chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When the shot was administered the patient said good job which seemed to indicate the injection did not hurt.  However, not long after the patient got home she experienced very strong pain in the arm. She tried taking NSAID but it did not help so she went to the ER where she received Tramadol for the pain.
inadvertently administered frozen vaccine / frozen temp ranging -8.2 to -13.4 C for 7 hrs; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old 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, HAV (Havrix) for prophylaxis and hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2021, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Havrix and Havrix Pre-Filled Syringe Device. On 6th May 2021, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was 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 follow: The patient was administered with frozen vaccine Pediarix and Havrix which was kept on temperature ranging from 8.2 to 13.4 Celsius for 7 hours, which led to incorrect storage of drug. The mobile cooler went too cold. The medical assistant wanted to know, if the patient could be re-vaccinated. The vaccine details were available. The reporter consented to follow up. This is 1 of the 7 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021100521:same reporter US-GLAXOSMITHKLINE-US2021100518:same reporter US-GLAXOSMITHKLINE-US2021100519:same reporter US-GLAXOSMITHKLINE-US2021100510:same reporter US-GLAXOSMITHKLINE-US2021100514:same reporter US-GLAXOSMITHKLINE-US2021100515:same reporter
BURNING PAIN ON THE INJECTION SITE AND HAS ALREADY SPREAD ALL OVER HIS BODY THAT PT ENDED UP GOING TO THE ER.
10/30/02, Pt received pneumococcal shot 0.5 ml IM left arm and Flu vaccine o.5 ml IM RA 11/1/02 called  health clinic w c/o left arm red, blotchy unable to lift, Hives on face, itchy welts on face and chin, She called her allergist took Clariton itching resolved welts resolving-advised to take Tylenol. Pt left clinic  some redness and cellulitis, Will call back Monday.
Slept 13 hours.  Exhausted.  Unable to do anything but sleep, light reading, TV. Weak, shaky, little appetite. 11/04:  Slept 13 hrs. Same symptoms only even worse. Mild fever. No improvement tonight. None seems likely tomorrow. Feel sick, fuzzy-headed.
No adverse events with first 2 Pfizer shots, nor with the booster.   Tinnitus started a couple months later and has been consistent since that time.
On Sunday, April 10th around 11:30PM, I had severe crippling cramps in my lower abdomen. The felt very similar to the rupture cyst that I experienced in October of 2021. After about an hour of pain and not getting batter, we went to the emergency room at midnight. I've been menstruating since I was 12 and I've never needed to seek medical care for any menstrual issues. They prescribed some pain medication to help. I missed two weeks of work. I'm still in slight pain. I was in the ER for about 7 hours that morning.
ABout 15m after shot, patient stated mouth felt "buzzy" and numb. Almost immediately after that she threw up. After throwing up, she said her mouth numbness was better, but now her fingers were numb and she felt like she couldn't bend them. Because she threw up, she was not given PO Benadryl. Onsite EMT called for ambulance so she could go to hospital and get IM Bendryl. Airway was fine the whole time and therefore EpiPen not administered.
fever to 103 on 28OCT92 w/myalgias, sl h/a; local erythema around inject noted on noc of inject, erythematos tonsils-cervical adenopathy, t102.1, tachycardia rate 120;
Medical Assistant inadvertently gave a 16 year old patient the FLUBLOK vaccine thinking the patient was 18 with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old female patient who was inadvertently administered the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] vaccine by medical assistant thinking the patient was 18 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Sep-2022, the patient received an unknown dose once of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot: UJ888AA; expiry date 06-Sep-2023; strength: standard; formulation: unknown) via intramuscular route in the left deltoid for prophylactic vaccination (immunization).  On 26-Sep-2022, the medical assistant inadvertently gave a 16 year old patient the flublok vaccine thinking the patient was 18 with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  Outcome: 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.
Vaccine not indicated; Sore arm; Pain at injection site; Headache; Body ache; Chills; Fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine not indicated), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PAIN (Pain at injection site), HEADACHE (Headache) and MYALGIA (Body ache) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 09-Feb-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine not indicated), VACCINATION SITE PAIN (Pain at injection site), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Fever). 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with EPINEPHRINE (EPIPEN) at a dose of 1 dosage form. On 09-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine not indicated) had resolved. On 12-Feb-2021, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102-103 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient will not be given second dose.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Added lab data. Added concomitant and treatment medications. Added second dose details of a patient. Added new events fever, sore arm. Updated reporter details. Updated patient details. Updated the time of first dose. Updated action taken. Updated event outcome. On 07-May-2021: Follow up information received on 07-MAY-2021 contains no new information.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year  old male) for mRNA-1273 (lot number 030M20A) with associated AEs reported as pain at injection site, headache, body pain, and chills.
patient returned for 1 month dose of engerix b. stated roughly a few days to a week after patient noticed shoulder pains when rotating shoulder in certain ways. patient also stated has a history of carpal tunnel that radiated up to elbow and has tennis elbow in the arm the vaccine was administered.
Patient felt very weak as if she was going to faint. Gave patient an ice pack and called EMS to check patient out. Patient refused to be seen at the hospital and left on her own feeling better.
administration error to patient <18 years old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration error to patient <18 years old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration error to patient <18 years old). On 05-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration error to patient <18 years old) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Significant Follow Up Appended - New event added
11:55: felt dizzy, throat tightening with difficulty swallowing, walked to the side of room, sat; continues to report dizziness; lied down, elevated legs on chair; Face became red and splotchy within 5 mins; 1203: O2: 99% HR: 86 BP: 118/82 Administered Benadryl 25 mg PO, coughed during 2nd dose of benadryl & c/o throat tightening; laid down; EMS notified; 12:08: Epi 0.3 mg Auto injector admin in right thigh; continues to c/o dizziness, and throat tightness; Voice clear; shaky, HR: 130s; Face became ashen and green; was sitting up, assisted to lie back down; EMS arrived 12:12 for transport to ED
severe headache; Muscle aches; Chills; feeling tired and rundown; This is a spontaneous report from a contactable other healthcare professional (HCP)(patient). A 50-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on right arm single dose for COVID-19 immunization on 07Jan2021, 12:00PM, at 50-year-old. Medical history included: asthma. Known allergies reported as: Latex, penicillin. Concomitant medication was not reported. No other vaccine received in four weeks. The patient did not have COVID prior vaccination. The patient had muscle aches, chills, severe headache, feeling tired and rundown; all on 08Jan2021, 04:00 am. No treatment received. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the event was resolving.   Information on the lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between event severe headache and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
Cellulitis left thigh 7/14/06 immunizations given 7/12/06.
Patient came into the store today 8/17 (vaccinated on 8/15 in the morning) with her right arm ,where the pneumovax 23 was given IM, tender to the touch, painful, red and swollen from her shoulder down to her elbow.   Patient experiencing no other symptoms reported other than the local reaction and pain to that arm. She said the swelling  had gone from mid arm to trying to swell past her elbow overnight on 8/16. Patient will try IBU and Benadryl OTC, and Dr. follow-up recommended, especially if swelling continues to worsen and not subside.
I immediately felt dizzy. RN observeors said that I lost all color and looked spacey.  The room was whirrling. Dr. was there along with an retired ER RN and a couple of the nurses from the Health department started taking my vitals.  I was extremely light headed for over an hour and my heart rate ranged from 43 - 54 during the event. Dr. at that time felt it necessary to call 911.  By the time the paramedics arrived, I was feeling better.  They told me that my rhythm was bradycardia but that my rate was is in mid to high 50's and felt that I would be okay.  They did not transport.
