chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dry heaves; lost 37 pounds; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaves), WEIGHT DECREASED (lost 37 pounds) and NAUSEA (nauseated) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus (diabetic for 4 or 5 years.).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced NAUSEA (nauseated). On an unknown date, the patient experienced RETCHING (dry heaves) and WEIGHT DECREASED (lost 37 pounds). The patient was treated with ONDANSETRON for Dry heaves, at an unspecified dose and frequency. At the time of the report, RETCHING (dry heaves) and WEIGHT DECREASED (lost 37 pounds) outcome was unknown and NAUSEA (nauseated) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication details was reported. Patient has never had Covid.   This case was linked to MOD-2022-542685, MOD-2022-542686 (Patient Link).
Started having shortness of breath/coughing around 5/2, had a video visit with dr on 5/6- prescribed Albuterol and allergy pill thinking it was related to allergies.   5/8 went to ER as continuing to have shortness of breath and coughing- in some cases was gasping for air.  Admitted to hospital, while they tried to figure out what was wrong- did several tests including COVID, raspatory panel and several others all came back negative.   Xrays, looked like "COVID lungs" per the dr but COVID tests were negative.   Had chest Xrays twice while in hospital as well as CT scan.   No identified cause but was diagnosed with community based pneumonia, one dr said "COVID era".  After 6 days in hospital released with o2 and dexamethasone regimen.   Seemed to get better, but then digressed approx. 5/25-  Dr prescribed 2nd round of steroids'  and asked for another chest Xray.   Xray showed some things they wanted to look at closer, had second CT on 5/28.   Based on that- diagnosed with Pulmonary Fibrosis-- still under treatment, Lung biopsy scheduled for 8/19/21
The flu vaccine triggered shingles (Herpes)- first time I have this; In the past no adverse reactions w/prior flu shots. Recovering
Patient with swelling on left upper deltoid and initially had numbness in her deltoid down to her fingers.  Numbness resolved one hour after taking ibuprofen about 4 hours after vaccine had been given;  Patient seen in office with localized reaction.
Pt experienced vomiting, diarrhea, dehydration. Pt was hospitalized for 20 hours with dehydration. Pt went into cardiac arrest and transferred to ICU where pt continued to arrest and sustained organ failure.Autopsy shows high fever, pleural effusion, acidosis, hyperkalalemia
Fever, headache, shivering, tiredness, muscle aches recognized at 2:00 am, 17 hours after vaccination.   Ibuprofen was taking to help with symptoms.
L shoulder area swollen, red and hot to touch. Mother states pt c/o pain and itching in area.
Headache started on the evening of 1/15, and lasted through the next day, but it was not terrible, Felt better on1/17 1nd 1/18.    On 1/19  began to feel achy, headache returned  and felt  feverish.  Temp reached 104, and could be brought down with Tylenol and fluids.  On 1/20 temp went back up to 103, again treated with Tylenol, fluids and rest which brought it down, It has spiked in the evenings and still today(1/23) has a fever of 100.9.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. A male patient received bnt162b2 (BNT162B2) (Lot number: FA6780) as dose number unknown (booster), single for Covid-19 immunisation; Covid-19 vaccine (COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. 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), outcome "unknown" and all described as "Had Covid after receiving the Covid-19 vaccine". Clinical Course: Her husband's brother and his wife also got Covid after being boosted. No further details, she doesn't know if they would want to report. Declines to complete a report for her husband's brother and his wife. Follow-up (28Mar2022): Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202200469651 same reporter/drug/AE, different patient.
Vasovagal syncope, I was taken out of the waiting room and laid down in a back room, they checked my blood pressure and let me go once my blood pressure increased again (I think this took 20-30 minutes; I'm not entirely sure)
01/03/2022:   Patient lives at home with her daughter and her husband.  History was obtained via the daughter who states her mother was having difficulty walking yesterday and had extreme fatigue.  Has not been complaining of chest pain, shortness of breath, cough, dysuria or abdominal pain.  She has not been eating or drinking for the past 2 days, and has also not taken her medication in that time. She had 2 falls due to weakness yesterday witnessed by the daughter. Patient's husband has been coughing for the past few days at home.  Both her and her husband are vaccinated however they have not for received their booster.  The patient's daughter is unvaccinated.  pulmonology was consulted for consideration of monoclonal antibody infusion, as patient's admission was not due to COVID-19. Patient received casirivimab and imdevimab.
