chrisvoncsefalvay/vaers-outcomes huggingface dataset:
second dose is inflaming me; pain is horrible; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (second dose is inflaming me) and PAIN (pain is horrible) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 006B21A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced INFLAMMATION (second dose is inflaming me) and PAIN (pain is horrible). At the time of the report, INFLAMMATION (second dose is inflaming me) and PAIN (pain is horrible) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   On 19-Apr-2021, post the second dose of vaccination, the patient reported that the dose was inflaming her and the pain was horrible.  Treatment included Tramadol and 2 muscle relaxers. The outcome for the events of inflaming her and the pain was horrible were unknown.   This case was linked to MOD-2021-081416 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081416:First dose
Day1: Arm hurt and red and swelling at site if injection general sore muscles and body tired and sleepy. No fever. Day 2 Cheeks red, swollen, and itchy, ,light headache,, body sore, fatigued. Began taking 30 mg. of benedryl 2x/d.  Day 3-22 2021 :Light headache, (no medications) Cheeks  and around eyes swollon  , red, and very itchy.. BP normally 130/80 rose to 160/102 156/100 140/96, 134/90, 106/84  Pulse was elevated to 98-108. nausea
Onset of hives 2 weeks after vaccination Hives presented on torso arms and legs in response to touch  Hives would persist for 1-2 hours Dermatographia  Whenever I scratch myself I break out in a rash with hives welts and redness which persist for 1-2 hours after scratching  Condition has been ongoing since 12/17/21 Dermatologist prescribed Allegra once a day to treat the hives
Patient presented to ED on 7/2 or 2 days following vaccination reporting of fever and tenderness in the area over the last couple of days.  Fever reached a high of 103.  Patient was seen and given fluids, Tylenol and ceftriaxone 1 gram injection.  Patient was sent home with antibiotic course consisting of cephalexin and Bactrim DS for a 10 day course.  Patient returned to ED on Monday July 4th with increased pain, ongoing fevers, pronounced swelling and redness that had spread.  Patient was discharged on clindamycin for treatment.
Immediately > Sore to touch and felt swollen Within 1 hr > very tired 10pm: Body aches, temperature of 99.9F, arm so sore I could not touch it, sweating, stomach muscle pain Saturday 1/16/21 @ 1am > 103F temperature, every part of body hurt (even my cheeks could not be touched), joints very sore, difficult to walk, very tired, sweating, dizziness Remainder of day until 10pm > Very tired, lethargic, fever not below 100 with medication, very sore muscles and joints throughout entire body, slight cough, difficult to sit or walk due to pain,  sweating, muscle weakness,  dizziness 10pm> temperature 99.9 without medication, muscle and joint pain not as severe, sweating, feet still very sore, tired, muscle weakness Sunday 1/17/21 @ 9am > temperature 98.8F without medication, a little tired, moderate joint pain in hips feet, slight cough, dizziness, sweating  (symptoms continued) 9pm> temperature 98.3F, mild joint stiffness in hips, mild pain in feet, moderate nausea Monday 1/18/21 8am > temperature 97.9F Mild pain where toes and foot connect, mild nausea, slightly tired 5pm> temperature 98.3F, very painful stomach muscle spasm while leaned over for approximately 30 seconds to 1 minute on both sides 1/19/21 8am > temperature 97.6F, mildly tired, mild stomach muscle spasms while sitting and standing  7:40pm temperature 98.3, mild stomach muscle spasms while sitting and standing
Cellulitis in left upper arm. Warm, red and hard that spread across entire upper arm.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 08:45 as dose 1, single (Lot number: HG4677) at the age of 67 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4, Manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE CELLULITIS (medically significant) with onset 07Oct2023 at 08:00, outcome "not recovered", described as "Cellulitis in left upper arm. Warm, red and hard that spread across entire upper arm.". Therapeutic measures were taken as a result of vaccination site cellulitis as patient received anti-inflammatory and antibiotics.   Causality for "cellulitis in left upper arm. warm, red and hard that spread across entire upper arm." was determined associated to device constituent of bnt162b2 omi xbb.1.5 (malfunction).  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported event Vaccination site cellulitis and the suspect drug cannot be excluded. The case will be reassessed once new information is available. There is a possibility of Vaccination site cellulitis having occurred as a result of malfunctioning of the device hence its association cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
PATIENT STATES THAT THE EVENING DAY AFTER THE VACCINE SHE WAS WEAK, DIZZY AND HAD NAUSEA. THE NEXT DAY, 24 HOURS AFTER THE VACCINE HER SYMPTOMS GOT  WORSE . SHE HAD FEVER OF 102 DEGREES  AFTER ABOUTH 28 HOURS OF THE VACCINE. ON THE THIRD DAY SHE STATES SHE WAS VERY ACHY ALL OVER AND HAS BEEN TAKING TYLENOL AROUND THE CLOCK.
This spontaneous consumer report (initial receipt 15-Oct-2012) concerns a female patient. Earlier this month the patient received AFLURIA (batch number was not reported) and experienced vertigo. The event outcome was not reported.
SEVERE HEADACHE, SEVERE STOMACH CRAMPS, CHILLS,FEVER, ACHES
415PM awoke from nap feverish t104.5, sz, eye rolling, stopped breathing, then shallow breathing; mom phone 911 taken by amb to hosp; blood work, CXR exam all neg; tx w/IV ATB; seen by MD;
Hives devel 10JUN92 & 11JUN92 erythema multiforme; Tavist given;
Moderna COVID-19 Vaccine EUA Eight days after first dose, developed rash on left upper arm. Rash was itchy and lasted 5 days. Also had pain/soreness in left underarm and back of left hand that abated 2-3 days after the rash began. Did not treat with anything.
Headaches coming in the afternoons starting at 1:00 pm after off the prednisone. Before the vaccines (dose 1 and dose2 the headaches were not a regular symptom I was experiencing -they would just come and go). But now it's regular every day in the afternoon. 2/11/2021 - ENT doctor - steriods; Flonase; Saw a Neurologist - on 2/26/2021 - She prescribed migraine medication - two pills - take one - lay down and see if that helps and she prescribed another one too - but neither one helped. Now I will also see a Rheumatologist.  I started a new med today - RIVA Tripton Benzonate - 5 mg tablet - take one when headache comes on and I took it at 1:00 today and it's a little bit better for me but I can still feel the headache.  I have started a special diet to see if that would help.
Swelling, redness, pain and warmth at injection site. Express care diagnosed cellulitis. Given oral prednisone and cephalexin.
This is a spontaneous report from a contactable physician (patient). This 62-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142), via an unknown route, on 30Dec2020 at single dose on the left arm for COVID-19 immunization, administered at hospital. Relevant medical history included glaucoma, hypercalciuria, osteoporosis and allergy to sulfa. Relevant concomitant medications included hydrochlorothiazide (HCTZ), diltiazem hydrochloride (DILTIAZEM CD) and brimonidine tartrate, timolol maleate (COMBIGAN). No other vaccine was received in four weeks. The patient developed xerostomia 18 days after receiving 1st dose of vaccine. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was not treated for the event. The patient had not recovered from the event. Amendment: This follow-up is being submitted to amend previously reported information: patient's age added.
Headache, UrticariaPruritus, Fatigue, Injection Site Pain Narrative:
Pt is a 23-year-old female who reports that 1-2 weeks following her second anthrax (AVA) on 21 Aug 2000 that she developed intense itching and dryness of her skin all over her body. She stated that she had a rash that consisted of tiny red bumps all over her body. She stated that they were not fluid filled. She then sought medical attention and was told that her skin was dry and to use Vaseline lotion and a humidifier. Then a couple of weeks later she noticed that the rash became fluid filled with a clear yellow fluid that started weeping, would dry and then the skin would crack. She said that her skin would bleed when it cracked, scab, and then fall off. She returned to the doctor and was told that she had atopic dermatitis and eczema and was given oral steroids for 2 weeks and used topical steroids for about 1 1/2 years. She stated that the cream and steroids would help but she did not like the side effects and that she would still have outbreaks so she sought a second opinion. She was referred to the dermatology and immunology clinic for skin testing and evaluation. She stated that she allergic to formaldehyde and mites. She stated that her medication was changed to Zyrtec, Elidel and a course of tetracycline. She reports that the medication helps to control her symptoms but that she still gets frequent outbreaks, especially while she is at work and exposure to any formaldehyde containing products, perfumes, smoke, and her uniforms. She states that her rash usually is not as bad at home but states that is because she has allergy proofed her house. She denies any other medical problems besides her skin.
Patient was accidentally administered Pfizer-BioNTech COVID-19 Vaccine Orange Top for patients 5 through 11 years of age instead of Pfizer-BioNTech COVID-19 Vaccine Gray Top for patients 12 years and older.  No adverse reaction.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 145 of 190 patients described by the reporter.  No concomitant medications were reported.  It was unknown patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Patient received a dose of Pfizer COVID-19Vaccine  Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial  was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL ,  0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the agency, due to lack of stability data, it was advised to revaccinate the patient.
Redness 5cm at injection site. Hot for 24 hours. No treatment at this time.
I have since tested positive for Covid on 1/12/22. Moderate symptoms including cough, chest congestion, severe headaches, muscle aches , fatigue and chills that last for 5 days. Then I had mild symptoms for 5 more days. Currently have a residual cough and chest congestion that have improved.
had Shingles shot but got Shingles/Suspected vaccination failure; Have it right now/have it on my shoulder, chest , left breast and back; pain has been excruciating; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included shoulder replacement (Recovering from shoulder replacement).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had Shingles shot but got Shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Have it right now/have it on my shoulder, chest , left breast and back) and pain (Verbatim: pain has been excruciating). The patient was treated with valaciclovir hydrochloride (Valtrex) and gabapentin. The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 16-MAR-2023 The case was received from the patient interactive digital media. The patient had it right now(at the time of reporting). The pain had been excruciating.  The patient had the Shingles shot but got Shingles anyway. The patient had it on shoulder, chest, left breast and back. The patient was just recovering from a shoulder replacement revision.  The pain started on his/her shoulder and then breast. The patient stated that this was worse than any pain he/she ever had, This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As per narrative, shoulder replacement seems to be patient's current condition and not adverse event, hence captured as current condition.
