chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is in follow-up to report(s) previously submitted on 12/12/2008. Initial and follow-up information has been received from a physician concerning an approximately 17 month old male patient who at 11 weeks old on 15-AUG-2007 was vaccinated with the first dose of ROTATEQ (Lot # 657522/0769U), the second dose of ROTATEQ (Lot # 657045/1053U) was given at 6 months old on 16-OCT-2007 and then the third dose of ROTATEQ (Lot # 657668/1390U) was given at 6 months old on 11-DEC-2007. Concomitant therapy included DTAP-IVP and PREVNAR. The physician reported that on 05-NOV-2008 the patient went to the emergency room and had a stool culture test, preliminary the test showed no Salmonella, Shigella, Campylobacter, or Shiga-toxins 1 and 2 producing strains of E. coli (including E. coli 0157) isolated in 24 hours and final results were positive to rotavirus: C Difficile Toxin Assay final result were negative for Clostridium difficile toxin A and/or B. The physician reported that the patient had diarrhea and rotavirus. The patient was not admitted to the hospital, on the emergency room was given 500cc and he felt much better on 10-NOV-2008. The patient was recovered. Additional information is not expected.
Patient had rash on chest area and also large red, hard area near injection site of pneumonia vaccine. Has had FLUZONE in past with no issues.
Headache & Myalgia Narrative:  chills, muscle aches and headache.
Patient developed pleuritic chest pain and difficulty breathing a few days after the vaccine and was ultimately diagnosed with DVT and PE
pregnant when she received a dose of MMR Il; This spontaneous retrospective pregnancy report was received from a nurse regarding a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, when the patient was pregnant, she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, route of administration, lot number and expiration date were not reported) for prophylaxis (exposure during pregnancy). The vaccine was reconstituted with a sterile diluent. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) was unknown. On an unknown date, the patient delivered a child (live birth). The child had unspecified developmental delays. The outcome of exposure during pregnancy was recovered.  This case is cross referenced with 1909USA008792 (child case).
Throat feeling like it was closing 5 minutes after vaccine. Felt like I was going to have trouble swallowing.  I took a sip of water & I swallowed easily.  The feeling of my throat swelling lasted about 2 hrs & then subsided.  Also, felt like I could taste medicine in my mouth immediately after the vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Throat cancer" (unspecified if ongoing). The patient's concomitant medications were not= reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for bnt162b2 omi xbb.1.5, bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
chills, muscle aching, fatigue  Advil/Tylenol   lasted about  5 hours
Pt recvd 1st dose of Recomb on 11JAN91 & 2 to 3 hrs post vax pt devel t101, myalgia & hives; pt rx meds; sx resolved w/in 24 hrs;
Extreme shivering (2 hours); nausea/vomiting; weakness upon standing; muscle ache; severe headache (2 days); redness and swelling at vaccine site. Lost time at work.
Covid19 breakthrough.  1st vaccine received on 02/14/2021.  78 y/o PMH of asthma, schizophrenia, NSTEMI, splenic lesions, adnexal soft tissue mass presents to ED with c/o diarrhea and progressive fatigue x10 days.  CXR nonspecific.  Room air sat 98, afebrile.  Treated with low dose steroids.
had a fever of 101 F; having chest pain that got worst on Monday; patient had a little bit of pain at the injection site; mild headache; body ache; patient took a Covid-19 test resulting negative; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 06-OCT-2023, the patient received Arexvy (left arm). On 07-OCT-2023, 1 days after receiving Arexvy, the patient experienced injection site pain (Verbatim: patient had a little bit of pain at the injection site). On 08-OCT-2023, the patient experienced chest pain (Verbatim: having chest pain that got worst on Monday). On 09-OCT-2023, the patient experienced fever (Verbatim: had a fever of 101 F). In OCT-2023, the patient experienced headache (Verbatim: mild headache), general body pain (Verbatim: body ache) and covid-19 virus test negative (Verbatim: patient took a Covid-19 test resulting negative). The outcome of the injection site pain, chest pain, fever, headache and general body pain were resolving and the outcome of the covid-19 virus test negative was unknown.   It was unknown if the reporter considered the injection site pain, chest pain, fever, headache, general body pain and covid-19 virus test negative to be related to Arexvy.     It was unknown if the company considered the injection site pain, chest pain, fever, headache, general body pain and covid-19 virus test negative to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-OCT-2023 The patient received Arexvy on Friday and on Saturday, she had little bit of pain at the injection site. 2 days after vaccination, on Sunday, she had chest pain which got worst on Monday. 3 days after vaccination, on Monday, she also had a fever of 101 Fahrenheit. In October 2023, the patient took a Covid-19 test resulting and it was result was negative. The patient also had body ache, describing that even sitting on her recliner she felt ache crossing and uncrossing her legs. During these days she also had mild headache. On 10th October 2023 (Tuesday), she was feeling a little bit better and then on 11th October 2023 (Wednesday) and on the day of reporting, the patient was better.  The reporter did not consent to followup.
His arm was sore immediately after but progressed to increased pain, and any motion was very painful at prox. one below distal clavicle on humerus, Medral dopak was given with relief. he is still taking meds. I always give vaccines myself. He has a tattoo on  that arm so I known exactly where I gave it. I always squeeze the muscle, use a 1" needle unless the patient has muscular arms, and aspirate before injecting, there was nothing at all usual about this vaccination. He seems relieable, He is right-handed.
extreme exhaustion/Really really tired; sore arm; This spontaneous case was reported by an other and describes the occurrence of FATIGUE (extreme exhaustion/Really really tired) and INJECTION SITE PAIN (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced INJECTION SITE PAIN (sore arm). On 02-Feb-2021, the patient experienced FATIGUE (extreme exhaustion/Really really tired). At the time of the report, FATIGUE (extreme exhaustion/Really really tired) and INJECTION SITE PAIN (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
After nine (9) days my right arm where the shit was given, I started having a red rash, with swelling. There is no pain nor itching. On the tenth day, April, 24, 2021, I woke up with nausea, and still with the swelling and rash on my right arm.
Hot; All she could do was sleep; Itchy; Spot is hard; Swollen; Covid arm where it is a little red circle that grew 3-4 inches in diameter; Sore to the touch; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot), SOMNOLENCE (All she could do was sleep), PRURITUS (Itchy), VACCINATION SITE INDURATION (Spot is hard) and VACCINATION SITE SWELLING (Swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot), SOMNOLENCE (All she could do was sleep), PRURITUS (Itchy), VACCINATION SITE INDURATION (Spot is hard), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE ERYTHEMA (Covid arm where it is a little red circle that grew 3-4 inches in diameter), VACCINATION SITE PAIN (Sore to the touch) and HEADACHE (Headache). At the time of the report, VACCINATION SITE WARMTH (Hot), SOMNOLENCE (All she could do was sleep), PRURITUS (Itchy), VACCINATION SITE INDURATION (Spot is hard), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE ERYTHEMA (Covid arm where it is a little red circle that grew 3-4 inches in diameter), VACCINATION SITE PAIN (Sore to the touch) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
I got my second Covid-19 Pfizer vaccine at 12:00pm on 12/16/21 in my left arm. Other than my arm being a bit sore, I had no other symptoms the rest of the day.  I woke up at 4:00am feeling like my body needed to stretch when my arms shot straight up, my legs straight down with my toes pointed, my chest and stomach twisted and pushed out, my lower back and butt twisted and pushed out the opposite way, and my body viciously shaking; it lasted 10-12 seconds and was extremely painful. I was half asleep and wasn?t sure what was happening, but my body was aching and I felt extremely exhausted; I wound up falling back asleep.  Two hours later I woke up again at 6:00am and the same exact thing happened again, I felt even more tired and my whole body hurt, I fell asleep again. I woke 30 minutes later (6:30am) to the same exact involuntary jerk of my arms going straight up, my legs pointing straight down, my torso contorted with my top half pushing out one way and my bottom half pushing out the opposite way and it was extremely, extremely painful, and my head was pounding. After that last involuntary convulsion I started having one every 5 minutes and I had no control over it. I started freaking out and was crying because it was so scary not to be able to control my body and being in so much pain. I thought I was going to have this condition for the rest of my life.  I called several friends who were nurses and then my doctor who told me if it doesn?t go away or slow down in a few hours to go to the immediate care. From 6:30 to 8:00am they went from every 5 minutes to every 10-15 minutes and went from being 10-12 seconds long to 3-4 seconds long. I was trying to control them and not do it but I had no control of my body. From 8:00am to 12:00pm I had one every hour. After 12:00pm they stopped. I never, ever, had anything like that happen to me in my entire life. I?ve never been so scared and gone through so much pain. It is now 12/19 and I haven?t had another convulsion. I still have a massive nonstop headache, my body still aches and it?s weird but my eyeballs hurt. It hurts to blink or close my eyes, it feels like I?m stretching my eyelid skin. I?m still extremely exhausted, fatigued, nauseous and I have no appetite. On 12/18 I woke up with my left armpit swollen the size of a baseball and it really hurts, it feels like it?s sore and bruised. It?s 12/19 and it hasn?t gone down at all.
