chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1.5 days post vaccine, patient developed a rash on right side of face.  Above Right eye brow spreading to the back of the ear to the bottom of the jaw line.  Some sensitivity and itching.   Provider thought it might be shingles, another clinic told patient to take Benadryl and Pepcid. (He already takes Zyrtec.  Patient plans to use this if reaction occurs again. ,RN   JD   4/15/21 3:23 PM Note    Patient sent a message notifying us that he has a facial rash which is tender to the touch. There is a photo attached to the message. APRN reviewed the message and picture and feels it is uncommon to develop a rash after the COVID vaccine. He can take benadryl and Pepcid to help. APRN will also send out a new prescription to increase patient's Acyclovir to 800 mg PO BID. Patient does not have a PCP to evaluate his skin at this time so it was recommended to him to go to the Urgent Care to be evaluated for shingles.  Patient verbalized his understanding.   Patient, RN   Conversation: Rash PA-C   PA-C   4/30/21 12:50 PM Incomplete Note    Chart review performed. Patient concerned about a rash that developed on the right side of his face 1 1/2 days after his 1st COVID vaccine on 4/9/21.   He called his provider on 4/9/21 to ask what he should do and uploaded a photo. The photo showed an evident raised somewhat erythematous rash located on the upper right side of his face near the eye with one area on the right nasal alae. Areas of redness appeared to have well-demarcated borders. No evidence of vesicles, pustules, scale, abrasions, excoriations, or ulcerations.      HisNo evidence in his chart that he went to a medical facility site, however he stated he went to medical facility o/a 4/9/21 to rule out shingles as recommended by his provider. States they told him he did not have shingles and recommended some OTC and other meds he already had at home.   benadryl, zofran (had some at home), and pepcid OTC. Added Benadryl cream.      Was itchy with sweating and a little tender, but not really. Rash disappeared a few hours after waking up one day after 2 1/2 weeks. No problems with vision. Second vaccine today. No problems after vaccine today. Has no PCM, because everyone is full. No meds since home. Little groggy. Disability. Nose lesions resolved and he scratched. He denies any new lotions, soaps, detergents, and states he has some facial wipes that he uses to clean sweat off his face for a long time.
Tinnitus.   I did not notice immediately,  but believe it started shortly after the first shot.  it has gotten progressively worse.
Three separate spots of phlebitis on my legs/These are technically not "blood clots"; This spontaneous case was reported by a consumer and describes the occurrence of PHLEBITIS (Three separate spots of phlebitis on my legs/These are technically not "blood clots") 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PHLEBITIS (Three separate spots of phlebitis on my legs/These are technically not "blood clots"). At the time of the report, PHLEBITIS (Three separate spots of phlebitis on my legs/These are technically not "blood clots") outcome was unknown.      Concomitant product use was not provided.   Treatment information was not provided.
expired Moderna vaccine administered to patients; vials were initially stored in the refrigerator on 05-Apr-2022 and then administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (vials were initially stored in the refrigerator on 05-Apr-2022 and then administered) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) 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 EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (vials were initially stored in the refrigerator on 05-Apr-2022 and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (vials were initially stored in the refrigerator on 05-Apr-2022 and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Reportedly, 20 doses were initially stored in the refrigerator on 05-Apr-2022. Manufacturing date was reported as 01-Dec-2021.  Patients had not reported any adverse reactions.  Doses were administered after 30-day Use By Date or after manufacturer date of expiry. Vaccines were administered in between 06-Apr-2022 to 09-Apr-2022.  The vials did not undergo any temperature excursions.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538689, MOD-2022-538701, MOD-2022-538672 (Patient Link).
I had a huge headache which had weird sensations in my arms and legs numbness and then had vomiting.
This spontaneous report was received from a nurse practitioner, and refers to a 15 month old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 27-SEP-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # M034189, expiration date 23-MAY-2019, for prophylaxis. No adverse effects reported. The temperature excursions were as follows: 32.8°F during 10 hours, 14°C during 12 hours, and 8.1°C during 30 minutes. Digital data logger involved.
slightly sore left arm (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slightly sore left arm (1st dose)) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Patient had never tested positive for COVID.  Previously administered products included for Product used for unknown indication: seasonal flu vaccine (Sometime in 2021) in 2021. Past adverse reactions to the above products included No adverse event with seasonal flu vaccine. Concurrent medical conditions included Seafood allergy (Shrimp) and Seafood allergy (Lobster). Concomitant products included ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (slightly sore left arm (1st dose)). At the time of the report, VACCINATION SITE PAIN (slightly sore left arm (1st dose)) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included unknown  low blood pressure medication used as preventative.  No treatment information was provided.   This case was linked to MOD-2022-533478, MOD-2022-533479 (Patient Link).   Reporter did not allow further contact
Severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 Immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Severe headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two days ago (01/25) arm was more sore/numb at some points. Injection site itself became hard; Patient increased arm movement. The arm soreness increased warm and red. Injection site mild, told him to see primary.
Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medication was given to the patient.  The vaccines were stored in freezer and took out one to two vials and placed in freezer each day as needed.
Immediate burning and pain at injection site. Pain and burning down arm over the next couple hours. Pain continued for a couple of days, but the burning subsided after a coupled of hours after injection.  On the 8th day - April 2, 2021 - woke up with numbness in right arm, arm was swelling. Swelling continued all day. At 9:30PM upper arm and shoulder started itching, and the injection site got a bump like an ant bite and a hive like rash around it. Looked like allergic reaction. Pain in arm started and traveled length of arm to numbness in hand. All happened very quickly. Found an article online about "vaccine arm" and found antihistamine was working for people. So I took 2 25mg Benadryl tablets. Went to sleep 30 min later.   4/3/2021 - woke up, bump in injection site gone. Pain in arm and numbness in hand still continuing, but has turned into a tingling numbness. Arm feels weak.
No reactions to the 1st shot (01/26/2021) No reactions to the 2nd shot (02/16/2021) VERY HIGH BLOOD PRESSURE FROM 3RD SHOT WHICH WAS ADMINISTERED 10/01/2021 ON 10/04/2021 AT 5:25 PM MY BLOOD PRESSURE WAS 239 / 143 i CALLED 911 AND WAS TAKEN TO THE ER  MY PCP PRESCRIBED AMLODIPINE WHICH I TOOK MY BLOOD PRESSURE "STABILIZED" AT ABOUT 150 / 110 ON 10/06 IT SPIKE AGAIN TO 204 / 130 AT 11PM.  I AGAIN WENT TO THE ER. BY 10/08 IT HAD RETURNED TO ITS NORMAL 111/ 75 IN SUMMARY: MY SIDE EFFECT WAS 1 WEEK OF VERY HIGH BLOOD PRESSURE
9 days after receiving 2nd vaccination, I began having extreme fatigue and muscle aches all over my body.  This lasted about 3 days, but the fatigue is lingering, although mild in comparison.  I had no fever, no respiratory issues, no digestive issues.
The adverse event effected mother only and had no effect on baby. The site where the shot was administered was not the right location and hit my rotator cuff. I had to attend 6 weeks of physical therapy to gain back mobility in my arm and it took well over a year for my arm to feel back to normal.
Indurated, erythema, warmth, swelling. Treated with OTC TYLENOL and topical triamcinolone cream.
Patient had knot at injection site on day 1. The patient developed a rash on the lower side of the arm down from the injection site. Also, the patient stated her arm was sore for 3 days cause she couldn't sleep on it all & it was warm to the touch.
Chills; Shivers; Headache; Fatigue; A spontaneous report was received from a consumer concerning a 73-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, shivers, headache, fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 002B21A) via unknown route for prophylaxis of COVID-19 infection.  On 9 Mar 2021, the patient experienced the event(s) chills, shivers, headache, fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), chills, shivers, headache, fatigue was unknown.
vial was exposed to room temperature from 24-26 hs when they administered; received dose after expiration time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose after expiration time) and PRODUCT STORAGE ERROR (vial was exposed to room temperature from 24-26 hs when they administered) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose after expiration time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was exposed to room temperature from 24-26 hs when they administered). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received dose after expiration time) had resolved. At the time of the report, PRODUCT STORAGE ERROR (vial was exposed to room temperature from 24-26 hs when they administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
Extreme soreness in vaccinated arm; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8130) via an unspecified route of administration in the arm left on 29Mar2021 at 11:30 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient did not have any known allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 at 16:00 (beginning the evening of vaccinated day), the patient experienced extreme soreness in the vaccinated arm. The patient did not receive any treatment for the adverse event. The clinical outcome of the event extreme soreness in vaccinated arm was resolved on 30Mar2021 (thru Tuesday).   No follow-up attempts are needed. No further information is expected.
Shortness of breath. Visited MD next day and had oxygen treatment to restore low oxygen and had steroid injection.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Nov2021 (Lot number: FH8030) at the age of 44 years as dose 3 (booster), single, administration date 25Mar2021 (Lot number: EK5730) as dose 2, single and administration date 04Mar2021 (Lot number: EJ1685) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM; LISINOPRIL; ZOLMITRIPTAN. Past drug history included: Injectible cortisone, reaction(s): "Known allergies: Injectible Cortisone", notes: Known allergies: Injectible Cortisone. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Feb2022 08:00, outcome "recovering" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Feb2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient received no other vaccine in four weeks. Prior to vaccination patient was not Covid-19 positive.
Breakthrough case admission after 3 vaccines Pfizer 3/28/21 Lot# ER8730;  Pfizer 4/18/21 lot# ER8729;  Pfizer 12/18/21 lot# FJ8757
Mom states that child screamed high pitch all night long beginning several hrs p/DTP was given; states that fever was 104 & pt was taken to ER & tx APAP;
accidently mixing together a standalone ACTHIB and PENTACEL and administering part of the doses to a patient with no reported adverse event; Initial information received on 18-Aug-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 2 months old male patient who experienced accidently mixing together a standalone HIB (PRP/T) vaccine [ACT-HIB] and Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] and administering part of the doses with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 18-Aug-2023, the patient received a dose 0.5 ml of suspects of standard strength Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine suspension for injection (lot: UJ859AA) with saline diluent of HIB (PRP/T) vaccine [ACT-HIB] Powder and solvent for solution for injection (lot: UG856AC) and combined with diluent (Expiry date: unknown) via intramuscular route in unknown administration site for Immunization with no reported adverse event (product preparation error) (latency: same day).  It was reported that " HCP states that today was the first day of vaccine administration. She gave the PENTACEL to a patient but states that it was reconstituted with the HIB's saline diluent and then she combined it with the diluent. But she mentioned that the patient was only suppose to be given 0.5, and she administered more than that and most of it was saline. What should she do? UJ859AA Expiration date is unknown. A Physician reporting a medication error described as accidently mixing together a standalone ACTHIB and PENTACEL and administering part of the doses to a patient. The Physician realized the error when injecting such a larger volume of fluid; that the dose was stopped part way through administration; that this is the first time the Physician has administered vaccines; that in the past the supportive staff were the ones performing the administration; that this is their new clinic and the role falls on the Physician; that the error was due to the misinterpretation of the ten vials she saw in the PENTACEL box, thinking they were just the liquid portion and not reading they were 5-dose vials with both the liquid and the powder portion. Information is limited and unknown due to the caller was not in the office with all of the information".  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   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 the 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.
PATIENT SAID LEFT ARM ONLY WAS STIFF AND SOAR AND COULD NOT RAISE HER ARM ABOVE SHOULDER HEIGHT AND COULD NOT USE ARM TO PULL ON CLOTHING
bruised injection site; injection site hurts to touch; looks like a ball is growing underneath; This case was reported by a consumer via interactive digital media and described the occurrence of injection site bruising in a 17-year-old patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, less than a year after receiving Meningococcal B vaccine, the patient experienced injection site bruising, injection site pain and injection site lump. On an unknown date, the outcome of the injection site bruising, injection site pain and injection site lump were not recovered/not resolved.   It was unknown if the reporter considered the injection site bruising, injection site pain and injection site lump to be related to Meningococcal B vaccine.  Additional details were provided as follows: This case was reported by the patient's parent. On Eleven and half weeks ago from the date of reporting, the patient received a dose of Meningococcal B vaccine. The patient experienced bruise near injection site and it appears like ball growing underneath and it also hurts to touch, after receiving Meningococcal B vaccine.
WARM FEELING IN THE BELLY; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood test (hba1c - 6.5%), and concurrent conditions included diabetes, sulfa allergy, cortisone allergy, non-smoker, epinephrine allergy, and dialkylthiolurea allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced warm feeling in the belly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warm feeling in the belly on 11-MAR-2021. This report was non-serious.
Visit to ER 4/29/04: left deltoid area with 5x5 circumferential, erythema, edema of soft tissue.
Expired Vaccine administered to patient; Product storage error; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) and PRODUCT STORAGE ERROR (Product storage error) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) and PRODUCT STORAGE ERROR (Product storage error). On 01-Aug-2021, PRODUCT STORAGE ERROR (Product storage error) had resolved. On 03-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported  No treatment medication was reported.  Vial of Moderna COVID-19 vaccine was taken out of the refrigerator, punctured and kept at room temperature (67.2 degree Fahrenheit) beyond 12 hours. The vial was first punctured at 01:01 PM on 31-Jul-2021 and that was when it was first moved to the room temperature.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: significant follow up received on 12-Aug-2021 included updated patient's race information.
pt recvd vax;v later in the day p/ each 4 capsules;devel rash all over face;rash lasted <24 hrs;
Rashed started on bilateral hands/arms. Red colored bumps, blister looking, itchy. She took Benadryl in the evening.