chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vomiting; very high fevers; extreme fatigue; so sick; nausea; Booster; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a female patient (neighbour). A 65-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot number was not reported), dose 3 via an unspecified route of administration on an unspecified date as DOSE 3(BOOSTER), SINGLE for covid-19 immunisation. Medical history included osteoarthritis. The patient's concomitant medications were not reported.Patient was healthy before vaccination. Historical vaccine included Covid-19 vaccine as dose 1 and dose 2(Manufacturere unknown) for covid-19 immunisation. It was reported that patient had minimal side effects with previous 2 doses. The patient experienced vomiting for 3 days, very high fevers, extreme fatigue, so sick, nausea for 10 days, reported booster on an unspecified date It was further reported that For patient it was mandatory to get the vaccines 2 weeks ago and had the booster dose and suffered from side effects for one full week. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Swelling on the area vaccinated and bussing lightheaded, headaches, chills, nausea, Numbness on the arm were vaccinated.
Patient was given expired vaccine today/ no AE; Initial information was received on 23-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Medical Information (Reference number- 00653605) and transmitted to Sanofi on 23-Jun-2021.  This case involves a one-year-old female patient who was vaccinated 4th and final dose with 0.5 mL dose of HIB (PRP/T) VACCINE [ACT-HIB].(once) (lot number UJ320AA, expiry date 13-Jun-2021) via intramuscular route in right thigh on 23-Jun-2021 for prophylactic vaccination and reported that was given expired vaccine today with no adverse event (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  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.
On Day 11 (4/18/2021) after receiving the vaccine, mild itching skin rash first appeared around inguinal areas then covered neck and all extremities.  As of Day 12 (today), the condition is still ongoing, I applied 2% Benadryl cream once daily before bedtime, the itchy seems to be under control.  Therefore, I don't need to see my doctor yet.  (I may send her an FYI email after this)  The related cause may be the small piece of salmon fish I had on Day 9 (4/16/2021) at dinner.   In my history, I had seafood allergy before my elementary age, but it was gone for many years until my peri-menopause years, there were a couple of occasions that I had severe itching hives after eating not freshly made cod fish dishes. However, I do eat Salmon on regular bases (3-5 times/month) and have never had salmon allergy in my adulthood.
This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a neonate female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis. On 12th November 1996, the patient received the 1st dose of Hepatitis B vaccine. On 26th December 1996, the patient received the 2nd dose of Hepatitis B vaccine. On 6th June 1997, the patient received the 3rd dose of Hepatitis B vaccine. On 17th January 2018, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine and not applicable after receiving Hepatitis B vaccine, the patient experienced therapy non-responder, hepatitis b antibody negative, therapy non-responder, hepatitis b antibody negative, drug dose administration interval too long and drug dose administration interval too long. On an unknown date, the outcome of the therapy non-responder, hepatitis b antibody negative, therapy non-responder, hepatitis b antibody negative, drug dose administration interval too long and drug dose administration interval too long were unknown. It was unknown if the reporter considered the therapy non-responder, hepatitis b antibody negative, therapy non-responder and hepatitis b antibody negative to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. It was unknown if the reporter considered the therapy non-responder and hepatitis b antibody negative to be related to Hepatitis B vaccine. Additional details were provided as follows: The caller stated that the patient received Hepatitis B vaccine on her date of birth. The patient was mentioned that she was going into a medical program. The patient was completed the 3 doses of Hepatitis B vaccine.The patient received 2nd dose and 3rd dose later than the recommended interval, which led to lengthening of vaccination schedule. The patient underwent for serology test and titer come back negative (therapy non-responder and hepatitis b antibody negative), therefore the patient was recommeded to get the booster dose. On 17th January 2018, the patient received another dose of Hepatitis B vaccine on left deltoid and less than a year after receiving booster dose of Hepatitis B vaccine, the serology titer was found negative (therapy non-responder and hepatitis b antibody negative). Lab Comments: On an unknown date, lab test was performed.
