chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 35-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In February 2020, the patient received Boostrix. In February 2020, couple of weeks after receiving Boostrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Boostrix.  Additional information was provided as follows: The reporter was mother of the patient. The age at vaccination was not reported. The patient received the Boostrix shot a couple weeks before the time of reporting and had a sore arm. This case is linked with US2020AMR037541, reported by same reporter for same patient.
Broke out with a case of shingles.  Had classic shingles symptoms.  After examination by Doctor was proscribed an anti viral medicine taken orally for a week.  Symptoms diminished after a week.
pt recvd MMR vax on 24OCT91 & 14NOV91 presented to the MD w/swelling of the rt parotid gland which was non-tender; p/3 days pt recovered;
Today noticed raised swollen red welt at injection site of LT arm. Slightly itchy at times. Have started with lower back joint pain past 5-6 days ago along with slight headache, I do have MS, but have fatigue and LT leg weakness more than usual. Noticed also RT ankle and foot joint pain today (mild). Had bad chills yesterday, no fever; dizziness when went to bed. Placed call to employee hotline, RN advise icing, report worsening symptoms, reach out to medical provider about receiving 2nd vaccine,
I started with swollen glands in my neck and collarbone and woke up the next morning with my arm really itchy. I developed hives and it remained itchy and swollen. My doctor advised me that it appeared to be covid arm & she prescribed an antibiotic. The next Saturday, I started having a severe UTI infection. I used the antibiotics already prescribed to treat it.
Post receiving vax, fever 5/17/2000 and 5/18/2000. Leg swollen since 5/18/2000 and red since 5/18, no pain, decreased appetite, no other symptoms.
This spontaneous report as received from a Registered Nurse refers to a 72 years old male patient with orthopedic unspecified issues, allergic rhinitis, hypertension, allergy to eggplant and penicillin. The patient was vaccinated with ZOSTAVAX (lot # (672675/0068AE), expiration date was 03-APR-2013, 0.65 ml, subcutaneous, left arm) on 15-MAY-2012. No other co-suspects were reported. Concomitant medications included: ASPIRIN one daily and AMBIEN for sleep PRN. The patient was seen in the office 15-NOV-2012 and complained of left arm swelling, lump, soreness at the injection site. The patient had been experiencing the effects for approximately 3 months or more (approximately in August 2012). The nodule/lump did not appear initially but appeared later, at least 2 months ago(approximately in September 2012). Treatment with BETAMETHASONE two times daily for 7 days. The patient had follow up visit at the doctor office tomorrow(on 16-NOV-2012). If he had not improved he will be referred to a infectious disease physician. The patient was seen in July 2012, but did not complain of any adverse effects at that time; only when he came in on 15-NOV-2012. The outcome of events were unknown. Additional information has been requested.
Hives, rapid breathing and puffy eyes starting immediately following the vaccines. He was gave BENADRYL and watched for a while, I continued BENADRYL through the rest of the day to ensure the reaction was kept at bay.
In June onset of severe thirst, urinary frequency and wt loss of about 20# since April.
Myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 21-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ejection fraction: 50% LVEF-50%. On an unknown date, Troponin I: 4.4ng/ml 4.4ng/mL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    Concomitant medications were not reported. Therapy for the event was not reported. It was reported that all patients recovered within 6 days of their presentation with complications. This analysis shows that myocarditis related to COVID-19 vaccine has an overall fast recovery with no short-term complications.  This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS  in a 21-year-old female patient after receiving the second dose of mRNA-1273.  Based on the current available information and reporter´s causality  a causal relationship cannot be excluded.   This case was linked to MOD-2021-317848, MOD-2021-317976, MOD-2021-317977, MOD-2021-317978 (Patient Link).; Sender's Comments: This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS  in a 21-year-old female patient after receiving the second dose of mRNA-1273.  Based on the current available information and reporter´s causality  a causal relationship cannot be excluded.
multiple organ failure; Flu; Initial information received on 26-Jan-2022 regarding an unsolicited valid social media serious case received from a non-healthcare professional.  This case involves an adult patient of unknown gender and age, who experienced multiple organ failure and flu while receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor and laboratory data/results .  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation: unknown) (lot number not reported) (route, frequency: unknown) in unknown administration site for Influenza, Immunisation. There will be no information available on the batch number for this case.  It was reported that, got a flu shot once in his/her life 12 years ago. Got the flu (influenza) anyway (onset date, latency: unknown). 6 weeks in the hospital. Multiple organ failure (multiple organ dysfunction syndrome) (onset date, latency: unknown) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event. Died 3 times and brought back. Never again. It is unknown if the patient experienced any additional symptoms/events.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (multiple organ failure, Flu).  At time of reporting, the outcome was Unknown for the event multiple organ failure and was Unknown for the event flu.; Sender's Comments: Sanofi company comment dated 03-Feb-2022: This case involves an adult patient who experienced multiple organ failure and flu while receiving vaccine INFLUENZA VACCINE. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and vaccination history, concurrent illnesses, laboratory investigations for the reported events and therapy details.
