures were taken as a result of chest pain, dyspnoea, condition aggravated, ejection fraction decreased. The patient stated that, she was doing great for two years after having heart attack her ejection fraction was good at 45 and living a great life. She had toe second shot she had severe chest pains thought we would have to call emergency numbers. Slowly after that her shortness of breath started a little and seemed to be getting worse. Finally backed forth with doctors it came to a point she had to go to ER. She had no blockage, but EF factor was 35. Now they are trying oxygen to help me. She was never on oxygen. Nobody could explain why this happened. She said after the shot things went downhill. AE resulted in emergency room and doctor visits.
Severe pain in arm that spread across upper one-third of  back all the way to just under my neck.
No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 22-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.   This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
Swollen lips Swollen, redness and tender to area where vaccine was giveb Trouble breathing Throat closing
Havrix pediatric administered to a 59 year old; Havrix pediatric administered to a 59 year old; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 58-year-old female patient who received HAV (Havrix pediatric) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th February 2022, the patient received Havrix pediatric .5 ml and Havrix Pre-Filled Syringe Device. On 11th February 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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: 24-AUG-2022 Reporter's Comment: The reporter was a medical assistant. The reporter reported that on 11 February 2022 the patient received a Havrix pediatric vaccine and on 24 August 2022 patient received a Havrix adult dose of 1 ml. The reporter consented to follow up.  Additional Supportive Information: The adult patient was administered a pediatric dose of Havrix on 11th February 2022, which led to underdose and adult use of a child product
Dose 1: 4/29/2021 Dose 2: 5/27/2021  Symptoms onset began on 4/28/2021 and included fevers, cough, weakness, heartache, diarrhea, headache, dizziness. Symptoms temporarily improved on 5/29/2021. On 5/30/2021 at approximately 1:00 AM patient experienced constant, pleuritic chest pain/pressure and shortness of breath which prompted him to go to the emergency department.
30 hour after the vaccine had chills, fever (103 F), headache, stomach ache, nausea, body aches, severe pain in the left arm, fatigue fever continued for two days (101-103F) Nausea, body aches, unable to eat for 3 days Pain in the arm resolved completely for 5 days Taken OTC aspirin, acetaminophen, Ibuprofen
Employee came to office, asked for Flu shot. Without checking history of immunizations, Flu shot was given and discovered already had flu shot 9-28-12.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Exhaustion / Lethargy-Mild, Additional Details: Gave patient 5ml of liquid benadryl, pt was not having any adverse effects within the 15 minute time frame but came back around 20 min after vaccine and stated she was experiencing tightness when swallowing and very weak feeling.