chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Licensed Practical Nurse referring to a 11 year old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 16-OCT-2017, the patient received the first GARDASIL 9 lot #N019923, expiry date on 28-APR-2020, for prophylaxis (strength, dose and route of administration were not reported). Then, the patient continued with the GARDASIL 9 series, but it was outside the recommended dosing schedule according with the prescribing information as the second dose was administered on 25-MAY-2018 (lot #N026814, expiry date on 15-JUL-2020, for prophylaxis; strength, dose and route of administration were not reported). On 21-JUN-2018, the patient received the third GARDASIL 9 lot #N026814, expiry date on 15-JUL-2020, for prophylaxis (strength, dose and route of administration were not reported). No adverse effects were reported.
Pt presented 7/23/18 with erythema and pain to the injection site. Site marked and pt started on Cephalexin. Pt re-evaluated 7/24/18, no progression of erythema, determined not to be bacterial infection but rather injection site reaction.
Patient claims that following the vaccine he had  side effects (standard soreness & redness  but has now developed into infection  He is currently out of town went to a pharmacy  and was told to contact MD.
severe pain on his lower back in the hips mostly -Little bit in the center of the spine, right knee and hand joints, main knuckles, 1st joint down the knuckles of the middle finger radiating to joints; severe pain on his lower back in the hips mostly -Little bit in the center of the spine, right knee and hand joints, main knuckles, 1st joint down the knuckles of the middle finger radiating to joints; severe pain on his lower back in the hips mostly -Little bit in the center of the spine, right knee and hand joints, main knuckles, 1st joint down the knuckles of the middle finger radiating to joints; This is a spontaneous report from a contactable consumer. This 81-year-old male consumer reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 15Mar2021 as dose 1, single for COVID-19 immunization. The medical history of the patient included ongoing mild arthritis. Concomitant medications included acetaminophen, ibuprofen and celecoxib (Celebrex) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 22Feb2021 as dose 1, single for COVID-19 immunization and had no side effects. On an unknown date in 2021, a month after vaccination the patient experienced extremely severe pain on his lower back in the hips mostly -Little bit in the center of the spine, right knee and hand joints, main knuckles, 1st joint down the knuckles of the middle finger radiating to joints- Worst pain was on his back that he cacouldn hardly move. It was being relieved by putting ice packs 20-25 minutes application- He received acetaminophen 2x a day 2 tabs - Ibuprofen 200mg 2x a day (little relief but not a lot). He was referred to an orthopedic doctor-Prescribed him with Celebrex 200mg but it does relieve the pain. He was also advised to have knee replacement. He asked if the COVID 19 vaccine has caused these symptoms. He had seen that 3rd dose was now available and he did not want to get it. The event outcome was unknown.
4-23-14 school nurse called reporting patient had a red localized swollen area at site of chicken pox vaccine. Advised warm compresses, TYLENOL and offered appt to see MD if warranted. 4-24-14 PC to school nurse about pt's status. Patient fine and area of concern completely resolved.
5 yr female with DTap and IPV given in left arm, MMR and HepA given in right arm as well as PPD right forearm on 4/3/03.  Per mom, left upper arm started to get red around the area of injections within the first 24-48 hrs and continued to enlarge in area of redness for the next 7 days.  no fever, no pain, some itching.  On exam 4/10/03, 10x6cm area of non-painful urticarial erythema in an irregular pattern on left shoulder and forearm with some areas of clearing within.  per mom wa starting to get better. Advised po benadryl q4-6.
Started out with night sweats, fever and chills, extreme fatigue and muscle soreness. By Sunday morning, I had also developed a deep cough with Phlegm in the back of my throat..  The cough was so deep and strained that I had piercing pain in my chest at my lumpectomy surgical site.  I still have pain in my chest and lower back when I cough.  I'm still having fever and chills that come and go - 101 last night, down to 100.4 to 98.4 - temperature.  I'm tired and don't have my normal energy.  Will this ever end?
Went to ED on 1/14/21. emailed caregiver for information. As far as what happened, I received my 2nd dose of Pfizer on Jan. 13th @ 05:15 at hospital and started feeling symptoms roughly six hours later, symptoms being nausea, chills, splitting headaches, muscle fatigue, feeling tired and joint pain. I had understood that these side effects were common and not to worry, however, the next day on Jan. 14th around 11:00am, I blacked out at home. Luckily, my partner had caught me before I feel to the ground, but he stated that my eyes had glazed over, my breathing was shallow, and I hardly had a pulse. He was getting ready to do chest compressions, but I had come out of whatever fog that had knocked me down and became responsive. Around 12:00 pm I had arrived at the ED where they had given me a bag on NS, Zofran for the nausea and Toradol for some inflammation management. I believe I discharged from the ED around 15:20.
This spontaneous report as received from a medical assistant refers to an unspecified number of unspecified patientsof unknown demographics. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally (lot # L048854, expiry date 31-AUG-2017, lot # L033694, expiry date 16-JUN-2017 and lot # M019707, expiry date 25-OCT-2016; dose was not reported). The doses of the vaccine were exposed to a temperature excursion of 32.3 degrees Fahrenheit for a time frame of 67 hours, 8 minutes (date unspecified), which was detected by a data logger. There were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA012930.
