chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at injection site) in a 56-year-old female 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 Rheumatoid arthritis.    The patient's past medical history included Surgery (from 30 years ago botched surgery). Concurrent medical conditions included Diarrhea (Since 1992, the patient had ongoing diarrhea).   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In February 2021, the patient experienced VACCINATION SITE PAIN (sore arm at injection site) (seriousness criterion medically significant). In February 2021, VACCINATION SITE PAIN (sore arm at injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant details were provided.  It was unknown if patient was enrolled in a COVID-19 vaccine trial. No treatment details were provided. Company comment: This spontaneous case concerns a 56-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Medically significant) event of Vaccination site pain. The exact date of onset of the event was not specified in respect to the administration of first dose of mRNA-1273, hence latency could not be assessed. Details of concomitant medications, clinical course and treatment were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per source document.   This case was linked to MOD-2022-584726, MOD-2022-584795, MOD-2022-584796 (Patient Link).; Sender's Comments: This spontaneous case concerns a 56-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Medically significant) event of Vaccination site pain. The exact date of onset of the event was not specified in respect to the administration of first dose of mRNA-1273, hence latency could not be assessed. Details of concomitant medications, clinical course and treatment were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per source document.
Injection site pain, stiffness, weakness in the right shoulder from 8 pm until 8 am following day.  On 2/20/21 (2 days later), had sudden episode of body aching, weakness, tachycardia, extreme fatigue, nausea that lasts 1-2 hours .  on 2/22/21 again had episode suddenly of shaking, aching, nausea, stomach pain, fatigue, chills, no fever, clammy skin that lasted 1-2 hours
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (lot # L030869, expiry date 08-JUN-2018) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with LIQUID PEDVAXHIB was unknown. There was no product quality complaint reported. It was reported that the vaccines were exposed to a temperature of 32.4 degrees farenheit a cumulative total of 13 hours. This is one of the 3 reports from the same source. Additional information has been requested.
Pt came to pharmacy on 8/25 night and complained that her left arm felt heavy since the flu shot on 8/21/10 and hard to lift and the degree does not decrease.
This spontaneous report was received from a medical assistant referring to a multiple unspecified patients. There was no information about the patients' concurrent conditions and medical history provided. The patients' concomitant medication included sterile diluent (MERCK) which was properly stored. On an unspecified date in December 2017, the patients' were vaccinated with an improperly stored dose of PROQUAD (dosage, frequency and route of administration were not reported), lot#: N013295 (expiration date: 28-APR-2019), lot#: N012489 (expiration date: 17-OCT-2018) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.6 F) for 15 hours, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. Lot number N013295 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. This is one of four reports received from the same source. Sender's Comments: US-009507513-1802USA008842: US-009507513-1802USA008838: US-009507513-1802USA008839: US-009507513-1802USA008840: US-009507513-1802USA008836: US-009507513-1801USA014257: US-009507513-1802USA008837: US-009507513-1802USA008835.
fatigue; vomiting (cramping in stomach that caused pain; chills; feverish; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), VOMITING (vomiting (cramping in stomach that caused pain), CHILLS (chills), PYREXIA (feverish) and PAIN (body aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FATIGUE (fatigue), VOMITING (vomiting (cramping in stomach that caused pain), CHILLS (chills), PYREXIA (feverish) and PAIN (body aches). At the time of the report, FATIGUE (fatigue), VOMITING (vomiting (cramping in stomach that caused pain), CHILLS (chills), PYREXIA (feverish) and PAIN (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This is a spontaneous report from a contactable physician. A 57-year-old female patient of an unspecified ethnicity received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) for immunisation. The  medical history and concomitant medications were not reported. The patient experienced allergy to the vaccination -"blisters". Event outcome was unknown.
received the 1st dose in 2021 and did not get the 2nd due to COVID; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 15-JUL-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient stated that he/she did not get the second shot because of Covid. The patient asked that did he/she need to restart the series. Additional supportive information: The patient did not get the second shot of Shingrix because of Covid, which led to Social problem. The follow-up would not possible, as no contact, details were available.
