chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per mother, scattered rash developed on 7/15/08; was evaluated at other medical facility and diagnosed with VARIVAX. Per mother, developed > 30 lesions on extremities, back and face with itchiness. Lesions noted by mother to be in various stages of development.
Diffuse erythematous, macular rash on trunk/extremities -itchy.  Confirmed allergic reaction by Dermatologist - treated with BENADRYL and PREDNISONE.
got another dose in June before waiting 6 months.; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (INFANRIX).   On 18th June 2022, the patient received the 4th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 18th June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 Information: GSK Receipt Date: 11-AUG-2022 Reporter's Comments: The nurse practitioner reported that a patient was on a catch up schedule and received a 3rd dose of Infanrix in March and got another dose in June before waiting 6 months. The reporter consent to follow up. The HCP (Health care professional) did not had the patient details and HCP believed the dose was given on 18th June 2022. Additional supportive information: The patient received the Infanrix dose earlier than the recommended interval, which led to shortening of vaccination schedule.
Saturday- Started to develope a fever 99 around 7 pm, increased to 100.5 by 10 pm -took 325 mg Tyelenol-slight chills and aches - fever increased to 103.7 by 3:30 am -took 650 tylenol - fever around 102.8 about 8 am- strong chills throughout Sunday - fever in the 102 range - aches - just closed my eyes and was semi asleep. - Monday the fever was now in the 100 range-chills were not as violent - I stopped feeling like a zombie - Tuesday -no fever/chills, feeling better.  ps -had covid in Dec 2020
No visible reaction at injection site, feels like I got hit really hard in the area of injection, muscles ache all over body, slight headache, teeth hurt, general feeling of not well, no energy, diarrhea, slight fever 100.4.  This is now eight hours after getting the shot.
Information has been received from a physician, who was not the treating physician, concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently, on an unknown date the patient fainted after receiving GARDASIL. It was unknown if the patient sought medical attention. At the time of the report, the patient was recovering. The physician did speak with said "this has already been reported". Additional information is not expected.
Patient is late for the second dose / first dose was administrated on May 24 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-b (received 1st dose on 24th May 2019).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Engerix-b vaccine, which led to incomplete course of vaccination. No adverse events was reported. No patient's identifiers was provided No LOT number and expiration date was provided The reporter did not consented to follow up.
Initial information received on 10/Jul/2006 from a health care professional.  An 11 year old male patient received a dose of Adacel, lot number C2457AA, administered intramuscularly in the right arm on 06/Jul/2006.  One day later, the patient developed swelling in his entire right arm.  The area was also hot to touch.  The patient's mother contacted the physician, who prescribed ice and MOTRIN.  At the time of this report, the patient had not recovered from the events.  Follow up received on 18/Aug/2006 from a health care professional.  The patient had no illness at the time of vaccination.  The patient had described the event as "upper arm was swelled the size of his fist".  Relevant diagnostic tests were none. The patient recovered from the events.
It has been reported that a pt rec'd Menomune A/C/Y/W-135 vaccination, lot #U0926BA, administered im at 5pm on 11/13/02. At 5:30pm that same evening, the pt complained of dizziness with nausea but no vomiting. Her vital signs are temperature 97F, BP 90/60, pulse 64 and respiration rate 20. The pt has no allergies. The pt's recovery status is unknown. Further info is expected.
12 hours later - low fever (101.5) and sore muscles and weak.   I have a scar from the shot (extremely similar to scars I've seem that people who received the small pox vaccine)
Left shoulder pain in joint. Decreased ROM, numbness, tingling in left arm, pain 8/10, painful through to reporting on Tuesday, symptoms decreasing now (over weekend total arm rest, ice and anti-inflammatories).
The patient received her third injection of Lymerix and 3.5 hours later experienced feeling cold, shaking, and could not walk. The information received on 04/14/2000 reports the symptoms resolved after 1.5 hours.
