chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extreme anxiety; neuro inflammation; headaches; vertigo; Central nervous system irritation/neuro inflammation; This is spontaneous report received from a contactable nurse (patient). This nurse reported same events for herself and 2 patients (twin sister and daughter). This is the first of three reports.  This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 23May2021 16:00 (at the age of 46-year-old) (Lot Number: EW0177) as single dose for COVID-19 immunisation. Relevant medical history included anaemia. The patient was not pregnant. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 28Apr2021 16:00 (Lot number EW0176) for COVID-19 immunisation. On 24May2021 12:00, the patient experienced extreme anxiety, neuro inflammation, headaches, vertigo and central nervous system irritation; all the events were considered serious due to disability. The patient specified that "this causes neuro inflammation. My central nervous system was so irritated. I have had headaches, vertigo, and extreme anxiety ever since". The events resulted in Doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient received unspecified treatments for the events, and she specified that tests were ongoing. The patient had not recovered from the events. The patient did not have COVID-19 prior to vaccination, and she was not tested for COVID-19 post vaccination.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events anxiety, inflammation, vertigo, headache and CNS disorder and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202100911256 Same reporter/ drug/ AE, different patient.;US-PFIZER INC-202100911266 Same reporter/ drug/ AE, different patient.
Attention deficit-hyperactivity disorder; Anxiety; Vaccination site pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit-hyperactivity disorder), ANXIETY (Anxiety), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled syringe. On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness). On an unknown date, the patient experienced ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit-hyperactivity disorder) and ANXIETY (Anxiety). The patient was treated with SERTRALINE HYDROCHLORIDE (ZOLOFT) at an unspecified dose and frequency. In April 2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. On 23-Apr-2021, FATIGUE (Tiredness) had resolved. At the time of the report, ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit-hyperactivity disorder) and ANXIETY (Anxiety) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported.  On unknown date, the patient experienced attention deficit hyperactivity disorder and anxiety. On 21 Apr 2021, the patient experienced tired and arm hurt after covid vaccination. On 23 Apr 2021, the tired resolved. In April 2021, the arm hurt after covid vaccination resolved.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB):The reporter's causality for the events of attention deficit hyperactivity disorder, arm hurt after covid vaccination, tired, anxiety was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-624462 (Patient Link).
After research, it is what is being dubbed ?COVID arm?.  Rash/red area around the injection site.   Didn?t notice before going to bed but it appeared the next morning.   It is itchy and roughly 1.5 inches by 4 inches at injection point then two other smaller areas above and below.  Still active at this time.
This spontaneous report was received from a healthcare worker referring to a 30 to 40 patients of unknown age and gender. Since an unknown date in September 2015 (the vaccinations occurred within the past 2 weeks) the patients were vaccinated with improperly stored doses of M-M-R II (therapy type: rHA, dose and frequency were not reported, lot # K024036 with expiration date: 26-NOV-2016). No adverse effects reported. This is one of the several reports received from the same reporter. Additional information is not expected. Reporters did not wish to be contacted.
Seen on 8/23/04 for evolving rash of the right leg. Diagnosed with varicella zoster. Confirmed by second opinion by another pediatrician.
Beginning on January 15 and lasting for 18 days, I experienced confusion, extreme migraine-strength headaches, ripping pain in chest, ribs, upper back, shoulders, neck, head. I could not sit or lie down comfortably.  I saw Dr. on February 1 who ordered a CT scan which was clear. He prescribed Prednisone and Robaxin 500 mg.  I saw Dr. again on February 4  at which time most of the pain subsided but my body was very sore.  It is now February 11 and I still feel a bit of cloudiness, but am much better. Hopefully, I'll feel like myself within a few days.
Blood sugar levels have increased from 80 to 133; Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar levels have increased from 80 to 133) and VACCINATION COMPLICATION (Vaccination adverse reaction) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar levels have increased from 80 to 133) and VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar levels have increased from 80 to 133) and VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Blood glucose: 133 (High) blood sugar levels have increased from 80 to 133.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
I had always had healthy PAP screens that can be normal until I received the Gardasil vaccine. Now I have received my second abnormal PAP. I believe that the vaccine has been the cause of these abnormal results.
L shoulder pain at site of injection radiating to elbow and wrist; sharp continuing pain, unable to lift arm with sleepless nights
PRETTY HIGH FEVER; TThis spontaneous report received from a patient via a company representative concerned a 30 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced pretty high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pretty high fever. This report was non-serious.
First time diagnosis of genital herpes.  Husband negative. Patient did not have any other sexual encounters.  Thought to be an activation of a dormant virus. Patient monogomous 30 years.