Received ZOSTAVAX - within 1 hr developed red face and hands, SOB, diaphoresis, itchiness (hands and forearms); took 50mg BENADRYL in 2 divided doses. F/U with ER: discharged with ZANTAC (x 3 days), Prednisone (x 2 days) and BENADRYL Q4 hours.
patch red and swollen at injection site.  arm felt heavy.  developed within 30 minutes of administration.
Stomach pain/cramping with diarrhea; Stomach pain/cramping with diarrhea; headache; pain at injection site; Slight congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 13:15 (Lot number: 301308) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Administration time: 01:15 PM, Vaccine location: Left arm, Lot number: FC3182), administration date: 19Aug2021, when the patient was 29 years old, for Covid-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), DIARRHOEA (non-serious) all with onset 09Sep2021 15:00, outcome "not recovered" and all described as "Stomach pain/cramping with diarrhea"; HEADACHE (non-serious) with onset 09Sep2021 15:00, outcome "not recovered", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 09Sep2021 15:00, outcome "not recovered", described as "pain at injection site"; NASAL CONGESTION (non-serious) with onset 09Sep2021 15:00, outcome "not recovered", described as "Slight congestion". Therapeutic measures were not taken as a result of abdominal pain upper, diarrhoea, headache, vaccination site pain, nasal congestion.  Additional Information: Patient had received Birth control, probiotic, and daily vitamin medications within two weeks of vaccination and also did not receive any vaccine within four weeks prior to covid vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 post vaccination. Patient had no known allergies. No other medical history.  No follow-up attempts are possible. No further information is expected.
patient was given vaccine at the pharmacy at 10:14AM, patient fainted 2 hours after receiving the vaccine at about 12:15PM in the deli/bakery, store management called EMS,  the patient was sitting up and talking to management and EMS after the fainting episode, she said she felt hot and had not eaten before fainting.
Headaches for a week; Lightheaded, duzzy and foggy brain for multiple weeks.; Lightheaded, duzzy and foggy brain for multiple weeks.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the right arm on 20Aug2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Aug2021, the patient experienced headaches for a week and felt lightheaded, duzzy and had foggy brain for multiple weeks. The patient was now concerned with taking the second dose. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient was tested for COVID-19. On an unknown date in 2021, the patient underwent COVID-19 virus test via nasal swab and the result was unknown. The clinical outcome of the events headaches for a week and lightheaded, duzzy and foggy brain for multiple weeks was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Mild body itching on and off a few days after shot.  9 days after shot woke up with 5 by7 inch red, very itchy oval rash around vaccination site. Lasted 3 days and went away..  However body itching got worse the next several days and has gradually been subsiding but is still present today which is 20 days after shot #1.
