chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My son is on his vaccination schedule for 6 months. He received the oral rotavirus and I believe this caused my mastitis. He had the vaccines on 7/8 and I got mastitis on 7/9. This happened before with my first son at the exact same time. He had his 6 months shot then next day I got mastitis. I realize that he has had these shots prior however he did not have teeth then. Also I understand mastitis is caused by scraping of the skin and by the babies mouth. I just find it such a coincidence that I got mastitis twice each time the day after the 6 month shots. I do not know if any one else is having this problem. Just wanted to report this and you all could look into it. Thank you.
Information has been received from a nurse concerning a 21 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine (yeast) and fainted. It was mentioned that on 23-JUL-2008, after the second dose of GARDASIL vaccine (yeast), injection route, the patient faint as well. All boxes refer to second dose. The patient sought medical attention. No further information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2008.  Follow-up information was received in the form of medical records. It was reported that the patient was a 16 year old female with a history of migraines and no known drug allergies, who on 26-JUN-2008 was vaccinated with the first dose of GARDASIL (Lot # 659182/1757U), IM into the deltoid. Approximately 5-10 seconds after getting the shot, the patient passed out. The office staff kept her in the office for a while but it took her 1-1/2 hours to recover sufficiently so that she could sit up and then ambulate. She was advised to go to the emergency department for further evaluation and care. This had not happened to patient before. It was reported that the day of vaccination the patient had had a bowl of cereal. She had not had anything else to eat but she did drink a large sized soft drink. The patient had not had any recent weight loss. In the emergency room on 26-JUN-2008 the patient had an EKG which showed normal sinus rhythm at 92 beats per minute with slight sinus arrhythmia, rightward axis. No other abnormalities were reported. The white count was 10.100, hemoglobin 13.6, platelet count 370.00. Normal red cell indices. White cell differential showed 75. polys, no bands, 19 lymphs, 5 monocytes, 1 eosinophil, 1 basophil. Urinalysis showed no significant abnormalities. Sodium 138, potassium 3.8, chloride 101, CO2 was 28, BUN 6, creatinine 0.6, glucose 82, calcium 9.3. Urine pregnancy test was negative. While in the emergency room, the patient had pulse and blood pressure orthostatics done with slight change from supine to standing. She was given 1 L of normal saline and her orthostatic improved. It was reporter's strong opinion this was not an allergic reaction but autonomic system dysfunction with slow reset. The clinical impression was vasovagal syncope. The patient was discharged to home from the emergency room the same day. Additional information has been requested. All medical records will be provided upon request.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown ages and genders. On an unknown date, the patients were vaccinated with incorrect storage because doses of M-M-R II (dose, route and lot # were not reported) that post supported excursion were administered to the patients. Also registered nurse mentioned that there has been no need for revaccination. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
11/4/15 Patient walk into clinic on 11/4/15 stating that since the day of the vaccine he has been on pain on his left shoulder and is having difficulty moving. 11/20/15 patient returned stating that he unable to move his left shoulder.
SHOT WAS ADMINISTERED ON 3/1/18. PATIENT EXPERIENCED CHILL, ACHE AND HEADACHE  ON 3/2/18. SHE DEVELOPED RASH ON 3/3/18. THEN SHE HAD ITCHING ON 3/4/18. SHE BROKE OUT IN A RASH THAT SHE THOUGHT IT LOOKED LIKE CHICKEN POX ON 3/5/18. SHE SAW HER PCP THAT DAY AND WAS TOLD THAT HER SIGNS AND SYMPTOMS WERE VERY LIKELY A REACTION TO SHINGRIX. SHE WAS NOT GIVEN ANY MEDICATION TO TREAT HER RASH. HER SYMPTOMS IMPROVED BY THE END OF THE WEEK. PCP ADVISED HER NOT TO GET THE SECOND SHINGRIX SHOT. SHE WAS HERE TODAY AND DISCUSSED HER REACTION WITH ME AND HAD COMPLETELY RECOVERED FROM THE ADVERSE REACTION.
he fainted for 1-2 seconds; palpitation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (he fainted for 1-2 seconds) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Neutropenia.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SYNCOPE (he fainted for 1-2 seconds) (seriousness criterion medically significant) and PALPITATIONS (palpitation). On 05-Mar-2021, SYNCOPE (he fainted for 1-2 seconds) and PALPITATIONS (palpitation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information reported.  Based on the current available information and temporal association between the use of the product and the onset date of the reported 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 onset date of the reported events, a causal relationship cannot be excluded.
