chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an RN concerning an 18 year old female patient with allergies to penicillin and morphine who on an unspecified date was vaccinated with her first dose of Gardasil (yeast). Concomitant therapy included Midrin. The patient was " a little lightheaded" during the first injection. On 05 Dec 2006 the patient was vaccinated with her second dose of Gardasil vaccine (yeast), lot # 653937/0637F. She developed syncope less than 10 minutes after the second injection was given. Her blood pressure dropped and she did not awake for 15 minutes. The patient was sent to the emergency room, and the nurse reported she was not sure if she recovered. Additional information has been requested.In follow up it was reported that the patient "felt faint" and that the patient "did faint" after her first injection with GRDASIL. The following significant reaction to GRDASIL was reported after her second injection: the patient began hyperventiling, complaining of headache, nausea, and feeling hot. She covered her eyes and was not answering questions, only nodding. There was no history of panic attacks, however she had been seen by another physician earlier that week and prescribed acetaminophen (+) dichloralphenazone(+) isometheptene mucate for migraine headache. She was lying down on the exam room table and was provided with a cool pack, cold juice, blanket and dark room. The nurse tool vital signs (see blood pressure measurements in laboratory data section). Her symptoms appeared to resolve and she "feel asleep?", but then apparently awoke in another panic and had a repeat of the same symptoms, worse then before. After attempts to calm the patient/stabilizing in the office failed, the decision was made to her go tot the ER for further evaluation. There was no evidence of anaphylaxis. The patient was reported as recovered from feeling hot, headache, hyperventilation, and nausea on 05-DEC-2006. Assessment of patient on 05-DEC-2006 included adverse effects of drug and panic disorder. Additional information not expected.
Pt reports to have received pfizer previouly. Pt reports persistent diffuse right arm pain following injection, from right clavicle to elbow. Resolves with nsaid then pain returns. Denies any pain currently. No tenderness on palpation. Full range of motion and use of arm. Denies any numbness or loss of sensation. Denies any signs or symptoms of anaphylaxis or allergic reaction following last dose. Pt did not seek medical care for arm as it has not been bothersome enough. This RN consulted with colleague, RN, we agreed pt is safe to receive second dose and to follow up with medical provider if arm discomfort does not resolve. Pt agreed. This rn strongly advised pt receive this shot in alternate, left arm, pt refused and adamantly selected right arm despite this rn?s education around reactogenicity. This rn educated pt on low threshold to seek medical care for any urgent/emergent s/s. Pt verbalized understanding. Pt had immediate localized reaction with marked swelling. Pt quickly Left and declined observation -Pt left against medical advice. Asa rn
About 36 to 48 hours after receiving dose number 2 for the covid pfizer vaccine, I began to have recurring severe nosebleeds. The bleeds were difficult to stop (lasting 15 or more minutes) and with clots. These lasted daily for 3 to 4 days and then ceased completely. I met virtually with Dr., my hematologist, and he encouraged repeat PTT/PT bloodwork and visit to ENT. Met with Dr.,  ENT. There were no structural issues in the nose and bloodwork came back normal, so both concluded that vaccine may be cause of bleeds.
Three hours after COVID19 vaccine, patient broke out in hives on her face, neck, chest and back. On exam at the ER, no hives seen. Only redness to face. No swelling.
Allergic reaction; full body rash; fatigue; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK5730, intramuscular, first dose on 20Dec2020 at a single dose for immunization. Medical history included diabetes mellitus (DM), depression, gastrooesophageal reflux disease (GERD) and hypercholesterolaemia. The patient had no known allergies. The patient have unspecified concomitant medications. She had other vaccines in two weeks (unspecified).  The patient experienced allergic reaction- full body rash, fatigue on 21Dec2020 with outcome of not recovered. Treatment received for the events included steroid and antihistamines. The events are reported as non-serious. The patient had doctor or other healthcare professional office/clinic visit. She had no covid prior vaccination. She was tested for covid post vaccination through nasal swab on 21Dec2020 with negative result.
