chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vials were initially stored in refrigerator on 22-Aug-2022 and adminsitered on 23-Sep-2022; No adverse event; Received expired  Monovalent vaccine after 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 22-Aug-2022 and adminsitered on 23-Sep-2022) and NO ADVERSE EVENT (No adverse event) in an 11-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2022 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 23-Sep-2022 at 4:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 22-Aug-2022 and adminsitered on 23-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 22-Aug-2022 and adminsitered on 23-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date) and PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 22-Aug-2022 and adminsitered on 23-Sep-2022).    No concomitant medication was reported.  It was reported that vaccine coordinator was calling to report that some patients (Adults and Pediatrics) received expired Moderna COVID-19 vaccine after 30 day beyond use date (22-Sep-2022).  There were unbroken cartons. Vial size for 6 months to 5 year patient was 2.5 milliliter and for adults 5.5 milliliter. The vial was initially stored in the refrigerator on 22-Aug-2022. The patient given vaccine after BUD date. Vials were initially stored in refrigerator on 22-Aug-2022.  The vial did not undergo any temperature excursions.  No treatment medication was reported.
client complained of lightheadedness . feeling like she "couldnt breathe." Also states feeling  numbness to left arm that radiates to chest and up to neck  Client reports history of panic attacks. Seen by NP: Vitals obtained : o2sat at 157pm o2sat 98% HR 88, 207pm o2sat 99% HR 87, 221pm o2sat 99% and HR 81. Client left site after over 30 mins in observation, reported feeling better her sister at her side.
Febrile seizure. 8/21/09 ERrecords received for DOS 7/17/09 with dx:  Acute fever and seizures recurrent. Generalized tonic-clonic seizures following vaccinations. Pt presented several hours after receiving vax, with fever and several episodes of tonic-clonic activity.  HR 180's. RR 30's. T' 101.6'F. No further seizures with meds and reduction of fever.  8/31/09 ICD-9 Code: 780.31 Febrile seizures (simple) unspecified.
Cystic, painful lumps in random areas of body, filling with serosanguinous fluid, forming a blister.  Once it opens and bleeds, it leaves a scar of discolored skin.  I have had 5 so far.  I have never in my life experienced anything like this. This started about 6 months after second dose of vaccine.
Patient came to clinic today and requested a third dose of covid vaccine. He stated that he had received two doses of Pfizer vaccine earlier in 2021. The Medical Assistant was not able to validate the previous covid vaccines received via database and she elected to proceed with the third dose. When the patient produced his vaccination card for the MA she realized that he had received Moderna previously (not Pfizer)
Information has been received from a physician concerning a 6-month-old patient who was vaccinated with the second dose of Rotateq. It was unknown if medical attention was sought. No adverse experience was reported. Additional information has been requested.
Patient developed itchy eyes and neck rash 24 to 48 hours after receiving the vaccine. Patient instructed to take OTC Benadryl.
I developed vertigo a week after receiving vaccine.  Had a second instance a week later.  Vertigo developed again within a week after receiving second dose of vaccine and I had a second instance two days after the first .
Sever skin rash, blemishes with itching and stinging all over hands fingers and feet.
2 days p/vax 29JUL96 in lt deltoid area there was swelling measuring 3" long x 4" wide, red & hot to the touch;pt was advised to use cold compress & take APAP;
Pain and burning immediately following vaccine. Fever in area at times. Up until the present time there is pain and burning over my body. X-ray, MRI, EMG, therapy, etc. Pain management is what I am doing now which still does not work. Steroids, cortisone, patches. I have tried them all. The Dr. want to block the nerve (nerve damage). Discussing acupuncture.
Roughly 7 days after receiving my first Covid shot, I have a 2? x 1? welt on the injection site. It began by itching and it is now, 10 hours later, swollen and warm to the touch and sore.
She had a breakout of herpes; This is a spontaneous report from a non-contactable consumer (patient's husband) via Pfizer-sponsored program Support. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in left arm on 19Jan2021 at 13:00 (at the age of 70-years-old) as dose 1, single for COVID-19 immunisation. Medical history included thyroid cancer from 2009 to an unknown date and herpes. Concomitant medication(s) included levothyroxine sodium (TIROSINT) taken for thyroid cancer from unspecified date of 2009 to ongoing (She takes Tirosint, which was Synthroid. She has not been on this pill but she has been on this hormone for 11 years, since 2009). No additional vaccines were administered on same date of the Pfizer suspect. No other vaccinations were administered within four weeks prior to the first administration date of the suspect vaccine. On 21Jan2021 late afternoon or early morning (2 days after the first shot), the patient had a breakout of herpes. 4 doctors said it was from the shot. She inquired with 4 doctors and they told her that the herpes breakout, which lasted for 6 weeks and needed medical treatment, was probably caused by a reaction from the Pfizer shot. She was scheduled to get the second dose of the Pfizer COVID-19 vaccine 3 weeks after the first dose but missed second dose because of the breakout. She previously had herpes, but she did not had an outbreak in 35 years and that was concerning. The event did not require a visit to emergency room or physician office. Therapeutic measures were taken as a result of the event. The patient mentioned that 2 of her friends got shingles after the second shot and did not want to take it. The one was still dealing with it 11 weeks later. Family medical history relevant to adverse event was none. Relevant tests were none. The outcome of the event was resolved on an unspecified date.  No follow up attempts are possible; information about lot number/batch number cannot be obtained.
Swelling and a lump at the shot site. was sore for quite a few days. Turned black and blue
Patient says she has been experiencing worsening arm pain. Starting from when she received the vaccine. She has tried taking BENADRYL and ADVIL, neither really help.
Patients wife approached the pharmacy 4.5 weeks after immunization and said that he has a frozen shoulder after the flu shot administration. Patient can move his arm forward but not backwards and the injection site and arm are sore and painful. PCP office has been contacted and awaiting PCP response since he also takes some cholesterol medications/statins which can cause muscle pain/rhabdomyolysis but since this episode was triggered post- flu shot- reporting to VAERS. Pharmacy advised patient to follow up with PCP and left message with MD office as well to call back and suggest course of action for the patient.
Given dose five days premature from 21 day recommendation. No adverse reaction or injury reported at time of occurrence.
No adverse reaction.  Pt was given a dose of covid vaccine that was past the beyond use date.  Parent was notified and given CDC recommendations but opted to not re-vaccinate at this time.
Next day post vax, the pt woke up in the middle of the night with pain and swelling in the left arm. Pt was seen by physician for worsening of his symptoms. Induration was 10 cm in diameter. Pt also complained of having pruritus. Pt was treated with ice compression and Motrin.
Pt. has red, warm, raised area approx. 4 cm x 6 cm circumference at injection site (posterior RUA).
A 44 yr old male with c/o feeling dizzyness and peri oral numbness in mouth 2 minutes s/p COVID Bivalent vaccine while seeing provider. HCT RN to bedside. Pt semi fowlers. VSS. Elevated diastolic on first BP and then elevated systolic and diastolic on repeat BP. See Nurse vitals. Dr. notified. Pt states he is feeling better within minutes. Assisted to sitting position and then to standing with minimal assistance. Tolerated well. Pt states Im feeling much better now. Pt has no further questions or concerns at this time and is in approval with the plan of care. Completed by: RN, April 20, 2023, 10:49 AM
Vaccine administered 10/1/22 with expiration date of 9/30/22.  No adverse event  observed or reported by patient.
4 1/2cm induration arm; Tylenol for discomfort prn.
