chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse and described the occurrence of cellulitis in the right lower extremity in a 4 year old female subject who was vaccinated with Infanrix for prophylaxis. Medical history included sulfa allergy. On 7/12/05, the subject received the 5th dose of Infanrix in the right thigh (lot DTPA596A2). On 7/12/05, the subject also received injections of MMRII, in the right thigh and IPOL in the left thigh. On 7/14/05, 2 days following the receipt of the vaccinations, the subject experienced "cellulitis in the right lower extremity". The subject was seen at a physician's office. The subject was treated with an injection of Rocephin and was prescribed oral Augmentin. At the time of initial reporting, 7/14/05, the cellulitis in the right lower extremity was ongoing. The nurse considered the cellulitis in the right lower extremity to probably be related to vaccination with Infanrix. Comment: Cellulitis in the right lower extremity was assessed as Medically Serious by mfr.
Approximately 12 hours after receiving the shot, I started itching on my torso area, behind knees, in armpits and groin area. Had hundreds of hives/rash over a 7 day period. Went to the clinic the next morning, told them what was going on, they said I probably did something else that caused it. I had done nothing differently. They told me to take BENADRYL. This was the front desk staff, not a doctor, they said to take the BENADRYL. I bought a bottle of generic BENADRYL, and followed the directions, taking 2 every 6 hours (or whatever it was). I usually fall asleep when I take that stuff, I was at work and was fine, never got sleepy. I had hives for a week, they finally went away the next Monday, 10/7/2013.
CONGESTION; FATIGUE; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced fatigue. On an unspecified date, the subject experienced congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and congestion was not reported. This report was non-serious.
Pt recvd vax approx 30 year ago & devel a rash; No further details were provided;
Presented to MD with symptoms on 10-26-09- Costochondrial pain- pain with swallowing - sore abd. muscles- mild arm paresthesias. -11/30/09 continued abd. soreness upper rib cage pain- arm paresthesias.
Patients reports arm swelling/sore. Muscle ache with prolong Sx of malaise. Multiple courses of steroid.
This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A 60-year-old male patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 60, in right arm, on Dec 31, 2021, single dose, for COVID-19 immunization. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (batch/lot# unknown); both single dose, for immunisation. Medical history not reported. No concomitant medications. The patient experienced ineffective drug/vaccination failure (medically significant), and COVID-19/treatment for COVID-19 (medically significant), with outcome of unknown. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure and COVID-19. The information on the batch/lot number for BNT162B2 requested and will be submitted if and when received.
Adult / patient / administered pediarix instead of an adult dose of engerix b; Adult / patient / administered pediarix instead of an adult dose of engerix b; Adult / patient / administered pediarix instead of an adult dose of engerix b; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 46-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th April 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 19th April 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced underdose, adult use of a child product and wrong vaccine administered. On an unknown date, the outcome of the underdose, adult use of a child product and wrong vaccine administered 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 details were provided as follows:  The reporter stated that, an adult male patient was administered pediarix instead of an adult dose of engerix b, which led to underdose, adult use of a child product and wrong vaccine administered. The reporter reported that, they are wondering how to proceed. The reporter consent to follow up.
I had a cryoablation on 02/24/2021, because I had a nodule in my left lung that was diagnosed 0n 01/20/2021 as an adenoid carcinoma. They did do a CT without contrast to make sure that everything was intact after the procedure, and everything looked fine. I went for a PET scan on 03/30/21, which showed concerns with the right auxiliary lymph node. They then performed an ultrasound They did a biopsy of the right auxiliary lymph nodes, and it ended up being inflammation of the lymph nodes, and the doctor's thought the only cause could have been from the COVID-19 vaccine at the time. Since then, I have some issues with the left auxiliary left lymph node. They could still see it on CT scan on 04/24/2021, but haven't followed up with it, or said whether or not it was attributed.
strange nerve condition  at the vaccine site/ sometimes there's a nerves that gets nicked at the vaccination site; left arm goes numb and it got very weak; my left arm can become so weak ;I can't use it; I have to be very careful walking; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EN6199) via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer stated that, the patient had a strange nerve condition at the vaccine site left arm, the patient left arm goes numb and it got very weak, so when it this was an intermittent condition sometimes it was there, sometimes it goes away and patient left arm can become so weak, was that the patient can not use it. Consumer stated that I have to be very careful walking and I have gone to my pharmacy and you know they seem to think that Pfizer did not have any nerve related issues, but they did say that sometimes there was a nerve that gets nicked at the vaccination site so (Further clarification unknown, event captured conservatively). The outcome of the events was unknown.  Follow-up attempts completed. No further information is expected.
I have been since with a unknown illness since about 12 days after my 2nd covid 19 shot.  Cough, congestion of the chest, congestion of the sinus, dizziness,  ear pain and severe sweating and shortness of breath. I have been seen by my doctor. I have been tested 3 times for covid19. All negative. My doctor thought maybe another illness so I was treated for 3 weeks with different antibiotics. No improvement. No one else in my home got sick. I definitely think this is directly linked to my covid19 shot. No I am not a crazy anti vaccine person.
25 cents-sized area of redness around injection site on left leg. Hardened area about 3 fingers width around injection site on left leg. Temperature 101F, yesterday, 3/6/01. None today, 3/7/01. Area not painful at this time. Instructed to call MD if increased pain or redness at site or if fever returns. Symptoms subsided on 3/08/01.
swelling in legs; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in legs) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sciatica aggravated. Concomitant products included HYDROCHLOROTHIAZIDE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ESOMEPRAZOLE, Furosemede and liprocil for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling in legs). At the time of the report, PERIPHERAL SWELLING (swelling in legs) outcome was unknown. Not Provided          A sonogram  was performed and showed no blood clots nor cysts. No treatment medication listed for event but reports having a steroid injection in back on 16-Apr-2021.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Swelling, pain, erythema to (R) deltoid at site of vaccine. Induration approx 6 cm (B). Told to take TYLENOL for pain and place ice on red/swollen areas.
It was reported that a 23 year old female pt received a JE-VAX vaccination on 10/16/00 at 15:00. Reported in the morning on 10/17/00, the pt noted redness of the face, itching of the face and hives. The pt required treatment with Zyrtec 10mg po every 12 hours. From additional information received on 02/01/01, patient and physician information were updated.
Pt came to the hospital  on 2/3/22 for constipation, abdominal distension, found to have a UTI.  Admitted for small bowel obstruction.  Remained asymptomatic for COVID during admission. Pt previously vaccinated Moderna 3/11/21, 4/8/21, 12/13/21.  Patient discharged 2/9/22
Patient under age 18 was vaccinated with Moderna, which is a vaccine error.  (If the person may receive a second dose, it will be per policy off-label use for a 17-year old). Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn away.  Unreported as error, found in data mining.
A report has been received from a Health Professional concerning a 1 year old, Female subject, who had been receiving Nasal FLUMIST. The patient's concurrent disease(s) included ACCIDENTAL POISONING BY SECOND HAND SMOKE. Concomitant Drug(s) Not Used. FLUMIST started on 09-Nov-2012. FLUMIST was GIVEN TO 23 MONTH OLD on 09-Nov-2012. The patient did not experience any adverse event. The outcome of the event of FLUMIST GIVEN TO 23 MONTH OLD is unknown. The report was considered to be non-serious by company physician. Summary of follow-up information received by AstraZeneca/MedImmune on 19-Nov-2012 from Health Professional: Disease, information regarding concomitant medications, occupation of reporter (Administered by) added, narrative updated. Corrected report 30-Nov-2012: Action taken of FLUMIST corrected from Unknown to Not applicable.
5/16 telephone call from supervisor canceling 3rd Twinrix due to patient telling her he developed alopecia after 2nd dose. Asked her to have patient call me but he hasn't.
Information has been received from an LPN concerning a 54 year old white female with bronchitis, hypertension, asthma and a smoker who on 09DEC2003 at 2:00 PM was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine, IM in the right deltoid. On 12DEC2003 at 11:00 am the pt developed swelling, redness and pain. The pt was treated with cold compresses and Benadryl , Tylenol or Advil. Subsequently, the pt recovered. Additional information has been requested.
Extremely terrible head pain and face pain. Like an intense ice cream headache that lasted for nearly 4 hrs and continued to come back later in the night in different strengths. I?ve been through a lot of physical pain in my life- this is the second worst pain I ever remember feeling. It was unbelievably intense and way beyond any migraine I?ve ever had. I thought that I was having a stroke or an aneurism it was unlike anything I?ve ever felt before. Afraid to get my second dose!
Red rash on left arm appeared around 1/24/2021 and has became larger as of 1/27/2021. Rash is not painful. Lymph node in left armpit is enlarged and painful since onset of rash and persists as of 1/27/2021. Rash and lymph node tenderness only started around 1/24/2021. Only immediate event after vaccine on 1/16/2021 was typical vaccine muscle pain that went away after 3 days.
Severe swelling at injection site and redness extending down to elbow bend; very tender, itcy; diarrhea and throwing up on third day.
Ten days after receiving the vaccine at the injection site, a little hard mass under the skin grew harder and larger,  to the size of my fist. It was itchy , red and painful. It slowly went away over the next 2 days.
2/17/2021 Patient called. noted 2/10/2021 started headache. 2/14/2021 started difficulty breathing.
Pain in shoulder/upper arm when extending or raising left arm; limited range of movement. Pain is not constant, only occurs when extending arm or after sudden movements.
gets the flu; Initial information received on 18-Oct-2020 regarding an unsolicited valid non-serious social media via a consumer.  This case is linked to case 2020SA294157.  This case involves an unknown age male patient who got the flu (Influenza), while he received vaccine INFLUENZA VACCINE.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route for prophylactic vaccination.  On an unknown date, 3 days, the patient got the flu (Influenza) following the administration of INFLUENZA VACCINE.  Final diagnosis was he gets the flu.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome was unknown for the event at the time of reporting.  There will be no information available on the batch number for this case.