Tested positive for covid-19; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and COVID-19 (Tested positive for covid-19) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 31-Mar-2021, the patient experienced COVID-19 (Tested positive for covid-19). At the time of the report, PAIN IN EXTREMITY (Sore arm) and COVID-19 (Tested positive for covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Coronavirus test: (Positive) Covid-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included azithromycin.
This was not an adverse reaction.  While the vaccine was being injected, some of the vaccine spurted between the needle and syringe.  Unclear how much vaccine was injected into the patient. This was the patients second dose of Moderna.
Less than 24 hours after the patient received her first dose, she had what appeared to be a partial seizure. During the episode, the patient acknowledged that she has had seizures in the past and takes Lamictal to control it. She stated that she has not had a seizure in over a year prior to getting the vaccine.
This spontaneous report as received from a other health professional refers to two 3 month old patients. On 23-APR-2001, those patients were vaccinated with M-M-R II for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). Additional information has been requested.
Sysmptoms are a constant loud tinnitus, off balance, brain feels like it's floating, and loss of balance. These symptoms progressed to the point of extreme vertigo, inability to walk or stand up straight, temporary loss of hearing and fullness/inflammation in ears and in neck and head with pain, and nausea coupled with unrelenting fatigue.  The symptoms appeared within five days (9/21 to 9/27) with medical staff noticing the lack of balance on 9/27 and sending me to the emergency room with severe vertigo on 10/11. PCP doctor followed up (10/12) with order for CT (10/15), vertigo medication, followed by ENT Specialists (10/19), Auditory test (10/25), and MRI (10/26).  Still having constant tinnitus, impaired hearing. to constant LOUD tinnitus and weakness in neck, pain in head and neck, fatigue, and worst of all the instability of the dizziness.  I'm having to use a cane to walk and pray that these symptoms diissipate soon.  This has been over thirty days since my 3rd shot (for immune compromised individuals) and I have been impaired with dizziness, vertigo, head pressure, and constant tinnitus since 9/25th.
I had strong lymph node pain in both under arms and right shoulder pain in muscles after my first Moderna Covid vaccine on Feb 19. I had a two hour massage and it helped tremendously. After the second shot I had on March 19 I continued to have under arm lymph pain and I had pain in my right breast around my breast cancer scar. It finally broke out into a herpes or shingles like rash about the size of a madjool date. I took ibuprofin for a few days and it helped a bit with the pain and itching. The rash was painful and resolved after about two weeks but I still have a red spot on my breast about the size of a quarter  a month later. It is located in about the 8 oclock spot if one were facing me and looking at my breast. My right arm and should er are still achy.  I had the double shingles vaccine in 2019 I think. Coincidentally my son had his Moderna   Covid vaccines in his left arm the day after mine. He was diagnosed with shingles a week or so later. His right arm was covered with rash and he had bone pain as well. He went to the doctor who prescribed antivirals. He decided not to take them as by the time he got the diagnosis his pain was receding. A month later he still has scabs  healing on his arm and pain in his arm and shoulder.
Dizzy started 2:00pm Monday 3/1. Had to lay down. Dizzy started clearing up today 3/2pm Nausea comes and god. Dry throw up.
This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (chest tightness), HEART RATE IRREGULAR (irregular heartbeat) and INSOMNIA (insomnia) in a 39-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (chest tightness), HEART RATE IRREGULAR (irregular heartbeat) and INSOMNIA (insomnia). At the time of the report, DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (chest tightness), HEART RATE IRREGULAR (irregular heartbeat) and INSOMNIA (insomnia) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medication was not reported. COMPANY COMMENT: This is a spontaneous case concerning a 39-years-old female patient, with no medical history, who experienced unexpected non serious AESI event of hear rate irregular, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. Additionally non serious events dysponea, chest discomfort, and insomnia. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 39-years-old female patient, with no medical history, who experienced unexpected non serious AESI event of hear rate irregular, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. Additionally non serious events dysponea, chest discomfort, and insomnia. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
I tested positive for Covid-19 on January 05, 2023 I experienced runny nose, sore throat, fever of 99.5, headache, body ache, hoarse; wheezing. I was prescribed Paxlovid for my symptoms.
