chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female who in May 2007, received her third dose of Gardasil. In approximately May 2007, the patient had an abnormal pap smear. The physician reported that the result of the pap smear came out positive for high risk HPV. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Information has been received from a pharmacist refers to a female patient of unknown age. On 13-JAN-2015 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, route not reported, lot# reported as K018173). Concomitant medication were not reported. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
pain in arm; insomnia/ not sleeping/ Sleep a little; been wired; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypothyroidism. Concomitant products included levothyroxine sodium (Synthroid).   On 16th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, insomnia and feeling abnormal. On an unknown date, the outcome of the pain in arm, insomnia and feeling abnormal were unknown.   It was unknown if the reporter considered the pain in arm, insomnia and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband.  The patient reported that the night of her first injection she had pain in her arm, but that was expected.  The first two nights she stated that she was able to sleep a little but since 17th August 2019, she had been wired, had insomnia and not sleeping. The reporter did not consent to follow-up. The case has been linked to the case US2019152138, reported by same reporter.
arm started hurting, it became swollen, hard, and red; arm started hurting again; the size of a grape at the site of the injection , it was a swollen; headaches after the shot and ongoing, right on the temples; a little redness, the size of a grape at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (arm started hurting, it became swollen, hard, and red), PAIN IN EXTREMITY (arm started hurting again), VACCINATION SITE ERYTHEMA (a little redness, the size of a grape at the site of the injection), VACCINATION SITE SWELLING (the size of a grape at the site of the injection , it was a swollen) and HEADACHE (headaches after the shot and ongoing, right on the temples) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, METOPROLOL, LOSARTAN POTASSIUM, LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (a little redness, the size of a grape at the site of the injection) and HEADACHE (headaches after the shot and ongoing, right on the temples). On 28-Feb-2021, the patient experienced INDURATION (arm started hurting, it became swollen, hard, and red), PAIN IN EXTREMITY (arm started hurting again) and VACCINATION SITE SWELLING (the size of a grape at the site of the injection , it was a swollen). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 25-Feb-2021, VACCINATION SITE ERYTHEMA (a little redness, the size of a grape at the site of the injection) had resolved. At the time of the report, INDURATION (arm started hurting, it became swollen, hard, and red), PAIN IN EXTREMITY (arm started hurting again), VACCINATION SITE SWELLING (the size of a grape at the site of the injection , it was a swollen) and HEADACHE (headaches after the shot and ongoing, right on the temples) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Headache, Myalgia, Fever,  Fatigue, Missed work on the next day, fever lasted 2 days Narrative:
Same day of ZOSTAVAX injection he started with hives, welts across my backside. He continues with welts/hives and fine, red raised itchy rash that has now spread to lateral and medial thighs and tops of feet. He and his wife reports rash as a chicken pox or measles type rash. They deny any fluid filled papules. Vet denies any fever.
moderate pain at injection site; mild fatigue; mild body aches; BNT162B2 on 09Oct2023; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023SA310727.  A 45-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), on 09Oct2023 as dose number unknown, single (Lot number: FJ1611) at the age of 45 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact split 4v (FLUZONE QUADRIVALENT), on 09Oct2023 (Lot number: UT8155JA) intramuscular, in left arm for influenza immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 09Oct2023, outcome "unknown", described as "BNT162B2 on 09Oct2023"; PAIN (non-serious) with onset 09Oct2023, outcome "recovering", described as "mild body aches"; FATIGUE (non-serious) with onset 09Oct2023, outcome "recovering", described as "mild fatigue"; VACCINATION SITE PAIN (non-serious) with onset 09Oct2023, outcome "recovering", described as "moderate pain at injection site". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, pain, wrong product administered.
Left arm cellulitis, tender, hot.  Erythema started 1 day after injection.  Rx: Bactrim, Benadryl, cold compresses.
Very swollen sore lymph nodes in left armpit and side of breast. Muscle soreness throughout body.
pain, swelling and redness in my upper arm; pain, swelling and redness in my upper arm; pain, swelling and redness in my upper arm; fatigue; low fever; decreased appetite; night sweats; dose number=3; This is a spontaneous report from a contactable consumer (patient).  A 68-years-old female non-pregnant patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FF8841), via an unspecified route of administration, administered in Left Arm on 07Oct2021 10:00 (at the age of 68-years-old), as dose 3 (BOOSTER), single for covid-19 immunisation. The patient's medical history included known allergies to sulfa drugs from an unknown date and unknown if ongoing. The patient' concomitant medications included diclofenac (DICLOFENAC) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; escitalopram (ESCITALOPRAM) taken for an unspecified indication, start and stop date were not reported; bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), om taken for an unspecified indication, start and stop date were not reported with in two weeks. The patient did not take any other vaccine in four weeks. The patient had no covid prior vaccination. The patient not tested for covid post vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in Left Arm on 13Feb2021 (at the age of 67 years old) as dose 1, single for covid-19 immunisation and received second dose if of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in Left Arm on 13Mar2021 ((at the age of 67 years old) as dose 2, single for covid-19 immunisation. On 07Oct2021, the patient received dose number=3, The patient experienced pain, swelling and redness in upper arm, fatigue, low fever, decreased appetite and night sweats on 07Oct2021 16:00. These symptoms lasted for about 4 days. The patient did not receive treatment. The outcome the events pain, swelling and redness in upper arm, fatigue, low fever, decreased appetite and night sweats was recovering.  Follow-up attempts are completed. No further information is expected.
missed mentrual cycle; extreme fatigue; slight dizziness ; mild itching the next day and intermittently to date ;
12 hours after my shot I developed a severe headache and fever of 102. This persisted for about 7 hours. Then the fever decreased to about 100.5 for the next 24 hours.  After my fever broke, however, I developed a chest cough with some phlegm. This feels like bronchitis and my doctor has prescribed azithromycin. I also feel rolling fatigue, which comes on randomly. The cough and fatigue has persisted so far for 6 days. In addition, though I do not have a fever most of the day, on some nights my fever spikes (last night, reaching 102 for a short period of time while trying to sleep). It has been 8 days since my injection. I have very little appetite (though I can smell and taste fine).
I?m a registered nurse and received my first vaccination 12/29/20, the second 01/25/21, and a booster dose 12/30/21.  In August of 2021 I began having issues with my right lower extremity and was diagnosed with a superficial thrombophlebitis. I continued to have discomfort and swelling in the extremity for several weeks. On 1/4/2022 I was diagnosed with a substantial DVT to the right lower extremity and was placed on an anticoagulant. I followed up with heme/onc and had genetic testing done(results pending) .  This was an unprovoked clot and I had no risk factors explaining the development of the issue.
Patient received Covid19 booster shot (Moderna) given 1 month to soon, second Covid19 (Moderna) vaccine received 05/28/2021, patient remained in clinic for 15 minutes for observation, no adverse reaction noted or complaints from patient.
I received this second HB shot during a 9:30 am appointment on 5-20-09.  The first HB shot I received was from the same physician a month earlier on 4-20-09. I did not have an adverse reaction to this first HB shot.  I did have a reaction to the second HB shot. I began to have severe chills with body aches, aches in joints and headache at 10:30 pm on 5-22-09.  My teeth were chattering very badly, I could not get warm, my pulse felt fast and my breathing felt faster and with some difficulty.  These symptoms occurred over the Memorial Day weekend on a Friday night.  I did not want to go to the ER. I thought I might be having a bad reaction to the shot.  I took an over the counter Benedryl tablet (25 mg) and used my nebulizer with abluterol sulfate.  I have severe asthma and this seemed to help my breathing get a little easier.  The chills subsided by morning, but the body aches, headache and feeling of malaise persisted for the next two days. I do not want to get the third series in this set because I am afraid of the bad reaction.  I have to get updated immunizations for a medical training program that I am attending.  I expect that my immune system has had enough of HB.  I will ask my doctor to to a titer test if possible so I can skip the third shot of HB. In retrospect, I probably should have gone to the ER.  I was very sick and very frightened by this reaction.  The respiratory symptoms in conjunction with my asthma was not good.
Patient was given Chicken Pox (Varicella) vaccine on 3/19/09.  On 3/24/09 she developed a 104 degree fever, runny nose, cough, sore throat, lethargic, loss of appetite.  Motrin and/or Tylenol could not bring fever below 101.  By 3/27/09 she developed an ear infection.  She was placed on Zithromax for five days.  She then developed stomach ache and diarrhea.  She continued to be sick until 4/3/09.  On 4/3/09 she developed a raised red patch at the injection sight that was itchy.  I also took her to a Pediatric Chiropractor on 3/23/09 and 3/31/09.
She felt "off' as if she was getting sick/Feelings of being ill; Very fatigued and weak; Very fatigued and weak; Very sore arm; This is a spontaneous report from a contactable nurse reported for a female patient (daughter). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced she felt off as if she was getting sick/feelings of being ill, very fatigued and weak, very sore arm. Nurse reported that, the afternoon after receiving the second dose of BNT162b2 in her left arm stated that she felt off as if she was getting sick. She felt very fatigued and weak. Her arm was very sore, much more sore than after the first vaccination. She reported that her daughter also had the same reaction as she did, with severe fatigue and feelings of being ill but with no fever and a very sore arm. Event took place after use of product. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
palpitations; upper body aches (arms, shoulders, chest, upper back); "reactive" lymph node under left axillary/left chest area; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Oct2021 (Lot number: FH8027) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation; calcium (VIACTIV [CALCIUM]) (Batch/Lot number: unknown). Relevant medical history included: "Eczema" (unspecified if ongoing); "Acne" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation, administration date 19Oct2021; VIT B COMPLEXE [VITAMINS NOS]; VIT D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EK9231, Location of injection: Arm Left), administration date: 13Jan2021, when the patient was 40 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL5730, Location of injection: Arm Left), administration date: 23Dec2020, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: PALPITATIONS (non-serious) with onset 07Nov2021, outcome "recovered" (Nov2021), described as "palpitations"; PAIN (non-serious) with onset 07Nov2021, outcome "not recovered", described as "upper body aches (arms, shoulders, chest, upper back)"; LYMPHADENOPATHY (non-serious) with onset 07Nov2021, outcome "not recovered", described as ""reactive" lymph node under left axillary/left chest area". Therapeutic measures were not taken as a result of palpitations, pain, lymphadenopathy.  No follow-up attempts are possible. No further information is expected.
Redness at site of shingles vacine inoculation ..2/1/2 inches by 1 1/2 inches; very hot to touch; skin raised and hardness like a lump under skin; itching.
Day 1 -  7PM, stomach pain with bloating, 10PM chills.  Day 3- 7AM headache (frontal then cluster and constant) X 14hrs, with nausea and chills intermittently.
pt recvd vax 24MAY95 & devel a rash w/over 100 lesions above the waist & very low on legs;No further details were provided;
Patient presented consent form to get Pfizer vaccine but could not find her vaccine record card. Pharmacy had processed her 2 previous doses under 2 different last names. Consent form said only one last name. When we looked up her record in the system, only 1 dose was listed on 9/6/21, so we gave a dose. Patient later found vaccine record card and we saw she had dose 2 on 9/27/21 and had hyphenated name. Booster was too early to give by over 3 months. No adverse events yet reported.
Headache, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative:
Got the Covid shot and I cannot wake her up, she sleep and sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 93-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 25Feb2021 (Lot number: EL9267) at the age of 93 years as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "Got the Covid shot and I cannot wake her up, she sleep and sleep". The event "got the covid shot and i cannot wake her up, she sleep and sleep" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of somnolence. Additional information: The patient was the reporter's mother. Concomitant medications included vitamins. The event was described as: "She is just like someone gave her, I don't know like a hallucinogenic, she is just out of it". The patient was tested for COVID in the hospital. The reporter was wondering what to do.  No follow-up attempts are possible. No further information is expected.
Patient received a pneumonia vaccine in left arm in 2005 in a camp (temporary) required after hurricane. Pt reported a reaction to vaccination. Pt alleges development of Basal Cell Cancer at site of  Pt had removal of basal cancer. Enclosed pathology.
COVID 19 test POSITIVE    Patient's husband was notified of positive test results from test completed on 5/2/21.  Stated patient was sleeping at this time, but she is already aware of the diagnosis.   Signs and symptoms: 1. When did your symptoms start? 5/2/21 2. What symptoms have you experienced? Diarrhea, weakness, upset stomach.    Close contact questions: 1.   # in household: 2 2.   Have you been in close contact with anyone two days before symptoms including going to work while you were sick? Yes
Pt complained of chest thighness, throat discomfort, lip numbness, hoarseness of voice. Vital signs initiated, Epinephrine x1 was given.  911 called. EMS came to the site and transferred patient to hospital.
even with the shot, you can get it / suspected vaccination failure; can get it; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's family member.. The age at vaccination was not reported. The reporter stated that his or her sister did, twice. The reporter mentioned that even with the shot, you could get it. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
pt recvd vax;day later,exp numbness & paresthesias in same forearm as inject;exp localized pain,swelling & redness;seen in er;f/u:dx allergic rxn to vax;T 104,emesis,d,HA;dx of probable viral infect;pt currently denies any cont sx;
On the date of injection (10/9/2021), I found a quarter size spot of red, hot skin on right arm near the elbow (opposite injection arm), took Benadryl, problem persists 2 days later.  On 10/10/2021, I found a quarter size spot of red, hot skin near the injection site, but not ON the injection site. Took Benadryl, problem persists 1 day later.  On 10/11/2021, the red, hot skin on the right arm has spread and covers the entire upper arm, from the elbow to the shoulder.
fatigue,headache,muscle pain,chills,nausea,fever. bed rest and tylenol
Case number PHEH2014US025081, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 13-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 06 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a Pfizer sales representative. The reporter is the patient. A 19 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 19 years as dose 2,  single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), when the patient was 19 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; HEADACHE (non-serious), outcome "unknown", described as "headache"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness at the injection site". Additional information: Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021.; Patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021.) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022 at 2:48 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Jan-2022 at 2:48 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Approximately 1/2 hour-45 minutes after vaccine, patient said he didn't feel well (per his school teacher) and broke into hives on neck and face and arm.  When I saw him he still had hives but no respiratory distress or other symptoms.  He felt better without prescriptions about 20 minutes later.