chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She too experienced increased pain at the injection site; This spontaneous report was received from a consumer (the patient's mother) via a company representative and referring to a 15-years-old female patient. The patient's pertinent concurrent conditions, medical history, concomitant medications, and previous drug reactions or allergies were unknown by the reporter.  In September 2017, also reported as approximately three years ago, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (vaccination scheme frequency, anatomical location, route of administration, lot number, and expiration date were not provided) as prophylaxis.  On an unspecified date in September 2017, the patient experienced increased pain at the injection site. It was unknown by the reporter if the patient sought medical attention, if any laboratory diagnostic or studies were performed or if any treatment was given to the patient. At the time of this report, the outcome of the event was unknown by the reporter.   The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the increased pain at the injection site was not reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2009USA010525:
pt had swelling and redness from injection site and full upper arm area. counseled pt to take benadryl  and ibuprofen and ice and to seek medical attention if gets worse or not better with medication, I contact Dr.'s office and reported incident with staff at mds and faxed pts immunization record over to office
Covid breakthrough. It wasn't any significant. I had a light sore throat, coughing and a slight fever (100.2 degrees). I was also blowing my nose a lot. I was prescribed paxlovid to treat my symptoms I started it on the 21st and felt better by the 28th. On the 29th I took an antigen test that was negative. However, today I took another antigen test and it came back positive. Now I just have some morning congestion that is lingering.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 89-year-old male patient who received SHINGRIX. On 22nd May 2018, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm and tenderness. On an unknown date, the outcome of the pain in arm and tenderness were recovering/resolving. The reporter considered the pain in arm and tenderness to be probably related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported, but it could be either 89 or 90 year old. The patient experienced a sore arm that lasted for about 3 days, but it still hurt if she touches the area for 5 days. The patient had denied permission to contact their physician. This case has been linked with case US2018096131, reported by the same reporter.
Redness and swelling at site of Varicella approximately 5.6cm in diameter.
Severe chills (worst the night after injection), weakness (first 48 hours), fatigue (first 48 hours), night sweats (first two nights after injection), pain at injection site (48 hours+), blotchy skin reddening and pain distal to injection site (further down arm, noticed 48 hours after injection), swelling and pain in axillary lymph nodes on left side (near injection site, first noticed 30 hours after injection), mild chest pain (worst 30 hours after injection), very mild bloody nose upon waking (first two mornings after injection). Took 650 mg aspirin every 4 hours, rested, hydrated.
Initial report was received from a health care professional, who was also the patient, on 22 March 2012. This reporter also reported another adverse event which was captured in case 2011-11668. A female patient (age and date of birth not reported) had received an injection of FLUZONE INTRADERMAL (lot number, route, site and date of administration not reported) and an unspecified amount of time later had a "painful experience." No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Client became pale and lightheaded at clinic, but recovered on own.  Mother called in this AM to report taking client to ER on 06/19/09 PM near midnight due to c/o dizzy, room spinning when eyes closed, afraid to go to sleep, thinking she was going to pass out; says O2 was a little low, unsure how low, blood sugar was fine, vitals were ok, never seen by MD x 7 hours, left.  Reports similar episode last PM, but not taken back to ER, plans to schedule appt with PHP today.  RN encouraged f/u with PHP, discussed continued symptoms with District Immunization Coordinator.
We gave the vaccine to a 17 year old; A spontaneous report was received from a healthcare facility staff member concerning a 17-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced product administered to patient of inappropriate age.   The patient's medical history was benign.  Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (LOT number unknown) on 07 Jan 2021 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection and experienced product administered to patient of inappropriate age.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the event, product administered to patient of inappropriate age, was not provided.   The event, product administered to patient of inappropriate age, was considered resolved on 07 Jan 2021.  The reporter did not provide a causality assessment for the event, product administered to patient of inappropriate age.; Reporter's Comments: This report refers to a case of 17- year-old female patient who experienced non-serious unexpected event of gave the vaccine to a 17-year-old by mistake (product administered to patient of inappropriate age) for mRNA-1273, lot # unknown, Exp date-unknown. There were no reported AEs associated with this case of gave the vaccine to a 17-year-old by mistake.
Per patient few days after receiving Flu vaccine her arm was red and itchy surrounding the site of injection. Pt seen in our office 10/08 Dr prescribed topical steroid cream (WESTCORT) and ZYRTEC.
Same day post vax, the pt developed a fever of 102. He also experienced a choking episode. Mother stated the child was drinking formula and began choking and mom says child turned blue and eyes rolled up into head.
1-12-11 Severe abdominal cramps, pain, diarrhea, nausea, vomit, chills, malaise till 5pm. 1-13-11 malaise, not able to eat. 1-14-11 ate smoothie.
Received Hep A #1 right deltoid at 1030 AM. TC at 4 PM c/o of itchy red rash to UE with swelling hot to touch. Took Advil and 50mg of Benadryl. Denies any other symptoms of allergy.
Vaccine was left at room temp for 19 hours and was expired at time of administration.  Patient did not report any side effects after administration.  Vaccine is only stable for 12 hours at room temp, efficacy of the vaccine can not be guaranteed.   Verified information with Pfizer pharmacist.
Pt received first dose of Pfizer at 2:33 pm. While waiting in observation after 30 minutes  (3:03 pm), pt notified nurse of development of rash to both left and right arms. 2 nurses responded, assessment done- no difficulty of breathing observed, observation nurse stated VS stable, pt denied any other symptoms. Nurse offered Benadryl, pt refused, pt insisted she wanted treatment of her rash at a hospital. Stated she will drive her straight to Hospital Emergency Dept.
Patient came in for vaccine, documented vaccine information and looked at vaccine information prior to giving the vaccine and I did not catch the expiration date. After I gave the vaccine and I was putting it in to the computer, I noticed that the vaccine had expired in April 2020. I immediately reported the incident to the manager and the physician. The patient's mother was contacted and was told of the incident. Patient's mom was advised to come back in for another dose.
Spontaneous Urticaria/dermatographism Beginning 11/30/2021 and continuing to this date. Received intramuscular (12/1/2021), intravenous (12/4/2021)and oral steroids that finished Jan 31, 2022.  Currently taking: Loratadine 10mg twice daily Famotidine 20mg twice daily
6TH DOSE ADMINISTERED; 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 2021, the subject experienced 6th dose administered. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of 6th dose administered was not reported. This report was non-serious.
Initial swelling about the size of a nickel.  As progressed during the night and next 7 days grew to approximately 6 inch diameter circle, red, hot to touch and very swollen.  Treated with Ibuprofen, Benadryl and cool compresses.
Initial 2 month vacines with excessive crying greater than three hours.  Second set with fever to 105 x 12 hours.
Consumer answered Yes when  asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Consumer answered Yes asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Consumer answered Yes when the ChatBot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect.). At the time of the report, VACCINATION COMPLICATION (Consumer answered asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported.  Treatment information was not provided.
Diagnosed with Bell´s Palsy; Stroke; Second dose scheduled 2 days past her 42 days; terrible dizziness; double vision; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and FACIAL PARALYSIS (Diagnosed with Bell´s Palsy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol, Hypertension and Thyroid disorder.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant), DIZZINESS (terrible dizziness) and DIPLOPIA (double vision). On 10-Apr-2021, the patient experienced FACIAL PARALYSIS (Diagnosed with Bell´s Palsy) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled 2 days past her 42 days). The patient was hospitalized from 28-Mar-2021 to 31-Mar-2021 due to CEREBROVASCULAR ACCIDENT, and then from 10-Apr-2021 to 13-Apr-2021 due to FACIAL PARALYSIS. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), FACIAL PARALYSIS (Diagnosed with Bell´s Palsy), DIZZINESS (terrible dizziness) and DIPLOPIA (double vision) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled 2 days past her 42 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had a stroke that affected her right side and affected her vision. She stated she had a very mild case of bells palsy, her mouth and her left side was drooping a bit, her left eye did not blink and would not close, she could chew and she could talk pretty good, she had to drink with the right side with a straw.  Products known to have been used by the patient, within two weeks prior to the event, included unspecified cholesterol medication, high blood pressure medication and unspecified thyroid medication. Treatment medications included: prednisone, 5 or 6 medications for the heart and valacyclovir HCL 1g tablet.  This report refers to a case of Inappropriate schedule of product administration for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (stroke, facial paralysis, dizziness, and diplopia), a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (stroke, facial paralysis, dizziness, and diplopia), a causal relationship cannot be excluded.
