chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COUGH; BODY ACHE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced cough. On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough, body ache, chills, and fever on 09-APR-2021. This report was non-serious.
11:30 am had vaccines. AT 4:30 pm woke from a nap pale, lips cyanotic, lethargic. To doctors, then pinked up. Started to cry at office and again went pale and lethargic. Discharge summary states reaction to DTaP. msv
Pt stated she didn't feel right.  She was able to move from chair to wheelchair with help. When taken back into exam room, patient was shaking and weak. When we asked her questions the patient could form words. She was struggling with getting any sound out. We called 911 and patient was sent to the ER.
large rash/hives on either side of his rib cage which was itchy; large rash/hives on either side of his rib cage; sides where the rash/hive were located is still sensitive to the touch; significant jock itch which primarily included his scrotum / scrotum is still painful to touch and itchy; scrotum is still painful to touch; scrotum is still painful to touch and itchy; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriatic arthritis (was taking humira for psoriatic arthritis for about 10 years). Concomitant products included adalimumab (Humira).   On 12th January 2021, the patient received the 1st dose of Shingrix. In January 2021, less than a day after receiving Shingrix and an unknown time after starting Lotrimin, the patient experienced injection site pain. On 15th January 2021, the patient experienced itchy rash, hives, sensitive skin, tinea cruris, tenderness and genital itching male. The patient was treated with clotrimazole (Lotrimin) and avena sativa (Aveeno Lotion). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the itchy rash, hives and sensitive skin were unknown and the outcome of the tinea cruris, tenderness and genital itching male were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, itchy rash, hives, sensitive skin, tinea cruris, tenderness and genital itching male to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in right arm and had injection site pain in right arm for a day which then resolved.  The patient developed a large rash and hives on either side of rib cage which was itchy.  The rash and hives did resolve but both the sides where the rash and hive were located was still sensitive to the touch.  The patient developed significant jock itch which primarily included scrotum and scrotum was still painful to touch and itchy.  The patient applied Lotrimin on and off on scrotum which had not helped.  The patient was also applying Aveeno lotion.  The patient had not yet spoken to physician. The reporter stated that the patient was due for the second dose of the Shingrix vaccine on 14thApril 2021 and received the 1st dose of the Moderna COVID vaccine on 18th February 2021. The reporter did not had the lot number. The reporter consented to follow up.
The woman administering my vaccine placed it really high into my shoulder instead of the deltiod muscle. Within 30 minutes of receiving the vaccine I had severe shoulder and arm pain, they next day 04/16/21 the pain was so bad that I could not use the arm/ shoulder at all. After 10 days I still had severe pain, minimum range of motion, could not dress myself, do my hair, lift my son etc. On 04/26/21 I saw my family Doctor, he told me these "wasn't much" he could do" and had no clue what SIRVA was. and told me to call the mass Vaccination Site. I spoke  on 04/27/21 she spoke to their Dr. at , Dr said that based on where the shot was administered that it is likely what I am feeling is bursitis. That I should not get another covid vaccine and the one I received high in the shoulder ?should? be effective. Advised me to follow up again with Dr,  my family Dr. Instead I went to see an Orthopedic Dr. on Thursday 05/06/21 at 9:45 am at . Dr agreed the shot was administered way to high based off of where the mark was still on my arm from the needle and my description of events, thought it was very likely that I have Bursitis based off of my symptoms. Made plans to schedule a steriod injection as soon as some other health issues clear up (diverticulitis)
Redness at injection site of PNEUMOVAX vaccine left arm, fever, cold sweats, decreased appetite.
When pt's 15min timer was up and nurse checked on pt he reported that he felt like his throat was closing. Pt was taken back to an exam room for this provider to assess. Pt c/o feeling like his throat was tight and he had pain in his chest. VS were obtained and were WNL, POX 98-99% on RA, exam was unremarkable, no stridor/wheezing, and no edema noted to face or tongue. Pt was monitored closely with Q5min VS and sx did not improve. I initially suspected sx were related to anxiety, but pt denied feeling anxious. Pt was given Benadryl 25mg PO X1 at 11:45AM. At 12:00 pt c/o worsening sensation that throat was closing, difficulty swallowing and breathing, chest pain, and was diaphoretic. Pt was given 0.3mg EPI IM X1 dose in R lateral thigh at 12:04PM and EMS was called. Pt's VS remained stable. Pt left clinic with EMS at 12:15PM to go to the ER for further evaluation.
