chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; Fetal exposure during pregnancy; The mother of the infant of unknown ethnic origin and unknown gender was participating in Moderna mRNA-1273 Study and patient developed COVID-19(COVID-19). Additionally, the patient had FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy).  The subject's mother medical history was concurrent conditions included Caffeine consumption (caffeinated beverages less than 3 per day).  No medical history was reported for the subject.   The subject received the dose of mRNA-1273 for COVID-19 vaccination on an unknown date. On an unknown date, the subject experienced COVID-19(COVID-19) (seriousness criteria hospitalization). Additionally, the subject had FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy). The delivery occurred on 04-Jul-2022, which was reported as Unknown. The outcome was reported as Delivered NOS.  No treatment information was reported by the reporter.  The subjects last dose date prior to the event and the action taken with mRNA-1273 was unknown.  The outcome of the COVID-19(COVID-19) was reported as unknown, and for the event FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy) it was reported as resolved.  The reporter did not provide the causality for event COVID-19(COVID-19) and FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy).  Company Comment:  This is a sponsored case concerning an unknown-year-old infant patient with no medical history, who was exposed to a dose of mRNA-1273 during mother´s pregnancy .  Foetal exposure during pregnancy was considered in this case. The infant experienced the unexpected seriousness criteria hospitalization event of Covid-19. No further clinical information was available for medical review. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The event of COVID-19 was assessed as not applicable to mRNA-1273 vaccine due to lack of biological plausibility. The event might be explained by current pandemic outbreak.; Sender's Comments: Company Comment:  This is a sponsored case concerning an unknown-year-old infant patient with no medical history, who was exposed to a dose of mRNA-1273 during mother´s pregnancy .  Foetal exposure during pregnancy was considered in this case. The infant experienced the unexpected seriousness criteria hospitalization event of Covid-19. No further clinical information was available for medical review. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The event of COVID-19 was assessed as not applicable to mRNA-1273 vaccine due to lack of biological plausibility. The event might be explained by current pandemic outbreak.
I had pain and swelling in the injection site but on the 8th day it got worse about the size of the palm of my hand. feels hot and itchy, I took benedryl last night and put some benedryl gell on it. I also have been fatigued by the afternoon each day.
At 8 am on Friday morning, about 14 hours after I received my 2nd dose of Pfizer covid vaccine, I had muscle soreness and aching.  I went home and slept after working night shift. I woke up at 11 am, 17 hours post vaccine, and had a 102.4 F fever, chills, body aches and headache. At 3pm I still had 102-103F fever and called employee health and in which was directed to take Tylenol or Advil. I took 600mg Advil, and my fever broke at 8 pm, 26 hours post vaccine. That night my fever returned 102-103 F, I continued to take Advil. I took Advil around the clock, but let it lapse in dose Saturday evening 50 hours after receiving my vaccine. I then had a 101.5 F temp, I waited and it continued to rise, at midnight tonight, 30 mins ago, I took 600 mg Advil
Pt to ED  6/9 with c/o sore throat, fever, and trouble controlling sugars, chills and sweats. COVID+ 6/9, pt on room air, denies pain and discomfort. 6/11 pt medicated as ordered for c/o sore throat and cough.  Pt states feels like she may have UTI starting. Pt A+Ox4, denies any cp or discomfort. 6/13 pt discharged in stable condition.  No c/o any pain or shortness of breath.  Ambulates without difficulty.
On 07/18/2022 I took a home test that was negative because I thought I had a chest cold. I had low fever never above 100.3, cough and felt like a chest cold. I spoke with my sister in law and she was positive so I took another test on 07/20/2022 and it was positive. I spoke with my doctor over the phone and he called in PAXLOVID and I started that night. My symptoms started improving within three days. I am  having no long term effects now everything went away. I did have a lot of fatigue but it is better now.
