chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inflammation in lungs; having problem with the platelets in his blood; started trembling and loose balance; started trembling and loose balance; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown (booster), single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PNEUMONITIS (hospitalization, life threatening), outcome "not recovered", described as "inflammation in lungs"; PLATELET DISORDER (non-serious), outcome "unknown", described as "having problem with the platelets in his blood"; TREMOR (non-serious), BALANCE DISORDER (non-serious), outcome "unknown" and all described as "started trembling and loose balance". The event "inflammation in lungs" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of pneumonitis, platelet disorder. Clinical course: After he got the booster shot, he started having problem with the platelets in his blood. So, a treatment with steroids was started. He was like 3 or 4 less than a month when he started trembling and loose balance so he was put to 'that' and they said it is like inflammation in lungs and told that it was a pneumonia. Patient never had a COVID but they saw a bacteria or a fungus so, they started treatment. When further clarified, patient was very 'epiploic' pneumonia. He is like pneumonia but the 'oleic' sounds no pneumonia it is like the inflammation of the lungs and they said like they have no idea how to treat it because it's something new from the latest information for COVID. They have been treating it with antibiotics but they suspended antibiotics today because they found with the 'latest thing' they have been doing that it's not a bacteria that it's not a fungus now they said it's no pneumonia but he is on a ventilator. So, the doctor told them that it was an inflammation of the lungs but this is very new for them. The patient's condition worsened and is now in the ICU on a ventilator.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vertigo feeling within 15 mins of initial vax. Has been increasing in frequency to multiple times per day.. Persisted after second vax on 7/12/21. A few days following 2nd vax, constant headache and head feels foggy. Feels like sinus headache. Have ruled out dehydration but not sure if related to having a new baby, breastfeeding and tiredness, but never had this before or with first child. On the worse day I got the whirling feeling every 2-5 minutes. Still have it and headache is constant.
Narrative:  Patient received two doses of Pfizer vaccine in Jun/Jul 21. The patient tested positive for COVID 19 on 15 Oct and was admitted to Hospital with COVID pneumonia and sepsis. The patient's condition deteriorated with sepsis and complete organ failure and died on 28 October 2021. Reported per EUA.
Pt states she "began to have a headache the evening she received the second COVID- 19 vaccine (02/01/2021)." States "I sat up all night and held my head because I could not lay my head down." Pt states the "pain was on the top of her head. " Pt states she took Excedrin Migraine that evening. The next morning 02/02/2021 pt states her headache had eased up, but she started running a fever. Pt states she had to have heat on her back because of intense pain in between shoulders. states she went to bed that evening 02/02/2021 with a electric blanket and was very achy.
No adverse event- just reporting that the dose was given inappropriately as patient just received her second dose of Moderna on 8/11/2021. Patient was not six months post second vaccine, and therefore was not eligible to receive a booster dose. Patient received a 0.25mL booster dose. Education was given to nurse administering vaccine about third dose and booster eligibility and verifying with vaccination card the dates of vaccines.
This case was reported by a pharmacist via sales rep and described the occurrence of syncope in a 71-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included syncopal attack (experienced for routine childhood vaccines). Previously administered products included Flu vaccine (routinely receives yearly and received both pneumonia shots with no adverse reaction) and Pneumococcal vaccine (both pneumonia shots, no adverse reaction). On 14th March 2019, the patient received the 1st dose of SHINGRIX. On 14th March 2019, less than a day after receiving SHINGRIX, the patient experienced syncope (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant) and unresponsive to stimuli (serious criteria GSK medically significant). The patient was treated with ammonia. On 14th March 2019, the outcome of the syncope, passed out and unresponsive to stimuli were recovered/resolved. It was unknown if the reporter considered the syncope, passed out and unresponsive to stimuli to be related to SHINGRIX. Additional details were provided as follows: The patient experienced syncope and passed out for about 30 seconds to 1 minute. The patient was unresponsive to ammonia inhalants throughout 30 seconds to 1 minute. The patient was admitted to local hospital. The patient was discharged on the same day. The patient did not received any other vaccine during the course of time. The reporter provided consent to follow up.
