chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bleeding and swollen @ injection site on 1st injection.  Flu like symptoms after injection for about 1 week with both injections persistent unbearable migraine headaches-  have not stopped since 1st injection, suffer about 1 a week that last 2-5 days- require urgent care visits.  11/4/08 Reviewed clinic records of 7/7-10/23/2008. FINAL DX: migraine headaches Records reveal patient experienced no improvement in HA symptoms on contraception & had stopped it approx 7 mo prior to 7/7/08.  Periods were irregular w/mild dysmenorrhea & PMS s/s.  Started on new contraceptive.  RTC on 7/22 w/increased anxiety s/s of sweaty palms, heart racing, difficulty sleeping.  Tx w/meds.  RTC 8/22 w/allergic complaints of sneezing, cough, wheezing, runny nose, congestion, ears clicking.  Tx w/meds.  RTC 9/6 w/migraine x 1 day w/nausea.  Improved w/meds.  RTC 9/10 w/recurrent migraine HA awakening pt from sleep w/pain, nausea, vomiting, photophobia.  Improved w/meds.  RTC 9/16 for colposcopy for (+) HPV pap smear.  RTC 10/9 for cervicitis, migraine HA & pain w/intercourse.  Results from copposcopy were CIN I & chronic cervicitis.  Tx w/meds.  Had stopped new contraceptive due to increase in migraines.   Started new contraceptive & tx w/cervicitis.  RTC 10/23 w/migraine hA.  Tx w/meds & referred to neuro.
This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 44-year-old female patient who received FLUARIX QUADRIVALENT (batch number 5C2L4, expiry date 18th June 2016. On 26th October 2015, the patient received FLUARIX QUADRIVALENT. On 26th October 2015, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced wrong injection technique. On an unknown date, the patient experienced site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site erythema and wrong injection technique were unknown. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: The reporter reported the patient believed the FLUARIX QUADRIVALENT was given too high up, and too close to the joint rather than the muscle, which led to wrong technique. An unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced reddened raised area at injection site. The batch number reported for Flu vaccine (5C214) did not exist and was updated to be 5C2L4. as per sale database.
Client woke 10/19/09 with cough, severe HA, nausea, no vomiting. Temporal temperature of 102 degrees F, dizziness. Ibuprofen and TYLENOL given. Fever resolved late pm. 10/19/09. 10/20/09- No fever, "hacking" cough, HA, dizziness, sore throat in the a.m.
Pt has #3 Hepatitis B Vaccination. While walking out to waiting room, he removed Band Aid, saw blood, had syncopal episode. He fell to the floor, hitting his head. BP 100/45 right arm. Legs elevated. Was confused, disoriented to date, time, season. Transported to ER via paramedic ambulance. Time frame <5 minutes from vaccination to syncope.
COVID vaccinated (2 doses) patient admitted through ED with shortness of breath.  Provider discharge note below:  "70 YO female with COPD presented with dyspnea, admitted with hypoxia due to covid pneumonia.  Placed on solumedrol for COPD exacerbation, remdesivir for covid.  Improved, not requiring supplemental O2 since yesterday.""
24hrs after shot #2 (4/7/2021 had low grade fever 99.6 on and off for day. Also had sharp muscle pain on right shoulder/back. 2 days later had painful neuropathy radiating down right arm to fingers. The "heavy arm" arm and neuropathy pain has subsided in arm- however I have painful burning neuropathy in my pointer and middle finger. and Thumb occasionally. My fingers feel tingly, painful, cold and as if I slammed them in a door. This has not subsided in a month.
