chrisvoncsefalvay/vaers-outcomes huggingface dataset:
thrombocytopenia; has a continued stomach problem that she went to the emergency room for; headache; her face was swollen a little bit/looked a bit different/still had her swelling; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD DISORDER (thrombocytopenia) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced SWELLING FACE (her face was swollen a little bit/looked a bit different/still had her swelling). On an unknown date, the patient experienced BLOOD DISORDER (thrombocytopenia) (seriousness criterion hospitalization), ABDOMINAL DISCOMFORT (has a continued stomach problem that she went to the emergency room for) and HEADACHE (headache). At the time of the report, BLOOD DISORDER (thrombocytopenia) and SWELLING FACE (her face was swollen a little bit/looked a bit different/still had her swelling) had not resolved and ABDOMINAL DISCOMFORT (has a continued stomach problem that she went to the emergency room for) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported.   Treatment included a blood transfusion.  On 14 Jun 2021, the patient had a swollen face and looked a bit different. Two weeks later, the patient had stomach problems which resulted in a visit to the emergency room (ER). While in the ER, the patient had unspecified blood work performed, which revealed her blood counts were dropping. The patient was released home and was to follow-up with their family doctor. A week later, the patient complained of a headache and still had swelling in the face. The patient's red blood cells (RBCs) were down below normal. The hospital gave the patient a blood transfusion and had a bone marrow biopsy performed, results not provided. At the time of this report, the patient was hospitalized.  Based on the current available information and temporal association between the use of the product and the start date of the events, 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 events, a causal relationship cannot be excluded.
Shortness of Breath. On December 25, the area became red, swollen and painful, to this day the area continues to be red.
I developed a rash very simular to shingles (which I have had before) with small round blister type sores with clear liquid discharge.   the sore were not going g away and it seemedto be spreading the rash is not exactly like shingle which when I previously had it it was only behind my ears. I looked up my symptoms and the timing and apparently others have had the same type of rash actual weeks after getting the Moderna covid 19 vaccine s I am reporting g it here.  I started treating the rash with a combination of calamine and Abreva which worked well when I had shingles previously and after 24 hours the rash seems to be getting better  if someone actually reads this maybe you could contact me and let me know if I can safely get the second vaccine.
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 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: GM9992), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sbma" (unspecified if ongoing); "known allergies: Penicillins" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (12Oct2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Oct2023) Negative. Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19 from 05Oct2023 to 09Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300329736 same patient/ reporter, different drug/ event;
Notified of redness to injection site five minute after varicella vaccination ( 11 am on 08/02/08). On examination left upper arm 4x5cm area erythematous. No itching, no wheezing, no shortness of breath noted. lungs were clear on asultation.Benadryl 25 mg p.o given at 11.05. Applied ice pack on left upper arm . No  further reaction noticed , patient was dismmed  to home with parents at 12 p.m.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19; COVID 19 Treatment included PAXLOVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day 7 after first vaccine, experienced fatigue, not sure if caused by vaccine or allergies. Day 10 after first vaccine, my right arm has a rash, is slightly swollen and a little sore to the touch.
31/2 x 21/2 red and swollen on top of left thigh.
L deltoid had lg 9x10.5cm erythema warm to touch and very tender. Sm 5cm central papule near needle insertion.
Patient has Covid confirmed via two positive tests yesterday/runny nose/tired/unable to focus; Patient has Covid confirmed via two positive tests yesterday/runny nose/tired/unable to focus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, 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), COVID-19 (medically significant) all with onset 19Jan2022, outcome "unknown" and all described as "Patient has Covid confirmed via two positive tests yesterday/runny nose/tired/unable to focus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Jan2022) positive, notes: Covid confirmed via two positive tests Yesterday; (19Jan2022) positive, notes: Covid confirmed via two positive tests Yesterday. The lot number for bnt162b2 was not provided and will be requested during follow up.
Left arm redness, 80mm x 80mm, soreness, nausea, loss of appetite, joint pain and chills.
Localized raised vesicular reaction in circular shape. Lightheadedness, itching localized.
Information was received from a registered nurse who reported that multiple unspecified patients with an unknown ages and genders. The patients' pertinent medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with multiple doses of improperly stored of multiple doses of VAQTA Lot # L045713, expiration date: 14-JAN-2017 (route, anatomical location and dose were not reported) for prophylaxis.  No adverse effects were reported.  No other information was provided. Temperature excursion was 33.1 F for 90 minutes as per data logger. As of 27-DEC-2016, all telephone attempts to obtain follow up information have been unsuccessful. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA001214: US-009507513-1610USA006216: US-009507513-1701USA001216:
Hospitalized 1/7/22-2/7/22 SOB, cough, congestion, dyspnea, fever w/ chills,  PNA, resp. failure w/ hypoxia
I have developed mouth sores since receiving my second dose of the vaccines. I'm not sure of the exact date and time of the occurance, but I believe it was around Wednesday, May 26.