18 y/o female while in the recovery area, @ 12:58 c/o feeling very sweaty, diaphonic, initial vitals @ 12:58: 110/82, 63, 20 and sats 99% on room air, no c/o any other signs of distress, monitored, after 5 minutes :  @ 1:04 patient stated feeling much better, sweating has passed, repeat vitals @ 1:06 112/75, 60, 20, sats remain 99% on RA, continued to monitor in recovery until 1:21, dc vitals 94/62, 73, 20, sats remained unchanged. DC home w/Mother who accompanied her to the clinic, stable in no further distress.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The concurrent condition, medical history and concomitant medication was not reported. On an unknown date in August 2014, the patient received the first dose of the series of GARDASIL intramuscularly (lot details unavailable). On 28-AUG-2015, the patient received the second dose of GARDASIL 9 (Lot: L019286, Expiry: 14-SEP-2017), 0.5 ml, intramuscular. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
26NOV93 acting strange, bizzare behavior-mean (between 26-31); temp highest 103-5;
Around April 28 I started to feel light headed, wobbly and sore throat. April 30 I was really sick loose stool and upset stomach. I went to the Dr. and both Flu and COVID-19 were both Negative. They gave a disclaimer that they couldn't be 100% sure that it wasn't COVID-19. I am still having sore throat and upset stomach.
WHEN I GOT TO WORK I DIDN'T FEEL AT MYSELF.  I WAS DIZZY AND VERY SHAKEY AND DIDN'T FEEL RIGHT THE MAIN PROBLEM IS IF I CLOSE MY EYES AND GET REALLY DIZZY AND GET SICK AT MY STOMACH
Ran a low grade fever for about 3 hours followed by extreme tiredness.  Tiredness lasted a couple of days.
Pt stated after 4 day of the flu vacc. pt fell very ill. Had to see MD and get antibiotics - still recovering. (Her and her husband both) - had horrible diarrhea with a very strong smell.
Redness and mild swelling around injection site - approx 2 inches in diameter.  Noticed approximately 8 days after injection.
This case was reported by a lawyer and described the occurrence of joint pain and swelling in an adult male subject who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced joint pain and swelling, fatigue, muscle pain and weakness, neuropathy, burning and tingling pain, sweats, hot flashes, sleep disorder, sensitivity to cold, headaches, cognitive problems, cramping of arm and leg muscles, malaise, tendon pain, decreased activities of daily live, rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events were unspecified. This information was received via a statement of injuries.
Felt faint and collapsed, VS stable, ammonia salts provided, patient awake but still feeling weak, EMT arrived and patient monitored in ER then discharged home. DX syncope.
Extra dose of Menveo administered; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 14-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA712A, expiry date 31st May 2023) for prophylaxis.   Previously administered products included MENVEO (The patient received first dose of Menveo on 5th February 2019).   On 23rd September 2022, the patient received the 2nd dose of Menveo. On 23rd September 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comments: The reporter stated that a extra dose of Menveo was administered in error to a patient. The reporter did not gave consent to follow-up. Additional Supportive Information: The patient received extra dose of Menveo was administered in error which lead to Extra dose administered.
Severe muscle aches; Headaches; fatigue; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (Severe muscle aches), HEADACHE (Headaches) and FATIGUE (fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (allergy to PCN), Sulfonamide allergy (sulfa allergy), Depression and Impaired fasting glucose. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression, METFORMIN for Impaired fasting glucose, INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) for Vaccination, DULOXETINE HYDROCHLORIDE (CYMBALTA) and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    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 MYALGIA (Severe muscle aches), HEADACHE (Headaches) and FATIGUE (fatigue). At the time of the report, MYALGIA (Severe muscle aches), HEADACHE (Headaches) and FATIGUE (fatigue) had resolved.        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 treatment information provided. The symptoms cleared after 48 hours. The patient's height was 60 and weight was 182 (unit : not specified).
