chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pharmacist confirms no symptomatic events or side effects reported. No additional AE/No PQC. / No adverse event known; VARIVAX Temperature Excursion. Improperly stored VARIVAX was administered; Varivax # of previous doses: 2; This spontaneous report was received from a pharmacist concerning a 11-year-old female.  The patient's concurrent conditions and concomitant therapies were not reported. Pre-existing physician-diagnosed allergies, birth defects or medical conditions were none known.  On 22-JUN-2023, the patient received the third dose (number of previous doses: 2) of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) with lot #W012165 and expiration date on 12-APR-2024, administered subcutaneously (SC) in the left arm for prophylaxis (Extra dose administered). The vaccine was administered by the healthcare professional at a pharmacy, and it was purchased with private funds. It was unknown if there was illness at the time of vaccination.  On unspecified dates, three separate temperature excursions occurred: one up to 12.092 degrees Fahrenheit (F) for 6 hours and 15 minutes, the second up to 13.6 F for 2 hours and 30 minutes, and the third up to 12.1 F for 1 hour, 45 minutes and 5 seconds. The temperature excursions occurred as a result of a reading from a Digital Data logger.    No adverse events were known.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA011966: US-009507513-2307USA000909: US-009507513-2307USA011965:
Patient had pain and mild tenderness at injection site evening of getting flu shot; 30 days later pain returned and patient cannot sleep well.
Dec 23 received booster 6:30pm Chills about an hour after, body aches, pain at injection site, extreme fatigue, mild pain in armpit of left arm  Dec 24 Muscle aches, painful swelling in armpit; could not comfortably lay arm against sides.  Dec 25 Very painful swelling in armpit; could not comfortably lay arm against side. 25/24 were the worst days.   Dec 26 Swollen lymph nodes. A small cluster of nodes were visible on the inside of my arm when I woke up. Went away within a couple hours. Shoulder/neck pain, causing blurred vision and headache  Dec 27 Swelling has gone down but armpit still tender Ocular migraine (with aura) 6:20pm. Have only ever had an aura with my migraines once before on Aug 28th. Saw an eye doctor and my vision is fine.  Shoulder/neck pain. Blurred vision  Dec 30 Saw doctor as a precautionary measure. Was told the lymph nodes might not go down for six weeks. Ocular/aura migraine might or might not be related Shoulder/neck pain, causing blurred vision and headache  Jan 7 Person in the household was exposed to covid Ribs hurt immensely and muscle aches. Stress? Shoulder/neck pain, causing blurred vision and headache  Jan 9 Got covid test. Shoulder/neck pain, causing blurred vision and headache  Jan 10 Odd left armpit pain again out of nowhere. Not swollen but tender and uncomfortable in the same area. Shoulder/neck pain  Jan 10 Shoulder/neck pain. No headache really, but exedrin seems to improve the shoulder/neck pain. It is the first and constant thing to come back however when the medicine wears off.  Jan 12 Received results from covid test and it came back negative. Still suffering from neck/shoulder pain
Hives, itching, warmth on bilateral face and neck and chest. Tachycardia. Facial swelling.
Drainage, scratchy throat and tiredness within 4 hours of receiving the vaccine. Both have continued through the night and are still ongoing as I report. Had no signs or symptoms prior to vaccine.
The next morning it was (left upper arm) red and swollen about 8" band around the arm, hot to the touch, very sore and painful, this condition lasted 4-5 days. No systemic symptoms.
Pt received influenza vaccine and  a "pneumonia" vaccine at physicians office. Pt had localized skin reaction, vomiting, and hives for 4 days afterwards. Both vaccines placed in same arm, unable to determine which vaccine caused reaction, but pt states every time she receives a flu vaccine it makes her ill.
Patient received vaccines beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccines beyond use date after the thaw process) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     It was unknown whether the patient was diagnosed or tested positive for covid-19.  Acute illness at the time of vaccination and up to one month before was not known.  Chronic and long-standing health conditions were unknown.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccines beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccines beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  Patient age was reported has 57 years 1 month.  The patient got Moderna with vaccine Ndc code 80777027399.  The medical team notified of an audit that was done which made aware that some vaccines were administered beyond use date after the thaw process.  There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  Treatment details were not given.   This case was linked to MOD-2022-542869 (Patient Link).
