chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose of Daptacel was given to a 15 month old/No AE; Initial information received on 24-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 15 months old male patient who received an expired 4th dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 20-May-2019 (expiry date: 16-May-2019) via intramuscular route in the left thigh.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and HAEMOPHILUS INFLUENZA (HAEMOPHILUS INFLUENZA).  It was of actual medication error case due to expired vaccine used.  No adverse event was experienced.  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.  List of documents held by sender: none.
child recv vax 6DEC95 & 21JAN96 mom devel a mild case of shingles w/lesions on abd, hip & back;no further details were provided;
Difficulty breathing; His chest still hurt; This is a spontaneous report from a contactable consumer. An 18-years-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EP7533), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 18 years). The patient medical history was not reported. Concomitant medication included somatropin (OMNITROPE) taken for an unspecified indication, start and stop date were not reported. On 08Apr2021 patient experienced His chest still hurt, on an unspecified date patient experienced He had difficulty breathing. Reporter stated that his chest still hurt, but it's easier for him to breath. He feels it's not a hundred percent, but it is better. The adverse events resulted in emergency room visit. The patient was not received treatment. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Positive COVID-19 TesT; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive COVID-19 TesT) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided). Concomitant products included METFORMIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FINASTERIDE and LOSARTAN for an unknown indication.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced COVID-19 (Positive COVID-19 TesT). At the time of the report, COVID-19 (Positive COVID-19 TesT) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This is a case of a 74 year old male who tested positive for COVID 19 and without any other symptoms after receiving the first dose of Moderna Vaccine. Based on the information available the event is considered unlikely related to the vaccine. Further information has been requested.
episode apnea & unresponsiveness p/vax;dusky, diaphoretic spontaneous return to nl p/30 sec interval;MD contacted & evaluated pt;scheduled for EEG prob secondary noxious stimuli & not related to Hep B per MD;
Low grade fever; 101.4 Centigrade; Feeling sick; This is a spontaneous report from a contactable consumer (patient).   A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Aug2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 20Aug2021, the patient was feeling sick and on 21Aug2021, the patient experienced low grade fever, 101.4 Centigrade. Clinical outcome of the adverse events was unknown at time of this report.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Pt experienced a syncopal episode within 5 minutes of vaccine administration. Pt was placed in supine position and regained normal vitals within 5 minutes. Pt symptoms of light headedness and palor resolved prior to discharge. Pt was monitored for 20 minutes w/o any other ASE.
I am a physician myself and would like to report the following adverse event:  - 2nd dose of Pfizer COVID 19 vaccine received on 1/8/21 - 1/9/21 Had body aches, chills, no fever, fatigue - relieved with Tylenol and ibuprofen and all resolved by 1/10.  - On the night of 1/12/21, after an intense gym workout, I was unable to lay flat in bed. I had sudden onset SOB, chest tightness, audible upper airway wheezing. Symptoms persisted and worsened through the night prompting me to drive to the Emergency Dept.
Headache, body aches, tired, lymph nodes under my arms are soar for the following two days bad enough to prevent me from working and doing house hold work.
Fine red raised rash to abdomen, arms, legs, back without fever appeared on 4-16-04.
Large hive at site of vaccination, almost all the way around arm. Painful when touched, self limiting after 5 days.
Walk in patient for COVID Vaccine POD. Patient received Janssen Covid vaccine @ 1127 and self reported chest tightness, shortness of breath, diaphoresis and pallor AT 1136 to RN in observation area. Epipen dose given to patient in observation @ 1139 and care transferred to ED Charge RN. Chest tightness and shortness of breath subsided at time of entry.
Starting a few days after receiving the vaccine, I experienced massive headaches. I suffer from migraines from Meniere's disease but these were much worse and they were every day. They were so intense I had to take a lot of painkillers (more than usual) to treat them but they seemed to persist no matter what I did. These lasted for several months. I developed neck problems (stiff neck and sore more so on the right side from neck through shoulder to arm). The pain in the shoulder/neck is still persisting but its getting better. The headaches have calmed down for the most part and I'm back to my normal routine.