Information has been received from an other health professional from the pregnancy registry concerning a 19 year old female patient with an amoxicillin allergy and no pertinent medical history who on 09-Feb-2007, was vaccinated with a 0.5ml dose of Gardasil (lot #655619/1427F).  There was no concomitant medication.  It was reported that the patient was pregnant when she received the vaccine.  Unspecified medical attention was sought.  The patient's last menstrual period was reported to be 14-Jan-2007 and her estimated date of delivery was 21-Oct-2007.  Method of pregnancy confirmation was not reported.  Follow-up information received from the Pregnancy registry indicated that the patient was a smoker.  It was reported that she had pre-term labor, and delivered the baby at 33 weeks on 07-Sep-2007.  The infant was a male weighing 5 lbs and 20 oz.  There were no congenital anomalies.  The baby was in RICN for 2 weeks and had an apnea monitor.  Medications used during this pregnancy for pre-term labor were Brethinc injection and bethamethasone 12 mg intramuscularly on 05-Sep-2007.  Laboratory diagnostic tests included an ultrasound on 07-Jun-2007 which was within normal limits and examination of cervical length on 18-Jul-2007.  On 14-Aug-2007 a diagnostic test for fetal fibronectin was performed.  On 05-Sep-2007, an ultrasound was performed for the preterm labor.  On 27-Dec-2007, a follow up phone call was made and it was reported that the infant is doing well and no longer required the apnea monitor.
Red at injection site; Itching at the injection site; Swelling at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 04-Feb-2021.    This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
pt recv vax 19OCT98 & approx 4hr later pt exp itching & scattered pin head size rash that progressed to welts, grandma applied caladryl w/o relief;taken to ER;
Fever, chills, aches, headache, fatigue, soreness in arm, nausea, weakness, lightheaded
experienced general localized reactions like warm and tender to touch, redness; experienced general localized reactions like warm and tender to touch, redness; experienced general localized reactions like warm and tender to touch, redness; This case was reported by a nurse via call center representative and described the occurrence of localized feeling of warmth in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date 31st August 2023) for prophylaxis.   On 23rd August 2022, the patient received Menveo. In August 2022, less than a week after receiving Menveo, the patient experienced localized feeling of warmth, tenderness and localized erythema. On an unknown date, the outcome of the localized feeling of warmth, tenderness and localized erythema were unknown.   It was unknown if the reporter considered the localized feeling of warmth, tenderness and localized erythema to be related to Menveo.     Additional Information: GSK receipt date: 26-AUG-2022 Reporter's Comments: Nurse Practitioner called to inquire any additional information on reactions.  The patient experienced general localized reactions like warm and tender to touch, redness.  Nurse stated read the adverse event section in the product (package insert) PI but wanted additional information on reactions.  The reporter did not consent to follow-up. The case US2022124287 was linked by same reporter.; Sender's Comments:  US-GSK-US2022124287:Same reporter.
Began a very heavy and unexpected bleeding period with cramping and sore breasts 2 days after shot.  I haven't had a period in 6 months.  Far heavier than historic cycles beginning at age 13.
This is a spontaneous report from a contactable pharmacist based on the information received by Pfizer from Merck & Co., Inc. A 31-month-old patient of an unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced asthma on an unspecified date. It was reported that patient was vaccinated with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) at 2 years and 7 months and patient subsequently developed asthma. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
8/25/11 Red, swollen thigh (L) (2-3 inches) no fever. Ice, steroid cream, BENADRYL 3.2 mg Q6 hours to (L) thigh.
10/29 eyes burn, ears ache, neck stiff, shoulders ache. 10/30 above plus knees warm and achy, incisions hot, red and itch above and below elbows itchy (no rash) -> ache all over; hurt to move, difficult to walk, red spots on thighs: BENADRYL q 4 hours started, hydrocor. 2.5% knees continue sl. edematous. 10/31 knees less achy, redness, body achy, continue BENADRYL. Ankle (R) edema starting. 11/1 (R) ankle 2+ times size - diff to walk 11/2-3-4 less edema - not gone.
This case was reported by a healthcare professional and described the occurrence of purpura in a 19-month-old male subject who was vaccinated with HAVRIX for prophylaxis. There were no concurrent medications. On 12 August 2008 at 10:30 the subject received 1st dose of HAVRIX at 0.5 ml in the left thigh. Approximately 4 hours and 25 minutes later (on 12 August 2008), the subject developed a rash on the left leg posterior to the injection site. The rash was described as purpura and petechial. At the time of reporting the subject was at the office and had not received any treatment for the rash. The events were unresolved. Follow-up information was received on 21 August 2008 via a nurse, who reported that the events were resolved as of 13 August 2008. The reporting nurse considered the events to be possibly related to vaccination with HAVRIX
No other AE; Caller is an office manager who reports vaccine was administered following multiple temperature excursions.; This spontaneous report has been received from an office manager referring a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.  On 18-JUL-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-Merck) virus vaccine live (PROQUAD) 0.5ml once (lot number W006583 has been verified to be a valid lot number, expiration date 23-AUG-2023) (strength, route of administration, and anatomical location were not provided) for prophylaxis, the vial was reconstituted with sterile diluent (MERCK STERILE DILUENT) (strength, dose, lot number, and expiry date were not reported) (product storage error).  The measles, mumps, rubella and varicella (oka-Merck) virus vaccine live (PROQUAD) vaccine experienced multiple temperature excursions: on 11-MAY-2022 was stored at a temperature of 5.7 Fahrenheit (F) for 7 minutes, 27-MAY-2022 5.7 F for 5 minutes, 06-JUN-2022 5.9 F for 6 minutes, 09-JUN-2022 5.4 F for 4 minutes, 14-JUN-2022 5.7 F for 7 minutes, 17-JUN-2022 29.1 F for 39 minutes, 20-JUN-2022 7.2F for 10 minutes, 22-JUN-2022 8.4F for 15 minutes, and on 28-JUN-2022 5.2F for 3 minutes. No temperature excursion occurred prior to the aforementioned date.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA007832: US-009507513-2207USA007847: US-009507513-2207USA007985: US-009507513-2207USA007729: US-009507513-2207USA007826: US-009507513-2207USA008018: US-009507513-2207USA007975: US-009507513-2207USA008097: US-009507513-2207USA007867:
Slight numbness - more tingling like it is falling alseep -  in left arm and hand.  Also tingling in left leg/foot .  These are constant and don't go away.  I get a slight tingling in left cheek but not constant - every day though - a few times a day.