I first had symptoms on 02/20/2023. That was a Saturday, I had sore throat that worsened into laryngitis. I had a severe dry cough it was very active. I would say it was a week later I developed conjunctivitis. It became extreme as far as I?m concerned. I went to the clinic and saw a RN on the Monday the 22nd, for the sore throat I got a COVID-19 test. It came back as negative. The symptoms of cough and sore throat, I had was given a prescription for a cough suppressant Benzonatate. I was having the symptoms for about four weeks. The middle of the week my conjunctivitis gotten worse by the 26th, it was itching I went to urgent care.  There I saw a NP; she prescribed eye drops for that. They were basically for symptomatic relief. I feel fine, but I still have occasional bout of coughing and laryngitis that?s episodic.
Received a call from patient stating that after thirty minutes of receiving Rabies vaccination patient began to experience Itchy swollen throat, numbness of her lips, body chills, and feeling weak. Patient stated that she contacted her primary Doctor and was told to go to ER Department. Patient stated that once in the ER Department they gave her IV fluids, and an EPI pen administered to patient.
Admitted 07/24/07/27 for weakness in legs, found to have O2 sat of 50% on room air. COVID test positive on 7/24 and pt diagnosed with acute hypoxemic respiratory failure due to COVID-19 . She was also found to be in acute renal failure. Pt was intubated, placed on vent and started on CRRT. She received Moderna vaccine, 2nd dose on May 15, 2021.  On admission, pt denied  any shortness of breath, body aches, headache, fever or chills. Patient condition deteriorated. was made comfort care on 7/27 and expired 7/27/21.
Fever 100.5, High Blood Sugar sudden Drop to Low, Fatigue, Feet Stabbing Pain
10/22/2021Elevated temp of 102.0 . Treated with Tylenol 500 mg. Effective.  10/25/2021 Scattered red rash noted on lower right extremity. Order received for Hydrocortisone cream 2.5%  2 times a day for 10 days. Effective. Benadryl Allergy Capsule 25 mg ordered this date. Effective. Seen by Nurse Practitioner. 10/27/2021 Physician in house visit. Resident complains of right neck, arm and right shoulder pain however is able to move extremity. MD note " Impression is reaction to COVID vaccine".  Order received to start Prednisone 20 mg 1 tablet 2 times a day for three days.
The 5 year old male was given both above vaccines above on the same day at the same time.  Currently no adverse effect.
Body aches, fever up to 102.  Extreme fatigue, upper respiratory symptoms.  Cough, congestion, sore throat still ongoing.  Two days of total laryngitis.  Difficulty breathing.  Swollen glands.  Also, local reaction on arm-pain, swelling and itching.
This case was reported by a consumer via sales rep and described the occurrence of rash in a 71-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included Baby Aspirin. On 9th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th May 2018, 6 hrs after receiving SHINGRIX, the patient experienced rash. The patient was treated with BENADRYL Spray. On 12th May 2018, the outcome of the rash was recovered/resolved. The reporter considered the rash to be almost certainly related to SHINGRIX. Additional information was received as follows: This case was previously reported to a physician. Concomitant products included COCOAVIA supplement. The patient received the SHINGRIX vaccine on the left arm. After about 6 hours of vaccination, the patient experienced rash which begun on the inside of the forearms and spread to the chest and abdomen. The patient applied a spray of BENADRYL on the rash and noticed improvement after 1 day and complete resolution after 3 days. The patient stated that, he was very impressed with the GlaxoSmithKline's response and patience in dealing with a question asked about the SHINGRIX vaccine who gave the best possible advice.
Hives began on December 11th at night. 10 days after receiving Moderna booster shot, after 2 previous Moderna vaccines in March and April 2021. Changed body wash, soap, locations, diet, animal, laundry detergent, and have no progress except for benadryl.
Patient reported swelling from shoulder down to elbow and tenderness up into neck that started the evening of 1/11/17. Advised that patient be assessed in urgent care that evening however he chose not to be seen.
Feels likes a burning sensation to the spine/It feel like burning is on the skin and there is nothing there; chills; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Feels likes a burning sensation to the spine/It feel like burning is on the skin and there is nothing there) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-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 BURNING SENSATION (Feels likes a burning sensation to the spine/It feel like burning is on the skin and there is nothing there) and CHILLS (chills). At the time of the report, BURNING SENSATION (Feels likes a burning sensation to the spine/It feel like burning is on the skin and there is nothing there) and CHILLS (chills) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 53-year-old female patient who received SHINGRIX. In April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema, redness, exhaustion and malaise. In April 2018, the outcome of the injection site erythema, redness, exhaustion and malaise were recovered/resolved. It was unknown if the reporter considered the injection site erythema, redness, exhaustion and malaise to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the week of 16th to 20th April 2018. The patient experienced redness from injection site that included an expanded area into chest area. Extreme exhaustion, malaise that lasted for 2 to 3 days.
