chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The swelling moved to under right jaw, then in front of right ear; The swelling moved to under right jaw, then in front of right ear. It stayed in front of right ear for about 3 days; so swollen that it was painful and woke patient up at night; woke patient up at night; swollen lymph nodes on the right side of neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A 70-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (Dose: 4, UNKNOWN MANUFACTURER), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 25Sep2022, outcome "recovering", described as "swollen lymph nodes on the right side of neck"; SWELLING (non-serious), outcome "recovering", described as "The swelling moved to under right jaw, then in front of right ear"; EAR SWELLING (non-serious), outcome "recovering", described as "The swelling moved to under right jaw, then in front of right ear. It stayed in front of right ear for about 3 days"; PAIN (non-serious), outcome "recovering", described as "so swollen that it was painful and woke patient up at night"; SLEEP DISORDER (non-serious), outcome "recovering", described as "woke patient up at night". Therapeutic measures were taken as a result of lymphadenopathy, swelling, ear swelling, pain, sleep disorder.  Additional information: On 25Sep2022, patient developed swollen lymph nodes on the right side of neck. The swelling moved to under right jaw, then in front of right ear. It stayed in front of right ear for about 3 days, so swollen that it was painful and woke patient up at night. Patient took ibuprofen around the clock. It is finally diminishing a week later. Patient had no reactions with the first four vaccines.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
he patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e. 0.25 ml instead of 0.5 ml.; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (he patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e. 0.25 ml instead of 0.5 ml.) 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 ACCIDENTAL UNDERDOSE (he patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (he patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) 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 ACCIDENTAL UNDERDOSE (he patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.).    No concomitant medications were reported.  It was reported that, nurses had no Standing orders other than what they had for the second booster, when first administering Bivalent boosters. So, they assumed the same dose as the second booster, hence they were administering 0.25 ml instead of 0.5 ml to uncompromised adults.  It was reported that approximately 100 patients were administered an invalid dose of 0.25 ml instead of 0.5 ml of the Moderna COVID-19 bivalent booster.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 24Apr2021 at 11:00 as dose 2, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Nov2021 at 15:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 10Apr2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 15Nov2010; TRUVADA, start date: 15Aug2009; FOCUS FACTOR, start date: 15Sep2018; FLONASE [FLUTICASONE PROPIONATE], start date: 15Jun2006. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jun2022) negative; (30Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: The patient taking other medications/products within 2 weeks of starting COVID-19 treatment and  the patient previously received a COVID-19 Vaccine. Reported Event: Patient reported "I felt better after 2 days. I completed treatment on 24Jun Saturday and tested negative on Sunday 25Jun. After feeling good all week I got grad cold symptoms on Thursday 30Jun and tested Positive again. I still have cold symptoms but getting less by the day (04Jul now).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
She got her vaccine, and felt fine.  She came home and did what she had to do and when she went to bed she felt fine.  When she woke up yesterday she sat on the edge of the bed for a minute and then passed out and woke up on the floor.  She called the manager of the apartments and asked if she would come and help her get up.  She helped her and felt that she should call the paramedics, which she did, and they came out and checked her out and she was okay.  Later in the day the dizziness hit her again and she passed out again.  She finally managed to get to her phone again, she was not able to get up, and she called 9-1-1 and they came out and got her in the chair, but did not take her to the hospital.  She has not passed out anymore but she feels very dizzy and woozy and does not move fast.  She also had some nausea, but that is pretty much gone.  She has not called her doctor as it was over the weekend.
This spontaneous report as received from a 73 year old male consumer refers to himself. In September 2007, the patient was vaccinated with a dose of ZOSTAVAX, (lot#, and strength not reported), injection. Concomitant therapies included lisinopril, omeprazole (manufacturer unknown) and aspirin (manufacturer unknown)/biannual KENALOG shot. In approximately November 2012 (a year ago), the patient experienced appendectomy. On 08-NOV-2013, the patient developed a rash and was diagnosed with shingles. Consumer said that the rash was very red, with pustules, but only one pustule itches and describes his skin as tight, tender, blistered and that it was starting to feel like sunburn. He was also listless and fatigued, and had more frequent urination. The patient mentioned additionally said that SUDAFED made him dizzy. No lab diagnostics studies were performed. The patient sought medical attention by saw healthcare professional (HCP). Triamcinolone ointment and valacyclovir pills were given to treat the events. The outcome of the event was unknown. Upon internal review, the event appendectomy was considered to be medically significant. This is one of the several reports refer to the same patient. Additional information has been requested.
No additional AEreported; Dose of ROQUAD was administered Intramuscular; This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On 17-JAN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U009262 and expiration date reported as 19-SEP-2022), 0.5 milliliter, intramuscular for prophylaxis (incorrect route of product administration). No additional AEs or PQC reported.
R thigh hard, red & swollen.  Mom states area was 1/2 size of dollar bill yesterday.  Now 1/2 of his entire thigh is affected, its swelling also.  Pt's mom advised to go to ER.  L thigh.
Case number PHEH2013US023757 is an initial spontaneous report received from a pharmacist on 11 Nov 2013. This report refers to a 42-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with an expired dose of FLUVIRIN (batch number: 123303, expiry date: Jun 2013) at a dose of 0.5 ml intramuscularly on 18 Oct 2013. No adverse event was reported following the maladministration.
Patient alerted staff after 30 minute wait time that she was feeling some fullness/swelling to throat and some minor itching.  Patient denies any difficulty breathing, no rash or systemic itching noted.     Treatment/intervention VSS - patient appears in no acute distress is calm.  VS at 0955 Pulse 93, BP 142/82 spo2 93% RA.   Patient given 50mg PO Benadryl per protocol with sips of water.  Patient denies any issues with swallowing.  Lungs are course however, patient significant hx of COPD.  Patient able to take deep breath without overt difficulty. Patient states after 10 minutes that her s/sx have subsided and she is feeling better.  Advised to wait at least 15 minutes longer to ensure she is feeling better. Patient agreed to additional observation at clinic.  VS remained stable after administration of PO Benadryl. 1015 - bp 138/76, P 92, spo2 95 percent.   Patient stated no intention to go to walkin or ED - plans to go home, feels well.  Patient counseled to report to ED with new or worsening s/sx and to contact PCP to update. Patient verbalized understanding.
ACUTE ST ELEVATION MYOCARDIAL INFARCTION SPONTANEOUS DISSECTION OF CORONARY ARTERY
A day 1/2 after the shot, I started having  hallucinations. These lasted for 3 days.
Patient immedietly felt dizzy and nauseas within 1 second of recieving vaccine. Patient reported feeling hot and needing to vomit.  Symptoms lasted approximately 30 minutes.
sore throat; Stomach Ache; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), ABDOMINAL PAIN UPPER (Stomach Ache), CHILLS (chills) and HEADACHE (headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included CALCIUM, Vitamin D, OMEPRAZOLE and MACROGOL 3350 (MIRALAX) for an unknown indication.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), ABDOMINAL PAIN UPPER (Stomach Ache), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), ABDOMINAL PAIN UPPER (Stomach Ache), CHILLS (chills) and HEADACHE (headache) 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.   Concomitant medications includes Hair/Nail/Skin Vitamin, Multi-Vitamins and Thyroid Medicine.
VOMITING, HIGH FEVER UP TO 103, JUST WANTED TO SLEEP, DAZED , EAR INFECTION, LOSS OF APPETITE INCLUDING FLUIDS.
Developed a large, painful, red, hard, hot circle around the injection site starting the morning after my shot. It is now 3 days (2/15/21) after I received my second dose, and the area is still hard, painful and red. I had zero issues after my first dose, and have had a lot of reactions my second dose.  Other reactions with this shot were chills, aches, fatigue and headache which mostly subsided 2/14/21.
I had a runny nose and then chills with flu-like symptoms beginning on Tuesday February 28, 2023. I tested positive for COVID-19 on March 3, 2023. I was extremely fatigued for 2-3 weeks. My symptoms lasted about 10 days.
Presented to ED with complaints of shortness of breath , cough, chest congestion x2 weeks. Patient was found hypoxic in ED.  Tested positive for COVID 19 infection. Tx w/steroids, zinc, O2. Dc'd to SNF.
patient had cold sweats, chills, low grade fever of approx 99. Her arm is sore, symptoms occurred the following day
Pt reports 1 day after vaccination woke up with "swollen lymph nodes to left side of my neck and clavicle area", same side as vaccine administration. Called clinic on 8/5/22 because "my swollen lymph nodes have not gone away after 2 weeks and it still hurts". Advised to apply warm compresses intermittently and scheduled for follow up appointment to assess on 8/7/22. At time of visit she stated "the warm compresses helped and it is better now". On assessment on 8/7 noted a dime sized mobile, tender palpable lymph node to left supraclavicular area only. None noted to cervical chain or axillary.  No local injection site reaction noted. Pt does state "my lymph nodes have gotten swollen like this also when I had the covid vaccine but it only lasted 2 days". Last covid vaccine April 2021.
We both did come down with Covid-19 4 week's ago; We both did come down with Covid-19 4 week's ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 78-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), in 2022 as dose 1, single (Batch/Lot number: unknown) and in 2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had gotten all 3 of the Covid-19 shots last year ending with the booster in Nov2022. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "We both did come down with Covid-19 4 week's ago". The patient did come down with Covid-19 4 week's ago just 5 days after getting the high strength flu shot that doctor's give the elderly. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300361856 same reporter/drug/event different patient;
pt recvd vax 10MAY94 & 4 days post vax exp chills,sweats,tingling in arms,diarrhea,cramps,irritability,fatigue,& chronic sinusitis;sx principally fatigue & chronic sinusitis cont
After previously feeling no side effects, at 3am the day following the vaccine I awoke with chills, dizziness, fatigue, whole body arthralgias that I can only describe as feeling like my bedsheets felt like broken glass. Around 6am I measured my axillary temperature to be 100.9 F and took 650 Tylenol once which broke the fever. I was unable to go in to work that day. Now, two days after the vaccine, my other symptoms have resolved aside from a painful, and visibly noticable, lymph adenopathy in my left arm pit the same side as the vaccine.
rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site) in a female patient of an unknown age 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 VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN (body aches). On 15-Mar-2021, PAIN (body aches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-053563 (Patient Link).
CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient 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 administration not reported, batch number: 1805029, expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection. This report was non-serious.; Sender's Comments: Medical assessment comment is not required as per standard operating procedures
Patient developed cold like s/s on the 11/12 of January 2021. By the 15th of January patient became weak with mild shortness of breath and was sent to the ER. ER sent patient home.  Patient was sent back to ER on January 18th as she remained weak with shortness of breath and was unable to get out of bed. On the 19 of January the patient was sent to a SNF for rehab services in which she remains as of today. According to the patient's son the patient is doing better but still requires assist with mobility. Patient is not on oxygen.
patient haven't had the flu in over 30 years, except for the year patient got a flu shot; Initial information received on 13-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a patient who have not had the flu in over 30 years, except for the year patient got a flu shot (influenza).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date,the patient received a dose  of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious patient havenot had the flu in over 30 years, except for the year patient got a flu shot (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was influenza.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as unknown for event.  There will be no information available on the batch number for this case.
sweating, dizziness, nausea 3hr p/vax lasting x 7hr;still c/o dizziness next day when leaning over OK by 24hr p/immun;
Headaches, flu-like symptoms, SEVERE joint pain, dizziness, very short of breath and weak, ears ringing, severe fatigue, nerve sensations/tingling below my elbows and knees, feels like arthritis in all my joints, feels like my muscles and tendons are tearing, my hips feel like they have sciatica, no stamina what-so-ever, feet sting, severe back pain. Basically I hurt all over my body and feel like my nerve endings sting and my feet are on fire and my hair has been falling out.
Rash at site of injection. Swelling of bottom lip. Rash on hip area--left and right sides
Pt given adacel - recommended for ages 17-64.  LOT# C3098AA EXP 9/1/2011 L deltoid