chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given a Boostrix (Tdap) vaccination and a Zostavax (shingles) vaccination in the same arm on 11/5/2015.  Patient came to pharmacy (he is an employee) to report he had experienced an adverse reaction to the Zostavax vaccine.  He had an injection-site reaction of pain, inflammation and bruising.  Patient had gone to his primary care doctor over the weekend and was given a Z-Pak as prophylactic antibiotic as well as the physician ordering him to rest and take a few days off from work.  Patient is feeling better now, but just wanted to let us know.
Beyond 42 days post first vaccine, Not received the Second Dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Beyond 42 days post first vaccine, Not received the Second Dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Beyond 42 days post first vaccine, Not received the Second Dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Beyond 42 days post first vaccine, Not received the Second Dose) had resolved.        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.   No concomitant medications were reported by the reporter. No treatment medicationa were reported by the reporter.
belching queasiness slight vomitus, feeling cold no fever, nasal congestion and left lower back and hip pain.
Chills, body aches, severe headache, vomiting, nausea, pain at injection spot
Joint stiffness, pain in neck, back, hips, shoulders and hands. Pain occurred one week after vaccine. First sign was migraine that went into back and hips. Pain is increasing and continues. Immediately felt sick (1 to 2 hours, post vax, had migraine).
On the injection day Tue 04/27/21, the left arm is hard to lift and a little fatigue; on the next day Wed, only the injection area pain and still sleepy early night; but since the morning Thu 04/29/21, I felt headache, chills, sore throat and fatigue. The situation got worse at the night, headache, chills, sore throat all more severe, the temperature rose from 37.3C to 37.7C, a little dizzy, congestion and runny nose at the same time. Occasionally shortness and sneeze. All together made me almost no sleep.  On Fri 04/30/21 I went to an urgent care and the provider did a few tests. He is affirming I have no COVID-19 but the test result comes out in 5 days. He didn't prescribe anything. But I am already much better after much sweating in the early morning: temperature dropped, headache almost gone, sore throat not so severe, shortness of breath also released after changing the mask, congestion in nose gone, but still a little runny nose.
My blood pressure is usually 126/62.  Over the next three days after the vaccine, my blood pressure continued to escalate until it was 185/98.  My blood pressure has remained high since that time.  I also had chest tightness/pressure/pain daily and daily headaches.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were provided.   This case was linked to MOD-2021-392458 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Nov-2021: Follow up received added reporter's details and added dose number.
Exactly a week later plus a few hours my arm felt hot and itchy at the injection site. There is a hard rash that is prominent at about one and a half inches in diameter and mildly spreads to about four inches in diameter. I can still faintly see the injection site itself with the mild swelling it still looks like I have a small scab/hole at the injection spot.
Rash devel w/in 24 hrs that disappeared w/in 3 days & returned w/in 10 days; "hives" in evening, facial; fever (not exact);
I tested positive for Covid-19 on January 9, 2023 I experienced tiredness; fatigue; I was prescribed Molnupiravir for my symptoms.
wrong vaccine given. moderna bivalent was given as first dose instead of moderna monovalent . adminstered by a differnt nurse other than the one reporting it.
Viral rebound on day 15 symptoms and tested positive again; Viral rebound on day 15 symptoms and tested positive again; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Viral rebound on day 15 symptoms and tested positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200730181 Same patient, different product and event.
Dull pain left arm can not touch left hand; Bone ache; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 09:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included left hip prothesis and COVID-19. The patient did not have any allergies to food, medications, or other products. Concomitant medications were not reported. 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 vaccination. On 07Apr2021 at 08:00, the patient experienced dull pain left arm cannot touch left hand and bone ache. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. The clinical outcome of the events dull pain left arm cannot touch left hand and bone ache was not recovered at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
My post moderna booster symptom was a delay in menstrual cycle by at least three days and a lighter than usual flow when it finally began.  My cycle is very predictable and I am not currently sexually active so there was no chance of pregnancy. I got the moderna booster two days before I was supposed to start my period.  I got the j&j vaccine 4/7/21 and did not experience a delay in my menstrual cycle post-vaccine.
I experienced severe back pain, high fever lasting about one day and a half after my second Moderna dose. I went to the ER and no lab work or imaging was performed. I have no symptoms today. I do not have lot# to provide.
received Tenivac after temperature excursion / No adverse event; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA164978, 2019SA166193, 2019SA166194, 2019SA166195 and 2019SA166196.  This case involves 66 years old patient (with unknown demographic) who was vaccinated with 0.5 ml DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] lot U6101AA (Expiry date 23-Oct-2020) via intramuscular route in the left deltoid, On 20-May-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage.  It was reported that had a refrigerator on which outside thermometer continued to read 5C even though there were multiple excursions, up to 23C for anywhere between 4 days and 1 month.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   List of documents held by sender: none.
This is the 1st dose and as the needle was injected into the arm, the drug leaked out of the needle from the junction of the syringe. The patient felt a significant amount of  liquid run down the arm as the nurse wiped it away. The patient asked how many CC's and was told 0.3 mL. The patient didn't feel they got the vaccine. The doctor was called over and also consulted with the lead doctor, who also had to call the pharmacist. The pharmacist said, "per CDC guidelines, they do not revaccinate." The lead doctor told the patient that the shot would be effective with whatever amount they did get, and furthermore, the 2nd dose would be the booster. The patient said there would be no booster if there was no initial vaccination.
Breakthrough COVID-19 case with  Fever >100.4 and Cough. Hospitalized 9/1/2021. Was still hospitalized at time of interview 9/4/2021.
Skin was dry and peeling; Serious Swelling of the face; Itching of the face; Redness of her face; Face was  hot; Swelling of eye; Her second shot was delayed. The second dose was supposed to be 25FEB2021. The first dose was received on 21JAN2021, and didn't receive the second dose until 09MAR2021.; A spontaneous report was received from a consumer concerning a 69-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling of eyelid, Serious Swelling of the face/swelling of face, itching/pruritus, erythema/redness of face, feeling hot/hot feeling generalized, inappropriate scheduling of vaccine, generalized, and skin damage/skin injury.   The patient's medical history was reported as she had facial fillers. Products known to have been used by the patient, within two weeks prior to the event, included metoprolol, lisinopril, celecoxib, losartan, citalopram and spironolactone.  On 21 Jan 2021,the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On 09 Mar 2021 ,the patient received their second of two planned doses of mRNA (Lot number: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  The first dose was received on 21 Jan 2021, and did not receive the second dose until 09 Mar 2021. The patient was delayed because of the weather, and also received a Tetanus shot, which all contributed to delay. On 10 Mar 2021, approximately after one day patient developed swelling around her eyes. On Thursday 18 Mar 2021 the patient's face was swollen, flushed, red,itchy and was hot. The patient also experienced dry and peeling skin. The event serious swelling of the face was considered as medically significant. The treatment medications used were diphenhydramine.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events swelling around eyes, flushed, red, itchy, hot were considered as resolved on 19 Mar 2021. The outcome of the events dry and peeling skin were considered as unknown.; Reporter's Comments: This report refers to a case of 69-year-old, female patient who experienced non-serious unexpected event of second dose delayed (inappropriate scheduling of vaccine,) for mRNA-1273, lot # unknown, and experienced swelling of the eyelid and face, redness of the face, feeling hot and skin injury after the second dose.  Based on a temporal association between the events and use of the mRNA-1273 , a causal relationship with the events cannot be excluded.
Pt recvd 3 doses of Engerix-B vax & did not seroconvert p/3rd dose of Engerix-B so 4th dose was administered;
arm still very sore (for 3 weeks); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm still very sore (for 3 weeks)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high.  On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm still very sore (for 3 weeks)). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm still very sore (for 3 weeks)) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Initial medication error report received on 08 November 2013 from unspecified reported. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE QIV (route, lot number and site of vaccination was not reported) on an unspecified date. Reported stated that 6 month old and 1 year old got FLUZONE QIV 0.5 ml dose. List of documents held by sender: none.
Dizziness, Fever, NauseaVomiting, chills, fatigue, stomach ache, torso cramps Narrative:
Frequent thirst and urination. Longer healing processes, yeast infection, constent hunger starting August after vaccine was taken. Continued in hyperglycemia state until symptoms continued and didn't improve. Went to doctor for multiple reasons to finally do a urinalysis then blood lab test the following day Jan 27 and Jan 28 respectively. Discharged from ICU Jan 29 with sliding scale method of insulin treatment. Visited Endocrinologist Feb 1st with a strong probability of a Diagnosis of Type 1 Diabetes.
My 16-year-old daughter, very healthy without any health conditions, got her first dose of the Pfizer vaccine on Saturday evening, April 10th, at around 5pm. On Wednesday, she started complaining of shortness of breath, chest pains, which she described as a feeling of someone stubbing her heart. By Thursday, she began blacking out repeatedly throughout the day, each blackout lasting about a minute. These progressed and whenever she blacked out, she would not remember what happened. At first, she and I brushed it off as maybe lack of calcium since she rarely drinks milk. But as they intensified, I began to become more concerned. I told her I cannot leave her by herself in the house as I prepared to go pick up her young siblings from school then schedule an appointment with her doctor. On our way back home, she blacked out again, however, it was for more than a minute. Straight away, I drove to the  ER close by. The doctor came back to inform me that her heartbeat was irregular and concerning based on her age. In that same moment, she began complaining of excessive pain like someone punching her heart out, and then she passed out again. Still with my two other children, the whole ordeal began to frighten them and illicit some heavy tears.  Being that this ER was general admission, the doctors insisted they call in the paramedics to transport her to another ER for children. However, after being transported to the other ER, her condition began to intensify rather quickly and the pediatric doctor at the second ER informed us we would have to be transferred to Childrens intensive care unit where the cardiologists could check her heart, find the ultimate cause, and monitor her closely. In that moment, as a mother, I was speechless and extremely terrified. Seeing my daughter being transferred from ER to ER, made it even tougher on me so much that I could no longer hold myself together. Here she was in terrible pain and being moved around with no clear diagnosis and treatment.  From there on, we spent a couple days in the Cardiac ICU waiting and praying with friends for answers and the best treatment she could get to ease the pain. By about the third day of being in the ICU, the cardiologists informed me, she had Acute Myocarditis. This was so shocking in a sense that both sides of the family have no history of heart issues. Secondly, she is a very healthy child.
Patient received first dose Pfizer COVID vaccine and was sitting in observation area.  Nurse came to get me and patient was found lying on the floor.  Patient was cool, clammy, eyes closed but easy to arouse.  Patient's friend states he sometimes has a seizure associated with feeling like this. Patient alert and oriented, able to converse, and states he did not fall but sat down in floor prior to lying down.  1119 VS:  98% RA, pulse 69 and regular, b/p 118/72.  Ice pack applied to patient along with fanning of patient.  Patient states feeling better and brought to sitting position without difficulty.  Patient offered juice which he was able to drink without difficulty.  Patient assisted into wheelchair and brought back to observation area.  1128 VS:  98% RA, pulse 79 and regular, b/p 122/72.  Patient no longer clammy, able to converse and follow directions without difficulty.  Patient states he is feeling much better, able to stand without feeling dizzy or lightheaded.  Friends present with patient and will drive patient home.  Patient transported to car via wheelchair.  Able to transfer into car independently.
Rash after 24 hrs - discrete lesions like tiny blisters mostly lower abdomen/sides one/two on arms.
Post 3rd vax, this pt experienced pneumonia. An unspecified specimen revealed Haemophilus influenzae type B. The pt's outcome was reported as yes.
1st Dose admininstered 1/10/2021 @0800 hrs.  Approx. 5 min later, 1st whole body Goosebumps/Chills lasting 3-5min. with clear nasal dripping/congestion. On 1/19/2021 in AM, started having SOB at rest, Febrile (101.1F), extreme fatigue,  whole body goosebumps/chills preceding every episode of SOB (upper airway compromised) and a total autoimmune response,   I am having episodes of whole body immune responses with severe SOB (>30 bpm), fever (Tmax 105.1F), whole body goosebumps (chills) preceding every episode.  Never became hypoxemia/hypoxic.  SpO2 was always >95%, with Blood Pressure and Heartrate always were WNL (115\75 +-20mmHg, HR 75-100 bpm, . Episodes lasted 4-5 days, after that episodes in a 'tolerable' range with full body goosebumps preceding each episode. Tx with 50-100mg Benadryl, 400-600mg Ibuprofen.
This spontaneous report was received from an office manager and refers to a 4-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 15-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Slept for 22 hours; Weakness; No appetite; Low blood pressure; Could not talk; Hot flashes; Fast heart rate; Lethargy; Pain in arm; Weird Headache; Swollen Lymph nodes; Chills; Nausea; Fever; A spontaneous report was received from a 29-year-old, female nurse, consumer who received Moderna's COVID-19 vaccine and experienced swollen lymph nodes, pain in arm, lethargy, weird headache, chills, hot flashes, nausea, fever, low blood pressure, fast heart rate, weakness, could not talk, no appetite, slept for 22hrs.    The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29th Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the left arm deltoid for prophylaxis of COVID-19 infection.  After receiving the vaccine, the patient experienced swollen lymph nodes, pain in arm, lethargy, weird headache, chills, hot flashes, nausea, fever, low blood pressure, fast heart rate, weakness, could not talk, no appetite, slept for 22hrs.  Treatment for the events included Excedrin which helped with the headache.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events were not reported..; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.