chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extremely fatigued; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extremely fatigued) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) 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 FATIGUE (extremely fatigued). At the time of the report, FATIGUE (extremely fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Fussy/irritable, decreased PO. Tm 105 at home. No rhinorrhea, cough, diarrhea, emesis, or focality on symptoms. 2 complex febrile seizures on 6/9, another 2 complex febrile seizures on 6/10; (full body convulsing "like seizures" involving all 4 extremities, eye deviation and with froth coming from the corner of her mouth, unresponsive and shaking) with postictal period. Maculopapular, erythematous and blanching rash developed on 6/11, trunk to face and arms.
Systemic: Diarrhea-Medium, Systemic: Nausea-Medium
On March 16th at roughly 1:30pm, the patient received his first dose of the COVID19 Moderna vaccine. Afterward, the patient experienced no adverse side effects. About 48 hours later, however, at 2pm on March 18th, the patient's spouse attempted to wake him from a nap. The patient seemed much groggier than normal and his expression appeared vacant. When pressed by his spouse, the patient could not say who he was, or who his wife was. He agreed to travel with his wife to the hospital. At the hospital, a healthcare professional asked the patient who he was. He answered with his correct name. He also correctly identified his spouse by name. But when asked where he was, the patient gave a long and incoherent response. After this initial screening, doctors at the hospital evaluated the patient for a stroke. They ruled this out as a possibility. Next, they suspected the patient's MS lesions may have contributed to his "cognitive event." However, after comparing his 2018 scan to a current scan, they determined this was unlikely the cause. After about 24 hours at the hospital, a neurologist hypothesized that the patient had experienced a seizure. Another doctor at the facility concurred with this assessment. By late Friday (more than 24 hours after the episode), the patient had regained most of their cognitive functioning, though he still experienced mild confusion around the week's events (even preceding the "cognitive event"). Prior to now, the patient has never had a seizure before.
15OCT96 pt recv vax 1030AM by 1130PM had fever 104.1, diff in urinating, retention of urine, & joint & muscle pain;16OCT96 urination Ok, temp nl, dizzy, gut pain, 6 episodes of diarrhea;17OCT96 tinnitus;18OCT96 all signs & sx gone;
Patient experienced about 3 inch diameter rash near injection site. Was given rx for triamcinolone cream by MD and given oral BENADRYL.
Started with headache 1 week post-vaccination.  That proceeded to distal neuropathy/paresthesia  in feet, hands, and face accompanied by head pressure, problems with focusing vision, light headedness, and problems with concentration.  This is not a coincidence as I had a similar response to the first dose of a Rabies vaccine back in 2006 that was reported to VAERS.  Clearly, given the past similar reaction to the Rabies vaccine, either one of the vaccines I received, or a combination thereof, trigger the same sort of autoimmune response.  It has the hallmarks of GBS.  I am not experiencing, yet, muscle weakness or respiratory problems, just the peripheral neuropathy.
pt return 9 days post vax  w/redness & swelling from lt elbow to shoulder;c/o itching;states since recv vax;
Received vaccine (L) deltoid 5/22 - onset swelling, redness, warmth 5/24 - failed oral abx - admitted for IV antibiotics 1 wk after vaccine given.
Information has been received from a patient's father in regards to his 8 year 6 month old son. On 05OCT2012, the child was scheduled to receive the second series of Hepatitis A Vaccine but mistakenly was administered GARDASIL. The patient's father reported he and his wife have researched the Quadrivalent Human Papillomavirus Recomb. Vaccine and the possible short term and long term side effects so they can support their son. Their concerns included that face that their son was under the age of the study group and he also had a diagnosis of autism. They were concerned that their son may not be able to inform them if he does experience possible long term effects> The parents have reviewed the Physician Desk Reference and saw there was a study of Quadrivalent Human Papillomavirus Recomb. Vaccine with REMOBIVAX vaccine and they were inquiring if there were any studies regarding Quadrivalent Human Papillomavirus Recomb. Vaccine and Hepatitis A and if there were any studies with persons with Autism or other developmental disabilities. The father stated he and his wife were not looking to assert a claim towards Merck & Co. They just wanted to determine if there was any reason for concern and to obtain as much information as they could. No further information is expected.
