chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient in the observation area post vaccination c/o  "hot feeling" tightness in her throat. The patient admits to having had anaphylaxis reactions in the past to latex, penicillin and clindamycin. Patient states this feeling is similar to what happens when anaphylaxis is pending. Patient was transported to the ER for observation.
This spontaneous report was received from a Registered Medical Assistant (R.M.A) concerning an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with doses of M-M-R II (rHA) (Lot # L012479; expiration date: 10-APR-2017) (dose was not provided) which were improperly stored at 34.7F for 2 hours and 23 minutes. There was no data logger nor PQC involved. No adverse effects were reported. This is one of two cases from the same source (MARRS # 1606USA010502). Additional information has been requested.
Administration error: Shingrix is approved for adults 50 and older. Was given to a 13 year old child. No Immediate effect.
About 11 hours after the vaccination, Monday 01/04/2021, I started getting chills, headache, puking, then muscles aches. I notified my direct supervisor how I was feeling. I woke up on Tuesday morning with the sickness and I called off work. I got into contact with my Doctor, on Wednesday and had a tele-appointment. He gave me three medications, and currently it has lasted for six days, and I am going to try and get an appointment with the doctor on Monday 01/11/2021.
Cough Muscle Ache Fatigue Lethargy Run Down feeling Chills
R09.02 HYPOXIA 3/23/2023 RIGHT FEMORAL ARTERY OCCLUSION R09.02 HYPOXIA 3/23/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA
10AUG93 30 mins p/vax pt devel heavy sweating, drowsiness, burning sensation in throat & soles, h/a, reduced visual power of accomodation; devel pain & numbness from the lt shoulder palm in the thumb; limb felt heavy; exp perioral numbness;
It started our with a very severe sore throat and extreme fatigue. Then I developed a cough and it lingered probably 2 weeks after medication. I had a virtual visit with my doctor on Wednesday and he prescribed medication, 4 days of Zypack. He said if by Monday I was not feeling well to call back.  Also, my resting heart rate was really elevated by that time. I also was having difficulty sleeping because of the coughing. By Monday I was feeling much better. Before I could not do my normal activities except for doing one thing a day. I tested twice for Covid, home tests, both were negative.
Erythematous, vesicular lesions on chest and arms which started on 5/7/02 AM and was intensely pruritic. Had a headache, runny nose and a low-grade temperature. Rx'd Acyclovir 800mg qid X 5 days. On 5/14/02, painful dots on tongue.
fever 103, approx 23-24 hrs later lasted x 1 hrs; irritable, screaming x 48 hrs w/max 15" rest between cries; MD advised DT only in future;
Throat and ears itching, Given Benadryl 50 ml IM injection. Symptoms resolved
Presented to ancillary facility on 6/8/2021 from a nursing home facility with increased secretions and coughing. Patient has history of traumatic brain injury leaving him wheel chair bound and minimally responsive. Patient was diagnosed with polycythemia vera and fluid overload. He was transferred to Covenant for further management by hematology.  Upon admission to Covenant, he was evaluated by neurology due to having increased seizure activity from his baseline. Neurology recommended workup for possible infectious etiology. During admission breathing worsened and was experiencing a fever. He was found to be COVID-19 positive on 6/14/2021. He was treated with remdesivir and dexamethasone and required supplemental oxygen. He was discharged back to his nursing facility on 6/21/2021 with supplemental oxygen.
MY DAUGHTER STARTED HAVING A SEIZURE AT APPROXIMATELY 5AM. I CALLED 911 AND AN AMBULANCE TOOK HER TO THE EMERGENCY ROOM. SHE WAS PUT THROUGH NUMEROUS TESTS, INCLUDING A SPINAL TAP. SHE WAS DIAGNOSED WITH HAVING A FEBRILE SEIZURE. SHE HAS SINCE HAD 3 MORE SEIZURES, THE LAST ON JANUARY 6, RESULTING IN HER BEING PLACED IN AN INTENSIVE CARE UNIT, AND ON A VENTILATOR.
MICR was not available. RN tried to accommodate a walk in appointment for an immunizations update. Assessment of immunizations due was incorrect by RN. The 3rd dose of Rotavirus was given to client who has since aged out and it no longer eligible to receive the 3rd and final dose. HIB #3 was also administered to client, however considering the alternative schedule baby was actually not due for HIB #3 until 08-24-2018. No adverse effects noted.
1 YEAR LATER APRIL 23, 2023 HAD SERIOUS COVID AND TESTED POSITIVE DR PRESCRIBED PAXLOVID - LASTED 3 WEEKS BEFORE TESTED NEGATIVE
6 days post vax developed macular papular rash and blister on chest, a few on abdomen and arms, 1 on face. Pt experienced itching. By the next day the pt developed  a few more blisters. Pt had no other symptoms. Pt recovered without incident.