A sudden feeling of extreme disorientation, time distortion; Dizziness/ a general feeling of wooziness; Sense of unreality that lasted about 3-4 hours; I still have a slight headache; The patient received JANSSEN on 12Mar2021 and BNT162B2 on 29Oct2021; The patient received JANSSEN on 12Mar2021 and BNT162B2 on 29Oct2021; The patient received the booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 32030BD) via an unspecified route of administration in the left arm on 29Oct2021 (at the age of 37-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 and known allergy to cane sugar. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included cyanocobalamin (B12), iron (MANUFACTURER UNKNOWN), hyaluronic acid (MANUFACTURER UNKNOWN), probiotics nos (MANUFACTURER UNKNOWN) and fish oil (OMEGA 3); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received sulfamethoxazole/trimethoprim (BACTRIM) for an unknown indication from an unknown date and experienced drug allergy and received first dose of jnj 78436735(JANSSEN COVID-19 VACCINE, Lot Number: 1805025) via an unspecified route of administration on 12Mar2021 (at the age of 37-year-old), as a single dose for COVID-19 immunisation. On 03Nov2021 at 16:15, the patient experienced a sudden feeling of extreme disorientation, time distortion, dizziness, sense of unreality that lasted about 3-4 hours. The patient still had a slight headache and a general feeling of wooziness. The events resulted in 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 sense of unreality was resolved on 03Nov2021 (lasted about 3-4 hours) and of the sudden feeling of extreme disorientation, time distortion, dizziness, and still have a slight headache, general feeling of wooziness was resolved with lasting effects on unknown date of Nov2021 at the time of this report.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 11:14 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 11:14 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 58.57  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit at 9 am. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
sore throat; tingling in her arm which migrate to shoulder and back.; difficult to swollow; extremely dry mouth; throat was swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (tingling in her arm which migrate to shoulder and back.), DRY THROAT (difficult to swollow), DRY MOUTH (extremely dry mouth), PHARYNGEAL SWELLING (throat was swollen) and OROPHARYNGEAL PAIN (sore throat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PARAESTHESIA (tingling in her arm which migrate to shoulder and back.), DRY THROAT (difficult to swollow), DRY MOUTH (extremely dry mouth) and PHARYNGEAL SWELLING (throat was swollen). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, PARAESTHESIA (tingling in her arm which migrate to shoulder and back.), DRY THROAT (difficult to swollow) and PHARYNGEAL SWELLING (throat was swollen) outcome was unknown and DRY MOUTH (extremely dry mouth) and OROPHARYNGEAL PAIN (sore throat) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient did not took the Second Dose as suggested by her Physician. No Treatment Medicines were Included. No Concomitant Medicines were included.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up was received on 23-APR-2021 Patient demographics were updated.Added new Event Oropharyngeal Pain. Patient did not take the second dose. The action taken with the Drug was updated from Unknown to Withdrawn.  Updated Outcome of the Event Dry mouth from Unknown to Not Recovered.
No adverse efects to date. Was advised by my clinical coordinator to fill this out as vaccine was administered out of state protocol (patient was 55 and state protocol allows vaccination of patients over 60 years old).  I realized patient was under 60 hence I should not have administered this vaccine after it was given.
Got shot at 2 pm on Thursday went home about 4 pm had bad headache followed by a high fever with heavy sweating all night long and the next day, Right side below my armpit became extremely tender making it difficult to breath. My right shoulder joint developed extreme pain at the joint running to the middle of the back and up my spine. These pains were so bad I could not move around, sleep eat and made my eyesight seem blurry and made me lose my balance.
3 minutes after flu vaccination, the patient reported lightheadedness and the feeling she was going to pass out in the pharmacy lobby. The patient then experienced a short episode of syncope with spasms that lasted less than 30 seconds in duration. She was supported by her father to the floor until she regained consciousness. With the help of her father, the patient was able to rise to a seated position, moved to a chair, and eventually stand/walk over the span of 25-30 minutes. No treatment requested by father during event. The pharmacy provided water to the father to give to the patient.
Unable to defecate. Unable to speak clearly. Intense fear. Nausea. Headache. Runny nose. Earaches. Symptoms continued for over two years.
Information has been received from a physician concerning a 10 year old female with a history of fainting when receiving shots, who on 08-APR-2008 was vaccinated with the first dose of Gardasil vaccine. After receiving the vaccination the patient fainted. Also, the patient had a history of disliking shots and she had fainted before and after receiving vaccinations, unknown medical attention was sought. The patient was recovered. Additional information is not expected.
pharmacy was at local facility to vaccinate community/  staff neglected to record previous bivalent vaccination given to patient 2 months earlier/  patient received 2 bivalent vaccines in a 2 month window
Case number PHHY0112BR041391 is an initial serious spontaneous report from a nurse received on 14 May 2012. This report refers to a 35-year-old female patient whose medical history, past drugs, current conditions and concomitant medications were not reported. She received a dose of AGRIPPAL 2011/2012 (seasonal influenza vaccine, batch number: 114102, expiry date: Nov 2012) on 08 May 2012 or 09 May 2012 when she was 4 months pregnant. She had an abortion on 13 May 2012. No further information was available. The causality was not assessed.