chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Determine course of action when covid vaccine given past expiration date/6 doses administered on 07May2022 with a published expiration date of 25Mar2022.; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Determine course of action when covid vaccine given past expiration date/6 doses administered on 07May2022 with a published expiration date of 25Mar2022.) 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. 033H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Determine course of action when covid vaccine given past expiration date/6 doses administered on 07May2022 with a published expiration date of 25Mar2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Determine course of action when covid vaccine given past expiration date/6 doses administered on 07May2022 with a published expiration date of 25Mar2022.) 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 EXPIRED PRODUCT ADMINISTERED (Determine course of action when covid vaccine given past expiration date/6 doses administered on 07May2022 with a published expiration date of 25Mar2022.).    No concomitant products were reported.  It was unknown if any other vaccines were given in the 4 weeks prior to COVID-19 vaccine. There was no information about previous COVID-19 vaccination doses. It was reported that determine course of action when COVID vaccine given past expiration date. 6 doses administered on 07 May 2022 from lot number 033H21A with a published expiration date of 25 Mar 2022. Health care professional stated that they were the 1st boosters.   No treatment products were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2023: Follow up received wherein the reporter information, product start date, dose information, event information and narrative updated.
Myopericarditis - still hospitalized, so outcomes not yet known.  Patient is being treated with a beta-blocker, ACE-I, loop diuretic, and colchicine.
This spontaneous report was received from a pharmacist and refers to a 19-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date in October 2018, the patient was inadvertently vaccinated with a dose of ZOSTAVAX injection (lot number, expiration date, exact dose, anatomical location and route of administration were not provided) reconstituted with sterile diluent (lot number and expiration date were not provided). Product quality complaint (PQC) was not involved.
Note: Inflammation had started as bursitis last summer - and then it started to recede and then I started to get inflammation everywhere but at different times. Swollen feet early 2021. Rotator cuff problems -May 21, 2021 and also carpal tunnel May 21. June, it went to my knees and a little bit in the hips. It was both pain and it was swelling of the feet, especially the left. I also had some swelling in the hands. I attributed that to carpal tunnel. I am diagnosed with both hands but getting surgery on right side only tomorrow. That side is the wrist. I started treatment myself just before I saw Dr. in (June). I was trying to treat the inflammation - I went on 600 mg of Ibuprofen four times a day and continued that to mid August when I cut it to three times a day. For pain. Then I skipped all the NSAIDs - at one time I had use Voltaren but it interferes with ibuprofen so I had dropped that and went to Australian Dream - Histamine Dihydrochloride and then I was using, for awhile, BioFreeze for the carpal tunnel and that wouldn't interact with the Ibuprofen. I also started Curcumin phytosome and Theralase - a proteolytic enzyme blend. I take that Theralase once a day. Bottom line, inflammation is much less. SED rate - did that test: first test (July 8th) was 75 and the 2nd one came back at (August  13) - 42 and the recommendation is under 20. That last one (42) was a month ago. The carpal tunnel in the right hand is not receding but it is not terrible. THe inflammation may be below 42 now. Swelling has gone down. For the swelling - I wore that nighttime brace on my right arm. Use support hose for inflammation in my legs.
Moderna Covid-19 Vaccine EUA.     12/28/2020 at 1500 received vaccine. 12/29/2020 1200pm left arm severe pain, took advil. 12/29/2020 2030- had upset stomach. 12/30/2020 0230am- chills, low grade temp and back ache.
No adverse event. But Kinrix given to 7yr old child. Was 5th dose of Dtap and 4th dose of Polio.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient with no pertinent medical history and no drug reactions/allergies. On 03-SEP-2014 the patient was vaccinated with ZOSTAVAX lot # K000330 (expired date 06-MAR-2015). There was no concomitant medication. A couple of days later, approximately on 05-SEP-2014 the patient experienced redness around injection site and size of redness was about 5 inches in circumference. About 2 weeks after vaccination, approximately on 17-SEP-2014 the patient noticed that glands around her neck were swollen. The patient went to physician's office for these symptoms but physician did not prescribe any treatment and advised the patient to just observe symptom. The pharmacist reported that swollen glands had been resolved but the patient still had little bit of redness around injection site, over 2 months after vaccination. Additional information has been requested.
This case was reported by a medical assistant and described the occurrence of injection site cellulitis in a 15 month old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On 06/30/2004, the patient received the fourth dose of Infanrix (lot DTPA614A9) in the left arm.  Approximately one day following the administration of Infanrix.  On 07/01/2004, the patient experienced injection site cellulitis characterized by red, raised painful area at the injection site.  The injection site reaction extended to involve the entire deltoid area.  The patient was seen at a physician's office and received treatment with amoxicillin.  The medical assistant stated, "I haven't heard back, so I assume the treatment we prescribed was successful."  The medical assistant initially considered the injection site cellulitis to probably be related to vaccination with Infanrix.  Subsequently she stated that the injection site cellulitis was possibly related to vaccination with Infanrix.
Information has been received from a Registered Pharmacist concerning a female patient who on an unspecified date, was vaccinated with the seventh dose of GARDASIL. On an unknown date, the patient experienced unspecified adverse event and was admitted into hospital. After months into her treatment the nurses were finally able to obtain her vaccination record from her previous school. There was no history of her receiving any GARDASIL recorded. Following her receiving one dose of GARDASIL in the hospital, her mother stated that this was her seventh dose. In obtaining further records from the patient's primary physician, four doses of GARDASIL were documented. At the time of reporting, the outcome was unknown. It is unknown if the patient sought medical attention. No further information is available.
After 9 days I had vaccine, I had red rash on my arm, it is about 1-2 centimeters below where they aurally gave vaccine. It became itchy, little swollen, slightly pain, it get redder and little bit bigger.
I woke up in the morning and I immediately knew that I was having a vaginal bleed. I let it go and it didn't ease up until 3 days later. I let it go that day until around 4pm. It seemed like it was becoming more and more blood loss. I went to the ER. This was 4 days after I received my vaccine. I am not sure that it was related. They did an exam and sent me home. They told me to go see my OBGYN on Monday. I went and saw him. He performed a blood test. I had just had blood work done with him the week before. I was down about 3 units of blood. About 4 days later it lessened up quite a bit and everything has been great since.
Two known adverse events from vaccine administration: 1. Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration.  2. Second dose was administered too early (22 days, instead of 30 days after 1st dose). Dose 1 - 8/9/21 Moderna lot 040B21A  Dose 2 - 8/31/21 Moderna lot 040B21A   On 9/7/21 patient was seen by PCP. No documented concerns regarding vaccine at that time or concerns for COVID during that visit.  Then on 9/22/23 the patient was found by his family deceased in his bed. Death certificate noted the following causes of death: - Non-ischemic Cardiomyopathy - Paroxysmal A. Fib - Pulmonary Hypertension
pt recvd vax about 1115AM & grandmother states by 12 pt would sleep-wake up-cry out & go limp & difficult to rouse; took to ER was told it was a normal react; pt became fussier & had abn unconsolable crying; MD dx pt/DTP rxn;
Slept 5 hrs post immun; 9PM awakened, feverish felt very hot, no temp taken; Screaming unconsolable holds lt leg (site of HIB), stiff; red lump rt thigh (site of DTP), still crying 830AM 11JUL91;
Got redness dropped down from the bicep to the insight part of her arm, where the elbow bent; Lump on the bicep; Fever; Extreme chills; Headache; Swollen lymph node; Circles of redness on the injection site; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Got redness dropped down from the bicep to the insight part of her arm, where the elbow bent), MASS EXCISION (Lump on the bicep), PYREXIA (Fever), CHILLS (Extreme chills) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced ERYTHEMA (Got redness dropped down from the bicep to the insight part of her arm, where the elbow bent), MASS EXCISION (Lump on the bicep), PYREXIA (Fever), CHILLS (Extreme chills), HEADACHE (Headache), LYMPHADENOPATHY (Swollen lymph node) and INJECTION SITE ERYTHEMA (Circles of redness on the injection site). On 20-Feb-2021, PYREXIA (Fever), CHILLS (Extreme chills) and HEADACHE (Headache) had resolved. On 23-Feb-2021, ERYTHEMA (Got redness dropped down from the bicep to the insight part of her arm, where the elbow bent), MASS EXCISION (Lump on the bicep), LYMPHADENOPATHY (Swollen lymph node) and INJECTION SITE ERYTHEMA (Circles of redness on the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills, headache, axillary lymphadenopathy, injection site erythema and fever are consistent with the known safety profile of mRNA-1273.
anaphylactic reaction; I had my 2nd Moderna COVID-19 shot near the end of the 42 day window; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history reported).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had my 2nd Moderna COVID-19 shot near the end of the 42 day window). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had my 2nd Moderna COVID-19 shot near the end of the 42 day window) had resolved.
uncomfortable to sleep; left arm was sore to raise above shoulder; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (uncomfortable to sleep) and VACCINATION SITE PAIN (left arm was sore to raise above shoulder) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced SLEEP DISORDER (uncomfortable to sleep) and VACCINATION SITE PAIN (left arm was sore to raise above shoulder). At the time of the report, SLEEP DISORDER (uncomfortable to sleep) and VACCINATION SITE PAIN (left arm was sore to raise above shoulder) was resolving.            Reported approx.6 hours post vaccine, left arm was sore to raise above shoulder and uncomfortable to sleep on. It has been reported feels better wed am. No concomitant medications were reported.  Treatment medications were not provided by the reporter.
