chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lost my voice; This non-serious case was reported by a consumer via sales rep and described the occurrence of loss of voice in a adult female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Concomitant products included ethinyloestradiol, ferrous fumarate, norethisterone acetate (Lo Loestrin Fe) and omega-3-acid ethyl esters (Lovaza).   On 26-SEP-2023 09:00, the patient received Flu vaccine (right deltoid). On 26-SEP-2023 18:00, 9 hrs after receiving Flu vaccine, the patient experienced loss of voice (Verbatim: lost my voice).  The outcome of the loss of voice was resolving.   The reporter considered the loss of voice to be related to Flu vaccine.     The company considered the loss of voice to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 27-SEP-2023 The patient received the flu vaccine via on site vaccination at site on Tuesday, 26 Sep around 9am. By about 6pm, the patient lost her voice and had to speak at a whisper. The patient did not know if she received the GlaxoSmithKline flu vaccine or not. The patient simply assumed that it was the GlaxoSmithKline product. The patient stated that her voice was coming back a little on the day of reporting.
Patient stated that she felt a little tingly for a minute. By the time she was evaluated the sensation has resolved with no other symptoms. No itchy throat, no shortness of breath. Exam negative.
I feel like I'm having tendon problems since having the vaccines.   I thought I should let someone know.
Hives beginning with small sports like bug bites to almost covering my thighs, on my legs, arms and torso
This spontaneous report was received from a pharmacist refers to two patients of unknown age and unknown gender. On an unknown date the two different patients were vaccinated with ZOSTAVAX (dose, route, indication, and lot # not provided) in the arms. The pharmacist had observed ZOSTAVAX leak or trickle from the injection site of the two patients' arms immediately after administration of ZOSTAVAX (after the needle had been removed from the patients arm). No adverse effect reported. Action taken with ZOSTAVAX was not reported. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
12/28/2020- received 1st vaccine 12/29/2020- very sore  noticed around the 31st redness and swelling appeared  01/05/2021- while in the shower it became extremely itchy, I  scratched it. Then forgot about it.  01/06/2021- woke up it was significantly swollen, significantly redder felt like a ball, a little warm to the touch. did not itch it,  01/06/2021 around 4:30 pm s/w Dr. she put me on Benedryl and Keflex.   01/07/2021 swelling and redness have gone done but size has increased. the diameter of the redness is about 3 to 4 inches.
None. Child was given MMRV and Varicella in the same day. Followed local reporting procedures, MD and mother notified. Reviewed potential risks to monitor for with mother as per MD, MPH, FACP, FIDSA recommendations. Continued to monitor through days 5-12 as instructed. Mother reported child is doing well with no adverse symptoms.
There was a Moderna vaccine given to a 17 year old; A spontaneous report was received from a healthcare professional concerning a 17-years old, unknown gender patient of unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, "COVID-19 vaccine given to a 17-year-old patient".  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, prior to the onset of event, the patient received their first dose of mRNA-1273 (Lot number: unknown), for prophylaxis of COVID-19 infection.  It was reported that, the healthcare professional while working at a clinic last week , after doing research, she found that there was a mix up. There was a Moderna vaccine given to a 17-year-old patient on an unknown date. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event "Moderna vaccine given to a 17 year old", was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of product administered to patient of inappropriate age.
pt recv vax 1NOV96 & 2NOV96 arm became very red in area of inj;lip was swollen & had been having stomach cramps;instructed to contact MD;saw MD 5NOV96 & given med;blood work done;
I woke up with a cough and having difficulty breathing and very tired. I waited 6 hours and did an at home covid test and it was positive. It was bad, the severe symptoms lasted 4-5 days and at one point oxygen level was down to 85. I just stayed in bed for the whole time, it was too hard to get up and have been extremely tired since then. I went to my regulary scheduled doctors appointment in march and she did bloodwork.
1. 12 hours after receiving vaccine I showed all symptoms of COVID 19 (I could not move) 2. I also began bleeding (menstrual) still have not stopped to this day.
Injection given (MCV4) one arm < 1 minute Gardasil other arm. In 5 seconds fainted few seconds - eyelids fluttered and then regained consciousness - c/o nausea ++
crying & screaming all noc; high pitched; swollen & tenderness on the rt anterior lateral thigh;
temp elevation 104 R on day of immun 3APR92; continued to run moderate temp 101-103 x 3 days between doses of APAP; Seen by MD 7APR92; impression roseola, hx rhinitis, poss rxn to immun;
"Reaction to the second dose was that of what I was informed about. I experienced joint/muscle aches and chills. Joint muscle aches lasted about 6 to 8 hours."
