chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Coughing; fingers joints hurt, joint pain; headache; Back hurts; Chills; pain; Fever; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of cough in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.   On 28th September 2022, the patient received Flu vaccine and COVID-19 BOOSTER. In September 2022, less than a week after receiving Flu vaccine, the patient experienced cough, pain in joint involving hand, headache, back pain, chills, pain, fever and fatigue. The patient was treated with guaifenesin (Mucinex). On an unknown date, the outcome of the cough, pain in joint involving hand, headache, back pain, chills, pain, fever and fatigue were recovering/resolving.   It was unknown if the reporter considered the cough, pain in joint involving hand, headache, back pain, chills, pain, fever and fatigue to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Flu and Covid booster shot and experienced coughing, fingers joints hurt, headache, back hurts, chills and pain. The patient also experienced fatigue, joint pain and fever. The patient took Mucinex to alleviate the cough.  The patient felt better today (on the day of reporting). Reporter provided limited information. The reporter did not consent to follow-up. Note: As the patient felt better today(day of reporting), outcome of all events captured accordingly. Additional supportive information:  It was unknown if the reporter considered the cough, pain in joint involving hand, headache, back pain, chills, pain, fever and fatigue to be related to Covid booster vaccine.
About a week after 1st vaccine I began having tinnitus in my right ear.  It still continues, but it did  not occur to me until today that it could very possibly be related to the Covid vaccine.  I never had it before I received the first dose of the vaccine.
Vertigo; Feeling nauseated; Lower extremity weakness; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient 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 02Mar2021 at 15:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder. The patient had allergies to fresh fruits and some tree nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC) and fluvoxamine (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021, the patient experienced vertigo, feeling nauseated and lower extremity weakness. 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 all the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vertigo, feeling nauseated and lower extremity weakness was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
I went to the doctor on April 6, 2023, my pulse was barely above 40. I came home because I did not want to believe that it was true, I did not want to go to the emergency room. I came home took my pulse, it was 44, took my blood pressure it was 210/189. I went to the Urgent Care where they confirmed they got the same readings. They had me sent by shuttle with a nurse to the emergency room. Once in the emergency room, they ran CBC, CMP, EKG, I was put on a heart monitor. All tests results came back negative, EKG showed bradycardia. I was given IV Lasix, where fourteen pounds of fluid came off of me. The hospital kept me for three days for observation they felt I may have congestive heart failure. I don't think I will ever be right, but I am as good as I can be.
30min later had facial rash, lip tingling and possible lip swelling. No SOB, cough, tongue/throat swelling, nausea/vomit/abdominal pain , confusion.
My patient was administered the COVID vaccine dose #1 from Pfizer on 12/6/21. I verified the vaccine at the time - there was a vial inside of an orange medication bottle, and I recall seeing a label that said Pfizer, COVID, and 2 ml. There was a syringe also on the tray, that contained liquid totaling 2 ml. I was later told that the vaccine was drawn up incorrectly and that the vaccine dose was inserted into the saline vial resulting in too little of the vaccine in the syringe.
Patient received a vaccine that was 10 days beyond its use-by date (3/6/23).  (mislabeled 4/6/23)  Per physician, patient did not experience any adverse effects
This case was reported by a physician via a sales representative and described the occurrence of cellulitis in a 4 year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included unspecified vaccine (multiple other childhood vaccines - manufacturer unspecified) given on the same date as KINRIX. On an unspecified date the subject received unspecified dose of KINRIX at 0.5 ml in an unknown thigh. Within a couple of days of vaccination with KINRIX, the subject experienced cellulitis. Signs included injection site redness, hot (injection site hot to touch) and swelling. The physician considered the events were clinically significant (or requiring intervention). The subject was treated with KEFLEX. The subject resolved on therapy. Product complaint was noted. The site claimed good aseptic technique was followed and there was no change in the appearance of the vaccine administered. It was reported that cellulitis was probably related to treatment with KINRIX. A note was made that other childhood vaccines were given at the same time, but infections have occurred only at either INFANRIX or KINRIX injection sites or that leg affected. Four subjects received INFANRIX from lot number AC14B126AA with expiration date 03 March 2013 and one subject each received KINRIX from lot number AC20B168AA with expiration date 02 December 2012 and lot number AC20B164BA with expiration 13 October 2012 (six subjects affected in total ranging in age from 15 months to 8 years). Additionally, no other subjects have received these vaccines from these lots and "not" had cellulitis with the exception of three subjects the site is still trying to locate.
Local reaction to vacc. at site of vacc. (Rt) lateral thigh (+) erythema and mild swelling c/o: redness and itchiness. Tx: 1) HC 25% cream 15 grams apply BID. 2) BENADRYL 25 grams/6 mL at HS.
