chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves patient (age and gender unknown) who experienced rash that started below the left arm injection site and then went down to her elbow and then developed into welts on the left side of her face, while received vaccine FLUBLOK QIV. The patients past medical history, concomitant medication and family history were not provided. On 16-Oct-2018, the patient received injection of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1809, expiry date 30-Jun-2019 via intramuscular route in the left arm. On an unknown date, the patient developed a non-serious rash that started below the left arm injection site and then went down to her elbow and then developed into welts on the left side of her face. (urticaria) with unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On an unknown date, the patient developed a non-serious rash that started below the left arm injection site and then went down to her elbow and then developed into welts on the left side of her face. (rash) with unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On an unknown date, the patient developed a non-serious rash that started below the left arm injection site and then went down to her elbow and then developed into welts on the left side of her face. (vaccination site reaction) with unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Lab data was not provided. Final diagnosis was rash that started below the left arm injection site and then went down to her elbow and then developed into welts on the left side of her face. During the evening on 17-Oct-2018, HCP instructed patient to take BENADRYL, ZYRTEC and ZANTAC. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for rash that started below the left arm injection site and then went down to her elbow and then developed into welts on the left side of her face. List of documents held by sender- none.
Vaccine given at 10:00 a, at 10.05 oz pt. c/o itchiness upper back area. Right arm with rashes, no SOB, not in pain, stable 11.27 am. Talked to pt on phone- feels better sometimes, took BENADRYL OTC.
This case was reported by a nurse to a sales rep and described the occurrence of welt injection site in a 5 yr old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The nurse reported that more than one 5 yr old experienced a welt at the injection site following the administration of Infanrix, however, a specific number of subjects was not provided. On an unspecified date on or before 18Jan06, the subject received a dose of Infanrix (dose number and lot number not provided). At an unspecified time following the administration of Infanrix, on an unspecified date on or before 18Jan06, the subject experienced welt injection site. The outcome of the event was not reported. The nurse reported to the sales rep that this vaccine has caused this reaction (a welt at the injection site).
She was complaining about pain after the injection, so I gave her some Tylenol. She also had a few muscle aches too. Then I October she woke up in the middle of the night with a high fever. This lasted for 2 days. I took her temperature on day 2 and her fever was 105. I took her to the Emergency Room. They told me the virus she had was going around and not to be alarmed if she got a rash. Sure enough, after her fever broke, she woke up with a rash on her belly. It went away in 24 hours though. This lasted for about 6 days total. No medications were prescribed. I gave her Motrin and Tylenol. She got better from that and now has Molluscum Contagiosum. I already filed a report about that.
This spontaneous report as received from a nurse refers to a 15 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 27-APR-2016, the patient was vaccinated with GARDASIL (dose: 0.5 ml, 0, 2,6 months) (lot #, expiration date and route were not reported) for prophylaxis. On 09-AUG-2016, the patient was vaccinated with GARDASIL 9 dose 2 for prophylaxis and on 08-NOV-2016 the patient again was vaccinated with GARDASIL 9 (dose 3) ((lot #, expiration date and route were not reported)) (inappropriate schedule of drug administration and interchange of vaccine products). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Patient received the Shingrix vaccine into the left deltoid at approximately 10:30am, after 30 minutes the vaccination site got hot and red and started to spread to a maximum of 5 1/2" in diameter.  The patient who is also recovering from a hip replacement was put on Doxycycline hyclate 100mg BID for 7 days as a preventative measure to ensure she wasn't at risk for a systemic infection as a result of a possible cellulitis infection. The doxycycline was only taken for a total of 2 days as the patient has experienced severe reflux from the antibiotic and has discontinued the antibiotic and will follow up with her provider in a few days.  After taking Doxycycline for a few days the swelling and redness has gone down and the patient has been advised to continue using Benadryl cream and/or hydrocortisone cream with Aveeno w/ colloidal oatmeal to help with itching.
Patient had Swelling, redness, and heat radiating from the site of injection after receiving the vaccine. She tensed up when receiving the vaccine due to fear of injections. She stated that later she felt like she had a low-grade fever (did not take a temperature to verify). Patient says she took two Tylenol 500 mg and then all side effects resolved the same evening.