Fever & sz devel 6 days p/immun wen to hosp where blood work & lumbar puncture was done;
Pt had Varivax on 09/7/95, had varicella on 10/9/04 and again on 04/30/05.
24 hours after shot, I had significant pain in left arm, some in right arm. Appeared to have swollen lymph glands in left arm. Low energy, then I developed joint pain throughout in the PM. Slept 4 hours during the day. I am a healthy older person with no history of reactions, and am an active member of a Fire Department. Symptoms have decreased significantly by 1900 tonight. No other symptoms.
Between 7 pm 01/12/2022 and 10 pm 01/13/2022 patient had 6 asthma attacks, which were relieved with Albuterol inhaler. Patient advised not to receive anymore COVID-19 Pfizer vaccine in future.
Within 48 hours, he had an 11 cm sized area of redness at the injection site that was firm & warm & his thigh was swollen.  The area was non tender.  This reaction was at the site of the DTaP vaccine.
First shot moderate symptoms, Arm pain, muscles aches and Head ache, eye pain. Second shot symptoms are ten times worse like flu related symptoms. Headache, Eye sensitive to bright light, Lower back pain, joint pain,  full body muscles aches and abdominal cramping. Symptoms started early the next day and have continued to worsen. Tylenol was taking at noon next day but hasn't done much to alleviate symptoms.
Post vax, the pt developed progressive muscle and joint pain, fever, and partial paralysis in muscles (severe leg and shoulder pain). I believe this is Guillain-Barre Syndrome. No tests have been done yet. They act like GBS doesn't exist. The doctors are no help.
UNABLE TO EAT; LOST 20 POUNDS WEIGHT; HAIR LOSS; FELT LIKE COLITIS; This spontaneous report received from a patient concerned a 65 year old female of unspecified race and ethnicity.. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with 2 doses of covid-19 vaccine ad26.cov2.s (Dose number in series was 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered 1 total on 09-MAR-2021, and the second dose was administered on an unspecified date, for prophylactic vaccination which is an off label use, and inappropriate schedule of vaccine administered (Dose number in series was 1).  On SEP-2021, the patient experienced covid-19 infection (diarrhea and vomiting). On an unspecified date, the patient experienced unable to eat, lost 20 pounds weight, hair loss, and felt like colitis occurred shortly after vaccine injection (Dose number in series was 1).  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series was 2) (suspension for injection, intramuscular, batch number and expiry was not reported) dose was not reported, administered 1 in total on 15-NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date, the patient experienced unable to eat, lost 20 pounds weight, hair loss, and felt like colitis occurred shortly after vaccine injection (Dose number in series was 2). Laboratory data (dates unspecified) included: Weight (NR: not provided) lost 20 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the unable to eat, lost 20 pounds weight, hair loss and felt like colitis was not reported. This report was non-serious. This case, involving the same patient is linked to 20220335284.
The next day I woke up with a temperature of 100.4. It went back to normal in three days. I did not take any medications for it. On the third day I noticed if I climb upstairs, I am having shortness of breath. This is not usual for me. In more than a week I am still having tiredness and fatigue, I breathe more heavily when doing physical activity. Even to this day, I still feel the tiredness and then it fades away. I am breathing very heavy and having shortness of breath in my everyday activities like cleaning my yard today. I went to the ER and told them about the fatigued and feeling of heaviness where my heart is on the left side of my chest. I had starting feel the chest pain the second or third day after the dose. Now I feel like the fatigue is decreasing and it goes down, but it's still present. The heaviness in my chest is still noticeable. I am waiting to see my PCP. I cannot do any physical activity, not even clean my apartment.
I exp fatigue and low grade temp (ranging 99-100.5) this lasted for 15 days.
pins and needles in the left arm/pins and needles feeling right arm; pain in left arm; numbness in face; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number: unknown, Formulation: Solution for injection, Lot number: EL3302, Expiration date: unknown), via an unspecified route of administration in left arm at the age of 64-years, on 20Jan2021, at single dose (dose number: 1) for COVID-19 immunisation. The patient's medical history included positive Covid test (tested positive is either 03Jan2021 or 07Jan2021, does not remember exact date. Got positive test on a Sunday and retested on Tuesday). Concomitant medications were none. Caller states she is a veterinarian, had Covid blow through the office, states during that time she got a positive Covid test but it was an inconclusive thing, states she got tested 4 days later and it came back negative, so she went ahead and got the Pfizer vaccine on 20Jan2021, states since she got the vaccine she has felt pretty bad pins and needles in the arm that she got it in (in 2021), clarifies her left arm, states it has moved up into her face, makes her feel like she wants to drool, states the feeling in her face is more numbness than the pins and needles feeling, states it is not drooping or she is not seeing a Bell's palsy kind of thing, just that she is not really talking properly out of the left side of her mouth because of it. States she also had the pins and needles feeling in her right arm but that has improved some. I still have some soreness in my left arm. Caller states she thought she may just get the second booster shot (booster scheduled on the 10Feb2021) in the opposite arm, but that she cannot afford to have both arms feeling like this as she performs surgeries and stuff. Caller states that maybe the positive test she thought was a false positive was actually a real positive and this could be why she is reacting this way. Caller states the symptoms started maybe a couple of days after the vaccine, unknown exact dates. The pins and needles in her hands on the left side where vaccine was given was worse than other side, no longer experiencing this symptom. It's now on left side of her face, numbness that has been persistent a couple of days after the vaccine. The events were reported as non-serious. The outcome of the events was not recovered.
pediatric dose was given to adult; Adult use of a child product; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 54-year-old male patient who received HBV (Engerix B pediatric) (batch number 9KG7R, expiry date 9th May 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th September 2021, the patient received the 1st dose of Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 7th September 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse was reporting that, a pediatric dose of Engerix-B was given to an adult patient, which led to underdose and adult use of a child product The reporter consented to follow up.
6:30 pm 4/20/07  Mother reports red, raised area at site of injection on right arm.  Area approximately 50 mm size.  Itching. gave Benedryl.   4/22:  not raised, less red, some itching.  4/24:  area red, not raised, no itching per mother report
This case was reported by a health professional and described the occurrence of an injection site reaction in a 15 month old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 17Jun03 the pt received the 4th dose of Infanrix. On 18Jun03, 24 hours post-immunization, the pt experienced an injection site reaction characterized by swelling and redness. The pt was seen by the physician, who prescribed an unspecified antibiotic. The events resolved within 48 hours of initiating antibiotic therapy. The reporter considered the injection site reaction to be related to vaccination with Infanrix.
Two months following vaccination, I was diagnosed with varicella meningitis. I had chicken pox as a child, and had received a varicella booster in 2013. I was hospitalized on March 17 and 18 while treatment was started. My doctors advised that for an unknown reason, my immunity dropped and the varicella virus increased in my body, but did not cross the blood/brain barrier. I did not have an immune deficiency prior to this event. I was treated for 2-3 weeks with IV and oral acyclovir. The correlation to the COVID vaccine is unknown. Am now continuing with lab work to monitor IGG subclass deficiency.
At the end of September, I began having moderate back pain. By October 4 it had become severe and within a few days moved to my hip/groin area. On October 12 my right leg became red and swollen. I went to the Urgent Treatment Center and they sent me to the ER. I was given some tests in the ER and admitted to the hospital. I was put on blood thinners. Because the clot was so extensive, I was taken to the Cath Lab for catheter assisted thrombolysis (EKOS). The next day it was determined that did not work so I was taken to surgery for IVC thrombectomy of the right common femoral, iliac, and external iliac vein. I stayed in ICU for several days and I was released from the hospital on 10/17. I am now am on blood thinners daily and am unsure of the permanent damage to my leg.
