chrisvoncsefalvay/vaers-outcomes huggingface dataset:
booster given less than 6 months after 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given less than 6 months after 2nd dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 048F21A and 939902) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given less than 6 months after 2nd dose). On 24-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given less than 6 months after 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment product use was not provided by the reporter.
I went home and wasn't too bad, but I was tired. Next morning, I woke up with an awful headache and I was nauseous and dizzy. I could hardly stand and every single part of me hurt. It was muscular aches and pains, and it just wouldn't go away. It was like that for a whole 3 weeks. I almost decided not to get the next shot. I couldn't get past the nauseous and dizzy feeling I had. It was like vertigo. I just moved from my bed down to the couch and eating and drinking was not something I was interested in because I wasn't sure if I could hold it down. And it was like that for 3 weeks. So I went to get the 2nd shot as well and the nurse there recommended ibuprofen and Tylenol. She also wrote a prescription for nausea if I needed that too. But the first 3 weeks were miserable, and it just wouldn't go away. I've never had a reaction to a shot before.
Headache; Tiredness; Upset stomach; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2019, the patient received the 1st dose of Shingrix. On 29th October 2019, 1 days after receiving Shingrix, the patient experienced headache, fatigue and abdominal discomfort. On an unknown date, the outcome of the headache, fatigue and abdominal discomfort were unknown.   It was unknown if the reporter considered the headache, fatigue and abdominal discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient age group was not reported but selected as an adult as per vaccine indication. The day before reporting, the patient received dose of Shingrix. On the day of reporting, the patient experienced Headache, tiredness and upset stomach. The patient asked, if over the counter medicines were ok to take.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic:  difficulty hearing-Medium, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: We called 911. EMT came in. All the vital signs were normal. After 30 minutes, the patient recovered.
Woke up w/ sore throat that was progressively worse, climaxing on Friday night/Saturday morning where I woke up ~ 10 @ night w/ pain swallowing, and it took an hour & salt gargle + throat spray + lozenges + honeyed tea to swallow w/out pain.  After Tylenol PM & extra sleep on Saturday night, I woke up Sunday w/out symptoms.
had vax 1JUN93, starting 8JUN93 @ noc started getting scratchy throat, glands started swelling; 9JUN92 hard to swallow;
The patient stated that the shot gave her a sore arm and hurt similar to the first shot, but now a month and a half later still have slight pain and discomfort with activity.
Symptoms: Chills, cold sweats, enlarged lymph nodes, enlarged tonsils, mild fever, trouble sleeping, headaches, muscle ache, muscle fatigue, muscle spasms, weakness, dehydration. Chills and cold sweats occurred several hours after receiving the vaccine, other symptoms progressed over 2 days.
On 7/11/01, fever increased to 103F and had intermittent low-grade fevers which responded to antipyretics. Pt had a large, localized reaction "erythema", lump and edema/swelling at injection site of approx. 8". Symptoms resolving on 7/18/01.
Pt c/o generial malaise & joint pain to both hips elevated  Neut & lymphs. Temp inc. IM steriods given & pain dec.
None stop screaming for several hours.  Followed by fever.  Fever still persisting as of this report.  Using acetaminophen every 4 hours.  Max dose for 9 pound infant. Patient is tired and not responsive.  The child is not herself in any way.  She is not eating well and cries in her sleep.
I felt very dizzy and started walking back to my room. Before I could get to my room I fell to the ground. I never lost consciousness but I couldn?t get up for about two minutes. I intentionally slept for the rest of the day and did not have any further severe adverse effects but that one really shook me!
This spontaneous report as received from a physician refers to multiple unspecified patients of unknown age. On an unknown date the patient was vaccinated with doses of improperly stored RECOMBIVAX HB (unknown lot #s and expiration dates). The vaccine was stored under 1.3 degree Celsius for 35 hours. No previous temperature excursion. No adverse effect was reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
1. 9/14/17 No pain at flu vaccine site but injection site pain at PNEUMVOVAX-23 site. 2. 9/15/17 Rash about 4-6 inches long with diameter of 2-3 inches (red, inflamed, and tender). 3. When patient flexed and extended arm she had arm pain.
Patient presented to the ED on 12/9/2021 with generalized weakness, respiratory failure and hypotension. He was intubated in the ED. Admitted into the ICU. Patient was severely septic 2ndary to COVID-19 pneumonia. Aggressively treated with IV antibiotics, IV steroids, and Vasopressors. Illness progressed and was complicated with progressive AKI on CKD, A. fib with RVR, and metabolic encephalopathy. On 12/24/2021, POA elected to pursue comfort cares. Patient was extubated and expired at 1643.
Extreme pain in all joints and some nerves, chills, and hot flashes beginning at 11;00 PM on 3/22/2021.  Treated with ibuprofen.