I was out of state and I thought I had allergies. Had to do a lot of screening to even go there right now. I started to feel like I had allergies on Saturday, Sept 25th. I was flying home that day so I didn't think anything of it. I was very congested. He asked me to take a home test. It was positive. I took that on Sunday on the 26th. I took another one on Tuesday the 28th (home test). I went in a for a professional test on the 30th at local pharmacy all tests came back positive. OTC cold medicine, Dayquil, Nightquil; and some cough medicine Robitussin; cough, congestion, loss of smell. No body aches etc, just felt like a cold or allergies. I had those symptoms for about a week. Had a phone consult with nurse at doctor's office. September 10th, Pneumonia shot, 2nd Sept 10th; Flu Shot on September 15th. I received these before going to out of state.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2021 as dose 1, single (Lot number: ew0182), in left arm, on 04Jun2021 as dose 2, single (Lot number: ew0178), in left arm and on 10Dec2021 as dose 3 (booster), single (Lot number: tj8760) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diet controlled diabetes-glucose intolerance" (unspecified if ongoing), notes: Diet controlled diabetes-glucose intolerance; "Diet controlled diabetes-glucose intolerance" (unspecified if ongoing), notes: Diet controlled diabetes-glucose intolerance; "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. Concomitant medication(s) included: COQ 10, start date: Jan2010, stop date: 08Aug2022; D3, start date: Jan2015, stop date: 08Aug2022; ROSUVASTATIN, start date: Jan2010, stop date: 08Aug2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, latency 10 days 20 hrs after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Negative; (Aug2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: re-bound COVID 4th day after treatment. presented with head congestion followed by positive test after testing negative. Anti viral details: Product: COVID 19 Treatment, Paxlovid, treatment start on 08Aug2022 and stop date was 12Aug2022.   No follow-up attempts are possible. No further information is expected.
Information has been received from a 61 year old male consumer with diabetes and a prostaglandin inhibitor allergy who on 24-JUL-2007 was vaccinated intramuscularly with a single 0.65 ml dose of ZOSTAVAX. Concomitant therapy included lisinopril (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), dorzolamide HCL (+)/ timolol maleate (MSD), ALPHAGAN and glipizide. On 24-JUL-2007 the patient developed "a little pain" at the injection site. No lab studies were performed, and no medical attention was sought. At the time of this report the patient had not recovered. There was no further information provided. There was no product quality complaint involved. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Initial information has been received from a 61 year old male with diabetes and a prostaglandin inhibitor allergy who on 24-JUL-2007 was vaccinated IM in the left arm with a single first 0.65 ml dose of ZOSTAVAX (Oka/Merck) (Lot#656858/0356U). Concomitant therapy included lisinopril (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), dorzolamide HCl (+)/ timolol maleate (MSD), ALPHAGAN and glipizide. There was no illness at the time of vaccination. On 24-JUL-2007 the patient developed "a little pain" at the injection site. No lab studies were performed, and no medical attention was sought. At the time of this report the patient had not recovered. No adverse event occurred. Follow up information from a licensed practical nurse indicated that the nurse recorded in the chart that the vaccine was given SC in the left arm. The patient came in later saying it was given IM and wanted to know if it would still work. The patient's outcome was not reported. There was no further information provided. There was no product quality complaint involved. Additional information is not expected.
day p/vax arm injected felt like a very bad bruise, then numbness occurred down into hand & fingers w/edema;no discoloration or blanching of skin;no other sxs; pain and swelling disppeared post 9 days;
14 month female with immunization delay, immunization catch up and well child check on 4/1/13. Developed fever to 103 that evening and had seizure. Parents called 911 and taken to ED.
Fatigue after vaccine. Headache for at least 4 days after vaccine. Fatigue 3 days after vaccine. Cluster of hives on hip region day after vaccine. Low grade fever and loss of appetite. Complained of stomach hurting.
ADMINISTERED EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned 2 female patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced administered expired vaccine. On 22-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine was not applicable. The outcome of the administered expired vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210944551.
FATIGUE, MILD FEVER FOR 2 DAYS POST-IMMUNIZATION; TREATED W/ IBUPROFEN AT HOME
Patient complains of injection site reaction several days after receiving the vaccine.. She reported the symptoms on 11/28/2020. States that she scratched the area and it "oozed" and had an "eruption".
Intern injected too high into the shoulder area leaving the arm extremely sore, tender to touch, and difficult to move without experiencing pain
This spontaneous case reported by a physician, describes the occurrence of erythema (arm really red, almost purple) and erythema (redness extends to her elbow) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 11, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 24, 2021, patient experienced erythema (arm really red, almost purple) and erythema (redness extends to her elbow). At the time of the report, erythema (arm really red, almost purple) and erythema (redness extends to her elbow) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments.
Tested positive for Covid 22 days after 2nd dose of vaccine (2/23/2021)
12-13 hours post vaccine, experienced severe chills and moderate fever and sweating. Gradual decrease in symptoms over the next three days.
