chrisvoncsefalvay/vaers-outcomes huggingface dataset:
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported. It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment medications were reported.  This case contains information for the 5th of 77 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:
Covid vaccine error - wrong vaccine given to complete primary series, minimal waiting period not followed; no adverse event reported per the pt, office staff will check on patient daily x1 wk
Headache, Sedation, Myalgia, Fever, CoughWheeze,  HOT AND COLD FLASHES, PAIN IN ARM Narrative:
This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (only have a little reaction after the second booster), vaccination site pruritus (a little swelling and itching on the site of the injection) and vaccination site swelling (a little swelling and itching on the site of the injection) in an male patient, of unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 5, 2022, patient received the fourth dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the 3rd, 2nd and 1st dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 6, 2022, patient experienced vaccination complication (only have a little reaction after the second booster), vaccination site pruritus (a little swelling and itching on the site of the injection) and vaccination site swelling (a little swelling and itching on the site of the injection). At the time of the report, vaccination complication (only have a little reaction after the second booster), vaccination site pruritus (a little swelling and itching on the site of the injection) and vaccination site swelling (a little swelling and itching on the site of the injection) outcome: unknown.  It was reported the patient had a little swelling and itching on the site of the injection, but he was fine. No concomitant medication or treatment information reported.
This spontaneous report as received from a healthcare worker and a nurse refers to unspecified number of patients. Mdical history and concomitant medications were unknown. It was reported that, improperly stoerd doses of PNEUMOVAX23 (single dose vials, route of administrations, doses, lot numbers and expiry dates were not reported) wer given to unspecified patients on unspecified dates (Incorrect product storage). No adverse experience was reported. No product quality complaint (PQC) was involved. Follow up has been received from a healthcare worker on 06-JUL-2015: It was reported that on 11-MAR-2014, the patient of unkonwn age and gender was associated with improperly stored PNEUMOVAX23 (Lot number: J010654, Expiry date: 17-OCT-2014). This is one of several reports from the same reporter. Additional information has been requested.
Late afternoon my face, scalp, neck and hands began to itch; Late afternoon my face, scalp, neck and hands began to itch, get red; Late afternoon my face, scalp, neck and hands began to itch, get red - hives; headache; This is a spontaneous report from a contactable consumer (patient). A 71-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 05Mar2021 11:45 (Lot Number: EN6203) (at the age of 71-years-old) as dose 1, single for covid-19 immunisation. Medical history included thyroid, hypertension, heart palpitations, shellfish allergy, sulpha allergy, bee allergy. The patient previously took naproxen sodium and experienced allergy. The patient received other concomitant medications within two weeks of vaccination. No other vaccine was received within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior to vaccination and was not tested for Covid since the vaccination. On 05Mar2021 14:00, late afternoon patient's face, scalp, neck and hands began to itch, got red, hives and headache. She had a busy afternoon and ignored it until about 5pm. It got worse through 07Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient received a Tdap injection on Wed. 10/31/2012 in the left deltoid area. Left arm and Tdap vial were both cleansed with alcohol. Patient tolerated the procedure well. She reported (via an email several days later) that her arm did have some Increased soreness later that day but she did not feel that is was anything out of the ordinary. She reports that the next morning Thurs. 11/1/2012 she woke up and the soreness had increased so she took Ibuprofen. On Friday 11/2/2012 around noon, she noted an area about 4 inches around the site of the injection site that was bright pink and hot that was going towards her elbow. She came back to the Health Center were the Tdap was administered to have a nurse evaluate it. The nurse Informed her that it looked like she was experiencing a reaction to the vaccine, and if the reaction continues to Increase that she should seek medical attention with a medical provider. On Sat. 11/3/12 she did seek care at a local Urgent care because she stated that the swelling had increased down to her elbow. She was given an antibiotic. On Sunday 11/4/2012 patient stated that when she woke up that morning the swelling redness and warmth had decreased some, but states that the area was more purplish in color and was itchy. She then waited until Monday morning 11/4/2012 and went to her regular provider office. There she was evaluated by a Physician Assistant whom she stated felt the antibiotics were working and the coloring was basically bruising and that the itching was not unusual. The information from 11/3/2012 was reported to me via an email form the patient that I received today 11/12/2012. She reported the incident to us on Friday Nov. 9th via email. We are closed on weekends in the department were the vaccine administered so the VAERS was not completed until today. At the time of this report and per the patient's email she is recovering from the reaction.
