chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HPI: Patient is a * year old * who presents following administration of a first dose of Pfizer (Lot#AW0173) COVID19 vaccine in the left deltoid.  She states about 15 minutes following administration of the vaccine she started to experience itching of the skin at the junction of the neck and shoulder, which she did itch.  Shortly after, a small raised bump appeared and her skin became red.  She denies involvement of other areas of her skin.  She denies experiencing an insect bite.  She denies wearing any jewelry that may have irritated the site.  She confirms allergies to sulfa drugs and IV/topical iodine, both of which resulted in a skin rash that did not necessitate medication management.  She affirms a history of keratosis pilaris.  She does not take medication on a daily basis.  She denies chest pain, difficulty breathing, swelling of the face/lips/tongue/throat, cramping abdominal pain, nausea, and vomiting.     Exam (update as needed): GEN: Alert and oriented x 4, NAD. HEAD: NCAT EYES: PERRL, EOMI ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD.  CV: RRR, no m/r/g PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN:Erythematous, palpable, and annular 1cm wheal that is blanchable on the ipsilateral side of vaccine site located at the junction of the left anterior neck and shoulder.  Bilateral outer upper arms display small erythematous papules located at the follicle that are consistent with keratosis pilaris.  Otherwise no other signs of urticaria elsewhere on the body. Skin is warm and dry.  No erythema or edema of the injection site. MSK: FROM, MS 5/5 NEURO: Alert and oriented x 4, CN 2-12 grossly intact, no ataxia, gait steady   Clinical Impression/Field Tx: Urticaria, possibly due to vaccine.  Patient demonstrated a small urticarial rash at the ipsilateral side of the vaccine administration site. Physical exam otherwise within normal limits. Vital signs stable. The affected area did not grow in size and became less erythematous about 15 minutes following intervention.  Patient given 10mg of loratadine and instructed to take 25mg diphenhydramine by mouth once she was home for the evening and the site was still pruritic.  Clarified that she is not to operate heavy machinery following consumption of the diphenhydramine.  Patient felt comfortable driving home, as she only lives 10 minutes away from the vaccine site.   Instructed patient to consult their PCP regarding the post-vaccination reaction and suggested that she receive her second dose of Pfizer vaccine in a more controlled clinical setting.  Patient instructed to go to emergency department should she develop chest pain, difficulty breathing, swelling of the face/lips/mouth/tongue/throat, or cramping abdominal pain with nausea/vomiting.  Patient demonstrated understanding of post-vaccination instructions.     Medications administered: Loratadine 10mg PO   Disposition:  Home
Injection site Reactions on the left arm as redness,warm,Hard and itchy; Injection site Reactions on the left arm as redness,warm,Hard and itchy; Injection site Reactions on the left arm as redness,warm,Hard and itchy; Injection site Reactions on the left arm as redness (redness around 5X 3 inches); This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Injection site Reactions on the left arm as redness,warm,Hard and itchy), VACCINATION SITE MASS (Injection site Reactions on the left arm as redness,warm,Hard and itchy), VACCINATION SITE PRURITUS (Injection site Reactions on the left arm as redness,warm,Hard and itchy) and VACCINATION SITE ERYTHEMA (Injection site Reactions on the left arm as redness (redness around 5X 3 inches)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site Reactions on the left arm as redness,warm,Hard and itchy), VACCINATION SITE MASS (Injection site Reactions on the left arm as redness,warm,Hard and itchy), VACCINATION SITE PRURITUS (Injection site Reactions on the left arm as redness,warm,Hard and itchy) and VACCINATION SITE ERYTHEMA (Injection site Reactions on the left arm as redness (redness around 5X 3 inches)). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site Reactions on the left arm as redness,warm,Hard and itchy), VACCINATION SITE MASS (Injection site Reactions on the left arm as redness,warm,Hard and itchy), VACCINATION SITE PRURITUS (Injection site Reactions on the left arm as redness,warm,Hard and itchy) and VACCINATION SITE ERYTHEMA (Injection site Reactions on the left arm as redness (redness around 5X 3 inches)) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Patient also used an anti-itch moisturizer as treatment for the events.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Apr2023 as dose 5 (booster), single (Lot number: Gs3275) at the age of 69 years 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: "Type 1 diabetes" (unspecified if ongoing), notes: Other medical history: Type 1 diabetes. The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Sep2023) negative, notes: I had two negative test 48 hours apart; (Sep2023) negative, notes: I had two negative test 48 hours apart; (Sep2023) positive, notes: I tested positive. Therapeutic measures were taken as a result of drug ineffective and covid-19 with paxlovid from 31Aug2023 to 05Sep2023.
Intially I ran a fever of 99.6, I kept going that day. On sunday I still ran a fever and laid around and rested and sometime that evening my fever spiked. The injection site started to get warm and was swelling and red. The injection site became very hot to touch. It looked like I get if I get a yellow jacket sting, which I have an epi pen for.  My over all fever went way. It took a week before the swelling and heat went away. I did develop an itch misd week as well. My doctor told me to take benadryl. I teach and drive a school bus, so I could only take small doses of benadryl.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 20-JAN-2015, the patient was vaccinated with a first dose of VAQTA (route, dose, lot # and expiration date were not provided). Then, on 09-MAR-2015, 49 days after the first vaccination, the patient was vaccinated with a second dose of VAQTA (route, dose, lot # and expiration date were not provided) which was an inappropriate schedule of drug administration. No adverse effects were reported. Additional information has been requested.
Information has been received from a RN concerning a 36 month old white female who on 14Jan04 was vaccinated with a dose of varicella virus vaccine live (lot 645578/0439N). There was no illness at the time of vaccination. Concomitant therapy included a dose of tuberculin purified protein derivative administered on that same day. The RN reported that on 14Jan06, the pt developed breakthrough chickenpox characterized by less than 50 lesions. The pt was noted to be afebrile. Unspecified medical attention was sought. At the time of this report, the pt was noted to be recovering.  The pt's brother (WAES0601USA01873) and sister (WAES0601USA01620) were noted to have developed chickenpox after vaccination with varicella virus vaccine live. No further information is available.
Aches/Pain; Has 99.9F temperature; A lot of chills; Bad headache; Exhausted; Does not feel good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Single), for COVID-19 immunization; Bnt162b2 (Dose: 2, Single), for COVID-19 immunization; Bnt162b2 (Dose: 3 (Booster), Single), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Aches/Pain"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Has 99.9F temperature"; CHILLS (non-serious), outcome "unknown", described as "A lot of chills"; HEADACHE (non-serious), outcome "unknown", described as "Bad headache"; FATIGUE (non-serious), outcome "unknown", described as "Exhausted"; MALAISE (non-serious), outcome "unknown", described as "Does not feel good". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient was asking if it is normal to experience symptoms on the first day and how long these symptoms will last. Patient stated that she never had reactions with the Pfizer COVID vaccines before. She also stated that she had reactions with the Pfizer COVID vaccine bivalent as her 4th shot/dose. Patient mentioned that she had a lot of chills, bad headache, aches and pain, exhausted and does not feel good, and had 99.9F temperature. 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.
Headache within 12 hours, Sore groin lymph nodes, throwing up 48 hours after injection
Symptoms: Full body rash that started on his abdomen upon getting home from the office visit and spread. Treatment:  Watch and wait.
Approx 12 hrs post vax pt c/o feeling funny, arm sore; mom noted arm swollen & red, hot to touch; pt w/fever 103 ax; mom used cold cloth on arms & gave APAP; mom states pt face & whole arm red; to ER; 3" red area noted lt arm-sore to touch;
Severe pain in shoulder joint. Unable to lift arm or rotate shoulder. Pain started a couple hours after vaccine but felt hot feeling immediately after shot. Treated with pain meds, ice.
Info has been received from a physician concerning an approximately 50 year old male physician with Hodgkin's disease diagnosed in 1980 and a history of splenectomy in 1980 who in 1985 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent. No adverse symptoms were noted. In 1990 the pt was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On the same day, the pt was concomitantly vaccinated with a dose of influenza virus vaccine. Subsequently, the pt developed severe muscle pain and fatigue for 3 days. Unspecified medical attention was sought. No treatment was needed: the condition resolved and no hospitalization was required. No additional info is expected.
pt recv vax & noc & day p/vax fever to 102;on second day p/vax pt devel rash;pt exp erythema mult;
Facial swelling, hives, SOB 8 hours after vaccine was given. Went to hospital 11/28/18, given oral BENADRYL. Returned to Clinic on 11/2/18 due to not resolving symptoms, given prescription for MEDROL DOSEPAK. Had follow up apt on 12/4/18 facial swelling, SOB resolved. Experienced intermittent hives given prescription for calamine and keep up with OTC BENADRYL PRN.
I20.8 STABLE ANGINA 3/24/2023 HYPOGLYCEMIA I26.99 ACUTE PULMONARY EMBOLISM 2/9/2023 HYPOGLYCEMIA
10 days post vaccine- I noticed I had lumps underneath my arm. They were hurting. They were not normal;  and they did not used to be there. 02/15/2021- I went to the doctor.  The doctor told me it was normal. It was a side effect from the vaccine. He said it should go away on it's own.  The lymph nodes resolved on their own within a week. Note: I was just scared at when I saw the lymph nodes because I have a history of breast cancer and I just want to be on the cautious side.
This spontaneous prospective pregnancy report as received from registered nurse for GARDASIL, a Pregnancy Registry product, refers to a 15 years old female patient with none pertinent medical history and none drug reactions/allergies. The patient's history of previous pregnancies and live births is not known. The nurse reported that the patient was vaccinated intramuscularly with a first, second and third 0.5 ml doses of GARDASIL on the following dates: 03-MAR-2010, 14-JUN-2011 and 26-SEP-2012 respectively. Lot numbers for all three doses were: 663453/0249Y, 666596/0766Z and 672652/0022AE respectively. Concomitant medications included prenatal vitamins (unspecified), calcium (unspecified) and vitamin D (unspecified). Subsequently, on an unknown date while having GARDASIL vaccination the patient became pregnant (LMP reported as 20-SEP-2012 and an EDD of 27-JUN-13). The patient sought unspecified medical attention (she saw nurse practitioner). The patient underwent urine pregnancy test. Additional information has been requested.
Pt received ADACEL and MENACTRA on 9-29-09. On 9-30-09 mother reports pt developed a high fever then evening of shots (103), wheezing, frequent urination, SOB, runny nose and 6# wt. loss.
Fevers up to 39.3 C on 03/02-03/05 with no other symptoms. On 03/04 seen in urgent care, blood work and urine. On 03/06 had an increase in irritability, mild cough, mild runny nose, and a maculopapular rash began on neck, face, upper back and chest.
Migraines, Fever of 100.7 for 5th day, Severe body pain The day following (unable to walk without assistance)  nausea, Light Headed, Unable to focus
Altered cardiac performance.  Previously tracked normal levels of exertion and corresponding heart rates have become altered. Established aerobic exercise routine that produced a sustainable 80% of max heart rate, now routinely produces a greater level of perceived exertion and an irregular rhythm at the upper end of effort along with a reduced max attainable effort and heart rate.  This set of symptoms appeared first during a workout session 3 days following 2nd dose, and has lingered for the subsequent 3 months. Irregular  heart rhythms also occur at random during normal activity.
Buzzing tinnitus of left ear. long standing history of left worse than right hearing loss- tinnitus started 2 days after first Moderna vaccination
Patient was present in the clinic on 8/05/2022 for her 2nd dose of Moderna (6 months ? 5yrs formulation, lot number AS1412B). RN, the vaccinator, went ahead to vaccinate on the left deltoid. Patient's arm moved back, and the needle left the injection site prior to vaccine administration (needle plunger has not been pressed).  Vaccinator and parent were able to witness that none of the dose enter the site. RN was able to assess the site for any scratching or bruising as well assessed for any bleeding. Patient notified the Charge nurse, RN.  Parent received education on the need for repeating vaccine per our protocol since none of the dose had entered the site. The parent was educated on watching the child for any bruising and that the child can be given Tylenol for comfort. Parent expressed understanding and consented to re-administration of dose in opposite site. Client was able to successfully receive dose.
Initially, a few minutes post-vaccination, dizziness and faint feeling requiring lying on the floor. Fatigue and flu-like symptoms occurred the following day. No symptoms two days later.
I am having a same concern with my father-in-law he got period is very heavy/So I have 2 members in my family with same situation.; This is a spontaneous report received from a contactable consumer or other non-health professional (patient daughter-in-law). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that her father-in-law got period is very heavy. So, she has 2 members in her family with same situation. Reporter was wondering tomorrow her son 12 years old was going to get the second shot, so reporter was really concerned what was happening, she asked could you tell me what was happening with this situation specifically with the Pfizer vaccine from any people are you getting this issue. The patient underwent lab tests and procedures which included blood test: with low platelets. The report was not related to study or programme. The outcome of the events was unknown  Follow-up attempts are needed; information about lot/batch number has been requested.
pt recvd vax; c/o arm pain about 1 hr p/ vax;apap given 20 mins later;mom though pt speech was slurred & pt cried, screamed off & on for about 30 mins; went to sleep & had no more problems so far;
fever of 102 degrees Fahrenheit; chills; body aches; turned pale; migraine; This case was reported by a other health professional via sales rep and described the occurrence of fever in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABX794AZ, expiry date 31st August 2020) for prophylaxis.   Previously administered products included Bexsero with an associated reaction of adverse reaction (1st dose received on an unknown date, refer case US2019AMR118220).   On 11th June 2019, the patient received the 2nd dose of Bexsero (intramuscular). On 11th June 2019, 1 hr 30 min after receiving Bexsero, the patient experienced fever, chills, general body pain, pallor and migraine. On 12th June 2019, the outcome of the fever, chills, general body pain, pallor and migraine were recovered/resolved.   It was unknown if the reporter considered the fever, chills, general body pain, pallor and migraine to be related to Bexsero.  Additional details were provided as follows: The patient received a dose of Bexsero on the right deltoid. About 1.5 hours after vaccination, the patient experienced a fever of 102 degree F, chills, body aches, turned pale, and a migraine. On the next day, the patient was feeling fine. The outcome of fever, chills, general body pain, pallor and migraine were reported as recovered/resolved, however in source document, it was mentioned as recovered/resolved with sequel. This was all the information the sales representative had to report.
Coroner's report consistent with SIDS baby was also fussy before put down for nap;
Headaches, shortness of breath, left droopy eye.....achy and tired....lasted 5 days.... droopy eye lasted a week
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Lot number: ER8734), in left arm, on 19Apr2021 as dose 2, single (Lot number: ER8734), in left arm, on 01Nov2021 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 15Jul2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL, start date: Jun1988. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: having a negative test. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 24Aug2022 to 29Aug2022.  No follow-up attempts are possible. No further information is expected.
6/22/13 Headache, swelling at injection site. 6/23-6/24 Dizziness / lightheadedness. 6/25 Tender lymph nodes, axillary.
Headache, treated with Tylenol for three days Nausea, treated with uncrystallized candied ginger for three days Muscle aches in calves and thighs, treated with rest and Tylenol for three days Fatigue, treated by take many naps over the course of  three days. Fever, treated with Tylenol for 1 day Chills on and off for three days
Patient complained of vision disturbance confusion dizziness, chills, clammy,  no trouble breathing. Nausea, Patient stated she did not have any breakfast. gave patient diphenhydramine 25 mg and EMS arrived to take her to the hospital.
Moderna COVID-19 Vaccine EUA 3 days after my second vaccine, I rapidly developed what felt like a marble on my neck (moveable), then swelling appeared rapidly to about the size of 4 inches in diameter. I had a nurse at work check me out, sent me to urgent care. They couldn't confirm, had not seen that before, but told me to apply heat and if it gets worse go to ER. It didn't go down until evening, slowly until today 2-15, is barely noticeable. No pain, just panic.
PATIENT CALLED PHARMACY TO REPORT FACIAL SWELLING. WAS ADVISED TO TAKE A COUPLE BENADRYL AND GO TO THE EMERGENCY ROOM. HE WAS UPSET  AND ACCUSED US OF MAKING HIM TAKE THE VACCINE  AND CLAIMED THAT WE SHOULD BE ABLE TO FIX HIS ADVERSE REACTION WITHOUT HIM HAVING TO VISIT THE ER OR COME BACK TO THE PHARMACY. HE CLAIMED THAT HE TOOK 3 BENADRYL AND THAT HE WILL WAIT TO SEE HOW HE FEELS.
I have only treated congested, it has been very mild, low fever brain fog, and a little fatigue and mild body aches.
Developed fevers and generalizes weakness day 1 post administration.  Admitted to our hospital on Nov 1 due to fevers.  Has had daily fevers with no other source.   Started on antibiotics with no significant change.
Information has been received from a registered nurse concerning a 69 year old female who on 28-OCT-2005 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 647661/0055R).  On 31-OCT-2005 the patient called with entire arm sore, stiff, difficulty sleeping on and moving the arm.  Unspecified medical attention was sought.  The patient was considered to be recovering.  It was also reported that two other patient's had an adverse experience following vaccination with pneumococcal 23v polysaccharide vaccine.  Additional information has been requested.
3/2, admitted 3 days after 2nd covid vaccine with PE. Patient ecently diagnosed GBM who is s/p chemo radiation and who presented to the ER with chest wall pain and SOB. Patient was found to have a large, saddle PE and treated with a heparin gtt. She did fairly well and was cleared for discharge to home by PT and OT. It was recommended discharge on lovenox until her f/u on 3/12 and which time she will likely change to pradaxa. She will continue to follow with oncology, her PCP as needed.