DRY TONGUE, RACING HEART, ITCHY MOUTH, PALE COLOR TO LIPS AND FACE.  150/89, 97.7, 100.
Both injection sites had been completely clear, unmarked, and pain had subsided. When child woke up, she noticed pain and a bump on left deltoid. Mother saw pencil point sized small white dot in center of red swollen area which was then the size of a nickel. Administered Motrin and Benadryl every 6 hours through clinic visit at 1:30 following day, when red spot was then 2.5 in long and 2 in wide. Nurse said it was probably infected, but she did not have a code for an infected injection site so she would code it as an infected bug bite. She prescribed a cephalosporin. After the first dose, pt developed a mottled rash across chest then back, and hospital's nurse was consulted, who determined ER visit was not necessary. Ped did not return call, but another MD was consulted who suggested this was simply a reaction to shot, and advised Motrin and Benadryl until spot was gone. Ceph was thrown away.
She could not move her hand; Body aches; High fever; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional (Reporter's Wife). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 14Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she could not move her hand, body aches and high fever on Mar2021. This was the extent of the information that I have about this AE. The outcome of the events was reported as unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Patient received shot and sat down in waiting area, after about 5 minutes started to feel lightheaded. Mom noticed she started shaking and then slumped over in chair, mom immediately grabbed hold of pt and stabilized her while calling out for help. Within a few seconds of me running over, pt was already awake and answering questions. She removed her face mask for better air circulation, asked for some water. Mom and I continued to hold pt until she felt ready to sit on her own accord. I asked mom if she wanted me to call, EMT, She declined. Pt has had this reaction before during blood draws. I asked them to wait at pharmacy for 30 minutes, periodically checking in. After 30 minutes mom and patient left pharmacyand she said she felt better
The patient should have gotten her booster 02/20/22 but instead was given the booster on 12/24/21. The patient exhibited same symptoms as expected fever and body pain for 1 to 2 days. Patient is fine and came in because she saw that she got it earlier than it was expected.
Narrative:  Pt received Moderna dose #1 on 1/19/2021 and died suddenly at home on 1/30/2021.
Felt sick after the day. On Thursday I woke up with sever chills and night sweats. The morning of I woke up with eye pain it?s been 2 weeks now. Went to urgent care and the ER they think the booster triggered migraines. But I still have chills and sweats and feel like I have a fever. Super tired
Started shaking uncontrollably like a seizure; He felt energized; Shaking uncontrollably like a seizure/shaking (jerking side to side) on a very strong tremor; This is a spontaneous report from a contactable consumer (the patient) via medical information team. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on Mar2021 as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included clonazepam and gabapentin taken as mood medications (as reported). It was reported that after the patient was administered with the first dose of the Pfizer COVID vaccine on 18Mar2021 or 11Mar2021 (he said that he does not remember it very well since he has bad memory), the next two hours (in Mar2021), he felt energized and then started shaking uncontrollably like a seizure although he takes a variety of medications that could cause that. He mentioned that it was like shaking (jerking side to side) on a very strong tremor. He wanted to know if someone has reported seizures as a side effect of the vaccine. He also mentioned that he is scheduled to get the second dose on 15Apr2021. He stated he has never had tremors like the one he is reporting. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Severe Side Effects after the Second Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Severe Side Effects after the Second Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced ADVERSE EVENT (Severe Side Effects after the Second Vaccine). At the time of the report, ADVERSE EVENT (Severe Side Effects after the Second Vaccine) outcome was unknown. Not Provided          Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.    This case was linked to -MODERNATX, INC.-MOD-2021-071353 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-071353:
Fever, Chills, soreness/knot at site and body aches, loss of appetite.
1 week after first covid vaccine had a rash on arm, went to urgent care and given steroid topical which helped.  This Sunday, 2 weeks after second dose, woke up with bilat flanks, tricep and thighs, went to urgent care. Took zyrtec and got up. Woke up and had recurred. Started methylprednisolone 4mg taper dose pack #21.
Redness and swelling noted around site of vaccine one day after administration. Redness and swelling were worse the second day after vaccine given. Mother reports yellow drainage from vaccine site.  Mother gave pt Benadryl. Mother brought pt to clinic 3 days after vaccine given. Mild swelling and redness around site to right thigh. Tender to touch. Mother reports pt had a fever after vaccines were given. Fever for one day.