Tinittus; A spontaneous report was received from a consumer concerning a 68-years-old male patient who received Moderna's COVID-19 (mRNA-1273) vaccine and experienced tinittus.  The patient's medical history was not provided. Concomitant medications included atenolol, ramipril and simvastatin.  On 03 Feb 2021, prior to the onset of event, patient received their first of two planned doses of mRNA-1273 (lot/batch number: unknown) on the left arm for the prophylaxis of COVID-19 infection.  On 04 Feb 2021, the patient experienced tinittus. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event tinittus was not recovered (still ongoing).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
On approximately 12/7/99, the pt developed chickenpox that consisted of fifty lesions on his neck and upper trunk towards his abdomen. The pt was afebrile.
Pt has Tdap on 3/21/14 per general ACIP recommendations. On 3/29/14, pt. started to ache in her knees. By 3/31 her leg was throbbing - was seen by dr. MRI done. Found small Baker's cyst - Later that day her neck was stiff and by that evening she could hardly move. By 4/1/14 every joint hurt. (L) foot swollen. In 2012 after salmonella dx, pt developed Reiter's syndrome. This recent incident was worse.
1 hr and 45 min after vaccine complained of weird feeling in chest or heavy feeling and could not take deep breath and duration of 10 minutes. Also complained of teary and watery eyes, face flushed, and ears red. Pt took Benadryl 25mg.
NO ADVERSE REACTIONS. PATIENT GIVEN EXPIRED VACCINATION (WXP DATE 9-21-21)
Fatigue, Fever (100 degrees), Muscle soreness all over body, inability to move arm with injection, Breathing difficulty (shallow and labored). Symptoms increased and peaked 24 hours after pneumonia vaccine. Treatment - home nebulizer treatment for breathing, advil for fever and muscle pain, hot shower after breaking fever on second day by laying under heavy covers for 12 hours.
Localized reaction to right upper arm:  Swollen/Hard/Red area noted, approximately 3.5cm in diameter.  Youth states that site is tender to touch.  MD Orders: Warm compress to the right upper arm area.  If swelling continues to increase use Benadryl.
Feel very badly/Just feel really badly; GI track feels badly; Back hurts; Ache all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feel very badly/Just feel really badly"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "GI track feels badly"; BACK PAIN (non-serious), outcome "unknown", described as "Back hurts"; PAIN (non-serious), outcome "unknown", described as "Ache all over".  Additional information: Consumer stated that he/she thought he/she was having an adverse reaction to second Pfizer vaccine shot (Unspecified vaccine). Adverse reactions: Consumer stated that feel very badly and GI track feels badly and back hurt and ache all over and dont know quite what to do because he/she thought would get through it fine. So he/she was little bit surprised. Consumer was informed about the role of Pfizer Drug Safety. Concern paraphrased: Consumer stated that he/she was not quite sure but it seems they might be connected, I don't know. Requested to probe to file a safety report. LOT: Consumer stated that Okay, he/she don't have card, have a bunch of papers. He/she was not sure this was the smartest thing to do because you were probably more interested in vaccine then you were in me but. Consumer was informed those information are to file a safety report on behalf of the consumer, consumer stated that he/she did not know that he/she was interested in filing a report, just want to get some advice about what to do. Consumer was informed about the role of Pfizer Medical Information and offered the number. Consumer stated that he/she thought to just wait and talk to a nurse for it. Patient just feel really badly don't really want to go through a different, mean who was he/she going to get when they call a different number? Consumer was provided with the number of Pfizer Medical Information and was requested to select option 3, timings as and 8 am to 8 pm Monday to Fridays as per. Further probing could not be done as the consumer was unwilling to share any further information. Hence limited information available over the call.   Information about lot/batch number has been requested.
Information has been received from a licensed visiting nurse concerning a female with no pertinent medical history or drug allergies who on 17-AUG-2007 was vaccinated with the fourth dose of Recombivax HB (lot# 655810/0041U). In 2007 the patient's titers came back negative even after the fourth dose. Medical attention was sought through a physician. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Irritability beginning at 11:00 am, and continuing all day with periodic uncontrollable crying. Woke up from nap at 4:00pm with puffy eyes. Contacted pediatrician. Poor feeding at 4:30. Sent to urgent care. Poor feeding at 7:00pm. Sent to hospital. Uncontrollable crying from 7:00pm until 11:30 pm, 1 hour after morphine was administered. Elevated white cell count. Currently admitted at medical center. Also undergoing Iv antibiotics. Poor feeding has continued, although, as of 10/18 uncontrollable crying has stopped.
Area where patient received ADACEL vaccine on 1/6/10 was reddened, warm to touch, felt itchy, tingling, blurry vision, fever. Tingling to both eyes.