This spontaneous report was received from a certified medical assistant via a company representative, referring to a 11 year old female patient. The patient's medical history or concurrent conditions were not reported. On 30-OCT-2015, the patient was vaccinated with the first dose of GARDASIL 9 (strength, route, lot number and expiration date were not reported). The second dose was received on 29-JAN-2016 and the 3rd dose was received on 12-APR-2016, which was a schedule different than what was recommended in the prescribing information. The patient's concomitant medication was not reported. Additionally, no symptoms were reported. Additional information has been requested.
Client began to have significant swelling of the right arm the day after receiving the BEXSERO vaccine. Reactions were redness, swelling, itching, and it had fever in it (hot to the touch). The s/s lasted for 4-5 days. No treatment was used.
A physician reported via a company representative, that a 35 year old pt received Flu Shield (2001-2002 formula) (influenza virus vaccine, trivalent, types A & B/2001-2002 formula) vaccine. At a later date, the pt tested positive for influenza by an office flu test. The flu immunization was given approx. 2 months prior to dx. The pt developed a "high" fever that measured 103-104F, lethargy, cough and runny nose. This is 1 of 6 pts from this office who developed influenza following receipt of Flu Shield (2001-2002 formula) lot 4078033. See case ID numbers: HQ0713214FEB2002, HQ1480125MAR2002, HQ1480225MAR2002 and HQ1480025MAR2002. One pt was not identified; an additional report will be generated when identifying information is provided. No additional information was available as of the date of this report.
Severe dizziness/vertigo upon waking, caused me to fall down the stairs. Went to local emergency room upon calling PCP for advice , also pupil dilation
Pt describes adverse event began with itching which progressed to redness.  On 07/08/2015 pt came by pharmacy around 10 am and she reported redness, warm to the touch and itching.  I applied an ice pack and she took acetaminophen.  Pt then came to pharmacy on 07/09/2015 in the am and pt is experiencing localized redness and swelling and warm to the touch with an increase diameter in redness from the previous day.
Approximately 10 minutes following vaccine administration, c/o itching of feet, hands and stated "I don't feel good". Hives were noted on neck and back which seemed to be increasing. Transported to ER across from clinic. Benadryl and Prednisone administered.
Information has been received from a certified medical assistant concerning an adult patient (gender unknown) who on an unknown date was vaccinated (route unknown) with a dose of Pneumovax 23 (Lot # 651319/1007P). After receiving the vaccine, the patient developed cellulitis. The outcome of the patient's experience was not reported. Unspecified medical attention was sought. No product complaint was involved. In follow up information, the medical assistant reported that  she can not confirm that the initial lot number reported was correct. She said "An antibiotic is sometimes ordered for a patient with cellulitis" but she does not know if the patient received an antibiotic. She has no further information to provide. Additional information is not expected.
The patient called the pharmacy to report that around 8pm around 8pm she noticed redness and itchiness at the injection site. She is using Benadryl for the itchiness. She is monitoring the redness and will go to urgent care if it worsens or does not resolve within the next several days.
No additional AE; patient received the first dose of GARDASIL 9 in Oct 2022. Patient just received the second dose of GARDASIL 9; This spontaneous report was received from a pharmacist and refers to a 40-year-old male patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On an unknown date in October 2022, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 10-MAY-2023, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #W011455, expiration date: 11-DEC-2024, administered for prophylaxis (strength, and route of administration were not provided) (Inappropriate schedule of product administration). No additional adverse events reported. No PQC reported.
Date removed from freezer 7/22/22. Thaw expiration date 8/21/22@0900. Dose administered 8/22/22  Second dose removed from freezer 8/9/22. Thaw expiration date 9/8/22@1100. Dose administered 9/19/22. Both Doss administered after 30 day expiration. Moderna was contacted for assessment of vaccine activity for both doses. Based on the assessment vaccine maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration per Moderna. No adverse reaction reported
The pt developed cellulitis, diagnosed by provider (redness, swelling and warmth), and 1 inch area of induration.