Clinic manager has reported the incidence to Director of Pharmacy and Clinics. The infectious disease specialist of the Hospital has been consulted immediately with reference to CDC guidelines on COVID vaccination errors. According to CDC guideline, "if age 16-17 years and moderna vaccine was inadvertently administered as the first dose, may administer Moderna vaccine as the second dose (as off-label use, because Moderna vaccine is not authorized in this age group)".  Contacted patient to inform the incident and recommendations.
4 days after administration of 3rd dose of Rotateq the patient had blood in his stool and abdominal pain.  No intussusception was found on evaluation in the ED but his symptoms were suspicious.
fever 37.5 last night for 3-4 hours; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (fever 37.5 last night for 3-4 hours) in a 28-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031279) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 28-Sep-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced PYREXIA (fever 37.5 last night for 3-4 hours). In September 2023, PYREXIA (fever 37.5 last night for 3-4 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Sep-2023, Body temperature: fever of 37.5 in last night.         No concomitant medications were reported.  The patient received all the Moderna vaccines in the past and have had strong reaction to them as more than 100 degrees of fever every time.  On 28-Sep-2023, the patient received booster dose of Spikevax 2023-2024 PFS vaccine.  No treatment medications were reported.   This case was linked to MOD-2023-743682 (Patient Link).
Initial unsolicited report received from a consumer on 18 January 2016. This case involves a male patient (age not reported) who was vaccinated with a 5 ml dose of INFLUENZA VACCINE (Flu shot) (batch number, expiration date, dose number, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medication were not reported. On an unspecified date, immediately (few seconds following the vaccination) the patient's arm burned at the shot spot and turned red and began to swell. About an hour later patient felt like an elephant was sitting on his chest and his breathing became labored. Lab data was not reported. Patient corrective treatment included Benadryl. It was reported that after taking Benadryl, the pressure eased. On 13 January 2016, the patient recovered from the event of breathing and outcome of the event of arm turned red and began to swell was unknown. List of documents held by sender: none.
on 12-30-20, after the injection , at the injection site, my left  arm was redness which grew for a couple of days, with hive and itchiness sensation. I  went to urgent care to get examined.
3rd dose administered; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received previous one being on 21st June 2021).   On 18th January 2023, the patient received the 3rd dose of Shingrix. On 18th January 2023, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 18-Jan-2023 Reporter's comment: The information was provided only for the third vaccine dose. The reporter provided details for patient and vaccine. The vaccine administration facility was the same as primary reporter. The call was escalated to second line. The reporter consented to follow-up. Additional supportive information: The patient had erroneously gotten a third dose of Shingrix , which led extra dose administered.
Case number PHEH2014US024948, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 53 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 04 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperatures was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
chills; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1 st dose), administration date: 03Feb2021, when the patient was 69 years old, for COVID-19 immunisation, reaction(s): "lightheaded, dizzy", "sudden weakness\felt very weak", "Tightness across stomach", "Stomach Spasms", "I never felt like I had trouble breathing", "It began to subside about 30 min later, felt very weak for about two hours". The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "body aches". Additional information: "I received the second shot after talking with Health Dept. and doctor. I did not have any reaction to the second dose- 10Mar2021. I did have chills and body aches about 10 hours after just normal side effects. Lasted into the 2nd day."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
