chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years 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's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I am still testing positive no symptoms; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that, patient received anti-viral drug paxlovid from 21Jul2022 to 26Jul2022 as COVID 19 Treatment. Adverse event: she was still testing positive no symptoms and she feel fine and adverse event start date on 30Jul2022 and no treatment for adverse events.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Pneumovax administered at approx 1100. Pt called at 1500 to report severe pain in her shoulder. I examined her on 8/3/09. At that time she was unable to raise her arm due to severe pain and weakness in the deltoid muscle and shoulder. She showed me the alleged injection site high on the upper arm over the brachial tendon. I believe the injection was given into the tendon rather than muscle. Today, 8-5-2009 the patient reports she can raise her arm enough to touch the side of her head but cannot hold it there yet. She has been using heat and cold to the area alternating and taking Lortab for pain.
This is a spontaneous report from a contactable pharmacist who reported for her mother via Pfizer sales representative. An elderly (over 65 years) female patient received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced redness up arm on an unspecified date with outcome of unknown. The information on the lot number has been requested.
knot under the skin about the size of an egg-getting bigger at injection site; burning at injection site; hot at injection site; itchy area at injection site; red area at injection site; burning at injection site; swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (knot under the skin about the size of an egg-getting bigger at injection site), SKIN BURNING SENSATION (burning at injection site), VACCINATION SITE WARMTH (hot at injection site), VACCINATION SITE PRURITUS (itchy area at injection site) and VACCINATION SITE ERYTHEMA (red area at injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced NODULE (knot under the skin about the size of an egg-getting bigger at injection site), SKIN BURNING SENSATION (burning at injection site), VACCINATION SITE WARMTH (hot at injection site), VACCINATION SITE PRURITUS (itchy area at injection site), VACCINATION SITE ERYTHEMA (red area at injection site), VACCINATION SITE PAIN (burning at injection site) and VACCINATION SITE SWELLING (swollen at injection site). The patient was treated with RANITIDINE HYDROCHLORIDE (ZANTAC) on 05-Apr-2021 at a dose of UNK, bid and TRIAMCINOLONE (topical) on 05-Apr-2021 for Allergic reaction, at a dose of UNK, bid. At the time of the report, NODULE (knot under the skin about the size of an egg-getting bigger at injection site), SKIN BURNING SENSATION (burning at injection site), VACCINATION SITE WARMTH (hot at injection site), VACCINATION SITE PRURITUS (itchy area at injection site), VACCINATION SITE ERYTHEMA (red area at injection site), VACCINATION SITE PAIN (burning at injection site) and VACCINATION SITE SWELLING (swollen at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided
The COVID-19 vaccine administered through vaccine administrator, between June 25 and July 30 came from the lot number 039K20A. It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
Muscle soreness; This case was reported by a consumer and described the occurrence of muscle soreness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2019, the patient received Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was unknown.   It was unknown if the reporter considered the muscle soreness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. In the afternoon on the day of reporting, the patient received dose of Shingrix and experienced muscle soreness. The patient asked, how long did it typically last and when was it ok to exercise.
the patient was administered an improperly stored dose of PNEUMOVAX 23; This spontaneous report as received from a nurse refers to a patient of an unknown age and gender. The report concerns 1 patient and 1 combination product. Information about concurrent condition, concomitant medication and medical history was not provided.  On 13-SEP-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), lot # S004548, expiration date 12-AUG-2020 (exact dose and route of administration were not reported) for prophylaxis. The administered dose of vaccine experienced temperature excursion of 47.3 degrees Fahrenheit for 20 minutes. There was no previous temperature excursion. The digital date logger was involved.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Redness swelling and itching of R arm and legs, (-) SOB, syncopy (-) wheezing warm now spreading down her arm.
Patient received a 4th COVID19 vaccine in addition to the influenza vaccine on 9/9/21  at Pharmacy. Patient had already received the COVID19 booster on 6/28/21.
colon cancer; This spontaneous case was reported by a consumer and describes the occurrence of COLON CANCER (colon cancer) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Arthritis and Colon operation on 08-Jun-2021. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for Arthritis.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced COLON CANCER (colon cancer) (seriousness criterion medically significant). At the time of the report, COLON CANCER (colon cancer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Colonoscopy: abnormal (abnormal) diagnosed with colon cancer.  She stated she had no known drug or food allergies.  Company Comment - This spontaneous  case concerns a 74-year-old female patient with no relevant medical history who experienced serious unexpected event of colon cancer. The event occurred approximately less than a month after the second dose of the Moderna COVID-19 vaccine .The patient was diagnosed with colon cancer after a colonoscopy.  She had colon cancer surgery as a corrective treatment for the event. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.   This case was linked to MOD-2021-391946 (Patient Link).; Sender's Comments: This spontaneous  case concerns a 74-year-old female patient with no relevant medical history who experienced serious unexpected event of colon cancer. The event occurred approximately less than a month after the second dose of the Moderna COVID-19 vaccine .The patient was diagnosed with colon cancer after a colonoscopy.  She had colon cancer surgery as a corrective treatment for the event. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
I received my second Moderna shot in April 2021. I contracted Covid September 31st 2021. Between September 2021 and April 2022 I had the flu and pneumonia several times. I was admitted to the hospital on April 2, 2022. I was septic with pneumonia. On April 4, 2022 they discovered I had a very large blood clot in the left ventricle of my heart. They transferred me to alternate hospital. On April 6, 2022 I underwent open-heart surgery to remove it.
t102-APAP given; persistent screaming began 18 hrs later (p/vax) & lasted 6 hrs;
Had a reaction to the Johnson and Johnson Covid vaccine that took him 2 years to recover from.  Brings in a map he made of his waxing and waning symptoms and the progression of illness.  Feels 100% recovered now.  Got the vaccine in May of 2021.  Had bouts of migraines, ringing ears, dizziness, exhaustion, chills, head heaviness, lump in throat, vision problems, hands and feet tingling and digestive problems.  Eyes were very sensitive to light or screen time.  Would feel bad when it rained.  Has never had a vaccines reaction outside of this one.
Pt stated Sx within hours of vaccine. Chills, body aches, nausea, redness and induration of site of vaccine.
Varicella vesicular lesions on neck, arm and face with erythematous margins.
Patient received Moderna Bivalent instead of Moderna Primary as their second dose in the series.
Tested positive for covid 19; Patient experienced inconsistent dosing/ On 30 Mar 2021, received 1st dose and on 20 Apr 2021, received 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid 19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient experienced inconsistent dosing/ On 30 Mar 2021, received 1st dose and on 20 Apr 2021, received 2nd dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient experienced inconsistent dosing/ On 30 Mar 2021, received 1st dose and on 20 Apr 2021, received 2nd dose). On 16-Aug-2021, the patient experienced COVID-19 (Tested positive for covid 19). In 2021, COVID-19 (Tested positive for covid 19) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient experienced inconsistent dosing/ On 30 Mar 2021, received 1st dose and on 20 Apr 2021, received 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, SARS-CoV-2 test: (Positive) Positive.         It was unknown if patient was enrolled in a COVID-19 vaccine trial. No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Immediate reaction: dizziness and muscle cramps, especially in left side and a lot in my left foot...whole foot cramped up immediately...dizziness and cramping went away in about 40 minutes.  Since then, I have been having extreme rushes of adrenaline for almost a week now...lasting almost all day.  I will wake up feeling ok, but as the day progresses, the adrenaline starts up.  It has been unbearable.  I've had heart palpitations, fluttering, jumping, etc because of it.  It feels as if I am on prednisone (I was on 60mg 8 years ago and it really messed with my adrenal glands).  I am unsure if I can take the second dose because of the side effects I had from the first.  I know thousands of people and I know no one
This spontaneous report was received from a nurse concerning multiple unspecified patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were administered doses of improperly stored VAQTA (Lot # L045713; expiration date: 14-JAN-2017) (dose and route not provided). Concomitant therapies were not provided. No adverse effect was reported. It was reported the following temperature excursion for the administered vaccines: high temperature: 49.1 F for 1 hour 48 minutes and low temperature: 33.0 F for 35.9 hours. No previous temperature excursion was reported. This is one of several reports received from the same source. Additional information has been requested.
Patient describing Dermatographism reactions three days after his last COVID booster.  He states it happens two to three times a day.  They come on and off and may last 30 minutes or so.   He states they come on when it is warm or under stress.  He describes them as appearing to be like scratch marks but go away after 30 minutes or so.
body pain; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 58-years-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 09:45 (Lot number: EL3247) at the age of 58 years as DOSE 2, SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID19, brand=PFIZER, Lot number=EL3247, Lot unknown=False, Administration date=22Feb2021, Administration time=09:15 AM, Vaccine location=Left arm, Dose number=1), administration date: 22Feb2021, when the patient was 58 years old, for Covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 15Mar2021 22:00, outcome "recovered" (2021), described as "body pain"; CHILLS (non-serious) with onset 15Mar2021 22:00, outcome "recovered" (2021), described as "chills". Therapeutic measures were not taken as a result of pain, chills.  Additional Information: After the second shot, the patient had body pain and chills all night. The patient had no known allergies and no other medical history. The patient had no other vaccines in 4 weeks. No treatment was received for the adverse events. The patient did not have COVID prior to vaccination and was not tested for COVID since the vaccination.  No follow-up attempts are possible. No further information is expected.
H/O anxiety & HTN- felt anxious and hot. D/C calm and seemed fine.