Reaction To Shindrix - Have never reacted to any vaccine. Had Shingles Vaccine 15 YRS ago. EXTReme shooting pain in arm - shoulder To hand - Pain scale 10. Took 800 mg Ibuprofen brought IT down to a 6 - Last for hours. Weakness - needed help getting out of bed. Fell in Bathrm. Tremors in legs. Rapid Resp BP + HR. NoRmal.
This spontaneous report was received from a certified medical assistant via a company representative and refers to a 13 year old female patient. The patient's medical history included eczema and other unspecified skin conditions. The patient's concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a first dose of GARDASIL lot # L033347 (also reported as LO33347), (expiry date, dose and anatomical site of injection were not reported) and then, on 21-DEC-2015, the patient received her second dose, lot # L039066 (also reported as LO39066), (expiry date, dose and anatomical site of injection were not reported). Concomitant therapies were not provided. On an unknown date, after receiving the second dose of GARDASIL the patient experienced hair loss. The patient spoke to the physician and an unspecified blood work was performed (result were not available). In addition, an unspecified treatment for alopecia was given, however, the event did not improve. It was also reported that the therapy was discontinued. No product quality complain (PQC) was involved. At the time of reporting, the outcome of alopecia was not recovered. The reporter did not provide a causality assessment between the event and the GARDASIL. Additional information is not expected, since the reporter did not allow further contact for follow-up.
Gave baby Hep B shot in R thigh IM. Immediately sit of injection swelled and rest of body got red and hives. Shot was given at 0633. Called Dr ordered Benadryl. Gave Benadryl at 0659. Then redness, and blotches started to go away. No respiratory difficulty at time of reaction.
Pt experienced unusual swelling and muscle pain/ache. Refused to go to hospital, but MD was contacted by patient. Left deltoid experienced swelling to half baseball size per pt, with no redness or SOB. Swelling decreased after 24 hours.
Acute anaphylaxis; itching @ inject site immed p/inject; drowsiness began 20min p/inject; 905AM BP 142/90, P 78, R 26; 908AM 1cc DPH given; 930AM pt's sxs completely relieved; 1030AM pt very drowsy p/inject of DPH; 11AM no evidence of rxn;
BlurredVision, Headache, Myalgia, chills Narrative: Symptoms resolved on 1/23/21
Within ten minutes after receiving his first HPV injection, my son fainted. We were waiting to check out and schedule his next appointment for his second injection. I was looking at him as we were chatting together and he stiffened, his knees buckled, and he started sliding down the wall. I grabbed him and helped support him, so he didn't hit his head on the floor. He was pale and stuff for only a minute at most. I thought it was a seizure at first, but after reading more, I believe he possibly only fainted. When he regained consciousness he did not know where he was for a moment, he didn't understand why he was on the floor. His knees were red and scraped from landing harshly (his legs were folded under him, I tried to keep weight off of them, but was more concerned with his head) and he was very sweaty and clammy. He drank two small cups of water, then threw up a small amount. After ten or fifteen minutes, he said the nausea passed and he felt very hungry. He did not eat breakfast in the morning before receiving the vaccine. He ate a sub after we left his pediatrician's office and felt "normal" again.
pt recvd vax; devel localized rxn of erythema, swelling & pain w/in 24 hrs p/ vax; tx w/ ice & ibuprofen;
Fever chills headache, two days in bed ,after two weeks I started giant  Weight like 7 pounds in one week and my doctor told me I have water inflammation caused by the vaccine
Pain in hip/on left side hip down to knee constant steady pain; Vaccination site pain/sore arm  at vaccine injection site; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in hip/on left side hip down to knee constant steady pain) and VACCINATION SITE PAIN (Vaccination site pain/sore arm  at vaccine injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Unknown. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain/sore arm  at vaccine injection site). On an unknown date, the patient experienced ARTHRALGIA (Pain in hip/on left side hip down to knee constant steady pain). In 2021, VACCINATION SITE PAIN (Vaccination site pain/sore arm  at vaccine injection site) had resolved. At the time of the report, ARTHRALGIA (Pain in hip/on left side hip down to knee constant steady pain) had not resolved.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of arthralgia and vaccination site pain was not provided with HUMIRA.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Pt received Pfizer Bivalent dose as his first covid vaccine. Pt was observed for 30 minutes no problems. Pt was called a few days later and had no symptoms or problems from vaccine.
