chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient left for a job on 4 Jan 2008 and reports symptoms of "the crud" and being "as sick as a dog". Recalls experiencing nasal congestion and runny nose, as well as generalized body aches and malaise. Does not recall experiencing a fever, chills, cough, sinus pain, N/V/D or headaches. Several members of his department experienced similar symptoms. He did not seek medical evaluation and reports all symptoms, except for malaise, resolved within 3-4 days. The malaise was thought to be related to mission tempo, change in schedule and diet, working 10-12 hour shifts, etc., but has persisted to date. Describes current energy level as 40-60% of his baseline energy level of 100% prior to JAN 2008 job. On 10 Jan 2008, patient reports episode of constant chest pain located in the center of his chest. Describes pain as "wrenching". At the time, patient recalls taking deep breaths to try relax and no change in character or intensity of pain was noted. Denies changes in pain with position changes. Reports pain intensity as 8/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Pain radiated to jaw with that episode, but does not always radiate with subsequent episodes. Reports pain lasted about 15 minutes. Denies accompanying symptoms like nausea, diaphoresis, palpitations, dyspnea, or cough. After initial episode, patient has experienced similar episodes about every 4-6 weeks. He reports episodes have never awakened him and never seem to occur when he is "at rest", but usually are associated with mild to moderate exertional activities like mowing yard. Patient first noted being "winded" after about 1 month in theater. Reports that he would become winded after climbing a flight of stairs, which was not his norm. He also noted that he felt winded during the course of a busy day at work. He thought this was unusual because the previous year he had work at high altitudes  and never had problems with his problems with his breathing. He never developed a cough or wheezing. He has been smoking cigarettes since age 14, up until Nov 2011, averaging about 1ppd. He currently notes mild dyspnea with exertion. He reports when he walks up a hill by his home, he often experiences tingling in his fingers about 1/4-way up the estimated 10-15% incline of hill - "always at the same spot". He has had some evaluation of dyspnea through the hospital since he has been out of work. He noted some improvement in overall ease of breathing after having surgery on his deviated septum in 2010. Has had PFTs performed in 2010 and was given albuterol inhaler which he does not use. On 7 NOV 2011, patient sought evaluation for back pain. While in the ER, patient's heart rate was running in the 120's. He denies any change in the character of his ongoing chest pain and dyspnea prior to this evaluation. He denies pedal edema and cough. Patient was admitted for 1 day for observation. ECHO during hospitalization showed EF of 43%. During this hospitalization, metoprolol and lisinopril were initiated. Patient was diagnosed with cardiomyopathy and had a repeat ECHO on 19 MAR 2012 was essentially unchanged - - > cardiac cath showed CAD - - > 4 vessel CABG.
This case was reported by a pharmacist via call center representative and described the occurrence of fever blister in a female patient who received SHINGRIX. Previously experienced adverse reactions included fever blister. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown. It was unknown if the reporter considered the fever blister to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient with history of fever blisters and again developed fever blisters after receiving a dose of SHINGRIX. No further information was available at the time of report.
Wife told pharmacy on 10/29/15 that husband had a reaction as conveyed by tech to me. I tried to directly receive a statement on 10/30 when I was notified, but the patient did not answer the phone.
Information has been received from a licensed practical nurse (LPN) concerning a 6 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 14-JUL-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M004508 with an expiration date of 29-JUN-2017) (dose was not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The  temperature excursion reported was 1 degree Celsius (C) for 48 hours. A digital data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA013756.
Cellulitis in the abdomen.  Treatment with two antibiotics.  No other factors to contribute to cellulitis.  In the middle of treatment currently.
Received 2nd dose of Pfizer, instead of Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received 2nd dose of Pfizer, instead of Moderna vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 31B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Received 2nd dose of Pfizer, instead of Moderna vaccine). On 28-Apr-2021, WRONG PRODUCT ADMINISTERED (Received 2nd dose of Pfizer, instead of Moderna vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment details were provided.
Nausea, low grade temperature, as day progressed had difficulty moving arms and legs, severe low back pain and memory loss.  She took Tylenol and went to bed- had complete resolution of symptoms AM 10/13/10.
This case was reported by a pharmacist via call center representative and described the occurrence of muscle soreness in a 77-year-old male patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) and (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. On 9th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was not recovered/not resolved. It was unknown if the reporter considered the muscle soreness to be related to SHINGRIX. Additional details were provided as follows: The event muscle soreness had been ongoing since receiving the 1st dose. On 25th June 2018, the patient received 2nd dose of SHINGRIX.
Extreme fatigue and fever for more than 8 days.  Onset 6 days after the second booster.
Next day - chills, body aches; tiredness. January 1, I was very dizzy and still had the other symptoms, too. January 2, all the symptoms gone except dizziness persisted - but only positional whereas the first day it was all the time. So I get it when I stand up, sit down, lie down. It is slowly going away. I did go to an audiologist on January 15th - and they did an epley maneuver to help get rid of the positional dizziness problem. Had second dose of vaccine on January 21st - had tiredness and chills the day after but it wasn't as bad as the first one. Dizziness still persisted but not new or worse symptoms.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe
No other AE/no PQC.; VAQTA was given today which expired on 03/28/2022; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 31-MAR-2022, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) (lot # T034003, expiration date 28-MAR-2022; strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis (expired product administered). The vaccine had no history of temperature excursions. No other adverse event (AE) or product quality complaint (PQC) was reported.
less than five minutes after administration while seated in the waiting room pt lost consciousness and was placed on the floor.  Staff called 911 instantly and EMSA arrived <60 seconds.   Pt stabilized and exited building into EMSA truck on his own feet.  EMSA reports that pt was not transferred via EMSA from pharmacy.
Fever; Chills; Whole body aches; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 09:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included cetirizine hydrochloride (ZYRTEC), lamotrigine (MANUFACTURER UNKNOWN) and vortioxetine hydrobromide (TRINTELLIX); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 09:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 23:00, the patient experienced fever, chills, whole body aches and headaches which were most intense from 23:00-5:00 and symptoms continued through following day decreasing slightly. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, whole body aches and headaches was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Tiredness within a couple of hours of the test. Soreness at the injection site 2 days after. Swollen lymph node after 5 days. At 8 days the area around the injection site was red, itchy and radiate heat.
COVID-19; This spontaneous report received from a patient concerned a 6 decade old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. Age at time of vaccination 56 years old. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient was recovering from covid-19. This report was non-serious. This report was associated with a product quality complaint: 90000232041.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
pt recv vax 16SEP96 to lt thigh on 17SEP96 reported 8x9cm area of tender erythematous induration @ site of inj;scratching;tx med;
This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: muscle mass on arms or thighs. The patient experienced severe reactions in arm when treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine given into gluteal muscle, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given into gluteal muscle and off label use was not reported. This report was non-serious.
Initial unsolicited report received from a non-healthcare professional on 8 December 2015. This case involves a 62-year-old female patient who was vaccinated with a dose of FLUZONE QIV (batch number: UI482AA, expiration date: 30 June 2016, dose, dose number and route of administration were not reported) in left deltoid on 27 October 2015. The patient had medical history of diabetes, hypertension, pancreatitis and no known allergy (NKA). The patient illness at time of vaccination was none reported. Any other vaccinations within 4 weeks of vaccinations was unknown. Concomitant medication was not reported. On 28 October 2015, one day following the vaccination, the patient experienced left sided neck pain. The patient saw her physician on 5 November 2015 and was diagnosed with C6-7 Neuralgia. The patient required ER or doctor visit. No laboratory investigation was performed. The patient received orally NEURONTIN, OTC medications, heat or ice as a corrective treatment. The outcome of the event was unknown. Follow up information received from non-healthcare professional on 26 January 2016. No new information was reported. List of documents held by sender: none.
Symptoms of Bell's palsy; This spontaneous case was received on 29-Oct-2020 from other health professional via Health Authority (reference number: SEQW20-04492) and concerned a 55-year-old, female patient.  The patient's concurrent condition included diabetic, hypertension and hyperlipidaemia. The patient's concomitant medications included Ozempic (semaglutide), Singulair (montelukast sodium), metoprolol, lisinopril, metformin, Humalog (insulin lispro), Zetia (ezetimibe) and Jardiance (empagliflozin), all used for an unreported indication.  On 23-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for flu prophylaxis. The batch number reported was 283847 and expiration date: 30-Jun-2021.  On an unspecified day in Oct-2020, within 24 hours after receiving Flucelvax QIV, the patient developed symptoms of Bell's palsy.  On 27-Oct-2020, the patient visited emergency room (ER).   The outcome of 'Bell's palsy' was not reported.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  The event of ' Bell's palsy' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 55-year-old, female patient was administered Flucelvax QIV. Within 24 hours after receiving Flucelvax QIV, the patient developed symptoms of Bell's palsy. The patient's concurrent condition included diabetic, hypertension and hyperlipidaemia. The patient's concomitant medications included Ozempic (semaglutide), Singulair (montelukast sodium), metoprolol, lisinopril, metformin, Humalog (insulin lispro), Zetia (ezetimibe) and Jardiance (empagliflozin), all used for an unreported indication. Causal role of the suspect vaccine is assessed as possibly related for facial paralysis, due to plausible chronology.; Sender's Comments: A 55-year-old, female patient was administered Flucelvax QIV. Within 24 hours after receiving Flucelvax QIV, the patient developed symptoms of Bell's palsy. The patient's concurrent condition included diabetic, hypertension and hyperlipidaemia. The patient's concomitant medications included Ozempic (semaglutide), Singulair (montelukast sodium), metoprolol, lisinopril, metformin, Humalog (insulin lispro), Zetia (ezetimibe) and Jardiance (empagliflozin), all used for an unreported indication. Causal role of the suspect vaccine is assessed as possibly related for facial paralysis, due to plausible chronology.