Attending Physician: (withheld)    Date of Admission: 2/1/2022   Chief Complaint:      Source of Information:  Patient   History of Present Illness:  This is a 68y.o. male  came to the hospital secondary to slurred speech. At time of my exam, patient states his speech is better but still somewhat altered. Patient was recently discharged from Hospital for about a one-month stay for psychiatric issues. Patient was discharged home on Effexor as well as Atarax. Patient denies any drug or alcohol issues. Patient denies any fever nausea vomiting diarrhea shortness of breath or chest pain. Patient's original COVID test was positive on January 10.
expired Fluzone High Dose given to patient over 65 years with no adverse event.; Initial information received on 21-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA392579, 2022SA400131, 2022SA400976, 2022SA400367, 2022SA400987, 2022SA400371, 2022SA401056 2022SA400981 and 2022SA401104(CLUSTER).  This case involves unknown gender (over 65 years) elderly patient who was given expired influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] for with no reported adverse event.  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 expired dose of suspect influenza quadrival A-B high dose HV vaccine (lot UJ772AA; expiry date: 30-Jun-2022) to patient over 65 years with no adverse event. (expired product administered) (unknown latency).  Action taken : not applicable.  Outcome : Unknown.   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.
Information has been received from a physician concerning her 15 year old daughter with no pertinent medical history or drug allergies who in September 2009, was vaccinated with a first dose of GARDASIL (lot # not reported). No concomitant medications were reported. It was reported that in September 2009, very soon after the injection of GARDASIL, the patient developed fatigue and nausea. When the patient was on leaving the physician's office she experienced syncope. The patient began having symptoms of high fever, headache and sore muscles. The patient was lethargic for months after she received GARDASIL. In June 2010 the patient had chest pain and went to the Emergency Room where she was diagnosed with anxiety. The EKG showed arrhythmias. The patient became weak and had to quit the Track Team at school. In June 2010 the patient was tired and lethargic and began to forget things. Approximately three weeks ago, in approximately August 2010, the patient developed a tremor in her left hand and she was unable to speak. The patient developed chronic seizures with chorea. On 08-AUG-2010 the patient was admitted to hospital. On 15-AUG-2010 the patient developed a stroke and was non verbal. The patient was diagnosed with drug induced systemic lupus erythematous with chorea. It was reported that there was central nervous system (CNS) involvement and the patient had vasculitis of the brain. The physician did not report what type of diagnostic testing the patient had received. The patient was being treated with ten different medications reported as follows: intravenous immune globulin (IVIG), antibiotics, anti hypertensive medications due to kidney involvement and high doses of IV prednisone. The physician stated that today, on 17-AUG-2010, the patient was to begin chemotherapy with IV cytotoxin for a duration of 24 hours. Currently, the patient had her voice back and was able to move all of her extremities except the left arm. As of 16-AUG-2010 the patient had not recovered from drug induced systemic lupus erythematosus with chorea, anxiety and arrhythmias. The patient was presently in hospital. The reporter felt that drug induced systemic lupus erythematosus with chorea was related to therapy with GARDASIL. Drug induced systemic lupus erythematosus with chorea, anxiety and arrhythmias were considered to be disabling, another important medical event and immediately life-threatening. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (couldn't lift left arm), PRURITUS (itching on the right forearm), RASH (rash on the right forearm), HEADACHE (headache) and CHILLS (chills so bad she was shaking) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 06-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 LIMB DISCOMFORT (couldn't lift left arm), PRURITUS (itching on the right forearm), RASH (rash on the right forearm), HEADACHE (headache), CHILLS (chills so bad she was shaking), PYREXIA (fever) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, LIMB DISCOMFORT (couldn't lift left arm), PRURITUS (itching on the right forearm), RASH (rash on the right forearm), HEADACHE (headache), CHILLS (chills so bad she was shaking), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: 103 (High) 103F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant medication history included respiratory inhaler for asthma.
This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in arm the size of a baseball and is growing in size), DIARRHEA (Diarrhea) and VOMITING (Vomiting) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in arm the size of a baseball and  is growing in size), DIARRHEA (Diarrhea) and VOMITING (Vomiting). At the time of the report, PERIPHERAL SWELLING (Swelling in arm the size of a baseball and  is growing in size), DIARRHEA (Diarrhea) and VOMITING (Vomiting) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.
Fever began at 12pm and peaked at 3:00pm at 103.7. Redness to sclera of eyes. Swelling to eye lids. Daughter with continual crying and restlessness. 120mg Tylenol administered. Fever relieved 1 hour later. Pt appeared back to normal by 7pm.