Headache; Slight fever; Nausea; ARM PAIN FOLLOWED COVID BOOSTER; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (ARM PAIN FOLLOWED COVID BOOSTER), HEADACHE (Headache), PYREXIA (Slight fever) and NAUSEA (Nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 01-Oct-2021, the patient experienced PAIN IN EXTREMITY (ARM PAIN FOLLOWED COVID BOOSTER). In January 2022, the patient experienced HEADACHE (Headache), PYREXIA (Slight fever) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (ARM PAIN FOLLOWED COVID BOOSTER) had not resolved and HEADACHE (Headache), PYREXIA (Slight fever) and NAUSEA (Nausea) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. On 01-Oct-2021, the patient experienced severe arm pain followed covid booster. In January 2022, the patient experienced headache, slight fever, and nausea. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
High blood sugars for a week now.  My son is 16 year's old and was diagnosed with Type 1 Diabetes in November.  He is thin and active, and an otherwise healthy teen and runner.  He is in his "honeymoon phase" of diabetes and I think the vaccine may be killing off beta cells.  He went from having blood sugar levels in the 80's to 90's at 12 units of Lantus to now 120's to 130's and up to 160's immediately after the shot.  His mealtime insulin is also not working at the same number of units and he's going in the 200's when he was around 160's before the shot. It has lasted now for a week instead of the 48 hours I was told about and read about.   As soon as we were leaving from getting his vaccine, he started experiencing extreme fatigue.  That night and for 2 days he had a headache.  He is still more tired than usual and having to take naps.
Flu like symptoms  Fever for 24 hours - top measured at 101° Chills & body aches
I have been fatigued since the booster. It went from moderate to mild. Then 07/07/2022 I went for my annual visit and had a higher blood pressure. It was about 140/90. I was keeping track of it and on 07/10/2022 it was 175-195/ 101-110. So, on 07/11/2022 I went to Urgent Care. When the doctor took my blood pressure it was still high. He gave me Lisinopril to take daily. When I took that, my blood pressure went down to 92/47. I took that about 2PM CT on 07/11/2022. Before the meds that day, my blood pressure was 135/92.  By 4PM it went up to 111/64. It spiked back up yesterday and has remained high today. I am seeing my doctor this afternoon. My blood pressure history was always about 120-130 so this is abnormal for me.
Was due for 2nd flu shot today. Called because of "no show", parent stated wasn't coming because he was ill & vomiting for a week after getting 1st flu shot. Was questioning a reaction to the 1st vax & will not be continuing the series.
Tingling finger and toes, loss of sensation on injection arm, loss of motor function left arm and legs, numbness hands and feet,   hands and feet became ice cold, headache,  joint pain, muscle spasms, feeling drunk and dizzy, loss of consciousness 3x (reported by friend).  confusion, inability to focus and complete thoughts and sentences.  911 called  @12:04 PM by friend.  At time of paramedics evaluation BP 175\100, O2 SAT 100%,  loss of consciousness 2x(reported by friend)  before being transported to University of Alabama at Birmingham (UAB) ER.   No treatment except basic vitals taken,  Held in waiting area for several hours then basic eval by ER doctor (unknown name) asked to attempt to stand, could not.  Moved to ER room for couple hours, second eval by nurse to see of i could stand, had difficulty standing, asked to walk, shuffled feet to move and notified that i could go home
large red skin reaction around the injection site. First noticed it 4 days after injection. red an warm with slight itchiness
Information has been received from a health professional concerning a 14 year old patient who was inadvertently vaccinated with a dose of Zostavax (Oka/Merck).  There were no adverse symptoms.  A product quality complaint was not involved.  Additional information has been received from the health professional who reported that the patient received a dose of Zostavax (Oka/Merck) instead of a dose of Varivax (Oka/Merck) (MSD).  It was confirmed to be product confusion (not further specified).  No further information is expected.
Temp. 101.6, Headache, feels nauseated, arm sore started at 11PM 06-09-08
Swelling, redness, itchy patches on right arm and shoulder (same arm that both  Shingrix and COVID19 Bivalent Pfizer vaccines were administered).