chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 59-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medicine were reported. lot 042J21A should have been reported with a BUD of 17-Feb-2022. No treatment medicine were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live  FU consists of non significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
PATIENT HAS INFLAMMATION AT THE SITE OF PREVNAR INJECTION. I RECOMMENDED ZYRTEC BUT PATIENT REFUSED AND INSISTED ON TAKING ASPIRIN (WHICH SHE STATES SHE IS ALLERGIC TO) AND MAKING A TEA OUT OF ONIONS.
Gave 0.5ml for 3rd dose instead of the 0.25ml.
EMPLOYEE RECEIVED FLUZONE 0.5ML IM AT APPROX 8AM 10/14/05. aT APPROX 1 PM DEVELOPED COUGH, FEELING OF SHORTNESS OF BREATH. SEEN IN EMERGENCY DEPARTMENT, HAD NEBULIZER TREATMENT AND RETURNED TO WORK.
Nausea, flushed, dizzy, after about 20 minutes  my throat closed, unable to breath. The workers did not know how to use epi-pen. I used my own  epi- pen,  ENT used heart monitor, intervenious  Benadryl was administered, I was transport to ER at hospital, treatment with more meds, prednisone.  I was kept in ER for several hours for monitoring. I had no more reaction.Y
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 14-MAR-2016 the patient was vaccinated with an improperly stored dose of VAQTA 50U/1ml (lot # L018498, expiration 28-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 840 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 168 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Dose administered on 06Jun2022 but it had expired on 22May2022.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number A955S, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th June 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 6th June 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 8-Jun-2022 Reporter's Comments: Registered nurse (RN) reported a Twinrix was administered on 6th June 2022 but it had expired on 22nd May 2022. The Vaccine Administration Facility was the same as Primary Reporter. Health care professional (HCP) had no patient info at time of call. The reporter consented to follow up via email. Additional Supportive Information: The patient received dose of Twinrix which was already expired, which led to expired vaccine used.
Information has been received from a health professional concerning a 13 month old male with a history of bilateral ear tubes and no allergies who on 07Jun05 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (lot648042/1134N). Concomitant vaccines that day included a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197) (PREVNAR). There was no other concomitant medication. On 24Jul05 the pt experienced a raised red rash on his back, legs and arms. He was afebrile. He was seen on 26Jul05 with a diagnosis of rash and ear infection. Treatment included diphenhydramine hcl (Benadryl) for rash and azithromycin (Zithromax) for the ear infection. No labs were performed. At this time the pt had not recovered. Additional information has been requested.
Pt presented to ER with subjective fever, chills and chest pain, dyspnea. Diagnosed with acute pericarditis and myocarditis, was admitted to medicine ward and discharged next day. Pt admitted that night and discharged in AM, treated with Indocin x 2 wks.  Follow-up: The initial VAERS was filed on this patient in August 2003. I sent a VAERS update in September 2006. Currently, the patient remains asymptomatic. The following is a summary of a recent telephone conversation with the patient: Denies any CP, SOB, dyspnea, cough, palpitations, fatigue, headaches and myalgias or arthralgias. Denies interval change in health history, surgical history, family history, allergies, sleep history and military status. (Still on AD). Not taking any medications. Last PT test in June 2007 - scored 89/100. Thinks he took flu vaccine since last contact; denies any adverse events following immunizations over past 12 months.
Covid; Chills; Slight fever 100&99; Very Tired; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced CHILLS (Chills), PYREXIA (Slight fever 100&99) and FATIGUE (Very Tired). On 11-Apr-2021, the patient experienced COVID-19 (Covid) (seriousness criterion hospitalization). The patient was hospitalized from 11-Apr-2021 to 23-Apr-2021 due to COVID-19. The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 23-Apr-2021, COVID-19 (Covid) had resolved. At the time of the report, CHILLS (Chills), PYREXIA (Slight fever 100&99) and FATIGUE (Very Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Body temperature: 100-99 (High) 100 to 99. On 08-Jan-2021, Body temperature: 100-99 (High) 100 to 99.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  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.; 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.
