chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from a registered nurse, concerning a 19 year old female patient with a history of left sided Bell's palsy (year unknown), who on 25-JUL-2007 was vaccinated with the first dose of Gardasil (lot # 658100/0525U). Concomitant therapy included birth control pills (unspecified manufacturer). On approximately 17-DEC-2007, the patient "developed symptoms" and on 31-DEC-2007 she was hospitalized with "probable Miller-Fisher variant of Guillain Barre syndrome." Her symptoms included ophthalmoparesis and areflexia with stocking-glove distribution. Treatment included immunoglobulin, IgG. On 01-JAN-2008 (previously reported as 07-JAN-2008), the patient was discharged from the hospital. The nurse indicated the patient had a follow up visit scheduled with a neurologist on 07-JAN-2008, though she had no knowledge of the results or findings from the visit. The nurse mentioned that the patient had not received subsequent doses of Gardasil, due to concern about the administration of IgG while in the hospital. At the time of this report, the outcome of the event was unknown. Additional information has been requested.  1/25/08 Follow up initiated at request of CDC.  1/25/08 Received vax record which reveals patient received Menactra U2380BA & Gardisil 0525U on 7/25/07.  Admitted to hospital 12/31/07 after outpatient vs to neurologist.  Numbness & tingling in hand started approx 2 wks prior & spread to left arm.  Developed difficulty focusing, eye pain & numbness in both feet.  Exam revealed ophthalmoparesis, areflexia & stocking/glove sensory disturbance.  MRI of brain reviewed which was WNL.  Nerve conduction studies done which was abnormal. Neuro hospital admit dx: probable Miller Fisher variant of Guillain-Barre syndrome. 2/5/08 Reviewed hospital medical records which reveal patient experienced numbness & tingling of hand & feet, difficulty focusing & eye pain starting approx 12/16/2007.  On admit had limited extraocular movements w/left lateral gaze nystagmus, dysmetria on finger-to-nose on left & unsteady gait.  Admitted 12/31/07-1/2/2008.  Tx w/IVIG x 3 days w/noted improvement.  Developed HA w/IVIG tx.  D/C to home & f/u w/neurologist. FINAL DX: Miller-Fisher variant Guillain-Barre syndrome.  2/8/08 Reviewed neurologist med records which reveal patient seen 12/31/07.  Pt had 2 wk hx of progressive numbness & paresthesias in bilat hand/feet which started w/left hand, as well as difficulty w/eye movements.  F/U visit 1/7/08 revealed pt had HA, left eye shaking, numbness/tingling of hand/feet improving but still present. FINAL Neuro DX: probable Miller Fisher variant of Guillain-Barre syndrome.
Swelling of her tongue; This is a spontaneous report from a contactable pharmacist via a sales representative. A female patient of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as a single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swelling of her tongue begin within 15 minutes after administration. Swelling was described as mild and did not inhibit breathing. Therapeutic measures were taken as a result of swelling of her tongue was given diphenhydramine. The outcome of event was recovering.  Information on lot/batch number has been requested.
6 days after I woke up with my arm swollen, hot, itchy, & sore. It is now 2:30 in the afternoon and it is the same symptoms but more swollen. I took a zyrtec this morning, have ice on it currently, and just took a benadryl
No additional AE details were provided.; PNEUMOVAX 23 syringes expired 30MAY2022 and were administered to a patient on 31MAY2022; This spontaneous report was received from a pharmacist referring to a 42-year-old patient of unknown gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 31-MAY-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, dose of 0.5 mL administered intramuscularly, lot number: T032761, expiration date: 30-MAY-2022 (dose number and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse event (AE) details were provided (no adverse event). The reporter stated that pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe has never experienced a temperature excursion.
general rash, large & small covering entire body, palms of hands, & soles of feet;
Pt recv vax on 3/4/99; on 3/5/99 pt exp urticaria; tx=Prednisone, Atarax
Approximately 2" induration and redness of upper left arm where VARIVAX was given. Mom contacted office and was given instructions to give BENADRYL one tsp every 4-6 hours and apply warm compresses. To call if no improvement. 4/13/09 spoke with mom by phone, states only has red ring where induration used to be.
