chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Patient passed out) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Patient passed out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Patient passed out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
My first dose on March 24th very next day I noticed I was getting light headed and a little dizzy. Tried to drink some water, however a half hour later I was having issues walking and collapsed. I was constantly dizzy for 2 weeks later, swaying side to side, I felt like I was spinning rather than the room itself. Intense brain fog, light headedness and fatigue. Saw primary care assumed BPPV and was given maneuvers to help BPPV to subside. Vestibular therapy was started and a week or two later slight improvement. Triggers like quick eye movement to the corner of my eye, looking down at my lap etc. would bring dizziness. 2nd Dose was administered however dizziness became worse for the dizziness. After 3 months of vestibular therapy I have seen some improvement. Uneven surfaces make my head spin and as long as I do not bend over walking is capable. Neurologist stated that there was nothing they could do from their stand point. Antidepressants were  administered for anxiety. After coming off of  Amitriptyline dizziness became even worse.  Currently  dizziness, headaches, night sweats, fatigue, brain fog, light headedness. Loss of hand eye coordination as well. Spatial Awareness becomes hard as well. Vestibular therapy would be good for an hour, however intense wave of dizziness can come and cause me to become fatigued. Shift in center of gravity is also a new sensation after weening off of Nortriptyline. With 3PD cognitive Therapy and Vestibular Therapy Specialized in 3PD.
3/17/21-Pattern of red bumps (rash) in a circular pattern, itch and I applied alcohol at 9:30pm 3/18/21-Contacted Physician because of welping that occurred on the site Dr viewed via Zoom session and sent in a prescription of Prednosone (5) pills, suggested benadryl and hydrocortisone cream 3/26- No improvement asked the doctor to prescribe a cream of Triamcinolon Acetonide cream 0.1% 3/26- Visit with Nutritionist and made her aware of the incident relative to  Chronic condition of Diabetes Prednosine makes blood sugars high 3/31- Vast improvement of site but not completely clear but shrinking in size
feeling worse; Fever of 100.5F; Chills; Nausea; Dizzy; Achy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PAIN (Achy), FEELING ABNORMAL (feeling worse), CHILLS (Chills) and NAUSEA (Nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included covid-19 in September 2020. Concurrent medical conditions included Rheumatoid arthritis.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizzy), PAIN (Achy), CHILLS (Chills) and NAUSEA (Nausea). On 04-Mar-2021, the patient experienced FEELING ABNORMAL (feeling worse) and PYREXIA (Fever of 100.5F). At the time of the report, DIZZINESS (Dizzy), PAIN (Achy), FEELING ABNORMAL (feeling worse), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever of 100.5F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 100.5 (High) 100.5F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   treatment include Tylenol and Advil No concomitant medication reported by the reporter
Site: Redness at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild
Fever 102, chills and shivering, headache, body aches, nausea and vomiting, fatigue. (Two days lost work)
New onset of rash on right foot, between 3rd/4th toes. Small blisters, skin peeling, hot/painful feeling. Followed up with primary care office after 3 wks of symptoms, prescribed topical steroid cream for eczema-like symptoms.  18wks pregnant at time of vaccine, first pregnancy - EDD 8/29/21. No adverse effects to pregnancy
expired Imovax vaccine was given to patient; Initial information received on 12-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 62 year old female patient who was vaccinated with 0.5 ml expired RABIES (HDC) VACCINE [IMOVAX RABIES] (formulation: Powder and solvent for suspension for injection) (lot: N1B901M, expiry date: 18-Mar-2019) via intramuscular route, on 12-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used (expired Imovax vaccine was given to patient).  It was unknown whether the patient had any adverse 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 Directive and Module VI of the 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.  List of documents held by sender: none.
Sense of taste is gone; This is a spontaneous report from a contactable nurse reporting for himself. A 49-year-old male patient received the 1st  dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BionTech), via an unspecified route of administration, on 20Dec2020, at single dose, for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included procaterol hydrochloride (PRO-AIR) as needed (inhaler) for asthma. The patient experienced sense of taste is gone on 21Dec2020 with outcome of unknown.    The information on the lot/batch number has been requested.
pt recv vax 23MAY96 & 30MAY96 pt became ill x 10 days;pt devel a fever, red, gums, bumps around mouth, bubbly tongue & 4 to 6 pox around mouth, neck, ears, hands & body;6SEP96 pt exp shingles;
This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult female patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020) for prophylaxis. On 5th November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown. Additional details were provided as follows: The age at vaccination was not reported. On 1st September 2018, the patient received 2nd dose of INFANRIX HEXA. In November 2018, a 3rd dose was administered, which led to shortening of the vaccination schedule. According to MA of INFANRIX HEXA, the 3rd dose should be given at least 6 months after the 2nd dose. During the administration, leakage was occurred (no details available regarding the level of the leakage). The physician gave a 1 by 4 of a replacement dose, which led to wrong technique in drug usage process. Sample would be available.
Fever that got as high as 101.5 starting around 7:00pm the day of vaccination and lasting 24 hours. Vomiting about 15 hours after vaccination, one time occurrence. Severe headache, fatigue, and and body aches all over, especially in the back and neck, starting around 7:00pm day of vaccination and lasting over 24 hours. Took two doses of acetaminophen over the course of symptoms.
Information has been received from a registered pharmacist concerning a 77 year old female patient with no pertinent medical history and no drug reactions or allergies, who on 28-APR-2012 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # not reported) SQ. There was no concomitant medication. The pharmacist reported that the patient developed shingles after being administered ZOSTAVAX (Merck). The pharmacist also reported that the patient was tired and achy after receiving the vaccine. The patient contacted the pharmacist and was treated with acyclovir 400 mg and ZOVIRAX cream. There were no Lab diagnosis/studies performed. At the time of the report, the patient had not recovered. Follow up information has been received from a health care professional via herpes zoster questionnaire concerning the patient with a history of chickenpox as child, who on 28-APR-2012 (also reported as around 08-MAY-2012) was vaccinated with ZOSTAVAX (Merck). The health care professional reported that 1-2 weeks after vaccination, on approximately 05-MAY-2012, the patient went with shingles. On 22-MAY-2012 a sample of a vesicle scab from left arm in the deltoid area was obtained. VZV DNA was amplified and identification showed a wild type strain. It was reported that the patient did not have recent exposure to chickenpox or shingles. At the time of the report, the patient had not recovered, still had fatigue and arm pain. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received SHINGRIX for prophylaxis.  On 28th December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 68 year or 69 years. The patient expereinced local injection site reaction of redness and swelling. On the day of reporting, the patient went to the pharmacy and she was asking about the local reactions. At the time of report, the patient was still experiencing redness and swelling. The pharmacist did not have any additional information to provide. The pharmacist did not give consent for follow up.
None reported by pt. Unable to contact pt by phone (2 doses Td given on same day by two nurses at two visits).
Cardiac arrest on 1/24/21 in the early morning hours then passed away on 1/25/21 around 1:51am in the hospital
Headache, nausea, extreme fatigue, muscle aches, big  red blotchy hot spot at injection site, hands swelled and turned blue/purple, stiff joints. Onset one week after injection lasting three days.
After second vaccine I experienced loud ringing in my right ear. Went to medical doctor who set up an appointment with an ENT doctor but it was going to be 6 weeks before I could see him.  I was able to see a NP ENT sooner who scheduled an MRI .  The MRI showed no problems.  I couldn't sleep or eat because of the ringing so my medical doctor prescribed anti anxiety and a sleeping pill.  I still have ringing in my ear but not as loud.
2 hours, asymptomatic after receipt took BACTRIM. Running x 1 hour - developed severe muscle cramping, myalgia, emesis. Tx in ER with potassium (K+ 2.8). 5 days later tightness in (L) arm (unvaccinated arm).
Fatigue, fever, back pain, left leg twitching, subjective weakness, dizziness.
Redness and swelling at injection site approximately 48 hours after injection. Recommended hydrocortisone cream OTC. Advised patient to call MD if symptoms continue for > 2-3 days and to call 911 if she has difficulty breathing/swallowing.
5 hours after my vaccine, I developed a bad headache, chills, a runny nose, muscle aches, and tiredness. Around 6:00 pm (7 hours later) I discovered I had a fever. The symptoms are still present at 11 hours post-vaccination.
13 days after my first dose my arm now has a rash/hive and starting to itch
My period has been irregular within 2 months of receiving final dose.  Has remained irregular since. Hormones are ALL over the place, which is not in my family genetics, nor has it ever been an issue to date.  This symptom coincided with that experimental vaccine.  Regulatory authority getting their ass protected by our government, yet again.  Its unfortunate to say the very least.
Vaccine injected into the skin, not in the muscle; A spontaneous report was received from a consumer concerning a 73-year-old, female patient  who reported that vaccine was injected into the skin, not into the muscle (incorrect route of product administration).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 4 Mar 2021, the patient received the first dose of two planned doses of mRNA-1273 (lot/batch: 0127A21A) for prophylaxis of COVID-19 infection.  The patient stated that the vaccine was not injected into the muscle but into the skin.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event, vaccine injected into the skin, not in the muscle (incorrect route of product administration) was considered as recovered.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # 0127A21A) with no associated AEs reported.
Inability to move head; Shoulder and neck pain. Severe neck and shoulder pain day Seven; Shoulder and neck pain. Severe neck and shoulder pain day Seven; Severe pain at injection site; This is a spontaneous report from a contactable nurse  (Patient). A 37-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ685), via an unspecified route of administration in left arm on 23Dec2020 14:00 at single dose for covid-19 immunization in hospital. Medical history included ankylosing spondylitis. Known allergies included sulfa antibiotics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient's concomitant medications were not reported. There was no vaccine in four weeks. The patient experienced severe pain at injection site on 24Dec2020 at 12: 00 PM for four days. Then on day 28Dec2020 and 29Dec2020, the patient experienced shoulder and neck pain. Severe neck and shoulder pain occurred on day 30Dec2020. The patient experienced inability to move head on an unspecified date. The patient went to doctor on 04Jan2021. The events result in doctor or other healthcare professional office/clinic visit. Treatment was unknown. The events were non-serious. The outcome of the events was unknow.
Has anyone reported the loss of smell, from having the second vaccine.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANOSMIA (non-serious), outcome "unknown", described as "Has anyone reported the loss of smell, from having the second vaccine.".  Additional information: Reporter just have a question, has anyone reported the loss of smell from having the second vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Medical assistant calls to report a temperature excursion that occurred on November 9, 2020 / The products were administered; No other information given at this time.; This spontaneous report was received from a medical assistant, referring to an unknown number of patients of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 09-NOV-2021, the following vaccines experienced temperature excursion, and then on unknown dates, they were administered to unspecified number of patients: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (formulations, strengths, doses, vaccination schemes frequency, routes of administration and anatomical sites of vaccination were not reported; lot numbers S007811, S029457 and S005248, expiration dates reported and validated as 14-MAR-2021, 19-SEP-2021 and 20-FEB-2021, respectively to each lot number), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  (formulations, strengths, doses, vaccination schemes frequency, routes of administration and anatomical sites of vaccination were not reported; lot numbers 1621929 and R025729, which has been verified to be valid, expiration dates reported and validated as 06-DEC-2021 and 18-JUN-2021, correspondingly to each lot number), haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (formulation, strength, dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported; lot number R014263, which has been verified to valid, expiration date reported as 26-JAN-2021, but upon internal review it was established as 26-MAR-2021), and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe (PFS)  (strengths, doses, vaccination schemes frequency, routes of administration and anatomical sites of vaccination were not reported;(lot numbers S005856, S029542 and T020638, which has been verified to valid, expiration date reported and validated as 03-DEC-2020, 10-JUN-2021 and 26-FEB-2022, respectively to each lot number), all the vaccines were administered as prophylaxis. The vaccines administered experienced a temperature excursion above 47 degrees Fahrenheit (F) for a time frame of 3 hours. There was a previous temperature excursion above 47 F (47.4 F) for 1 hour and 20 minutes, 47 F (46.7 F) for 50 minutes and 47 F (47.6 F) for 40 minutes, as recorded by a data logger. No additional adverse events were reported. At the reporting time, some of the lot numbers had expired, but were not expired at the time of the administration, neither the lot numbers had expired at the time of the report.    This case has been considered non-valid due to the lack of patients' identifiers. ; Sender's Comments:  US-009507513-2103USA005178:
Initial information received on 09-Oct-2018 regarding an unsolicited valid serious case received from a nurse. This case involves a 4-year old female patient who experienced cellulitis on left upper arm and abnormal swelling and redness at injection site, while she received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 21-Sep-2018, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5497AA via unknown route in the left arm. On an unknown date the patient developed a serious reaction was cellulitis on left upper arm following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. This event was assessed as medically significant. On an unknown date, the patient developed a non-serious abnormal swelling and redness at injection site following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. It was also reported that the patient came back on 24-Sep-2018 for TB check but then showed the staff the reaction on the arm. (Other relevant tests included No lab data.) Final diagnosis was abnormal swelling and redness at injection site and cellulitis on left upper arm. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovering / Resolving for abnormal swelling and redness at injection site and as Recovering / Resolving for reaction was cellulitis on left upper arm. List of documents held by sender: none. Sender's Comments: This case involves a four years old female patient who presented with cellulitis after vaccination. Time to onset is not known. There is, moreover, no information regarding patient's medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
15-30mins after Yellow Fever vaccine given, Pt experienced difficulty breathing and wheezing, rash around his right side of his neck, eye swollen and dizzy/lightheaded. Pt went to the Hospital around 5pm and was given EPI, Benadryl, Prednisone and Zantac told to follow up with Doctor next day. Pt told to take medications as directed, and excused from taking YF vacceine in the future, and never to take it again, placed on allergy list.
Myalgia, Arthralgia, Fever, NauseaVomiting, itching Narrative: Nausea, myalgia, arthralgia, fever tmax 100.1, itching
No additional AEs; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.   On 06-OCT-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (rHA) subcutaneous injection, (lot number W017574, expiration date 29-NOV-2023) (strength, dose, route of administration and anatomical location were not provided) as prophylaxis (product storage error). Temperature was 10.8 fahrenheit (F) for time frame 1 hour and 39 minutes. There was no previous temperature excursion. No additional adverse event details were provided (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA002259: US-009507513-2210USA002344: US-009507513-2210USA002172: US-009507513-2210USA002083: US-009507513-2210USA002276: