chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was received on 9/19/2019. Within 7 days, I began experiencing extreme fatigue along with some other minor symptoms. Initially, I wrote off the symptoms as being not connected to the vaccine. Within the following 2 weeks, I began having muscle tremors throughout my entire body, including facial. The tremors started out mild then progressed to being much worse (e.g. unable to hold a smile or walk up stairs without significant muscle tremors). Fatigue by this time had become debilitating to the point where I was only able to move around for a few hours at a time.   In December 2019, I went to see my primary care doctor. She had multiple labs performed to rule out other items (such as electrolyte imbalance and some additional more severe possibilities such as parkinsons) as an effect of Hep A vaccine in this way is rare. After ruling out multiple possibilities and seeing no connection with the symptoms, she referred me to Dr. with Neurology.   Dr. was able to see me in February 2020. By this time, the fatigue was so crippling, I was only able to get out of bed 2-3 hours a day with the rest being bedridden. Muscle tremors and extreme muscle weakness had also increased along with mental related problems such as memory issues, focus and the like.  Over the following 12 months, Dr. performed numerous in office tests as well as labs ranging from electrical tests to lab draws to MRI's. After ruling out several issues unrelated to a bad vaccine, such as Myastenia Gravis and other possible related diseases, and after performing a battery of tests, he has diagnosed me with the following:  1. Chronic fatigue - R53.82 (Primary) 2. Mild cognitive impairment with memory loss - G31.84 3. Encephalitis - G04.90  I reported the findings to nurse with epidemiology. Her information is below. I asked her about filing a VAERS report. She sent me the details and said that it would be best to do so personally as the health department is so incredibly overloaded and short staffed at the moment.
She spiked a fever the next morning of 101.5 degrees that persisted for 4 to 5 days. She now is being treated by PCP for pneumonia.
Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Severe, Additional Details: Pt came in weak. complained of back pain prior to injection.  After giving vaccine wife reported patient had not eaten today. pt in and out of states of confusion.
Case number PHEH2015US026970, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 33 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 05 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were no problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. Follow up information received via nurse on 26 Jan 2016: Reporter's comments updated.
HEART ISSUE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) 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 patient experienced heart issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart issue was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Dermatitus.  Very itchy \bBumps on both arms, upper chest, and forehead
Post vax, the pt developed flu-like symptoms, body aches, fever to 102, dizziness, headaches, and fatigue. Treated with rest, observation, and Tylenol.
itching all over; This case was reported by a consumer and described the occurrence of generalized pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2020, the patient received the 1st dose of Shingrix .5 ml. In November 2020, less than 3 months after receiving Shingrix, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as per vaccine indication. The patient experienced skin itching, all over, from about November. Itching was continued. The second dose due on 19th January 2021. The patient wanted to know should I receive 2nd dosage?
Within 36 to 48 hours of nasal FluMist vaccine, my son started complaining of stomach pain and runny nose.  This progressed to Upper Respiratory Congestion, Hoarseness, Loss of Voice, and some difficulty breathing within 48 more hours.
tiredness, muscle pain, joint pain, feeling unwell, dizziness, weakness rest for one day recovered second day
Anxiety; Every now and then throughout the day, I have pain about my heart pocket; Muscle ache; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (muscle ache), ANXIETY (Anxiety) and CHEST PAIN (Every now and then throughout the day, I have pain about my heart pocket   ) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CELECOXIB (CELEBREX), AMLODIPINE, HYDROCHLOROTHIAZIDE and IRBESARTAN for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle ache), ANXIETY (Anxiety) and CHEST PAIN (Every now and then throughout the day, I have pain about my heart pocket   ). The patient was treated with MELOXICAM for Muscle ache, at an unspecified dose and frequency. At the time of the report, MYALGIA (muscle ache), ANXIETY (Anxiety) and CHEST PAIN (Every now and then throughout the day, I have pain about my heart pocket   ) 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.
