chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received his third dose of the vaccine; received his third dose of the vaccine; exacerbation of COPD; fatigued; His symptoms have worsened; shortness of breath; difficulty walking more than 10 feet; This is a spontaneous report from a contactable consumer (patient wife) from a Pfizer sponsored program regulatory authority Support. A 87-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: FD8448) via an unspecified route of administration on 16Aug2021 13:00 (age at the time of vaccination was 87 years) in left arm as dose 3, single for covid-19 immunisation; Influenza vaccine (FLU VACCINE VII), via an unspecified route of administration from 16Aug2021 (Batch/Lot number was not reported) on 16Aug2021, as dose number unknown, single for influenza. The patient medical history included ongoing chronic obstructive pulmonary disease had this condition for 6-7 years (stated it was Emphysema), limb injury from Jun2021 and ongoing almost completely healed. The patient concomitant medication(s) included prednisone (RAYOS) and dicloxacillin (DICLOXACILLIN) taken for wound treatment. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN6199) via an unspecified route of administration on 03Mar2021 as dose 1, single for COVID-19 immunisation and patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EP7534) via an unspecified route of administration on 27Mar2021 as dose 2, single for COVID-19 immunisation. On an unspecified date in Aug2021, the patient experienced shortness of breath more than usual, as well as difficulty walking more than 10 feet, his symptoms have worsened, exacerbation of copd and fatigued. The patient not visited to Emergency Room and Physician Office. The clinical outcome of the event shortness of breath and difficulty walking more than 10 feet were not recovered. The clinical outcome of the other events were unknown.
Immediately DTaP site turned red, patient pale(02/25-suggested Benadryl) 24 hours later arm hard and red from shoulder to elbow. Taken to ER and given steroid shot and Benadryl (02/26/2005). To ER, given prednisone x4 days and to continue Benadryl. 02/27/2005. Called again on 03/02/2005-arm slightly pink, feeling good.
Difficulty with ADLs; Temps: ranging from 99.2-101.8; Lymph nodes swollen; Achy joints and muscles; Achy joints and muscles; Exhaustion; Abdominal Pain; Headache; Chills; blurred vision; This is a spontaneous report from a contactable nurse (Patient).   A 60-year-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EL9266) via an unspecified route of administration, in left arm on 09Feb2021 (age at the time of vaccination was 60-year-old) as a single dose for COVID-19 immunization. Medical history included HTN (Hypertension). The patient had sulfa allergies. Concomitant medications included coreg (CARVEDILOL), advil (IBUPROFEN), tylenol (PARACETAMOL) and ASA. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was E189982) via intramuscular route of administration in left arm on 19Jan2021 (age at the time of vaccination was 60-year-old) as a single dose for COVID-19 immunization. The patient did not have any other vaccine in four weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. On 09Feb2021, at 21:30, the patient experienced Temps: ranging from 99.2-101.8, Lymph nodes swollen, Achy joints and muscles, Exhaustion, Abdominal Pain, Headache, chills, blurred vision and Difficulty with ADLs. The patient did not receive any treatment for adverse events. Patient underwent lab test and procedure which included Body temperature ranging from 99.2-101.8 on 09Feb2021. Outcome of all the events was not recovered.  Information on the lot/batch number has been requested.   Follow-up (12May2021): Follow-up attempts completed. No further information expected
Within one week, experienced symptoms which a few days later resulted in diagnosis of a ruptured appendix which was addressed with emergency surgery.
developed loss of taste and loss of smell  and fatigue on 12/04. THen developed chest pain and admitted to Hospital on 12/05. Then transferred to Hospital on 12/05 with an aortic dissection.  Underwent surgery. Moved from ICU on 12/13 to a COVID floor. Currently on 1-2 liters of oxygen.
Medication error: Patient received 2nd dose of Moderna COVID 19 vaccine 23 days after first dose.    No immediate adverse reactions noted.   Volunteer Nurse  was counseled regarding vaccination intervals.
On 2.23.20321 began to note itchy hives over both arms. More concentrated at vaccine sites, legs and torso.
Pt came in for 5yr wellness check. Pt needed vaccines (Proquad (MMR, Varicella) and Dtap) Proquad was given but instead of Dtap the MA gave an Adacel. The LPN pulled the vaccine, and the MA administered the vaccine.
Nausea Dizziness Had slight seizure (lasted approximately 5 seconds- arms up and shaking, eyes closed, fell back in chair) Cold sweats      (still nauseous 3 1/2 hours after injection, unable to keep anything down (including water)
joint pain; pain; I got very sick; Shaking; Fever; This is a spontaneous report from Pfizer-Sponsored program. This contactable 28-year-old female consumer(patient) reported which includes that :  A 28 years female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247) dose 1 on 04Feb2021 and dose 2 (Lot number: EN5318) on 20Feb2021 via an unspecified route of administration administered on left arm (At the age of 28 years) at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. On an unspecified date in Mar2021, Patient had stated I got very sick, I had pain all over my body specially my joint, Shaking and Fever. Treatment They just gave me medication for pain, I stopped it so I am not taking any medication now. I just use only Aleve Every time I have pain I take 2 pills. I did use Meloxicam but I stopped using it." At the time of reporting, the outcome of the events were unknown.  Additional Context:  Consumer stated, "I wanted to tell you my experience about the vaccine Covid vaccine Pfizer. After few weeks I got some symptoms that I never had in my life. I got very sick and it stated pain like I had pain all over my body specially my joints and other symptoms like I have shaking, sometimes fever not all the times. I went to ER and I went to another doctor they sent me to neurologist and he write I didn't had any problem before and he thought it might be from the vaccine because sometimes what happen that chemical can attack our joints and he did some test. My test number was so high which means my immune system has antibody. I want to know if somebody called you and had some history about that because it is so strange and I never had joint problem and the test result is showing I have joint problem. And is this possible from the vaccine is somebody has these symptoms?"      No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Left arm red from elbow to shoulder warm to touch. Mom applied ice gave Benadryl- Seen in ER- continue with Benadryl.
After receiving the COVID vaccine patient felt flushed/hot. Upon taking her BP we found it to be extremt.ely high 240/140.. PA  did a quick chart review and intake, finding the patient had not been taking blood pressure medication and had not been to her PCP since 2019.
Mom called on 12/15/2016 @11:50 AM and said that patient was having  diarrhea and vomiting a lot last night about 4-6 times she said it was a lot like everything for the past 2 days. His diarrhea was an orange rusty color. He hasn't had any fever, he was very restless last night 12/14/2016 more than normal. He hasn't thrown up this morning 12/15/2016 but he did have the diarrhea this morning. He is acting more normal today 12/15/2016. He is taking his nap right now but other than that he seems pretty normal, he did want to lay on the couch a little but right before his nap. Mom was wondering if it could be from the vaccine from yesterday 12/14/2016 or if he caught something at the daycare at the gym yesterday. Medical Assistant spoke to Physician and she informed me to let mom know that it could possibly be from the vaccine, or could possibly be that he caught something from the daycare at the gym. Physician also said to let mom know to bump up his probiotic and make sure to keep him nice and hydrated, and if he is not getting better by tomorrow to give us a call. Mom was happy with the call and said that she will let us know how he is doing and i told her i would call her in the am to check and see how patient was doing. She said she is making him soup right now and she will call us if anything changes. 12/16/2016  Medical Assistant called mom and asked her how patient doing and she said that he is better hasn't thrown up but has had the really bad diarrhea still. He had two yesterday that were super full, one was a rusty color and the other one was a yellowish color. Before he went to bed he did have a little fever it was 100 but he slept ok. He didn't want to eat anything yesterday and this morning he only ate toast. Yesterday every time she tried to feed him he gagged like he was going to vomit. He is still drinking great and taking his probiotics. They are going to be traveling starting Sunday and mom wanted to know if she should give patient anything else to kind of support his immune system like the immunogen(immune support Homeopathic) because he always seems to catch something when they travel.
The pt experienced swollen, erythematous and tender injection site which occurred 12 hours post vax.
delayed second dose of shingrix / first dose July 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The pharmacist asked can the series be continued or should it be restarted. No further information was reported. Reporter did not consented to follow-up.
On Saturday, August 21, 2021, client (DOB: 05/26/2008) received the first dose of the COVID vaccine (Pfizer, dose 1, lot# FC3183, exp: 9/17/21) in to his left deltoid at approximately XXXpm. After vaccine was administered, client was to wait in the Observation Area for 15 minutes. At 11:16am, Co-Lead RN witnessed client's mother (DOB:10/03/1987) alert EMT that client felt like he needed to vomit. EMT handed client an emesis bag. Co-Lead RN, responded and client proceeded to belch into emesis bag one time. Client assisted to zero gravity chair. At 11:16pm, client stated he felt better after belching and notes he was feeling nauseas about 5 minutes after vaccination. Client denied abdominal pain, chest pain, shortness of breath, swelling in face or mouth, rash, itching or any other symptoms. Upon assessment by Co-Lead RN, client's skin was dry, warm, and pink. At 11:16am vitals were taken: BP: 125/83, HR: 120, RR: 20. Client was alert and oriented x4 during entire interaction. Client's mother states client last ate a piece of toast at 8:00 am. Per mother, client does not have a medical history, allergies, or take any prescription medications at home, but does note that the client has a history of fear to needles and injections. At 11:30am vitals were taken: BP: 113/82, HR: 105, RR: 20. The client skin was warm, dry and pink. At 11:46am, vitals were taken: BP: 105/81, HR:92, RR:20. Co-Lead RN educated client's mother on ED precautions and advised to follow up with PCP. Client's mother verbalized understanding. Client walked out of observation area with a steady gait at approximately at approximately 11:47pm
Malaise on 4/8/14 9:00 pm. Question of fever 4/8/14 at 900 pm felt warm then cold. Sweaty this morning 4/9/14 at 900 AM. States her head feels full and myalgias all over neck. Question of a reaction to MENACTRA vaccine given abt 24 hours ago. C/O H/A and fatigue symptom started last night. Felt totally fine until tried to fall asleep last night, had considerably more trouble than usual. Malaise didn't feel well. Achy arm started last night, until evening time felt totally herself. Went to school and lacrosse. Has been practicing lacrosse a couple weeks. ?Fever last night. Warm then cold. Sweaty this AM when woke up. Face flushed. No HA per se but head feels full. No nasal congestion. No cough. No diarrhea. No nausea or abdom pain. Some myalgias all over and neck. Denies rash and itchy skin. No sore throat. Mom thinks may have had some reaction to MENACTRA first dose, but not signif enough that was seen or recorded in chart in my review of such and patient herself doesn't remember it.
Patient felt flushed, tired and unable to sleep. Felt soreness the day of vaccine and noticed redness that night. Left arm has 3" red swollen area, splotchy, slightly raised, reddened areas up to shoulder. Soreness at the site but feels it has improved. Patient received both flu and pneumonia in same arm.
Other than the two days of extreme fatigue, headache, fever, I developed a twitch in my left eye, my second toe on my left foot, and my left ankle.  The eye twitch lasted  for 4 months. The toe twitch lasted for 5 months.  The ankle twitch is still present.  In  addition, I developed a fluttering heart that starts and ends sporadically and is still present.  It comes and goes.
Immediately after IM inj in deltoid-area approx. 50mm x 30mm oval inflammation occurred. There was no paralysis, itching, tingling-and only slight tenderness at site. Applied ice and monitored v.s.-began resolving in 15-20 min. After 5 hrs reduced (stable) 80%-next day completely resolved.
Multiple events of legs collapsing and falling down. Numbness. Tingling, No control of legs. Went to ER on 12/4, held in ER for testing and admitted to hospital on 12/5. Diagnosed with Guillain-Barre Syndrome (GBS). Moved to ICU due to respiratory distress and swallowing issues. Numbness in arms and hands. 5 Courses of IVIG administered.  Moved to Hospital on 12/18/19 for Inpatient Acute Rehabilitation. Discharged on 12/27/19. Currently homebound, had in home PT eval, and starting  outpatient PT.
This spontaneous report as received from a health professional refers to a 13-month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
2/18/2021 fever 100.5 and scratchy throat 2/20/21-Covid test positive. No contact with covid positive, patient is still admitted in the hospital from December. 2/20/21 patient was drowsy, lung sounds rhonchi, Respirations 36, O2-78 % on room air. 4L per NC applied.
Patient stated to  - RN who gave the vaccination that she has been extremely nervous and anxious about getting vaccine.   Was very nervous about getting vaccine.  She stated that she had her own epi pen because she had anaphylaxis reaction to something in her MVI.   then stated that he could give vaccine lying down on a cot- but she declined.  She was in the observation center (going to watch for 30 minutes) instead of normal 15minutes.  She leaned over to her husband at 9:30 and said they she felt like she was going to pass out.   Nurses brought over the gurney to patient and she laid down and vital signs were taken 9:33- 50/43  100%  with o2 nasal canula  9:34  64/30   100% with o2 nasal canula . Patient also had to defecate- just did so on sheets.  9:35  78/33 and 99/53    100% with o2 nasal canula  9:35 EMT called and arrived at 9:38 9:44  100/64 9:46- BP sitting 100/66 9:50 standing  98/60 Ent spoke with patient and also husband.  She states that she was feeling much better. Patient decided that she did not want to go to the ER. Advised patient to call her PCP and if it is decided to get second dose- that she eats and drinks prior to coming to vaccine center and that we give her second shot lying down.  Took patient out to the car in wheelchair.   She felt good and was very thankful for the care.