5 MIN AFTER VACCINATION PT DEVELOPED RED RASH ON NECK, FACE AND RIGHT UPPER ARM. PT REPORTS THAT THE RASH IS EXTREMELY ITCHY. PT DENIES ANY SOB, THROAT OR FACE SWELLING. LUNGS CLEAR.  NO OTHER SYMPTOMS NOTED. VITALS OBTAINED AND MONITORED. VSS. PT REPORTS SHE DEVELOPED A RASH AND HEADACHE FROM FIRST DOSE OF MODERNA. PT REQUESTING BENADRYL AND STATES SHE DOES NOT WANT TO WAIT TO SELF MEDICATE AT HOME. PER PT BENADRYL DOES NOT MAKE HER DROWSY BUT HYPER. BENADRLY 25MG PO ADMINISITERED AT 1102. PT TOLERATED WELL. RASH AND PRURITIS IMPROVED. PER CLINICAL  PT OK FOR RELEASE AFTER 15 MIN POST BENADRYL ADMINISTRATION AND INSTRUCT PT TO  DRIVE STRAIGHT HOME. PT ALSO INSTRUCTED TO SEEK MEDICAL ATTENTION IF SYMPTOMS PERSIST OR GET WORSE. PT RELEASED AT 1122. PT WAS ESCORTED TO EXIT BY STAFF WITH NO FURTHER ISSUES. VITALS AS FOLLOWS: 1054 BP 143/89 HR 103 RR 16 SPO2 96 1059 BP 152/91 HR 93 RR 18 SPO2 95 1106 BP 147/83 HR 82 RR 18 SPO2 95 1113 BP 134/86 HR 77 RR 18 SPO2 97 1119 SITTING BP 138/95 HR 80 RR 18 SPO2 97 1121 STANDING BP 145/94 HR 80 RR 18 SPO2 97
Developed a head to toe maculopapular erythematous exanthem on 4/19/11.  Felt warm to mom on 4/19/11.  Mild fussiness on 4/19/11.  Evaluted in clinic on 4/20/11 and reassurance given.
Patient presents to the ED with complaints of an allergic reaction that started approximately 5 minutes after receiving the COVID-19 vaccine. Patient states that she started to experience throat swelling, tingling on her nose and lips, as well as feeling a little dizzy. Patient denies any trouble breathing but states that she has slight chest pain on inspiration. Denies any other symptoms, denies any significant medical history, has not ever had a reaction to a vaccine before.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 immunisation.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 28-Dec-2020, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment information was not provided.  This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
sick for over six weeks; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a social media consumer (patient).  This case involves patient (unknown demographics) who experienced sick for over six weeks, while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date (last time), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick for over six weeks (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information on the batch number for this case.
For 6 days after the shot I experienced a metal taste in my mouth and tenderness in left tonsil with a sore throat.
Information has been received from a representative concerning a 10 year old 150 lb. 4 oz, 58 inch female with an allergy to penicillin and history of similar injection site reactions to other unidentified vaccines who on 13-SEP-2007 received her second dose of 0.5 ml subcutaneous dose in the left arm of varicella virus vaccine live (Oka/Merck) (lot # 657999/1005U). It was reported that she was well at the time of the vaccination. 5-6 days after receiving her second dose (dates not reported) she experienced swelling at the injection site. She was seen by the physician who implemented therapy with diphenhydramine (BENADRYL), and topical hydrocortisone cream. The patient fully recovered. No product quality complaint was received. No further information was available.  Follow up information by a registered nurse reported that on 13-SEP-2007, she developed a three inch area of redness, warmth, dry crusty feeling, light red area encircling it from arm pit to elbow, itchy, and that the puncture site was dark red, and crusted. Vaccination history included influenza virus vaccine (FLUZONE) (lot# 02512AA) intramuscular in the left deltoid (20-OCT-2007). Additional information has been requested.
Weird smell and taste, vomiting. After receiving 2nd dose weird taste and smell disappeared.
NONE COVID VACCINE EXPIRED 7/26/2022 Given 10/27/2022
ARTHRITIS; Dull headaches; Head and neck hurting; stiff neck/ PROBLEM MOVING MY NECK; crackling sound from her neck; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Head and neck hurting), MUSCULOSKELETAL STIFFNESS (stiff neck/ PROBLEM MOVING MY NECK), JOINT NOISE (crackling sound from her neck), ARTHRITIS (ARTHRITIS) and HEADACHE (Dull headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cerebral palsy.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN (Head and neck hurting) and JOINT NOISE (crackling sound from her neck). 17-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck/ PROBLEM MOVING MY NECK). On an unknown date, the patient experienced ARTHRITIS (ARTHRITIS) and HEADACHE (Dull headaches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Head and neck hurting), MUSCULOSKELETAL STIFFNESS (stiff neck/ PROBLEM MOVING MY NECK), JOINT NOISE (crackling sound from her neck), ARTHRITIS (ARTHRITIS) and HEADACHE (Dull headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) CT scan results includes diagnosis of  stenosis of spine..         No Concomitant medication was provided. Other treatment included 8 Hour arthritis   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up was received on 20-JUL-2021 Patient lab details CT scan was Added  diagnosed with stenosis of spine and Treatment information was added 8 hour arthrits
Pt recvd vax & devel panniculitis of the supraclavicular area characterized by local swelling; dx was confirmed by MRI;
devel nasal congestion & tightness in throat w/diff swallowing onset 2hrs p/vax;took antihistamine 4hrs p/inj w/sl relief;total relief in   24hrs;
2 -4  days after second I woke up and felt a  Sharp pain in L scapular area and behind  L shoulder. I then noticed numbness in my R palm and numbness in my left pinky finger. I also have weakness in my left hand, and decreased strength in my left hand
Information has been received from a physician concerning a 4 year old patient with morphoea skin diagnosis 24-SEP-2007 who on 11-MAR-2005 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 647264/0437P) in the right deltoid. Concomitant therapy included measles-mumps-rubella vaccine (MSD) (lot# 649614/0777P) in the left deltoid. On 12-FEB-2008, the patient developed raised lesions on the right arm and shoulder. The patient was found to have papulovesicular lesions of the right arm. The sample of th lesion was collected from an independent lab on 13-FEB-2008 two times. The sample was take from a skin lesion and right antecubital skin lesion. The PCR (VZV Varicella-Zoster Virus of the specimen from the skin lesion and right antecubital skin lesion was positive. The sample of the lesion was collected from an independent lab on 13-FEB-2008. The sample was taken from the right antecubital skin lesion. The PCR (HSV) Herpes Simplex Virus results for the specimen from the right antecubital skin lesion was negative. The patient was treated orally with acyclovir. At the time of reporting the outcome was unknown. Additional information is not expected.
According to parent purple bumps (purpura) appeared on child's shins starting day after immunizations MMR, Dtap, and varicella. Symptoms resolving on 18 Jan. Noted UTI then hematuria 22 Feb. 13 Mar noted purpuric nephritis.
Rash (red papules and ruptured blisters with red base) all over the body.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age. The nurse reported that on an unknown dates unknown number of patients might have been vaccinated with M-M-R II (dose, lot number, expiration date and route of administration not reported). Other suspect therapies included (oka/merck) VARIVAX (dose, lot number, expiration date and route of administration not reported), GARDASIL (dose, lot number, expiration date and route of administration not reported) and PNEUMOVAX23 (dose, lot number, expiration date and route of administration not reported) that had multiple excursions. No adverse effects were reported. The follow-up information has been received from a nurse with the information that an unspecified patient was in the office at the time of the report and was about to be administered (it was not reported whether the patient received the vaccine) A dose of (oka/merck) VARIVAX (dose not reported, lot # J005726 and expiration date: 08-MAY-2015) which was stored outside of recommended temperature range as noted in prescribing information. No adverse effect reported. Additional information has been requested.
Difficult breathing; Started getting pins/needles/tingling/pain on both of my hands; Started getting pins/needles/tingling/pain on both of my hands/Pins/needles/tingling/pain throughout my body; Chest tightened; Pins/needles/tingling/pain throughout my body; This is a spontaneous report from a contactable pharmacist (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at the left arm on 22Jan2021 13:45 at single dose for COVID-19 immunization. Medical history included birth control. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included ethinylestradiol, levonorgestrel (LEVORA) for birth control. The patient previously took the first doe of BNT162B2 on 31Dec2020 administered at the left arm. The patient got the vaccination on 22Jan2021 and in less than 5 minutes she started getting pins/needles/tingling/pain on both of my hands. Then suddenly her chest tightened and had difficult breathing which lasted for 2-3 mins. Now (22Jan2021), she has pins/needles/tingling/pain throughout her body. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the events. The patient underwent lab tests and procedures which included Nasal Swab and SARS-CoV-2, RT-PCR on 21Jan2021 and both are negative. The outcome of the event general body pain was unknown and recovered for the rest of the events.