chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Quadracel instead of Pentacel, no AE; Initial information received on 02-Jul-2021 regarding an unsolicited valid  non-serious case from a consumer/non-healthcare professional.  This case involves a 1-years-old female patient who was vaccinated with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) (lot number and expiration date not reported) via unknown route and site of administration for prophylactic vaccination.  On 09-Jun-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number : C5778BA and expiry date : 07-Oct-2022) via an intramuscular route in the left vastus lateralis for prophylactic vaccination.  It was an actual medication error case due to wrong vaccine administered (wrong product administered, latency: same day).  At the 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 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.
This spontaneous report as received from a healthcare professional refers to a 12 month old patient of unknown gender. On 20-JUN-2014 the patient was vaccinated with first dose of VARIVAX (Merck) 0.5 ml once, subcutaneous in the left leg (lot # J014228 and expiry date 08-NOV-2015). Concomitant therapies included PREVNAR 13 and fourth dose of ACTHIB given on the same day (20-JUN-2014). On 30-JUN-2014 the patient experienced raised, large area, red, 1.5 inch by .75 inch wide evaluated at the time of the report so treatment was not yet determined. There was no Lab Diagnostic Studies Performed. The patient sought medical attention by visiting doctor's office. At the time of the report the patient did not recovered from adverse events. The relatedness between the events and VARIVAX (Merck) was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
COVID-19; COVID-19; Vaccination site pain; Psoriasis flare-up; MARKETING PROGRAM NAME NOT AVAILIBLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4409065-00.  A 60-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and on 04Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown) for psoriasis. 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 "COVID-19"; VACCINATION SITE PAIN (non-serious), outcome "unknown"; PSORIASIS (non-serious), outcome "unknown", described as "Psoriasis flare-up". The action taken for risankizumab was unknown. Patient stated that she experienced a flare following covid and she had sore arm from covid vaccine.  It was unknown if patient was enrolled in a covid 19 vaccine trial.   Causality for SKYRIZI (RISANKIZUMAB): The reporter causality for the events of covid/Experienced a flare following covid, Sore arm from covid 19 vaccine and plaque psoriasis flare was not provided.   The reporter's assessment of the causal relationship of "covid-19", "vaccination site pain" and "psoriasis flare-up" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Suspected Covid-19, Drug ineffective, "vaccination site pain" and "psoriasis flare-up" and the administration of the vaccine cannot be excluded.
Patient given shot. ~5min later patient became pale and nauseated. Went to bathroom and vomited x1. Came back still light headed but better. BP 85/50. Had patient lie down with feet up. Gave a piece of candy and water. Checked about 10 minutes later. Color improved and patient no longer light headed and left office with mom without additional assistance
she developed cough shortness of breath and tested positive for COVID19 approximately 1 week ago.  She was unable to give me to the exact day her symptoms started or she tested positive.  Since then she has had fevers, chills, nausea, and has now developed a cough productive of thick yellow sputum.  She is on 2 L nasal cannula baseline and today was noted to require up to 4 L nasal cannula for proper saturations prompting evaluation in the emergency department.  On arrival to the ED she is hypertensive into the 160s with a normal heart rate.  She was satting in the mid 90s on 4 L nasal cannula.
About 2 hours after the vaccination in the L deltoid he began to have stiffness in the deltoid muscle, and then it started aching about 1.5 hours later and has persisted till now (3.5 hours later).  No swelling or warmth, no fever noted.