Td given 11/24/99. Also, given Tig at another hosp later that day. Started w/nausea & vomiting during night of 11/25/99 that lasted 2 days.Dvlped red blotchy rash over body 11/27/99 that lasted 3-4 days.Tx w/prednisone and Benadryl in ER.
Ached all over (bones hurt); Very tired (slept 10-15 hours); Left arm was really sore; A spontaneous report was received from a Consumer concerning a 73-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain in extremity, fatigue, bone pain , fatigue, bone pain.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient experienced the events pain in extremity, fatigue, bone pain.   On 16 Jan 2021, the patient experienced the events fatigue, bone pain   The treatment details were not reported.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, pain in extremity, fatigue, bone pain not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sepsis in the presence of  COVID-19 infection; ruled UTI was the result of the Sepsis
This spontaneous report as received from a healthcare worker referring to unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patients received improperly stored doses of GARDASIL 9 lot # M023169, expiration date 13-JUN-2018 (dose, route and frequency unknown) for prophylaxis. The temperature and time frame was reported as 31 degree Fahrenheit) (F) or colder (30.8 F) for 5 days. There was no previous temperature excursion and it was not because of a data logger.; Sender's Comments: US-009507513-1708USA010417:
stomach pain (upper abdomen) began approximately 4 weeks after shot. unknown if it is related. another 4 weeks later, a rash was noticed on my torso, usually originating where the pain is (stomach area). the pain comes and goes and recently it is pretty constant. i started with a prescribed proton pump inhibitor today (4/6/2022).
Myalgia fatigue Narrative:  By pt. report: "I got my second COVID-19 vaccine shot yesterday 2/2/2021 @ 13:00. I started feeling achy and fatigue this morning [2/3] around 9 and slowly feeling worse. "
On 25 apr 2007 at approx 2100 hr. c/o fever and chills, bodyaches. Temp 101.8F-oral. resolved with Advil-better now. Member also c/o severe site reaction-size approx-12cm x 7cm this is resolved today-now smaller area of redness
Fever, fatigue, chills approximately 12 hours after vaccine. Ibuprofen reduced these symptoms.  Approximately 36 hours after vaccine (morning of august 4th) experienced tightness in chest, cough, and fatigue. Still experiencing these symptoms as of 7pm august 5th.
Redness and itchiness on torso and neck. Took Benadryl.
This spontaneous report was received from a nurse and refers to a 2 year-old female patient. There was no information about the patient's pertinent medical history, drug reactions or allergies and concomitant therapies provided. On 30-JUN-2017, the patient was vaccinated with improperly stored second dose of VARIVAX, one unspecified dose in the left thigh (lot # M047622 with the expiration date of 02-DEC-2018, route of administration was not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The administered dose of vaccine experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was involved. There were no previous temperature excursions reported. This was one of several reports received from the same reporter. Additional information is not expected as the reporter had no further information to provide. Sender's Comments: US-009507513-1706USA009938.
Patient got the 2nd dose at 12:00pm. Around 2:00 PM he noticed rash on both of his arms. No other symptoms were noticed.
Fever Chill Body ache  Headache  Sour left arm Tigh neck and shoulder muscles Those symptoms is been continued until now ( 1:00pm Tuesday April 13th 2021)
middle finger rt hand collapsed pains in both shoulders; pains in both legs; could not lift up & swelling in hands; pain in rt knee;
Sore arm; 16 year old patients that received the Moderna covid vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patients that received the Moderna covid vaccination) and PAIN IN EXTREMITY (Sore arm) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patients that received the Moderna covid vaccination). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). On 04-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patients that received the Moderna covid vaccination) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-221042, MOD-2021-257236, MOD-2021-257250, MOD-2021-257236, MOD-2021-257250 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up received on 14-Jun-2021 contain significant information-updated patient information, vaccine information, event added.; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknown  with no associated AEs.
Client immediately became light headed after vaccination. She was observed for additional 30 minutes with no additional symptoms reported.