chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 30-OCT-2013 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # reported as J006827, EXP date 14-SEP-2014) intramuscularly. The reporter reported that the patient was going to receive an unspecified flu shot (manufacturer unknown) in the same vaccination session and that she administered the ZOSTAVAX intramuscularly due to product confusion. No adverse effects reported. It was unknown if the patient sought medical attention. At the time of report, the status of patient was unknown. Additional information has been requested.
A non-serious spontaneous report of "7 patient were inadvertently administered expired H1N1" was received from a health professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. On 26-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
Case number PHEH2014US003608 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 16-year-old male patient. His medical history and concomitant medications were not reported. On an unknown date in NOV 2013, he was vaccinated with FLUCELVAX (batch number: 004011A) intramuscularly. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration"  was erroneously captured as listed and hence the labeling was not changed as unlisted and second indication off-label use was added to the case.
Breakthrough Case of COVID beginning 05:05/09/2022. SX began with mild cough and phlegm. It got worse I had a fever on 05/10/2022 or 05/11/2022 of about 100.5 for two days. I tested on 05/12/2022 and saw the APRN on 05/13/2022 and got PAXLOVID and I took my first doses that day. I was still pretty horrible, hoarse and sore throat and felt better almost immediately. Now I am better but still coughing and tired. My mouth tastes like I've been sucking on a rusty penny.  I am going to take the week off of work because I can.
Fatigue; dizziness, light-headedness; repeated episodes of atrial fibrillation and heart rate ranging between 37 and 180; nausea; repeated sensation that I might pass out.  These symptoms began on 2/23/21, 5 days after receiving the 2nd Moderna vaccine. Symptoms were similar to but more intense than symptoms experienced after my 1st Moderna vaccine. I was taken to the ER during the night of 02/24/2021 beause of intensification of symptoms.  Symptoms continued intermittently until 03/23/202 when a cardiac ablation was performed at a Cardiovascular Center.  I also experienced some post-op Afib in first 2 weeks following the procedure.
Patient reports continuous inflammation and pain in left deltoid 4 weeks after vaccine was given. Also reports stiff neck and upper back pain. There is a small wound that patient says has not healed at all, from where the vaccine was given. I suspect cellulitis, even if no longer active infection.
At 1146, RRT was called at the post-vaccination monitoring area for an 85 y/o female that was experiencing tingling throughout left arm after administration of the Pfizer vaccine at 1132. No other symptoms reported. Client?s car was off and she was accompanied by her neighbor, who was seated on the passenger seat. Client was the driver at the time. 2 RRT nurses responded to the scene with the E-kit and stethoscope. Head-to-toe assessment done, all WNL. Client speaking clearly, able to extend both arms, face symmetrical. Bilateral arms and legs have equal strength. Initial HR: 65, BP: 117/70, RR: 20, denies pain. Client?s arm tingling did not get worse or better. 911 assistance not needed at this time. Client recommended to be monitored for an additional 10 minutes by Recovery Nurse. Client was encouraged to have neighbor drive her home, which she consented. After additional 10-minute monitoring period, left arm remained the same and client did not experience any other symptoms. Neighbor moved to the driver?s seat and client is now in the passenger seat. Client advised to speak to her PCP about incident and if SOB and/or life-threatening problems occur, to call 911 or get to the nearest hospital/ER. Client and neighbor verbalized understanding.  All questions answered, all concerns met. Client left premises, her neighbor driving, via car @ 1210. Client exited with head-to-toe assessment WNL.
After about 25 minutes, tasted a funny taste in my mouth. My mouth started to feel funny like it was going numb. My chest felt warm and my arms started to feel like they were tingling. I told the RN nurse and they brought me to the back to be monitored.
Headache, SkinRash,  SKIN RASH APPEARED ON FACE BUT WENT AWAY ON JANUARY 3RD, 2021  Narrative:  PATIENT USED HYDROCORTISONE CREAM ON FACE WHICH HAD HELPED RESOLVE THE RASH
pt recv vax 17APR96 & 25APR 8th day p/vax pt ran t100-101 in AM;by PM fever inc to 104-105;5AM 26APR96 fever inc 106;MD notified 29APR96 of rxn;had swollen lymph glands in neck area;
About 5 hours after the vaccination the injection site became extremely sore and is still sore on the third day after the vaccination.  On the first night after the vaccination I began to get body aches.  During day 2 the body aches became extreme, where getting out of bed or moving was painful.  The body aches were less severe on days 2 and 3, but are still continuing on day 4.  I was running  a fever all of day during days 2, 3, and 4.  I was throwing up on day 3.  I had GI pain and diarrhea on day 4.  I never have headaches, but have had a headache since day 2 and it is now day 5.  I have had lower back pain since day 2 and that also continues today (day 5).