12 days post vax devel minor diffuse rash 2x4cm warm red area @ site;seen in ER;2 days later vertigo & fatigue;NKA to meds;additional 4 days later inc vertigo & inability to concentrate- 3 days later to ER w/vertigo & sz;
Mother mentioned that girl was scratching a lot everywhere and only behind the neck had a small rash.  No treatment by pediatrician.  She was only put in the Emergency Room.  By Sunday 4/30 she did not have anything; patient does not have a rash nor red area.
Pt received COVID Vaccine, Pfizer 30mcg, IM left deltoid at 1250. Pt waited for 15 minutes prior to leaving facility.  Patient reports that he noticed itchiness as he drove back, he returned at 1355, and reported symptoms.  Pt ambulated to triage area accompanied by RN.  Pt sit on gurney, assessment completed, itching/redness on trunk, no difficulty swallowing or breathing.  Vital signs at 1401: 125/89, HR 89, 100% SPO2, resp 16. Pt with allergy to PCN, unknown reaction, no previous adverse reaction to vaccines.  Pt currently prescribed Adderall, and tramandol.  1418: pt continues to report itching, redness observed on trunk.  As the vaccination location does not have medical treatment capabilities, will contact EMS for further evaluation.  911 contacted at 1418.  Vital signs at 1420: 125/85, HR 84, 99.7% SPO2, resp 17. pt denies difficulty swallowing/breathing.  1425 - EMS arrives, SBAR given to EMT.  1427 - pt ambulate to ambulance.
Started off as body ?twitches? and a few days later became pronounced dance like tremors at all waking hours.
Rash on side of head occular droop shingles - herpes zoster shingles
I tested positive for COVID-19 on 04/30/2022, I used an at home test. I was very fatigue and had a fever for four days.
This is a spontaneous report from a contactable consumer, reporting for herself. This 65-year-old female patient received PREVNAR 13, via an unspecified route of administration on 16Jun2016 in left shoulder at single dose for pneumonia immunisation. Medical history included ongoing diabetes mellitus, myocardial infarction from 29Oct2012, road traffic accident on an unknown date. Concomitant medication included metformin, acetylsalicylic acid (ASPIRIN), and simvastatin. The patient previously took SALONPAS and it did not help with shoulder since getting the vaccine. The patient experienced feeling sick, dizziness, nausea/ sick to her stomach on an unspecified date with outcome of not recovered. Also experienced vomiting, get phlegm in throat, cough more, her shoulder was bothering me more than it usually does on an unspecified date with outcome of unknown, pain, pain in her left shoulder, so that arm hurts a lot on an unspecified date with outcome of not recovered, her arm got completely numb at 3 O' clock in the same afternoon when she got the shot on 16Jun2016 with outcome of unknown, she stumble all over, it affects her vision too on an unspecified date with outcome of unknown, she has a hard time sleeping at night on an unspecified date with outcome of not recovered. The patient underwent lab tests and procedures which included blood test: B negative on an unknown date, and other blood test with unknown results.
Two weeks post vax, the pt experienced increased fatigue and depression. No treatment was given. These events resolved after two weeks. The outcome of the event is resolved.
This patient had right arm numbness, left frontal headache, aphasia, mental status altered changes, nausea and vomiting. Sickness occurred over 1 - 2 hour period and progressed to confusion and aphasia with in 6 hours; better in 12 - 15 hours.
pt recvd vax on 13APR91 & subsequently exp epiglottitis; No further details were provided;
feeling unwell; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient (wife) that: A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: Unknown), via an unspecified route of administration as dose 2, single on 23Feb2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller reported that his wife received the second dose of the vaccine today and was feeling unwell on 23Feb2021. Caller wanted to know if she ever starts to feel any joint or muscle pain can she take Tylenol. At the time of this report, the outcome of event was unknown.  Information about lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
On February 15 when I got up I had rapid, pounding heartbeat, felt exhausted, and had panic attacks
About 9 days after receiving the vaccine, I started getting redness, bumpiness, and itchiness just around the injection site. The redness has increased over the last day or so. The spot is also hot to the touch. Otherwise, I am feeling fine.
Patient got vaccinated on 06/26/18.Patient came to the Pharmacy on 06/28/18 with a complaint of soreness of the left arm and also a fever.I promptly advised pt to see primary care  physician.Patient went to urgent care today per pt where she was taken care of cos fever per Patient went over 103.
Erythema entire upper arm-shoulder to elbow w/ indurations(2cm) at the injection sites(2).
This case was reported by a healthcare professional and described the occurrence of itchy hands and feet in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medications included Hydrochlorothiazide. On 5 June 2009, the subject received 2nd dose of ENGERIX B (1 ml, unknown, left arm). On 6 June 2009, one day after vaccination with ENGERIX B, the subject experienced itchy hands and feet and skin peeling. On 02 July 2009, 27 days after vaccination with ENGERIX B, the subject experienced vertigo, dizziness and nausea. The healthcare professional reported that this subject was given the ENGERIX vaccination on 05 June 2009 and the next day 06 June 2009, she started experiencing intense itching of the hands and feet that was followed by peeling of the hands. The itching resolved on 10 June 2009 but the peeling of the skin on the hands continued at the time of the report. On 02 July 2009, the subject also experienced vertigo (dizziness and nausea) that required her to obtain medical attention at the emergency room (ER). The physician in the ER prescribed ANTIVERT and FENERGAN to treat the symptoms of vertigo. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). The subject was treated with ANTIVERT and FENERGAN. At the time of reporting the itching resolved, peeling of skin was unresolved, vertigo was improved, nausea and dizziness were unknown. Follow-up information was received on 14 July 2009, via healthcare professional who reported the subject received ENGERIX B in the right arm on 05 June 2009. The subject experienced itchy hands and feet, skin peeling, vertigo and pharmaceutical product complaint after vaccination with ENGERIX B. The subject was hospitalized. The subject was treated with ANTIVERT 25 mg tablets and FENERGAN (as needed) for vertigo and a moisturizing cream for skin peeling. The skin peeling had improved and vertigo resolved on 03 July 2009. The healthcare professional considered the itchy hands and feet and skin peeling probably related to vaccination with ENGERIX B and the event of vertigo was possibly related to vaccination with ENGERIX B.
One week after my Moderna booster  on 1/4/22I had a flare up of hives. These come and and go all over my body including my face. I started getting hives about a month after my 2nd dose of Moderna, but they were in control with daily Zyrtec and were  mostly non-existent.  This time, the hives are worse. They are appearing in more locations on my body. In addition, I had lumps on both sides of the back of my next, and behind my ears for 12 hours one day. Yesterday I had an appointment with my doctor who put me on a strict regimen of Zyrtec, Pepcid (2 times a day) and Benadryll at night. If they are not better in a few days, she may give me steroids.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA002453: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA003062.
Patient presenting to the ED with fever and chills x1 day after receiving shingles vaccination.  States she measured her temperature at home at 108 °F, which she acknowledged was likely due to faulty thermometer, however states it scared her enough to come to the ED.  Patient was deemed safe for discharge by the physician, and to return if symptoms worsen.
pt reports continued pain in right arm to point she cannot sleep. There is not bruising, redness or swelling. started day after and is still having 9 days later.
Constant Heart Palpitations since 4/3/2020.  Began 2 days after taking the vaccine.
This case was reported by a physician via sales rep and described the occurrence of influenza like illness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza like illness and activities of daily living impaired. On an unknown date, the outcome of the influenza like illness and activities of daily living impaired were unknown. It was unknown if the reporter considered the influenza like illness and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced grade 3 flu like symptoms which limited her activities of daily living for 4 to 5 days.
Big red itchy welt at injection site; Big red itchy welt at injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Big red itchy welt at injection site) and VACCINATION SITE ERYTHEMA (Big red itchy welt at injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), MULTIVITAMINS [VITAMINS NOS], ZINC, CALCIUM CITRATE, COLECALCIFEROL (CITRACAL PLUS D) and ELDERBERRY [SAMBUCUS NIGRA] for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 24-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Big red itchy welt at injection site) and VACCINATION SITE ERYTHEMA (Big red itchy welt at injection site). On 17-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 24-Apr-2021, VACCINATION SITE PRURITUS (Big red itchy welt at injection site) and VACCINATION SITE ERYTHEMA (Big red itchy welt at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medication was reported.
upper left arm pain at injection site & under axilla with swelling, pain also radiating to left side of breast, left side of cervical neck area.; Severe, upper left arm pain at injection site & under axilla with swelling, pain also radiating to left side of breast, left side of cervical neck area.; under axilla with swelling, pain also radiating to left side of breast, left side of cervical neck area.; Severe, upper left arm pain at injection site & under axilla with swelling, pain also radiating to left side of breast, left side of cervical neck area.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Jul2021 10:45 (Lot number: EW0196) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes type II" (unspecified if ongoing); "Hypertension" (unspecified if ongoing), notes: no. Concomitant medication(s) included: LOSARTAN; JANUMET. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 28Jul2021 22:00, outcome "not recovered", described as "upper left arm pain at injection site & under axilla with swelling, pain also radiating to left side of breast, left side of cervical neck area."; PAIN IN EXTREMITY (non-serious), PAIN (non-serious) all with onset 28Jul2021 22:00, outcome "not recovered" and all described as "Severe, upper left arm pain at injection site & under axilla with swelling, pain also radiating to left side of breast, left side of cervical neck area."; PERIPHERAL SWELLING (non-serious) with onset 28Jul2021 22:00, outcome "not recovered", described as "under axilla with swelling, pain also radiating to left side of breast, left side of cervical neck area.". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, peripheral swelling, pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received multi-vitamins within 2 weeks of vaccination. No Known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
has not yet received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on November 2019 received 1st dose.).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not yet received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 10-NOV-2023 The patient was self-reported.  The patient received the first dose of Shingrix November 2019, and had not yet received the second dose.  Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up. The vaccine administration facility is same as primary reporter for 1st dose.
headaches; rashes; bruising; nerve damage; skin sensitivity; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810 Expiry date: 04Mar2021), dose 1 via an unspecified route of administration on 11Feb2021, as single for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. It was reported that patient received Pfizer Covid vaccine on 11Feb2021. Since then, the patient had terrible headaches, rashes, bruising, and skin sensitivity which the doctors believe to be nerve damage. It resulted in multiple hospital trips in February, and close to a dozen doctors visits since then. Patient has taken multiple tests to determine exactly what going on, including blood tests, CT scans, and an MRI.As you might imagine, this has resulted in extremely expensive medical bills. The patient suffered everyday from side effects which the patient did not even know could happen from a vaccine. The patient was hoping it would go away on its own, but this had been going on nearly 3 months at this point and did not show signs of stopping any time soon. The patient thought was doing the right thing by getting the COVID vaccine, but would never take another one again. The patient underwent multiple tests as mentioned above and has resulted in extremely expensive medical bills. over 2 months later. This has resulted in medical bills that would keep the patient in debt for years, as well as pain that affected every day. The patient needed financial assistance to pay for these medical bills and for the doctors appointments and tests that would come up. The patient underwent lab tests and procedures which included blood tests, CT scans, and an MRI on unspecified date. The outcome of events was not recovered.  Follow-up (10May2021): This is a follow up-spontaneous report from a contactable consumer. New information included: The events and clinical information was added.  Information about lot/batch number has been requested.