Second Moderna vaccine.  Itching, Swelling and redness on arm from just below injection to elbow and covering  that part of my upper arm. Appeared on  next day and getting worse today. Tried ice pack.  This happened with first vaccine injection also and eventually went away.  This might not be adverse to you but it is to me.
The day following receiving my shot (Pfizer Covid-19 EUA) I started noticing heart flutters, pounding heart, and slight difficulty breathing. These got worse on Wednesday the 18th.  On Thursday the 19th I went in to Urgent Care.
Pt became dizzy, sweating, pale  - states it happens when he gives blood for tests. Pt A&O x4, vitals stable. Pt given water. Pt BP normalized, was able to stand and walk proper. Given OJ, Patient stable upon exit. BP 97/59; HR 58 RR 18 SpO2 100% (flushing/sweating, dizzy)
Information has been received from a nurse referring to a female patient of unknown age. Information about medical history and concurrent condition was unspecified. On 03-MAR-2016 the patient was vaccinated with ROTATEQ (lot number, dose and route were unknown). Concomitant medication was unspecified. On the same day, following administration of ROTATEQ, the patient spit up a significant amount of the vaccine (underdose). The outcome of the event was unknown. The causality between the event and ROTATEQ was unspecified. Additional information has been requested.
Shot given while standing up. Patient was still at the doctor's office when reaction occurred. Patient had similar reaction as his brother. Within 2 minutes, patient started feeling dizzy, then ended up vomiting, and had headache. Patient moved to another room to lay down. Patient given water and apple juice.  Patient stayed in the room for 15-20 minutes if not more. Everything subsided; patient felt better and enough to get up on his own and walk. Left doctor's office after about 1 hour. The site of vaccination sore until the next day. Did not take any meds or did any treatment at home.
Early in May I started experiencing pain and thickening on my left inside lower leg. It has persisted for three months  until the present. I experience extreme pain, edema and redness.  The "thick" parts seem to move around on my leg, one time above the ankle bone, then on the calf, then along the entire vein of my leg  or back ankle.  It frequently feels like "fireworks".  Dr. has treated it with Pentoxifylline, low dose aspirin, moist heat and elevation. A week ago I was prescribed a 7 day regimen of Cephalon antibiotic as well as Naprpxen EC 500 mg. I have elevated my leg at night higher, worn compression stockings during the day, ;lubricate the skin in addition to regular walking.   The reason I suspect the vaccine is that my leg had been normal for over 10 years.
She is reporting that her parents both received their first dose of the Pfizer-Biontech Covid19 vaccine on 06Apr2021 and contracted Covid illness shortly after; She is reporting that her parents both received their first dose of the Pfizer-Biontech Covid19 vaccine on 06Apr2021 and contracted Covid illness shortly after; a fall that resulted in a stroke; a fall that resulted in a stroke; This is a spontaneous report from a contactable consumer (patient's daughter).   A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 06Apr2021 and contracted COVID illness shortly after (unspecified date in Apr2021). The patient was due for his second dose tomorrow, but their quarantine will not be over by then. The patient suffered a fall that resulted in a stroke during this same time period (unspecified date in Apr2021). The reporter indicated that she did not think the stroke was due to the vaccine, but rather due to the fall. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Patient told nurse that after her 1st shot she had an itchy throat so she pre-medicated with Benadryl at 8:20.  Pt. was sent for 30 minute observation period.  At 0840, pt. started complaining of throat itching, SOA and heart racing.  It was hard to get words out.  Denied trouble swallowing.  Respirations fast and shallow.  This lasted less than 2 minutes, denied CP.  After 2 minutes, pt. started feeling better.  Pt. encouraged to be assisted to ED for monitoring.  Pt. stated feeling better and refused to go to ED.  At 0900, pt. stated feeling much better and ready to check out.  Pt. instructed to go to ED if worsening symptoms or new concerning symptoms.  Pt. verbalized understanding.
Patient hospitalized for heart failure and pneumonia of both lungs within 6 weeks of receiving covid vaccination booster.
