chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient arrived to the ER with c/o SOB onset 4 weeks ago, worsening in the past 2 weeks.  Patient reports having a productive cough with green phlegm and chest congestion. Pt 02 sat was in the 80's at home. Patient diagnosed with acute hypoxemic respiratory failure secondary to Covid-19 pneumonia. Patient received IV Decadron, IV abx. Patient discharged home with home o2.
market shortage; This case was reported by a consumer and described the occurrence of product supply issue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, not able to get 2nd dose of Shingrix becasue of market shortage, which led to product supply issue. The reporter asked, it was been 1.5 years could go ahead and get second dose now or did have to restart the series. The reporter did not consent to follow up.
patient reported pain in the back/armpit area and then noticed swelling under the armpit. he said it was very tender
VAXELIS was administered to 6 patients after product experienced an excursion was was not suitable to use.; This non-serious spontaneous safety report was received on 23-FEB-2023, from a HCP. This case is linked to case MCM-004541 (reference number 2023SA055890 and Inquiry number 01495388).  Due to the nature of the event, the causality between the reported event "VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use" and Vaxelis was not applicable.  No further information is expected given that there were no adverse events following Vaxelis administration post-excursion.  For reference purposes this case is linked to MCM-004541 (source case), MCM-004562, MCM-004564, MCM-004565, and MCM-004566, due to same reporter.
third dose of Shingrix administered; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On 23rd September 2021, the patient received the 3rd dose of Shingrix. On 23rd September 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The pharmacy intern reported that, the patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
Sharp headache, fever, chills, exhaustion, sleeplessness, mild dizziness, pain at injection site that increases with time
His eye doctor feels this vaccine has re-activated his shingles in his left eye which has been asleep for over 2 years.; His eye doctor feels this vaccine has re-activated his shingles in his left eye which has been asleep for over 2 years.; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6201) via an unspecified route of administration, administered on the left arm on 09Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included sleep apnea, afib and shingles in his left eye (asleep for over 2 years). Concomitant medications included levothyroxine; hydrochlorothiazide, lisinopril (LISINOPRIL/HYDROCHLOROTHIAZIDE); aspirin [acetylsalicylic acid]; colecalciferol (VIT D3); rivaroxaban (XARELTO); atorvastatin; prednisolone acetate; chondroitin sulfate, glucosamine (MOVE FREE [CHONDROITIN SULFATE;GLUCOSAMINE]). The patient's eye doctor felt this vaccine has re-activated his shingles in his left eye on 12Mar2021 which has been asleep for over 2 years. The events resulted to a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included increase dosage of the prednisolone ac 1% and is now taking Valacyclavir HCL. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was not recovered.
The initial spontaneous case, received from other health professional (Pharmacist) on 19-Dec-2017, concerns a 15-year-old adolescent female patient. The patient's medical history and concomitant medication were not reported. On 18-Dec-2017, while administering the vaccine, about one-third to half of the FLUVIRIN vaccine was not injected into the arm (dose: less than 0.5ml (as reported), route of administration: intramuscular, anatomical location: deltoid, batch no: 179901P and expiry date: 31-May-2018) (explicitly coded as incomplete dose administered). It was reported that, the patient did not experience any adverse event and product complaint had been submitted. The patient was administered with second dose of FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid). The PTC (product technical complaint) number was 1026788. Based on the investigation performed, it was concluded that FLUVIRIN batch 179001P was manufactured in accordance with cGMP requirements and in compliance with approved procedures. No issues were identified in the manufacture of the product batch or the syringes used. The leakage location was reported that the fluid was leaking out through the locker device while the vaccine was administered, however, without a complaint sample available, sample analysis cannot be performed to verify a defect or determine a root cause. It was not possible to rule out that the cause was due to a defective needle or the use of an incompatible needle, however, this cannot be considered as a confirmed root cause. No CAPA(s) are required as a definitive root cause could not be determined. At this stage, although there has been a total of nine complaints received for leaking syringes, there was no indication of a trend for the manufacturing campaign. None of the implicated product batches share common syringe batches and there were range of different leakage locations reported. Six of the complaints have been deemed not to be justified and the other three cases concluded as not determinable, as no internal root cause could be confirmed and no complaint sample was available to confirm defect. The reporter assessed this case as non-serious. Follow up received from QA department on 27-Mar-2018: PTC (product technical complaint) results was received which was integrated in the case narrative. Non-significant case correction received 27-Mar-2018: The PTC result in follow-up line of version 1 (received on 27-Mar-2018) was deleted and added the sentence 'PTC (product technical complaint) results was received which was integrated in the case narrative' to signify the batch review report results received in FUP version. Update on 11-Nov-2018: Non-significant case correction (19-Dec-2017): The term 'PTC Reference Number' was added in the notes section of the additional information tab.