ADULT OBSTRUCTIVE SLEEP APNEA 3/1/2022 -- RECURRENCE OF SAME SYMPTOMS
This spontaneous report was received from a registered nurse referring to a patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 17-OCT-2017, the patient was vaccinated with an improperly stored and expired dose of GARDASIL 9 lot number M004116 and expiration date of 12-OCT-2017, intramuscularly for prophylaxis (dose was not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of  9°C to 24°C with a time frame of 64 hours and 24 minutes.There was no previous temperature excursion neigther "data logger" involved.
Itching in arm since vaccine, swollen axillary lymphnodes (started 6 days later), extreme fatigue/weakness.
Left arm cellulitis. Patient treated at Medical Center by M.D. Patient was given antibiotic Doxycyline on 10/25/20.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (A little bit of fever) and NAUSEA (Nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), PYREXIA (A little bit of fever) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache), PYREXIA (A little bit of fever) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided. No treatment information was provided.
Was given a Moderna booster dose incorrectly in place of a pfizer booster dose.  Pt has reported lots of itching ever since. She will be seeing her doctor in a week and will be bringing it up there.
One to two days after the pfizer vaccine the taste buds on the tip of my tongue were swollen and uncomfortable for about 5 days.
pain at injection site right arm; stiffness; kink upper right arm joint; weakness in her upper right arm; pain in her upper right arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 2nd dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced injection site pain and pain in arm. On an unknown date, the patient experienced stiffness, joint clicking and weakness of arms. In November 2019, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the pain in arm, stiffness and joint clicking were unknown and the outcome of the weakness of arms was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, pain in arm, stiffness, joint clicking and weakness of arms to be related to Shingrix.  Additional details were provided as follows: Four and half months before the date of reporting, the patient received Shingrix in the right arm. The first week after receiving the injection, she experienced pain at the injection site, right arm. In the second week of vaccination, the injection site was not painful but started experiencing sharp pain in her upper right arm when she reached to grab something or moving her arm sideways to the right.  Less than 2 months after vaccination, the patient experienced stiffness, joint clicking and weakness of arms. She also noticed that when she moved her arm backwards she experienced stiffness and when she rotated the arm she heard and felt a kink in her upper right arm joint.  She also reported that she was experiencing weakness in her upper right arm. The patient had an appointment with a nurse practitioner on 21st April 2020. The patient consented to follow up.
From 05:30 to evening I was fine, then I noticed I was feeling a little funny. I felt achy and my left arm got a little sore. I think I had a temperature. Next day, I couldn't sleep on my arm and couldn't move my arm. It was red and swollen and had a knot on it. It was a very tender to touch. It had a golf ball size knot on it. I became feverish, developed a cough and had body aches. By Monday, my husband and my daughter picked up the symptoms  - except the swollen - that I had and we all went to the clinic and we were all testing  positive for COVID. The next two days, my second daughter came down with it. My arm was still sore during those 5 days. They gave me prescriptions for VIT C - 500 mg - twice  a day; and elderberry prescription and diabetic Robutussin; Zinc - 100mg Baby aspirin - 81 mg and Tylenol as needed. They seemed to help with the symptoms.  I had the cough up until about three weeks ago - I started taking elderberry cough medicine and that's clearing up - it comes and goes but it's much better.
23 SEPT 99 RECEIVED ANTHRAX #6 AND ON 15 OCT 99 RECEIVED INFLUENZA. ON 18 OCT THROUGH 30 OCT NOTICED HEADACHES THAT REQUIRED MEDICAL ATTENTION. ON 01 NOV DEVELOPED LESIONS ON EAR AND NOTICED SPOTS IN VISUAL FIELD OF LEFT EYE. EAR LESIONS CLEARED IN 3-4 DAYS AND PT WENT ON TO DEVELOP LEFT CENTRAL VISUAL LOSS BY 22 NOV 99. NO FURTHER CHANGES IN VISION SINCE THAT TIME.  26 Jan 00:  Examined by Dr.  His impression which includes no definitive diagnosis is provided in attached letter dated Jan 26, 2000. Letter reports: Pt has evidence for a left optic neuropathy. A definite possibility would be post-vaccination optic neuropathy from influenza. I cannot put that together with his red ear nor with the cells in the vitreous. I do not think anthrax is a possibility here. Another possibility would be a nonarteritic anterior ischemic optic neuropathy, however, I would not anticipate that would cause cells in the vitreous. I do not think that his MRI is consistent with a diagnosis of multiple sclerosis. Nurse follow up on 06/28/04 states: "ADD: swelling of ear, eschar of ear, iritis."
