chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient Received An Expired Dose of Heplisav-B; Initial Report Received on 13-Oct-2022  This is a spontaneous report, received from an office manager/health professional  regarding a female patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 13-Oct-2022, dose 1 of HEPLISAV-B (Lot #935840, expiration date 11-Sep-2022, NDC # unknown), intramuscular, site not specified, was administered for hepatitis B immunization.  The dose was 32 days past the expiration date. No adverse reactions were reported by the patient.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient reported softball size rash that is red, itching and slightly swollen.  Other than this patient is feeling fine.
After having vaccine I began having ongoing congestion and it causes the spasms in my throat to get worse. Went to walk in clinic and was prescribed cough syrup which offers varying degrees of relief. The congestion is ongoing.
Driving home after getting the vaccine my vision was very blurry/cloudy. I didn?t think much of it and just went home. The next day I started having shooting pains in my left arm, I also started experiencing pains in all my previous injury areas. I broke my ankle when I was much younger and have had hip surgeries on both sides when I was much younger. All these areas were suddenly having pains. 2 days later after eating around 8pm I was standing in my bedroom and my heart started suddenly racing. A beating out my chest kind of feeling. I called emergency, my heart rate was very high and my blood pressure was super high. The doctor at the ER gave me toradol, and blamed anxiety, I?ve never had anxiety my entire life. I?ve been in and out of the ER the past 6 months after getting vaccinated more times than my entire life. No one wants to say it has anything to do with the vaccine, I haven?t been able to work since. I got vaccinated because as a city worker it was required or I?d lose my amazing job at the department of sanitation. Now I can?t work at all anyway. I still get chest pains almost everyday, my head feels like it?s going to explode if I walk around or sit around for a long period of time. I can?t sleep on my stomach, I get random episodes of my heart going from 70 bpm to 160 bpm for absolutely no reason. My life has completely changed, I now have high blood pressure and take metoprolol.
Local reaction, redness with 2 welts at injection site.  No respiratory distress.  Provider ordered Benadryl po, given at 4:55 PM. Patient observed for 40 minutes. Provider examined and discharged patient.
Febrile, red, hardened area of (R) thigh 8 x 5 cm.
4:00pm (3/9) Severe headache 6:00pm (3/9) - 12:00pm (3/10)Severe flu-like symptoms  12:00pm (3/10) - 3/14intermittent headache, diarrhea and vomiting - no other symptoms  3/15 - I feel normal
This spontaneous report was received from a registered nurse referring to unspecified number of unspecified patients. Patients' medical history and concurrent conditions were not reported. Starting on 11-JAN-2016 and after, the patients were vaccinated with an unspecified umber of improperly stored doses of M-M-R II lot # L024265 and expiry date on 01-JUL-2017, (strength, route, dose and frequency were not reported). Concomitant medications were not reported. No adverse effect was reported and no product quality complaint was involved. The stored temperature reported was 48.6 F degrees for 40 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Fevr 103.4 - for 2 days. Excessive red arm - still 3 days after vaccine.
AFTER THE VACCINE, SHE COMPLAINED OF ANXIETY. ON SITE EMS RESPONDED. VITALS ARE BELOW SHE REFUSED ADDITIONAL EVALUATION AND CARE.
onset of throbbing headache. No nausea, vomiting, chills. Vitals within normal limits. Patient given acetaminophen. Symptoms resolved.
9:50 am:  phone call received by health department nurse from patient's mother with complaints of patient having itching throat, hives, and SOB, stating "feels her throat closing up" which just started after receiving vaccines earlier.  Mother advised to have child seen in ED ASAP.  2:30 pm:  nurse spoke with mom & daughter doing better.  Given benadryl
102 temp starting at 1 pm on 7/25/12 with headache. Mother called physician & is giving TYLENOL. No redness at injection site.
Caller received her booster shot today and the nurse told her she gave her a full dose instead of a half dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Caller received her booster shot today and the nurse told her she gave her a full dose instead of a half dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. (O)02BK21A, 031M20(O)A and 013L20(O)A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 06-Jan-2022, the patient experienced ACCIDENTAL OVERDOSE (Caller received her booster shot today and the nurse told her she gave her a full dose instead of a half dose). On 06-Jan-2022, ACCIDENTAL OVERDOSE (Caller received her booster shot today and the nurse told her she gave her a full dose instead of a half dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Muscle tenderness in left bicep, tricep & radiating into pectoral muscle. Warm to touch. Increased pain with reaching & moving. Swelling, itching x 5 days.
Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
In approximately 10/2000, pt was vaccinated with pneumococcal vaccine 23 polyvalent. On 10/04/00, pt experienced swelling and redness on the day after vaccination. The pt was seen by MD who noted several bright red spots on the left arm, one over the bicep, not palpable but almost vasculitic in nature. There was some diffuse redness in the lower arm. Possible allergic reaction or vasculitis. No infection. Subsequently, the pt recovered. The reporter indicated that other pts experienced events post vax: WAES 01020487, 01020488, 01020490 and 00102088. Addtl info has been requested. Pt has a history of vaccination with pneumococcal vaccine 23 polyvalent in 1/1992.
approx 2-2 1/2hr p/vax became fussy;by 4hrs p/vax pt was crying&could not be calmed;rt leg @ inj site was swollen;cried for 1 1/2hr;fam MD was called;pt given motrin 3/4tsp;parents had been giving APAP;p/ 1/2hr pt calmed&slept;
Her injection arm swollen from her shoulder to her elbow; Extra sleepy the next day; A sore injection site for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Extra sleepy the next day), VACCINATION SITE PAIN (A sore injection site for a day or two) and VACCINATION SITE SWELLING (Her injection arm swollen from her shoulder to her elbow) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (A sore injection site for a day or two). On 07-Mar-2021, the patient experienced HYPERSOMNIA (Extra sleepy the next day). On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (Her injection arm swollen from her shoulder to her elbow). On 07-Mar-2021, HYPERSOMNIA (Extra sleepy the next day) had resolved. On 08-Mar-2021, VACCINATION SITE PAIN (A sore injection site for a day or two) had resolved. At the time of the report, VACCINATION SITE SWELLING (Her injection arm swollen from her shoulder to her elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included supplements. Treatment medications were not provided.
Vaccines given 8/20/15. On 8/22/15 Rt arm swollen and warm. Went to ER and started on antibiotic and steroids.
Lace-like urticaric rash anterior thighs, progressing to full torso and thighs over 48 hours until presentation in clinic.
About 10-12 days later, starting to itch and get welts all over. Did not get any treatment, tried eliminating shampoo, heating temperature, washing clothes etc. welts form wherever scratched, are continuing, taking allergy medication . Also had symptoms immediately after the booster shot, informed medics at site of dizziness, feeling of heat, throat constriction , facial tingling,  was told I had anxiety
This spontaneous report as received from a patient's mother refers to a 12 year old female patient with attention deficit/hyperactivity disorder.  On 10-JUN-2016, the patient was vaccinated with GARDASIL intramuscular (lot #, expiration date, dose and site of administration were not reported). Concomitant medication included "VYVANCE". On 16-JUN-2016, the patient experienced bad headaches, fatigue, nausea and migraines. In approximately 2016, the patient did  not want to eat anything and her eyes rolled to the back of her head. The patient had an office visit. No treatment was given and no lab diagnostics studies were performed.  The outcome of all events was reported as not recovered/not resolved. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Low grade fever for 48 hours. Headache for 2 hrs. Swelling and tenderness at site.