Site: Pain at Injection Site-Mild, Systemic: TINGLING SENSATION/ NUMBENESS-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: PT REPORTS SHE COULD NOT MAKE A FIST WITH HER LEFT ARM. TINGLING SENSATION/ NUMBNESS THIS STARTED 24 HOURS POST VACCINE AND LASTED FOR ABOUT 2-3 MINS
I had a syncope on Wednesday night with a nose bleed. I also had bleeding from the back up from my throat.  My family called 911  and at home the paramedics checked blood sugar, blood pressure and said everything looked ok.
Chest palpitations and tachycardia within 10 minutes of vaccine administration. Heart rate of 145 and sustained for about 15 minutes. Reported to medical staff at clinic site and vital signs were obtained.  Held for observation at clinic site and released once heart rate came down.
Pt became disoriented the evening after receiving the vaccine. He experienced a severe headache and was unable to walk. Parents were unable to rouse him, he could not speak. Parents called 911. Pt was taken to Hospital. Spinal tap was negative. Diagnosis of viral meningitis was given. Information from 60 day follow-up report states: you may consult with doctor's office where the immunization was given.
06 NOV, 0430: woke with 102.4 degF fever; chills; stiff, popping joints; muscle stiffness; swelling in right arm at injection site. Took Tylenol. Resolved until mid-day. 06 NOV, 1230: frequent irregular heartbeats for multiple hours. Resting seemed to resolve. 07 and 08 NOV: frequent irregular heartbeats for multiple hours in the late afternoon to evening. Resting seemed to resolve. 09 NOV, late afternoon: Lethargy/deep fatigue; Lots of palpitations, several to five in a row of skipped beats; Light headed; Feels like weight on chest; Short of breath; Slight blurring of vision; Indigestion/belching; Some confusion/felt slow(?)/ needed to take notes; Left wrist pulsing a bit. Called cardiologist on-call. Went to ER, as I happened to be down there. BP was151/94, P79 (usually <130/<80, P70). EKG indicated possible left atrial enlargement. Could not get Echocardiogram that night. 10 NOV, 1100: followed up with Cardiology. Did EKG and Echo. Showed no variation from last year, but did not have measurements to determine enlargement, only pressure across conduit.
Shortly after getting the GARDASIL shot patient c/o arm pain dizziness and sweating. Dr. checked him. He remained in the office for 30 min to be monitored. Then he went home.
Within 1/2 hour of shot breasts got sore and glands hurt. I took  1 Tylenol  3/25 and 1 on 3/26. One week later 4/1/2021 I had a visual migraine in my left eye while looking  at computer screen very intense  at near 2pm , 4/2 visual migraine (lighter shorter duration),  4/3 visual migraine 11 am  with 10 minute duration field much smaller. Visual migraine was followed by a mild headache.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  OBSTRUCTIVE SLEEP APNEA ACUTE PULMONARY EMBOLISM HYPOXEMIA
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted and fell within one minute of recieving the vaccine. EMS came and cleared the patient to go home.
This spontaneous report was received from a nurse concerning a multiple unspecified patients unknown ages and gender. Medical history and concurrent conditions were not reported. The reporter refers that multiple unspecified patients received MMR II that went through an unsupported temperature excursion on 20-NOV-2013 and another unsupported temperature excursion on 02-JAN-2014. No adverse effects reported. Additional information has been requested.
I had a low fever and achiness. Fever of 100 degrees. I started getting tired, I lost my sense of smell. The doctor gave me a Z-Pack, I took Mucinex, vitamin D, zinc, ibuprofen, Benadryl. It took me 2 months to test negative.
Myalgia, Fever, Diarrhea,  Fatigue Narrative:
tested positive for Covid-19 a week after the first dose of the vaccine; tested positive for Covid-19 a week after the first dose of the vaccine; This is a spontaneous report from a contactable Physician. A female patient of an unspecified age (reported as around 80 with no unit) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The caller was calling regarding a patient who tested positive for Covid-19 a week after the first dose of the vaccine. The reporter asked what the timing of the second dose was for someone who has active covid. The patient underwent lab tests and procedures which included Covid-19 test with a positive result. Outcome of the events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
About 2 hrs after receiving flu shot at medical center, patient developed wheezing and red, itchy eyes. This lasted about 2 hrs and cleared with antihistamine (next day).
22MAY96 recv vax t101 @ 2PM, crying more than usual;unable to console pt 5PM;PMD contacted advised APAP, cool baths;8PM t103;23MAY96 3AM t104.9, vomited x 3 while febrile;by PM 23MAY t98.6-100;24MAY96 runny nose
large local react; 3SEP93 f/u recovered; treated w/compresses, APAP, Advil;
I feel I have covid. High fever for 5 days, headache, sore throat, weakness, I couldn't eat because I feel my throat was closed.
8 hours post-injection: moderate arm soreness at injeciton site, mild headache 17 hours post-injection: moderate arm soreness, fever (100.6 F), chills, moderate-severe heache and body aches (lower back, legs), moderate fatigue, moderate dizziness, mild nausea Symptoms resolved completely 36 hours after injection.
Patient began to feel light headed, hot, and flushed.  Over the next few minutes, the patient began to start breathing rapidly and become short of breath.  Also, red blotches started to develop around her neck.  Epi 0.3 mg IM given along with diphenhydramine 50 mg orally.
pt recvd vax;fine rash,had fever 101.4;slept 10 hrs, more than usual;sore throat;saw MD & was on amoxicillin;
Information has been received from a RN concerning a 10 yr old white male with no known preexisting allergies, birth defects or medical conditions who on 25Apr96 was vaccinated in the arm with a first dose of varicella virus vaccine live (lot616997/1656B). There was no known illness at the time of vaccination. Concomitant therapy that day included a first dose of measles mumps rubella vaccine (lot 617129/1469B). On 24Feb06 the pt was noted to have 2 lesions, and following day was noted to have 30 lesions. No fever was noted. The lesions were red, and were noted to get a little blistery, but did not open. It was noted that some lesions just get a little darker in color. The lesions were mostly on the pt's back, chest, and arms and one lesion was noted on the pt's hip. No problems with itching were noted. No new lesions developed after 25Feb06. The pt recovered on 28Feb06. There were no relevant diagnostic tests or lab data. No additional information is expected.
PATIENT HAD PREVIOUSLY RECIEVED TWO DOSES OF  MRNA COVID VACCINE AND SUBSEQUENTLY ALSO RECIEVE A DOSE OF THE JANSSEN COVID VACCINE
Patient is a 74 y.o. female patient of MD with history of right 4th toe OM s/p right 4th toe amputation, essential HTN, gout presented to Hospital with "jitters."  On admission found to be febrile and testing positive for COVID-19.  During no time during hospitalization did she require supplemental oxygen.  Labs improved with fluid resuscitation.  She was initially placed on IV antibiotics which were able to be discontinued with negative infectious work-up.  She completed courses of p.o. antibiotics that she had been on outpatient while in the hospital.  With resolution of symptoms and feeling significantly improved she is to be discharged home with outpatient follow-up.  Restart home meds   Severe Sepsis COVID-19 infection Present on admission: yes Etiology: COVID 19 SIRS criteria: Temperature greater than 100.4 or less than 96.8, Heart rate greater than 90, WBC greater than 12,000, less than 4,000, or greater than 10% bands Initial lactic acid: 3.5-> 1.7 CTA pulmonary arteries, abd pelvis with - no PE; no other acute findings XR foot - no fracture, s/p amputation 4th toe, no bone destruction, no soft tissue gas Was on Keflex, Doxy, p.o. vancomycin prior to admission, completed antibiotic courses while inpatient Culture data: COVID 19 + (3/10), blood cxx NGTD ESR 20, CRP 33.8 ECHO 3/6/2023 - EF 62%, mild LVCH, mild MVR On admission eID consulted  Previous antibiotic courses completed while inpatient and no further signs of underlying bacterial infection.     Hyperglycemia, suspect reactive Glucose 123 Last HbA1c 2/23/2022 - 5.3% A1c 4.9   Hypertension, essential BP 109/55 Hold lisinopril in setting of sepsis   Hyperlipidemia Continue Crestor   Gout, stable Continue allopurinol   History of seizure Had witnessed seizure during recent hospitalization, evaluated by neurology with no indication for AED   Right 4th toe amputation due to 4th toe OM Seen by surgeon this AM 3/10/23 and per patient, was told wound looked good and no dressing changes until next appointment
First day of menstrual cycle has produced large clots and severe cramping. Normally my periods are light with zero cramps. I was in so pain today I was unable to work even after taking 1200mg of ibuprofen
patient received dose from expired vial/Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vial/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 029A21A and 042L20A) for COVID-19 vaccination.     Previously administered products included for Congestive heart failure: Bisoprolol (5 mg orally) on 23-Mar-2021; for an unreported indication: FLUZONE [INFLUENZA VACCINE] (Sanofi vaccine, Batch no:UJ704AA and intramuscularly on right deltoid) on 30-Sep-2021. Concurrent medical conditions included Asthma on 20-Mar-2018, COPD on 20-Mar-2018, Coronary artery disease on 08-Feb-2015, Heart failure on 08-Jul-2018, Obesity on 08-Apr-2015 and Peripheral vascular disease on 12-Apr-2021. Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) from 19-Nov-2015 to an unknown date for Depression, ATORVASTATIN CALCIUM (LIPITOR) from 07-Sep-2019 to an unknown date for High cholesterol, LISINOPRIL from 25-Apr-2015 to an unknown date for Hypertension, DABIGATRAN ETEXILATE MESILATE (PRADAXA) from 08-Feb-1018 to an unknown date for Stent placement.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vial/Dose administered after 30-day Use By Date or after manufacturer date of expiry). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vial/Dose administered after 30-day Use By Date or after manufacturer date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vial/Dose administered after 30-day Use By Date or after manufacturer date of expiry) to be not related.    Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Significant follow up received on 29-Oct-21 :- reporter HCP details, relevant history, concomitant medications and narrative updated.