Started itching on 1/23/2021 evening which was one week after vaccine day of 1/16/2021. Noticed small area of rash in middle of arm below injection site. Next day, rash got worse and had firm area under it. It continue to get worse till tuesday when it stopped growing. it is a bit smaller today 1/27/2021 but still present. main area is circular and then there was extension to left upper area of the circle.
Headache, vertigo, nausea, fever greater than 101F x 2 days, vertigo and nausea x 31 days so far. Headaches x 23 days.
administered expired dose; medicine taste; sore arm; fatigue; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired dose), TASTE DISORDER (medicine taste), MYALGIA (sore arm) and FATIGUE (fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced MYALGIA (sore arm). 12-Apr-2021, the patient experienced FATIGUE (fatigue). On 13-Apr-2021, the patient experienced TASTE DISORDER (medicine taste). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired dose), TASTE DISORDER (medicine taste), MYALGIA (sore arm) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medications and treatment information was not provided.  "Follow-up received on 21 May 2021 included no new information.   This case was linked to MOD21-074055, MOD21-075500, MOD21-075517, MOD21-075527, MOD21-075540, MOD21-075532, MOD21-075544, MOD21-075549 (Linked Report). This case was linked to MOD-2021-076892 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up information received on 05-MAY-2021,patient demographic details was updated, dose information was updated, event was updated. On 21-May-2021: Additional information received on 21-MAY-2021 and does not contain any new information NNI; Sender's Comments:  MOD21-074055:Cross linked case MOD21-075500:Cross linked case MOD21-075517:Cross linked case MOD21-075527:Cross linked case MOD21-075540:Cross linked case MOD21-075532:Cross linked case MOD21-075544:Cross linked case MOD21-075549:Cross linked case
I (patient) broke out in itchy hives, extremities became swollen, experienced dizziness, feverish, had diarrhea, experienced slight difficulty breathing.  I took Claritin, but that didn't help.  I then took Benedryl and that did help.  However, my work took one look at me and told me to go to the doctor.  She took a swab for strep (she said it could be scarlet fever - even though I didn't have any white dots in my throat nor did I have a high fever), but that test came back negative.  The hives have gone away (48 hrs later) and now I'm just left feeling dizzy, nauseated, diarrhea, and have a rash.
24 doses drawn from one vial and administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (24 doses drawn from one vial and administered) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 10-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTRATION ERROR (24 doses drawn from one vial and administered). On 10-Nov-2021, PRODUCT ADMINISTRATION ERROR (24 doses drawn from one vial and administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
On day 2/11 upper left arm at injection site red and swollen including arm pit with selling the size of a small lemon.
Information has been received from a nurse practitioner concerning a 4 month old patient who on 11-SEP-2007 was vaccinated with a 2.0ml oral dose of Rotateq (no lot number provided).  On that same day, the patient developed severe vomiting and diarrhea after vaccination.  Unspecified medical attention was sought.  The patient's recovery status was unknown.  There was no product quality complaint.  Additional information has been requested.
Woke up with a very sore arm in the exact area where I received the injection. The area became red and warm to the touch. The pain was the worst on 09/03 and started to feel slightly less sore on 9/4.
Severe headache, dizziness, nervousness also sore, red arm at injection site.
Patient received first dose of Pfizer vaccine at 1505. Patient waiting designated 15 minutes under supervision. Patient reported reading email and then noted difficulty reading email and notified RN. Notified to go to Clinic check out due to patient's report of "light headed, like I had a drink or something.". Reported heart racing. Heart rate 112 and BP 130/86 initially.  Upon patient being supine,  heart rate elevated to 123. Symptoms improved and then start again. Flushed area around neck. "I think I'm okay.: "I feel so much better." Patient reported, "I felt out of it. Like I had a drink of something."  Patient continued to wait under supervision of RN. Upon reassessment, sitting blood pressure of 118/78, heart rate 79, and oxygen saturation of 90% on room air.  "I feel fine. After two waves of weirdness."  Patient left at 1540. Patient reported symptoms had resolved.
Inappropriate Age at Vaccine Administration; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old female patient who received DTPa-IPV (Kinrix) (batch number 27D9A, expiry date 16th June 2020) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, unknown after receiving Kinrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional information received were as follows: The 7 month old patient received Kinrix, which led to inappropriate age at vaccine administration.
This case was reported by a consumer via out of hour services and described the occurrence of pruritus in a elderly male patient who received SHINGRIX for prophylaxis. On 11th October 2018, the patient received SHINGRIX. On 12th October 2018, 1 days after receiving SHINGRIX, the patient experienced pruritus, swelling and erythema. On an unknown date, the outcome of the pruritus, swelling and erythema were not recovered/not resolved. It was unknown if the reporter considered the pruritus, swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that he experienced itching, redness, and a bump on his left foot. The patient reported that he contacted his physician's office. On 12th October 2018, at 1:38 AM, the patient contacted via after hours voicemail.