0900, 8 Apr:  Vaccine administered. 2100, 8 Apr:  Muscle aches and pains.  "Pinprick" sensations on body. 2230, 8 Apr:  Went to bed.  Exceptionally poor night's sleep, with constant wakefulness (confirmed by FitBit). 0816, 9 Apr:  Got out of bed.  Went downstairs.  Began washing dishes and making breakfast. 0820, 9 Apr:  Felt light-headed.  Sat down in a chair. 0825, 9 Apr:  Husband reports finding me with muscles constricted, eyes wide open, and pupils fully dilated.  I did not respond to his touches or yells to get my attention. 0916, 9 Apr:  Ambulance arrives at Hospital Emergency Room.  Attending physician examines me and blood samples are taken. 1207, 9 Apr:  Discharged with diagnosis of vasovagal syncope.  Instructed to follow up with primary care manager and cardiologist on 12 Apr for further evaluation.
Information has been received from a physician via Pfizer referring to a 56 year old male patient with allergic to insulin beef, mycins, zoster vaccine (captured in case# 1510USA014354), REGLAN, KEFLEX, TIAZAC and DARVOCET-N 100. The patient was a former smoker and did not drink alcohol. He quit smoking in 2013. On an unknown date the patient was vaccinated with a dose of M-M-R II (dose, route, lot# and expired date were unknown). No concomitant therapy was reported. On an unknown date the patient experienced allergy to the vaccine. The outcome of the event was unknown. Additional information has been requested.
severe dizziness; disorientation; Tired; muscle aches; L ear pain; chills; This is a spontaneous report from a contactable Other HCP (patient). A 38-year-old female (pregnant: No) patient received 1st dose of BNT162B2 (COVID vaccine, lot number= EK9231) on 11Jan2021 12:30 PM on Left arm for covid-19 immunization. Medical history and concomitant drug were not reported. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Patient experienced severe dizziness, disorientation, unable to finish any tasks. Tired, some muscle aches, L ear pain and chills (no fever) on 11Jan2021 01:00 PM. No treatment. Outcome of the event was Recovered/Resolved with Sequel.   No further information is expected. Information on the Batch/Lot number has been obtained.
Flu shot at 4pm. Stomach starts hurting about 7:30pm. Diarrhea. Fever at 8:30 of 101.7. Ibuprofen at 8:30 pm. Freezing, uncontrollable shivering, crying, achy all over, headache. Another dose of Ibuprofen at 1:30am (10/29/18). Fever 101.5. Same symptoms, shivering, etc. 6am on 10-29-18, lips were really swollen like a bad lip injection. Called Hospital. Gave Ibuprofen and BENADRYL at 6:30am. Temp was 100.6 at 8:30 am. Went to doctors later that morning.
Redness and itchiness at injection site on the first day, which turned into a large blister and larger area of redness, itchiness, and swelling, The blister popped 36 hours after injection, but the rash spread for another day. The rash directly surrounding the blister was also painful and swollen, while the larger rash was just itchy on Friday and Saturday (day 2 and 3). It is less itchy and swollen today (day 4), but still a large red rash, with the section around the former blister still sore to the touch.
Pain in left arm even now after 8 months muscle pain trouble turning head left to right - pain behind left ear goes up it muscle between shoulder and neck.  I have about 3 months of daily papers. As of 5-29-16 got worse. I have 3 months of records daily and weekly if needed.
Pt had Hep B vaccine #2, 4/23/03. Developed fever 101.2, myalgias, headache, confusion.
So my right eye was swollen and had hives under my eyebrow and inside of my nose on both sides and on my mustache above my mouth. I had a headache. My throat was hurting.
hives over face, neck,chest and upper arms. Took benadryl and it resolved
Patient reported fever and a burning sensation at the injection site and has had it for a few days. it has not been resolved as of today (8/31)
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.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 27Sep2021 at 01:15 as dose 4 (booster), single (Lot number: 301458A) at the age of 79 years, 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: "meningioma left side" (unspecified if ongoing); "Known allergies: Sulfur drugs" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Opioids, reaction(s): "known Allergy: opioids". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment for COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had Paxlovid (Lot no: 608744) from 26Jul2022 to 28Jul2022 for COVID 19 Treatment.  Follow-up attempts are completed. No further information is expected.
I was a healthy pregnant woman age 43 who was 11 weeks 2 days pregnant.  I was having a normal pregnancy with no complications.  I'm in healthcare and in the operating often for airway and ENT procedures.  I received my shot at 9:00am on 1/29/20201 and began spotting at 11:00am.  The spotting continued (very light) until 9:00pm.  I decided to go to bed since I wasn't feeling well.  I woke at 2:00am with contractions and heavy bleeding.  I went to the ED at 3:00am on 1/30 to confirm my miscarriage.  I weighed 121 at the ED when triaged. My EDD was 08/19/2021
Information has been received from a registered nurse, concerning a 12 month old patient who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Concomitant vaccination included a dose of varicella virus vaccine live.  Subsequently within a week the patient developed a rash all over his/her body.  Unspecified medical attention was sought. Attempts to obtain follow-up have been unsuccessful, as the registered nurse was unable to recall the name of the patient involved, despite review of the information.  No further information is available.
2:30pm vaccine. By midnight had chills, couldn't get warm, headache, upper arm muscle ache that worsened through the night then gradually eased over the course of the following day
Patient received Flu Vaccination on 12/4/10 at approximately 2:16PM. At approximately 3:45PM, patient called and said she was experiencing pain radiating thru arm (down to fingers and in neck). I recommended patient seek immediate medical attention. On follow up with patient, she called us back on 12/7/10 and said the pain dissipated over the last couple days and she feels better now. Patient said she did not seek medical attention.
Patient admitted to the hospital due to COVID 19. Reported per Moderna  COVID vaccine EUA.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 62-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing), notes: Other medical history: DM; "HTN" (unspecified if ongoing), notes: Other medical history: HTN; "hypercholesterolemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (10Aug2022) positive, notes: tested positive again on 10Aug2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient completed Paxlovid course prescribed on 29Jul2022, and had rebound of symptoms and tested positive again on 10Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient received Covid vaccine number 2 before we confirmed date of Covid number 1 dose provided at an outside resource.  Covid number 1 was provided on 11/17/21 which was only 16 days prior to covid number 2 dose.  CDC recommendations reviewed and noted that dosing under 17 days apart require a readministration of covid number 2 dose 3 weeks after erroneous dose.  Parent of child called and made aware of this event and she voiced understanding .  Note placed in chart to offer a readministration of dosing for covid number 2.
the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy; the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy; the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy; the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy), INJECTION SITE RASH (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy), INJECTION SITE WARMTH (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy) and INJECTION SITE PRURITUS (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy), INJECTION SITE RASH (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy), INJECTION SITE WARMTH (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy) and INJECTION SITE PRURITUS (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy). At the time of the report, ERYTHEMA (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy), INJECTION SITE RASH (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy), INJECTION SITE WARMTH (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy) and INJECTION SITE PRURITUS (the whole upper arm appears a red, slightly raised rash that is warm to the touch and slightly itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 14-OCT-2012 18:57, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Left thigh induration (2 cm) at site of PEDIARIX vaccine. RX: Warm compress, supportive care.
Approximately 1 hour after receiving Flu immunization, site of immunization on arm became largely swollen, red and itchy. Swelling persisted. 45 minutes after that, patient began coughing and within 30 minutes from then began a generalized wheeze. Child was given 2 puffs of inhaled albuterol which helped the wheezing to resolve and it did not reoccur. Today, 10/15/2015, patient continues to have a moderate localized reaction on same arm as he received vaccine, swelling and redness extending from elbow to shoulder.
I woke up in the middle of night with chest pain and trouble breathing. I had a pulmonary embolism. The pain and difficulty breathing lasted several days. Since then, I have experience a flare of the antiphospholipid syndrome - low platelets (blood work), splinter hemorrhages, clots, and the like. Whether from the embolism or other, the pulmonary hypertension has gotten drastically worse - with increased shortness of breath, irregular heart beats, dropping pulse ox.