Got the vaccine and waited the 15 minutes per their recommendations, and while driving her car home within 10 minutes felt that her face, bridge of her nose and spreading into her cheeks became numb and tingling.  Then the lower part of her face, spreading down into her windpipe and clavicle area, then her  (outer 2 toes on each foot, pinky and next finger) started to get numb and tingly, as well as the upper lip.  As the day wore on that evening the feeling went to the either side of her spine, the numbness and tingling.  She waited to see if it dissipated, and called her doctor on Monday 3/15/21 and saw a PA who felt that she may have upset her whole nerve system and told her that it was going to take a while for it to straighten out.  She consulted with her PCP and gave her some samples of Horizant, but she did not try it as she has multiple allergies to medications.   She also from the time of her vaccine that she started to get horrible burning and tingling throughout her body everywhere, (arms, stomach) woke her up from sleep.   The other symptoms previously mentioned continued as well.  On Wednesday 3/17/21, called her cardiologist who told her to call the hospital and perhaps go to the hospital and they told her to call her doctor.  The cardiologist told her she needed to see a neurologist who she saw on 3/31/21.  The patient was afraid she had Guillain Barre syndrome, and the neurologist felt that if that was the case and that she would not have been able to walk at this point.  She did the neurologic testing, and she was going to give her Gabapentin (which she had already been given samples of and did not want to take).  The burning and tightness of her face down to her throat/clavicle area was concerning to her and still continues.  Her conclusion was that if she got worse to go to the hospital, and the basically do not know what to do.  She herself is wanting to know if this is going to disappear, and what are the long-term affects.  She is now hesitant to have her eyes dilated, is scheduled for some procedures and afraid to have them done as it has been 5 weeks since the vaccine and still having the same reactions, and does not know what she should do.    Since the vaccine the worst is in the morning, and residual in the face/burning of her face to throat/clavicle, and also continues with the burning in her spine as well.  The burning is not as bad as it was, but the face, throat/clavicle area is the worst.
Mild itching on upper left arm about 6 days after Moderna 1st shot on Thursday, March 18.  On  Saturday, March 27, redness can be seen on upper left arm and mild itching continues.
Had vaccines on 11/11, temp 100 "tympanic on 11/12 temp 104.9 tympanic 11/12 with decrease appetite increase fluid intake good, hydrated. Seen 11/15, labs ordered CBC,CMP, direct bili, blood culture. Monday 11/14, temp 104.5, 11/15 at home T-103.4, decease 101.8 when see 11/15.
patient noted no sx for 2 months after vaccination- just hyperpigmented scar at site of injection right upper arm- approx 3 days ago noted darkening of site and then pain with erythema- extending approx 2cm- neg exam for joint/shoulder pain
18 month old male patient received dose of Quadracel, no AE; Initial information received on 29-Jan-2021 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 months old female patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (product administered to patient of inappropriate age).  Past vaccination included Pentavac on 28-OCT-2020.  Medical history, medical treatment, concomitant medication and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 06-Jan-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5635AA and expiry date: 21-Jan-2021) via an intramuscular route in the right vastus lateralis for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (same day latency).  It was also reported that the nurse states that an 18 month old received Quadracel in error and she would like to know what they need to do for the patient. Additional Description of event adverse events. She said she was trying to do their counts and that is when she realized the patient was not the right age to have received Quadracel. She states that they were catching the patient up on vaccines. She states that she has not heard a thing from the parents and that they have not reported any adverse event information. She states that they have standing orders from Doctor. This is all the information she provided at the time of her call. Reporter relationship: HCP (health care professional).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored ROTATEQ (lot: M044395: expiry date: 31-MAY-2018) (incorrect product storage). The vaccine was stored at 32F to 35F for 15 hours. No adverse effects were reported.  There was no prior temperature excursions. This is one of the three reports received from the same reporter. Additional information has been requested.