Client received Moderna Booster on right arm . Client was sitting in observation area when she alerted at approximately 1548. Client had a previous reaction to Moderna second dose and received Benadryl.  Client stated she was feeling a similar sensation in her throat, inflammation. Oral Benadryl was given 50mg and it was self-administered. Client sat in anti-gravity chair from regular chair without assistance. Client denies SOB, no difficulty breathing. No redness observed on face.  Client stated she felt no other symptoms. Vitals were taken 1605 BP 160/90 HR 60 RR16. 1618 BP 158/92 HR 62 RR 19. At 1624.  Asked client how she was feeling. Client stated she felt better. 1633 BP152/102 HR 62 RR 16. At 1630 . Was asked client how her throat was feeling, client stated the sensation was going down. 1641 BP158/80 HR 70 RR 16. Client was speaking with no difficulty and answering all questions. Her 30-minute observation ended and  gave client Emergency precautions to seek emergency care if throat sensation came back or worsened. Also, was advised to see primary care provider to check her blood pressure assessed as well as what she had felt in her throat. Client verbalized understanding and walked with a steady gait accompanied by her husband. She was advised  to not drive. She verbalized understanding.
Information has been received from a physician concerning an 18 year old female who on 20-OCT-2007 was vaccinated with a first dose of Gardasil (lot# unknown).  On 17-DEC-2008 the patient was vaccinated with a second dose of Gardasil (lot# "0710U", expiration date 04-JUL-2009) IM injection.  On 18-DEC-2007, "within 24 hours" the patient experienced headaches, body aches, fever, nausea, and dizziness for eight days after receiving her second dose of the Gardasil vaccine.  Medical attention was sought.  The physician reported that the patient was seen for an office visit for her symptoms on 22-DEC-2007, and then again on 24-DEC-2007 where she was beginning to feel better.  The physician reported that the patient called the office on 26-DEC-2007 and said she was feeling better.  "The patient is fine now".  No further information was provided.  Additional information has been requested.
2nd vaccine and broke out into a rash all over his body; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: Not reported), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: not reported), via an unspecified route of administration on an unspecified date as 1st Single Dose for COVID-19 immunisation and experienced a small rash on the arm. It was reported that the patient received the 2nd vaccine and broke out into a rash all over his body. The reporter did not specify any seriousness for event. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
"I" feel achy and bad, almost like when "I" caught Covid-19 about 7 months ago.; "I" feel achy and bad, almost like when "I" caught Covid-19 about 7 months ago.; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10Mar2021 at 11:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date in 2020, about seven months before the time of report and had shrimp allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any concomitant medications.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 at 09:00, the patient felt achy and bad, almost like when he caught COVID-19 about 7 months prior to this report. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt achy and bad, almost like when he caught COVID-19 about 7 months prior to the report was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt experienced redness and swelling to the size of a half dollar. Area was hard to touch. Treated with ice compressed and Motrin.
2 days post vax pt exp deep aching muscle pain in upper chest arms, & down into biceps in both arms, sinus area & jaw x 3;
38 weeks pregnant at time of first dose, 1 week postpartum at time of second dose. At my baby?s 1 month pediatrician appointment she still had elevated bilirubin levels and a blood panel showed that she has neutropenia. We had to go to the hospital to confirm these results and will have to consult a hematologist in a couple weeks.
little dizziness; bit nausea; bit body aches; little bit headache; like welt, like swelling at the injection site; big rash on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (little dizziness), RASH (big rash on her left arm), NAUSEA (bit nausea), MYALGIA (bit body aches) and VACCINATION SITE SWELLING (like welt, like swelling at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced RASH (big rash on her left arm) and VACCINATION SITE SWELLING (like welt, like swelling at the injection site). On 15-Mar-2021, the patient experienced DIZZINESS (little dizziness), NAUSEA (bit nausea), MYALGIA (bit body aches) and HEADACHE (little bit headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (little dizziness), RASH (big rash on her left arm), NAUSEA (bit nausea), MYALGIA (bit body aches), VACCINATION SITE SWELLING (like welt, like swelling at the injection site) and HEADACHE (little bit headache) outcome was unknown.            Concomitant product use was not provided by the reporter.