This spontaneous report as received from a physician via company representative refers to an elderly female patient. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (route and site of administration, dose, lot number and expiration date were not reported) however it is not documented in her medical record. On an unknown date, the patient developed shingles on her face and complained of pain in her face. The patient sought medical attention via physician visit and was treated with unspecified "antivirals and steroids" and gabapentin. The outcome of herpes zoster and facial pain was unknown. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
There was no adverse event, however patient visited a drive thru event to received the first dose of COVID-19 vaccine (Pfizer) and after getting the vaccine notified the nursing staff that he already received a dose of COVID-19 on 03/04/2021 at another drive thru managed by FEMA. (His next dose was due on 03/25/2021) time frame between two vaccines were 16 days
After the first shot, she noticed her breasts were growing back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: BREAST ENLARGEMENT (non-serious), outcome "unknown", described as "After the first shot, she noticed her breasts were growing back".  Additional information: It was reported that, this report was not related to study or program. It was stated that Caller states she does not have her vaccine card or have this information to provide. Other products and investigation assessment not provided. She states that she called before, after her first dose and had a problem because she had been taking hormone blockers. She wasn't sure and probably should have done some research. She had been taking hormone blockers to transition. After the first shot, she noticed her breasts were growing back. She lost all of her progress for pre-op. She thinks that with the estrogen, she was losing all the progress and it is effecting her relationships. Caller states she does not have her vaccine card or have this information to provide. She states that her vaccine card was in her partner's belongings, and she was not with them any longer. She has been double vaxed and boosted and everything was ok, aside from the interference with the hormone blockers.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (24Feb2022):Follow-up activities closed. Batch/lot number not available for [Vaccine, BNT162B2].
1600 - tightness in chest, BP 102/72 P58 R20 Headache 1610 - Blurry vision 1630 Dry tight throat, BP 116/72 P60, R14, 02 95 Discharged to mom. Instructed to go to ER or urgent care if symptoms get worse
Pfizer-BioNTech COVID-19 Vaccine EUA: Within fifteen minutes of receiving vaccine patient experienced lightheadedness and dizziness. Remained awake alert and oriented and able to stand and ambulate. Initial vital signs were within normal rnage except blood pressure 152/67 mmHg. Patient denied chest pain, palpiatations, shortness of breath, difficulty breathing, nausea, vomiting, and pain. Patient stated they had not eaten yet that day and was immediately given juice, food, and water. One hour after vaccination patient stated symptoms were resolving. One hour and fifteen minutes after vaccination patient stated lightheadedness and dizziness returned and were slightly worse and developed a new symptom of "ear and head pressure". Repeat vital signs were within normal ranges except blood pressure was 139/92 mmHg. After discussion with healthcare provider decision made to transfer patient to urgent care/emergency department.
Dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HEADACHE (Headache). On 08-Mar-2021, the patient experienced DIZZINESS (Dizziness). The patient was treated with IBUPROFEN for Headache, at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizziness) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Blood pressure measurement: 128 (Inconclusive) 128. On 08-Mar-2021, Heart rate: elevated (High) Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for cognitive impairment, glaucoma, anxiety, schizoaffective disorder, venous insufficiency, mitral regurgitation, lymphedema, elevated liver enzymes, hyperlipidemia, vitamin d deficiency, hypertension, cerebrovascular accident, seizure. Note 5/11 and 5/12 states that patient was in nursing home refusing food, drinks, and medications for 3 days. Patient also experienced seizure like activity as recent as 3 weeks ago. Patient also presented to ER on 5/3 s/p witnessed seizure. Patient deceased 5/15, found unresponsive by caregiver. No cause of death listed.
Soreness in arm at injection site; It was like getting dry mouth really bad; Area was a little tender; hard to swallow; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 14:00 (Lot number: EW0169) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: WELLBUTRIN taken for depression; PROPRANOLOL taken for anxiety; CITALOPRAM taken for anxiety. Past drug history included: Codeine, reaction(s): "Allergy", notes: verbatim: Is allergic to Codeine. Vaccination history included: Flu vaccine (verbatim: she had the flu shot), for Immunisation. The following information was reported: DYSPHAGIA (non-serious) with onset 20Apr2021, outcome "recovered" (21Apr2021), described as "hard to swallow"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness in arm at injection site"; DRY MOUTH (non-serious), outcome "unknown", described as "It was like getting dry mouth really bad"; TENDERNESS (non-serious), outcome "unknown", described as "Area was a little tender". Therapeutic measures were not taken as a result of dysphagia, vaccination site pain, dry mouth, tenderness.  Additional information:When reporting symptoms about her daughter, had mentioned that she had experienced sore arm at the site and having a hard time swallowing after the vaccine. After the shot, was drinking stuff constantly because she felt thirsty. Additional Vaccines Administered on same date was no.The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not visited emergency room or physician office due to events.  No follow-up attempts are possible. No further information is expected.
numbness in fingers of right hands last couple weeks; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in fingers of right hands last couple weeks) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced HYPOAESTHESIA (numbness in fingers of right hands last couple weeks). At the time of the report, HYPOAESTHESIA (numbness in fingers of right hands last couple weeks) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.
This spontaneous report was received from a pharmacist referring to a 19 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 12-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 09-NOV-2017, the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported.