chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HIVES; rash on upper chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on upper chest) and URTICARIA (HIVES) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure increased since 05-Jan-2014 and Drug allergy (Lisinopril ,Hives and rashes). Concomitant products included LOSARTAN for Blood pressure, OSTEO BI-FLEX [ASCORBIC ACID;BOSWELLIA SERRATA RESIN;CHONDROITIN SULFATE;COLLAGEN;GLUCOSAMINE HYDROCHLORIDE;HYALURONIC ACID;MANGANESE SULFATE;METHYLSULFONYLMETHANE;SODIUM;SODIUM BORATE] for Joint ache.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced RASH (rash on upper chest). On an unknown date, the patient experienced URTICARIA (HIVES). On 05-May-2021, RASH (rash on upper chest) had resolved. At the time of the report, URTICARIA (HIVES) outcome was unknown.            Treatment include anti histamines , and cortisones Patient had consulted her PCP   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up information received on 16-Jun-2021 contains medical history, concomitant treatment, treatment information and second dose details.
12y female who became dizzy after receiving 3 vaccines: HPV, MCV4,Tdap  DR at bedside with pt now laying supine with feet elevated . alert oriented, pale  bp supine 94/60, hr 76.  mom reports she just ate lunch prior to appointment  no prior reaction to injections in the past  HR normal. lungs CTA per auscultation by DR   bp re checked with pt supine 1337 99/64, hr 86, color improved reports no dizziness  so pt moved to sitting upright position with stable vs  transitioned to standing with stable vs and no return of dizziness  pt dc home with mom 1443  instructed to inform staff at next HPV injection of near syncope /dizzy episode and to remain laying down longer
RECENT CVA; HX OF COPD, HTN, ASTHMA; PNEUMONIA DUE TO POSITIVE FOR COVID
Itching at injection spot, with hot rash. High fever 102 degrees, chills, weakness, not feeling well, with lost appetite. Also had a cough, lost 9 pounds, visited Dr. and he said I had the flu and xrayed my chest and said I had Bronchitis. He did not prescribe anything. Now my hair is coming out when I comb it.
Pt vaccinated /w Heptavax /w in 40 min. experienced a warm flushing & numbness w/tingling on the lt side of the body. Paresthesias continued onset to present w/out resolution.Jun88 episode of paresthesias increase severity.DX mult.sclerosis
Sore left upper arm and swollen under arm (pt. stated) hives on left AM 8/4/11. Hive began or right arm 8/6/11.
reddness covering entire thigh area, swelling, pain when applying pressure to area, soreness, marble size bump left weeks p/vax, crying;
Parent brought in their child for a 2nd COVID Pfizer shot. They believed that we were providing the pediatric doses at our location. During the busier hour at the pharmacy, patient was mistakenly given the adult dose of Pfizer COVID 19 vaccine instead of pediatric dose.
gave Fluzone QIV instead of the intended Fluzone HD QIV to patient with no reported adverse event; Initial information was received on 21-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 67 years old male patient who gave influenza quadrival a-b vaccine [Fluzone QIV] instead of the intended fluzone hd qiv to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Aug-2023, the patient received a dose of 0.5 ml of suspect influenza quadrival a-b vaccine (Suspension for injection) (strength was unknown) (lot V80418A, Expiry date : Jun-2024) via intramuscular route in the left arm for gave fluzone qiv instead of the intended fluzone hd qiv to patient with no reported adverse event (wrong product administered) (latency : same day) following the administration of influenza quadrival a-b vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event gave fluzone qiv instead of the intended fluzone hd qiv to patient with no reported 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 the 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.
13 mo M with possible seizure (staring, unresponsiveness, and head and L hand shaking every 30 seconds, currently undergoing  further evaluation) 2 days after receiving vaccines, had fever and URI sx concurrently but no known fever at the time of the possible seizure. Episode lasted approximately 15 minutes and resolved spontaneously. Patient taken to ED after episode.
Evening of shot (5/9) tongue bled after brushing and was sore with a red stripe in the middle, throat also felt sore. Lasted about 2 days. 2 days after shot started developing a rash which progressively spread to cover entire stomach, breasts, and back. Rash is small red bumps that itch mildly. Rash is still here after 2 days.  Since shot I have also woken up drenched in sweat every night- but I?m not sure if this is related to the vaccine or post-part I?m pregnancy hormones.
Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 04-Oct-2020 and the estimated date of delivery was 19-Jul-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information were not provided.