Redness from shoulder to elbow, warmth, too painful to move Previous cellulitis with a flu vaccine
CHEST PAIN EVERYDAY; VERY TIRED; TERRIBLE MUSCLE AND JOINT PAIN EVERY SINGLE DAY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 03-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included acetylsalicylic acid. On an unspecified date, the patient experienced chest pain everyday, very tired, and terrible muscle and joint pain every single day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very tired, chest pain everyday and terrible muscle and joint pain every single day was not reported. This report was non-serious.
Approx 9-10:00pm on day of immunization patient stated had headache and nausea. Drank SPRITE, laid down and symptoms resolved about 2 hours later. On 08/17/09 patient stated he developed blisters on legs (1 on left, 2 on right) and blisters have not resolved. No other complaints.
Flat feet; Cold; Pain in the body which has worsened by the winter; Issues with knee/pain; Sore arm after covid vaccines and flu shots; Sick; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of FOOT DEFORMITY (Flat feet), NASOPHARYNGITIS (Cold), RHINORRHOEA (Runny nose), PAIN (Pain in the body which has worsened by the winter) and ILLNESS (Sick) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2022, the patient experienced RHINORRHOEA (Runny nose) and ILLNESS (Sick). On an unknown date, the patient experienced FOOT DEFORMITY (Flat feet), NASOPHARYNGITIS (Cold), PAIN (Pain in the body which has worsened by the winter), ARTHRALGIA (Issues with knee/pain) and VACCINATION SITE PAIN (Sore arm after covid vaccines and flu shots). In 2022, ILLNESS (Sick) had resolved. At the time of the report, FOOT DEFORMITY (Flat feet), NASOPHARYNGITIS (Cold), RHINORRHOEA (Runny nose), PAIN (Pain in the body which has worsened by the winter), ARTHRALGIA (Issues with knee/pain) and VACCINATION SITE PAIN (Sore arm after covid vaccines and flu shots) had not resolved.            No concomitant medication provided. No treatment information mentioned.  Patient reported on an unknown date, issues with knee and pain, flat feet, sore arm after COVID vaccine and flu shots, cold and pain in the body worsened. On 23AUG2021, patient underwent surgery for right knee due to ongoing pain, was recovering from it. In Jan 2022, patient got sick and had a runny nose. Reported burning occurring for 5 minutes after injecting with Humira. Had pain in the body due to winter weather.  Reporters causality for events of burning with Humira is reasonable possibility to Humira suspect.  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   This case was linked to MOD-2022-632050.
fever of 101.8 lasted 2 days. Severe joint pain and pain in arm (couldn't use it). Upset stomach. Severe thirst that had persisted 4 days.
pt recv vax 23OCT96 & pt devel raised red hard area yesterday;today area red warm down to elbow;
Heart rqate up, red edema at site of vaccination, joint pain began approximately 6-8 hours after injection, saw PMD he prescribed benedryl.  Allergic reaction to shot according to PMD
High fever to 102.5, chills, nausea, severe headache, body aches, unable to function with severe weakness for 1 day, very sore arm, swollen arm
Cellulitis over left thigh with redness and warm to touch about 10.5cm to 7.5cm. Admitted 7/25/02. Treated with Keflex X 7 days and Benadryl X 2 days.