Patient describes Soreness at injection site, later experienced body aches, headache, fever that is rising and hoarseness in voice
BLOOD PRESSURE     Pt reports "SBP was 235 at dialysis this morning and my blood sugar was so high they couldnt get a reading they told me to come here instead."     Patient is a 44y.o. male with past medical history of CVA, hypertension, diabetes mellitus, ESRD on HD who presents to the emergency department for evaluation of hyperglycemia and elevated blood pressure..  Patient typically receives dialysis Monday, Wednesday, Friday.  He presented to dialysis this morning and was told that his pressure was too high, 235/100s and was sent to the emergency department.  He was also told that his blood sugar was high.  He reports he has been compliant with his insulin.  He states he feels somewhat shaky this morning, denies other symptoms.  Denies any headaches or vision changes.  Denies any weakness or numbness.  No chest pain or difficulty breathing.  No abdominal pain, vomiting, diarrhea.  No urinary complaints.  He does report a history of COVID-19 infection approximately 5 weeks ago for which he did test positive and was symptomatic at that time.  He has no COVID-19 symptoms today.   Review of Systems  Constitutional: Negative for chills and fever.  HENT: Negative for sore throat.   Eyes: Negative for visual disturbance.  Respiratory: Negative for cough and shortness of breath.   Cardiovascular: Negative for chest pain and palpitations.  Gastrointestinal: Negative for abdominal pain, nausea and vomiting.  Genitourinary: Negative for difficulty urinating and dysuria.  Musculoskeletal: Negative for arthralgias and myalgias.  Skin: Negative for rash.  Neurological: Negative for weakness and numbness.  Psychiatric/Behavioral: Negative for confusion.
Swollen arm with redness and rash Swollen face, throat, feet, hands, flushing  Shortness of breath
Information has been received from a registered nurse concerning a mid thirties old female patient with no pertinent medical history and no known allergies who on 12-NOV-2008 was vaccinated intradermally (lot # 659199/1541U). There was no concomitant medication. On 14-NOV-2008 the patient experienced soreness, swelling and erythema at the injection site. No lab diagnostics studies were performed. The patient's sought unspecified medical attention. No further information is available.
Headache, muscle ache, tired, injection site red and hot and swollen, fatigued, chills, fever, stomach pain and nausea.  All of them that were listed! ugh Took some Tylenol and rested, next day had a dizzy spell and threw up in the morning and the rest of the symptoms all day. Towards evening  I started to feel more energy and still had headache and stomach ache. Next day a little fatigued and sore arm still.
pt recvd DTP/OPV on 6APR92 & that evening, pt cried for approx 4 hrs & devel erythema @ inject site; ice packs & APAP recommended for tx; not seen by MD;
On 8/17/09 on right arm injection site developed a rectangular red, slightly raised area 1" X 2".  The area itches and is warm to touch.  Advised to consult with PMD.
3/13/13 initial headache and "air hunger", VS within normal limits, BP decreased at 1015 when assessed by RN, 1100 took BENADRYL. Nausea, gut ache, weakness set in by 1830, profound weakness neck down and fatigue, pain. 3/14/13 vomited, no food in AM, increased weakness, fatigue, weak from neck down, pain. BENADRYL and TYLENOL 1000mg around the clock. 3/15/13 fatigue/weakness/air hunger/chest tight, went to urgent care 1015 AM. Prednisone - symptoms improved slightly with prednisone, had hives. 3/16/13 hives/flushing, tight chest, increased prednisone 80mg, urgent care 3/17, 3/18 and ongoing medical care to date (3/30 stiff neck, abnormal vaginal bleeding). 3/17/13 severe arm/shoulder pain cont. to present.
10 minutes post injection, sudden of burning sensation at site of injection.  Slowly spread to chest and lower body area.  "Feels similar to taking a shot of whiskey".  Subsided after 10 minutes.  No SOB or other cardiac symptoms.  Improved after lying down and drinking cold water.  Shorter episode of flushing 15 minutes after first episode.  Subsided within 5 minutes.
Discharge Provider: MD Primary Care Provider: NP Admission Date: 2/21/2023 Discharge Date: Feb 26, 2023 PRESENTING PROBLEM: Hypoxia [R09.02] Pneumonia of both lower lobes due to infectious organism [J18.9] Pneumonia, unspecified organism [J18.9]   HOSPITAL COURSE: Patient is a 42-year-old man with past medical history significant for chronic obstructive pulmonary disease on chronic oxygen at 2 liters/minute, cavitary lung lesions, primary ciliary dyskinesia who presented with shortness of breath and hypoxia at home.  Found to be hypoxic on presentation to the hospital requiring increased O2 supplemental needs.  Admitted initially due to concern for chronic obstructive pulmonary disease exacerbation and concern for bilateral lower lobe pneumonia with possible bronchiectasis exacerbation. Started on IV Solu-Medrol, vancomycin, cefepime and azithromycin which was continued from home.  DuoNebs were also initiated.  Urinary pneumococcal and Legionella antigen were negative. Patient was seen by wanted to exclude fungal infection or mycobacterial infection.  They performed a bronchoscopic evaluation on 02/23 with BAL fluid sent for various cultures.  MRSA screen was negative vancomycin as well as azithromycin were discontinued.  Patient was continued on IV cefepime throughout hospitalization.  Initial COVID-19 PCR on admission was negative but subsequent respiratory film array was positive for COVID-19.  Patient was started on remdesivir as well as scaling back on IV Solu-Medrol 2 times a day.  Sputum cultures as well as BAL cultures were positive for Pseudomonas aeruginosa resistant to cefepime.  Of note pretty much since the beginning the admission, patient appeared to be close to his normal baseline from a respiratory standpoint.  He was back on 3 liters/minute on day 2 though he started to have cough at that time.  Given likely hypoxia due to COVID-19 given patient appeared improved while on in adequate treatment IV cefepime for resistant Pseudomonas.  Discussed with pulmonology who recommended stopping steroids, remdesivir given his current clinical status at discharge but continuing antibiotics to decrease Pseudomonas colonization.  Patient was discharged on 5 days of ciprofloxacin.  Patient was discharged home in medically stable condition.
About 8 hours after the shot, the fever started; body aches; 103 temperature and really bad headache (worst I have ever had). It lasted two days straight (the symptoms) and the third day I felt okay. I had arm pain and swollen and very sore. Then I didn't have anything except off and on waves of fatigue that would come and go every couple of weeks. I could tell something was different. I almost felt like I was getting sick but didn't get sick - that beginning feeling of getting sick. July, I started having issues with my breathing. I started having swallowing difficulties and then by August, I started having a cough that doesn't go away. The only way I can make it go away is that if I lay down and my heart rate goes down. My lungs sound good. I am waiting to see a new pulmonologist (my other one has moved). The lungs sound good though so they aren't sure what it is. I have never experienced anything like this before. My normal asthma is induced by sickness or exercise and this is different. I can't walk very far right now.
Healthy child that came to the clinic for covid/booster vaccine. No sign or symptoms after the vaccine. Other siblings got the vaccine and family was in the clinic for over an hour and did not notice/reported any side effect of the vaccine
Itchy rash over most of body, looked like chickenpox. Had to seek treatment and was put on was prednisone 5 days later after covid 19 shot.  Rash is clearing up after treatment with prednisone.  Have not had 2nd shot yet.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not provided. On 27-JAN-2016, patient was vaccinated with PNEUMOVAX 23 (lot# and expiry date was not provided) and another dose was received on 29-JAN-2016. No adverse effects reported. No information on concomitant medication was provided. No further information was provided. No product quality complaint (PQC) was involved. Additional information has been requested.
Pt given vaccine at 1130. Has hx of SVT and inappropriate tachycardia. 1131 pt c/o   metallic taste. 1140 pt c/o increased HR and numbness in lips and mouth. No c/o SOB, dizziness, or   nausea. 1140 HR 130s. numbness in lips and mouth   1150 HR 110-115. decreased numbness in lips and mouth1200 HR 114 BP 103/83 100% O2   1205 HR 113 100% O2; MD called to bedside for Pt numbness of mouth and tongue subsided. HR back to 100-110. Cleared to leave clinic. Nurse provided assessment.