19 years old female presented at COVID clinic (08210) for her second dose of COVID vaccine (Moderna). Patient reported having needle anxiety. Pharmacist confirmed with the patient if she experienced any adverse reaction after she received her first dose. Patient stated after first dose she felt week but nothing major happened.  About 8-10 minutes after vaccine was given, patients started having some side effect such as nausea/vomiting and dizziness. she stated that she feels burning up. She denied any shortness of breath. Pharmacist used cold wet towel to rub her forehead and back of her neck. Blood pressure was checked and it was128/80, HR was 70. Store manager and pharmacist manager were notified. One of the technician called patient's mom. Patient stated she had not ate any thing in the morning so she was given water and some protein bar. Patient waited until all symptoms resolved (with supervision of the pharmacist) and after she felt better patient's mom took her home.
fifteen minutes after receiving varicella virus vaccine live the pt developed a large welt at the injection site about 3 cm in diameter. It was reported that the welt did not go away.
Myalgia, Arthralgia, Fever, NauseaVomiting, Fatigue,Chills Narrative:
Patient claims the vision  in the peripherals of her left eye became blurry/pixelated.  The vision change was reported about 30 minutes after the vaccination. The vision change did start to go away after about  an hour after vaccination.
On evening of receiving 1st dose, patient started experiencing extreme tingling in left arm/ tingling in both legs; Patient had a sleep walking episode on the night of receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (On evening of receiving 1st dose, patient started experiencing extreme tingling in left arm/ tingling in both legs) and SOMNAMBULISM (Patient had a sleep walking episode on the night of receiving 1st dose) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Mar-2021, the patient experienced PARAESTHESIA (On evening of receiving 1st dose, patient started experiencing extreme tingling in left arm/ tingling in both legs) and SOMNAMBULISM (Patient had a sleep walking episode on the night of receiving 1st dose). At the time of the report, PARAESTHESIA (On evening of receiving 1st dose, patient started experiencing extreme tingling in left arm/ tingling in both legs) and SOMNAMBULISM (Patient had a sleep walking episode on the night of receiving 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient reported that she had tingling in left arm and both legs. It was very extreme as if someone was stabbing. She had sleep walking episode on Monday night. It was very unusual since this was the first time this had happened to her. Treatment information included warm bath.
Within that week of my 2nd vaccination 03/25/2021 I gradually started having symptoms. My chest felt like it was about to explode right down the middle of my chest, right above my sternum, and it would radiate to my shoulder, to my elbow, down my arm. The pain and the heart racing, heart palpitations, would make me feel like I was gagging. First it started every 5 to 10 second intervals, and then it became more and more frequent until my heart was racing even if I was just sitting down. It took about a month and 1/2 to get an appointment in the middle of May. I was put on the ZIO patch heart monitor for 2 weeks. They found that I was having inappropriate sinus tachycardia. My heart beats at the wrong rate at the wrong time. With me, my heart beats like I'm running a marathon but I'm just going to bed. I was put on Bisoprolol fumarate morning & evening. They started me on a low dose and now they have increased the medication in the middle of June, I haven't had any more symptoms. I have recovered under medication.
Measles- Brought in and diagnosed- No treatment. Type I diabetes during measles onset.
Severe soreness, pain, aching, stiffness, lack of range of motion in shoulder, neck and upper portion of arm above injection site.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2007, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2009 and 2011, the patient was treated for the onset of a severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Information has been received from a pharmacist and a nurse referring to a 68 year old female patient. No concurrent or historical conditions were provided. On 14-APR-2015, the patient was vaccinated with ZOSTAVAX, 0.65 ml once subcutaneous (lot # K016318, expiration date 24-DEC-2015). Concomitant therapy included levothyroxine sodium. On 15-APR-2015, the patient developed a varicella-like rash at the injection site after ZOSTAVAX was administered. The nurse also reported that patient experienced an unspecified reaction to an unspecified formulation of DARVON, SULFA (manufacturer unspecified).The patient sought medical attention at the pharmacy without any treatment and lab tests. The outcome of varicella-like rash at the injection site was reported as not recovered. Additional information has been requested.
This spontaneous case, initially received on 08-Mar-2018 was reported by other non-health professional (consumer) and concerns a 61-year-old adult female patient. The patient's current condition included diabetes and concomitant medications included unspecified diabetes medications. On 29-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date: not reported). On 30-Sep-2017, the next day of vaccination, the patient developed flu symptoms. On an unspecified date, the patient consulted physician, who diagnosed upper respiratory infection (URI), fatigue and cough. The patient was prescribed with ROBITUSSIN for cough. At the time of this report the patient had not recovered from the events. The reporter assessed the case as non-serious.
She felt a little bit nauseated; This is a spontaneous report from a Pfizer-Sponsored Program, from a contactable consumer (patient). This female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 24Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that she had the first shot today (24Mar2021) and she felt a little bit nauseated. The clinical outcome of nauseated was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
I started getting ringing ears that ended up persisting to a chronic ear popping. My left ear was worse than my right, but it was affecting both ears. The ringing would last for several hours at a time in the evening then go away. By the next evening it would return again. I tried some over the counter ear drops. That did not work. After about a week I saw my doctor. He did a hearing test and everything was normal. He referred my to see an ENT. After about 2 weeks I saw the ENT and he did another hearing test which again came back normal. I was prescribed a nasal spray to help with my ears popping. The ear ringing lasted for that last 8 weeks or so. My ears still pop from time to time and I use the nasal spray as needed.
