chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second Dose not received in allowed time window; Urinary Tract Infection; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second Dose not received in allowed time window) and URINARY TRACT INFECTION (Urinary Tract Infection) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second Dose not received in allowed time window) and URINARY TRACT INFECTION (Urinary Tract Infection). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second Dose not received in allowed time window) had resolved and URINARY TRACT INFECTION (Urinary Tract Infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Information has been received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. It was reported that the patient received 4 doses of GARDASIL (dose, route and site of administration unknown) for prophylaxis, on the following dates: first dose on 25-OCT-2013 (lot # H020002, expiration date 08-AUG-2015), the second dose on 06-MAY-2014 (J006850, expiration date 31-MAR-2016 ), the third dose on 29-JUN-2015 (K007264, expiration date 02-MAR-2017) and the fourth dose on 26-SEP-2016 (lot # unknown, expiration date 06-APR-2017). No adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Patient states that 5 hours after receiving flu vaccine on 10/31/22 patient began having reaction. Migraine started in back of head, went to eyebrows, whole head aching pain. Hearing became "staticky like an old radio." Sight got dark with flashes of light. Persisted for 45 minutes. Patient also shook for 3 hours even though not cold. Wife thought patient was having seizure because patient was shaking. Patient was sweating.    Patient states this is the sixth year patient has had these symptoms the evening after getting flu vaccine. Last two years have been the worst.
This case was reported by a consumer and described the occurrence of bruise injection site in a 60-year-old female subject who was vaccinated with ENGERIX B. A physician or other health care professional has not verified this report. Concurrent medications included Hepatitis B immunoglobulin. On 27 January 2008, the subject received 1st dose of ENGERIX B (20 mcg, unknown, unknown gluteal) and experienced bruise injection site and intramuscular formulation administered by other route. At the time of reporting the outcome of the events were unspecified.
PATIENT WAS ALERT AT THE TIME OF VACCINATION; HE WAS ABLE TO ANSWER THE VACCINATION QUESTIONAIRES AND QUESTIONS THAT I ASKED PRIOR TO GIVING THE VACCINE. I ASKED THE PATIENT TO WAIT FOR 15 MINUTES FOR MONITORING AFTER THE VACCINATION. ABOUT 5 MINUTES IN, PATIENT FELL OFF CHAIR AND HIT HIS HEAD ON THE GROUND. HEAD WAS BLEEDING. PHARMACY CALLED 911. PARAMEDIC CHECKED ON PATIENT AND OFFERED TO TAKE HIM TO THE HOSPITAL. PATIENT DECLINED. PATIENT'S FIANCE (ALSO CAME TO PHARMACY FOR COVID-19 VACCINE AND WAS BY HIS SIDE AT THE TIME OF INCIDENCE) STATED THAT SHE AND PATIENT HADN'T EATEN ANYTHING SINCE LAST NIGHT. PATIENT WAS ABLE TO ANSWER QUESTIONS BEFORE LEAVING PHARMACY.
Injection site redness became very large and red about 5 days later. THe circle around the injection site looks like the welt that I get when I get stung by a  bee- 2.5 inches around. On and off extreme exhaustion. Two to Three times within the week of getting the shot. Starting5 days after receiving the shot, am feeling chest tightening and difficulty expanding my lungs fully. Diaphragm pain. More on the Left side of chest.
Fussy, morbilliform rash on trunk, fever, also with ROM which mother insists is from MMR.