From mailed correspondence from reporting health professional stated that a 2 month old patient received a Tripedia, an ActHIB, an IPOL and a Prevnar (Lederle) vaccination on 06/05/01 10:30 am. Reportedly,the patient began crying for more than 1.5 hours follows by pallor. Reportedly, the patient recovered from this experience.
AFTER 5 MINUTES OF RECEIVING 2ND DOSE OF PFIZER COVID 19 VACCINE. THE PATIENT COMPLAINED OF PALPITATIONS AND WAS JITTERY.  SHE DEVELOPED RASH ON CHEST.  911  WAS CALLED AND EMS CAME AND TOOK PATIENT AWAY FOR OBSERVATION
Patient stated he had received Moderna vaccine at hospital prior to today?s vaccine after vaccine was given. No adverse reaction but reporting because he may have received the Moderna vaccine followed by the Pfizer vaccine. Could not confirm with hospital today. Nursing home  following up tomorrow with hospital.
57-year-old female history of hypertension, hyperlipidemia, type 2 diabetes, COPD, subsegmental PE is not on anticoagulation, multiple cardiac stents presenting with greater than 12 hrs of worsening left-sided chest pressure, headache and shortness of breath.  Patient takes a daily aspirin and had no improvement of symptoms with her at-home nitroglycerin. Here afebrile, HTN, remaining vitals wnl. Non-toxic, in moderate distress 2/2 to pain. EKG with minimal ST depressions in leads II and III. Will plan for CXR and labs. Pt given zofran and morphine for pain control. Will give additional aspirin for total 324 mg in last 24 hrs.   On re-evaluation, pt with mild improvement in pain. Troponin elevated at 0.18, remaining labs wnl. At this time concerned for NSTEMI, pt treated with 1 mg/kg of lovenox and MOD consulted for admission. MOD evaluated pt and cardiology was consulted. Given concerning PMHx and current hx of chest pain with findings consistent with NSTEMI, cardiology at recommended likely transfer for cardiac cath. Will pend repeat troponin and EKG for dispo decision.
Patient states that they recieved the vaccine and a bit over 24 hours later developed hives all over their body. The patient states that they were very itchy for an additional 24 hours after initiation of the hive reaction. They do not recall changing anything in diet or topical products. He did not recall being in any new environments or touching any new plant/animal.
Redness and swelling noted to left deltoid 10/16/14 in AM. C/O itching. Shot flu received 10/15/14.
Initial itching, then large area of raised, red skin/swelling that is sensitive/painful to the touch and hot
Arm sore; Back hurt; Left hip felt weird and was hardly able to stand on it.; I am not sleeping; Panic attack; Pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), BACK PAIN (Back hurt), MUSCULOSKELETAL DISCOMFORT (Left hip felt weird and was hardly able to stand on it.), INSOMNIA (I am not sleeping) and PANIC ATTACK (Panic attack) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis. Concomitant products included LOSARTAN and PREDNISONE for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), BACK PAIN (Back hurt), MUSCULOSKELETAL DISCOMFORT (Left hip felt weird and was hardly able to stand on it.), INSOMNIA (I am not sleeping), PANIC ATTACK (Panic attack), PAIN (Pain) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Arm sore), BACK PAIN (Back hurt), MUSCULOSKELETAL DISCOMFORT (Left hip felt weird and was hardly able to stand on it.), INSOMNIA (I am not sleeping), PANIC ATTACK (Panic attack), PAIN (Pain) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Additional information received on 07-Jul-2021 and does not contain any new information
Pt arrived at the pharmacy with is mother to receive his Covid-19 vaccine. I administered the covid-19 Pfizer PEDS age 5 to <12Y vaccine, dose: 0.2mL, LOT: FK5127 intramuscularly into the left deltoid of the patient at around 11:50am. I then went to check on the patient at approx 12:00pm and noticed a rash around the injection site. Rash was approx 2 inches in diameter. I drew a line around the rash to see if it would spread more or not. I then proceeded to give the patient Benadryl around 12:03pm. I went back to check on the patient about 12:13pm. I noticed the rash had gone down a little. I advised the mother that she could give her son another dose of benadryl when they got home if the rash had not gone down more.