Got Covid19; Got Covid19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Got Covid19". His wife got COVID19. Prior to getting COVID19 his wife had completed two primary COVID19 vaccine shots and the COVID19 booster shot.  Clinical information: Prior to getting COVID19 the patient had completed two primary COVID19 vaccine shots and the COVID19 booster shot  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pain on the R arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain on the R arm of injection) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain on the R arm of injection). At the time of the report, VACCINATION SITE PAIN (Pain on the R arm of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-100771, MOD21-084883 (E2B Linked Report).; Sender's Comments:  MOD-2021-100771:Second dose case MOD21-084883:Husband acse
Day of vaccination (Monday) - arm sore, Tuesday - body aches, muscles sore, headache, Wednesday- muscles less sore, headache, Thursday - symptom free
Large amount of swelling @ & around site of inject; 1 wk post vax area still swollen, hard to touch; area very sore;
Soreness in left shoulder, patient states it started night of immunization, sore when she lies on it, pain comes and goes, no stiffness, no redness, no bruising at injection site
4/6/21Day 1: Severe headache/Migraine, arm pain and tingling, loopy drugged feeling, dizzy, sleepy, nausea Day2: tired weak, migraine, nausea, dizzy, loopy, sore throat Day 3: : Severe diarrhea, nausea, faintish, not hungry, weak, dizzy, loopy, sore throat. headache Stayed in bed Day4: moderate diarrhea, (took Imodium) moderate nausea, slight dizzy, very weak, not able to leave house  I am still experiencing symptoms.
Upon leaving 5-10 mins after shot started "feeling funny" in mouth, tongue and throat. Lips started to swell a little. Started to break out "hives" over trunk. Mom left and went to K-Mart and bought liquid BENADRYL and gave her 25 mg. States she was O.K. and doing better within several hours. Did not have to repeat dose. Did not tell RN or call dr.
This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 05-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There was no Digital Data Logger involved. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received. Sender's Comments: US-009507513-1704USA001661:
2-12-21 Sharp chest pain; rested 2-20-21 Skin reaction red raised areas x 6; Took Benadryl and the spreading stopped; Used Benadryl cream and the itching stopped 2-22-21 Saw cardiologist for an already scheduled check-up and from 2-12-21 to 2-22-21 had similar sharp chest pain 2 times; to f/u on 3/15/21 as of 3/06/21 The first red raised areas just below where I received the vaccination are still red and occasionally itch
This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.
diarrhea; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and PYREXIA (fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PYREXIA (fever). On 31-Jan-2021, the patient experienced DIARRHOEA (diarrhea). On 31-Jan-2021, PYREXIA (fever) had resolved. At the time of the report, DIARRHOEA (diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included acetaminophen.
A few hours after the injection some bumps formed around the injection site and it has since been very itchy, a little sore and feels like two pea sized lumps around the injection site. Main thing it has been very itchy.
0843: Received shot 1300: Mild headache/injection arm sore 1700: Fatigue, headache, nausea 1800-0400 the next day: Fatigue, headache, nausea, chills, fever, skin sensitivity to where putting a sheet or blanket on me hurt my skin (mainly on legs/stomach), muscle aches, restlessness of body (kept needing to move my arms and legs)
A retinal vein occlusion, and I noticed right away; I scheduled an appointment with a retina specialist, and I was told I had a small blood clot in my right away; Exactly seven days after, something happened to my right eye that caused me issues with my vision.; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 15Apr2021 18:15 (Batch/Lot Number: EW0162) as single dose for COVID-19 immunisation. Medical history included type 1 diabetes and thyroid issues, allergic to shellfish and to fluconazole. Concomitant medications included insulin and thyroid medication. Exactly seven days after (on 22Apr2021), something happened to patient's right eye that caused issues with her vision. Patient scheduled an appointment with a retina specialist and was told patient had a small blood clot in right away. A retinal vein occlusion and patient noticed right away because it was right in the middle of vision field/where the light enters through in the eye. Patient was type 1 diabetic with perfect control and patient had never had issues with vision (even got checked last year before COVID and no problems). Her endocrinologist did not think it was diabetes related either. The only different thing was the vaccine. Now patient was not sure if she should take the second dose and also her retina doctor wanted her to get checked for further blood clots to make sure she was okay. No treatment was received for the events. The events resulted in physician office visit and disability. Outcome of the events was not resolved.
c/o headache, cough, fatigue and SOB. hypoxia, COVID Pneumonia,  asthma, pt on 2L O2. Dexamethasone & Zinc given. Physician wrote Remdisivir per ID. No notes from ID, not remdisivir documented. walk study done, weaned to RA.
Patient experienced a brief loss of consciousness about 3-5 minutes following  administration of Moderna Covid19 vaccine. Patient was examined by EMT and reported feeling dizzy, weak and lightheaded. About 20 minutes later, the patient was able to leave the facility on their own.
Severe cramping, pain in injection site. Cannot move arm. Had to call out sick from work.