PT did not have previous vaccine card unable to locate it, no picture of card, wife could not find it at home asked 3 times if received Pfizer pt stated "Yes"  no internet connection at this time, given Pfizer vaccine.  When finally got online found he had received Moderna vaccine 0n April 8,2021 at Pharmacy, which did not answer their phone previously.
Overall mild flu like symptoms; grogginess / tiredness.; grogginess / tiredness.; Mild headache; Overall 'hung over' like feeling; Later that evening, mild injection site pain and stiffness.; Later that evening, mild injection site pain and stiffness.; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 17Mar2021 10:00 (Lot Number: EL3248) as single dose (at the age of 39-year-old) for covid-19 immunisation. Medical history was reported as none. Patient had not known allergies. There were no concomitant medications taken within two weeks of vaccination. First dose of bnt162b2 (BNT162B2) was administered on 24Feb2021 03:30 PM in Left arm for COVID-19 immunization (at the age of 39-year-old), Lot Number: EL3248. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient stated that he received his second (2 nd) dose at 10am EDT. No initial adverse event (ae). Later that evening, on 17Mar2021 at 10:00 PM, mild injection site pain and stiffness. The next morning (at the time he was writing this) more significant injection site pain. On 18Mar2021, overall mild flu like symptoms; grogginess / tiredness. Mild headache. Overall 'hung over' like feeling. Patient was a Pfizer employee and received both doses at a Pfizer site as part of the employee vaccination program. Patient was not treated for the events. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient was recovering from the events. No follow-up attempts are needed. No further information is expected.
Swollen lymph node in my left armpit; Pain radiating from swollen lymph node my entire left side of upper body; pain radiating from swollen lymph node my entire left side of upper body; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 09Dec2021 at 16:00 (Lot number: unknown) at the age of 37 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0185, vaccine location: Left arm, Administration time: 16:00), administration date: 19May2021, when the patient was 37 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0180, vaccine location: Left arm, Administration time: 16:00), administration date: 09Jun2021, when the patient was 37 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 at 16:00, outcome "unknown", described as "dose received: 3"; LYMPHADENOPATHY (non-serious) with onset 11Dec2021 at 01:00, outcome "recovering", described as "Swollen lymph node in my left armpit"; LYMPH NODE PAIN (non-serious), PAIN (non-serious) all with onset 11Dec2021 at 01:00, outcome "recovering", both described as "pain radiating from swollen lymph node my entire left side of upper body". The events "Swollen lymph node in my left armpit" and "pain radiating from swollen lymph node my entire left side of upper body" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain and pain.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
I got the Moderna vaccine and 4 hours later had diarrhea throughout the night and next day.
Pt was administered Hep B and IPV vaccine at 9AM and pt died of unrelated causes at 12 noon same day. Case is in hands of medical examiner and has ruled out vaccine reaction as cause or contribution to death. Term added from Autopsy report rec'd 12/21/2005: SIDS/sr
Influenza vaccine administered instead of Tdap on 10/10/2023. Recently received quad influenza vaccine on 10/2/2023.
22 minutes after the vaccination, the patient reports tingling and felt "fat" in the lips and back of the tongue. VS stable. The patient looks well and in no acute distress. Has a history of multi-drug allergy and seasonal allergy. 50 mg Benadryl given orally. Symptoms improved shortly and resolved before leaving the site. Stable throughout.