2 days p/vax pt noticed joints were tender & sore;both ankles were swollen (as if had a severe sprain) & very tender to touch (absolutely no trauma had induced this); also general malaise;tx self medicating w/Ibuprofen 3-4x day;
Information has been received from a nurse concerning a 17 year old female with codeine intolerance who on 31-JAN-2008 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL (lot # 659657/1487U).  On 01-APR-2008 the patient was vaccinated intramuscularly with a 0.5 mL second dose of GARDASIL (lot # 659180/1758U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 04-APR-2008, "three days later", the patient developed a rash on her legs.  It was reported that she went to the emergency room.  On 07-APR-2008 the patient was followed up at her doctor's office and was diagnosed with vasculitis.  On 09-APR-2008 the patient "had a flare up again".  The nurse reported that she had "many tests done".  At the time of this report the vasculitis persisted.  The patient is being treated with prednisone.  Laboratory tests performed on an unspecified date showed an "elevated sed rate" and an "elevated white count".  Additional information has been requested.  6/3/08  Reviewed PCP medical records for 4/7-5/1/2008. FINAL DX: vasculitis Records reveal on 4/7 visit, patient experienced itchy rash over bilateral LEs, aching in bilateral LEs & muscle spasms.  Had been seen in ER on 4/4, 2 days s/p 2nd HPV vax,  & diagnosed w/vasculitis, unclear etiology.  Had undergone tanning session on day of ER visit.  Intolerant of steroids.  Tx w/antihistamine.  Had no reaction s/p 1st HPV vax.   Exam revealed bilateral LE multiple erythematous round macules & plaques generalized over lower pretibial area.  Returned to office 4/9 w/worsening symptoms of rash & calf pain.  Exam at that time revealed tenderness of bilateral calves w/trace edema, diffuse nodular urticarial erythematous lesions, coalescent purpura mostly over distal tibial area w/sparse involvement over thighs.  Attempted tx w/steroids & additional labs.  Testing for celiac disease (+) on 5/1/08.  6/3/08 Reviewed ER medical records of 4/4/2008. FINAL DX: vasculitis Records reveal patient experienced rash which started at ankles & progressed up to her knees over approx 4-5 hrs w/cramping of calves & stiffness when walking.  Exam revealed scattered 1-3 mm erythematous plaques & macules over LEs, confluent on pretibial areas down to mid dorsum of feet & up to knees.
Diarrhea; irritable bowel syndrome; Medical history included ongoing HIV positive; Medical history included ongoing HIV positive; This is a spontaneous report from a contactable consumer reported for himself. This 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 15Jan2021 at 14:00 PM at single dose in left arm for COVID-19 immunisation. Medical history included ongoing HIV positive from an unspecified date for 26 years, ongoing AFib from an unspecified date for 8 years, ongoing diabetes from an unspecified date for 15 years. Concomitant medications included lisinopril for the heart, warfarin as blood thinner, cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide fumarate (GENVOYA) for HIV, atorvastatin as a statin. The patient experienced diarrhea on 17Jan2021. The patient started to get like irritable bowel syndrome, diarrhea on 17Jan2021 like 2 AM. He stated he felt good all day long, but then at night he has the bouts of these bowls. The diarrhea got okay after imodium, but then it continued. He was calling to see if this was a side effect. It was reported no emergency room and physician office involved. He is scheduled to get second vaccine on 05Feb2021. The patient mentioned in Dec2020 he had a complete lipid panel and everything was within range except one or two things. However, he was informed it was not that bad. The outcome of the events irritable bowel syndrome, diarrhea was not resolved.   Information on the lot/batch number has been requested.
sore right injection site arm after his second Moderna vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore right injection site arm after his second Moderna vaccination) in a 46-year-old male patient 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (sore right injection site arm after his second Moderna vaccination). At the time of the report, INJECTION SITE PAIN (sore right injection site arm after his second Moderna vaccination) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-363447 (Patient Link).