This individual received COVID-19 vaccine JANSSEN twice - first on July 2, 2021, and second on August 19, 2021.
heart palpitations; This case was reported by a pharmacist via call center representative and described the occurrence of palpitation in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number FG2D4, expiry date 19th September 2021) for prophylaxis.   On 6th August 2019, the patient received the 1st dose of Shingrix. On 6th August 2019, less than a day after receiving Shingrix, the patient experienced palpitation. On an unknown date, the outcome of the palpitation was unknown.   It was unknown if the reporter considered the palpitation to be related to Shingrix.  Additional case details were reported as follows: The patient experienced heart palpitations within 24 hours of getting first Shingrix vaccination. The reporter said, she was unsure of patient's history, but stated patient told her she had no heart conditions, and did not experienced that event before.  The patient told her that she went to a cardiologist, who did an echocardiogram, and it was normal. The patient said she had only experienced one occurrence of the palpitations. The reporter consent to follow up.
This spontaneous report was received from a physician assistant via a company representative referring to an 11 year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 17-JUL-2017, the patient was vaccinated with her first dose of GARDASIL 9 for prophylaxis (strength, dose, route, lot # and expiration date were not reported) and on an unknown date experienced pain at the injection site for two weeks. Then, on 22-JAN-2018, the patient was vaccinated with her second dose of GARDASIL 9 for prophylaxis (strength, dose, route, lot # and expiration date were not reported) and on an unknown date in 2018, she experienced again pain at the unspecified injection site for two months. The causality assessment between the events and vaccination with GARDASIL 9 was not provided.
Patient received ZOSTAVAX vaccination on 10/26. 10/31 was diagnosed with shingles outbreak on his back and treated with valacyclovir.
I had weakness, high fever, chills, vomiting, nausea, headache after this vaccine. Following that I was out of work for 2 days, my mitochondrial myopathy has not been the same. I had a rash show up on my stomach and arms, I had to seek treatment for that. The area that I was given the shot, my skin looked like it was peeling away, like eaten away. It was red and sore and scaling off. Now there is a red scar there. There is still slight pain there where I was given the shot. I went to seek care for the rash and was given dexamethasone.
Initial report received from healthcare professional on 18 September 2013. A female patient, who has no relevant medical history with no illness at the time of vaccination and concomitant medications were not reported, had received intramuscular dose of ADACEL, batch number: U4646AA having expiry date 28 November 2015 in right deltoid on 16 September 2013. It was reported that on an unspecified date, after receiving ADACEL vaccine, the patient's right deltoid became red, hot and tender to touch. Clindamycin was prescribed as a corrective treatment and laboratory investigations were not performed. At the time of this report, the outcome was not recovered. Documents held by sender: none.
Severe symptoms dissipated a week after vaccine. Then deep deep joint pain set in. Fingers, elbows, knees, neck, back. Still not gone by 4/29/21. Telehealth visit Dr put on burst and taper steroids. Doing better. Two more days of steroids to go.
Patient reported on 3/20/2020 that a few weeks after his immunization on 2/3/2020 that he had a rash on the injection site and on the opposite shoulder.
the legs turned to jelly, didn't had any strength in the legs; muscle pain; Joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (the legs turned to jelly, didn't had any strength in the legs), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (the legs turned to jelly, didn't had any strength in the legs), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, LIMB DISCOMFORT (the legs turned to jelly, didn't had any strength in the legs), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated she had to call fire department and police department for the reported events.   Concomitant product use was not provided by the reporter.  Treatment information was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (the legs turned to jelly, didn't had any strength in the legs), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (the legs turned to jelly, didn't had any strength in the legs), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, LIMB DISCOMFORT (the legs turned to jelly, didn't had any strength in the legs), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated she had to call the fire department and police department for the reported events.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
On 05/24/2021 at 09:27am, the individual received an Varicella shot (1 shot) in the left arm after checking if patient had any positive titers (the individual did not have pos titer for varicella). There was no physical symptoms reported prior to the vaccination nor any reported history of reactions to vaccines in the past (patient denies before and after the administration of the vaccine). Patient was given subcutaneous shot on the left tricep area. Patient notes redness and swelling of the vaccination site on 05/26/2021 at 09:00am at the urgent care clinic at Health Clinic. The provider that diagnosed the patient stated it was cellulitis (with redness/swelling of the area) and will be treated with Bactrim. Patient will be under close observation.
WHILE ADMINISTERING THE PFIZER COVID VACCINE, THE NEEDLE CAME OFF OF THE SYRINGE WHILE IN PT'S ARM. MORE THAN 1/2 THE DOSE WAS ADMINISTERED BEFORE THIS OCCURRED.
gave Fluzone High Dose to a 64 year old with no reported adverse event; Initial information received on 27-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 64 years old and unknown gender patient to whom influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] was given with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient of 64 years old received a dose of suspect influenza quadrival A-B high dose HV vaccine (lot number, strength, expiry date, form, dose not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization) with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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 had a flare up of Gout; This is a spontaneous report from a contactable consumer (patient).   A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6198) via an unspecified route of administration on 03Mar2021 at 02:45 on left arm, single dose for COVID-19 immunization. The patient's medical history included gout immediately following surgery on her foot 5 years ago. It was reported that the patient did not receive any other vaccine in four weeks, he did not have covid prior to the vaccination, he did not test for covid post vaccination and had no allergies. The concomitant medication of the patient included pravastatin taken for an unspecified indication, start and stop date were not reported. The historical vaccine of the patient included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9269) via an unspecified route of administration on 03Feb2021 at 10:15 AM on left arm as 1st dose, single dose for COVID-19 immunization. On 04Mar2021 at 1800 hours, one day after second dose of vaccination the patient experienced a flare up of gout. No treatment was received for the event.The outcome of event was reported as recovering.    No follow-up attempts were possible; information about lot/batch number could not be obtained.
Extremely hungry after both shots, ate 50% more food for a few days. After more than 3 months, still get hungry very easily, about 1-2hr after each large portion full-size meal. Never happened before. Weight was maintained very well for many years prior to vaccination. Gained a few pounds in the last 3 months uncontrollably. Never happened before. Have to train my mind to battle hunger every day to keep food intake the same amount as before the vaccination. Very difficult. Very concerned about diabetes if this continues. Is the vaccine material made from people with obesity? Do feel like genetically modified even after 3 months.
The adverse effects started the next day after the vaccine.  Started having extreme fatigue.  10 days after the vaccine started having fasciculations of major muscle groups-   Upper and lower extremities primarily. Upper and lower extremities felt very heavy.  Started having sensory changes in hands and feet.  Numbness in hands and feet that would come and go.  Hot/cold sensation in left foot. The above fasciculations and sensory changes were bilateral.  Tightness in throat and dizziness.  Some difficulty breathing.  Difficulty sleeping.  The numbness in the hands and feet have improved, however I continue to have the same symptoms as stated above to date.
Had 2nd Pfizer vaccine at 11:00 a.m. on April 2, 2012. On morning of April 3, 2021 woke up around 7:15 a.m. and walked to kitchen to get Tylenol and fainted. Received 8 staples at Emergency Room. Had a fever for 5 days between 100.4 and 102
I was playing video games when I noticed I couldn't grip my controller as normal with my left hand. After a few minutes, my face got red and hot. My left arm tingled and then my heart started beating like it never has in my life. I also had shortness of breath.