This case was reported by a healthcare professional (nurse) and described the occurrence of injection site cellulitis in a 64-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included anxiety, arthritis and seasonal allergy. Concurrent medications included LEXAPRO, ALLEGRA and FLONASE. It was reported that the subject had not previously received any flu shots and there were no known adverse events following previous vaccinations. On 12 September 2012, the subject received dose of FLUARIX (.5 ml, details unknown, left deltoid). No other vaccines were administered on this same date. On 13 September 2012, 1 day after vaccination with FLUARIX, the subject experienced left shoulder warm, hot and painful above the injection site, "previous vaccination site was red" and bruise injection site. On 14 September 2012, 2 days after vaccination with FLUARIX, the subject experienced injection site cellulitis. This case was assessed as medically serious by GSK. The subject's primary care physician diagnosed her with cellulitis and prescribed antibiotics and ZYRTEC to treat it. The subject required medical attention at the doctor's office. The left shoulder warm, hot and painful above the injection site, "previous vaccination site was red", and injection site cellulitis resolved on 17 September 2012. At the time of reporting the bruise injection site was improved.
8/9/21: Pt presents to the ED  with the CC of SOB x 2 days.  Patient admits to SOB, loss of appetite, fever, diarrhea, loss of sense of taste and smell, cough but denies chills, nausea, vomiting, chest pain, abdominal pain, headache, or any other symptoms at this time.  Patient verbalized receiving Johnson & Johnson  COVID-19 vaccination-admin March 2021.  Patient also verbalized been noncompliant with diabetic medications because it makes her tremble. 8/9/21: Pt tests positive for COVID upon admission 8/15/21: Pt discharged
little pain; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little pain) and PAIN IN EXTREMITY (sore arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 10-Feb-2021, the patient experienced PAIN (little pain). At the time of the report, PAIN (little pain) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
I awoke at 2 or 3 AM, dizzy-room going around. Stayed in bed until 9:30 AM. I thought I was having a stroke with sweating, vomiting. I called the ambulance and went to hospital. I am still light headed; not able to drive. A neurologist was called in while in the hospital (3 days).
pt recvd vax 26APR93 this AM 27APR93; mom noted spontaneous startle response x 3 or 4 (also fever 103);
TDAP and PNEUMOVAX given 10 am 9/15/10. Six hours later increased discomfort. 24-48 hours signif. edema (7x8 cm and 4x6 cm) and erythema and pain.
No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medications were reported.  Reporter stated she had been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and has seen 88-90% success rate in resolving the symptoms of long-haul COVID. Vaccine was given within current guidelines except seven were under 65.  It was reported that, vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms of 50% or more.  Patients were treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches. No adverse reactions occurred.  No treatment medications were reported.  This case contains information about patient third out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case Patient 1
Hives, then numbness started in right middle and ring finger then moved up to arm and shoulder. then stared in toes.  Toes don't have the tingly feeling like the arm.  Now noticing right eye vision is not as good  A little blurry.
MOM CALLED 11:30 04/01/2014 STATING CHILD HAD ALLERGIC REACTION BETWEEN 1 OR 2 HOURS AFTER HAVING THE VACCINE. Patient arm swelled up, high fever of 102.7, swollen throat. Mom gave 2 Motrin right away and made the child lay down for a few hours contacted a friend who is a nurse and went to local ER last night they gave her something for fever last night. She has improved and is better. I suggested child to follow up if need asap.
Felt ill, tired, achy.  No fever detected.  Sore arm, nothing too serious.  Symptoms lasted one day.
Information has been received from a health professional concerning a 7-year-old male who on 09/11/1997 was vaccinated in the left arm with a first dose of Varicella virus vaccine live. On 03/26/2001, the pt's mother reported that the child was experiencing "red mosquito like bumps". The report indicated that there were seven "bumps" total and that one was fluid filled and one the child scratched open. The child was afebrile and no treatment was ordered. Unspecified medical attention were sought The health care provider reported that two other children in the practice had Varicella after vaccination.
She tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 09Apr2021 as first dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her first dose of the Pfizer COVID Vaccine on 09Apr2021. On 21Apr2021 she tested positive for COVID and was not able to receive her scheduled second dose. She was asking if it would be okay for her to receive her second dose if the 3 weeks have already passed. The patient underwent lab tests and procedures which included test for COVID: positive on 21Apr2021. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Rash Red spots on arms and neck and upper back shoulder area.   I spoke with Dr. today..  this reaction started on 1/14/2021  and I still have it..   He asked that I let you all know..  Nothing hurts but is still there.   They are going to let my doctor know.    I plan on still having the 2nd injection on 2/09/2021 as planned.