Attendee received first dose Pfizer vaccine at 11:54 am in the right arm.  Lot# FA7484. Attendee was directed to observation area.   At 12:15 voiced complaints of nausea.  Attendee assisted to the cot to lie down.   HR:  68   BP:  124/70   RR:   14   O2Sat%:  99   Temp:  98.1      12:22 - Attendee stated she felt better and wanted to leave.  EOA called for assistance.  12:25 - Attendee attempting to leave.  Refused to let the site get another set of vital signs. EOA spoke with attendee, but she was adamant that she was leaving. 12:26 - Care Practitioner educated on home discharge/adverse reaction instructions and attendee was discharged to home with her mother and her child, who were in attendance with her at the site.
This spontaneous report as received from the female adult healthcare worker reporting on herself. The health care worker stated that she may have received the last (third) dose of GARDASIL when she was 27 years of age. No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Had body aches and low grade fever 99 +, took Tylenol 500mg, and fever broke. Next day just didn't feel well, tired and little nauseated. That lasted all day but next day felt fine.
This spontaneous case, initially received from a pharmacist on 31-Oct-2018 and follow up received on 06-Nov-2018 (combinedly processed), concerns an 83-year-old, elderly female patient. On an unspecified date, before administration of the product FLUAD TIV [dose: 0.5 ml, batch number: 250803, expiry date: 30-Jun-2019, route of administration and anatomical location: not reported], the pharmacist accidently stuck herself with the PFS. The pharmacist reported that the needle was stuck due to her gloves which stuck onto the adhesive residue present on the syringe barrel where the batch number sticker was removed. No adverse reactions were experienced due to accidental needle stick. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was 1034932. The reporter assessed this case as non-serious. This case was considered as lost to follow up as the reporter did not provide consent for follow up.
psoriasis like symptoms on fingernails / currently have extreme fingernail; diagnosed with nail psoriasis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NAIL DISORDER (psoriasis like symptoms on fingernails / currently have extreme fingernail) and NAIL PSORIASIS (diagnosed with nail psoriasis) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002V21A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included Neuropathy (in leg.). Family history included Skin disorder since an unknown date, Psoriasis (Mother's side) and Eczema (father's side). Concurrent medical conditions included Diabetes (2), Drug allergy (Statins), Rheumatoid arthritis, Cholesterol and Asthma. Concomitant products included MONTELUKAST from 05-Jan-2020 to an unknown date and SALBUTAMOL (ALBUTEROL HFA) from 05-Jan-2020 to an unknown date for Asthma, EZETIMIBE from 01-Jan-2016 to an unknown date for Cholesterol, METFORMIN HCL from 01-Jan-2016 to an unknown date for Diabetes, VITAMINS NOS for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, 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 experienced NAIL DISORDER (psoriasis like symptoms on fingernails / currently have extreme fingernail) and NAIL PSORIASIS (diagnosed with nail psoriasis). The patient was treated with HYDROGEN PEROXIDE at an unspecified dose and frequency. At the time of the report, NAIL DISORDER (psoriasis like symptoms on fingernails / currently have extreme fingernail) and NAIL PSORIASIS (diagnosed with nail psoriasis) had not resolved.            Patient had COVID-19 test in Feb 2021. Patient visited general practitioner(GP) on 06 Apr 2021 and he sent pictures of nail on 22 May 2021. Patient visited dermatologist on 14 Jul 2021,fungal samples and toe nails samples were given and awaiting for results.     .   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up Information Received. Event Outcome updated from unknown to Not recovered On 14-Jul-2021: Follow-up Information Received.  Added new event [diagnosed with nail psoriasis]. On 16-Jul-2021: Updated family history [ Psoriasis and Eczema]. Added Vaccination center details. Added Concomitant medicines[ ALBUTEROL HFA] and other concomitant doses.
