chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MUSCLE ACHES; FATIGUE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-MAR-2021, the patient experienced muscle aches. On 07-MAR-2021, the patient experienced fatigue. On 07-MAR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle aches, and fatigue on 08-MAR-2021, and had not recovered from fever. This report was non-serious.
Body pain, headaches, chills, rash and cellulite at the injection cite. Chickenpox rash over the body. Need to take cephalexin 500mg for 7 days
Patient reported slight fever and redness at site of injection about the size of a 50 cent piece. No itching or pain. Using TYLENOL and hydrocortisone OTC.
This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the 6-11-year-old monovalent Moderna COVID-19 vaccine instead of the 12 plus bivalent Moderna COVID-19 vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the 6-11-year-old monovalent Moderna COVID-19 vaccine instead of the 12 plus bivalent Moderna COVID-19 vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the 6-11-year-old monovalent Moderna COVID-19 vaccine instead of the 12 plus bivalent Moderna COVID-19 vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.       Concomitant medications were not reported.  The patient received booster dose of Moderna vaccine.    Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.  The excursion duration was unknown. The vaccine was returned to the freezer.   The visual inspection showed the vaccine state as still frozen.  The vial underwent temperature excursion for the first time.
Left arm hurt, red, hot, swelled, welts, heavy duty itching This happened the day after the shot.   Had a reaction with the first 3  Moderna but this time it also swelled and had welts and itching is lasting longer.   I read on the internet that this reaction could happen 5-7 days after shot but it happened to me the next day.
High fever with severe back and neck pain during night. Much less pain and temp. 88 - normal in AM. No local site redness or swelling.
Patient reported itching under her skin all over her body, including her face. She reported no rash and itching was not localized to the injection site.  Patient saw her doctor for the itching and received Benadryl, however she did not report the recent vaccination to her doctor at that time.
Pt recvd DTP/HIB/OPV 19MAY92 & mom reported screaming unconsolable cry 6-7PM; pt went to sleep p/APAP, woke up 9PM mom noticed eyes tightened w/head twitching & eyes twitching & jerky movements for aobut 15-20mins;
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX and SHINGRIX with an associated reaction of pain in extremity (1st dose received on an unknown date, see case US2018GSK19311). Concurrent medical conditions included shingles. Concomitant products included VALTREX. In September 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was received via click to chat. The age at vaccination was not reported. The patient received 2nd dose of SHINGRIX injection previous month when he had an active case of shingles and was receiving VALTREX. The patient wanted to know would this hurt him in any way. The patient did not want to provide date of birth or physician's contact information or other adverse event information. The patient had denied permission to contact their physician. The patient had provided limited information.
Delayed hypersensitivity exhibited by a very itchy rash that started on ankles and moved up my legs.  While moving up my legs began on my forearms and moved up my arms.  My trunk was spared.  It started as small red papules and then became purpuric.  Likely vasculitis.   Treatment: Initially steroid cream that did not work. Then prednisone 40mg x1 week,  20mg x1 week and high dose antihistamines.  After 1 day on prednisone, rash no longer itchy and gone by day 2. Once off prednisone, rash returned within 1 day. Restarted Prednisone and took a long taper x 39 days Near the end of that taper with only a week left, started feeling itchy again.  Saw Derm who prescribed an uber strong steroid cream to use.  Once taper done and off prednisone again x 1 day, rash returned but seems to be only confined to my ankles-calf area.   Not as itchy either.  Still purpuric. Will be getting a biopsy this week through derm hopefully
Estimated due date: 03/17/2021 On the day of the vaccine during observation I had tingling in my mouth, numbness in tongue and I just used my Benadryl and it eased the symptoms. But at night I started wheezing, had sweats and chills, did not check my temperature but I had pretty severe chills that night. In the morning I checked no fever, but still chills, severe cough and sore throat.. Headache and fatigue.  All got worse more severe on Saturday and then I decided to go get tested for Covid on the Care Clinic. I had a known exposure to COVID before I got the vaccine around  01/04/21 - my husband who tested positive on the 6th) I tested positive. All symptoms continued (except the tingling on the mouth it stopped on the 8th) and I saw my OB-GYN on the 11th due to a low amniotic fluid - I had an ultrasound at the facility and was referred to MD and saw him on the 11th as well.  Now I lost my sense of taste and smell. The chills have subsided a little bit and so the headache, but fatigue, congestion and cough are still there. I had increased intermittent shortness of breathe but could be the baby's position.