This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (chest pain) and CHEST DISCOMFORT (still feels a pressure on her chest) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A, 010M20A and 013L20A) for COVID-19 prophylaxis. The patient's past medical history included Suspected COVID-19 (Not sure but may have had in February or March of 2020. Treatment received: antibiotics) in 2020. Concurrent medical conditions included Blood pressure high. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain) and CHEST DISCOMFORT (still feels a pressure on her chest). The patient was treated with ROSUVASTATIN for High cholesterol, at a dose of 5 milligram once a day. At the time of the report, CHEST PAIN (chest pain) outcome was unknown and CHEST DISCOMFORT (still feels a pressure on her chest) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jul-2022, Magnetic resonance imaging: could not find a cause. On an unknown date, Blood cholesterol: had high cholesterol. Concomitant product use was not provided by the reporter. The patient experienced chest pain within the last few weeks of this report. She went to see her cardiologist 2 weeks ago, was told she had high cholesterol and was put on Rosuvastatin 5mg daily. She went to the ER due to the chest pains a day before the date of this report, they did an MRI and they could not find a cause. She still felt a pressure on her chest. This case was linked to MOD-2022-607259 (Patient Link).
On day 7, lymph node under same arm was swollen and sore and itching started at injection site.  On day 8, felt extremely fatigued but worked; lymph node still swollen. On day 10, developed a rash about 4-5 inches long and 3-4 inches wide, tear drop shaped starting at injection site and running up my arm. It was itching, red and hive-like. Cortisone cream was used.  On day 11-12: redness is gone but a cordlike circle around the tear drop pattern remains and it itches at times. Redness comes and goes.
Sore arm on going, extreme fatigue, light headache, could not get comfortable, body aches and chills lasting 24 hours
kidney's shut down; This case was reported by a consumer via interactive digital media and described the occurrence of renal failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced renal failure (serious criteria GSK medically significant). On an unknown date, the outcome of the renal failure was unknown.   It was unknown if the reporter considered the renal failure to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. It was reported that the patient got Shingles vaccine recently and her kidney's shut down. The follow-up would not possible as no contact details were available.
itching in the area of the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching in the area of the shot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced VACCINATION SITE PRURITUS (itching in the area of the shot). At the time of the report, VACCINATION SITE PRURITUS (itching in the area of the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: follow up received on 4-jun-2021:contains no new information
Pressure in chest; fluttering/racing heart; side effects continue to this day. Periodic throughout the day.
Information has been received from a Nurse Practitioner concerning a female patient who completed GARDASIL vaccine (lot # not provided) series. The patient was sexually active and she was positive for the HPV Test. This is one of two reports from the same source. Additional information has been requested.
I had wheezing, shortness of breath, chest pain when coughing, swelling in my left foot around the ankle and the instep, and lots of coughing. Urgent care prescribed doxycycline.
at the injection site there is a 2in x 2in circular red rash that is itching and burning its a welt and its raised about quarter of an inch
Patient received a little of over half; Syringe was defeating while giving the second dose/ The seal broke after pushing the plunger; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a little of over half) and DEVICE CONNECTION ISSUE (Syringe was defeating while giving the second dose/ The seal broke after pushing the plunger) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a little of over half). 27-Apr-2021, the patient experienced DEVICE CONNECTION ISSUE (Syringe was defeating while giving the second dose/ The seal broke after pushing the plunger). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a little of over half) and DEVICE CONNECTION ISSUE (Syringe was defeating while giving the second dose/ The seal broke after pushing the plunger) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medicine Pharmacist calling to report an adverse event. Syringe was defeating while giving the second dose. The seal broke after pushing the plunger. Pharmacist believe patient received a little of over half.  Patient received the vaccine in the right arm in the muscle. Patient received the second dose on 27APR2021 and the lot number is 048B21A. Patient is not taking other medication.
This spontaneous case reported by a consumer, describes the occurrence of urticaria (hives traveling all over body) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included drug allergy. Allergic to sulfa. On Jun 15, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 16, 2021, patient experienced urticaria (hives traveling all over body). The patient treated with hydrocortisone for itching, at an unspecified dose and frequency. At the time of the report, urticaria (hives traveling all over body): not resolved. For mRNA-1273 (Moderna COVID-19 vaccine), intramuscular dosing remained unchanged. Concomitant medications not reported. Patient experienced itchy, red bumps; popping up all over body (including scalp).
She did not sound very well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 02May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset May2021, outcome "unknown", described as "She did not sound very well".  Additional information: Caller received her first dose 02May and she has Epilepsy. She did not sound very well and she wanted to know if there are any affects receiving the vaccine when having Epilepsy.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Also reported fever 102.5, weakness, chills. Unable to work on 12/17/21 Narrative:
After injection, began to feel faint.  BP 90/50, Blood Sugar 107, 911 activated.  Transported via ambulance.  On 3/26/2021, follow up phone call - Subject indicated it was most likely a Vagus Nerve response and not an adverse reaction.  Stated she was a little achy and tired today, 3/26/21.
The skin on my hands had cracked and were bleeding; rash; feet were swollen; The skin on my hands had cracked; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date on 13Nov2021 15:00 (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 2), administration date: Apr2021, for COVID-19 immunisation, reaction(s): "rash"; Bnt162b2 (dose 1), administration date: Mar2021, for COVID-19 immunisation. The following information was reported: HAEMORRHAGE (medically significant) with onset 15Nov2021, outcome "unknown", described as "The skin on my hands had cracked and were bleeding"; RASH (non-serious) with onset 15Nov2021, outcome "unknown", described as "rash"; PERIPHERAL SWELLING (non-serious) with onset 15Nov2021, outcome "unknown", described as "feet were swollen"; SKIN FISSURES (non-serious) with onset 15Nov2021, outcome "unknown", described as "The skin on my hands had cracked". The patient stated, "I had my booster shot at 3pm on Saturday, 13Nov2021. Monday, 15Nov2021 I woke up with a more sever rash. The skin on my hands had cracked and were bleeding. My feet were swollen." The patient underwent the following laboratory tests and procedures: biopsy: having a reaction to a medication, notes: having a reaction to a medication.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Per vaccinator,  while administering vaccine he attempted to push the dose, the needle separated from the syringe leaving the needle in the patient's arm  and vaccine sprayed out. Vaccinator removed needle and hub from patient's arm. A replacement dose was administered as the patient did not receive any of the dose.  Syringe and needle was Haiou brand.
On approximately, 01/15/2023, in the morning, I began to have head cold and upper respiratory symptoms. Each time, it resolves, then lasts another ten or so days. I have had nasal congestion, runny nose, cough, no fever. I am still having these symptoms, this is the third occurrence. I treat with NYQUIL and cough medicine. I went to my doctor a couple of days ago.
Information has been received from a health professional concerning a over 60 year old female who was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot number, injection site and route not reported). Subsequently the patient developed shingles "a couple days post vaccination". The patient sought unspecified medical attention. Additional information has been requested.
Received vaccination on 10/3/18. That evening she started feeling very light headed/foggy as well as having extreme joint pain all over her body, legs, hips, arms, hands. On 10/4/18 she was still feeling foggy headed and very nauseous. Her joint pain improved, but was still feeling pain of like 6 to 7. She was not having any pain or swelling at the injection site at all.
Patient presented with hives immediately after receipt of the vaccine. We gave her 50mg Benadryl by mouth. She was not in anaphylaxis so we sent her directly to follow up with her MD.
My son was a healthy happy twin who met all his milestones early or on time. After receiving the HEP A, DTaP, Influenza, MMR, Varicella, and Pneumococcal vaccines at his 12 month well baby visit my son soon became ill with a fever and rash all over his body. With in the next few weeks he lost all of his speech, lost eye contact and my happy and outgoing baby became reverted and wanted to be by himself. By 18 months my son was diagnosed with autism, speech delay, and sensory processing disorder. With in months after this adverse reaction he also started getting food allergies. He is allergic to wheat, peanuts, has asthma, eczema and has gastric intestional problems along with sleeping disorders.  My son has received ABA, ST, and OT therapies.
On 5/14/19, rash noted at injection site.  Applied Benadryl Cream.  Soaked clothing with perspiration during sleep.  On 5/15/19, noted pain and warmth at site of injection. Rates  pain level at seven (7). States she has been taking Advil, Motrin and Aleve, but pain continues.  An area of hardness approximately 1 1/2 inch in diameter at site of injection.  Denies that she has had fever.