passed out; loss of hearing and vision; loss of hearing and vision; bad headache; tingling; difficulty to process words and thoughts and difficult to speak; difficulty to process words and thoughts and difficult to speak; Nausea; Slurred speech; was acting weird like she could not process her thoughts; This is a spontaneous report from a contactable consumer (mother). A female patient of unspecified age received meningococcal group b rlp2086 (TRUMENBA) on unspecified date at single dose for immunization. Medical history and concomitant medications were not reported. Mother calls for information about for how long does the symptoms presented after the administration of the vaccine meningococcal group b rlp2086 will pass on patient. She reported that patient was administered today with the vaccine meningococcal group b rlp2086 and after 15 minutes of the administration the patient passed out, reporting a bad headache, tingling, loss of hearing and vision, difficulty to process words and thoughts and difficult to speak. She reported that the patient was administered with the vaccine on an empty stomach. She said that her daughter also had lost vision in one eye, was acting weird like she could not process her thoughts, and had slurred speech. She said that she called the physician back to ask them what they should do and they said to bring her back to the office so they could look at her. She said that she took her back to the doctor's office and her blood pressure was good and her daughter started feeling better and the vision in her eye was coming back. She said that her daughter took the vaccine on an empty stomach. She went to feed her and her daughter felt like she was going to throw up again. She told her daughter to eat and she got an extremely bad headache. She said that her daughter was trying to text and her daughter could not get her words to keep up with her texts. She took her daughter to the hospital and it was really busy so they left and her daughter is currently laying down with her head in her lap. She said that her daughter's symptoms started with nausea. The outcome of events was unknown.  Information about batch/lot number has been requested.
She received her COVID19 booster in mid-October 2021, shortly after which she began to notice weakness in her legs. Initially her legs felt "jumpy" (started ~4 days after booster). The weakness continued to progress and she had multiple falls at home in November 2021. She was only having minor tingling in her feet at this time. Due to the multiple falls that she had, she decided to come to the hospital, and thus she presented to the ED on 11/29/2021. She reports that this time was likely the worst of her condition. She was admitted to the hospital for ~1 week. At that time, she also started having weakness in her L hand, and some tingling. MRI brain/spine showed no nerve root enhancement, and showed some C3-C4 bulging disc, likely not contributing to her condition. EMG/NCS was abnormal for sensorimotor polyneuropathy.   Based on her subacute onset, with nadir reached in 4-6 weeks, and subsequently resolving symptoms, as well as abnormal EMG (though not typical for AIDP, but possibly due to resolving condition), it is suspected that her episode was likely Guillan-Barre Syndrome.
Patient received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date).    This case included information of patient 42nd out of 190 reported patients.  No concomitant product reported by reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 190 patient received a vaccine past the beyond use date from 9 different lot number vials.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
patient received two vaccines, pfizer and flu and was doing great about an hour later patient notified staff that she was experiencing chest pain. EMS was called and patient was taken to the hospital
No adverse effect reported; one patient "who already has positive measles, mumps, and rubella titers" accidentally received a dose of M-M-R II; one patient "who already has positive measles, mumps, and rubella titers" accidentally received a dose of M-M-R II; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's historical conditions, concurrent condition, and concomitant medications were not provided.      The nurse reported that one patient who already had positive measles, mumps, and rubella titers; on 01-MAY-2019, accidentally received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (extra dose administered) subcutaneously (strength and dose were not reported; lot # R036582 and expiration date 17-DEC-2020), as prophylaxis instead of varicella virus vaccine live (Oka/Merck)(VARIVAX) (wrong product administered). No adverse effect reported.
Received dose #1 of Heplisav-B on 7/19/19.  At first, it seemed she was having a localized reaction with pain and swelling within a couple of hours.  The site was also itchy.  She self-treated with ice only, no topical anti-itch cream. Her symptoms have continued with achy, flu-like symptoms. This past weekend she has also been feverish. On 7/29/19 the redness has subsided, but it is now purplish in color.  The site is throbbing and she is still achy and flu-like.  She is probably going home sick today. Sent for evaluation, but declined at this time.
This case was reported by a nurse via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of rash (1st dose received on an unknown date, refer case US2019055861). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced rash. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced rash after the second dose of SHINGRIX. Rash appears to resolve and then come back. No further details were available. The reporter did not give consent to follow up. The reporter declined to provide the patient identifiers and full demographics for herself.
On day 7 following first vaccine, the vaccine site, approximately 2inches in diameter, became swollen and turned red, as well as became warm to the touch and tender. Over the next 5 days (days 7-12 post-vaccine), the redness transitioned to a red ring around the swollen area. The warmth felt on the injection site was gone by day 10 post-vaccine. All symptoms were cleared 2 weeks after initial vaccine. I have seen articles refer to this as Covid Arm.
About one week after vaccine (noted after both the first however worse after the second) palpitations to 120 beats per minute, shortness of breath, chest tightness and chest pain, and fatigue present intermittently daily for 2 months now.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Pt reports getting very anxious around needles and cautioned immunizer about history of getting dizzy/fainting with previous vaccines. About 5 minutes after vaccine was given, pt was feeling faint, dizzy and nauseous. Had patient lay on the floor and position her legs upright on a chair. She laid down for ~5 minutes and felt better. Pt did not fully lose consciousness. Did not want me to inform primary care doctor about situation because this is not a new phenomenon for her.
Right arm has area approximately 4 inches in diameter that is red, warm and edematous.  Pt states low grade fever last night. Temp today was 98.5.
Patient received third dose of Hep B after new employee physical recommended. Patient reported five days later the area of injection was burning and continuously itching. Patient has been taking benedryl. Patient is not in distress.
symptoms of COVID/ positive result from the COVID test after first dose; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (symptoms of COVID/ positive result from the COVID test after first dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE BESILATE (NORVASC) and ENALAPRIL MALEATE (VASOTEC [ENALAPRIL MALEATE]) for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2020, the patient experienced COVID-19 (symptoms of COVID/ positive result from the COVID test after first dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (symptoms of COVID/ positive result from the COVID test after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-1 test: positive.     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.   Treatment included paracetamol maybe once or twice.; Sender's Comments: Very limited information regarding this event has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
My arm was red and itchy in a cup size circle for 8 days. It was shown to my primary care dr. She thought it was an odd place to have the injection. Left Arm toward the inside. She said I was having an allergic reaction. It is better now. I was visiting my dr the day after the shingles vaccination.
Day after injection I woke up at 4:30 am  with sore arm, severe headache,temp of 100.4 that went up to 102 through the day, body aches, slight cough,chills and just feeling terrible. I felt like I had the Covid Virus. Friday 2/5/21 and today Saturday 2/6/21 I am coughing with a throat that feels itchy and as if I am getting sick. I felt GREAT on Wednesday 2/3/21 and Thursday 2/4/21. I did call my Dr. the Day after injection when I was feeling so bad to see what to do about work because I can not take off work.
pt devel localized swelling w/redness in inj site following vax 25JUL92; also had high temp, loss of balance, limping follow w/high pitched screaming & loss of speech; dx PPD/Autistic
Woke up with severe chills. When able to, my temperature was 103.5 F. I took 2 Extra strength Tylenol, I also had a bad headache (5 out of 10) and I went back to bed. I felt slight more out of breath than is normal for me and more tired. I monitored my temperature during the day and it went down but remained elevate at around 101.5. I contacted my PCP the next day and after speaking with her and telling her that my temperature was still elevated and that it was day 13 after my second Moderna vaccine she sent me for a Covid test. It tooke through the weekend for my temperature to return to normal and until the end of this week for any stamina to return.
Approx. 1.5hrs. after receiving 1st dose of vaccine PT. returned TO treatment area c/o rash/hives TO R arm, shoulder. PT. examined & hives also found on back and abdomas. History and vitals obtained. PT. given 25mg. benadryl and 20mg pepcid. PT. monitored for 30mins. PT. stated she felt better and hives had started to dissipate. PT. released and advised TO call 911 w/ any further problems. Hives R arm, back, abdomen. Scratchy throat Approx. 1.5hrs. after 1st dose of vaccine PT. noticed hives on her R arm/shoulderand scratchy Throat. PT. returned to Treatment area where pt. was examined. PT. noticed hives on her back and abdomen. HisTory and vitals obtained and PT. given 25mg. Benadryl and 20mg Pepcid. PT. monitored for 30mins. PT. stated she was feel better and hives had started to dissipate. PT. released and advised to call 911 w/ any further problems.
