chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.).    This case contains information for the 7 of 16 patients described by the reporter.  No concomitant medications were reported.  It was reported no adverse event reported on any of the patients involved.  No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:Master case
NEVER HAD AN IRREGULAR CYCLE THE MANTH AFTER VACCINE BEGAN A 5 WEEK CYCLE DOCTOR PLACED ON BIRTH CONTROL TO REGULATE BLEEDING.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, pre-filled pen. On 27-Jul-2022, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2022, SARS-CoV-2 test: (Positive) Positive. No concomitant medications information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were provided. Co-suspect Humira action taken were unknown. Company comment: This is a spontaneous case concerning 60 years old male, with no medical history, who experienced the unexpected non serious AESI event of Covid-19 (reported as Tested positive for COVID) which occurred unspecified days after third dose of mRNA-1273 vaccine. SARS-CoV-2 test is Positive. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Reporter did not allow further contact. Sender's Comments: This is a spontaneous case concerning 60 years old male, with no medical history, who experienced the unexpected non serious AESI event of Covid-19 (reported as Tested positive for COVID) which occurred unspecified days after third dose of mRNA-1273 vaccine. SARS-CoV-2 test is Positive. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pt arrived to ER with shortness of breath. She has a PMH of CHF with diastolic dysfunction, obesity, and COPD. She was found to be COVID positive and was admitted with acute hypoxic respiratory failure.
received the liquid vial of Menveo only; received the liquid vial of Menveo only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA673A, expiry date 30th June 2023) for prophylaxis.   On 16th June 2022, the patient received Menveo. On 16th June 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-JUN-2022  Reporter's comments: The medical assistant reported that, the patient received dose of Menveo liquid vial only without reconstitution with lyophilized MenA powder.  The reporter consented to follow up. Additional Supportive Information: The patient received dose of Menveo liquid vial only without reconstitution with lyophilized MenA powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments: Medical assistant reported that a patient received the liquid vial of Menveo only (without reconstitution with lyophilized MenA powder) on 16-Jun-2022.  ~~~~~~~Consented to follow up.
Information has been received from a pharmacist concerning a female with a history of cancer and Shingles and with no known drug reactions/allergies, who on 15-JUL-2008 was vaccinated with a single dose of ZOSTAVAX (Oka/Merck) SQ. There was no concomitant medication. On 18-JUL-2008 the patient experienced redness at the injection site of the left upper arm and swelling of the left eyelids. The patient's redness at the injection site of the left upper arm and swelling of the left eyelids persisted. The patient sought medical attention by calling the pharmacy. Additional information has been requested.
Burning sensation in left lower calf and foot. Can vary in exact location, comes and goes, at times intense. Doesn't appear changed with movement. Pain/burning in second toe on L foot. Majority of discomfort in concentrated on ventral aspect of L foot. No change in sensation or appearance. Capillary refill test is normal.
Around 4 pm on 2/27/21, I started feeling slightly chilly. By 6 pm, I was experiencing chills and starting to feel body aches in my upper body and upper arms. I went to bed at 8 pm as my symptoms felt quite strong however they continued all day Sunday, 2/28. I slept a lot and took Advil throughout the day but didn?t notice much improvement. By noon on Monday, 3/01 I had begun feeling normal.
7 days post COVID #1 vaccine, onset of bilateral leg claudication (1/31/21). Subsequently dx'd with acute bilateral arterial clots in both legs requiring thrombolysis, bilateral popliteral/artery thromboembolectomy, heparin. Acute clot per vascular surgeon. Surgery performed 2/12/21.
On 11/18/09-  Pt noticed sore arm and itching then on PM of 11/18/09 noticed hives on hands and neck (left side) and arms.  Took BENADRYL and hives resolved by 11/20/09.
pt recvd vax;devel chills,pharyngitis,dysphagia,v,macular rash,sweating,weakness,myalgia,adenopathy,heart rate=110 beats/min;t=40.6C;lab showed alkaline phosphatase 324 units/L;hepatitis,effusion of lt knee,leukocytosis,pneumonitis;
approx. 2-3 minutes after receiving the vaccine client started c/o feeling lightheadedness and she already had SOB which she normally has. She didn't bring her oxygen with her. She said the dizziness lasted a few minutes and she was monitored and then she said she felt better and was allowed to leave. She denies any other problems at this time.
Headache, vomiting & fever of 103 x 2-3 hours, beginning 3 1/2 hours after vaccine administration.
Case was hospitalized and died from Covid 6 months after completing Covid vaccine series.  Was admitted 10/26 with onset of URI symptoms 10/18. Was already on chronic 4 L NC O2 prior to illness. Required high flow nasal cannula oxygen immediately upon admission. Was treated with full course of dexamethasone with some initial improvement in oxygenation. Then began to decompensate again and failed attempts at diuresis with worsening renal function. He wanted to go home on hospice, but was requiring too much supplemental O2 to make this feasible, and probably would have been in florid respiratory distress before leaving the hospital. He further decompensated and his family was called into the hospital. He removed his bipap and placed 15 L mask so could talk with his family. Then he removed the mask and quickly drifted to sleep. Time of death 1620.