severe allergic reaction; This is a spontaneous report from a contactable consumer (patient's Sister). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced severe allergic reaction on an unspecified date with outcome of unknown. There was an article in the paper about how he almost died and he was called up by a doctor who he talked to this was person was wanting to do a study. The reaction was a couple weeks later, clarified as 3 weeks later after receiving his Pfizer COVID vaccine that the patient had a severe allergic reaction. Reporter seriousness for severe allergic reaction: Hospitalization.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
presents to ED on 11/1/2021 with 6 days of fevers, cough, myalgias, fatigue, worsening dyspnea and diarrhea. Unclear exposure but has been spending time with his spouse and adult daughter. Vaccinated in April 2021. He noticed today that his cough and dyspnea were getting worse and his spouse insisted he come to the hospital. Patient admitted to ICU for increased O2 requirements, is still admitted at the time of this entry.
Petechial rash possibly associated with immunization 4 days prior. No treatment required, observation at hospital, no infectious etiology. no fever.  Additional terms from Dis. Summary rec'd 11/28/2005 -- splenomagaly and purpura/sr
I woke up with a sore throat in the middle of the night of July 3/4, 2022. On July 4, 2022, I took a nasal swab to test for COVID-19. The result was negative. Knowing I had been exposed (my husband had tested positive a week earlier), I took a second test and swabbed my throat instead; that test was positive.
Severe headache, fever, chills, body aches for approx 12-14 hours
Child was accidently administered the whole undiluted vial of the Pfizer Covid 6 mos to 4 year dose
Within 24hrs of administering TDAP 0.5ml IM left deltoid. The injection site swelled to the size of a tennis ball. C/O moderate pain. Pt was still able to perform activities of daily living. No fever, no drainage and no extra heat noted to injection site. Pt left yesterday morning to go commercial fishing. He denied need for medical attention now. Agreed to seek medical attention only if condition worsens.
within a minute of receiving the vaccine patient was dizzy, nauseated and vomited . Blod pressure went down to 98/68( was 106/68) on entry. Kept in trendelenburg position, it took one hour for patient to be able to sagfely walk out of clinic with her mother.
pt recvd vax & 12AUG92 same day devel rash lasted for 2 wks;
Temperature 100.8 and Slightly Fussy. Mom gave Tylenol 2.5 ML every 4 hrs as needed.
About two days after my 2nd vaccine, my was swollen and extremely red above the injection site. Soon after, I developed a rash (starting on my back).  Eventually the rash moved to my face (including scalp), behind my ears, arms, and legs.  This morning, June 14, 2009, I woke up with blunt pain in the joints of my right thumb.  I have taken anti-inflammatory medicine (ibuprofen), and have applied cortizone cream to the rash areas.  Nothing is helping.
complete brain fog, could not think, plan or organize at all; it incapacitated her thought process; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from the Medical Information Team, Program ID. The reporter is the patient.  A 73-year-old female patient received bnt162b2 (BNT162B2), on 25Feb2021 at 08:00 as DOSE 2, SINGLE (Lot number: EN6200) at the age of 73 years, administered in the left arm for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (first dose (Pfizer COVID Vaccine), via an unspecified route of administration (batch/lot number: EL9264) as DOSE 1, SINGLE), administration date: 29Jan2021, when the patient was 73 years old, for COVID-19 Immunization. The following information was reported: BRAIN FOG (non-serious) with onset 25Feb2021 at 14:00, outcome "recovered" described as "complete brain fog, could not think, plan or organize at all"; THINKING ABNORMAL (non-serious) with onset 25Feb2021 at 14:00, outcome "recovered" described as "it incapacitated her thought process." Therapeutic measures were not taken as a result of brain fog, thinking abnormal.  Additional information: Initial inquiry from patient was reported as follows: "I am a believer in vaccines in general. I have had four Pfizer Covid vaccines so far. The second vaccination produced a strong reaction. Now, many months later I am experiencing/have experienced since March, some symptoms of being a long hauler. I would like Pfizer's advice on the safety of me getting the new vaccine this fall. Thank you." Dosage text was reported as "unknown dose injection with a syringe left upper arm." Indication reported as "scared to get Covid." On 19Sep2023 follow-up, patient stated one reaction she had that was finite took place after second vaccination on Friday morning at 8:00 in the morning and by 2:00pm had complete brain fog, could not think, plan or organize at all. Otherwise, she was fine, but it incapacitated her thought process. Since she had reaction that lasted 36 hours had no other reactions after second, third or fourth injection.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300304621 same patient and product; different dose and events;
MOM CALLED OFFICE STATING HE WOULD NOT STAND OR WALK, PAIN IN LEGS. NO BRUISING OR SWELLING, WAS SEEN IN OFFIC ON 10/9/09 AND NO TREATMENT GIVEN
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD lot # N001489, expiration date 12-JUL-2018 for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). The vaccines and sterile diluent(STERILE DILUENT) were excursed under -9°C to 8°C for about 15 minutes. Digital data logger involved. No adverse events reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA004400:
Shaking violently; Could barely speak; Temperature began to rise, stopping at 99.9; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2022 15:00 (Lot number: FMO698) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Dairy" (unspecified if ongoing), notes: Verbatim: Known allergies: Dairy; "COVID-19" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EWO217, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 02Aug2021, when the patient was 29 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EWO180, Location of injection: Arm Right, Vaccine Administration Time: 02:30 PM), administration date: 12Jul2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: TREMOR (non-serious) with onset 27Feb2022 03:00, outcome "recovered" (Feb2022), described as "Shaking violently"; DYSARTHRIA (non-serious) with onset 27Feb2022 03:00, outcome "recovered" (Feb2022), described as "Could barely speak"; PYREXIA (non-serious) with onset 27Feb2022 03:00, outcome "recovered" (Feb2022), described as "Temperature began to rise, stopping at 99.9". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tremor, dysarthria, pyrexia.  Additional information: 14 hours after my 3rd shot (booster) I woke up at 3am shaking violently, so badly patient could barely speak. Patient did not have a fever at the time (97.9). This lasted for 30 minutes. Shortly after the tremors stopped, patient noticed that my temperature began to rise, stopping at 9.9. No other vaccine in four weeks. Yes Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Achy feeling all over started and headache 45 minutes after shot received, but able to still function.  Took Tylenol 1000 mg about 3 hours later due to achy feeling getting worse.  About 9 hours later achy feeling worse, low-grade fever and feeling cold.  About 2 hours later chills and uncontrollable shivering began.  Oral temp was 100.3. Took 400 mg of Ibuprofen and chills stopped about 30 minutes later.  Slight feeling of nausea, but never had emesis.  Woke up about 9 hours later feeling very achy and very weak and tired.  Had a low grade fever, took 400 mg of Ibuprofen and it didn't drop the fever or help with achiness.  Achiness continued throughout day and low grade fever continued throughout day.  Highest temp during day was 100.3 and lowest temp was 99.3.  Took Ibuprofen 400 mg again about 4 hours after last dose due to having temp of 100.3.  About 27 hours later from time of shot,  still feeling achy and weak and when I try to do simple, like getting dressed, wears me out and I have to lay down and sleep for a while.  Dizziness comes on when I stand up every once in a while but goes away in a few seconds.  I have had pain at the injection site from the time of the shot until now (pain when site touched or when I move my right arm).  Currently about 31 hours later achy feeling still ongoing, but feel a little bit more strength and energy.
Facial swelling with lip swelling, first dose; Facial swelling with lip swelling, first dose; Rash on leg, first dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SWELLING FACE (non-serious), LIP SWELLING (non-serious) all with onset 22Oct2021, outcome "recovered" (31Oct2021) and all described as "Facial swelling with lip swelling, first dose"; RASH (non-serious) with onset 22Oct2021, outcome "recovered" (31Oct2021), described as "Rash on leg, first dose.".  Additional information- Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Adverse event facial swelling with lip swelling on 22Oct2021 around 10:30AM or 11:00AM after first dose. Rash on leg around 1 PM after first dose. Relevant Tests were none. Caller asks that she was due to get her second dose, and she has heard the second dose was more intense. Patient did not visit any emergency room and physician office due to adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recv vax on 7/24/98; on 8/7/98 pt exp swollen right face w/ eye shut, splotches on stomach, legs &back, fever, noisy breathing; tx="oral medicine, 2 shots"
(+) erythema, (+) increased warmth at site of immunization (+) SOB.
Rash, itching & burning, started approx 4 hrs after administration. Within 24 hrs, erythemous, macular papular rash with epidermal sloughing, involving axillary region. Rx'd Depmedrol 80mg/IM and Atarax 25mg/po.
49 yo male h/o coumadin for DVT 2013 and family hx of leukemia vaccinated 01/14/2021 and noted purpuric rash and nose bleed without clos 01/18/2021 but denies bleeding gums or blood in stool or blood in urine. denies asa or nsaid usage . platelet count on cbc drawn 01/21/2021 was normal
Injected site swelling, pain, redness & hot to the touch.  Nausea, loss of appetite, vomited once on 2/23, headache, lethargic. Feeling off since 2/22.
Open sore at injection site oozing clear fluid; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 77-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown Expiry date: unknown) via an unspecified route of administration in left arm on an unspecified date as single dose for COVID-19 immunization. Patient medical history included known allergies to penicillin, codeine. Patient concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 05Feb202 at 10:15 AM for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not diagnosed with COVID-19. On 28Feb2021 at 08:30, patient experienced open sore at injection site oozing clear fluid. Patient did not receive the treatment for event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from certified medical assistant refers to an unspecified number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown dates the unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ oral solution, (dose, dose number, lot number and expiration date were unspecified). No adverse effects reported. No concomitant therapies were reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
dizziness/light headed, cold, clammy and sweating in face, fainted, then vomited. Occurred 4 hours after shot was given.
Red arm, swelling, pain lasting 2.5 weeks in left arm radiating down to hand, pain in left breast, cold sore formation (already chronic condition, but did not have one before vaccine)
Vaccine was given at 10:30 in AM. Feeling slight pain and swelling on the arm and fatigue for the rest of the day. Went to bed at 11:30 PM  because feeling tired and having headache. Immediately  started getting shaking chills, rapid heart beat, shortness of breath and stridor. Got up (feeling dizzy and weak) and took one tablet of Ibuprofen. Difficulty breathing and stridor continued for about 15 minutes and resolved, but the shivers continued for over 2 hrs. Could not sleep for the rest of the night but started feeling better. I had nausea in AM  and could not eat breakfast. I am a retired physician (MD)and did not seek any medical attention immediately and the symptoms resolved rather quickly. It appears as I had
Patient received flu shot on 10-5-20. Redness had spread by the next day with swollen and warm to touch at site & itchy and & pain. He went to urgent care the next day 10-6-20. He was told to use hot packs and started antibiotic and Primary rechecked 2days later
Distinct one inch long linear erythematous lesion associated with prodromal burning and tingling sensation appeared under opsite dressing, one inch posterior to fully scabbed vaccination site on day 36. Minimal serous exudate seen on dressing on day 36, insufficient to test.  No lab testing performed.  Lesion healed in 48 hours.  Famcyclovir TID X 5 days starting day 36.
One week after flu vaccination developed numbness in hands/feet.  Weakness in extremities progressed.  Seen by PCP as well as another clinic.  Diagnosed with Guillain Barre Syndrome in Novemeber 2006.  Pt with continued weakness.  Uses walker.  Unable to perform ADLs. Medical records state pain, gait abnormal, reflexes decreased. msv I believe he still has weakness, fatigue, decreased endurance.  According to patient report.  May contact patient for further information at phone # listed.
ACUTE DVT, UNSPECIFIED VEIN ACUTE DVT OF BILAT FEMORAL VEINS