chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Recalled Lot  Product was administered; Recalled Lot  Product administered; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter's Comments: The vaccine coordinator reported a dose of Engerix-B from recalled Lot Product was administered to patients. The patients were administered this lot number but no adverse event reported. The reporter inquired what information should they send to patient regarding Engerix recall from back in October 2021. The reporter did not consent to follow-up. Additional Supportive Information: The patient received engerix B from recalled Lot which led to recalled drug administered and drug dispensing error. This is one of 10 cases reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR085025:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085026:Same Reporter US-GLAXOSMITHKLINE-US2022084603:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085028:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085029:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085030:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085031:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085032:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085033:Same Reporter
Patient said he had an appointment for his second Pfizer vaccine. He did not have his card with him. I thought he had the first one on 01/19/22 but when I wrote out his new card after the shot I realized he had it on 01/29/22 - 7 days too soon.  The patient said he is not worried, just glad he got the vaccine.
While getting up after receiving shots, the pt fell and hit left eye on counter. The pt had laceration to left upper eyelid was diaphoretic and dizzy.
Hib (ActHIB) was reconstituted with a single vial of sterile water instead of the 0.4% sodium chloride diluent that comes with the vaccine. No adverse effects, signs or symptoms were shown by patient.
Pt came to the pharmacy on 7/14/12 with her upper arm red, bruise and warm to the touch. Pt reported that the injection site started out with a small rash the slowly spread to the size of a tennis ball. No trouble breathing or SOB. Pt was instructed to tk BENADRYL and follow up with MD.
Patient presented 2 hours after receiving influenza vaccine with facial and earlobe swelling. Prednisone 40 mg BID, Diphenhydramine 50 mg TID, Ranitidine 150 mg BID.
On day 3 after receiving the second dose of the Pfizer vaccine, all the lymph nodes on the left side of my body from behind my ear, down my jawline, down my neck, under my arm,; my upper torso well all enlarged and swollen; fever of 101 and was completely exhausted; completely exhausted; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration, administered in Left Arm on 15Apr2021 09:15 AM (at the age of 50 years old) as DOSE 2, SINGLE for COVID-19 immunisation at Pharmacy or Drug Store.  Medical history included malignant melanoma (recovered). The patient has known allergies to Iodine, codeine, Cephdiner. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Device Date was reported as 12Jul2021.Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY); ascorbic acid, betacarotene, biotin, calcium carbonate, calcium phosphate, chlorine, colecalciferol, cupric oxide, ferrous fumarate, folic acid, iodine, magnesium oxide, manganese sulfate, molybdenum, nickel sulfate, nicotinamide, pantothenic acid, phosphorus, potassium chloride, pyridoxine hydrochloride, retinol acetate, riboflavin, selenium, silicon, thiamine, tin, tocopherol, vanadium, vitamin b12 nos, zinc oxide (MULTIVITAMINS AND MINERALS PLUS LUTEIN) and Birth control. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: unknown), as first dose in arm Left on 17Mar2021 as dose 1, single for COVID-19 immunization. On 18Apr2021, day 3 after receiving the second dose of the Pfizer vaccine, all the lymph nodes on the left side of my body from behind my ear, down my jawline, down my neck, under my arm, my upper torso well all enlarged and swollen. I had a fever of 101 and was completely exhausted. This lasted for 10 days before she started feeling better. The fever would come and go. No treatment was received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included pyrexia: 101 Fahrenheit on 18Apr2021. The outcome of the events was recovered on an unspecified date in 2021.    Was requested for additional information  Information about lot/batch number is requested.
Approximately 17 days after 1 dose administered patient noted chord like feeling in armpit of right arm.  Followed up with his PCP who stated they could  not be sure but thought there may be a correlation between the superficial thrombosis that was discovered and the administration of the COVID-19 vaccine.
Immediately after administering vaccine Very weak, difficulty breathing.  Respiration rate dropped to 91%. Took blood pressure, observed me.
Patient received Pfizer BioNTech dose 1 on 11/24/2021 and Pfizer BioNTech dose 2 on 12/15/2021. Received Moderna booster dose (0.25mL) on 08/02/2022.
Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C; Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C; This spontaneous case was reported by a health care professional and describes the occurrence of the first episode of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) and the second episode of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced the first episode of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) and the second episode of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C). On 02-Apr-2021, last episode of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Warm Transferred from Moderna Customer Care Case No.00135704. HCP reported on 02Apr2021 that they had power outage on 02Apr2021 and vials were in Freezer and Refrigerator where Temperature dropped to : Frozen Vaccine 47Minutes -13.79 C Refrigerator 59 Minutes 12 C and effected vials are: Lot no 003B21A, 100 doses Lot no 027B21A 100 doses Lot no 030B21A 100 doses Lot No 02B21A 140 doses HCP said that 63 doses were administered to 63 Patients. She provided all requested information of patients who received the effected Vaccine.  No concomitant medications were provided.   This case was linked to MOD-2021-066578 (Patient Link).; Sender's Comments: This report refers to a case of Product storage error and Expired product adminsitered for mRNA-1273, lot # 003B21A  with no associated AEs.
Pt recv vax on 4/21/99; on 4/22/99 pt exp red vax site, fever (102), favoring a leg
Indigestion; Ringing in ears; increase in her Blood pressure; headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Indigestion), TINNITUS (Ringing in ears), BLOOD PRESSURE INCREASED (increase in her Blood pressure) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced DYSPEPSIA (Indigestion), TINNITUS (Ringing in ears), BLOOD PRESSURE INCREASED (increase in her Blood pressure) and HEADACHE (headache). On 16-Apr-2021, DYSPEPSIA (Indigestion) and HEADACHE (headache) had resolved. On 19-Apr-2021, BLOOD PRESSURE INCREASED (increase in her Blood pressure) had resolved. At the time of the report, TINNITUS (Ringing in ears) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Blood pressure measurement: increased (High) blood pressure is increased..         Action taken with  the product mRNA-1273 is not applicable.  Concomitant drug included  blood pressure medications.  Treatment medications were not reported.
headache, dizzy, Nausea; symptoms began with a headache about 4.5 hours after injection.  increased throughout the afternoon/evening.  Feeling ok 48 hours after injection
She got tested positive for the Covid-19 virus; This is a spontaneous report from a Pfizer-sponsored Program, COVAX US Support. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 06Feb2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the caller's got her 1st vaccine last 06Feb2021, but after a week last 14Feb2021, she got tested positive for the Covid-19 virus and started seeing symptoms on 15Feb2021. Patient next schedule will be on 27Feb2021, and patient was asking if it will be possible to continue. The outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Left arm site became red, tender, raised. Severe vomiting for 12 hours.
Confusion; This spontaneous case was reported by a patient and describes the occurrence of CONFUSIONAL STATE (Confusion) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter. .     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced CONFUSIONAL STATE (Confusion). At the time of the report, CONFUSIONAL STATE (Confusion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter. No  concomitant medical  provided by the reporter
I went to bed on January 26th and my arm felt a bit sore. I woke up the next morning (Jan 27th) the site where I was injected with the vaccine was red, swollen, and hot to touch. I immediately called the urgent care where I got it done, no answer. I then went to another urgent care and they wouldnt see me. I then took myself to the ER they suspect it was an infection most likely cellulitis of the left shoulder. The dr prescribed me Bactrim, he drew a circle around the area and if it gets bigger or doesnt change in size in 2 days to come back and get it checked for further information. I then tried the Urgent care again NO ANSWER! the dr suspects maybe I got an infection from the needle not cleaning the area well...
Achy; Cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) and PAIN (Achy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Daily dose, Solution for injection in pre-filled pen. On 25-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NASOPHARYNGITIS (Cold). On an unknown date, the patient experienced PAIN (Achy). At the time of the report, NASOPHARYNGITIS (Cold) and PAIN (Achy) had resolved.            Concomitant Drugs were not reported.  The reporter's causality for the events of Cold and Achy with HUMIRA(Adalimumab) was no reasonable possibility.  No treatment information was provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Large local reaction approximately 10cm size, characterized pain, swelling, inc warmth, induration & lump.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 78 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Pt received a vaccination from an expired vial of Hep B. (exp date 2-2-09). Parents were advised to revaccinate the child. No adverse reactions have been reported to date.
Myalgia,SkinRash, Rash, HYPERtension,  Pain at the insertion site, myalgia, rash to neck & back, itchiness to the throat Narrative: Developed pain at the insertion site and myalgia on 12/31/2020 1 hour after vaccination. On 01/01/21 developed rash to the neck & back and itchiness to the throat. She was seen at ER on 01/01 with a temp of 36.8 C, B/P 175/90, and HR 102. She was given Solu-u-Medrol 125mg IVP, Pepcid 20mg IVP, and Benadryl 25mg IVP. Symptoms resolved and B/P post treatment 125/80. Discharged home with Prednisone 40mg x 5day PO, Vistaril 25mg Q 6 hours PRN, and Pepcid 20mg x 5 days PO. Reports today 01/2/21 rash completely resolved. Has a history of allergic reaction to antibiotics. Reports had an anaphylaxis reaction to cephalosporin 4 years ago requiring a Epi injection in the ER. Reports history of allergic reaction to antibiotics; PCN, Macrolide, and Fluoroquinolones treated with High Dose Steroids.
Intermittent dizziness. Started on DAY 2 after covid test, started when I had any amount of alcohol, I thought it was just the alcohol. I have stopped having any alcohol since 5 days ago but starting on Wednesday the 21st I started getting dizzy randomly throughout the day-- felt more like car sickness, no room spinning but definitely noticable and had to lie down a few times. I am still feeling dizziness throughout the day (it is 4/24). It is mild, I would say it is 4 out of 10. Today I also had fatigue and didn't really leave bed.
(L) outer thigh with 8 cm erythema & 3 cm induration at injection site. Temp 100.1.
An expired MMRII was administered to the left thigh. The expiration date is 11/20/2019. No adverse reactions occurred. Mother was made aware and will bring child back after four weeks for MMR dose.
Hard knot at site. Redness, swelling, fever x 3 days. All Sx gone at 7 days except knot and  tenderness. Site of SQ injection, not TDAP.
Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer reporting same event(s) under the same suspect product(s) for 37 patients. This is for 14th (69-year-old-male) of the 37people. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 06Feb2021 (Lot Number: EN5318) as dose 2, single and dose 1 via an unspecified route of administration on 16Jan2021 (Lot Number: EJ1686) as dose 1, single for covid-19 immunisation. Medical history included ongoing diabetes, ongoing Parkinson's disease, ongoing rheumatoid arthritis.  The patient's concomitant medications were not reported. Caller was an Assistant Director of Health and works at a local health department called because she had some concerns, and the health department was tracking breakthrough cases in her area. Stated 15% of breakthrough cases were from one Pfizer Covid 19 Lot number: EN5318. On 30Jul2021, patient tested positive for covid virus, longer than two weeks after both doses. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Jul2021. Product Complaint description included Caller reported 37 breakthrough cases, for fully vaccinated patients testing positive for Covid. The clinical outcome of the events was unknown at the time of report.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/ drug/ AE, different patient
2 days after DTaP administered on Rt thigh on 3/3/17 pt began with redness on Rt thigh. On 3/6/17 induration and erythema measured 15x14cm on Rt thigh.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or around 13-NOV-2013 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live(ZOSTAVAX) inoculation (unknown date), he was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. Outcome of shingles was not provided. The lawyer considered the shingles to be related to zoster vaccine live(ZOSTAVAX).
Patient started to have nausea and daughter took patient to ER on 10/12/18, patient was given Zofran for nausea at the ER and prescription to take home and he felt much better, but he is still experiencing some nausea.
PCV-13 administered to (R) arm 1/12/16. Had soreness for several days, then redness and itching, mild swelling. Seen 1/19/16 and redness on (R) arm noted, 14 cm x 11 cm with mild skin swelling. No fever.
Had her second dose of the Moderna Vaccine 6 days ago.  On day 2 she had a headache, fatigue and fever of 100.9 which went away after 24 hours.  The fever was proceeded by eye puffiness and a rash on day 3 in all flexure surfaces, buttocks, bikini line and axillary area included.  Rash with sunburn appearance.  Called nurse  when rash occurred and advised to take benedryl which made her more tired but helped symptoms.  Rash went way after 24 hours.  Puffy eyes still remain but less pronounced.  Patient has picture of rash with her today.  Since that time feeling body aches, migraine and fatigue.
Initial case report received from a physician via MedCom on 19 OCT 2009. A male patient was vaccinated with S-OIV FLUVIRIN (batch no. 102124P1) i.m. on 13 OCT 2009. No adverse events were reported. MedCom reference no.: NA09-008308. This case was earlier reported as MA2009-5163. Follow up received on 04 Feb 2010: The patient's demographics was amended.
Aches; Chills; Slight fever; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 15Apr2021 at 13:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medications included melatonin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 15Apr2021 at 17:00, the patient experienced aches, chills, slight fever and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events aches, chills, slight fever and diarrhea was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
The injection site became inflamed, reddened, and induration on 03/03/2002 and the vaccine was administered two days prior.
Hives, redness, and swelling a few millimeters below injection site; the reaction is confined to the upper left arm, no spread.
Dizziness, unable to read newspaper, paleness,weakness, fast heart beat. Went to ex-husband's medical office to lie down. BP=110/70, Pulse low. Rested there 2 hrs. Felt weak all day