whole upper body became itchy; hives on her upper body; the hives are "bumps and red/they are getting to her neck and she feels like may be a few getting to her face; swelling in her throat that hurt; swelling in her throat that hurt; rash was worse on her left arm/it also went "over my back and boobs and bellybutton; This is a spontaneous report from a contactable consumer (patient). A 25-years-old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration, administered in left arm on 22Apr2021 (Thursday) as dose 1, single (at the age of 25-years-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 25Apr2021, 3 days after the vaccine, patient got hives on her upper body and whole upper body became itchy and stated that throughout the rest of the week, it worsened, so patient saw her doctor on Saturday who prescribed her medicine and told her the hives were due to the vaccine. Patient stated that she has already had a week with hives and that hives normally go away within 24 hours. Patient stated that the hives were bumps and red and they were getting to her neck, and she feels like may be a few getting to her face, but she was not sure on Apr2021. On an unspecified date of 2021, patient rash was worse on her left arm where she received her vaccine versus the right arm, and states that it also went over my back and breasts and bellybutton. On an unspecified date of 2021, patient also had swelling in her throat that hurt, but stated she was never not able to breathe. Patient stated that she still has to get second dose of Pfizer COVID vaccine. Patient stated that she has read that when allergies come to being weird after the first dose of Pfizer COVID vaccine, that the person may not need the second dose. On 01May2021, patient went to the doctor on 1May2021 (Saturday), said it was fine for patient to get the second dose of Pfizer COVID vaccine, but the caller was interested in what Pfizer has in regard to information about getting the second dose of Pfizer COVID vaccine. Patient had doctor office visit for the events. Therapeutic measures were taken as a result of pruritus, rash, urticaria and erythema. The outcome of hives on her upper body was not recovered and unknown for rest of the events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Raised red rash in circular pattern, hot to touch.  Pain radiates down arm and into shoulder. Lasting 9 days so far.
Strong Chemical Taste and body*** Headache*** Body Aches Eyeball pain *** Muscle pain  Chills Fever 101-102 Nausea  Diarrhea  Symptoms lasted till 3/16 PM
pt recvd vax & woke up w/fever, feeling nauseated & c/o stomachache; had sz, face, lips blue; dx w/febrile seizure; vomiting;;
Pneumovax given R deltoid on 10/25/05 pt. noted redness, swelling on 10/26/05 IM. Seen Dr. 10/27/05 advised Benadryl & cold pks. On 10/31/05 no symptoms
Patient was administered a Fluzone HD Vaccine on 10/24/23 per her request. Resident had already received a Fluzone HD vaccine on 9/27/23. Error was related to patient  and  PCP on 10/15/23. Patient reported on symptoms as sore arm and minor nausea on 10/25/23.
As soon as I got the vaccine, I felt a mild pain from my arm all the way to my neck.   Since the vaccine, I feel extremely tired. My Eyes get fatigued early in the morning.   I got my vaccine on a Saturday 04/27/21, and by Monday  I started to feel a lot of pain in my back especially on my upper back and shoulder and it has been inflamed since then.   On the following Friday, I noticed my left side  Supraclavicular  lymph node was inflamed. Additionally, my  pectoral lymph nodes are also inflamed. My neck and left arm ache and in some instances feels numb.
headache; achiness; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (achiness) and FATIGUE (tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced HEADACHE (headache), MYALGIA (achiness) and FATIGUE (tiredness). At the time of the report, HEADACHE (headache), MYALGIA (achiness) and FATIGUE (tiredness) outcome was unknown. Not Provided          No concomitant medications reported. No treatment reported.    This case was linked to MOD-2021-042992 (Patient Link).
I was so sick; headache; body ache; Diarrhea; stomach pain; lung pain; Bone pain; Fever; confussion; Depression; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 03:48 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "pinched nerve" (ongoing); "Allergies" (unspecified if ongoing); "Covid-19", start date: Jul2021 (not ongoing); "Anxiety attack", start date: 2021 (unspecified if ongoing); "pressure was too much", start date: 2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I was so sick"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body ache"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "Diarrhea"; ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "unknown", described as "stomach pain"; PULMONARY PAIN (non-serious) with onset 2021, outcome "unknown", described as "lung pain"; BONE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Bone pain"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "confussion"; DEPRESSION (non-serious) with onset 2021, outcome "unknown", described as "Depression". Therapeutic measures were taken as a result of illness.  Additional information:Patient had delayed my covid due to severe reason one, Patient was having allergies two, she had covid in July which was serious she had to go the emergency room but she discharged herself for lack of proper care because I was unmarried at the time. It took me several weeks to recover and was still not feeling quite myself when she decided on 30Sep2021 to take her vaccine because the pressure was too much, and she was having anxiety attack. The day she took my first shot was great but after next day she was so sick she had medicated. The next day was went worst she had to call my doctor.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Staff reported that patient was found Friday morning (Jan 8) sitting at a table with his head tilted forward and unresponsive to verbal or physical stimuli. Staff lowered patient to floor and started CPR. EMS was called and continued CPR at scene, however they were not able to revive patient. Patient was pronounced dead at the scene. Staff written statements following the death of patient show that he had a fall about 1 hr. prior. It is unknown if this fall contributed to patient's death. An autopsy has been requested.