Tested Positive for Covid19 on 19APR2021, after receiving his second dose of the Covid Vaccine on 8MAR2021.; Tested Positive for Covid19 on 19APR2021, after receiving his second dose of the Covid Vaccine on 8MAR2021.; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 08Mar2021 (Lot Number: EL9269, at age of 65 years old) and first dose on 15Feb2021 (Lot: EN6200), both as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first vaccine dose of BNT162B2 on 15Feb2021 for COVID-19 immunisation, LOT: EN6200. The patient Tested Positive for Covid-19 on 19Apr2021, was diagnosed with Covid19. The patient stated that was going to require glasses he thought when asked to read the numbers off of the vaccine card. Treatment: None. The outcome of events was recovered on 27Apr2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021484060 same drug/reporter/event, different patient
Approx 1 1/2 hrs post injection pt. became hot and flushed. Hands became clammy. At approx 0630 pt. having difficulty breathing and itching. Pt. seen in ER and treated with IV Solumedrol, BENADRYL, Epi. Pt dc'd home and returned back to ER with chest tightness. Treated with Solumedrol, BENADRYL, Epi and Vistaril. Pt. admitted for observation then transferred to ICU.  12/09/09 MR received for DOS 11/14/09.  DX: Allergic reaction.  Pt presented with wheezing, stridor, chest tightness, rash, pruritus. tx: EpiSQ, vistaril, Solu-medrol, Methylprednisolone. Pt discharged home in stable condition.
Patient is still having arm soreness as of 1/7/20 and have trouble using it like driving. She will see orthopedic md 1/9/20
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 12-OCT-2012 08:19, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Severe headache that doesn?t go away with ibuprofen or acetaminophen. Very tired. Muscle pain for 1 of the past 3 days.
injection site arm warm; A spontaneous report was received from a 72-years-old  female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event injection site arm warm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date in Feb 2021, the patient experienced the event injection site arm warm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, injection site arm warm was not recovered.
Left arm swelling, shortness of breath, leg pain, generalized discomfort 4/5/21 - was seen at Urgent Care - no orders 4/6/2021 - seen at Hospital ER - CT showed blood clots/pulmonary embolism of left arm and lungs and lymph nodes. Received IV fluids in ER.  Kept overnight for observation and discharged from hospital next day. Sent home on Eliquis and Prednisone
Local redness and swelling (cellulitis) at site of injection. Redness and swelling started day following immunization. Treated cellulitis with SEPTRA DS.
A non-serious spontaneous report of ER gave FLUMIST to a 54-year-old patient was received from a licensed practical nurse concerning a 54-year-old female. The patient's medical history and concomitant medications were not provided. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event was considered resolved.
A red, raised, closely clustered, rash of small spots covered patients body for approximately 7 days after DTaP vaccination, at which point the rash dried and disappeared. The rash appeared approximately 24 hours after administration of the vaccine. The DTaP vaccine was the only shot administered. Patient who was an established walker since 10 months of age also appeared clumbsy and off-balance. Patient began to walk with head to the side or infront of his body within 24 hours after the vaccination and repeatedly bumped into things and fell alot. Patient also ran a fever of 102 deg. within a few hours of the vaccination which lasted approximately 48 hours, accompanied by general grumpiness and whining and had restless sleep for the week following the DTaP vaccination.
4 days post vaccination, patient developed acute abdominal pain, appendectomy 08/22/2019, discharged from hospital 08/25/2019
Reddened neck and chest. Warm to touch, flushing of face within 15 minutes of vaccine. Patent airway. Pt to take PO Benadryl. Offered to call EMS pt declined. Patient stable, rash fading prior to her leaving.
No Adverse Reaction.  Reporting Administration Error Only.  Patient was inadvertently given an extra booster due to documentation error from host SNF.  F/U 2 days later revealed that patient's status is still normal.
"Moderna COVID-19 Vaccine EUA"  Became feverish during the night after the vaccine.  By morning fever was around 100.  Stayed between 100 and 101 all day.  Next day fever stayed between 99 and 100 all day.  By the following morning fever broke.  Not much appetite.  No other symptoms.  Treated symptoms with Tylenol.  By third day, feeling better.
2 hours after injection developed a headache throbbing posterior. This was followed by persistent headache, nausea and then dizziness. Local ER informed patient this is a side effect. In ER 1 week post injection. No peripheral neuralgia.
EXTREME SWELLING AND PAIN AT SITE couldn't Raise arm Bruising to Elbow towards inner arm from shot given down
7 days after the vaccine I developed a severe rash on my torso requiring urgent care visit. Now 24 hours later, rash has spread to neck, face, legs; is responsive to Benadryl (somewhat) and was prescribed cortisone
This spontaneous report was received from a Certified Medical Assistant referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 02-MAY-2016, the patient was vaccinated with an expired dose of VAQTA lot #: L018498, expiration date on 28-APR-2016 (strength, dose number, route and anatomical location were not provided). There was no concomitant medication described. No adverse effects were reported. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Mar2021 as dose 1, single (Batch/Lot number: unknown), on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 27Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic type 1" (unspecified if ongoing), notes: Other medical history: Diabetic type 1. Concomitant medication(s) included: LISINOPRIL.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (24Jun2022) Positive, notes: Tested slightly positive on 24Jun and 25Jun; (25Jun2022) Positive, notes: Tested slightly positive on 24Jun and 25Jun; (26Jun2022) Negative, notes: negative on 26Jun and 27Jun; (27Jun2022) Negative, notes: negative on 26Jun and 27Jun; (28Jun2022) Positive, notes: positive on 28Jun, 29Jun and 30Jun; (29Jun2022) Positive, notes: positive on 28Jun, 29Jun and 30Jun; (30Jun2022) Positive, notes: positive on 28Jun, 29Jun and 30Jun. Therapeutic measures were taken as a result of covid-19.  Additional clinical information: Anti-viral details, Product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=19Jun2022,Treatment Stop date=23Jun2022. Adverse event: Rebounded after treatment. Tested slightly positive on 24Jun and 25Jun, negative on 26Jun and 27Jun and positive on 28Jun, 29Jun and 30Jun. Other medication in 2weeks product=Lisinopril. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
11/19/22 presents to ED for "vomiting" "lethargy, body aches and generalized weakness". PMHx of "chronic A fib on coumadin, GERD, HTN and hypothyroid"
Case number PHEH2012US016142, is an initial spontaneous report received form a pharmacist on 14 Aug 2012. This report refers to a 12-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with two MENVEO (batch number: X11052, Expiry date: Mar 2014; A11052, Expiry date: Apr 2014), injections at different pharmacies on the same date of 14 Aug 2012. No adverse event was reported.
patient experience slight congestion; This is a spontaneous report from a contactable physician (patient) via Pfizer Sales Representative. A patient of unspecified age and gender received bnt162b2 via an unspecified route of administration on an unspecified date at single dose for administration of Covid-19 vaccine.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced slight congestion on an unspecified date with outcome of unknown. Event took place after use of product. Information on the lot/batch number has been requested.
diagnosed with COVID; diagnosed with COVID; This is a spontaneous report form a contactable consumer. This consumer reported for a 5-decade-old (mid 40's) patient of an unspecified gender, who received both doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection); dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single; and received dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single; both for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that reporter have a friend who has two patients, mid 40's, with no underlying health issues, fully vaccinated with the Pfizer product for over 2 months who have recently been diagnosed with COVID on an unspecified date. On a unknown date, after vaccination, patient experienced COVID and drug ineffective. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was reported as unknown.  Information on batch/Lot number was not received. Further information has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021873180 same drug/event/reporter, different patient
One shot in right arm for flu and pneumonia pain in right when lying on left arm - need to change to right side to relieve pain - pain continues as of 03-11-15.
Pharmacist unsure of which vaccine administered in (R) arm. Patient has body ache and chills next day. Currently has 5 cm erythema to (R) arm surrounding injection site. Hardness palpated under skin.
Aside from more arm pain than expected- more pain than flu and guardasil.  That resolved after 3 days.  Then my left breast felt tender.  Then my right breast.  They are both tender and swollen.   Feel like I?m in my 20?s and  preparing to menstruate.  Or? I?m pregnant for my first and only time and my breasts are are so tender and swollen in prep of feeding a baby.  I?m 45.  I?m not pregnant- my tubes are tied.  My boobs hurt in such a way that only registers as hormonal.    Like- I?ve got Plan B in my system.  I did that once years and years ago.  I?ve not ever experienced other breast pain.  They feel heavy, tender, uncomfortably sensitive and sore.     I?ve got swollen glands on my head, under my hair and at  the base of my skull on the left side.