Information not available.  Patient died at home.  Covid 19 listed as cause of death on death certificate.
3-4 days later a local reaction occurred around the site of vax; It was slightly erythematous area w/papules scattered throughout;
Approximately 13 hours after the injection I started having a mild headache. By the 15 hour point I started to have flu like symptoms such as severe headache, fever chills, muscle and joint pains, My tinnitus also increased significantly and my eczema, which had not bothered my in over a year returned.  Most over the symptoms went away over the course of the next 24 hours.  However, the tinnitus and eczema did not and have not to this day.  My lower back, which I have a history of issues with has been aggravated since this vaccination.  At the time I thought it was just due to aggravation from the shivering which occurred the first night after the vaccination.  It may well be, but it is still  significantly more painful than it was prior to the injection.  I did not make a point of the back pain when I saw the Doctor as I thought it would resolve quickly, as it usually does.    The tinnitus has not decreased since this event and there is no treatment for it.  The eczema has continued and I am using a topical steroid prescribed by the Doctor who was consulted shortly after the vaccination.  The steroid helps but it is only a temporary solution as the eczema pops up in different places every day.
Vaccine administered 9/26/09. Patient returned to pharmacy with hives over most of her body.
Received 2nd dose of COVID-19 vaccine 1/26/2021.  On 4/5/2021 developed chills, cough, and nasal congestion.  Tested positive for COVID.
Extreme chills, muscle aches, blisters in mouth, blisters on lips, convulsions.
History of mother finding infant blue and not breathing on morning of 5/11/03.  Transported code 300 by EMS, resutation unsuccessful.  State Medical Examiner, autopsy pending.
Woke up at 12:35 AM with a fever, chills, body aches, and nausea. chills in the morning that went away, nausea was on and off and had an on and off headache. Started having intense chest pain around 10 AM- felt like pressure on my chest and almost squeezing, it kind of shot out and I could feel it in my throat and in my headache. It was still happening around 1 PM so I went to the ER after calling urgent care but the pain subsided once I was at the ER. Nausea, dizziness, haziness, and headache were on and off the rest of the day, subsiding around 6 PM.
Neck pain, upper back pain, neck stiffness, spinal stiffness, upper back muscle spasm
lower back pain; My arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 12:45 (Lot number: EP6955) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "Pork causes rosacea" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL. Past drug history included: Cipro for Known allergies: Cipro; Nexium for Known allergies: Nexium. Vaccination history included: Bnt162b2 (Dose 1; lot number: EL3247, administration time: 11:15 AM, vaccine location: Left arm), administration date: 12Mar2021, when the patient was 48 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Apr2021 08:00, outcome "not recovered", described as "My arm was sore"; BACK PAIN (non-serious) with onset 06Apr2021, outcome "not recovered", described as "lower back pain". Therapeutic measures were taken as a result of pain in extremity, back pain.  Additional information: There was no other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. After second shot the patient went to bed, during the whole night she was not able to turn because her arm was sore, the next morning she woke up without the sore arm but started experiencing lower back pain. She thought it was caused because she stayed in the same position all night, but it has been 4 days and the pain was not going away. The patient confirmed that she started experiencing pain in her lower back the next day after receiving her second vaccine, however, she attributed it to a bad position while sleeping, this has happened to her in the past and the pain usually went away after a few days. She became aware of this event Tuesday 06Apr2021 when her back pain became more severe. Tuesday 06Apr2021 was the day she connected the back pain with the vaccination. Advil has lowered the pain.  No follow-up attempts are possible. No further information is expected.
Patient had an injection site rash that was the size of a half-dollar. She reported no pain or itching.
Lightheadedness; Red spot on arm that is tender and warm; Red spot on arm that is tender and warm; Red spot on arm that is tender and warm; Arm was sore; Slept alot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), SOMNOLENCE (Slept alot), DIZZINESS (Lightheadedness), VACCINATION SITE WARMTH (Red spot on arm that is tender and warm) and VACCINATION SITE ERYTHEMA (Red spot on arm that is tender and warm) in a 55-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.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and SOMNOLENCE (Slept alot). On 23-Mar-2021, the patient experienced DIZZINESS (Lightheadedness), VACCINATION SITE WARMTH (Red spot on arm that is tender and warm), VACCINATION SITE ERYTHEMA (Red spot on arm that is tender and warm) and VACCINATION SITE PAIN (Red spot on arm that is tender and warm). At the time of the report, PAIN IN EXTREMITY (Arm was sore), SOMNOLENCE (Slept alot), DIZZINESS (Lightheadedness), VACCINATION SITE WARMTH (Red spot on arm that is tender and warm), VACCINATION SITE ERYTHEMA (Red spot on arm that is tender and warm) and VACCINATION SITE PAIN (Red spot on arm that is tender and warm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Heart rate: 117 (High) Increased and 105 (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment medication included that the patient took Pedialyte on 23 Mar 2021.