This patient received MMR at their primary physicians office on 03/09/01 (after neg mump titer). By 03/28/01, she noted right node by both, right jaw / neck very swollen, she had a low grade temp, intense facial pain with spasms, especially after eating. The symptoms gradually went away in 10 days. Fatigue lasted 10 days. Diagnosed with Mumps disease
vax was given @ pts work site; pt works in a sewing factory; told supervisor felt bad began crying & shaking, broke out in rash, face & neck began itching; no SOB or other life threating sx; sent to ER; 27OCT92 pt ok still had rash;
This is a spontaneous case, initially received on 15-Dec-2017 from a pharmacist, concerning a 39-year-old adult male patient. The patient's medical history and concomitant medications were reported. On 15-Dec-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 179102, expiry date: 31-May-2018, recommended for the patients more than 65-year-old). The reporter assessed the case as non-serious.
-she was having chest pain with radiating arm pain; NSTEMI -went to cardiac cath and received drug eluting stent. treated with Brilinta 90 mg BID, atorvastatin 80 mg, aspirin 81 mg, and increased her carvedilol to 50 mg BID -discharged home.
A little before bed I was feeling cold (I think it was a little after 10pm). I took a warm shower thinking the house was just cold, but when I went to bed after I started shaking with chills. I didn?t sleep well that night and during the day Thursday (01/21) I felt feverish and a throbbing headache. I tried sleeping throughout the day, still having the chills come and go. I took ibuprofen before heading the bed the next night and slept great other than feeling a little hot and sweaty. I showered the next morning and felt 100% again.
He is a primary vaccinee who received his smallpox vaccination 02/21/2003.  On 08/29 while he was on leave, he noticed "2 small, pimples" just above the smallpox vaccination on his left upper arm.  He also states that periodically he has "some itching at lesion".  The day before August 28th.  He recalled having some "soreness of his neck and of his left elbow that traveled down into the knuckles of his hand", a low-grade fever and some mild nausea.  He denies any edema or erythema, lymphadenopathy, shortness of breath, chest pains or fatigue.  He was seen at a health care center and referred for an evaluation.  When evaluated on 08/30.  He had developed "hives on both sides of my face".  He denied any known contact to irritants, new foods or insects.  Labs were drawn for CBC, CMP, sed rate, LFT's, Immune Complex, Ultra sensitive CRP and Raji cells.  The lesions were scraped and cultured for VZV, HSV-land HSV-2.  Except for a slightly elevated immune complex-4.3 (0.0-4.0) his labs and cultures were negative.
morning of 01/13/2021 awakened with early Bell's Palsy on right side
injected arm has reddened area form top of shoulder to anticubital space;area is warm;no rash or raised area noted;pt c/o body aches, low fever, malaise s/sx 4 days;
PT started to feel dizzy w/blurry vision o2 97%, B/P 110/89 RR 20 at 13:15 PT started to feel better w/vision. itching in L arm w/tingling, no rash reported. p69, o2 97% RR18.
got COVID after receiving first vaccination; loss of taste and smell; headache; body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (got COVID after receiving first vaccination), HEADACHE (headache), MYALGIA (body aches) and AGEUSIA (loss of taste and smell) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got COVID after receiving first vaccination), HEADACHE (headache), MYALGIA (body aches) and AGEUSIA (loss of taste and smell). At the time of the report, COVID-19 (got COVID after receiving first vaccination) outcome was unknown and HEADACHE (headache), MYALGIA (body aches) and AGEUSIA (loss of taste and smell) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Within seconds of administering vaccine, the patient developed swelling about the size of a quarter around the injection site. An ice pack was immediately placed on it for about 15-20 minutes. Swelling significantly subsided but a hard knot was still underneath the skin. Patient was contacted at home around 1:30 PM and stated the knot/swelling was completely resolved.
1 dose HepA in 2003, not finish series; 1 dose HepB in 2003, not finish series; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Hepatitis A vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis A vaccine (received 1st dose of Hepatitis A vaccine in 2003) and Hepatitis B vaccine (received 2nd dose of Hepatitis B vaccine in 2003).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis A vaccine and the 2nd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine and not applicable after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination and incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt Date: 22-FEB-2023 Reporter's Comment: The reporter had patient who were traveling to Morocco and she wanted to finish the hepatitis B and hepatitis A series before this trip.  The patient received only one dose of Hepatitis A and Hepatitis B in 2003 but did not finish the series. The vaccines administered were the generic versions of Hepatitis A and Hepatitis B because healthcare professional could not confirm brand names. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Hepatitis A vaccine and Hepatitis B vaccine, which led to incomplete course of vaccination. The case had been linked to US2023AMR030354, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR030354:Same reporter
Tingling Tongue - PO Benadryl 25mg. Tingling improved and felt fine to leave