Pt was ordered to get Tdap vaccine at routine physical, but instead Kinrix was given by medical assistant.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 31-AUG-2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 18-JUN-2016, the patient was treated at a medical facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. On or about 30-JUN-2016 the patient sought subsequent treatment from a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Left upper arm - "3 diameter of erythema appeared 1d after vaccine. Patient advised to take OTC- Benadryl, Ibuprofen and to follow-up if persists.
small raised erythemic bumps on both legs & abd;started @ 8PM 9JUN98;no fever, non itching, no drainage;bumps non fluid filled;mom reports child was last in a spa last PM & plans to check acidity of water for poss skin rxn
A few red spots on back and belly a few days after vaccine. October 1 and 2, had a fever of 100.9. October 4 red spots on legs, back and abdomen.
At 2 mo. well child visit, pt. was given Live Oral ROTAVIRUS vaccine & she vomited soon thereafter.  It was repeated within minutes, & she again vomited.  At her 4 mo. well child visit, she was given 1/2 the dose of Oral ROTAVIRUS vaccine & she vomited promptly.  She was given the 2nd 1/2 & again vomited.
Adacel was given to a 2 yr old instead of pediatric DTap/no AE; Adacel was given to a 2 yr old instead of pediatric DTap/no AE; Initial information received on 22-Jan-2020 regarding an unsolicited valid non-serious case received from the other health professional.  This case involves a 24 month old male patient who was vaccinated with a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: C5519AA)  via an unknown route at an unknown administration site instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [DTAP] (Batch number, expiration date, dose, route and site of administration were not reported) on an unknown date.  Medical history, medical treatment, vaccination and family history were not provided  It is an actual medication error case due to Inappropriate age at vaccine administration and Wrong vaccine administered. It was reported that by mistake Adacel was given to a 2 yr old instead of pediatric DTap for the 3rd dose.  At the time of reporting, 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.
sick for 2 weeks; Initial information received on 07-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).  This case involved a patient with unknown demographics who got sick for 2 weeks (Illness), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site.   On an unknown date, unknown latency, the patient took the flu shot 1 time and was sick for 2 weeks (illness) and the patient have not had the flu in 20 years.  No relevant laboratory details were provided.  It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.
Urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). The patient was treated with CEFDINIR at a dose of 300 mg and CIPROFLOXACIN at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants were not reported.   Reporter did not allow further contact
Parent called school nurse, child had fluid-filled lesions on trunk and extremities. Onset 10/17/05 times 5 days. Not confirmed by Dr.
2 months after J&J vaccination, pt had episode of severe vertigo.  CT scan showed cerebellar stroke with thrombus in vertebral artery.  Pt had normal platelets.   Pt only had one episode of vertigo ( which has had in the past ) and no other neurological symptoms.  Unclear if stroke is related to J&J with normal platelets.  Pt only had mild elevation of cholesterol, prediabetes and occasionally on hormone replacement.   She is 54 year old female, relatively healthy.  Has family history of strokes
Dr. ordered SHINGRIX for this patient due to the patient having a history of shingles. Patient verified to RN on 12/7/18 prior to administration of SHINGRIX dose #2 that she was not pregnant as she had done a home pregnancy test with negative results on 12/5/18. She since reports having done home pregnancy tests on 12/18/18 and 12/28/18 with negative results. Then, on 1/3/19 the patient called  Health Services to report that she had a positive home pregnancy test on this day and reported her last menstrual period as 11/12/18. Dr was notified of positive pregnancy test on 1/3/19.
Sore Arm x48 hours; fatigue; mild nausea; This is a spontaneous report received from a contactable physician (who is also the patient). A 59-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231, Expiry date unknown), intramuscular in left arm, on 23Dec2020 15:00, at single dose, for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient is not pregnant. The patient experienced "sore arm x48 hours", fatigue and mild nausea all on 24Dec2020 03:00. No treatment was received for the events. The patient did not have COVID prior and post vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The reporter assessed the events as non-serious. The outcome of the event vaccination site pain was recovered on 26Dec2020 at 03:00 and the outcome of the remaining events was recovered on an unspecified date in Dec2020.