Case number PHEH2014US015696 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 11 year old patient of an unspecified gender. The past medical history and concomitant medications of the patients were not reported. On 29 Jul 2014, the patient was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) at a dose of 0.5 ml intramuscularly which had multiple temperature excursions while in storage. The temperature of the vaccine reached a maximum of 47.5 F for one hour and 17 minutes on 18 Jul 2014, a maximum of 47.5 F for 42 minutes on 21 Jul 2014, a maximum of 47.5 for one hour and three minutes on 24 Jul 2014 and a maximum of 47.5 for one hour and three minutes on 31 Jul 2014. No adverse events were reported following this maladministration.
nodular eruption rectangular pattern of distribution 3-4cm wide x 10cm long pruritic & onset w/in 48hr of vax;pt was seen in clinic 23SEP97 5 days p/vax 3OCT97;desquamation @ site remains;
405PM HIB #4 given 410PM MMR given began 1-2min p/MMR w/facial & upper body flushing began walking across sreet to hosp ER pt began w/sl facial edema on trip to ER;
Shingles on right breast; Headache; Trouble focusing eyes; This spontaneous case was reported by a nurse and describes the occurrence of VISUAL IMPAIRMENT (Trouble focusing eyes), HERPES ZOSTER (Shingles on right breast) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (Trouble focusing eyes), HERPES ZOSTER (Shingles on right breast) and HEADACHE (Headache). At the time of the report, VISUAL IMPAIRMENT (Trouble focusing eyes) and HEADACHE (Headache) had resolved and HERPES ZOSTER (Shingles on right breast) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient went to urgent care on 21-Apr-2021 after developing shingles on the right breast on an unknown date. The patient was prescribed valacyclovir 1 gram three times a day.   This case was linked to MOD-2021-089181 (Patient Link).
Irritation and sleeping began after the first shot in March. Second shot has seen two hospital ER visits (4.20.21;      2-week mark and again at Medical Center on 4.7.21-4.8.21. MRI, blood tests on file. These visits were due to severe migraine, intractable vomiting, dehydration from vomiting and profuse sweating, chills, heart palpitations, headache, light/sound/smell/touch sensitivity, high blood pressure, dizziness, disorientation, language aura, leg "seizure", faintness, visual aura, cognitive impairment. Many of these symptoms continue. I am unable to drive or work at a computer for more than 30 minutes at a time. This form is difficult for me to complete and I have no help.
Pt recv vax 24Dec97. 09Jan98 Pt exp rash, 17 lesions, fever,sore throat & chills. 08Jan98 Pt exp chills,neck pain, sore throat & a few chickenpox lesions. Recovered 12Jan98.
Cannot stay asleep. Waking up every 2 hours with vivid nightmares for 5 straight days and counting. Feeling terrible every 2 hours I wake up like an alarm bell during middle of REM sleep or taking a 2 hour nap in the afternoon.
A non-serious spontaneous report of administration of expired product to a 52-year-old was received from a Nurse concerning a 52-year-old female. The patient's medical history and concomitant medications were not reported. On 22-Dec-2008, the patient received expired FLUMIST (expiration date 21-Dec-2008). The reporter inquired about dosing with expired product and information in patient over 49 years of age. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
The patient reported that she received an injection of 1997-1998 formula influenza virus vaccine (manufacturer unknown) in 1997 and subsequently developed shingles. The patient recovered.
Headache, Myalgia, Fever, NauseaVomiting, Chills, FACIAL FLUSHING Narrative:
Started having a sore throat and cough. Took the Home COVID-19 test and was positive. Started taking a lot of herbs and supplements and felt better a week later.
The vaccine was given in the deltoid tendon/shoulder bursa area NOT in the deltoid muscle.