Extreme fatigue, dizzyness, brain fog, tingling feet, joint pain and getting worse 1 week later.
Following vaccine the pt became ill, was fussy, crying, and fever. The child remained ill for weeks. The administering hospital researched and discovered route should have been by per cutaneous disc. No disc was supplied with the vaccine.
Severe flu like symptoms - myalgia, malaise, fever (subjective), terrible shivering, diffuse body ache including severe headache and back pain. Moderate pain at injection site radiating down the left arm to wrist.
Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a six months old male patient who was vaccinated with a dose of PENTACEL (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to product storage error (vaccine was exposed to temperature below 0 degree C). No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Needs interpreter. Child had DTaP vaccination 10/22/02. Ran fever and had a seizure. Parents took to Er 10/23/02 8:30am. ER doctor said child had throat infection, fever and seizure. They gave child Tylenol-no more seizures no more problems. 11/8/02 TC to mon-pt is fine no more seiuzres. Mom states brother had a seizure at one year of age mild fever but it was not related to an immunization.
I have a patient that got the FLUZONE QUADRIVALENT on Oct 1, 2018 and 3 hours later she developed hives and swelling of face. She took some over the counter medications and the next day was still swollen. She took prednisone and ATARAX and after 6 hours without antihistamines she still had tightness in throat. She went to the Clinic, ER, with hives in chest and neck. Diagnosed with anaphylaxis, allergic reaction and urticaria. She has never had issues in the past. Now on Oct 5 she is in the doctors ofc for a follow up and she still feels weak and has pain, but is much improved.
Husband returned for second dose of COVID-19 vaccine and reported that wife, expired the day after her first dose of the COVID vaccine. Medical team did not feel that there was a correlation so we were not notified prior to that date
Few hrs p/immun pt had sz lasting a couple of minutes; Was noted to have a fever & brought to MD; exam revealed BOM;
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 12:13 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 12:13 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  On 03-Mar-2021, total doses given for the day was unkown, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 03-Mar-2021. 20 vial was moved to clinic. Vaccine BUD date was 26-Mar-2021.  Vial was stored on cooler 1 , on 03-Mar-2021, Excursion duration At, 9 AM: 51, 10 AM: 34, 11 AM: 44, 12 AM: 46, 1PM : 35, 2 PM : 36, 3 PM: 36 and 4 PM: 36.  Vials only punctured right before administration. It was reported that patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Post injection;  the site was reddened, warm to touch and indurated on 01/05/2021.  The noted redness was not in the deltoid region but in the subcutaneous tissue distal of the deltoid.   Our Medical Director, Dr. gave orders for all of our residents to receive Benadryl and Tylenol prior to injection.  On 01/07/2021 the area became more diffuse, remained warm and indurated we had to obtain additional Benadryl po orders as well as Hydrocortisone topically from the Medical Director.  The Resident remained with her function of her arm at her baseline.  Dr. has seen resident the last two Tuesdays during his rounds, it is slowly resolving.
APPROXIMATELY 10 MINUTES AFTER VACCINATION, MY SON BEGAN TO ACT EMOTIONALLY UPSET, COMPLAINING THAT HIS EYES HURT AND THEN SCREAMING IN PAIN AND GRABBING HIS BELLY.  WE WENT BACK INSIDE THE CLINIC AND REPORTED THAT HE WAS POSSIBLY HAVING A REACTION.  A NURSE CAME OUT TO ASSESS HIM AND THEN LEFT TO SPEAK WITH THE DR. IMMEDIATLEY FOLLOWING THAT, MY SON BEGAN TO VOMIT. WE RUSHED HIM INTO AN EXAM ROOM AND A DR CAME TO ASSESS HIM.  WE NOTICED A COUPLE HIVES ON HIS BACK/TRUNK.  A NURSE GAVE HIM PO BENADRYL PER THE DR.'S REQUEST. THE DR THEN SAID WE COULD WATCH HIM.  MY CHILD WAS SCREAMING THE ENTIRE TIME.  UPON THE DR.'S EXIT FROM THE ROOM, I NOTICED HE WAS TURNING RED ALL OVER HIS BODY.  I CALLED THE DR. BACK IN AND SHE AGREED WE NEEDED TO GIVE HIM HIS EPI PEN.  I ADMINISTERED THE EPI PEN. SYMPTOMS IMPROVED WITHIN 3-5 MINUTES. I THEN TOOK HIM TO THE ER FOR OBSERVATION.  THEY TREATED HIM WITH ZYRTEC AND PREDNISOLONE.  WE WERE SENT HOME WITH PREDNISOLONE TO BE CONTINUED FOR 4 DAYS.
Itching/itching at the injection site; injection site and area around it is really red; This is a spontaneous case received report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 20Feb2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation.  Medical history and concomitant medications were not reported. No prior vaccines were administered within 4 weeks. The patient experienced injection site and area around it was really red on 21Feb2021; itching/itching at the injection site on 22Feb2021. The patient did not undergo any lab data or investigations. The outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.