Fluctuating INR; This spontaneous case was reported by a consumer and describes the occurrence of INTERNATIONAL NORMALISED RATIO FLUCTUATION (Fluctuating INR) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DULAGLUTIDE (TRULICITY), INSULIN, METFORMIN, GLIPIZIDE, METOPROLOL, WARFARIN, WARFARIN and LOSARTAN.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced INTERNATIONAL NORMALISED RATIO FLUCTUATION (Fluctuating INR). At the time of the report, INTERNATIONAL NORMALISED RATIO FLUCTUATION (Fluctuating INR) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
A 39 year old female patient with an unknown medical history had received an administration (route and site not reported) of Adacel (lot number not reported) on an unspecified date. 24 hours post vaccination, the patient developed swelling, hardness, redness from the shoulder to the wrist and shooting pains in the lower arm. The signs and symptoms are persisting. There were no reports of fever. At the time of this report the patient had not recovered from these events.
Previous COVID 19 infection 2 weeks prior to 2nd vaccine. 8 hours after 2nd vaccine, muscle aches, chills, fever started. All symptoms persisted throughout the first night. Muscle aches, chills, and fever returned every 4 hours with alternation of Tylenol 650mg every 4 hours and Ibuprofen 600mg every 6 hours. Last fever was at 12:30pm on 1/9/21. Some chills without fever noted at 4am 1/10/21. Sweats and right arm soreness with localized redness to injection site have continued into 1/10/21 to the time of this report.
Mild Headache -15 mins. after injection Nausea- evening 3/9/21 Tummy ache- 3/10/21 @11 am Low grade fever-3/10/21 @ 5 pm Chills-3/10/21
Sickness; stressed before 2 dose; Flu like symptoms; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), STRESS (stressed before 2 dose), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NAUSEA (nausea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sickness), STRESS (stressed before 2 dose), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NAUSEA (nausea). At the time of the report, ILLNESS (Sickness), STRESS (stressed before 2 dose), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NAUSEA (nausea) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant informations were not provided.  Treatment informations were not provided   This case was linked to MOD-2021-103017 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Significant follow-up appended On 07-Jul-2021: Follow-up received on 7-July-2021 and contain no new information On 28-Jul-2021: Follow up received included updated action taken of suspect product
Muscular achyness; Polymyalgia rheumatica like syndrome; This spontaneous case was reported by a physician and describes the occurrence of CONNECTIVE TISSUE DISORDER (Polymyalgia rheumatica like syndrome) and MYALGIA (Muscular achyness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was not provided by reporter.  Concomitant products included LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZIDE), MELOXICAM and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced CONNECTIVE TISSUE DISORDER (Polymyalgia rheumatica like syndrome). On an unknown date, the patient experienced MYALGIA (Muscular achyness). The patient was treated with PREDNISONE for Pain, at a dose of UNK dosage form. At the time of the report, CONNECTIVE TISSUE DISORDER (Polymyalgia rheumatica like syndrome) and MYALGIA (Muscular achyness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter mentioned that stopped rosuvastatin calcium as therapeutic measure, but it did not help with the muscle pain.  Company Comment: Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
2/3rds of patient?s torso covered in rash,  rash under arms and center of lower back particularly.  Fever Headache, fatigue.
Diffuse maculopapular rash of the B/L UE and Torso 10 days after vaccination.
Initial and follow up information has been received from a healthcare professional concerning a 76 year old male patient with no known drug allergies and a thyroid disorder, who on 18-SEP-2007, at 10:00 am, was vaccinated IM in the left deltoid, with a dose, 0.5 ml, of PNEUMOVAX (lot #658075/0962U).  Later that day, he developed swelling and redness of his whole left arm, as well as a fever (value not specified).  On 19-SEP-2007 ("the next morning"), the reaction had moved up and down the whole upper arm.  On 20-SEP-2007, he visited the physician and was treated with BENADRYL, an injection of KENALOG, and an injection of ROCEPHIN.  At the time of this report, the patient had recovered from the events (duration not specified).  The HCP requested that a lot check be performed.  The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory.  The lot complies with the standards of the research center and was released.  Additional information is not expected.