some dizziness; Headache; Slight fever (100); muscle/joint ache; muscle/joint ache; slight nausea; fatigue; This is a spontaneous report from a non-contactable consumer or other non hcp.     A 24-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown), via an unspecified route of administration in the left arm on 20Mar2021(at the age of 24-years-old) at 22:00 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via an unspecified route of administration in the left arm on 28Feb2021(at the age of 24-years-old) at 06:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four week prior to COVID-19 vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. The patient experienced headache, fever (100- units unspecified), muscle ache, joint ache, dizziness, nausea, fatigue on 21Mar2021 16:00. The patient underwent lab tests and procedures which included body temperature: 100 on 21Mar2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of events headache, fever, muscle ache, joint ache, dizziness, nausea, fatigue was recovering.    Amendment: This follow-up report is being submitted to amend previously reported information: For "Historical Vaccine": "Age/Unit" captured as "24 years" per vaccination date 28Feb2021 and DOB. For Lab Data "Body temperature": Test date captured as "21Mar2021". Final sentence "Information about lot number cannot be obtained. No further information is expected." updated as "No follow-up attempts are possible; information about lot/batch number cannot be obtained." Initial information need review.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
ON 6/30/05 MOTHER STATES OBSERVED CLUSTER OF RED PUS FILLED BUMPS ON L ARM. AREA WAS RED AND SWOLLEN. REPORTED TO HEALTH DEPT 07/05/2005. NO REDNESS, SWELLING, OR BUMPS NOTED. 1CM X 3CM AREA SCABBED OVER AND HEALING.   MOM INSTRUCTED TO KEEP AREA CLEAN, APPLY NEOSPORIN TO AREA.
Lightheaded, diaphoresis.  Left observation area at 6:25pm.
She completed Pfizer vaccines in January 2021. She is a long-term resident at the local nursing home, and she was tested positive for COVID at the facility 9 days before admission to the hospital. Her oxygen saturation dropped to the 80s, and she was brought to hospital and admitted on 8/28/21. She is expected to be discharged on 8/31/21. (Number of hospitalization days: 4).
Headache, chills, nausea, sore arm, swollen neck lymph glands
Mom states gave Tylenol per instructions following immunization. Next AM awoke with temp of 102 acted fine during day. That night at 5pm, eyes rolled back and had shaking right extremity-temp 103.4 in ED. Admitted for 23 hrs. N further problems.
pt recvd vax; pt began to have severe pain in lower left arm which spread to upper arm & shoulder;
Rash and warmth on injection site; Rash and warmth on injection site; itching; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 14:00 as dose 1, single (Lot number: HG4628) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: FLUSONE taken for immunisation, start date: 19Sep2023, stop date: 19Sep2023; DOXAZOSIN; DOXYCYCLINE. The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 26Sep2023, outcome "not recovered" and all described as "Rash and warmth on injection site"; PRURITUS (non-serious) with onset 26Sep2023, outcome "not recovered", described as "itching". Therapeutic measures were not taken as a result of vaccination site rash, vaccination site warmth, pruritus. Additional information: Patient had no known allergies and also received "Arexvy".   No follow-up attempts are possible. No further information is expected.
Upon administering the injection into my left arm upper muscle , the muscle clinched and rejected the dose. The best way to describe the feeling was like testing your reflexes. My muscle continued to be sore for a week following the injection.
1. Sudden feeling of weakness 2. Legs felt numb  3. Drowsy/sleepy/ tired
Client first recv'd the Flu Vaccine in the left arm, and then approximately 1 minute later received Pnuemococcal vaccine in the right arm. About 2 minutes later, client c/o not feeling good, with queezy stomach and nausea. Client became very flushed in the face and neck area. Both sites of injection appeared to be minimally swollen and slightly red. Client denied any shortness of breath. HR was 80 -88.  BP was 140/80. Epinepherine was not administerd, as client stated that she felt better after a few minutes.  BP returned to 110/70, and HR 80. Flushing subsided significantly, and nausea subsided. Clients allergist was contacted. She advised pt to take Allevert when she got home. Per, post-event phone conversation with Client, Client stated she did take Benedryl when she got home, and was feeling fine.
Patient asking if she can take Advil for headache today as she. received second Pfizer yesterday. She stated she is not sure headache is from vaccine. She stated she does have a sore arm too. RN reviewed she may take the Advil today.
Pt had great social skills and imitation skills until he received the MMR vaccination. He then became withdrawn, wanted to play by himself, lacked imitation skills and did non acquire language. 60 Day FU states he is now autistic.
Decreased appetite, nasal drainage, overall rash (except legs), high fever (started 10/17/2001) and constipated. Seen by Dr. 10/25/2001 and 10/28/2001.