Muscle and joint pain; Muscle and joint pain; headache; extreme fatigue; sore arm; chills; unable to sleep; Overall just don't feel well; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were not reported) via an unspecified route of administration on left arm on 08Feb2021 (at the age of 66-year-old) as 1st dose, single for COVID-19 immunization. The patient medical history included pacemaker, replacement knees and left hip. The patient had known allergy with cipro and vancomycin. The patient had COVID prior vaccination. The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks. The patient was not tested COVID-19 post vaccination. On 09Feb2021 at 02:00, the patient experienced muscle and joint pain, headache, extreme fatigue, sore arm, chills, unable to sleep. Overall, the patient just did not feel well. The patient did not receive any treatment for the event. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
This spontaneous report as received from a other health professional refers to a female patient of unknown age. On 06-SEP-2017 the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On 06-SEP-2017, 1 day after onset of therapy the patient experienced nervousness and malaise and "was taken into the office in a wheelchair and was seen by unspecified healthcare staff but they did not need to send for an ambulance". The outcome of nervousness and malaise is unknown.
No adverse event; a 52-year-old patient received Monovalent Red Cap Moderna COVID-19 Booster dose on 16FEB2023; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (a 52-year-old patient received Monovalent Red Cap Moderna COVID-19 Booster dose on 16FEB2023) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071B22A) for COVID-19 prophylaxis.     Patient did not received any other vaccines 4 weeks prior to Moderna COVID-19 vaccine.     On 16-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (a 52-year-old patient received Monovalent Red Cap Moderna COVID-19 Booster dose on 16FEB2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (a 52-year-old patient received Monovalent Red Cap Moderna COVID-19 Booster dose on 16FEB2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (a 52-year-old patient received Monovalent Red Cap Moderna COVID-19 Booster dose on 16FEB2023).    No concomitant medications was reported. No treatment medications was reported.
Started feeling sick; Itchy throat; Brown mucus; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Started feeling sick), THROAT IRRITATION (Itchy throat) and SPUTUM DISCOLOURED (Brown mucus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced MALAISE (Started feeling sick), THROAT IRRITATION (Itchy throat) and SPUTUM DISCOLOURED (Brown mucus). At the time of the report, MALAISE (Started feeling sick), THROAT IRRITATION (Itchy throat) and SPUTUM DISCOLOURED (Brown mucus) outcome was unknown.            No concomitant medications were reported   No treatment information was provided   Reporter did not allow further contact
severe myalgias, arthralgias, worsening of HTN, now over 2wk p/flu vax;
sore armpit on arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (sore armpit on arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY PAIN (sore armpit on arm). At the time of the report, AXILLARY PAIN (sore armpit on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter
Patient felt bad shortly after receiving vaccine "whole body felt lazy" then had vomiting and fever 102 degrees went to ER at 3 AM 10/11/14. Hypotensive at ER gave fluids was released afternoon of 10/12/14.
Parent reports that child's arm was swollen and rashy at the insertion site. Reports there is a bump the size of a "50 cent piece" at the site. Reports that site is itchy. Instructed to give Benadryl by mouth and apply a cool compress to area.
I had my vaccination on 09/20/2022. On 01/31/2023 I started to have a sore throat. I tested COVID-19 Positive on 02/01/2023. I contacted my physician and was prescribed Paxlovid on 02/02/2023. I stopped taking it after 3 days. I had horrible mucous and unable to leave my bed. It felt like I had the flu and cold with all the symptoms. I had brain fog and fatigue. These symptoms lasted for a full 2 weeks. It took till 03/2023 till I started to feel better but I have not been able to exercise at full capacity since diagnosis. I have had cardiac issues since as my symptoms for edema of the ankles presented 02/28/2023. I do have follow up appointment upcoming with primary care physician for a referral to cardiology.
Death. Coroner said collapsed of unknown cause.  Autopsy performed. Awaiting final report and toxicology report.
pneumonia; bronchitis; This spontaneous report has been received from a lawyer referring to a female elderly patient of unknown age. The patient's historical vaccines included measles vaccine and mumps vaccine. The patient was a non-smoker. The patient's medical history and concomitant medication were not reported.  In 2011 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, strength, batch/lot# and expiration date were unknown) for prophylaxis. In the same year, the patient also received flu vaccine.   On an unknown date the patient experienced pneumonia and bad bronchitis. The outcome of both events was unknown. The reporter considered pneumonia and bronchitis to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown).  Upon internal review, pneumonia was determined to be medically significant.  The case is linked to case# US-009507513-1806USA003153 due to the same patient.; Sender's Comments:  US-009507513-1806USA003153: