chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other health professional refers to a male patient of unknown age. On 25-OCT-2011 the patient was vaccinated with the first dose of VAQTA (route, dose and lot number unknown). On 17-APR-2012 the patient received the second dose of VAQTA (route, dose and lot number unknown). No adverse event was reported. Additional information is not expected.
Patient had a red line going down left arm from injection site and red rash around his left arm pit. Patient denied any pain or itching at this time and stated he hadn't had any problems with the previous moderna vaccines. called patient on 4/20/2022 to see hoe the rash was he stated it was going away and had no other issues at this time.
One 1/2/22, 12 days after receiving the Moderna Booster vaccine on 12/21/21, I woke up with hives from my head to my ankles. I was covered in hives. I was prescribed prednisone and ciproflaxin, and that helped the hives, but did not cure them. I developed dermagraphism, where if ay pressure is put on my skin, hives appear at that spot for 15-20 minutes. I was referred to doctor for a Dermatology clinic and met with him on 1/31/22.  Doctor sent me for bloodwork. I was prescribed loratadine 10mg by my primary physician and I continue to take that daily. I still experience chronic hives every single day and most every minute of my life (as of 2/22/23). I had no previous issue of skin issues ever before, until I took the Moderna Booster
Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with 2018SA220773, 2018SA220774, 2018SA220775 and 2018SA220766 (same reporter). This case involves a four years old patient (four years one month old, gender not reported) who experienced patient received a dose of PENTACEL (lot number, expiry date, dose, route and site of administration were not reported) instead of QUADRACEL (lot number and expiry date were not reported) on 24-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Within 2 minutes pt began to dry heave, turned very pale and appeared to faint briefly. Responsiveness slowly returned. By 30 min after injection pt was playing and speaking normally with normal visual signs. Telephone follow up 7 hrs later pt ok.
Reports that within 8 hrs of receiving the FLULAVAL vaccine she developed "inflammation" and erythema to L upper arm, along with thoracic back spasms. She was treated by a medical provider in N Carolina with 10 day course of PREDNISONE.
I had a fever of 101 for a maximum of 24 hours. That involved chills and sore legs. For the next 24-48 hours I was fatigued. I had a headache, and that was about it.
This spontaneous report as received from a nurse refers to 14 patients of unknown age. The nurse reported that 14 patients received a dose of VARIVAX (Merck) (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect reported. It was unspecified if the patients had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Presented to hospital with shortness of breath for one week on 4/13/2021.  Additional symptoms reported include productive cough with blood tinged sputum, diarrhea, and food tasting like salt.    Supplemental oxygen, tocilizumab and remdesivir treatment initiated
Following DTaP #5, MMR #2, IPV #4, L deltoid area became swollen, indurated, purplish by 24 hrs. 2 wks after shot, L ankle became raised,indurated, purplish & itchy. Then 2 wks after that R ankle became raised, indurated, purplish & itchy. Area around deltoid area - symptoms decreased, but discoloration still present ankles remain swollen, raised, itchy and indurated. Benadryl cream being used - but not working well, according to mom.
17 year old female arrived at clinic today to receive first dose of Moderna COVID-19 Vaccine. Patient and patient's mother unaware of age guidelines for Moderna Vaccine (18+). Patient able to apply for appointment via Prep Mod due to profession. Patient is an active health worker falling within tier based on profession, not meeting age requirements for vaccine. Patient received Moderna vaccine on left deltoid Lot # 013A21A Expiration date 04/02/2021. No adverse reactions noted at this time. Appropriate patient education provided to patient and parent regarding strict age parameters for COVID-19 vaccine. Patient and patient's mother verbally acknowledged understanding of Moderna age requirements.
Client received Pfizer vaccines on March 7 and April 7, 2021.  He developed Covid symptoms (fever x 2 days, myalgia, headache, nasal congestion) on 8/26.  Tested positive for Covid on 8/27 PCR.  Reported as a breakthrough Covid case in fully vaccinated person.
DTaP, polio, MMR given 04/18/02. Left arm received the DTaP and polio. On 04/19, parent noticed significant redness and hardness on left. Applied ice and child took Tylenol. No fever. By 04/23 redness gone. No other problems occurred.
Patient received Dose #2 of JYNNEOS intradermally. Lead RN noticed patient was seated in tripod position over side of chair. Lead RN approached patient, and patient said he was feeling anxious and nauseated. Lead RN encouraged him to vomit if he was feeling the need. Patient was given a receptacle and vomited liquid only. Patient stated he did not have much fluid or food before vaccination. Also, the vaccination process made him nervous.  1205: BP 130/80; HR 92; RR 18; Diaphoretic; Subjective Warm; Lung Sounds Bilateral Clear 1210: BP 125/90; HR 70; Skin Dry; Skin Tone Normal; Patient Conversational; AOX4; Went to bathroom to wash face.  Patient observed for another 30 minutes & discharged from field clinic.
Patient has been in pain and has had increasing soreness since the injection. There is now a bruise in the area around the injection site. The injection site also appears to be higher up on the patient's arm, approx 2 inches from the top of the shoulder, indicating it possibly reached into the bursa area.
very hard to walk; sick for 3 days; achiness; sick feeling; nauseous; fever 102F; chills; dizzy; dry  mouth; tired; achy joints; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 3 days), GAIT DISTURBANCE (very hard to walk) and MYALGIA (achiness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Itching and Cataract operation. Concomitant products included DUPILUMAB from 06-Dec-2018 to an unknown date for Eczema.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick for 3 days), GAIT DISTURBANCE (very hard to walk) and MYALGIA (achiness). At the time of the report, ILLNESS (sick for 3 days), GAIT DISTURBANCE (very hard to walk) and MYALGIA (achiness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: Positive. On an unknown date, X-ray: (Inconclusive) no improvement on the chest x-ray.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-188550 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: reporter details, lab data, vaccination information , even t were updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
received 1st dose of vaccine 1 or 2 weeks before 2nd dose; arm got hurt on injection site; every bone in body got hurt; High Fever; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (every bone in body got hurt), VACCINATION ERROR (received 1st dose of vaccine 1 or 2 weeks before 2nd dose), PYREXIA (High Fever) and VACCINATION SITE PAIN (arm got hurt on injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced BONE PAIN (every bone in body got hurt) and PYREXIA (High Fever). On an unknown date, the patient experienced VACCINATION ERROR (received 1st dose of vaccine 1 or 2 weeks before 2nd dose) and VACCINATION SITE PAIN (arm got hurt on injection site). At the time of the report, BONE PAIN (every bone in body got hurt), PYREXIA (High Fever) and VACCINATION SITE PAIN (arm got hurt on injection site) outcome was unknown and VACCINATION ERROR (received 1st dose of vaccine 1 or 2 weeks before 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.; Sender's Comments: This report refers to a case of Vaccination error for mRNA-1273, lot # unknown.  Based on the current available information and temporal association between the use of the product and the start date of the events, Bone pain, Pyrexia, vaccination site pain, a causal relationship cannot be excluded.
I gave the Pfizer vaccine first dose to patient and consulted patient waiting in the store for 15minutes and told him common side effects. After 10 minutes sitting down, his mom notified us the patient fell on the floor. He hurt his right eye brown and caused bleeding  and we called 911 . I took the patient sat on the chair in the lobby and tried to clean his opened wound on the eye brown. We gave him drink some water and he felt tired and light dizziness.After 20 minutes, 911 came and checked his pulse, oxygen, and clean his wound. After 30 minutes, patient felt okay and no longer having dizziness and he refused to go to Emergency. He still had pain from hurting eye brown.
This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0167), via an unspecified route of administration, administered in left arm on 30Apr2021 15:00 as 1st dose, single for COVID-19 immunization. Medical history included amoxicillin allergy. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient experienced difficulty breathing, feverish on 01May2021 23:00. The events resulted in emergency room/department or urgent care visit. The patient was hospitalized due to the events. Therapeutic measures were taken as a result of the events and included treatment with prednisone 20 mg for 5 days. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Seriousness of the events was reported as non-serious. Information on lot/batch number was available. Additional information has been requested.
I had chills, a low grade fever, and vomiting, and was extremely fatigued, which lasted about 2 days.    NOTE:  The same symptoms occurred with my first vaccine on February 26, 2021.