C/O chills, fever, headache, body aches and joint pain, lethargy x 6 days.
Pt. states that after receiving the 1st dose of Moderna 08/18/2021, started experiencing symptoms 08/19/2021 of loose stool (2 weeks), A-Fib (2 weeks), and pressure in the head (6 weeks). No noted Primary visit/communications.
(L) arm swollen, close to twice the size of (R) arm, hot, a 4-5" round area, itchy. (Per mother's phone call).
w/in 1-2 hr p/vax;h/a that got worse;by evening n/v, dizzy, unable to get out of bed;2wk on less severe flu sx, chills, sweats, fever, feels like fever, h/a;
very extreem chest pains to the point i thought i was having a heart attact and had to take my nitrowent to my PCP on 1/18/21 they did an EKG and said everything there is fine i am continuing having chest pains even today just alot less
Pt experienced chills, achy bones in arms for 2-4 days, loss of appetite in the morning for 2 days. Pt stayed home and rested.
Pt recvd 3 Hepatitis-B vax on 26JUL89, 29AUG89, & 23JAN90 & following these, titer was neg; Pt recvd a 4th dose of vax on 15AUG90 p/4th dose titer was neg;
She broke on in hives on her face. They started off small and got larger. Some of them disappeared off of her face and then she had then on her arms and legs. Accompanied by a fever of 102.1 being the highest. After the dr told me to give her Benadryl she continued to get them. The following morning her legs were covered with small clusters of hives and her face had larger ones. The Benadryl was administered every 6 hrs 1.5 ml. It did help after an hour or so but they always came back. This last for 5 days. I kept returning to Drs. Office considering her she had a fever for so long and still had rash.
This spontaneous case was reported by a consumer and describes the occurrence of LOCALISED INFECTION (Infection in a finger) in a 74-year-old patient of an unknown 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 LOCALISED INFECTION (Infection in a finger). At the time of the report, LOCALISED INFECTION (Infection in a finger) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient wanted to know if the patient could get Moderna booster dose or not, if the patient was taking antibiotics. The patient had an infection in a finger. Treatment medication included antibiotics.No Concomitant drug details was reported.This case concerns a 74-year-old patient of an unknown gender with no relevant medical history, who experienced the unexpected event of Localized Infection. The event occurred on an unknown date after receiving an unknown dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This case concerns a 74-year-old patient of an unknown gender with no relevant medical history, who experienced the unexpected event of Localized Infection. The event occurred on an unknown date after receiving an unknown dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Admitted from ED on 7/8/21 with c/o nausea, diarrhea, body aches, headache, SOB, malaise, diffuse muscle cramps.  Headache on L side worsening.  Also c/o heartburn
left side face numb, drooping, couldn't move it, stroke ruled out, appeared to be symptoms of Bell's palsy
Information has been received from a registered nurse concerning a 13 year old female who on 17-JUL-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 657006/0188U). On 27-AUG-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 657006/0188U). On 20-FEB-2008, the patient was vaccinated intramuscularly with her third dose of GARDASIL (Lot # 659657/1487U). Concomitant therapy included ALLEGRA. On 20-FEB-2008, a few minutes after her third dose, the patient developed hives on her arms, shoulder, neck and some lip swelling. The patient was given BENADRYL in the office and seems to have improved. The patient's father noted that the patient has developed rashes and wheezing several times over the last six months. No further information was provided. Additional information has been requested.