hives; itch; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "hives"; PRURITUS (non-serious), outcome "unknown", described as "itch".  Additional information: The patient experienced hives since the first dose. Hives occur with 1-8 and itch badly. The patient had repeated hives. The event took place after the use of product.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a vaccine error patient was given a MMRV and  Varicella. Patients hasn't had any reaction noted
DUE TO A CLERICAL ERROR, PATIENT RECEIVED DOSES OF SEASONAL INFLUENZA, IPV, HEPATITIS A & HEPATITIS B 10 DAYS AFTER RECEIVING THE SAME VACCINES AT ANOTHER CLINIC
it itches sometimes/developed a rash / rash/rash is red and it; it itches sometimes/developed a rash / rash/rash is red and it; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had in the past 2 episodes of Shingles in her lifetime).   On 21st September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 22nd September 2020, 1 days after receiving Shingrix, the patient experienced itchy rash and red rash. On an unknown date, the outcome of the itchy rash and red rash were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash and red rash to be related to Shingrix.  Additional details were reported as follows: The reporter ws the spouse of the patient. The patient received her 1st Shingrix dose in left arm. The reporter stated that the patient developed a rash a day or so after receiving the injection. The rash was red and it itches sometimes.  The rash was located inside of the area of her left elbow. The reporter stated that patient had in the past 2 episodes of Shingles in her lifetime. The patient was scheduled to get her 2nd dose day after reporting day but would consult with her healthcare professional first. The reporter did not consent to follow-up
Patients husband reported patient experienced fever and sluggishness for 1 week after. Patient also had rash develop a few days after vaccine that is itchy and all over her body and still present on 9/8/15.
patient developed red rash that started to get streaks and was seen by her primary doctor and placed on keflex on 10/13/23.  patient went to urgent care on 10/19/23, developed an ulcer and was extremely painful.  she missed 5 days of work and it continues to weap and the pain is slowly resolving
Headache, Fever, First symptom was migraine on 2/20 in the morning, then fevers; now fever gone. Narrative:
10:25 AM Hep B Vaccine administered R deltoid 10:45 AM Reported red rash upper chest, right arm 11:03 AM Reported generalized itching- Medical Staff contacted for evaluation  Transported to First Aid Station 11:30 AM Benadryl 50 mg IM- then 25mg by mouth @ 5:30 PM and 11 PM today 11:55 AM Claritin 10 mg by mouth then QD x6 more days
I noticed my mind being unusually foggy since after the second dose (after the first and second dose my mind was extremely foggy the day immediately after the vaccination) and have been forgetting things I normally would not. I have not sought treatment for this as I was hoping to get more information on why this is happening and if there is a treatment for such a thing.
Breakthrough case admission after 2 vaccines Moderna 2/11/21 Lot# 015M20A;  Moderna 3/11/21 Lot# 030A2  (That is the information from the database)
At 7:30 p.m. on the day of the vaccine, I started to feel chills, which steadily increased throughout the evening. My temperature increased from 97 to 104.4 over the next 6 to 7 hours and stayed above 100.4 until about 24 hours after initial symptom onset. The chills subsided as my temperature declined. I felt drained, had no appetite, and had a low grade headache that intensified on movement, particularly bending over. The headache, lack of appetite and energy, lingered after the chills and fever had subsided into the following day (5/1). On 5/2, I felt much better and was up and about at 80% of normal activity. I expect to be fully back to normal tomorrow.