Case number PHEH2014US025063, is an initial spontaneous report from a nurse on 09 Dec 2014. This report refers to a 55-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN  (batch number: 145701) intramuscularly at a dose of 0.5 ml on 05 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between F during excursion. No adverse events reported after the maladministration.
At 7pm client noticed his hands swelling at the base of his thumbs and then itching and hives on upper body including extremities; he went to the pharmacy and was recommended Benadryl; he went home and took two tabs and went to sleep; the next morning there was no evidence of above signs/symptoms and he reported feeling fine.
Pt had immediate pain on injection of the SHINGRIX vaccine, pain did not go away and by the next morning was so severe he could not move his arm.
vaccines experienced multiple excursions, Vaccine stored at temperature outside the recommended range; expired vaccine administer to patient; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA125033, 2019SA125047, 2019SA125008, 2019SA125094, 2019SA125087, 2019SA125072, 2019SA125066 and 2019SA125054 same reporter.  This case involves a 4 years old female patient who received vaccines DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and TUBERCULIN PPD (TUBERCULIN PPD) for Immunisation received on 23-Feb-2019.  On 23-Feb-2019, the patient received a 0.5 mL dose of suspect IPV (VERO) (Suspension for injection) lot N1K931M, expiry date- 19-NOV-2018 via intramuscular route in the deltoid nos.  On 23-Feb-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection) lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to incorrect product storage and expired vaccine used.  This was reported to the MIA- Fluzone Quadrivalent, Daptacel, ActHIB, Pentecel, IPOL, Adacel, Menactra. The vaccines experienced multiple excursions. 1st excursion excursion: 13Feb2019-14Feb2019 was out of range for 8 hours and 45 mins was at 1.56 degrees C. for the Fluzone Quad, Daptacel and ActHIB. 2nd excursion: 13Feb2019 9 hours 15 mins 1.56 degrees C. 3rd Excursion: 15Feb2019-22Feb2019 was out of range for 9 hours 30 mins at 1.56 degrees C. 4th excursion: 13Feb2019-22Feb2019 was out of range for 13 hours at a temperature of 1.18 degrees C for the Daptacel, Menactra and Adacel 5th excursion 13Feb2019-25Feb2019 were out of range for 24 hours and 15 mins at a temperature of 1.18 degrees C. Fluzone Quad and Pentacel 6th excursion 22Feb2019-26Feb2019 out of range for 23 hours 45 mins at 1.18 degrees C. Fluzone Quad, Pentacel and Daptacel 7th excursion: 13Feb2019-26feb2019 out of range for 33 hours and 4 mins at 1.18 degrees C for Adacel, Menactra, Ipol, ActHIB, Dapatacel, Pentacel and Fluzone Quad  It was unknown if any adverse event was occurred.   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 and Module VI of the 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.  Information on the batch number was requested.  Documents held by sender: none.
Mom reported on 6/20/18 (when she was being seen for travel vaccinations) that her son developed a sore neck and body rash later in the day on 6/5/18. Rash was described as being all over his body; itchy but not painful. She did call the pediatrician; they recommended use of OTC topical steroid ointment. He was not evaluated in person by the pediatrician. Per mom, the symptoms resolved within 12-18 hours. No residual effects reported at this time.
10/4 Fever of 101 - R arm hurting - 2 Tylenol and temp nl. 10/5 - stiffness, numbness, dime size red spot on R arm. 10/6 - hives on both arms - temp 103 - fever abated after large intake of fluids 10/7 Muscle tightness in both arms, no fever.  Tylenol taken with no relief of muscle 'pain'- instr to take to private physician by HD.
TOOK UNREFRIGERATED DOSES OF VIVOTIF; This spontaneous case (PVX2019-1596) report was received from a caregiver on 19-Jun-2019. It describes a 21-year-old adult female consumer who "took full unrefrigerated course of Vivotif". She was receiving Vivotif for an unknown indication.  Case report: The consumer took full course of Vivotif on unknown dates, but never refrigerated it.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took full unrefrigerated course of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took full unrefrigerated course of Vivotif" was considered as not applicable.
This spontaneous report as received from a Registered Nurse refers to 6 patients of unknown demographics. The patient's medical history and current conditions are not reported. On 21-SEP-2014 the 6 patients were inadvertently administered improperly stored RECOMBIVAX HB injection (strength, dose and frequency not reported) (Lot # and expiry date not reported). No adverse effects reported. Product quality complaint was not involved. The outcome of the event was unknown. This is one of the several reports received from the same reporter and Linked to cases MARRS # (1410USA007243, 1410USA007242, 1410USA000627 and 1410USA007241). Additional information has been requested.