Shortly after receiving the Covid booster, I had shooting pain in my left eye.  It didn't last long.  That was on Friday afternoon and it happened again on Saturday.  I contacted pharmacy on Sunday (they were closed but called me back) and told them about the pain and asked if it was a symptom of the booster.  They said no, but to check the fact sheet online.  I only had the shooting pain twice but my left eye felt tired and sore especially if I looked to the left for several days.
Narrative: This was the patient's 3rd Covid shot. She tolerated the first 2 doses. Her previous dose was given on 5/13/21. She has only gotten Moderna. Since she was considered immunocompromised, she was given the full 0.5mL dose. Approximately 5 minutes after receiving her shot, patient began to report "feeling funny." She described her symptoms as "feeling buzzed;" as if she had just drank alcohol and felt flushes and a little lightheaded. Face appeared flush and eyes were watery. Her blood pressure was taken and it was 164/121, pulse 68 to 74 with O2 saturations between 96% and 98%. Patient reported "slight headache, metallic taste and super dry mouth." Patient reported that she started 3 new medications since her last Covid shot and she had a CT scan with contrast at approximately noontime on 12/10/21. Patient then developed slight, left sided chest pain that was stabbing in nature. Urgent care was called and the patient was evaluated. Urgent care provider noted that patient had some trouble expressing herself or quickly responding to questions although her speech was not slurred. Blood pressure was rechecked and went down to 142/105. No respiratory distress noted. Patient transported to area hospital for further evaluation. Patient was called on 12/13/21 to see how she was doing and she was at home and "not feeling well" since Covid shot. Patient said she would call if she needed any additional medical needs.
Fever; Muscle spasms or glitching; This is a spontaneous report from a contactable consumer (Patient's parent). A 15-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FA7485), via an unspecified route of administration, administered in left arm on 07Aug2021 at 10:30 (at the age of 15-years) as dose 1, single for covid-19 immunization. The patient medical history included none (Patient History: No). There were no concomitant medications. The patient had not received any other vaccine within 4 weeks prior to Covid-19 vaccination. Following vaccination on an unspecified date in Aug2021, the reporter stated that the patient had fever and muscle spasms or glitching. The reporter queried that whether having muscle spasm as a side effect was normal. The patient underwent lab tests and procedures on an unspecified date after vaccination which included lab work count was done like a physical (unknown). Therapeutic measures were taken as a result of fever, muscle spasms or glitching and included treatment with Ibuprofen. The outcome of the events was not recovered at the time of report.   Follow-up attempts are completed. No further information is expected.
small rash itchy around the injection site (R arm); small rash itchy around the injection site (R arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (small rash itchy around the injection site (R arm)) and VACCINATION SITE PRURITUS (small rash itchy around the injection site (R arm)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (small rash itchy around the injection site (R arm)) and VACCINATION SITE PRURITUS (small rash itchy around the injection site (R arm)). At the time of the report, VACCINATION SITE RASH (small rash itchy around the injection site (R arm)) and VACCINATION SITE PRURITUS (small rash itchy around the injection site (R arm)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt says,  she has itching & bumps on right arm for last 4 weeks since she got shot
Severe rash on body 2 days after vaccination. Skin is very red and burns in some locations
My lymph nodes under my chin are swollen, hurt, and are warm to the touch . approximate size of swollen area is larger than a golf ball in diameter.
received doses from the same lot number #015h22a administered after 30-day Use By Date; The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015h22a) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date).    No concomitant medications were reported.   The vial size reported was 2.5 milliliter. The vial was initially stored in refrigerator on 01-Nov-2022. The vial did not undergo any temperature excursion.   No treatment details were reported.