Nine days later she had a pruritic rash with urticaria lasting four days; Nine days later she had a pruritic rash with urticaria lasting four days; This spontaneous case was reported by a health care professional and describes the occurrence of RASH PRURITIC (Nine days later she had a pruritic rash with urticaria lasting four days) and URTICARIA (Nine days later she had a pruritic rash with urticaria lasting four days) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 RASH PRURITIC (Nine days later she had a pruritic rash with urticaria lasting four days) and URTICARIA (Nine days later she had a pruritic rash with urticaria lasting four days). At the time of the report, RASH PRURITIC (Nine days later she had a pruritic rash with urticaria lasting four days) and URTICARIA (Nine days later she had a pruritic rash with urticaria lasting four days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Covid diagnosed by home test 06Dec; Covid diagnosed by home test 06Dec; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 3 (booster), single (Lot number: C-H902) at the age of 79 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Dec2022, outcome "unknown" and all described as "Covid diagnosed by home test 06Dec". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Dec2022) Positive, notes: Covid diagnosed by home test. Therapeutic measures were taken as a result of drug ineffective, covid-19 (paxlovid).
RAISED BLOOD SUGAR TO DANGEROUS HIGH LEVEL, 400 AND GOING STRAIGHT UP; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry date: UNKNOWN) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, after vaccination the patient did not have any flu reaction but the vaccine raised blood sugar to dangerous high level. It was 400 and going straight up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of raised blood sugar to dangerous high level, 400 and going straight up was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210347311-JANSSEN COVID-19 VACCINE Ad26.COV2. S - Blood sugar increased. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Per mom, child had temp of 103.2, vomiting & diarrhea day after immunizations; says she took child to Med Ctr same day, was admitted for "dehydration".
Information has been received from a registered nurse referring to a 57 year old female patient. The patient was allergic to FLUZONE. On 07-OCT-2013, the patient receivd a dose of FLUZONE intradermally. Due to eggs being in the vaccine, she developed redness at the injection site and subsequently, was recovered from this event on an unknown date. The patient had no other pertinent medical history. On 18-JAN-2015, "around 1:00 PM", the patient was vaccinated with her first dose of PNEUMOVAX 23, lot # k019386, expiry date: 09-JUN-2016, 0.5 ml, subcutaneously. There was no concomitant medication reported. On that day at around "4:00 pm", the patient developed swelling and redness at the injection site. On approximately 19-FEB-2015 (reported as "yesterday"), the patient also developed fevers with body temperature as high as 100.2 (unit unknown) and chills. The patient sought medical attention via calling and speaking with the nurse on the phone. There was no treatment given for the events. No intervention and lab diagnostics studies were performed. At the time of reporting, the patient was not recovered from all the events. The causality between of PNEUMOVAX 23 an all events were not reported. Additional information has been requested.
Flu vaccine given 10-8-13 about 2 PM. By 6 PM was having frequent palpitations. Took 2 full days for improvement. (I work in an ER - PVC's). No tx except for hydration.
I got vaccinated, I got shingles; I got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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 Information: GSK Receipt Date: 10-May-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient got vaccinated, still patient got shingles.  Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed mild breakthrough with less than 50 lesions. It was noted that the patient was part of 7 children, 4 male and 3 female, some of which were siblings who were vaccinated with varicella virus vaccine live. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned six other patients who were vaccinated with varicella virus vaccine live and experienced similar reactions. Additional information has been requested.
A report has been received from a Physician concerning a Child, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. INADVERTENT INOCULATION IN EYE is unknown. The report was considered to be non-serious.
A pfizer booster shot (3rd shot) was administered to the pt  even though patient is under 18 years old.  The booster shot has not been approved for under 18 years old yet.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    Concomitant medication was not provided. 196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received and added age group and updated narrative.
approx 2yrs p/vax pt exp impetigo secondary to varicella. pt seen by MD 6x & treated w/bactroban, atarax, & hydrocortisone.
This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-JUN-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018) (dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (°F) to 77 degrees Fahrenheit (°F) (60.33 °F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069.
This spontaneous report as received from a nurse, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 09-FEB-2018, the patient was vaccinated with an expired dose of M-M-R II lot # M004305, expiration date 25-JAN-2018 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with a sterile diluent (MERCK) which was properly stored. There was no adverse effect reported. No product quality complaint was involved.
pt recv vax; arm red,swollen to elbow area;warm moist pack to area;13apr, lt arm feels numb,cold,arm discomfort;c/o heart breathing fast;MD checked pt;
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298512, 2018SA298593, 2018SA298603, 2018SA298611, 2018SA298622, 2018SA298631, 2018SA298644, 2018SA298649, 2018SA298573, 2018SA298692, 2018SA298695, 2018SA298701 (same reporter). This case involves a 76-year-old patient (gender not reported) who was vaccinated with a dose of FLUZONE HIGH DOSE lot U1995AB, expiry date: 20-Jun-2019 via intramuscular route in unknown site on an unknown date (reported as during the period 01Oct2018 to 08Oct2018). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were administered with the FLUZONE HIGH DOSE. It is an actual medication error case due to incorrect product storage. It was reported that temperature report of the refrigerator showed that the FLUZONE HD was frozen at some time and were injected to 15 patients. It was unknown whether the patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
headache, chills, cramps, sweaty, nauseous, no appetite for 3 days
Psoriatic Arthritis Flare Up; Fatty Liver; Pain on Right Side; Allergic to Spider Bites; Swollen Lymph Nodes in Left Under Arms; Slight Fever; Chills; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4423021-00 (Agency).  A 36-year-old female patient received BNT162b2 (BNT162B2), on 20Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), on 13Apr2022 (ongoing) (Batch/Lot number: unknown) subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Route of administration: Intramuscular), administration date: 20Mar2021, when the patient was 34-year-old, for covid-19 immunization; BNT162b2 (Dose 2, Route of administration: Intramuscular), administration date: 20Apr2021, when the patient was 34-year-old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021); PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Slight Fever"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "Swollen Lymph Nodes in Left Under Arms"; PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "Psoriatic Arthritis Flare Up"; HEPATIC STEATOSIS (non-serious), outcome "not recovered", described as "Fatty Liver"; PAIN (non-serious), outcome "unknown", described as "Pain on Right Side"; ALLERGY TO ARTHROPOD BITE (non-serious), outcome "not recovered", described as "Allergic to Spider Bites".  The reporter's causality for the event of first booster caused swollen lymph nodes in left under arms, second booster caused sore arm on right side, allergic to spider bites, Pfizer vaccinations caused slight fever and chills for six to eight hours onset in 2021, fatty liver, Pfizer vaccinations caused slight fever and chills for six to right hours onset in 2021 and pain on right side with Humira (Adalimumab) was no reasonable possibility.  Causality for events Swollen lymph nodes, Vaccination site pain, Insect bite allergy, Chills, Fatty liver, Fever, Psoriatic arthritis aggravated and Pain localized with the suspect product(s) BNT162b2 was not provided at the time of this report.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on available information and known profile of the Comirnaty vaccine  ,the reported events of Pyrexia, Chills and Lymphadenopathy   were assessed as related to the  Comirnaty vaccine.  Based on the information provided by the reporter, it appears unlikely that suspect drug contributed to the reported  events Psoriatic arthritis aggravated, Hepatic steatosis , Pain and Allergy to arthropod bite .
Severe body aches that affected pt's ability to sit and walk. Headache, nausea (no vomiting), fatigue, chills, temp 98.0. Symptoms started at 2300 on 04-02-15.
headaches following; Fuzzy headed/ should make important decisions type feeling/mind has started to clear but continues to have a bit of fuzziness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Fuzzy headed/ should make important decisions type feeling/mind has started to clear but continues to have a bit of fuzziness) and HEADACHE (headaches following) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002f21) for COVID-19 vaccination.     The patient's past medical history included Pregnancy induced hypertension.    On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced FEELING ABNORMAL (Fuzzy headed/ should make important decisions type feeling/mind has started to clear but continues to have a bit of fuzziness). On an unknown date, the patient experienced HEADACHE (headaches following). At the time of the report, FEELING ABNORMAL (Fuzzy headed/ should make important decisions type feeling/mind has started to clear but continues to have a bit of fuzziness) was resolving and HEADACHE (headaches following) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was stated have not seen physician yet.  No concomitant medication was reported.                   No treatment medication was reported.
Ten minutes after shot patient felt throat was closing, no swelling of lips or tongue noted called 911 and sent patient to Hospital
2nd dose Moderna tingling of extremity and tongue. Itching. post vaccine dose. Benadryl 50 mg and Solumedrol 125 mg IM given by nurse practitioner on site. Symptoms resolved within 15 minutes.    patient received 1st dose without reaction on site/during observation period.
swelling warmth & redness around site of vax; prob reaction to vax but could be early cellulitis;