allergy; itching / pruritus; hives / urticaria; She experienced Shooting Pain in the Left Arm from Elbow toWrist, and Left Shoulder-blade to Collar bon; she experienced a Red Blotchy Rash all over her body; Diarrhea; She is Very Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She experienced Shooting Pain in the Left Arm from Elbow toWrist, and Left Shoulder-blade to Collar bon), RASH (she experienced a Red Blotchy Rash all over her body), DIARRHOEA (Diarrhea), SOMNOLENCE (She is Very Sleepy) and HYPERSENSITIVITY (allergy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: EMGALITY [GALCANEZUMAB GNLM] on 15-Apr-2021. Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs allergy-Red splotchy and itchy). Concomitant products included ONE A DAY WOMEN'S, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ESTRADIOL from 15-Jul-2020 to an unknown date and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (She experienced Shooting Pain in the Left Arm from Elbow toWrist, and Left Shoulder-blade to Collar bon), RASH (she experienced a Red Blotchy Rash all over her body), DIARRHOEA (Diarrhea), SOMNOLENCE (She is Very Sleepy), PRURITUS (itching / pruritus) and URTICARIA (hives / urticaria). On an unknown date, the patient experienced HYPERSENSITIVITY (allergy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 22-Apr-2021 at an unspecified dose and frequency. On 22-Apr-2021, PRURITUS (itching / pruritus) and URTICARIA (hives / urticaria) had resolved. At the time of the report, PAIN IN EXTREMITY (She experienced Shooting Pain in the Left Arm from Elbow toWrist, and Left Shoulder-blade to Collar bon), RASH (she experienced a Red Blotchy Rash all over her body), DIARRHOEA (Diarrhea), SOMNOLENCE (She is Very Sleepy) and HYPERSENSITIVITY (allergy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Patient demographics were updated includes patient height, weight, ethnic group was updated. Updated the allergic drug describe reaction includes Red spot itchy was added. Historical vaccine were added. Added Emgality with the start date of vaccineAdded concomitant medication. Added Zyrtec, women a day, estradiol with the start dat and Vitamin C was added. Added outcome of event.
Red, swollen,  painful rash, warm to touch  with minor itching .   Size of affected area :  10cm X 8cm located  5 cm below injection site.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2009, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a medical center/hospital (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 07-AUG-2015, the patient was treated (by an unspecified health care professional) at a healthcare facility(hospital/clinic) for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed valacyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Low grade fever, dizzy shortly after injection. In 6-7 hrs facial swelling, muscle aches, shivering, eyelids swelling, abdominal pain, injection site warmth. At 2 AM, patient took 25mg Benadryl and swelling subsided enough to see. later in AM, swelling increased. Administered 100mg Diphenhydramine. Called patient's doctor. Doctor prescribed Medrol dose pack and continue Benadryl q 6 hours for 1 week.
About a week - 10 days after second dose of Moderna hives began to show up on body parts, about 3 days into that large full body hives showed up all over legs, arms and face. Went to my family Dr. and was prescribed 20 mg Prednisone for 10 days 2 times a day and Montelukast for 30 days and Benadryl. These cleared up the hives, the day after I was finished with Prednisone I woke up with full body hives again with my back covered and felt hot and sick. Went to Ugent Care and was prescribed a "taper method" of Prednisone 10 mg for 12 days, Zytrec, Benadryl and Tagamet. Again as soon as the Prednisone ended the hives came back but not as aggressive. Still take Zytrec and Benadryl on days that they come back bad. The course of this has gone on ~ 2 months. In this time I have not changed anything that would cause an allergic reaction besides getting the Moderna shot.
Symptoms started on 04/14/04 at 17:00.  Migrain AA, chills, frequent urination, insomnia, aching, low pain in back-deep pain, left deltoid local pain, redness, Temperature 99.9 (ear), Blood pressure: 130/80LA, Pulse: 96;
1) Almost immediately following injection I had significant pain in left shoulder/shoulder blade area.  This continued for ~ 14 days.  Pain was significant enough that it prevented me from being able to lift/use that arm/shoulder for several days.  I did not see a physician and self treated at home with nsaids, lidocaine patch, and heating pad.   2) I also had golf ball size swollen lymph nodes under my left arm on day 2 - 4 after receiving vaccine. No treatment needed.
Rash, warm, swelling of Right arm. around 5:45pm. Administered diphenhydramine Hcl 25mg & Methylprednisolone Acetate 40mg
She was offered Moderna vaccine at work through on-site clinic --lot unknown at this time -she does not have card with her.  Three days after vaccine she developed swollen lymph node under arm.  Next day she developed redness at site of vaccination.  Presents with warmth redness and tenderness at vaccine site and swollen lymph node under left arm.  Treated with Doxycycline, medrol dose pack, famotadine 40mg at night
Bell's Palsy - weakness on left side of face. Went to ER and treated with steroids and anti-viral medication.
My arm turned very hard and painful I couldn't move arm got rash on arm very itchy and felt extremely hot to touch got severe pain between shoulder blades pain down legs nd on L hip stomach cramps lots of sneezing and some cough lungs felt very heavy hard to breathe had to keep using albuterol and got headaches also got hives all over my back
56 adults patients received doses after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case