She did not take the second dose yet; Blood clot in one my legs; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in one my legs) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced THROMBOSIS (Blood clot in one my legs) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She did not take the second dose yet). At the time of the report, THROMBOSIS (Blood clot in one my legs) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She did not take the second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.  Patient had a blood clot in one of her legs in May-2021. She had to take blood thinners.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient has been on Xarelto and most likely have a condition that is prone to develop thrombosis even before vaccination. Unlikely, that the events are related to the vaccine. Further information is expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient has been on Xarelto and most likely have a condition that is prone to develop thrombosis even before vaccination. Unlikely, that the events are related to the vaccine. Further information is expected.
MOM NOTICED RED AREA TO RIGHT THIGH ON 6/29/2008  RED AREA 10CM BY 12CM TO TOP OF THIGH.  NO PAIN OR DISCOMFORT PER PATIENT
Patient began to grow faint and lost color in her face.  She was immediately taken into the evaluation room and the paramedics on scene found that she was having palpitations, pvc's and nausea.  They stabilized her and transferred her to the hospital where she would be further evaluated by the hospital.
Pt vax w/ 3 doses; testing indicated pt did not convert.  Recv 4th & 5th doses.  Pt in borderline status.
Patient presented with 3 day history of chest pain, found to have myositis based on labs and cardiac MRI
From the medical record: "He did have a flu vaccine 2 1/2 weeks ago." Pt. was complaining of urinary retention, tingling in his feet, increasing and progressive numbness and weakness to his extremities.
I received the second dose of the vaccine at 28 weeks pregnant (estimated due date 6/18/21).  The morning after receiving the vaccine I suddenly passed out while working from home and subsequently vomited after coming to.  I called the doctor's office, and they recommended that I stay home and rest, and that if I continued to struggle with keeping food down that I should go to OB triage at the hospital.  I felt weakened and feverish throughout the rest of the day and had similar symptoms at a lower level the following day.
I developed a cyst on my left eye April 19, 2021.  Went to eye doctor on 4/22/21 and it was identified as a conjuctival retention cyst
Loss of taste; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a male patient (reporter's husband) that:  A male patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for Covid-19 immunization; Bnt162b2 (DOSE: 2), for Covid-19 immunization. The following information was reported: AGEUSIA (non-serious) with onset Oct2021, outcome "unknown", described as "Loss of taste".  Additional information: Reason for no lot number: of Covid-19 Vaccine: Complainant hung up abruptly/transfer incomplete Expiry Date of Covid-19 Vaccine: Unknown  Additional Context: Reporter stated, "I am calling on behalf of my husband (consumer), we have a question. "When probed for the concern, reporter stated, "My husband and I both had our Booster vaccination, the third vaccination on last Friday but my husband is now experiencing no taste (loss of taste). Is that a side effect?"   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (28Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Information has been received from a consumer concerning her 18 year old daughter with pseudotumor cerebri and scoliosis and no drug reactions or allergies, who on 15-APR-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included YAZ and acetazolamide (MSD). The patient's mother stated that her daughter has the condition known as pseudotumor cerebri. As a result of this condition, she sometimes has a build up of intercranial and spinal pressure which causes severe headaches and problems with her eyes, such as pain and sensitivity to light. Prior to receiving the vaccine on 15-APR-2008, her last episode of this increase and build up of intercranial and spinal pressure took place in March 2007. On 11-MAY-2008 the patient had another one of these episodes which caused her to have severe headaches, and problems with her eyes such as pain and sensitivity to light. She was hospitalized for one day so that her physician could do a spinal tap. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.7/21/08-records received for 5/16/08-DC DX: Pseudotumor cerebri. Presented to ED with 5 day history of intermittent headache and 1 day of nausea and vomiting. Headache worse at night and associated with phot and phonophobia. Nauseated and vomiting times two.
Pt was given Proquad and Varivax which makes 2 doses of Varicella.
First 24 hours had a sore arm at injection site, slight chills and lethargy. About 26-28 hours later the  arm started getting red in  an oval shape, abput 2-3   inches  at the site, swollen and sore to  touch.  Did not follow up with tests - read about 'covid arm'   My reaction came  26 hours after the vaccination and is swollen.  Concerned since there was a small quantity of blood on the badaid when I took it off a couple of hours after injection.  Curious if the shot went into something it should not have?
Patient was given flu injection on 9/21 and it started hurting hours later. Patient was seen for another visit on 10/2 because she was still having pain in her left shoulder/arm and had limited movement in her arm.
Patient said they had tingling in feet, sweating. No other side effects, recovered on their own within few minutes and refused EMS. Vital signs stable. No interventions needed.
her mother also went positive for Covid; Positive for covid; This is a spontaneous report from a contactable consumer, mother of the patient.   A 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on unknown date at single dose for COVID-19 immunization. The patient had not medical history. Concomitant medications were not reported. The patient went positive for covid. The outcome of the event was unknown. The reporter mentioned that her mother has no prior health conditions and her physician recommended to receive the second dose regardless she had covid or not.  Information on lot/batch has been requested.
Tested positive after 1st dose; A spontaneous report was received from a consumer concerning a 77-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive after first dose/COVID-19.  The patient's medical history, was not provided by the reporter. No concomitant medications were reported.   On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number : 012L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 13 Jan 2021, the patient tested positive for COVID-19.  Treatment for the event were not reported. Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event tested positive was unknown.
Patient received TDaP and PCV 13 vaccines on 5/10/17. Patients daughter called 5/11/17 to report her father had fever 101.4 with chills, headache, body aches. She gave TYLENOL at 6:00 and symptoms resolved.
First 4-9minutes after shot; Swollen uvula,  tongue, throat, difficulty swallowing. Benadryl and EpiPen. After discharge medications: prednisone 50mg x 4days, Benadryl every 6hrs. Other symptoms; swollen underarms both sides, pubic area, recurrent angioedema, still taking zyrtec Am, benadryl Pm day #7.  Day #6 diarrhea, after 72hrs left side face arm, leg swollen.
ADMINISTERED FROM THE VIAL OF 5-11 DOSE 0.2ML INSTEAD OF THE ADOLESCENT/ADULT DOSE 0.3 ML. NO ADVERSE REACTION AFTER 30 MINUTE OBSERVATION.
RASH AND HIVES, ALL OVER BODY BUT MOSTLY ON BILATERAL ARMS AND FACIAL AREA. MOM STATES, 'GIVEN  OTC BENADRYL. PATIENT CAME INTO OFFICE. PROVIDER SUGGESTED SHOTS OF STEROIDS. PATIENT REFUSED. AS PER PROVIDER, CONTINUE WITH OTC BENADRYL.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (she had chicken pox as a child). Previously administered products included Shingles vaccine (received shingles shot in 2011). On 28th January 2019, the patient received the 1st dose of SHINGRIX. On 1st February 2019, 4 days after receiving SHINGRIX, the patient experienced shingles, skin abrasion, rash, pain and skin peeling. The patient was treated with VALTREX and hydrocodone. On an unknown date, the outcome of the shingles, skin abrasion, rash and pain were not recovered/not resolved and the outcome of the skin peeling was unknown. It was unknown if the reporter considered the shingles, skin abrasion, rash, pain and skin peeling to be related to SHINGRIX. Additional details were provided as follows: The patient experienced chaffing under her arm from the front of her breast bone to the back of her back bone under her bra strap. The chaffing continued both undersides of her arm to her elbow. The worst part was under her arm and she had a rash that was giant in a circle and very painful. When she touches herself, or puts her arm down the skin seems to be adhering to the fold on her arm and it pulls skin off each time. She went to a physician and she was diagnosed with shingles on Monday 4th February 2019. They put her on VALTREX and Hydrocodone and her symptoms are still unresolved.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB (dose, frequency, route of administration and indication were not reported, lot # L048848 with expiration date: 09-AUG-2018). Concomitant medications were not reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration, on unspecified date, single dose, for immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, after the use of meningococcal group B rlp2086, the patient experienced flu like symptoms, body aches, stiff neck and fever. Patient was admitted to emergency room. The outcome of the events was unknown.
Hives daily, which increased in severity after receiving the second vaccine (pfizer) on 12/29/2022. Hives covered the entirety of the body. The hives would last about 24 hours, in which new ones would appear as the old ones begin to disappear. Severity ranges day to day.
MMR given 12/26/05 - 24 hrs later developed firm, red, warm, and swollen area at inj site (left glut.) approx 4 1/2 inches x 5 inches. Dr. notified and Benadryl given. On 12/28/05 area increased to approx 8" x 5". Dr notified and Benadryl cont. On 12/29/05 area has decreased to approx 7" x 4 1/2" continuing to give Benadryl at this time.
Pt received HI DOSE FLUZONE & PNEUMOVAX 23 injections in the left deltoid. Upon awakening the next day, the pt had muscular weakness all over. It was predominant in the (L) arm x 3-4 days and the all-over weakness subsided within 1 day. Pt also had extreme redness/swelling at injection site, but no infection. (Pt is physician). The pts wife had to help him out of bed the morning after the flu shot.
involuntary muscle spasms from head to toe-approx every 5min initially then diminished frequency & severity over 18hr;
Diagnosed with warm antibody mediated hemolytic anemia on 6/21/10. Received vaccines 6/7/10. On 6/8/10 reported injection sites red and swollen. Presented with symptoms 6/21/10.