About an 1 1/2 hours after getting my first shot I had what I can only describe as a RUSH/High energy feeling along with a soreness in my chest around my heart area. Lasted for about  2 hours and that was it no other symptoms that I noticed.  Then after getting my second shot had the same thing only much more intense to the degree I was worried I may be having the start of a Heart Issue. This last for a couple days. And now I?m about 14 days after my second shot and my heart area feels much better but my whole back from my neck almost to my waist feels like sore and achy. Never had fever chills shortness of breath or anything really other than what I?m describing above. I?m starting to feel a little better each day. I just boy wanted to report this because I could not find anyone else who had felt like this after the shot. Thank you
ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/12/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Vaccine given @ 5:20pm, at 5:27pm I started having palpitations and checked my pulse on Watch (read 95). Pharmacist that administered vaccine said that it was most likely due to anxiety (but I didn?t feel that it was) and to go walk around. At approximately 5:30 pm, I became lightheaded and had bilateral ear ringing, my Watch showed my pulse was 50. I had my husband help me to the chair as the pharmacist was busy with customers. I finished sitting for the remaining 5 minutes, checked my pulse which was 74 and my husband and I left. At 5:45pm, I started getting a severe headache followed shortly with mild chest pains and shooting pain down the right arm. Around midnight I woke up with chills, nausea, vomiting, fever of 102.8, fatigue, body aches and still had chest pain and headache. On 9/8/21, my temperature without the use of Tylenol or ibuprofen was averaging 104.8. I continued to have chest pain and headache, body aches, fatigue, trouble concentrating, diarrhea, and then started itching on both arms and on my chest (without noticing a rash).  Contacted my PCP?s office for direction and was advised that if symptoms worsened to go to the ER for evaluation. Around 6 pm that evening the lymph glands in my axilla became swollen and painful to the point I couldn?t wear a bra and needed to apply ice packs. On 9/9/21 my fever had reduced to 102 without fever reducing medications and the chest pain lessened but sTill had headache, body aches fatigue.
(R) leg bumpy and discolored -red/brown. Not bruised - discolored. (L) leg got swollen that day - knots, hot to touch. Pt. cried - now no pain.
Vaccine lot # had been extended and had remained frozen until date of administration but was administered 2 days past expiration date. Moderna consulted and they deemed the vaccine still viable so no revaccination was required. Pt did not report any adverse side effects.
Extremely uncomfortable above the waist. Muscle and joint pain virtually everywhere. Went away on Sunday. More importantly, some time shortly after booster, developed intermittent hacking cough, resulting in phlegm in throat. This continues to this day. I am out of town, and won?t be able to discuss with MD until Monday. Breakthrough case??? Or simply a mild URI?
Mild fever and chills 12 hours after injection (resolved after 12 hours). 7 days after the injection, I began having minor bouts of vertigo, especially when turning suddenly toward the right or dropping my head back. At night, I experienced consistent, low-level dizziness & nausea with more extreme vertigo when changing positions, especially when moving my head to the right. Symptoms have not yet abated
Swelling and redness/induration (R) upper arm at site of inj measuring 7cmX7cm.
Swelling in the shot area at 10 pm day April 23 of first dose. April 28, swelling and soreness under the armpit. April 30, rashes on the shot area at 530pm.  May 1st at around midnight, swelling spreading to the left chest and chest pain like a heartburn but it was not due to food as I was fasting that day. I have been on intermittent fasting for a year now.  May 1, at 3pm, rash is bigger. Swollen parts feel sore like touching a bruised area kind of feeling.
Information has been received from a nurse practitioner concerning a 17 year old female with no pertinent medical history who on 13-JUN-2009 was vaccinated with the first dose of GARDASIL. Lot number was not available. Concomitant therapy included (ADACEL) and hepatitis B virus vaccine (Unspecified). On 13-JUN-2009, the patient fainted after receiving her first dose of GARDASIL. The patient received all vaccines at the same time. The patient sought unspecified medical attention. Patient's heart rate was checked but no results were provided. On 13-JUN-2009, the patient recovered. Additional information has been requested.
Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: patient states her temperature was 100.2 F-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Additional Details: Patient called 2 days after vaccination to speak to me and stated her first doses she had not experienced any side effects and wanted me to report her side effects which include fever (100.2 F), chills,and similar flu like symptoms.
Person was given 0.3cc dose of Janssen Booster dose instead of standard 0.5 cc. Dept of Health notified and Manufacturer (Janssen) notified and all persons reported to Janssen Manufacturer for their Pharmacy department, recommendations from the Manufacturer and with agreement from Dept of Health are to notify all of the recipients that received an incorrect dose and submit a VAERS report for each.
p/4mo vax pt noted staring episodes lasting 20-30sec in the 48 hr p/vax;also dx as hyperirritable;no known fever; episode resolved on own;
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 03-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Pt got MMR and IPV L lat thigh today later became red at site-enlarged 2d later-not ill-afebrile. L lat thigh 7x9cm tender erythema without fluctulance. Dx L leg cellulitis. Tx Keflex 125/5 200cc qid x 10d.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The reporter stated that on unspecified dates ranging from 15-JUN-2015 through 18-JUN-2015, the patients received doses that were improperly stored of RECOMBIVAX HB (strength, lot number, expiration date, dose # and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Rash to face, thighs, feet + some SOB x 2d pt took otc Benadryl & helped with symptoms SOB improved pt was offered Appt for symptoms  she declined appt pt states she will be getting 2nd dose was advised that she should not get 2nd vaccine but pt insisting to get 2nd dose
Rash about 3 inches in size. Noticed after it started itching. Itches occasionally, then goes away. Started a week after first dose of vaccine. Currently on day 2 of the rash. Tried Zyrtec, Benadryl, and Hydrocortisone ointment with some itching relief, but rash hasn?t decreased in size or has gone away yet.
This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 58-year-old male patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020) for prophylaxis. The patient's past medical history included shingles (the patient had prior). On 7th May 2018 15:15, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain and bedridden. On an unknown date, the outcome of the muscle pain and bedridden were unknown. It was unknown if the reporter considered the muscle pain and bedridden to be related to SHINGRIX. Additional details were received as follows: The reporter had a patient that received a dose of SHINGRIX vaccine in left deltoid and experienced bad muscle pain and could barely get out of bed for a day after the vaccination.
Mother says that child ran fever of 102F and had a seizure at about 14:30. Mom had given Tylenol. Was taken to ER and was told that seizure was due to immunizations.
upper arm was red and swollen, patient went to the MD office earlier that day, they determined COVID arm, was suggested to take Benadryl and ibuprofen, followed up with patient 5/9/22, patient says swelling has gone down, no pain and seems to be improving.
After I got the shot I got nauseous then the pain around my heart and rib on the left side began it was so sharp it made me scream. I had to use heat and take pain pills and I couldn't do anything I was bedridden for days! I won't have the second shot!!! Please warn people 67 years old that smoke that this is a high risk shot! I had pneumonia last year then I had double pneumonia! I don't want pneumonia but I don't want this pain either. I'll take my changes from now on.
J&J vaccine given on 4/9, and patient states she started having chest pain, chest tightness, shortness of breath, abdominal pain, bilateral leg pain with right leg warming sensation and left leg tenderness to palpation with rash, headaches and jittery feeling that was progressively getting worse.
Severe soreness at injection site, lethargy, muscle aches and pains, lack of appetite and sleepiness.
Erythema multifore reaction - hive-like lesions w/mild purpura on extremities mainly 13 days post vaccination.
Tightening in the throat. Still able to breathe but slight closing. Lasted for 1 hour. Then need to cough and clear throat for 7 hours.
Pr received a Pneumovax & flu injection during her office visit.  Pt states that 6 hours after receiving the  injection,she presented with sx - chills, sweats, lowgrafe fever, nausea, arm pain, localized redness and swelling @ injection site, Also c/o some left sided joint pain (arm & knee), Poor appetite Sx: resolved in approx 3 days.
Elevated blood sugar levels beginning 6 hours after injection; Diarrhea multiple times 5 hours after injection; Fever of up to 102.5 starting 12 hrs after injection; Chills and shaking starting 12 hrs after injection; Very swollen and tender lymph node above clavicle noticed approximately 42 hours after injection; Muscle and joint pain
arm swelling from shoulder to fingers (lt) required removing rings; throbbing, inc heat @ site & red bump @ site; elevated arm & applied cold packs; able to use arm & hands;
Allergic reaction - Rash (located at injection site - left deltoid, back of neck, abdomen, thigh)
Approximately 4 minutes after vaccination (12:55pm) patient experienced a syncopal episode. Characteristics observed: profuse sweating, clammy extremities, tonic-clonic seizure-like movements, eye rolled toward the back of the head. When the patient regained consciousness water and cold compress was provided. 911 was called (12:57pm); EMS arrived in approximately 3-4 minutes. The responders asked the patient a multitude of questions - she indicated she was fine and needed to lay down. A bench was provided for her to regain composure. The responders also collected her blood pressure reading once she was more comfortable . She refused transportation to the hospital.
2days p/vax pt exp flu-like sx consisting of achiness & upset stomach. addl info requested
Severe fatigue (slept all day could not get up), dizziness and muscle pains through out shoulders and upper back.
was supposed to get the 3rd dose of HPV and the MA grabbed the wrong one and gave him by mistake a meningitis vaccine; has gotten Menactra in the past on 2009 and then in June 2013, so it has been at least 6 yrs since his last dose; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 24 years old male patient who received meningitis vaccine instead of HPV VACCINE and reported that patient was supposed to get the 3rd dose of HPV and the MA grabbed the wrong one and gave him by mistake a meningitis vaccine and has gotten MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] in the past on 2009 and then in June 2013, so it has been at least 6 years since his last dose.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  In 2009, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site. In June 2013 he also received a dose of the same vaccine with an unknown batch number via unknown route in unknown administration site.  On an unknown date the patient received a dose of meningitis vaccine produced by unknown manufacturer instead of HPV vaccine (dosing details not reported, lot number not reported) via unknown route and site of administration.  It was a case of actual medication error due to wrong vaccine administered and extra dose administered.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.  List of documents held by sender: none.
no further ae reported; Temp excursion occurred on 11/22/21; This spontaneous report was received from a nurse referring to a 40 years old, male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  Temperature excursion occurred on 22-NOV-2021. On 10-DEC-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the left arm (lot U010398, expiration date 01-APR-2023) (strength and dose were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously in the right arm (lot T027914, expiration date 18-AUG-2022) (strength and dose were not provided).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
Pt had shrill cry for 4 hrs p/receiving vax, also pt to MD;
RASH AROUND INJECTION SITE AND IT HAS REACHED TO HER RIGHT ARM, BOTH OF HER LEGS, AND STOMACH AREA.
breathing problems, fatigue, headaches, low grade fever lymphadenopathy, pain shoulder, sleeplessness, sore throat, sweating weakness;
Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00601597) and transmitted to Sanofi on 14-May-2021.  This case involves a patient (demographics unknown) who was tested with a whole vial of TUBERCULIN TEST [TUBERSOL] (lot number and expiry date not reported) via unknown route at an unknown administration site but was supposed to receive a TETANUS TOXOID (Wrong product administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to Wrong product administered (latency same day)  At the time of report, no adverse event was reported.  The pharmacist called for guidance because a nurse injected a whole vial of Tubersol to a consumer. The consumer was supposed to receive a Tetanus vaccine but the vials got mixed up. The pharmacist was not sure of their phone number so she provided 2 options. It was attempted to get more information regarding the event and the consumer but the pharmacist said that this happened in a site, and they just called it in so she does not have any other information. Lot number and expiration were also unknown to pharmacist at the time of the call.  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.  There will be no information available on the batch number for this case.
Patient was given Booster dose ( 0.25 ml) of the Moderna Vaccine instead of Fluad. Pt did not have any reaction at the time she left the pharmacy.