Tiredness; Achy joints; rash on feet, torso, chest, and arms; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rash (the past 30 years, he gets a similar rash that goes away after 3 to 4 days).   On 8th October 2021, the patient received the 1st dose of Shingrix (intramuscular). On 9th October 2021, 1 days after receiving Shingrix, the patient experienced tiredness, joint pain and rash. On 11th October 2021, the outcome of the tiredness and joint pain were recovered/resolved. On an unknown date, the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the tiredness, joint pain and rash to be related to Shingrix.   Additional details were reported as follows: This case reported by the patient for himself. The patient was received Shingrix vaccine and next day he felt tiredness and achy joints, that resolved a couple days later. The patient also reported that the next day after receiving the Shingrix vaccine he experienced a rash on the bottom of his feet, across his torso, chest, and both arms. The patient also stated that the rash was not itchy and it was pretty much faded. The patient mentioned that prior shingrix vaccine he didn't think about rash because every time he got any virus for the past 30 years, he got a similer rash that goes away after 3 to 4 days. The patient was not sure if this rash was related to shingrix vaccine. The reporter did not consented to follow-up.
Severe headache, vomiting, nausea, body aches.  Most severe symptoms lasting 24 hours. Milder symptoms persisting 48 hours beyond.
Information has been received from a health professional concerning a 22 year old white female who on 14-NOV-2007 was vaccinated with a dose of Gardasil (lot# 659435/1265U). On 16-NOV-2007 the patient felt dizzy. On 17-NOV-2007 the patient developed rash. On 19-NOV-2007 the patient's rash subsided. The outcome of dizziness and nausea were unknown. Additional information has been requested.
WHILE GIVING AN IMMUNIZATION TO THE PATIENT, THE HEAD OF THE NEEDLE WAS NOT SCREWED ON COMPLETELY AND DRIPPED DOWN THE PATIENT'S ARM. I TOLD THE PATIENT THAT THE HEAD OF THE NEEDLE WAS NOT SCREWED ON TIGHT TO THE NEEDLE, SO I WOULD HAVE TO READMINISTER THE VACCINE. I TOLD THE PATIENT THAT THE NEEDLE WAS IN THE ARM BUT THE VACCINE MAY NOT HAVE WENT INTO HIS ARM AT ALL. SO HE AGREED TO RETAKE THE VACCINE.
sleepy; Made me really sick; Dizziness; Fever; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE, ILLNESS (Made me really sick), DIZZINESS, PYREXIA, and VOMITING 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE, ILLNESS (Made me really sick), DIZZINESS, PYREXIA, and VOMITING. At the time of the report, SOMNOLENCE, ILLNESS (Made me really sick), DIZZINESS, PYREXIA, and VOMITING outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided. Action taken with mRNA-1273 in response to the drug was not applicable.   This case was linked to MOD-2021-015191.
Patient received the vaccine on 1/4/21 and she is 17 years of age (Moderna is 18+).
This spontaneous report as received from a 69 year old female registered nurse refers to herself. The patient's current conditions included herpes simplex and mitral valve prolapse. The patient had no known drug reactions. On 11-JAN-2016 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# unknown) at an unknown pharmacy. No concomitant therapies were reported. On 12-JAN-2016, the patient experienced a runny nose, dizziness, nausea and headache. The patient took a dose of over the counter SUDAFED PE with acetaminophen on the same day at an unspecified exact dose and it helped her symptoms. On an unspecified date in January 2016 the patient experienced redness (diameter of the reddened area was unspecified) and warmth at the injection site of ZOSTAVAX vaccination. The patient did not seek any medical attention. The outcome of the events was reported as recovering. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of nausea in a female patient who received FLUARIX QUADRIVALENT (batch number ZG3S5, expiry date 30th June 2017). On 8th October 2016, the patient received FLUARIX QUADRIVALENT. In October 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced nausea, vomiting and hypotension. On an unknown date, the outcome of the nausea, vomiting and hypotension were unknown. It was unknown if the reporter considered the nausea, vomiting and hypotension to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously not reported to anyone. The other health professional stated that she would call back with details regarding the other two adverse events. This case has been linked with case US2016GSK149944 and US2016GSK149945.