pt shows localized edema redness @ inj site plus swollen eyes, all over body itching, some ankle swelling;poss allerg rxn or drug interaction;
Burning, tingling, swelling, pain in feet, hands, knees.  Could not walk without assistance. Swollen lymphnode under right arm, right hand was completely asleep for 24 hours.  As of today, 10/22/2014, I still do not have full mobility of my arms and legs and experience great pain in my joints.  I have had two doctor visits, and my nerve testing for my arms came back abnormal as of yesterday. I am scheduled to see a neurologist on 11/08/2014.  I was perfectly fine before I got the shot on 10/09/2014.  Now I am suffering from partial paralysis and still do not have a diagnosis.
Immediately after vaccination I instantly had a headache that couldnt get rid of for 3-4 days. 9-10 days after receiving covid 19 vaccination I Developed blood clot in left leg located on left side of knee/thigh area. Started off painful then turned into severe bruising. Day 11 post vaccination I was rushed to ER for numbness on leg side of body. While waiting in ER I started having numbness in my head and slurred speech. Nurse noticed speech slurring when pushing me in wheelchair to do ultrasound on my leg. Ultrasound was postponed and stroke alert was alarmed. Ecg results came back abnormal, platelets high, glucose high, anion gap Low, electrolyte imbalance.
Information has been received from a physician's assistant concerning a 26 year old female with no pertinent medical history who was vaccinated with a 0.5 ml second dose of GARDASIL. There was no concomitant medication. Subsequently, the patient developed a swollen face, neck and lips. Eight days after the vaccination, the patient went to an emergency room, she was given an unspecified antibiotic and was released from the emergency room. At the time of this report, the outcomes were unknown. Additional information has been requested.
Patient presented to the emergency department initially due to shortness of breath. She recently had an ablation for AFib and following that ablation was admitted to the hospital for a day and received intravenous hydrocortisone Her blood pressure was systolic of approximately 200. She was hypoxemic and required BiPAP.  Chest x-ray noted with left lower lobe atelectasis improving versus prior study.   Influenza was negative but COVID-19 was positive.  CBC normal.  CMP unremarkable.  BNP was normal at 94.  She was started on a nitroglycerin drip.   February 15, blood pressure is now normal and patient complaining of a significant headache.  She is off BiPAP.  Nitroglycerin drip was stopped.  I   February 16, patient back to baseline.  She is on room air.  Blood pressure is reasonably well controlled.  However, looking endocrinology wishes her to receive 24 hr of additional intravenous hydrocortisone due to her adrenal insufficiency.  She will be kept in the hospital for IV hydrocortisone.  Iron and ferritin levels are low at 61 and 52 respectively.  In light of her restless leg and anemia I will supplement with iron sucrose 200 mg IV times 3 doses   February 17, BP controlled, on room air, at baseline. She has been given written instructions on dosing hydrocortisone and fludrocortisone. She is discharged home.
Severe neck pain and headache. Stiffness of neck and muscle spasm. Lasted two weeks before becoming more tolerable.
Mild area of induration over deltoid (L) arm; large lump under (L) axilla - measuring 9 cm x 9 cm with erythema and tenderness.  1st visit to examine adverse reaction placed pt. on antibiotics - AUGMENTIN. F/U visit scheduled.
57 year old received Fluzone HD which is intended for 65+ age group - no side effects.
RESTLESSNESS; RIGHT ARM INJECTION SITE PAIN; HEADACHE; NASAL CONGESTION; CHEST CONGESTION; BODY ACHES; RUNNY NOSE; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: not reported) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced nasal congestion. On APR-2021, the subject experienced chest congestion. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced runny nose. On APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced restlessness. On 11-APR-2021, the subject experienced right arm injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the right arm injection site pain, nasal congestion, chest congestion, headache, body aches, runny nose and restlessness was not reported. This report was non-serious.