Dose 1: 3/24/2021; Moderna; Lot #012A21A Dose 2: 4/26/2021; Pfizer; Lot #ER8736  Patient received Dose 2 of Covid-19 Vaccine series as Pfizer instead of Moderna.  Patient made aware following vaccine administration, denies any physical symptoms at time of incident.  No adverse event or side effects noted during 15 minute waiting period.  Departs without toxic appearance or distress.   Advised regarding best practice to not re-administer Moderna Dose 2 at this time.
Waited 15 minutes after the vaccine felt fine passed out 3 hrs later at work. Seen in Hospital ED with shoulder injury and dx'ed syncope r/t pertussis. Reported by patient we have not seen any hospital documentation.
I experienced eczema patches on my face which had never had never appeared in this location before, developed subcutaneous horns on my face, forearms, arms. The skin reactions worsened over the course of one week and did not resolve 4 weeks. Started taking antihistamine and was prescribed steroidal topical creams and non steroidal topical creams. I'm experiencing more severe eczema flare ups with more frequency and in locations I had never had patches before.
Information has been received on 30-JUN-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 17-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M035696, expiration 07-NOV-2017 subcutaneous for prophylaxis which was improperly stored. Concomitant therapies included sterile diluent lot number M026304 expiration 13-MAR-2019. The pharmacist confirmed that no adverse events were present for the patient. The vaccine was stored at temperatures of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 24 hours 30 minutes and at temperatures of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 8 hours 39 minutes. The pharmacist reported a previous temperature excursion but did not have the details. The call was made due to a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA004031.
Fatigue Injection site pain/soreness for 3 days Chills at 24 hours Joint aches Symptoms lasted total of 36 hours
Beginning roughly 12 hours after vaccination,  I had a very sore injection site, which lasted an additional 32 hours. Also about 12 hours after injection, I experienced a low grade fever, shaking and chills, entire body soreness/achiness, fatigue, and a headache.  These symptoms lasted appx 24 hours, with the fever, shaking and chills dissipating around 20 hours and the remaining symptoms gone after 24-30 hours.  Additionally,  I am lactating and noticed a dramatic color change in my expressed milk roughly 17 hours after injection (normally a creamy yellow, 17 hours post-vaccination it appeared much more translucent and blue-tinted).
RA flare; Joint pain; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "RA flare"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain". Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently provided, the reported serious event RHEUMATOID ARTHRITIS is considered not related to PREVENAR 13 but more likely due to worsening of the patient's underlying medical condition.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
High pitched unusual scream; temp to 105 R starting 2 days p/vax recvd;
hardly a sore arm; This is a spontaneous report from a contactable consumer (patient himself). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 02Feb2021 (Lot Number: EN5318, Expiration Date: 31May2021) as unknown, single for COVID-19 immunisation. Medical history was none and there were no concomitant medications. On an unspecified date of Feb2021, the patient experienced hardly a sore arm. The patient thought it was a good idea to get the vaccine. He did not have anything except hardly a sore arm. The patient underwent lab tests and procedures which included sars-cov-2 test: positive, for it hadn't been 90 days since he had COVID that he got the vaccine on an unspecified date of Dec2020. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
I want to make a report because I had a sole of my foot that started swelling (mild) on Thursday (I got my shot on Wednesday). Then after that it felt my forehead akin was swelling. Now my chin and lips and right foot are swelling more. Other (more normal) side effects I had were:  tired and headache, on Wed night fever and nausea (only short time, 1-2 hours), On Thu swelling started (See above for description) and pain underneath my left armpit and swelling there too, small shocks/cramps in my arm muscles, especially left side.