chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red rash on injection site arm; red rash on injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red rash on injection site arm) and VACCINATION SITE RASH (red rash on injection site arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red rash on injection site arm) and VACCINATION SITE RASH (red rash on injection site arm). The patient was treated with CORTISONE for Rash, at a dose of UNK UNK, qd. At the time of the report, VACCINATION SITE ERYTHEMA (red rash on injection site arm) and VACCINATION SITE RASH (red rash on injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.
Did you/the patient previously receive a COVID-19 Vaccine?: Yes; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 03May2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 24Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 21Jun2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos Thyroiditis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing), notes: high cholesterol under control with meds; "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex allergies-rash/hives/itching; "rash" (unspecified if ongoing), notes: known allergies: Latex allergies-rash/hives/itching; "hives" (unspecified if ongoing), notes: known allergies: Latex allergies-rash/hives/itching; "itching" (unspecified if ongoing), notes: known allergies: Latex allergies-rash/hives/itching. The patient took concomitant medications. The following information was reported: COVID-19 (medically significant) with onset Nov2022, outcome "unknown", described as "COVID 19 Treatment"; VACCINATION FAILURE (medically significant) with onset Nov2022, outcome "unknown", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid from 28Nov2022 to 03Dec2022 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swelling to hands, fingers, and feet rec'd vaccines on 7/18/13 at 11 am - at 4-5 pm mother noticed swelling in one finger. Pt woke up on 7/19 hands/feet very swollen - no resp involvement.
This spontaneous report as received from a 78 year old male consumer reporting on himself who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The consumer reported that he was experiencing in approximately August 2013, skin irritation and he was going to see his health care provider to determine if this was shingles. At the time of the report, the patient's outcome was unknown. The relatedness for skin irritation and ZOSTAVAX was unknown. Additional information is not expected.
A 12 month old was administered an improperly stored MMRil Vaccine and an improperly stored VAQTA Vaccine; No additional AE; This spontaneous report was received from a physician referring to a 12-month-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, concomitant medications and previous drugs reactions or allergies were not provided.  On an unknown dates, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA)  and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location, lot number and expiration date were not provided) (product storage error).  No adverse events were reported for the patient.      According to the reporter, the temperature excursion was above 9 degrees Celsius (8.81 degrees Celsius) for a time frame of 1 hour and 30 minutes on an unspecified date, with previous temperature excursion of above 9 degrees Celsius (8.69 degrees Celsius) for a time frame of 1 hour and 30 minutes, and above 9 degrees Celsius (8.68 degrees Celsius) for a time frame of 13 hours; which was detected by a digital data logger.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2010USA002664:
She tested POSITIVE for COVID-19; She tested POSITIVE for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 86-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Congestive Heart Failure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She tested POSITIVE for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: She tested POSITIVE for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I passed out for a few minutes (unsure of amount of time) on the toilet 8 hours after receiving the dose, then proceeded to become nauseous and vomit, unable to hold down water for a few hours.  Next day, low energy, pain in injection site and slight headache.
I started having incidents of blacking out and falling down once a day.  After that it happened four times in one day.  I couldn't get up and they called an ambulance and took me to hospital.  At the hospital, I was there for 8 days of diagnostics before I was discharged.  They discharged me with diagnosis of Syncope.
presented to ER after 3 days of diarrhea nonbloody, 1 day of severe abdominal pain. no trauma. ended up going to surgery and a large amount of intraperitoneal blood clots.  per surgeon, no clear active bleeding, no perforated viscous.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 24-APR-2015 the patient was vaccinate with a dose of improperly stored VARIVAX (Merck) (lot # K021936, expiration date: 10-NOV-2016, subcutaneous, dose not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
anaphylaxis; A spontaneous report was received from a hospital CMO concerning a patient who was a frontline worker and received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date in Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 29 Dec 2020, it was reported that the frontline healthcare worker experienced anaphylaxis. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, anaphylaxis, was not reported.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting anaphylaxis.  The event is possibly related to the vaccine, and additional information including temporal relationship between dosing and event and whether patient has history of anaphylaxis could provide details needed for medical assessment.
09/19/12 Patient c/o excruciating pain "entire body hurts". Started 4 days after receiving Tdap. States every muscle in charley horsing & cramping pain --> Tx increased fluids, TYLENOL, FLEXERIL, check CK.
fever; chills; Diarrhea; fatigued; staying in bed because is sick; joint pain; muscle pain; coughing up mucus/cough; difficulty tasting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), DIARRHOEA (Diarrhea), FATIGUE (fatigued) and ILLNESS (staying in bed because is sick) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0D1B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN (NEURONTIN) for Neuropathy, CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (chills), DIARRHOEA (Diarrhea), FATIGUE (fatigued), ILLNESS (staying in bed because is sick), ARTHRALGIA (joint pain), MYALGIA (muscle pain), COUGH (coughing up mucus/cough) and DYSGEUSIA (difficulty tasting). At the time of the report, PYREXIA (fever), CHILLS (chills), DIARRHOEA (Diarrhea), FATIGUE (fatigued), ILLNESS (staying in bed because is sick), ARTHRALGIA (joint pain), MYALGIA (muscle pain), COUGH (coughing up mucus/cough) and DYSGEUSIA (difficulty tasting) 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.   Treatment Medications were not provided by the reporter.
1825 Patient reported feeling "Shaky", patient reports having same reaction with first vaccine and was observed in ED for 90 mins, had increased BP at that time that resolved by discharge. 1825 BP 156/101 HR 80 Patient declined ED, food, drink and had a rapid response nurse friend at chairside.  assessment repeated at 1840  B/P 136/94 HR 80,  1850 BP 140/100 HR 75 pt. reporting feeling better.  Pt. reported feeling much better and left with friend at 1900.
Shortness of breath and weak - patient was given Epipen x1 dose Benadryl IM 25 mg  Patient was tachypneic and hyperventilation very lethargic  patient did not feel better EMS called by 911 and was transfer to eth ER and spoke with the Dr who was triaging patient at the ER 10 :14 SAT 97-%, hr - 87 BP -111/78  10:21 am 99  hr- 98 bp 138/79  no wheezing patient had near syncope episode and was very weak had to be supported for transportation and was listless all through, no stridor or
Arm is still bruised at vaccine site.  Much less so than initially; however, I thought it worth noting since it?s been 3 months.
This spontaneous report was received from a consumer, as part of a marketing research study referring to a 18 month old female patient. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with MMR (manufacturer unknown) (lot number, dose, route and anatomical location unspecified) and the patient experienced autism (onset date reported as 21 years ago) following vaccination. At the time of the report, the patient had not recovered from autism. The causality between autism and MMR (manufacturer unknown) was unknown. The primary reporter considered autism to be an other important medical event and immediately Life threatening (reported as severe). Additional information has been requested.
Patient had a large, warm red area on her right arm - about 4 inches in diameter. She stated that the area was itchy.
reactive lymphadenopathy poss r/t vax;swollen glands in neck, h/a, minor sore throat;anterior & posterior cervical lymphadenopathy, mandibular lymphadenopathy, inguinal lymphadenopathy 5//14/99;
Finding related to left upper arm, a 12 x 13 cm area of increased warmth and erythema left deltoid region. Central punctum noted.
65yo rec'd routine TD 3wks ago; that day had sl itching of the arm; developed swelling of entire deltoid w/warmth & tenderness; most of this resolved x/knot size of quarter @ inject site;
The baby had a low grade fever that started in the early hours of the morning the day after the vaccine. At some point one of the four vaccine sites became swollen and red. I treated with a cold compress but saw no immediate improvement yet. I considered both of those reactions to be fairly normal. Almost 24 hours after the vaccine the baby became unusually fussy and then forcefully (not quite projectile) vomited an entire feeding. As I type he's currently sleeping after the event.
On February 18th - My dad started with fever/chills within the next day after getting his second shot, stopped eating/lost appetite, couldn't eat anything - couldn't eat any solid food - only had liquids and Ensure for 10 days.  He has also experienced pain in his chest pain (unclear if muscle pain).  He is still experiencing discomfort.    Has lost weight. Then got a little better for 2 days, then lost appetite and unable to get out of bed.  Then arm and legs swollen on 3/9/2021 but swelling has gone down today. He is conscious but is having a hard time getting out of bed and has no energy.
Patient received DTAP immunization on 01/24/2005; Mother called today and reported that left thigh was swollen, child seen by doctor, child has erythematous patch on left thigh about 8cm in diameter - no induration.  Ordered to continue with Tylenol and return in 1-2 days if not resolved.
pt exp shoulder pain @ the side of inj had approx 50 cent piece size, small superficial area of erythema;
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (005570). A 70-year-old patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Feb 7, 2021; and received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Feb 27, 2021, single dose, for COVID-19 immunisation. Medical history included allergic to cats (unspecified if ongoing). The patient took concomitant medications. The patient reported pain (local soreness for a couple of days), with outcome of recovered. Additional information: There was no problem except local soreness for a couple of days. The patient regularly takes steroid inhalant for reactive airway disease. The patient would like to know whether taking steroid inhalant (before and after administration of vaccine)/if this steroid (in particular) changes antibody generation or other response to COVID-19. No follow-up attempts  possible. Information about batch/lot number cannot be obtained. No further information expected.
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.
pt recvd vax 24NOV93 & 26NOV93 devel a bumpy area @ the site of inject; 5 to 6 days following inject exp stiffness & tenderness in elbows & lacked ROM; several days later devel stiffness in both knees
Vertigo, inner ear pressure, nausea, constant dizziness even when laying down, pressure headaches that I?ve never experienced before, severe anxiety paired with unprovoked rage which is exceptionally abnormal for me, unusually heavy period with at least double my normal amount of clotting
Patient is a 87 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot EN6208 on 3/11/2021. The patient experienced the following reaction(s) during the immediate of observation: 1:50pm: Patient c/o dizziness during observation period. Reports PMH of CHF, HTN, CKD, arthritis, glaucoma, and defibrillator. Patient unable to provide home medication list. Patient has allergy to penicillins. Patient was treated/managed as follows:  1:55pm: VS BP 110/64, HR 75, RR 18, O2 sat 97% on room air. Patient reports "feeling better." 2:05pm: VS BP 122/60, HR 75, RR 18, O2 sat 96% on room air. 2:10pm: Patient wheelchaired to chair by son and RN. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance.
No adverse event; Patients have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (Patients have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) for an unknown indication.    Concurrent medical conditions included Type 2 diabetes mellitus, Chronic back pain (Pain) and Drug allergy (Gabapentin). Concomitant products included TRAMADOL from 20-Nov-2022 to an unknown date for Pain, ATORVASTATIN from 15-Sep-2022 to an unknown date, SITAGLIPTIN PHOSPHATE (JANUVIA) from 15-Sep-2022 to an unknown date, METFORMIN from 19-Sep-2022 to an unknown date and HYDROCHLOROTHIAZID from 19-Sep-2022 to an unknown date for an unknown indication.   On 13-Dec-2022 at 3:46 AM, the patient received third 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 received first dose of INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) (Intramuscular) 1 dosage form. On 13-Dec-2022, the patient experienced UNDERDOSE (Patients have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patients have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patients have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    No information about previous COVID-19 vaccination doses.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had received Moderna first dose on 05Nov2021 at 01:32pm, lot number: 066F21A on left deltoid with a dose of 0.5ml and second dose on 03Dec2021 at 02:22 pm, lot number: 018F21A, on left deltoid with a dose of 0.5ml.  Treatment medication not reported by the reporter.  This case contains information about patient 9th out of 17 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow up received and included Patient details were added, Medical history was added, Dose details were added, Co suspect was added and Concomitants were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1
CONSTANT BILATERAL TEMPLES HEADACHE (8 HOURS POST VACCINATION); ON/OFF NAUSEA AND NOT CONSTANT; VOMITING (ONE EPISODE BETWEEN 4:00- 5:00, CONTENTS WERE UNDIGESTED FOOD); This spontaneous report received from a consumer concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy to pet dander (causes itchy eyes and sneezing). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202F21A expiry: UNKNOWN) dose was not reported, administered on 10-AUG-2022 for covid-19 prophylaxis. Age at time of vaccination 18 years old. No concomitant medications were reported.  On 11-AUG-2022 at 04:00, the patient experienced constant bilateral temples headache (8 hours post vaccination). On 11-AUG-2022 04:00, the patient experienced on/off nausea and not constant. On 11-AUG-2022 04:00, the patient experienced vomiting (one episode between 4:00- 5:00 contents were undigested food). Laboratory data included: Pain scale 6/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant bilateral temples headache (8 hours post vaccination) and on/off nausea and not constant, and the outcome of vomiting (one episode between 4:00- 5:00 contents were undigested food) was not reported. This report was non-serious.
Report fever of 101, HA and stomach pain.  Treatment: Nothing, Outcome: Does not interfere with ADLs
Pt recv vax on 10/27/98; on 10/28/98 pt exp red spot & pain w/ warmth & swelling on LA(6x4 in), nausea, fever
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Weakness-Severe, Additional Details: patient started feeling hypotensive, sweating, lethargic post covid 19 vaccination. paramedics called due to low blood pressure. patients symptoms resolved gradually and didn't necessitate ER trip.
swollen lymptnode on the lower part on my neck  close to the collar bone area on same side of my injection
This spontaneous report was received from a nurse refers to a 73 year old female patient. The patient's medical history included congestive heart failure and leaky valves, there were not known drug allergies. On an unspecified date in 2011 the patient was vaccinated with PNEUMOVAX 23 (dosage, route and lot number were not reported). Concomitant therapies were not reported. The nurse informed that on an unspecified date in September 2014 the patient was admitted to an unspecified hospital, also stated that the patient was administered another PNEUMOVAX 23 (dosage, route and lot number were not reported) while in the hospital for atrial fibrillation, it was not known how long the patient was in the hospital. The nurse also informed that on 23-SEP-2014 (also reported as three weeks ago) the patient was administered another dose of PNEUMOVAX 23 (dosage, route and lot number were not reported). The outcome of the event was unknown. Additional information has been requested.