Saturday 02/27 thru this morning: Low pains in upper left chest / Low pains in middle of left side of back   Tuesday 03/02/2021:  Headache and pain in left eye / Sitting watching tv on Tuesday 3/2/2021 and almost passed out Have never experienced anything like this before so think it may be vaccine related.    Then saw the news report about women getting false positive  mammogram results only on the same side they had their vaccine in and that seems to be the case with my events - all on left side.
2nd flu shot was given by mistake, a month after the first seasonal flu shot. No adverse signs or symptoms reported by patient or his mother.
The patient experienced pain at the vaccination site; Mild fever (around 100.8 degree Fahrenheit); Dose received: 3; This is a spontaneous report from a contactable reporter (physician).   A 16-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 15Jan2022 at 11:00 (Lot number: 30135BA) at the age of 16 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EP6955, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 27May2021, when the patient was 15 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EP6955, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 17Jun2021, when the patient was 15 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Jan2022 at 11:00, outcome "unknown", described as "Dose received: 3"; VACCINATION SITE PAIN (non-serious) with onset 16Jan2022, outcome "recovered" (16Jan2022), described as "The patient experienced pain at the vaccination site"; PYREXIA (non-serious) with onset 16Jan2022, outcome "recovered" (16Jan2022), described as "Mild fever (around 100.8 degree Fahrenheit)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain and pyrexia.  Additional Information: The patient experienced the events on the day after vaccination. The patient did not require any medical attention or treatment and recovered the same day. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
injection site pain, tiredness, muscle pain, chills, joint pain, nausea, feeling unwell, dizziness and weakness
A non-serious spontaneous report of '2 children each received a dose of expired H1N1 LAIV' was received from a pharmacist concerning a eight-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 25-Jan-2010. On 26-Feb-2010, the patient received expired H1N1, Intranasal, for an unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Started  with numbness onLeft side of face, face drooping  and then diagnosed with Bells Palsy
It was later determined that my son already had all his shots but the doctors did not have that updated in their system - so the DTaP, MMR, Polio and Chickpox vaccines were administered and were extra doses. Extreme fatigue, body aches began the evening of the vaccine. Swelling and redness at injection site. Symptoms worsened over the next week and included a low grade fever, stomach pain and continued on for over 2 weeks now. Patient has missed 5 days of school, had developed a serious cough and was prescribed breathing treatments for asthma (though he doesn't have asthma). Blood tests showed no infection, but his health continues to be poor.
parents states that pt had extreme pallor, was screaming, sweating heavily-then was staring straight ahead rolled eyes back & appeared to faint; on exam in the office appeared well;
Patient was not seen at our facilities prior to or after COVID-19 vaccination. Patient received first dose on 1/23/2021 and as reported by the family member, patient expired on 2/5/21. Symptoms were reported to have stared on 2/1/2021, 9 days after receiving the first dose with a drop in oxygen levels and fever.  He was reported to also have a history of chronic lung disease.  Patient's family member to be contacted if necessary.
Hives, red spots apppeared; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives, red spots apppeared) in an 86-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, the patient experienced URTICARIA (Hives, red spots apppeared). At the time of the report, URTICARIA (Hives, red spots apppeared) outcome was unknown.            Concomitant product details not provided.  Treatment product details not provided.   This case was linked to MOD-2021-162466 (Patient Link).
2 days after the injection she developed an itchy rash around the injection site. Symptoms are improving.
Child came to appointment for 4 mo WCC on Amoxil started on 1-6-09.  Appoint date 1-12-09.  Had dry rash primarily on Abd. & torso.  Dr. instructed mom to use hydrocortisone cream up to bid for few days.  Today 1-14-09 appears with bright red blotchy rash to cheeks with widely scattered dotted rash to Abd / legs / arms / head etc.  Local site to RT where PCV given "hardened lump.  Dr. unsure of rash cause by PCV or Amoxil.  Thinking ? Amoxil? or the Pentacil?
Initial report received via search of the literature on 16 April 2013. This case contains information for 1 of 22 patients whose clinical data were provided. Information regarding the other 21 patients is captured in case numbers: 2013-05188, 2013-005251, 2013-005253 to 2013-005263, 2013-05268, 2013-05269, 2011-03827, 2006-03086, 1995-00668, 2006-03230, 1995-00224 and 2003-02926. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. Regarding this case which involved a 36-year-old male patient who had received Combination tetanus and reduced diphtheria vaccine (manufacturer unknown; lot number, route, site and date of administration not reported) and eight days later reported the onset of GBS. No further information was provided. Outcomes were not reported. Documents held by sender: none.
Patient was administered with the  Covid Vaccine 2023-2024.  The vaccine is a 3 dose multi dose vial.  This was not diluted with the Sodium Chloride.  Pt received .3  ml of the Covid vaccine of the vial undiluted.    Patient's mother was notified and patient did not have any adverse reactions.