Red welt the size of 4 inches by 5 inches occurred at site of injection. Lasted for 2 days. Recommended ice, Acetaminophen, and oral antihistamine occurred on side PNEUMOVAX 23 was given.
"My left arm is very swollen and injection site looks like a huge wasp sting. I have an ongoing stinging pain in my left axilla, swelling and pain of my LT breast, as well as pain in my LT TMJ. Fever of 100.0, H/A, fatigue and runny nose. These sx started Fri. Pm  and my LT arm feels at its worse this morning" - 9/10/23
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 at 15:00 as dose 3 (booster), single (Lot number: Gh9693) at the age of 59 years, in right arm 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. No other medication was taken in 2weeks.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300102512 same patient, different drug/event;
Sinus problems; Sound like she has a cold; Spitting up; A spontaneous report (United States) was received from a consumer concerning a 96-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sinus problems, sound like she has a cold, spitting up.  The patient's medical history was not provided. Concomitant medications reported were vitamin B1, vitamin B12, armour Thyroid for drug use for unknown indication.Patient states she lost her vaccination card but received the 1st dose of Moderna COVID19 vaccine 3-4 weeks ago. Approximately on 10 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly  in left non-dominant arm for prophylaxis of COVID-19 infection. She is due for the 2nd dose on 12Mar2021.  On 4 Mar 2021, the patient experienced the events sinus problems, sound like she has a cold, spitting up.She wanted to know if she can still get the second dose. Patient did not consent for safety team to contact her health care professional.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, sinus problems, sound like she has a cold, spitting up were unknown.
dizziness; diarrhea; headaches; nausea; vomiting; soreness of arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of arm), DIZZINESS (dizziness), DIARRHOEA (diarrhea), CLUSTER HEADACHE (headaches) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness of arm) and CHILLS (chills). On 02-Apr-2021, the patient experienced DIZZINESS (dizziness), DIARRHOEA (diarrhea), CLUSTER HEADACHE (headaches), NAUSEA (nausea) and VOMITING (vomiting). The patient was treated with ACETAMINOPHEN ongoing from 02-Apr-2021 at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness of arm), DIZZINESS (dizziness), DIARRHOEA (diarrhea), CLUSTER HEADACHE (headaches), CHILLS (chills), NAUSEA (nausea) and VOMITING (vomiting) had not resolved.            Treatment Medication was Acetaminophen.
Severe pain at injection site at time of injection, tingling in fingers, unable to use left arm because of pain, difficult to find a position to rest left arm that doesn't cause pain.
Received Moderna COVID-19 vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Received Moderna COVID-19 vaccine while pregnant) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical histroy).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 05-May-2021. On 29-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Received Moderna COVID-19 vaccine while pregnant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Received Moderna COVID-19 vaccine while pregnant) outcome was unknown.        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.   The patient received prenatal and heartburn treatment medicine during her pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Information has been received from a medical assistant concerning a 65 year old female patient with no known drug allergies or pertinent medical history who on 12-JUL-2010 was vaccinated IM in the left deltoid with a dose ZOSTAVAX (Merck) (lot number 665531/0698Z, expiration date 28-APR-2011). There was no concomitant medication. The medical assistant reported that the patient called on 16-JUL-2010 to report that she had developed a rash at the injection site. The patient was scheduled to be seen in the office on 19-JUL-2010. No therapy was prescribed. No laboratory tests were performed. At the time of the report the patient had not recovered. The patient contacted the physician's office by phone. No further information is available.
Moderna - First Shot body aches slight sore throat nausea vomiting Fatigue for at least 24 hours. 2nd  shot  bad body aches headache for 24 hours  bad chills , sweats , nausea,  slight dizziness. And fatigue. Both Bad
cold chills Narrative: Patient states he received his second Moderna vaccine on 3/6/21. He and his wife visiting their son's family on 3/15 and 3/16. Patient developed cold chills on 3/21/21 for 2 days but has no symptoms today. His son tested positive for COVID-19 yesterday. Patient COVID screening is positive due to exposure. He denies symptoms. Patient would like a call back from his clinic to let him know "do I need to be tested for COVID?" RN provided education to Patient as he wanted to know if he was fully vaccinated. Per CDC, RN advised him that "it takes time for your body to build protection after any vaccination. People are considered fully vaccinated two weeks after their second shot of the Pfizer-BioNtech or Modena COVID-19 vaccine. You should keep using all the tools available to protect yourself and others until you are fully vaccinated." He verbalizes understanding stating his wife has not received her second vaccine.