Pneumovax site raised 1 cm diam, bluish & hard from day 1-3; Influenza vax site also raised & bluish had flu like sx w/about .75cm in diam; fever x 3 days;
seizure; Dose 1 was on 04Sep2021 and Dose 2 was on 06Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administration date 06Nov2021 (Lot number: FF2590) as dose 2, single for covid-19 immunisation. Relevant medical history included: "autism" (unspecified if ongoing), notes: Her son is a 15 year old male with Autism. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot: FD8448, he got an ear infection on both ears with perforation and bleeding after the first dose), administration date: 04Sep2021, for COVID-19 immunization, reaction(s): "ear infection", "got an ear infection on both ears with perforation and bleeding ", "may have been getting sick cause of the vaccine". The following information was reported: SEIZURE (medically significant) with onset 10Dec2021, outcome "unknown", described as "seizure"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 06Nov2021, outcome "unknown", described as "Dose 1 was on 04Sep2021 and Dose 2 was on 06Nov2021".    No follow-up attempts are possible. No further information is expected.
I was told by my Neurology Dr. that my Bell's Palsy was caused by my COVID 19shot it is located on the right side of my face as of August 29,2021 I still have some effects of the Palsy .I was treated with Prednisone and Valacyclovir.
Pt received vaccine (FLUVIRIN) 9/2/10. Approx 4 pm vomited approx. 430 PM and twice more between 430 PM and 7 PM. Called pt, 10:45 AM on 9/3/10- pt no vomiting since 9/2/10 but still has some nausea. States did not eat all day on 9/2/10 prior to vaccine.
Information has been received from a physician concerning a 12 month old Caucasian female patient who on 07/10/01 was vaccinated with the first dose of MMRII, administered in the right leg. Concomitant therapy, that day, included the first dose of Varivax, administered in the left leg,and the  fourth dose of IPV administered in the left leg. It was reported that the MMRII and Varivax were reconstituted with Hemophilus B conjugate vaccine (+) Hepatitis B Vaccine recombinant (yeast), instead of the saline diluent. The physician stated that the error occurred as a result of "human error"on the part of the nurse. The vaccinations were administered at two different sites. On 07/10/01, it was reported that the patient "now has a temperature of 100.4 deg F". The patient sought unspecified medical attention. On an unspecified date, the fever resolved, with no further problems. Measles, Mumps and Rubella titers were all reported to be positive. It was noted that the patient is "immune". No further information is available.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 4 month old male patient who experienced fever as high as 103 degs F and became irritable. At 4 months of age, the patient received the second dose on 12/13/2004. The patient previously experienced pyrexia and agitation while taking Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection). Indication for Prevnar was immunisation. Product was administered on 12/13/2004. Dose regimen was 1 dose intramuscular. Concomitant medications were not reported. A mother reported that her son developed fever as high as 103 Degs F and became irritable (agitation) on 12/13/2004 after receiving Prevnar injection. The child recovered within a couple of days. See related case HQWYE270407SEP05 (adverse event non expedited) and HQWYE997313OCT05 (adverse event non expedited. No additional information was available at the time of this report.
Shingles. First symptom appeared November 5, 2021 -- sensitive/tingly skin on right thigh. Saturday Nov 6 a rash appeared on right upper thigh, Sunday Nov 7 a second smaller rash appeared on right middle of thigh. Went to emergency room Wednesday Nov 10, diagnosed shingles, and treated with antiviral and lidocaine gel. No prior history of auto immune issues or other potential causes.
Rash/hives all over his body and large swollen lump on the back. Itchy and irritable. Doctor prescribed Benadryl and Prednisone 10 mg.
One week after vaccine patient had numbness in her feet and hands. Went to doctor was advised to take a week off.patient is now unable to walk or talk . cant not follow finger with eyes. patient has bad headaches and sees flashes .
Headache & diarrhea for 24 hours. Pt believes that this was reaction to vaccine.
Patient called the during the day on 2/17/19 to let me know that she was experiencing tiredness, a headache, arm soreness, and feeling so run down that she had to call out of work. She also sounded congested, said she had a cough and phlegm in her chest and throat.
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired vaccine in a 42-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 026B21A) for COVID-19 immunization. No medical history reported. On Sep 17, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 17, 2021, patient administered expired vaccine. On Sep 17, 2021, administered expired vaccine: resolved. The vaccine was stored in a freezer. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Hives on Chest and Right Side of Face, Numbness in Right Cheek, Some Difficulty Breathing, Raised injection site, Itchiness on Right side of neck and arm  -- Took 50 mg Benadryl at home and in the ER received Prednisone and Claritin.