Pain head ache extended from the base of her skull through to her neck.; Headahces; pain extended from the base of her skull through to her neck; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain head ache extended from the base of her skull through to her neck.), HEADACHE (Headahces) and NECK PAIN (pain extended from the base of her skull through to her neck) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 010A21A) for COVID-19 vaccination.     No treatment information was provided.  Concurrent medical conditions included Hashimoto's disease, Drug allergy (Sulfa Drugs), Penicillin allergy, Gluten sensitivity and Adhesive tape allergy. Concomitant products included PARACETAMOL (ACETAMINOPHEN), MINOCYCLINE, PROBIOTICS NOS, COLECALCIFEROL (VITAMIN D3), CALCIUM and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (Pain head ache extended from the base of her skull through to her neck.), HEADACHE (Headahces) and NECK PAIN (pain extended from the base of her skull through to her neck). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. On 04-Apr-2021, PAIN (Pain head ache extended from the base of her skull through to her neck.), HEADACHE (Headahces) and NECK PAIN (pain extended from the base of her skull through to her neck) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-060646, MOD-2021-054469 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up was received: does not contain any new information On 20-Jul-2021: Follow up was received allergies was added
tested positive for covid on 4/8/2021. Fully vaccinated with 2 Pfizer doses given 12/29/2020 and 1/19/2021.   Members of her household tested positive first and then she tested positive asymptomatically on 4/8.   She developed headache on 4/9 and is currently remaining in isolation.
Since taking the vaccine I have been sneezing randomly on and off. Early in June I began having a runny nose and a headache which I took a Tylenol for. I also had slight appetite loss during this time and through this time chills, body aches and sporadic fevers occurred. I sought care from Urgent Care and they said something viral. I kinda got my appetite back around the 7th. On June 13, I had a cough and sore throat with a fever as high as 100.4 which lowered to 98.6 for the next few days. In July, I started to have a headache and sore throat on July 9 and noticed around  there were bumps on the back of my throat. My temperature has averaged 99F throughout this time which continues until now. I?ve had sporadic headache, warm throats, warm foreheads, body pains which started on the right side and migrated to the left. Going to Urgent Care for this it was after my August 7 visit I was prescribed Doxycycline Hyclate
cold; chills; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced NASOPHARYNGITIS (cold), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, NASOPHARYNGITIS (cold), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.            no concomitant medications reported. no treatment details reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-080289 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080289:second dose
Vaccine may not have been effective, but would not be harmful.  On 9/14/23 had Temp Excursion in Med Refrig to 0* celcius.  Reported this to staff on 9/15/23.  Vaccines were held, Vaccine companies contacted by staff and on 9/18/23 was told by her these vaccines were safe to give including the DTAP/IVP.   But then on 9/29/23 staff with office contacted me again at our office and said after 2nd review, the DTAP/IPV might be INEFFECTIVE after all and should contact anyone who had dose of this to notify them possibly INEFFECTIVE, but NOT HARMFUL. and that they should come back after a month to have vaccine repeated.    Called patient's mother and notified of this information. She chose to bring patient in for appt scheduled  11/6/23 at 8:30am to have this vaccine repeated, so appt still pending.  She did not sound upset on the phone.
About 20 hours after having the vaccine hives developed. They keep popping up every day in different places. She now has a temperature as well
Patient began with significant soreness that progressed into severe arm pain with decreased range of motion. On morning of 1/27/15 she reported some relief of symptoms. Been taking ibuprofen. Not reported to pharmacy until 1/27/15.
Fatigue; Weakness; Dizziness; Diarrhea; Dehydration; Headache; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730), dose 1 via an unspecified route of administration, administered in arm left on 25Mar2021 14:00 as  single dose for covid-19 immunisation. Medical history included parkinson's disease from an unknown date and unknown if ongoing. Concomitant medications included carbidopa, levodopa (SINEMET); opicapone (ONGENTYS); rasagiline mesylate (AZILECT); clonaazepam (KLONOPIN); docusate sodium (COLACE) and Dulco. The patient experienced fatigue, weakness, dizziness, diarrhea, dehydration, headache, and she stated her medications didn't work well, could not get herself up to do anything on 25Mar2021 05:00 (as reported, specified time pending confirmation). There is no treatment for the events. The patient did not have covid prior vaccination, she did not test covid test post vaccination, she did not have known allergies. The outcome of the events was resolving.
Fever to 102F, chills, sore throat, fatigue, R arm redness, swelling and pain. No specific rx given.
Provided 6 patients with Moderna vaccines from a vial that they realized expired two days prior; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Provided 6 patients with Moderna vaccines from a vial that they realized expired two days prior) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Provided 6 patients with Moderna vaccines from a vial that they realized expired two days prior). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Provided 6 patients with Moderna vaccines from a vial that they realized expired two days prior) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  No adverse reactions were experienced by the patient.