Chills; headache; body ache, muscle pain; joint pain; fever; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (headache), MYALGIA (body ache, muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever) in a male 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 COVID-19 on 16-Jan-2021.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced CHILLS (Chills), HEADACHE (headache), MYALGIA (body ache, muscle pain), ARTHRALGIA (joint pain), PYREXIA (fever) and NAUSEA (nauseas). At the time of the report, CHILLS (Chills), HEADACHE (headache), MYALGIA (body ache, muscle pain), ARTHRALGIA (joint pain), PYREXIA (fever) and NAUSEA (nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Right arm swollen and redness wrapped around arm. Was not able to use arm. Lasted for about one week. Only treatment received was Tylenol.
Patient stated in VARS form that she "might" pass out after receiving shot. She said that she has anxiety when receiving vaccination shots. Patient received vaccine and about one minute later the patient passed out and fell forward. I was able to catch her and lower to the ground safely. I called for pharmacist on duty to assist in the care of the patient. Less than a minute after the patient passed out she was awake and alert.  The patient was asked multiple times if she needed to go to the hospital and asked if she was okay to drive home.  She insisted that she faints frequently from vaccines and denied any further care.  She stayed in the waiting area while being checked on several times. The patient left after she said she was "100% good." She thanked us for taking care of her and apologized for what happened.
This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 1st April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2019, 1 day after receiving SHINGRIX, the patient experienced feeling cold, influenza-like symptoms, weakness and diarrhea. On an unknown date, the patient experienced tremor and cough. On an unknown date, the outcome of the feeling cold, influenza-like symptoms, weakness, diarrhea and cough were unknown and the outcome of the tremor was recovered/resolved. It was unknown if the reporter considered the feeling cold, influenza-like symptoms, tremor, weakness, diarrhea and cough to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient stated that he woke up next day at 1 am with shaking and then it went away. Next day he woke up feeling cold, weak, flu like symptoms, and diarrhea. He was still experiencing this effect which come and go. A few days ago, he also developed a cough. The reporter consented to follow up. No further details were provided.
Five days after receiving the Chicken Pox Vaccine, my son started breaking out with sores.  They got very large in size and oozed and bled.  He ran a high temperature for four days.  He broke out for eleven days before being put into the hospital by his doctor for staph infection due to reaction to Chicken Pox vaccine.  He was treated with Clendomycin through an IV for three days.  After his release from the hospital he is taking seven days of Cefelexin.  We are also treating the sores with Bactroban.  07/02/2007 MR received for 2 night admission 5/16-18/2007 for a skin infection. Child began to break out in vesicular lesions approx 1 week after Varicella vax. Topical antibiotic tried initially, but lesions continued to spread and fever developed. Admitted with dx of bullous impetigo. PE significant for crusted vesicular lesions and crusty green nasal discharge. Txd with IV and po abx and hydroxyzine. Discharge DX:  MSSA Impetigo.
On 31 Mar he suffered a stroke and was admitted to the hospital until 2 Apr 2021; He tested positive for Covid19 on 30Mar2021; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199), via an unspecified route of administration, administered in arm left on 19Mar2021 (at the age of 52-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid19 on 30Mar2021. On 31Mar2021, the patient suffered a stroke and was admitted to the hospital until 2Apr2021. He was scheduled for second dose and he got COVID, so would like to know the protocol and ins and outs and steps for that. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Mar2021. The patient did not receive any treatment for the events. The clinical outcome of the On 31 Mar he suffered a stroke and was admitted to the hospital until 2 Apr 2021 and He tested positive for Covid19 on 30Mar2021 were unknown. No follow up attempts are possible.
Experienced fatigue, arm pain, fever, chills as expected.  Continue to feel mild tightness at base of neck.  Shirt collars are even bothersome.  Went to physician who did not feel adenopathy.  Wondering if this is normal.  Due for second shot and have concerns.
My baby started to refuse feedings.  She was later diagnosed about 1 month later with failure to thrive, dysphagia, slow growth, eczema, intolerance to milk protein, severe GERD.
Increased temeperature and redness around the injection site, which spread all over the upper arm and became itchy after 2-3 days. As of the date of reporting it is getting better.
66-year-old male admitted 1/12/2022 with a past medical history significant for hypertension, HLD, COPD, OSA, DM2, CKD III, MTHFR deficiency, Factor V Leiden chronically anticoagulated on coumadin, and chronic respiratory failure secondary right diaphragmatic paralysis related to remote CVA (plus residual right-sided weakness and dysphagia) on chronic 6L NC. He presents today with complaints of progressive generalized weakness and falls going on for several days. Patient stated about 10 days ago he had productive cough, myalgias, loss of taste and smell and dyspnea. Patient's family was concerned and brought him for evaluation by PCP. He tested positive at outpatient visit on 1/10/2022. He is vaccinated X2. He presents today with complaints of persistent congestion and recurrent falls due to weakness. He denied head trauma or LOC.
low-grade fever, chills, body aches, fatigue and pain at the injection site - first s/s began almost 12 hours after the injection and completely relieved about 48 hours later
Patient was given his vaccines and he walked over to his seat nearer his mother, when he fainted, around 09:45, 5 min after he was vaccinated. He was unconscious for approximately a minute, he then woke up and was startled that we were all standing around him. He had no recollection of  fainting. His BP was 108/70, HR 44. He was alert and oriented. He claimed that he has fainted before when he has had to get his blood drawn. His VS did not change from his earlier assessment. He is noted to have a slow HR from his previous visit. His provider did come into the injection room to see him.
Within 24 hours of administration of DTaP and Hep A patient began temperatures exceeding 101. Extreme fatigue, Prolonged screaming, grabbing head, unable to walk or feed self. Rash developed by day 4 and staring of into space events were noted. 4/29/08-DC Summary received for DOS 4/15-4/16/08-DX: Cerebellitis. Presented with fever to 101, beginning on 4/8/08. Developed ataxia and fevers persisted. Erythematous rash developed on torso and extremities. Two days prior to admission noted to have difficulty walking and fell. Twin sisiter also became ill with high fevers and rash. 1/26/2010 Follow up: Still has problems with fine motor skills and coordination.
On 8/6/21 Client reports welts in her mouth, on her face and arms. Took benadryl and a breathing tx. Then on 8/8/21 client presented to the ER with more swelling. Diagnosed with an abscess to her jaw from the welts. Received Rocephin and steroids' in the ER. Recovered from the event shortly after.
51 yoF endorsed feeling "hard to breath", lightheadedness, weakness, nausea and vomiting 20-30 minutes after 2nd dose of moderna vaccine.  Initially her chief complaint was difficulty breathing (specifically that she felt she had a hard time breathing).  This occurred 20-30 minutes after her 2nd vaccine.    This resolved without intervention.  She then complained of lightheadedness and weakness followed by a sensation of tingling in her hands.  She proceeded to have intermittent chills.  On brief physical exam, there was no evidence of facial swelling or hives.  Her respiratory exam was normal including no wheezing and good air movement. Cardiac exam was WNL. Neurologic exam was grossly normal including  upper extremity sensation and grip strength.    On attempting to stand up, she felt lightheaded and had to be assisted in a wheelchair.  She continued to endorse lightheadedness and chills as well as nausea and vomiting.   She stated that she once again had difficulty breathing.  At this point EMS was contacted given her continued symptoms that did not appear to be resolving  On arrival by EMS, her vitals were O2 sat = 97%, HR = 60, SBP 160s-170s.   She was transported to local hospital for further evaluation.
itching from her waist down to knees and on her elbows, and it almost looks like welts or hives; itching from her waist down to knees and on her elbows, and it almost looks like welts or hives; Injection site ache on left arm/injection site pain; Low grade fever; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6203), via an unspecified route of administration in the left arm on 22Mar2021 at 13:00 (at the age of 68-year-old), dose 2, single for COVID-19 immunisation. Medical history included ongoing high blood pressure and ongoing high cholesterol (started 15 years ago maybe). The patient had no family history. The patient did not receive any concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201) administered via an unspecified route of administration on 01Mar2021 (at the age of 68-year-old), dose 1, single for COVID-19 immunisation. The patient did not administer any additional vaccine on the same day of COVID-19 vaccine and did not experience any adverse events. On 22Mar2021 afternoon the patient had the usual injection site pain. The patient stated the left arm was more of an ache than a pain and she still have it but it was getting better.  On the same day in the evening, the patient had a low-grade fever that only lasted for twenty-four hours and then it was gone. The patient stated that she started itching on 25Mar2021 at 11:00 from her waist down to knees and on her elbows, and it almost looks like welts or hives. The patient stated that she put some Eucerin cream on it and it has subsided a bit with the cream. The patient stated that the paper said she may get a rash, but this was not all over her body. The patient was asking if this could be from the vaccine. The patient stated that she was wondering if she could take some Benadryl to help.  The events did not result in emergency room visit or physician office visit. The outcome of the event low grade fever was recovered on 23Mar2021 and outcome of other events was recovering.  No follow-up attempts are possible; No further information is expected.
Fever, chills, headache for 2 days.  In June the left side of my lip starting going numb, then it spread to my tongue, chin and cheek (left side only).
This literature report concerns a series of 10 cases of fatalities after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (6 of 10) concerns a 49-year-old patient, who had a medical history of Type 2 diabetes, stroke, chronic obstructive pulmonary disease, emphysema and substance abuse. The patient died of a suspected cardiovascular event three days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacturer: unknown). Reporters comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).
At 6pm developed intense chills and muscle spasms, could not walk for 2 hours. Then she couldn't breath, so I gasped for a little while, then went to hospital and was admitted. Was treated with oxygen and a steroid. Hospitalized for 24 hr then released, spent another 10 days recovering with sore lungs (very bad asthma attacks)
on 5/26/21 patient given a 2nd dose of Janssen,  Provider in office explained signs and symptoms for patient to watch for and to notify our office immediately if needed.  Patient had no complaints after being seen in office by provider
Deltoid area swollen, red, warm to touch-much tenderness and pain in area surrounding vaccination site-Tenderness/swelling in lymph nodes(armpit)-lasted 4 days. general nausea, intense at times - 5 days. Symptoms started 8th-9th day after vaccination.
Information has been received from a physician concerning a female patient with cerebral palsy who had strong reaction to PNEUMOVAX 23 (type of reaction not reported). The reporting patient had recovered. The physician was not the patient's Primary Care Physician. The physician did not have any additional information concerning the patient. This is one of several reports from the same source. No further information is available.
pt devel hives on arm (around inj site) a few hr p/vax given;devel shingles 2 days later was seen by pvt MD who advised against cont hep b series;
Began having neck pain that gradually progressed into headache that worsened over several days and began having severe vomiting, admitted to Medical Center on 10/24/2016 with a diagnosis of Aseptic Viral Meningitis and treated with narcotic pain medications, antiemetics, and fluids. Discharged from hospital on 10/29/2016 and was absent from work with continuing headache and neck pain until 12/2/2016.
two doses before adequate time elapses; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA653A, expiry date 28th February 2023) for prophylaxis.   In July 2022, the patient received the 2nd dose of Menveo. In July 2022, unknown after receiving Menveo, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 27-Jul-2022 Reporter's comment: The nurse reported that two patients received early second dose with unknown details, while only one patient had an incorrectly reconstituted dose administered. 3 patients were vaccinated with the same lot so the reporter was asking what happened if a patient receive two complete doses of Menveo .  All patients were vaccinated on July 2022. The reporter consented to follow up. The case is for 1 of 3 linked patients, reported by same reporter. Additional supportive information: The patient received second dose earlier than the recommended interval, which led shortening of vaccine schedule.; Sender's Comments:  US-GSK-US2022AMR112789:Same reporter US-GSK-US2022111770:Same reporter
Shortly after the second dose of the vaccine, a rash appeared on the sunburns of my face. It gradually continued to the checks, nose, forehead, eyebrows, and edges of the ears. I was treated with 2.5% Hydrocortisone cream with no improvement. I am currently treated with 1% ivermectin cream. I saw 4 dermatologists. The prognosis: Dermatitis and Rosacea. I did a total blood test + Allergy test. Today, 10 months later despite using several medications, the rash still covers most of my face and edges of the ears and forehead.
Fluzone High Dose was administered to a patient after too long in transit, no AE; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA318341 and 2019SA318342 (same reporter).  This case involves a 65 years old female was administered with a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ307AB, expiry date: 29-Jun-2020) via intramuscular route in the left upper arm, after too long in transit on 11-Nov-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  At the time of reporting the patient had no adverse event.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.