w/in 30 mins p/vax devel intense itching & fine red raised rash @ inject site; itching rash spread up to shoulder-arm-elbow & back adm to ER:
Arm pain; Dizziness; Difficulty walking; Severe pressure in head; Akathesia; Agitation; Eye pain; Sensitivity to light; Tinnitus; Sore throat; Vomiting; Nausea; Severe headache; 101.8 far fever; Myalgia; This is a spontaneous report from a contactable healthcare professional, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6206) via an unspecified route of administration in the left arm on 07Mar2021 at 13:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19 infection, asthma since an unknown dates. The concomitant medications included duloxetine hydrochloride (CYMBALTA), allopurinol (ELAVIL), lurasidone hydrochloride (LATUDA), alprazolam (XANAX) and omeprazole (OMEPRAZOL) for an unknown indications, from an unknown dates and unknown if ongoing. The patient previously received levofloxacin (LEVAQUIN) and ciprofloxacin (CIPRO) and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 17Mar2021, at 13:30, the patient experienced severe headache, 101.8 far(Fahrenheit) fever, arm pain, myalgia, dizziness, difficulty walking, severe pressure in head, akathesia, agitation, eye pain, sensitivity to light, tinnitus, nausea, vomiting and sore throat. Therapeutic measure were taken as a result of adverse event which included treatment with non-steroidal anti-inflammatory drugs (NSAIDs). The clinical outcome of the events severe headache, 101.8 101.8 far(Fahrenheit) fever, arm pain, myalgia, dizziness, difficulty walking, severe pressure in head, akathesia, agitation, eye pain, sensitivity to light, tinnitus, nausea, vomiting and sore throat was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore arm) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 29-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy since 22-May-1991, Drug allergy (Keflex) since 22-May-1991 and Allergy to antibiotic (minocycline and Clarithromycin) since 22-May-1991.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 25-Jan-2021. On 31-Dec-2020, the patient experienced PAIN IN EXTREMITY (sore arm) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). On 01-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2020, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was on her second pregnancy.First pregnancy due date was 4 Dec 2019 with resulted in live birth.  No concomitants or treatment medications were reported. Estimated date of conception was 05 May 2020.; Sender's Comments: This is a case of product exposure during pregnancy with associated AE for this 29-year-old female.Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
a 62 year old female patient was administered expired Tenivac vaccine, no AE; Initial information received on 24-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 62 years old female patient who received an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (booster dose 0.5 mL, lot U5882AA, expiry date: 08-Mar-2020) inadvertently via intramuscular route in the left deltoid on 10-Mar-2020 for prophylactic vaccination  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  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 holders 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.
PRESSURE BEHIND EYE ON THE SIDE OF THE INJECTION AND AND LATER DOUBLE VISION.
1st dose on 04 09 2021 & 2nd dose on 05 15 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 04 09 2021 & 2nd dose on 05 15 2021) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008c21a and 016b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 04 09 2021 & 2nd dose on 05 15 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 04 09 2021 & 2nd dose on 05 15 2021) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-492444 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2022: Non significant follow-up appended contains NNI.
big red circle on upper (L) arm, 4" diameter.  Lasted for about a week.  Also a rash - red dots all the way from upper (L) arm to wrist.  Lasted about 2 days.  Pain at site of injection.