Pt was given influenza vaccine and Pneumovax on 11/20/02. Pt c/o dizziness, 2 days later did not contact this office until 11/29/02 sx resolved. Decreased energy level until 11/25/02 when felt fully recovered.
Patient woke up with nausea and vomiting.  She felt dizzy and pale.  Her temperature read 101 F.  She almost fell going to the restroom. Luckily, her husband was there to help and called the ambulance.  She received I.V. fluid in the ambulance and at the hospital.  Urine samples indicated UTI.  She discharged from the hospital and picked up antibiotic.  Later on, she had a followed up with her primary and had a discussion that her symptoms was from the vaccine.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 28-DEC-2015 the patient subcutaneously received both VARIVAX (Merck) (lot# and dose were unknown) and PROQUAD (Merck) (lot# and dose were unknown) in error (overdose). No known adverse effects were reported. Additional information has been requested.
Patient missed his second dose; No additional AE reported; This spontaneous report has been received from a pharmacist referring to a 12-years-old male patient. The patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not provided.   On an unspecified date in Jun 2021 (reported as a year ago), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). It was reported that the patient misses his second dose  of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product dose omission issue). No additional adverse events were reported.
Right arm pain , hot to touch, pain in joints a d muscles like flu, fever of 100.0, fatiqued, sleep a lot.
I have had the worst headaches and dizziness ! Fatigue is really bad and I did have pain in my left leg for a week and a half however that?s gotten better ! The headaches are the worst
Exact events unk. Pt coded. Unable to resuscitate at hospital. Autopsy not done. Discharge Summary received which stated patient experienced asytole, unresponsive, respiratory arrest, cyanosis and corneal clouding. Medical records from PCP received which revealed patient experienced muscular dystrophy, GERD, apnea, agranulocytosis, prior jaundice & equinovalgus.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had Covid-19 back in Sep2021.) and DRUG INEFFECTIVE (Lack of drug effect) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 026L20A) for COVID-19 vaccination. Concurrent medical conditions included Latex allergy (allergic to latex). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and CALCIUM, COLECALCIFEROL (CALCIUM & VITAMIN D [CALCIUM; COLECALCIFEROL]) for an unknown indication. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced COVID-19 (had Covid-19 back in Sep2021.) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (had Covid-19 back in Sep2021.) had resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 antibody test: positive (Positive) Had COVID-19. Company comment: This spontaneous case concerns a 42  year  old, female patient with no reported relevant medical history, who experienced the unexpected non - serious AESI event of COVID19. The event occurred approximately 7 months after the second dose of mRNA-1273. Drug ineffective was captured since both mRNA  1273 doses were given 31 days apart. No medical assessment or treatment has been informed. At the time of the report the outcome of the event COVID19 was recovered. The Benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-460284 (Patient Link). Sender's Comments: This spontaneous case concerns a 42  year  old, female patient with no reported relevant medical history, who experienced the unexpected non-serious AESI event of COVID19. The event occurred approximately 7 months after the second dose of mRNA-1273. Drug ineffective was captured since both mRNA  1273 doses were given 31 days apart. No medical assessment or treatment has been informed. At the time of the report the outcome of the event COVID19 was recovered. The Benefit-risk relationship of mRNA-1273 is not affected by this report.
During the past 16 months (but soon after first injection), sporadic hard crusty skin 'spots' (some projecting outward) began appearing.  Both PCP and dermatologist dismissed them, but they are sporadic, have no effective treatment (creams don't work, spraying with liquid nitrogen doesn't work, surgery is ill advised, and they are extremely uncomfortable - and they were NOT noticed BEFORE the injection).
TREMORS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced tremors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tremors was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 74-year-old male patient who received SHINGRIX (batch number 7X743, expiry date 22nd May 2021) for prophylaxis. On 10th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 10th December 2018, less than an hour after receiving SHINGRIX, the patient experienced headache, nausea, vomiting, general body pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the headache, nausea, vomiting, general body pain, injection site swelling and injection site erythema were unknown. It was unknown if the reporter considered the headache, nausea, vomiting, general body pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the right deltoid. The pharmacist stated that the patient developed a severe headache (so bad that they could not function), nausea, vomiting, body aches, swelling and redness at injection site (about a 2 inch diameter) within an hour after receiving the SHINGRIX. The reporter consented to follow up.
On 11/21/03, pt developed abdominal pain. He was seen in the office and sent to the ER where an ultrasound showed intussusception. The condition was treated in the presence of a pediatric surgeon. The pt was observed overnight and discharged on 11/22/03. Since then, he has been well.
9/8/21 hx of CAD, HTN, CHF, OA, gait instability, who presented as directed by her PCP, due to coronavirus concerns.
Received Moderna booster. 24 hrs later, aside from a headache which I previously experienced, I lost partial vision in one eye. Went to my opthomologist immediately. He determined that I had an ocular migraine. My vision did improve after couple of hours. Don't know if it was from the booster and he couldn't tell either. Never happened before.
Body aches; Difficulty breathing; Unable to perform daily activities,do anything,Could not walk; Sore/ache neck; Got sick the same night; Can't work while standing; Could not talk; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), MOBILITY DECREASED (Unable to perform daily activities,do anything,Could not walk), NECK PAIN (Sore/ache neck), ILLNESS (Got sick the same night) and ASTHENIA (Can't work while standing) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 01220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced DYSPNOEA (Difficulty breathing), MOBILITY DECREASED (Unable to perform daily activities,do anything,Could not walk), NECK PAIN (Sore/ache neck), ILLNESS (Got sick the same night), ASTHENIA (Can't work while standing), SPEECH DISORDER (Could not talk) and HEADACHE (Headache). On an unknown date, the patient experienced MYALGIA (Body aches). The patient was treated with ALBUTEROL [SALBUTAMOL] ongoing since an unknown date for Dyspnea, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Difficulty breathing) had not resolved, MOBILITY DECREASED (Unable to perform daily activities,do anything,Could not walk) and ASTHENIA (Can't work while standing) outcome was unknown and NECK PAIN (Sore/ache neck), ILLNESS (Got sick the same night), SPEECH DISORDER (Could not talk), HEADACHE (Headache) and MYALGIA (Body aches) had resolved.            Concomitant products includes Diabetes medication Action taken with mRNA-1273 in response to the events is not applicable   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Additional information received on 12-JUN-2021. Outcome of the event Difficulty breathing is changed from Unknown to Not recovered
I developed a runny nose similar to seasonal allergies on the evening of 01/12/21. The next day my nose continued to run even after taking a Zyrtec,  and by early afternoon I felt like I couldn?t take a deep breath. I?m an RN, so auscultated my lungs and thought I could detect wheezing. I went to an Urgent Care clinic and they sent me via ambulance to Hospital. I received a chest x-ray, labs, and an ultrasound of my left calf because it felt tight. I had a left knee arthroscopy on 01/07/21 and my knee and lower leg had some edema. (I was on ASA, 81 mg BID to prevent post op blood clots. I forgot to mention this and Zyrtec under medications above.) All tests and scans were within normal limits. I received two albuterol breathing treatments via nebulizer and was discharged with an albuterol inhaler.
Patient was in car in 1st dose waiting line after getting the vaccine. I was checking on patient and she c/o swelling in face and neck and redness in face. I told her husband to drive her up to the front parking lot where EMS was waiting. I notified EMS of her symptoms. EMS attended to her and advised her to be taken in to be seen at the ER. The patient refused. EMS once again advised her to go to the ER, patient refused. Patient was told to wait in car for an additional 30 minutes before leaving.  EMS advised pt to report to ER if symptoms get worse. Patient signed a declination for EMS. I checked on the patient again before her 30 minutes were up. She c/o her throat hurting. EMS attended her again and advised her to go to the ER either by them or POV. Husband of patient stated he would take her to the ER.  Patient left by POV @ 1345.
Seizure 1 week after MMR, Prevnar, Varivax. Febrile seizure with mild pneumonia. Twin exact reaction with 15 minutes same shots.