Approximately 5 mins after vaccination, patient notified writer that she was "having some sort of reaction." Reported feeling numbness and tingling in all four extremities, also reported feeling "heavy" and weak. Patient then complained of pressure in the chest and tightness in the throat. Epi pen administered to L thigh and EMS activated. Vital signs stable, patient transferred via EMS to local ER for evaluation.
Maternal exposure during pregnancy; Severe body ache; Fatigue; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), MYALGIA (Severe body ache) and FATIGUE (Fatigue) in an adult female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), MYALGIA (Severe body ache) and FATIGUE (Fatigue). On 01-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, MYALGIA (Severe body ache) and FATIGUE (Fatigue) outcome was unknown.            Treatment, Concomitant product  information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Reporter details updated
C/O MUSCLE PAIN IN LEFT ARM 2 HOURS AFTER INJECTION GIVEN.
Diarrhea; Vomiting; Raw in the mouth; Difficulty in swallowing; Muscle aches; Weakness; Tiredness/fatigue; Very ill; This non-serious case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In OCT-2023, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced diarrhea (Verbatim: Diarrhea), vomiting (Verbatim: Vomiting), raw mouth (Verbatim: Raw in the mouth), swallowing difficult (Verbatim: Difficulty in swallowing), muscle pain (Verbatim: Muscle aches), weakness (Verbatim: Weakness), tiredness (Verbatim: Tiredness/fatigue) and unwell (Verbatim: Very ill). The outcome of the diarrhea, vomiting, raw mouth, swallowing difficult, muscle pain, weakness and tiredness were unknown and the outcome of the unwell was not reported.   It was unknown if the reporter considered the diarrhea, vomiting, raw mouth, swallowing difficult, muscle pain, weakness, tiredness and unwell to be related to Shingrix.     It was unknown if the company considered the diarrhea, vomiting, raw mouth, swallowing difficult, muscle pain, weakness, tiredness and unwell to be related to Shingrix.   Additional Information: GSK Receipt Date - 08-NOV-2023 The reporter was the friend of the patient. The reporter reported that the patient received 1st dose of shingrix vaccine 2 week ago . The reporter stated that patient experienced severe side effects and very ill.  The patient had diarrhea, vomiting, raw in the mouth and difficulty in swallowing and patient also had muscle aches and weakness and fatigue. The reporter stated that he or she did not know the date of vaccination, location of vaccination center or in which arm the vaccine was administered. The lot number and expiry date was not provided. The reporter did not consent to follow up.
Mother states had continuous cry >3 hours after immunizations were given. Cry started 8:00pm. Called P.P at 12:00.
Pfizer-BioNTech COVID-19 Vaccine EUA Cold sore on upper lip-first a bump then large blister today. If I hadone before, it must have been many years ago. Have not had sex in decades or kissed anyone since the pandemic started. Have no idea how I could have gotten this unless the vaccine triggered it.
diagnosed with Covid; diagnosed with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 65-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, in May2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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) all with onset 19Sep2023, outcome "unknown" and all described as "diagnosed with Covid". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 102.3; SARS-CoV-2 test: (19Sep2023) Positive. Clinical courses: The patient's temperature was 102.3, he had fever. Patient working from home, isolating.   The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300307925 same reporter/drug/AE, different patients;
Patient was advised to wait in store for 15 minutes after receiving vaccine.  She walked from the pharmacy to the meat department and fainted in front of the meat department.  The store staff came to get the pharmacy staff and called 911.  Patient was laying on the floor and reported she was "just having a hot flash".  She was conscious and aware with no difficulty breathing.  EMS arrived on the scene and patient refused service.  An EpiPen was not administered
After the patient received both vaccines, he turned white and became sweaty. The wife said he passed out, but I did not witness that event. He kept closing his eyes, so I brought him a bottle of water, a cool paper towel for his forehead, and suckers to keep him active. I talked to him constantly and made him continue answering my questions. I checked his blood pressure and it was initially 74/58. I called the store manager and he helped me observe the patient. The patient said the flu shot didn't bother him, but it was the shingles vaccine. His wife was there and was helping us keep him coherent. I checked his blood pressure two more times and it was 81/62, then 105/68. I did not want them to leave until his blood pressure increased further, but he insisted he felt better and that they had somewhere to go. The color did return to his face and he was able to hold a lengthy conversation with the store manager. He remained in the same chair the majority of the time, and was then transferred to a wheel chair. The store manager wheeled him to his vehicle. The whole incident took about 60 minutes.
On 3/15/2021 Moderna COVID19 Vaccine Vial Lot #014M20A was punctured at 10:45A, vaccine was given at 5:05P.  Vaccine expired at 4:45P (6 hours after punctured).  Reported to VAERS Report Moderna same evening, received response from Medical Affairs 3/18/2021.Representative gave instruction that repeat dose was not needed as viability of vaccine was demonstrated 12 hours after puncture time, however as there was no preservative there was increased likelihood of infection.  Patient was informed, patient denied signs of infection.  Patient was instructed to monitor for signs of infection at vaccine site.
pt brought to ED earlier in the day with abnormal labs which included acute on chronic renal failure and positive for COVID; admission to hosp recommended by pt refused and was dc'd to home; later in the day, pt brought back to ED with nausea and inability to urinate; pt began agonal breathing with a drop in heart rate; asystole on the monitor; family informed and stated she is DNR/DNI; pt passed away in the hospital
The patient received the Hepatitis B Vaccine at about 1:00 PM. at about 1:40 PM she became, dizzy, drowsy, flushed and confused. Initially she did not report these symptoms to any staff member. At about 2:00 PM she reported these symptoms to a staff member. Only the confusion had resolved. She stated all her symptoms were minor. Her vitals were obtained (BP 116/72 & pulse 78) At about 2:35 EMS was requested as her symptoms (except for her confusion continued.
A little Fluidy Macular Rash left arm Injection Site after booster; really tired; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE RASH (A little Fluidy Macular Rash left arm Injection Site after booster) and FATIGUE (really tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 36D21A, 040A21A and 03120A) for COVID-19 vaccination.     Concurrent medical conditions included Immune disorder (NOS) (Positive ANA since 1988 and very immune reactive).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-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. In 2021, the patient experienced FATIGUE (really tired). On 27-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (A little Fluidy Macular Rash left arm Injection Site after booster). The patient was treated with IBUPROFEN at a dose of 100 milligram. In October 2021, VACCINATION SITE RASH (A little Fluidy Macular Rash left arm Injection Site after booster) had resolved. At the time of the report, FATIGUE (really tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: abnormal (abnormal) abnormal and abnormal (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The patient had a little Fluidy Macular rash on the left arm injection site. Thee patient took Pediatric Ibuprofen 100mg and used Ice on the area. Finally after 2-3 days it resolved.  Patient used Ice on the area where had a little fluidly macular rash on the left arm injection site. . Patient believed patient could had myocarditis or pericarditis and that unusual things were happening.  On Nov/Dec patient was really tired when patient  "was not usually" tired and patient  "never though about the time frame of the Eco's related to the booster dose".   This case was linked to MOD-2022-551364, MOD-2022-551599 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2022: Live Follow-up received, contains new events of tiredness added, laboratory test added and narrative updated.
This is spontaneous report from a contactable physician. A 68-year-old female patient of unknown race/ethnicity received on an unknown date a single dose of PREVNAR 13 for immunization. Medical history and concomitant medications were not reported. In Feb2016 the patient experienced pneumonia and was hospitalized. It was mentioned that pneumonia occurred right after receiving a dose of pneumococcal 13-val conj vac (dipht crm197 protein). The patient has been treated and followed. Outcome was unknown. No follow up attempts are possible. No further information is expected. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative pathological/serotype results and vaccination date are needed for full medical assessment.