sz generalized tonic clonic sz approx 24 hrs post vax; exp aobut 8 sz w/in a 36-48 hr peirod; rx included Ceftriaxone, acyclovir & Phenobarbital;
Bivalent booster given as second dose erroneously instead of primary COVID-19 vaccine
Visit 11/13/15 arm redness and swelling 5 1/2" x 3". Thickened red area in center of larger swollen area. Warm and tender to touch. Client states swelling began day 1 after vaccination in right arm. She received Tdap and flu shot. Unaffected arm received (left arm) Hep A and MMR. 11/13 saw Dr at office, no Rx - sent client to an urgent care for MD f/u if nec. Diagram of erythema 8 1/2" -> 11/16 called pt, states getting a little better, size smaller.
PATIENT CAME TO PICKED UP HER REGULAR MEDICINE ON 01/29/2020 . SHE MENTIONED HER VACCINE INJECTED ON 11/04/19 SITE WAS TOO HIGH ON HER ARM AND  CAUSED HER JOINT OF ARM HAD DIFFICULTY ON MOVEMENT FOR FEW DAYS. SHE JUST WANT MY NAME AND NO EXTRA  COMPLAINED OR SIGN OF DISCOMFORT AT 01/29/2020
Tested positive with Covid 11/26.  Felt shortness of breath and lots of coughing so went to ER and was admitted to hospital on 11/30 /21 treated with steroids and put on O2 per NC and dishcharged 12/3/2021 to home.
CHILD'S DATE OF BIRTH WRITTEN AS  AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS MOTHER. CHILD IDENTIFIED IN (#150788293)  WITH DATE OF BIRTH. CHILD IS TOO YOUNG FOR VACCINE. SEE VAERS FOR REPORT OF FIRST DOSE RECEIVED ON 8/5/2021.
Case number PHEH2014US003649 is an initial spontaneous report from the pharmacist received on 21 Feb 2014. This report refers to a 67-year-old male patient who was accidentally vaccinated with MENVEO (batch number: A11051) intramuscularly on 01 Jun 2013. No adverse event occurred to the patient following this medication error.
Worried because he was exposed to COVID-19; Redness; Sore arm; Light headache; Little fatigued; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Worried because he was exposed to COVID-19), ERYTHEMA (Redness), MYALGIA (Sore arm), HEADACHE (Light headache) and FATIGUE (Little fatigued) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced ERYTHEMA (Redness), MYALGIA (Sore arm), HEADACHE (Light headache) and FATIGUE (Little fatigued). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Worried because he was exposed to COVID-19). On 11-Aug-2021, ERYTHEMA (Redness), MYALGIA (Sore arm), HEADACHE (Light headache) and FATIGUE (Little fatigued) had resolved. At the time of the report, EXPOSURE TO SARS-COV-2 (Worried because he was exposed to COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant treatment was provided. No treatment medication was provided.  The patient was exposed to COVID-19 since the patient works in close quarters with the people and the patient's boss was tested positive for COVID-19. The patient did not had any COVID-19 symptoms but was worried about being asymptomatic and if that might affect the efficacy of the vaccine.
Pt recvd 3 doses of Hep B vax 27SEP90, 25OCT90, & 26MAY91 & 9JUN91 It was determined that titer was neg; Booster dose given 1JUL91 & 15OCT91 titer was neg; 2nd booster dose given 30OCT91 & outcome pending as of 3JAN92;
MMR vaccine #2 given 3 weeks early. Date given for #2 1-17-07. Patient checked on 1-18-07 and found to have no adverse effects and no complaint of rash, pain, swelling of right arm at site of vaccine. CDC notified as well as MD. MMR vaccine given 1-17-07: Patient had no S/S of adverse events.  Report sent because MMR #2 given to soon after MMR #1 which was given 1-11-07.  Patient decided to get this in 6 wks rather than first repeating vaccine.  Reminder notice to get this sent to patient. RN
Patient presented to ER from PCP on 09/03/2021 with complaints of left lower neck mass that started on 09/01/2021. Parents reported patient received first dose of Pfizer Covid Vaccination on 08/25/2021. Patient had  CBC, BMP,  Hepatic, TSH, mononucleosis screen, strep group A, and Covid-19 test. Patient given 0.9% NS 500ml,  Decadron IV and Ativan IV. Mono test negative, Strep negative, Covid negative. CT soft tissue neck W contrast completed with impression of palpable lesion appears represent a large thyroid cyst.
pt became lightheaded shortly p/vax;2hr later pt was still lightheaded;
Received dose 7 days prior to the indicated second dose date; A spontaneous report was received from a healthcare professional concerning a 57-year-old, male patient who received a second dose of Moderna's COVID-19 vaccine administered seven days prior to the indicated second dose date.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (Lot number:032H20A) unknown route of administration on 14 Jan 2021.   On 04 Feb 2021, patient received their second of two planned doses of mRNA-1273 (Lot number: 043L20A) unknown route of administration for prophylaxis of COVID-19 infection.  The patient got the first dose of mRNA-1273 vaccine on 14 Jan 2021 and second dose should have been in on 11 Feb 2021 but got it on 04 Feb 2021 at 15:42, seven days prior to the indicated second dose date. No treatment information was provided.  The patient received both scheduled dose of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The event, vaccine administered seven days prior to the indicated second dose was considered resolved on 04 Feb 2021.; Reporter's Comments: This report refers to a case of Incorrect schedule of product administered for mRNA-1273 (Lot number: 043L20A) with no associated AEs.
had soreness in lt hand & wrist that PM p/shots 13APR92; 14APR92 had pain, swelling & extreme soreness in lt hand & wrist; hand hot to touch; severe pain unable to sleep; seen by MD dx atypical-seronegative rheumatoid arthritis;
Patient stated he became dizzy about 20-30 min after vaccine, then nauseated.
Seven days after receiving  vaccination patient presents to urgent care with fatigue, fever, rash and erythema at vaccination site, and lymph node swelling. Vital signs within normal ranges except for blood pressure  131/90 mmHg and temperature 37.7 degrees. Prescribed methylprednisolone and hydrozyzine and discharged to home stable.
Intense Intense pain at site immediately.; then about 18 hours later a severe stinging (like a bee sting) on the instep of left foot that is till happening.  Does not respond to Motrin; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) in the left arm on 01Apr2021 at 09:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications included losartan potassium (LOSARTIN) for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) in the left arm on 11Mar2021 at 09:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 09:00, the patient experienced Intense pain at site immediately then about 18 hours later a severe stinging (like a bee sting) on the instep of left foot that is till happening. Does not respond to Motrin. The patient received ibuprofen (MOTRIN) as treatment for the reported events. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vaccination site pain and pain in extremity was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Tactile fever x2 days after administration, chills x2 days, malaise x2 d, nausea x2 days, arm swelling.  BENADRYL 50mg 1 tab po BID.
Headache, Sedation, Myalgia, Arthralgia, Fever &  Diarrhea Narrative:  Other Relevant History:
extreme fatigue; migraine like headache; body aches; nausea; dizziness; issues with vision focusing; muscle weakness; sick; low grade fever 100-101; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 19-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) (batch number PVT-36633 ?, expiry date June 2020) for prophylaxis.   Concurrent medical conditions included celiac disease.   On 21st October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On 21st October 2019, less than a day after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced fatigue, migraine type headaches, general body pain, nausea, dizziness, blurred vision, low grade fever, muscle weakness and sickness. On an unknown date, the outcome of the fatigue, migraine type headaches, general body pain, nausea, dizziness, blurred vision and muscle weakness were unknown and the outcome of the low grade fever and sickness were recovered/resolved.   It was unknown if the reporter considered the fatigue, migraine type headaches, general body pain, nausea, dizziness, blurred vision, low grade fever, muscle weakness and sickness to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter was the patient's mother. The patient received a flu vaccine in her left arm. Within hours of vaccination, she developed extreme fatigue, migraine like headache, body aches, nausea, dizziness, muscle weakness, vision focusing issues and a low grade fever of 100 to 101 degree F. The patient was sick for ten days and the fever lasted for four days.  The reporter stated that, the nurse provided a paper with information regarding the flu shot, but the name of the medication was not given just GlaxoSmithKline with lot number: pvt-36633 and Expiry date June/2020. The reporter took the patient back to the doctors three to four days after receiving the flu vaccine, the doctor ran several tests including for Mono, but no results were given. The patient in the past had been positive for Mono. The reporter consented to follow up and provided her doctor's details. The reporter was referred to daughter's physician to obtain additional information on the flu vaccine. The reported batch number PVT-36633 was not found in sales data sheet, however it was captured as PVT-36633 ?      Lab Comments: in past, the patient was positive for mono
missed her second dose and as of 26May2021 it has been 58 days since her first dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed her second dose and as of 26May2021 it has been 58 days since her first dose.) in a 76-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed her second dose and as of 26May2021 it has been 58 days since her first dose.). On 26-May-2021, PRODUCT DOSE OMISSION ISSUE (missed her second dose and as of 26May2021 it has been 58 days since her first dose.) had resolved.        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.   No concomitant information was provided by the reporter.  No treatment information was provided.