bones hurt; takes all of my energy to get up; had a rough night.; fatigued; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bones hurt), ASTHENIA (takes all of my energy to get up), SLEEP DISORDER (had a rough night.), FATIGUE (fatigued) and HEADACHE (severe headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BONE PAIN (bones hurt), ASTHENIA (takes all of my energy to get up), SLEEP DISORDER (had a rough night.), FATIGUE (fatigued) and HEADACHE (severe headache). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, BONE PAIN (bones hurt), ASTHENIA (takes all of my energy to get up), SLEEP DISORDER (had a rough night.), FATIGUE (fatigued) and HEADACHE (severe headache) outcome was unknown.            No concomitant product was reported by the reporter  Treatment medication included Aspirin   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: TCR / NNI
Sick; Dont feel well; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st August 2021, the patient received the 1st dose of Shingles vaccine. On 22nd August 2021, 1 days after receiving Shingles vaccine, the patient experienced sickness and feeling unwell. On an unknown date, the outcome of the sickness and feeling unwell were not recovered/not resolved.  It was unknown if the reporter considered the sickness and feeling unwell to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient stated that got the shingles vaccine on Saturday, got sick from it yesterday and still don't feel well. The follow-up would not possible as no contact details were available.
Felt heart was racing last night around 6:30,pm. started getting chills around 7pm. Woke up at 1am freezing and having muscle aches. I shook all night long and could not get comfortable. Woke up at 6am today and got a shower and felt nauseous. Went to work for about 30 min and then came home  because I couldn?t stand up. I ache everywhere and cannot get comfortable.
lethargy w/in 30mins of vax; ? apnea-choking, stopped breathing; adm for observation-improved spontaneously;no apnea in hosp
+ COVID 19 test  debilitating dyspnea, palpitations, chest pain, nausea, and vomiting.
felt dizzy and became sweaty,brought to cot to lay down,VSS,  felt better after 30 minutes and let on own
Feelings of severe nausea and headache. Bedridden with this for 10 days, mental confusion, lack of focus and clarity, completely different personality.  Contacted PCP for assistance.  ER visit for psychosis on 11/17/14.
Vomiting and weakness occurred on 4/25/01. Visited ER on 4/26/01 at 03:00 and transferred to ER of another hospital at 10:30 on 4/26/01, Pt died at hospital.
Syncope, patient didn't completely pass out, but wasn't alert. Blood pressure was low and HR was low. Patient sat down in chair for 15 mins while we waited for ambulance. By the time ambulance arrived patient's BP and HR was back to normal levels.
Swollen armpit on the same arm as injection.  Vaginal bleeding for 9 continuous days (not related to menstrual cycle as I am have been regular my whole life and was not within the normal time frame).
High fever over 102°F, severe fatigue, severe chills and night sweats, severe body aches, lack of appetite for the first 48 hours after receiving the vaccine. Bad taste in mouth and bad smell in nose since recieving the vaccine and currently still experiencing (causing foods to taste or smell spoiled, sour or rotten , unable to enjoy things that I previously liked)- the taste and smell are like that of dirty, old, wet paper towels and are present all the time even when I'm not eating.
Unborn child started moving less frequently. Baby measured normal at 20 week ultrasound but then growth slowed. Was born at 40 weeks at only 6.4 lbs and had meconium. Baby was born with a neuromuscular disorder and hypertonia. Child is now 3 years old and is barely growing. He is now 24 lbs and 34 inches tall. He cannot was unassisted and has developmental, gross and fine motor delays due to his condition.
This case was reported by a physician via sales rep and described the occurrence of vomiting in a 2-month-old male patient who received ROTARIX for prophylaxis. On 17th October 2017, the patient received ROTARIX (oral). On 17th October 2017, less than an hour after receiving ROTARIX, the patient experienced vomiting and accidental underdose. On an unknown date, the outcome of the vomiting was recovered/resolved and the outcome of the accidental underdose was unknown. It was unknown if the reporter considered the vomiting to be related to ROTARIX. Additional details were provided as follows: The physician prepared other vaccines and came back to find that, the patient had vomited, which led to accidental underdose. The patient was revaccinated.
Patient received vaccine approximately 2.5 hours outside 6-hour window (refrigerated). Contacted Manufacturer and stated" Janssen has not conducted studies to evaluate the efficacy or safety following administration of expired vaccine or vaccines stored outside of the recommended storage conditions." Representative asked to inform patients to contact their PCP.