lymph node under my left arm, close to my left breast is swollen; it is sore; felt chills; injections site pain; tiredness; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 11:15 (Lot number: EN5318) via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included high blood pressure from an unknown and unknown if ongoing. Concomitant medications included lisinopril, amlodipine, metoprolol and levocabastine hydrochloride (Zyrtec). The patient had no allergies to medications, food or other products. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that the lymph node under his left arm, close to his left breast was swollen. The patient also felt chills, injections site pain, and tiredness on 27Jan2021 04:00. The events assessed as non-serious by the reporter. It was unknown if the patient received treatment. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Patient experienced an unspecified side effect lasting more than 24 hours.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient experienced an unspecified side effect lasting more than 24 hours.) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient experienced an unspecified side effect lasting more than 24 hours.). At the time of the report, VACCINATION COMPLICATION (Patient experienced an unspecified side effect lasting more than 24 hours.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided.  No treatment medications was provided.   Reporter did not allow further contact
Patient received her second dose of Moderna.  (Her first dose of Moderna was administered without any incident.) During patient's 15 minutes of monitoring she became lighted headed and was going to pass out.  Patient passed out,  squad was called.  Patient's 1st BP was 102/56 and thready pulse.  Patient regained conscious and stated she has Pots syndrome and passes out frequently. 2nd BP per squad 110/88. Patient refused to be transported to ER.  Applied cold compress to face and back of neck.  Advised her to drink 2 bottles of water and saltine crackers. Rechecked BP before going home and patient was stable 118/78. Home health nurse called stating patient receives IV fluids once a week and electrolytes weekly.
This case was reported by a consumer via call center representative and described the occurrence of unconscious in a 80-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 21st January 2019, the patient received the 2nd dose of SHINGRIX. On 22nd January 2019, 1 days after receiving SHINGRIX, the patient experienced unconscious (serious criteria GSK medically significant), dizziness, fall, head injury, runny nose and sneezing. On 24th January 2019, the outcome of the unconscious, dizziness, fall, head injury, runny nose and sneezing were recovered/resolved. It was unknown if the reporter considered the unconscious, dizziness, fall, head injury, runny nose and sneezing to be related to SHINGRIX. Additional details were provided as follows: It was not known when dose one occurred, but no events were noted with that dose of SHINGRIX. The patient experienced dizziness, fell down, hit her head, and was unconscious from the fall for a few minutes. The patient also experienced a runny nose and sneezing attacks. The patient slept a few hours and felt better. Symptoms began the next day, after receiving SHINGRIX and at time of report had resolved. The patient did not consent to follow-up.
The patient had severe menstrual cramps and a menstrual period after not having one for several months.  The pain was very severe and the bleeding was very heavy.  Due to patient's age and hormone cycles, the patient was not expecting to get a period at this time of the month/year.
No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    No concomitant medications were reported. No treatment details were reported. Number of doses from vials were 2 second booster doses. The vial was initially stored in the refrigerator and moved from freezer to room temperature to thawed on 23-Aug-2022. The vial did not undergo any temperature excursions.   This case was linked to US-MODERNATX, INC.-MOD-2022-635821 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-635821:1 of 2 Patient
DIZZINESS, NOT FEELING WELL DAY BEFORE REPORTED.. RASH AT AND AROUND INJECTION SITE AND PAIN IN AREA OF INJECTIONS BOTH ADMINISTERED ON SAME ARM.BENADRYL ADVISED BY RPH AND SUBSEQUENTLY PCP AND TYLENOL ADVISED BY PCP.