Pt received MMR, Varivax, Kinrix. Within 10- 15 minutes, she felt nauseated, vomited, mother noticed little bumps on her face. MD examined her, was crying, had no LOC, she had 2-6 mm flesh colored papules with welted appearance scattered over face, especially cheeks, and smaller ones scattered over upper arms. A few on trunk as well, 1-2 mm. Her lungs were clear, she had no stridor or difficulty breathing, tongue and mucous membranes, lips ok. Left eye with sclera pink, not swollen. she was given Benadryl, 18.75 mg, observed. Ate a popsicle, rash gone on arms in about 25 minutes, face mostly cleared and eye not red. She was playing and happy.
Vaccine given subcutaneously; Given lower on arm than where intramuscular injections are usually given; Injection site is red-purple in color and measures 2" by 2'; It occasionally itches; A spontaneous report was received from a consumer, regarding himself, a patient who received Moderna's COVID-19 vaccine, but it was given subcutaneously instead of intramuscularly, it was given lower on my arm than where intramuscular injections are usually given, my arm at the injection site is red-purple in color and measures 2" x 2", it occasionally itches.   No relevant medical history and concomitant medications were provided by the reporter.   On 02-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) in the arm for prophylaxis of COVID-19 infection.   Patient reported that she received vaccine on 02-Jan-2021 and she taught that it was given subcutaneously instead of intramuscular as it was given lower on her arm, where intramuscular injections are usually given. Ona n unspecified date, patient also stated that her arm was red purple at the injection site and the discoloration measures 2" x 2", which occasionally itches. No treatment information was provided.   Action taken with mRNA-1273 in response to the events were not provided.   The events, it was given subcutaneously instead of intramuscularly and it was given lower on my arm than where intramuscular injections are usually given were considered to be resolved on 02-Jan-2021. The outcome of the events my arm at the injection site is red purple in color and measures 2" x 2", it occasionally itches were not reported.; Reporter's Comments: This report refers to a case of a patient who experienced non-serious event of mRNA-1273 vaccine was given subcutaneously instead of intramuscularly, it was given lower on my arm than where intramuscular injections are usually given (Vaccine given subcutaneously Vaccine administered at inappropriate site)   and events of injection site is red-purple in color and measures 2" by 2, it occasionally itches. (lot # unknown), Exp date-unknown). The event of injection site is red-purple in color and measures 2" by 2 is temporarily associated with the administration of mRNA-1273 vaccine, hence a causal association cannot be excluded. The events of vaccine given subcutaneously, and vaccine administered at inappropriate site are considered not applicable
after 2nd dose of Hepatitis B vaccine, my 5 year old son developed swelling around the left eye, a few days later, developed full blown facial swelling, redness and itching
Information has been received from a registered nurse concerning a 10 year old male with no medical history who on 05-AUG-1999 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There were no concomitant medications. The child never received second dose of vaccine. It was reported that the patient's grandmother (his caretaker in the afternoons) was vaccinated with a dose of zoster vaccine live (MSD) on approximately 27-SEP-2007. The child developed lesions on 03-OCT-2007, 6 days after his grandmother was vaccinated. The child was seen in office on 04-OCT-2007 with over 100 lesions on his face, trunk, arms, and mouth. The doctor diagnosed the child with chickenpox. The child was recommended to have diphenhydramine hydrochloride (BENADRYL) and baths. There were no laboratory or diagnostic tests performed. It was not known if the child had any other recent exposure to chickenpox. At the time of report the patient was not recovered. A product quality complaint was not involved. No further information is available.
DROPPED DEAD OF BLOOD CLOTS; This spontaneous report received from a consumer via social media  via company representative concerned a 4 decade old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, therapy start date was not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, reporter said that "my coworker was a healthy woman in her 30's and dropped dead of blood clots two weeks later". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211242178-COVID-19 VACCINE AD26.COV2.S-Dropped dead of blood clots. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: BLOOD CLOTS
Patient's left arm became itchy 5 minutes after receiving vaccine.  Given 50mg Benadryl PO, itching spread throughout body but did not progress to hives. Patient declined to be transported to ED for monitoring.
He had a fever since 8/5 pm then on 8/6 he had a lot of arm pain.  His face was swollen, he couldn't hardly breathe or talk.  We took him to the ER where he was given Benadryl and steroids.
24 hours after the shot (Wed afternoon) I started to get a fever a little over 100F, chills, aches and fatigue.  That subsided after about 18 hours.  Then on Friday I broke out in hives.   I currently still have hives one week after the vaccine, and my medical provider called in a prescription for me.  Hopefully, it will be remedied in a few days.
Big allergic reaction. Sneezing, nasal drip, face swelling and some breathing issues. Taking Loratadine (Claritin) brought some relief to all symptoms.
I had a heavy arm, swollen vaccine area and light iching on the vaccine areas for 2 days right after taking the shot. Then the heaviness went away. Since last night I have a ring like, red swollen lump, itching on the arm. Also now slow pain is occurring on the area, as if I had just taken the vaccine.