Recieved booster shot. Pt reported no ade's after first 2. That evening after getting the shot she reported she started being sore. All next day she was in increasingly intense pain, to the point where she was taken to the ER by her boyfriend and monitored with pain management for a few hours that Friday or Saturday. Hospital told her to put this as a new allergy for her. Pt stated it felt like she was dying, worse than the back pain she has ever felt, even after her back surgeries. Didn't feel back to normal until Monday.
When I woke up, I seen hives on the back of my legs, and they were on my chest and big hives on my back. They were on my arms. I had hives on my belly and my face.  It was itching really bad at night on 22MAR23. I took Benadryl. The doctor gave me a shot of Benadryl 25mg. They also gave me a proscription of Hydroxy me- Syrup 10mg; Famotidine 20mg; Claritin 10mg. 24MAR23 the doctor gave me a shot of Benadryl. 30mg and a shot of  Epinefrina 0.2mg.
HEADACHE; MILD FEVER (98F OR 99F); MUSCLE ACHE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included hepatitis b, and other pre-existing medical conditions included no known drug allergies and drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 16-MAR-2021 15:00 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced muscle ache. On 17-MAR-2021 23:00, the subject experienced headache. On 17-MAR-2021 23:00, the subject experienced mild fever (98f or 99f). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 98 or 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, mild fever (98f or 99f), and muscle ache on 19-MAR-2021. This report was non-serious.
Client received 2nd COVID vaccine of Moderna (Lot# 021C21A expiration 05/26/21). Client has already completed 30 minutes of observation. At 1800, Client reported to EMT a tightness in her throat and vitals are blood pressure 159/99, heart rate 88, oxygen saturation 97%. At 1801, RN responded to this event. After taking the first set of viral signs, Client states the tightness in her throat has passed and is no longer there. Client reports that her heart was racing when her throat felt tight. Client reports a history of anxiety, takes Xanax as needed, with no known allergies. At 1810, vital signs are blood pressure 169/97, heart rate 88, oxygen saturation 99%. Client reports no chest pain, no tightness in the throat, no headache, no blurred vision, no nausea. RN educated Client about ED precautions and common adverse effects of COVID vaccine. Client was offered supplemental nutrition and fluids. Client accepted fluids, but denied nutrition. At 1818, vital signs are blood pressure 166/90, heart rate 92, oxygen saturation 98%. Blood pressure was taken with an automatic cuff, after this point a manual cuff was used. At 1820, blood pressure is 138/88. Client reports no changes to her symptoms. At 1827, vital signs are blood pressure 122/82, heart rate 97, oxygen saturation 99%. Client reports light headache and reports that she saw white spots when initially entering the observation area but has since subsided. At 1828, left facility with resolved symptoms and with a steady gait. Upon walking out of facility, Client had concerns about adverse effect, PHN reviewed ED precautions, educated about common adverse effects and clarified any questions.
Pt received FLUVIRIN immunization on 9/24/10 (FLUVIRIN Novartis 2010-11 formula lot 111808P1 expiration 4/30/10). Pt came back 9/25/10 with mildly red left upper arm. Pt was advised to see MD fu, possible infection. MD prescribed antibiotic for possible skin infection.
Swelling, redness, pain at injection site, warm to touch, extremely tender and sore. Increased breathing difficulty, fever, fatigue,
Left upper arm red, swollen, achy, hot, and itching. Took BENADRYL without relief. Reported to HD on 12/21/2016 and was referred to PHP. Saw Dr. on 12/22/2016. Received "steroid shot" and prescribed "2 antibiotics".
Woke up on the morning of July 6 and felt  big lumps under my arm pits then noticed them on my neck and now as time goes by more are appearing all over me 3 months dealing with this 3 doctors been to nobody now's nothing unreal that this happening to me
I was having chest pain a few days after the vaccine. It went on for days and then one day in the grocery store I started to feel dizzy. I had the chest pain and dizziness for about a week. The chest pain/ pressure is still there but luckily haven't been getting dizzy anymore.