3rd dose administered to non-immunocompromised patient; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (3rd dose administered to non-immunocompromised patient) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jun-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (3rd dose administered to non-immunocompromised patient). On 13-Jun-2021, OFF LABEL USE (3rd dose administered to non-immunocompromised patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  Per reporter, patient was not immunocompromised and received a full dose of the vaccine.
tingling in both hands; Left arm soreness, left side, site of the injection; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 16th May 2019, 5 min after receiving Shingrix, the patient experienced injection site pain. On 17th May 2019, the patient experienced tingling of extremity. On an unknown date, the outcome of the injection site pain and tingling of extremity were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. Almost immediately, after receiving Shingrix, the patient experienced a sore arm, left side, site of the injection. The patient reported that the next morning, 1 day after vaccination, she experienced tingling in both hands. The reporter gave consent to follow up.
Spontaneous Uticaria 11 days after Moderna booster shot. Has continued for the past 2 months. Claritin provides some relief.
About 3 hours after the afternoon shot, I noticed I began to feel bad. Not in any specific way, just bad. That evening, I noticed chills, pressure at the top of my head, sensitivity to sounds, and aching body.  That night, I had trouble sleeping due to all of this. The next day, an additional thing I noticed was how much my lymph nodes hurt, especially in the throat and armpits. The left armpit in particular was more swollen and painful than at any other time in my life. I could not put my arm down without pain. The day after that, the feelings subsided. This 3rd day after the shot, my left armpit lymph node is a little sore, but  I am able to do my daily activities. I took children's chewable aspirin tablets the first evening, day and 2nd evening.
Client states injection site sore from time of injection to onset sx. c/o redness, discoloration (yellow) at injection site on 6th day (June 2nd) Redness spread to bicep area almost to elbow. Area became swollen and itching on 6/2. Client seen at clinic by PA-C. Received 5 day course of prednisone and 5 day course of AUGMENTIN. Clinical Dx-Delayed urticarial reaction to tdap.
Injection site swelling and soreness; soreness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 (Lot number: EL3247) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 24Feb2021, outcome "recovered with sequelae", described as "Injection site swelling and soreness"; VACCINATION SITE PAIN (non-serious) with onset 24Feb2021, outcome "recovered with sequelae", described as "soreness". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site pain.  Additional information: It was reported that no other vaccine was administered in four weeks. Reportedly, the other medications in four weeks were reported as none. No COVID was reported prior vaccination. The patient was not COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
At the 15 wait time, patient became flushed, c/o chest pain "crushing" 6 out of 10. with S.O.B. Patient stated some type of reaction to Janssen vaccine on 04/09/21 Lot 1808978 at Pharmacy. made vague statement of almost being intubated with past Janssen vax. V/S @ 11:50 P-112, B/P- 176/102 R/R-16, SaO2 @ 100% Lungs clear, no wheezing, no urticaria, 11:55 C/P 7/10, Headache, Nausea, Vitals P-103, B/P-145/102 R/R-16. patient complained of numb fingers. 911 activated. Placed on 02 with nasal cannula 2L. Fire arrived and assumed care. Emergency arrived. Report given to medical professional. Patient transported to Medical Center.
Once given flu shot, area began to swell and harden. Pt says she didn't feels symptoms. Gave pt BENADRYL and Hydrocortisone/not EPIPEN.
Ear sensations; Pain in the lower right jaw implants; Roaming pain in her teeth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR DISCOMFORT (Ear sensations), PAIN IN JAW (Pain in the lower right jaw implants) and TOOTHACHE (Roaming pain in her teeth) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced EAR DISCOMFORT (Ear sensations), PAIN IN JAW (Pain in the lower right jaw implants) and TOOTHACHE (Roaming pain in her teeth). At the time of the report, EAR DISCOMFORT (Ear sensations), PAIN IN JAW (Pain in the lower right jaw implants) and TOOTHACHE (Roaming pain in her teeth) had not resolved. Not Provided          Treatment included muscle relaxants, as advised by their HCP to try to alleviate the symptoms.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-101893 (E2B Linked Report). This case was linked to MOD-2021-101871 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101893:case for wife(dose2)
history included type 2 diabetes, high cholesterol, high blood pressure and neuropathy; all were from an unknown date and unknown if ongoing. Concomitant medications included metformin, ergocalciferol (VIT D), amlodipine and paliperidone (INVEGA [PALIPERIDONE]); all were taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient experienced My body got really hot, cold sweat, Right leg is swollen and my feet swollen; I got pain in my leg and headache. Consumer stated as, got a question, Pfizer vaccine yesterday for the first time and my body got really hot last night and I had like cold sweat last night. Is that one of the side effects. My body got really hot you know I had to take cold shower to cool down and my right leg was swollen and my feet swollen. I got type 2 diabetes, I got neuropathy in my feet (history). I got pain in my leg and it was my first shot. The patient further stated, I want to ask was this make me sweat, body was hot it make me sweat. I just want to know if this is the side effect. The patient took a cholesterol pill and took a blood thinner too. Only got really really hot sweat last night again, the day I got really really hot again like come home took a cold shower and cool down with a fan. I had no fever only got really really hot. Therapeutic measures reported as, patient took two Tylenol for the headache, it was like a slight headache. No investigation assessment reported. Outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.