Initial report received from a healthcare professional on May 18, 2006. A 53-year-old male patient, with a medical history of hypertension, had received a left deltoid injection of Menactra, lot number U2004AA; a subcutaneous, left arm injection of YF-Vax, lot number UE813AA; and a right deltoid injection of Hepatitis B vaccine, lot number 1121R; on May 16, 2006. Thirteen hours later, the patient developed nausea, vomiting, muscle aches and lightheadedness. One day after that, the patient was unable to eat and continued to have some muscle aches. The event did not require examination by a physician. At the time of this report, the patient had recovered. Follow up information received on 07/Jun/2006 from a health care professional. The patient had not received any other vaccinations within four weeks of the 26/May/2006 vaccinations. He had not had an adverse event following any prior vaccinations. The patient did not have any relevant testing performed.
Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: PT as given the vaccine and waited 15min. during the waiting period she reported she didn't feel too good. her BP was taken every 5min BP was 115/71. 911 was called but she said she was feeling better and wasn't transported with the ambulance
On 03/01/2001 the patient experienced injection site swelling, redness and injection site pain. The physician felt the booster shot may have been administered into a vein. A few days later the physician saw the patient and a little swelling remained. The patient was not experiencing discomfort. The patient was treated with antibiotics to prevent cellulitis. Additional information has been requested. Per F/U 6/18/02: This was the pt 2nd dose of varicella vaccine. On 3/1/01, the pt experienced a local reaction, distal to the injection site. Some swelling with warmth, redness and injection site pain (to touch) was noted. The pt's mother felt the booster shot may have been administered into a vein. A few days later, the phsycian saw the pt and a little swelling remained. The pt was not experiencing discomfort. Therapy with antibiotics was initiated to prevent cellulitis that might occur. On 4/27/01, the physician noted that the pt was "doing fine". On 5/14/01, the physician reported that his condition completely resolved and did not anticipate any further symptoms. Additional info has been requested.
TESTED POSITIVE FOR COVID-19; This spontaneous report received from a patient concerned a 68 year old male. 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: 204B21A expiry: UNKNOWN) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-DEC-2021, the patient experienced tested positive for covid-19. Laboratory data included: COVID-19 virus test (not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tested positive for covid-19. This report was non-serious.
he started experiencing vertigo which lasted 5 or 6 days; only experiencing dizziness when he tries to stand; This is a spontaneous report from a contactable consumer (wife). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Reporter stated that her husband (patient) received the first dose of the Pfizer COVID-19 vaccine and about 4 days later (date unspecified) he started experiencing vertigo which lasted 5 or 6 days. Patient was now (since an unknown date) only experiencing dizziness when he tries to stand. Patient did speak with his primary care provider to let her know about this reaction after receiving the first dose of the Pfizer COVID-19 vaccine and she prescribed meclizine as a treatment for his vertigo and dizziness. The reporter would like to know if her husband should receive the second dose considering his reaction after the first dose. The reporter would like to know if the two doses of the Pfizer COVID-19 vaccine are the same and would like to know how effective the Pfizer COVID-19 vaccine is after the first dose. The events were reported as non-serious. Therapeutic measures were received in response to the reported events. The outcome of the events vertigo and dizziness was unknown.   Information on the lot/batch number has been requested.
Severe back and hip pain on left side; frequent urination; burning and irritation during and after urinating
On 7/20/98 pt recv vax and exp local erythema at injection site for 3 weeks.
after her first Covid vaccine, she felt a little tired and fatigued; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on Feb2021 at the age of 43-years-old as DOSE 1, SINGLE for covid-19 immunization. Medical history included immune thrombocytopenia from 2004 and ongoing Caller believes she was diagnosed in 2004 , splenectomy from an unknown date and unknown if ongoing she does not have a spleen, so she tends to get sicker and stay sicker longer than most people. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was diagnosed with Covid 19 and has been tested for Covid-19 Since the vaccination. On Feb2021 the patient experienced after her first covid vaccine, 4-6 hours after the vaccine ,she felt a little tired and fatigued .The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 05Aug2021 she tested positive for Covid on 05Aug2021 and quarantined until 14Aug2021. On an unspecified date in Feb2021, the patient had recovered from the events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
6 days after vaccines developed crampy abdominal pain and bloody stools. CT showed ileocecal intussusception. Surgical reduction was performed after barium enema failed.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In July 2016, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In October 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.