Day 1: Fever, chills, sweats, body ache, nausea Week 2-5: "Covid arm" swelling of arm at injection site, raised red rash Next 6 months+: Sudden onset of hypertension, rapid heartrate, shortness of breath
Development of varicella zoster in the left groin/hip.  Started on valacyclovir ~5 d after onset of symptoms.  Symptoms remain but slowly improving.
Informed pt's mom that the Pfizer vaccine that pt received in April and May is invalid. Revaccination is not required. She states she will converse with her husband to see if they wish to re-vaccinate pt.
Post varicella vaccine administration developed hive and warmth to touch at injection site. Took BENADRYL. Reaction resolved. No fever.
Headache 24 hours Diarrhea continual  5 days  Blood Sugars elevated  continual past week highest 375
tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient tested positive for Covid on 22Dec2020. She wanted to know if there is any more information on receiving the second dose after testing positive. The outcome of the event was unknown.  Information on the Lot/batch number has been requested.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (in this case 2 days). However, a causal relationship between event "tested positive with Covid " (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded.
NEEDLE MALFUNCTION WITH VACCINE ADMINISTRATION, SOME OF THE VACCINE SQUIRTED OUT THE TOP OF THE SYRINGE DURING ADMINISTRATION THEREFORE PATIENT DID NOT RECEIVE FULL DOSE OF VACCINE. PATIENT HAS BEEN REVACCINATED.  NO ADVERSE REACTION OCCURED.
Myalgia, Arthralgia & Fever Narrative: With 1st dose had horrible joint pain the day after injection (12/24/21) and one week later. With 2nd injection pt experienced fever and myalgias starting 1/21/21. Symptoms lasted about 8 hours. Missed work x 1 day. No known prior COVID infection
3" redness at site, 1/2" raised area, warm to touch, painful, swelling.
shingles; rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th June 2019, 3 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provideda s follows: The case was reported by the patient's wife. The patient developed rash after receiving Shingrix vaccine. On 16th June 2019, the rash was daignosed as shingles, at urgent care. The consumer consented to follow up with herself, but declines healthcare professional follow up. The consumer did not have vaccine information for her husband's adverse event. This case is linked to case US2019109682, reported by the same reporter.
On 6/1/01 the pt experienced severely swollen lymph nodes and a temp of 104 for 5 days. On 6/13/01 blood pressure was 190/100 and remains very high. Blood pressure was normal on the day of vaccines.
1st 24 hrs low grade fever, would not walk on leg; 23JUn t103; 24JUN rash on body; 24JUN t105.6, wouldn't drink or swollow inside of mouth swollen;
Urticaria, unspecified   Hives, itching and severe dermatographia that have lasted from Nov 16, 2021 until day of this report.
RINVOQ WAS NOT WORKING/TREATMENT STOPPED WORKING AFTER RECEIVING COVID VACCINE/EXPERIENCED SWELLING with RINVOQ (UPADACITINIB).; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (RINVOQ WAS NOT WORKING/TREATMENT STOPPED WORKING AFTER RECEIVING COVID VACCINE/EXPERIENCED SWELLING with RINVOQ (UPADACITINIB).) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 15 Milligram, Extended release. In 2021, the patient experienced SWELLING (RINVOQ WAS NOT WORKING/TREATMENT STOPPED WORKING AFTER RECEIVING COVID VACCINE/EXPERIENCED SWELLING with RINVOQ (UPADACITINIB).). At the time of the report, SWELLING (RINVOQ WAS NOT WORKING/TREATMENT STOPPED WORKING AFTER RECEIVING COVID VACCINE/EXPERIENCED SWELLING with RINVOQ (UPADACITINIB).) had not resolved.            No concomitant drugs taken. In 2021, the patient experienced RINVOQ WAS NOT WORKING/TREATMENT STOPPED WORKING AFTER RECEIVING COVID VACCINE/EXPERIENCED SWELLING. MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA 1273)) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported. Causality for RINVOQ(UPADACITINIB): The reporter's causality for both the events were a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Live Significant follow up received: Event Drug effect decreased as reported term and causality was updated. New event swelling was added.
An expired IPOL was given to a patient with no reported AE; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00813142).  This case involves a five-year-old female patient who was vaccinated with the expired dose of suspect vaccine IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   Concomitant medications included VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination.  On 14-Oct-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot R1F801M and expiry date: 28-Sep-2021) (Frequency: once) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error case due to expired product administered (latency on same day).  At time of reporting, no adverse event was reported.  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.
Lower half of body turned ruddy/purple, then pale for 8-10min post inject; VS good; Was little hypoactive; No fever;