chrisvoncsefalvay/vaers-outcomes huggingface dataset:
on 2/11/08(8 pm) had small spit-up and some drooling; face turn to the side and she was staring for about 1 minute; then she started to cry and she started to regain her face. A similar episode recurred at about 10 pm same night and also at 1 pm the following date. Temperature was 100.4 to 100.8  after the immunization. No jerky movements no rolling of eyes back; no cyanosis. She was addimeetd to the Hospital on 2/13/08 discharged 2/16/08  8/11/2008 MR received for DOS 2/13-16/2008 with D/C DX:  Sinusitis. Pt admitted after 3 episodes of staring following spitting up where the face was turned to the side and pt was pale and drooling. Pt had temp of 101.8'F following immunizations and had nasal congestion 2-3 days prior to vax. Tx with abc and d/c.
In Dec 2021, I began experiencing severe chest pain and took medication which didn't help so I called the ambulance.  I saw the cardiologist the same night and he put a catheter in me. He advised that I didn't have a heart attack but I had a lot of inflammation around my heart.  I was on a few different IVs for 3 days and afterward the pain lessened but is still sore.
Information has been received from a health professional concerning an 8 year old male who on 3/4/97 was vaccinated with 1 dose of varicella virus vaccine live (site unknown) (lot 619272/1339D). Subsequently, it was reported that on 6/1/01, the pt was dx'd with "a mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. The reporter also indicated that the pt was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the pt recovered. No further information is available.
Very soon after receiving the shot, my throat began to feel tight and I told my husband it felt funny.  Within about 45 minutes, it hurt swallow, more than any sore throat I have ever had.  It wasn't like a dry, scratchy sore throat, it was almost like ti was on the outside of my throat.  Had the clinic that gave me the shot kept me for monitoring, they would have been able to catch this reaction but they didn't.  When I called them they told me it could be 24 hours before I would get a call back so I went to the ER because I was afraid I was having an allergic reaction of some type.  The ER monitored me for 3 hours and then released me.  About 12 hours later, the pain in my throat and when swallowing began to subside.
persistent headaches; bouts of extreme fatigue; This is a spontaneous report from a non-contactable other health care professional (patient). A 25-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 04Feb2021 (Batch/Lot Number: EL3247) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included Known allergies: dairy, shellfish, SULFA, gluten. There were no concomitant medications. The patient received first dose of BNT162B2 on 14Jan2021 (at 24-years-old) for COVID-19 immunisation (product=COVID 19, Brand=Pfizer, Lot number= EL1283, Lot unknown=False, Administrator route: Intramuscular, Vaccine location= Left arm, Dose number=1). On 14Feb2021, the patient experienced persistent headache, bouts of extreme fatigue. The patient did not receive treatment for the events. The outcome of the events was recovering. The patient did not have COVID prior vaccination, and was not COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
I experienced inflammation/rosacea issues on my face, especially around my cheekbones; I experienced inflammation/rosacea issues on my face, especially around my cheekbones; I experienced inflammation/rosacea issues on my face, especially around my cheekbones; I experienced inflammation/rosacea issues on my face, especially around my cheekbones; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jul2021 02:15 (Lot number: FA6780) at the age of 53 years as dose 2, single and administered in arm left, administration date 26Jan2022 10:15 (Lot number: PJ1614) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FW0181, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 28Jun2021, when the patient was 53 years old, for COVID-19 Immunization. The following information was reported: INFLAMMATION (non-serious), ROSACEA (non-serious) all with onset Jul2021, outcome "recovered" (Dec2021) and all described as "I experienced inflammation/rosacea issues on my face, especially around my cheekbones"; INFLAMMATION (non-serious), ROSACEA (non-serious) all with onset 28Jan2022, outcome "recovering" and all described as "I experienced inflammation/rosacea issues on my face, especially around my cheekbones". Therapeutic measures were not taken as a result of inflammation, rosacea, inflammation, rosacea.  Additional information: The patient has not been tested positive for covid post or prior to vaccination. It was reported that patient experienced inflammation/rosacea issues on his face, especially around my cheekbones. Patient don't have a history of skin issues. After his second dose, patient also experienced the same (much worse) issue; however, patient didn't recognize it was related to the vaccine until now. The previous case lasted from July through December before his skin returned to normal.  Follow-up attempts are completed. No further information is expected.
Patient called on 07/16/14 about 4pm, spoke with RN Supervisor. Patient reported pain, redness, swelling to left arm (injection site). Patient also reported headache and possible fever.
Afebrile, 10-15 pustules on chest, scattered pustules around upper arm at site, redness extending site anteriorly to left axilla. Treated with Augmentin for cellulitis left arm (875mg BID x 10 days), Benadryl, Neflex.
Initial information received on 18-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves 24 Months old female patient who received 0.5 ml fourth dose of vaccine PENTACEL without the powder ACTHIB portion (lot number and Expiry date unknown) via unknown route in unknown administration site. The patients' medical history and concomitant medications were not reported. It was a case of actual medication error due to inappropriate reconstitution technique. It was not reported that if any adverse reaction was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Severe pain in left arm at injection site. Pain, tingling and numbness running down left arm to fingers
L arm dermal reaction to pneumonia vaccine, superficial ovate, marginated, blanching pink patch 4in x 3in. Mild, warmth, minimal muscular, tenderness to deep pressure, no spreading erythema or induration. Tx: ice and NSAID, monitor.
After receiving the third dose, she experienced a sore arm and fatigue. On October 23, 2022, she had Herpangina and missed preschool for a week. She saw the doctor twice that week for it. On January 11, 2023, she was diagnosed with Scarlet Fever. The doctor prescribed Amoxycillin for 10 days. On March 23, 2023, she was diagnosed with a Double Ear Infection and Croup. She is taking Amoxycillin for 10 days for that as well.
Initial unsolicited report received from a consumer, who is also the patient, on 30 January 2015. A male patient received FLUZONE HD on an unspecified date at a pharmacy. Within 48 hours of vaccination, he underwent routine blood work and subsequently received an urgent phone call from his physician informing him that he had a critically low level of neutrophils, and that he needed to see a hematologist as soon as possible. Upon consulting a hematologist, he was informed that he "possibly had a pre-leukemia" condition, and was ordered to undergo additional blood tests and a bone marrow test. After undergoing the addition unspecified blood testing, the patient was informed that his neutrophil count had returned to normal and that a bone marrow test would not be necessary. According to the patient, the hematologist had indicated that the patient's flu shot was the cause of the low neutrophil level. Documents held by sender: None.
This spontaneous report as received from a physician via two company representative refers to two patients of unknown age and unknown age. The patients pertinent medical history was unspecified. On an unknown date, the two patients were vaccinated with ZOSTAVAX (dose and frequency were unknown). Concomitant medications were unspecified. On an unknown date, the two patients a shingles like rash (rash vesicular) few days after the vaccination. The outcome of the event was unknown. The relatedness of the events with ZOSTAVAX was not provided. Additional information is not expected as the reporter contact details were not provided.
redness at injection site; swelling at injection site; achiness at injection site; fatigue; itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (achiness at injection site) and FATIGUE (fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included DOXYCYCLINE and PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at injection site). On 06-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (achiness at injection site) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE PRURITUS (itchiness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (achiness at injection site) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.  Patient gave consent to safety for Follow-up.
Initial report was received on 16 April 2010 followed by additional information received on 19 April 2010 from a health care professional. A 29-year-old female patient had received an injection of YF VAX and IPOL (lot numbers, routes and sites of administration not reported) on 02 April 2010 and approximately two weeks later, she complained of lower back pain which radiated to the chest and a severe headache. She also "felt warm to hot at night". According to the reporter, a temperature reading was not obtained. The patient had no concurrent illness at the time of vaccination and her past medical history and usage of concomitant medications were unknown. According to the reporter, the patient called their physician's office to report the symptoms which had just begun, but the patient had not been evaluated by the physician. Recovery status was reported as unknown. Follow-up information was received 21 April 2010 from a health care professional. The lot number for YF VAX was UF629AA and the lot number for IPOL was D0304-2. According to the reporter, the patient's symptoms had subsided. Documents held by sender: None.
Flu like response; Chills (After Second Shot); Sick; Swollen Mouth; Aches and pain; Nose Feels Stuffy; This spontaneous case was reported by a health care professional and describes the occurrence of ILLNESS (Sick), MOUTH SWELLING (Swollen Mouth), PAIN (Aches and pain), NASAL CONGESTION (Nose Feels Stuffy) and INFLUENZA LIKE ILLNESS (Flu like response) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced ILLNESS (Sick), MOUTH SWELLING (Swollen Mouth), PAIN (Aches and pain), NASAL CONGESTION (Nose Feels Stuffy) and CHILLS (Chills (After Second Shot)). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like response). At the time of the report, ILLNESS (Sick), MOUTH SWELLING (Swollen Mouth), PAIN (Aches and pain), NASAL CONGESTION (Nose Feels Stuffy), INFLUENZA LIKE ILLNESS (Flu like response) and CHILLS (Chills (After Second Shot)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-079311 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: No further information On 24-May-2021: Initial Additional document received on 24-May-2021 contains no further information. On 21-Jul-2021: Significant FU received on 21-Jul-2021, new event added- flu like response and event outcome updated from unknown to recovered/resolved.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079311:For first dose
I contracted COVID-19 twice just eight weeks apart. The first time I contracted it in January, I had cold-like symptoms including head congestions, aches, chest congestion, sore throat, and general lethargy. However, this second time around in March, I had all of the same symptoms including headache, diarrhea and stomach pain/constipation. I took an at-home COVID-19 test on 01/28/2023 which came back positive; in March, I started having symptoms on 03/23/2023 and took a test on 03/26/2023. In January, I let it run its own course for self-recovery. In March, I contacted my doctor because the diarrhea wasn't stopping. He prescribed Imodium even though I didn't take since it ended on its own the next day. I started feeling better days following with no treatment.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Recently treated for recurrent prostatitis-UTI" (unspecified if ongoing); "UTI" (unspecified if ongoing); "Known allergies: Nuts" (unspecified if ongoing); "Known allergies: Fish" (unspecified if ongoing); "Known allergies: Sesame" (unspecified if ongoing); "Known allergies: Cumin" (unspecified if ongoing); "Known allergies: Turmeric" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; CLARITINE, stop date: 19Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient said she felt pain almost immediately at the time of the flu vaccine. She mentioned pain and limited mobility of her arm to her doctor (no exam done) and they recommended therapy. Pain remains.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with an improperly stored Oka-Merck vaccine PROQUAD lot #N021730, expiration date on 06-FEB-2019 or lot # and expiration date reported as N025719, on 17-MAR-2019, for prophylaxis (strength, dose and route were not reported), that was reconstituted, concomitantly, with MERCK STERILE DILUENT. The vaccine was improperly stored at a temperature between 6°F to 14°F (6.1°F) during a time frame of 30 minutes. No previous temperature excursions neither adverse effects were reported. The call was because of a data logger.
swelling of lymphnodes left anterior and left supervlavicular nodes  follow up with pcp in 2-3 days for re-evaluation
woke up with 101; had a fever of 101 and less than an hour after that it was 103.; Extreme chills; Aches all over; woke up soaked in sweat; lymph in my neck sore.; Armpit lymph was enlarged and painful; Armpit lymph was enlarged and painful; Tired; This is a spontaneous report from a contactable other healthcare professional, the patient. A 45-year-old non-pregnant female 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 02Apr2021 at 11:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included hashimotos, rheumatoid arthritis and asthma. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) and thyroid (NATURE THROID); both from unspecified indication from unknown date. The patient previously took propylene glycol (MANUFACTURER UNKNOWN); for unspecified indication on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 13:00, the patient felt tired the day after .On 04Apr2021 the patient experienced lymph in armpit was enlarged and painful. On 09Apr2021, one week post shot, the patient woke up soaked in sweat and lymph in neck sore.  Around 11:00, (exactly one week post shot to the hour) patient experienced extreme chills, aches all over. An hour later, at 12:00, patient had a fever of 101 and less than an hour after that it was 103. The patient slept most of the day and on 10Apr2021 woke up on the with 101 (fever). The patient underwent lab tests and procedures which included body temperature on 09Apr2021 at 12:00 and result was 101 (units unspecified) and body temperature on 09Apr2021, less than hour after 12:00 and result was 103 (units unspecified). On 10Apr2021, the patient underwent body temperature and the result was 101 (units unspecified). The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event tired, armpit lymph was enlarged and painful, woke up soaked in sweat, lymph in neck sore, extreme chills, aches all over  was unknown at the time of reporting. The clinical outcome of the event fever of 101 and 103 (on 09Apr2021) was not recovered and clinical outcome of fever (on 10Apr2021) was unknown at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a 4-year-old female patient who received KINRIX (batch number 2AG24, expiry date 10th SEPTEMBER 2017). Concomitant products included PROQUAD and VAQTA. On 11 AUGUST 2015, the patient received the 1st dose of KINRIX (intramuscular) .5 ml. In August 2015, less than a month after receiving KINRIX, the patient experienced injection site redness. On an unknown date, the outcome of the injection site redness was not recovered/not resolved.  The reporter considered the injection site redness to be probably related to KINRIX. Additional details were provided as follows: On 11th AUGUST 2015, the patient received PROQUAD and VAQTA on the left thigh. The patient experienced redness on right leg (injection site). Only partial information was provided by the nurse.
DOSE 1; LIGHT HEADED 30 MIN; STOMACHE ACID REFLUX;CHRONIC DIAREA. DOSE 2; LIGHT HEADED 5-7 MIN;STOMACHE ACID REFLUX; CHRONIC DIAREA; HEART PALPATATIONS.
Golf ball size swelling below the injection site. Arm is red and itchy; Golf ball size swelling below the injection site. Arm is red and itchy; Golf ball size swelling below the injection site. Arm is red and itchy; This is a spontaneous report from a contactable other-HCP (patient). This 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 28Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included pulmonary embolism and known allergies: penicillin. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), vitamin b complex (VITAMIN B), ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), tocopherol (VITAMIN E), received within 2 weeks of vaccination. Facility that the most recent COVID-19 vaccine administered was in Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 14:45, the patient experienced golf ball size swelling below the injection site. Arm was red and itchy. No treatment received for the adverse event. Outcome of the events was recovering. This report was assessed as non-serious.   Information about Lot/batch number has been requested.
Patient presented to OB triage w/ URI symptoms; sore throat; cough productive of white sputum; fever; tachycardiac and hypertensive. Tx (1) Supportive Therapy, (2) Start TAMIFLU, (3) Labs for preeclampsia. Vaccine Failure.
My daughter has been waking up in the morning for school with nausea and vomiting on a daily basis since the 2nd covid shot. She was diagnosed with Cyclic Vomiting Syndrome because of the shot.
1/7 Friday night started with a runny nose and on saturday he had a phlemy voice. Later developed into a 101° fever with a sore throat. Decided around 1:30PM to get tested for CoVid. Tested for flu as well but only CoVid came back positive. Could go to school in 5 days but had to isolate until then and when going back to school, he must wear a mask. Tylenol and Cold liquids for treatment OTC.
Patient experienced tachycardia and diaphoretic.  His heart rate was in the 170s.  He was taken to the hospital emergency room.  He had an EKG - results normal.  Lab work was performed - basic metabolic panel and CBC.  All results normal.  Symptoms resolved - he was discharged.  No further treatment needed.