Left arm aching 5/10 with worsening. Sx with movement and gripping.
notified at approximately 3pm on Friday, March 6, 2023 infant passed away that day
An event of entire dosage of FluMist in the same nostril occurred in a 46 year-old employee; the report was received from a registered nurse. No medical history or drug history information has been reported for this employee. The employee received FluMist intranasally. The reporter indicated the employee was inadvertently administered the entire dosage of FluMist in the same nostril; this is not in accordance with FluMist dosage and administration requirements. No adverse events were reported. Outcome the employee had no ill effects. Further dosing with FluMist is not indicated. The reporter did not provide a causality assessment for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
A spontaneous report was received on 11-JUL-2016, from a male registered nurse concerning an unknown patient (gender not specified, but the doctor's office was an OBGYN office) (the third of three patients) who on 11-JUL-2016 was vaccinated with a dose of expired PNEUMOVAX 23 (Lot # was reported as K012424, expiration date: 05-JUN-2016)(exact dose and route of administration were not reported). The NDC number reported was 0006-4837-03. [Reference MARRS # WAES1607USA005542 for the first of 3 (unknown) patients who was vaccinated on 22-JUN-2016 with a dose of expired PNEUMOVAX 23 (lot # K012424, expiration date: 05-JUN-2016)(exact dose and route of administration were not reported). Reference MARRS # WAES1608USA010414 for the second of three (unknown) patients who was vaccinated on 07-JUL-2016 with a dose of PNEUMOVAX 23 (Lot # was reported as K012424, expiration date: 05-JUN-2016)(exact dose and route of administration were not reported)]. The reporting nurse stated that the office staff just realized after the third injection that the vaccine was expired. The nurse had concerns on how to proceed and questioned if the injections should be readministered. The reporting nurse stated there have ben no known complaints from any of the patients (3) that were vaccinated, an no treatment has been given thus far. No further information has been provided. Additional information has been requested. This is one of three reports received from the same reporter.
Client called to report that the day after vaccine received, she noticed her arm was swollen, red and very sore. She reports that on the second day she had a red circle around the site of injection that was 3-4 inches in diameter. The area was red, warm to touch, hard and very sore. The third day after vaccination it was no worse but had not gotten any better.  The area was also very itchy. She describes the area as "sore as the dickens."  Day 5 client reports that it is still tender and itchy.
Bone pain; Muscle pain; Not feeling good since she had the shot; Headache; Gas; Feeling tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 91 year-old female patient received bnt162b2 (COMIRNATY), administration date Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Oct2021, when the patient was 91 years old, for Covid-19 Immunization, reaction(s): "She had a lot of sickness, so she couldn't do it". The following information was reported: BONE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Bone pain"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Muscle pain"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "Not feeling good since she had the shot"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; FLATULENCE (non-serious) with onset 2021, outcome "unknown", described as "Gas"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Feeling tired".  Additional information: Reporter stated, "The concern is that my mother, she had her second shot of COVID up there like a month 'after' she had the first one. She is not feeling good since she had the shot. She has like muscle pain, bones pain, gas, headache. I want to know if this is a normal thing that happens to elderly people after the second shot?"Name of the vaccine: Pfizer COVID-19 Vaccine .On confirming the name of the vaccine, Reporter stated, "Yes, she took the first dose in October. Then she was taking (Voice not clear) because she had a lot of sickness, so she couldn't do it. She did the second shot 2 days ago, 2 or 3 days ago and since then she is not feeling good. She has a headache, muscle pain, bones pain, gas, feeling tired.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101775885 Same patient and drug, different dose
Rash 36 hours after second dose of COVID. This also happened with dose #1, rash 48 hours after vaccine.
Erythema, swelling Lt-lateral arm 4cm x 3cm tenderness.
T.C. from mother, states child has a big bump on his son's (L) arm - Referred the patient to clinic for an evaluation ASP.
As per insurance company child is 11 years old but Dad very clearly gave DOB as 11/30/2008
Patient is a 79 y.o. female patient of local MD with history of COPD, hypothyroidism, chronic pain syndrome, essential hypertension, hyperlipidemia presented to ED with shortness of breath.  Found to have COVID-19 infection with acute hypoxic respiratory failure and AKI .  Patient transferred to Doctors Hospital for further medical care.   Covid-19 Virus Infection Acute hypoxic respiratory failure Acute COPD exacerbation Date of onset of symptoms: 1-2 days Symptoms present on admission: URI symptoms including cough, shortness of breath Date of covid positive test: 02/7/23 Vaccination status: vaccinated Imaging: Chest x-ray with bibasilar opacities Oxygen requirements on admission: 2L  Current oxygen requirements: 2L Medical therapy: dexamethasone Consultants following: None Anticipated special isolation end date: 02/16/23 Hypoxia has resolved, pt is stable for discharge     AKI 1.45 on admission at hospital Received IV fluid hydration, AKI resolved, Cr .75   Sinus bradycardia HR in 39-84, sinus rhythm, TTE: EF 55% Mostly asymptomatic, but states she did have syncopal episode < 3 mn ago Cardiology consulted, sinus brady has been present for several yrs Pt is stable for discharge      Generalized weakness In the setting of above Consult PT/OT   Essential hypertension On amlodipine, losartan and hydrochlorothiazide Cont current home medications   Hypothyroidism Continue Synthroid, TSH .47    Chronic pain syndrome NARx reviewed Continue hydrocodone/acetaminophen  Hyperlipidemia Continue statins   Depression Continue Lexapro   GERD Continue PPI
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L029934 with expiration date: 01-MAY-2017 and lot # M019690 with expiration date: 02-NOV-2017 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 35.6 degrees Fahrenheit for 10 minutes and 36.6 degrees Fahrenheit for 10 minutes. Data logger was involved. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Dizziness, nausea, sore throat, fever chills, severe joint pain and muscle weakness. Patient self-treated with ibuprofen and acetaminophen. Reports symptoms ceased 9/22/16 in the afternoon.
Information has been recvd re: 4-month-old male who received his second dose of blinded study vaccine. The pt nursed at 4 AM on 7/5/01 and then fell asleep with his mother. He was found on his back at the edge of the bed at 10:25 AM and was cold and non-responsive. He was pronounced dead by the medical crew that answered the call. The cause of death was "probable" sudden infant death syndrome (SIDS). The investigator reported that SIDS (unexpected per the Investigator Brochure) was not related to study vaccine administration or concomitant vaccines. The medical monitor considered the event to be probably not related to the study vaccine. This case is being submitted as a 15-day expedited report as requested by the FDA. A 15-day follow up report received 4/19/2002 adds: Follow-up info was received on 11/28/2001. An autopsy revealed the cause of death to be Sudden Infant Death Syndrome. The coroner's findings revealed the same. Both the investigator and medical monitor did not consider the event to be related to study vaccine administration or concomitant vaccinations. NOTE: This case is being submitted as a 15-day follow-up, expedited report, as requested by the FDA.
Received vaccines on 8/18. Beginning on the evening of 08/18, the patient began to experience unexpectedly severe pain in her L deltoid with associated swelling and erythema. She began to feel fatigued with malaise and a headache shortly after despite taking Tylenol Q6H for her symptoms. This continued until 08/19 when she became febrile to 101 F and experienced one episode of NBNB emesis follow dinner. The patient fevered again to 102 F on the day of admission which prompted her mother to seek care at a health care facility. She was started on IV clinda with rapid improvement within 24 hours. Difficult to say for certain if this was cellulitis vs vaccine reaction. Given her immunocompromised status we decided to be more cautious and treat as a true cellulitis.
Hospitalized 10/9/2021; COVID-19 positive 10/9/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider at Discharge: MD Admission Date: 10/9/2021 Discharge Date: 10/13/2021 DETAILS OF HOSPITAL STAY:   HOSPITAL COURSE: Patient is an 86 y.o. female with past medical history of RA on prednisone, DM II, HTN, hypothyroidism, and remote hx of right sided breast cancer who lives with her husband at independent living facility. Patient presented to the ED with chief complaint of generalized weakness and cough. She was subsequently found to be positive for COVID-19. Vaccinated in Feb 2021. Upon arrival to the ED, the patient was afebrile, hypertensive 196/83 and hypoxic to 87% on room air requiring 2L oxygen. She was admitted for acute hypoxic respiratory insufficiency secondary to COVID 19 pneumonia. She was started on decadron to complete a 10 day course. Also found to have a Klebsiella UTI for which she received Rocephin x 3 days then was restarted on home prophylaxis macrobid. Given generalized weakness, multifactorial but likely due to concurrent infections, therapy recommended subacute rehab. She improved throughout her hospitalization and therapies changed recommendation to home with therapies. She was seen by pulmonary rehab and discharged on 2L oxygen around the clock. She was also set up with the COVID at home program to continue to monitor her closely at home. She was discharged home in stable condition. She was instructed to restart her home prednisone once she completes her course of decadron.