A child dose of the Hep B vaccine was pulled and given should had gotten the  adult Hep b
pain at the injection site; They both received their 1st dose of the covid vaccine on 23Mar2021. They are scheduled to receive their 2nd dose tomorrow, 9Apr2021; They both received their 1st dose of the covid vaccine on 23Mar2021. They are scheduled to receive their 2nd dose tomorrow, 9Apr2021; This is a spontaneous report from a contactable consumer (reported for her husband) via Medical Information Team. Caller reporting on behalf of her husband and her mother-in-law (85-years-old). A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 23Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller would like to know whether it is okay or safe to receive both doses of the covid vaccine 17 days apart. She explains the facility that gave the first dose doesn't have anymore dates available at 21 days or more. It says "unavailable vaccines" so they scheduled it at 17 days to get the second dose, which is 4 days before the recommended 21 days. Caller would like to know whether a person could die from receiving the 2nd dose of the vaccine so close; 17 days apart. She then states there is actually two people in the house that are getting the same vaccination. She clarifies her husband is also getting it and  his second dose is booked for 17 days. The patient experienced pain at the injection site (injection site pain) on an unspecified date, they both received their 1st dose of the covid vaccine on 23Mar2021. They are scheduled to receive their 2nd dose tomorrow, 09Apr2021 (inappropriate schedule of product administration) on an unspecified date. with outcome of unknown. The outcome of the events was unknown.  No follow-up information needed. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392477 same reporter/drug/event, different patient
experiencing "baby covid"; body aches/sore; tired; night sweats; nauseated; This is a spontaneous report from a non-contactable consumer (patient). A 59-years-old female patient received BNT162b2 (Comirnaty, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 15Oct2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On Oct2021, patient experienced baby COVID, had body aches, sore, tired, night sweats and nauseated. Patient stated that she was not running a fever. Patient asked how long these side effects should last and how long can she wait to get the second dose of Pfizer COVID-19 vaccine if she is still experiencing these side effects. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hospitalized for ruptured aortic aneurysm also increased cough and dyspnea.  Taken to surgery for repair.
Headache and nose bleeding around 18-20 hours after vaccination. No treatment requiered. Symtoms stopped 24 hours after started.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 58-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE PAIN (Pain and tenderness arm) and the second episode of VACCINATION SITE PAIN (Pain and tenderness arm) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced the first episode of VACCINATION SITE PAIN (Pain and tenderness arm) and the second episode of VACCINATION SITE PAIN (Pain and tenderness arm). At the time of the report, last episode of VACCINATION SITE PAIN (Pain and tenderness arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-033892 (Patient Link).
Extreme itchiness throughout the body and a feeling of needles and arms and legs and my lips
This spontaneous report as received from a 54 year old female patient reporting of herself with allergie and pain. No pertinent medical history and no drug reactions. Concomitant medications, included unspecified medicine for allergy and unspecified pain medicine. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and lot were not reported). On an unknown date, the patient developed round the insertion site ( red 4 inches all around). Unspecified treatment was given and no laboratory diagnostic test were performed. It was unknown if the patient sought medical attention. The outcome of developed around the insertion site ( 4 red inches all around) was unknown. Additional information is not expected because there is not contact patient information.
hives; burning sensation; I just had bad sweat; I got a rash; I got like a burning fever; This is a spontaneous report from a contactable consumer (patient himself).  A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EW0173 and Expiry date Sep2021), via an unspecified route of administration on 03May2021 (at the age of 51 years old) as dose 2, single for COVID-19 immunization. Patient received co-suspect of diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for an unspecified indication. The patient medical history was not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW10153 and Expiry date Jul2021), via an unspecified route of administration on 04Apr2021 as dose 1, single for COVID-19 immunization. Concomitant medications included lisinopril (LISINOPRIL) taken orally for blood pressure abnormal, start and stop date were not reported; rosuvastatin calcium (CRESTOR) taken orally for blood cholesterol, start and stop date were not reported; methadone (METHADONE) taken for back surgery, start and stop date were not reported. On unspecified date in May2021 patient experienced little hives and feel like a burning sensation and he got setup taken second dose and queried for was it all right if he had taken Benadryl. When probed for the dose of vaccine, patient stated, that yes, he had this morning about 9:45 this morning. Patient was informed about the Medical Information and provided with the number and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday and for Saturday and Sunday timings are 9 AM to 3 PM. Patient's initial was confirmed. Patient reported that, he just had sweat and he just had bad sweat with it and further stated that he knows what he mean that's now he mean that's the first start he had with it and he got a rash, he got like a burning fever. Outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.
PATIENT SELF DESCRIBED OVER PHONE A WARM, 7 INCH, RED REACTION AFTER RECEIVING ZOSTER VACCINE. SHE MARKED THE ARM TO MAKE SURE THAT THE SITE IS NOT GETTING WORSE. PATIENT ALSO TOOK DIPHENHYDRAMINE.
Developed a feeling of itchiness within entire body. No rash, no swelling, did not see primary medical doctor. Took own Benadryl at home for duration of symptoms-3 days.
Pt received his Pfizer vaccine second dose 7 days early. Pt first dose was on Friday 09/17/21 and should have returned on Friday 10/08/21.
Patient returned to our office on 5/17/07 (12 pm) with temperature of 101.1 F.
Psoriatic arthritis; Uveitis; Blepharitis; Deformation in fingers; Finger pain/fingers hurts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4257369-00.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administration date Feb2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous since 2019 (ongoing) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "Psoriatic arthritis"; UVEITIS (medically significant), outcome "not recovered", described as "Uveitis"; BLEPHARITIS (non-serious), outcome "not recovered", described as "Blepharitis"; FINGER DEFORMITY (non-serious), outcome "not recovered", described as "Deformation in fingers"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Finger pain/fingers hurts". The events "psoriatic arthritis", "uveitis", "blepharitis", "deformation in fingers" and "finger pain/fingers hurts" were evaluated at the physician office visit. The action taken for risankizumab was unknown. Clinical course: As of 27Jan2022 Patient was on Skyrizi and until first covid shot in Feb, it was doing wondered for all those conditions. After each vaccine, everything flared, but then patient came due for the next Skyrizi shot and everything, except the Psoriatic Arthritis, settled. Patient as of 27Jan2022 seeing even more deformation in fingers and they hurt so badly that typing hurt. Just that little bit of hitting of the keys sent spikes of pain into fingers. Patient had to change out all plush towels to the thinnest could find, ditto or wash cloths. It hurt too much to get into the cracks and crevices with the thick ones. Patient list of accommodations went on and on. Patient working with a pain doc who was also a functional doc to see if she can get pain under control. Patient knew that patient should see, but patient scared was going to suggest the addition of Plaquenil or Methotrexate and patient was leery of those two drugs. The reporter's causality for the event(s) of psoriatic arthritis, uveitis, blepharitis, deformation in fingers and finger pain/fingers hurts was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-SEP-2017, the patient was vaccinated with an expired dose of RECOMBIVAX 2.5/0.5 dosing form, injection, lot number L048208, expiration date 15-SEP-2017 (route and dose was not reported) for prophylaxis. No adverse effects were reported.
Chills; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Chills) in a 56-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concomitant products included DILTIAZEM (CARDIZEM [DILTIAZEM]), LOSARTAN POTASSIUM (LOSARTIN), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]), MULTIVITAMIN IRON and PROBIOTICS NOS for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-654636 (E2B Linked Report). This case was linked to MOD-2022-654626 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654636:Other patient case
Injection not felt - moderate soreness 4 hours after and lasted 1.5 days - day 3: headache, mild itchiness, L axilla pain (especially with applying deodorant and swollen, ?lymph node/immune system response?) - day 4: severe fatigue, nausea, severe headache (acetaminophen, nor ibuprofen helped), generalized mild itchiness - day 5-6: persistent fatigue, moderate to severe headache, L axilla pain and noticed redness and moderate itchiness to half of the upper arm from injection site towards elbow (not hot to touch, nor swollen, nor red streaks) - day 8: headache and fatigue became mild/subsided - day 12: itchiness very mild and redness faint, no longer with L axilla pain
Pt. states that after receiving the 3rd dose of Moderna 12/22/2021, started experiencing symptoms 12/23/2021 of fatigue, soreness of the injection arm, and Left under arm area swollen (Lymphnoid). 12/25/2021 Left arm pain throughout, self-treating with Tylenol. No noted Primary visit/communications.
Redness, swelling pain began few days after immunization. Area enlarged to 6-7 cm size.
received Ipol from a MDV that was opened and deemed not safe to use / no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.   This case is linked to case 2019SA264011 (same reporter).  This case involves a 14 years old female patient who received 0.5 ml dose of IPV (VERO) lot PIE70 via intramuscular route in the right arm on 11-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP), MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) and HEPATITIS B VACCINE (HEPATITIS-B).  It was a actual medication error case due to incorrect product storage.  It was reported that 2 patient's that received Ipol from a MDV that was opened and deemed not safe to use. The physician mentioned that she thinks that she should be able to use her clinical judgment as to whether or not to reinjection her patient's and she did not believe that this situation warrented it.  At a 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.  List of documents held by sender: none.