I had episodes where I was uncontrollably walking backwards. Not able to manage my right leg. My memory got worst. My tremors gotten worst.
After injection in left deltoid, c/o burning at injection site 1/2 hour after injection c/o excessive sweating, light-headed, progressed to shakiness, puffy eyelids. Developed rash on arms and torso.
6X8 cm tender erythematous area on rt lateral arm, 12 cm above the lateral epicondyl;
Pfizer COVID-19 EUA Vaccine  Pt received first COVID vaccine 2/25/21. Tested positive for COVID late February. Reported to ED 3/5/21 with near syncope. Patient was seen emergency department laying in bed. The patient had a noticeable scalp laceration to posterior parietal area.  After being symptomatic with COVID-19 for a few days, the patient reports getting up at 5:00 a.m. to use the bathroom, feeling lightheaded, then ended up on the floor, she reports sitting on the floor and then hit her head at some point, but was not entirely sure of this timeline.  She states she ended up moving to the living room when she noticed that her head was bleeding a lot and her fiance called 911. She reports a history of syncopal episode in 2001 when she had influenza and apparently the story was much the same as this time, but she actually lost consciousness in 2001. Admitted to observation.    3/7: 73-year-old female recent COVID-19 infection admitted on 03/05/2021 for an episode of syncope probably secondary to bradycardia versus volume depletion.  Paramedic on arrival at home reported bradycardia with heart rate in the 30s but has been normal since admission. The CT angiogram of the chest done at the emergency room showed bilateral infiltrates compatible with recent COVID-19 infection.  No PE.  However patient has no respiratory symptoms and O2 saturation is perfectly normal.  Urinalysis was suggestive of infection and subsequent culture was positive for E coli and it is pansensitive.    She was admitted to hospital for overnight observation.  She was commenced on IV Rocephin and azithromycin.  The EP cardiologist was consulted and she recommended and echocardiogram and it revealed mild global hypokinesis with LVEF of 45-50% but patient denied any prior history of cardiac problem.   On re-evaluation this morning the vital signs remains normal.  Patient has not had any episode of bradycardia since she presented to the emergency room.  She will be discharged home follow up with the EP cardiologist for further evaluation. Patient does not need outpatient oral antibiotics as IV Rocephin for 3 days should be adequate for uncomplicated UTI.
She is having allergic reaction to booster; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (She is having allergic reaction to booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (She is having allergic reaction to booster). At the time of the report, ALLERGY TO VACCINE (She is having allergic reaction to booster) outcome was unknown.            No Concomitant medication was reported.  No treatment medications were reported
1. Localized edema. 1. Acetaminophen 325 mg QID PO. 2. Hydroxyzine 25 mg TID PO.
Child was given a 2nd dose of FluMist and only should had received 1 dose, due to age. Child is 910years of age. No treatment. Per mother child had cough, sore throat, and head-ache after adverse event. Symptoms have since resolved. Adverse event was reported.
Very Low Grade Fever, Vomiting, Diarrhea, Joint Pain, Muscle aches, Uncontrolable body tremors (Similar to Fever Chills, but more violent in nature), injection site sensitivity-redness-warm to touch, loss of appetite, headache & isn't that enough
My lefr bicep from shoulder to elbow became extremely itchy, red, hot to touch, and slightly painful. After going to urgent care, I used a topical medication for the itch and Benadryl for the first dew days and then switching over to allergy medicine. Over a week the symptoms subsided.
Sore arm at injection site for a couple of days.  Developed a light red rash on the shoulder of the injection site 2 days after injection.  Developed a ping pong ball size swelling under the right armpit 2 days after injection.  Currently at day 8 and the rash and swelling have not yet subsided.  There is some tenderness of the swelling if compressed by the arm in specific motions.
Lymphadenopathy. Lymph nodes under left arm (side of vaccine administration) became swollen and painful. Lasted for approximately 1 week. No treatment, did not see anyone for it. I did not take any over the counter pain medication either. It gradually went away on its own.
Small rash developed on both lower legs.  Rash worsene, spread to face, hands, arms and rest of body and began to look like hives on 10/11/09 AM.  Was seen at urgent care center on this date AM, hydroxine was prescribed to help stop itching of rash and hives.
Pt reported sore arm right away after shot. Next day was so sore she could not be touched. Had back pain also.
Presented w/ sycope secondary to orthostatic hypotension and SOB. Dx w/ bilat. Pleural effusions and pulm infiltrates. Tested covid +, tx w/ O2, abx
PATIENT CALLED TO INFORM OF SHORTNESS OF BREATH IN THE MIDDLE OF THE NIGHT BEGINNING A FEW DAYS POST-VACCINATION AND CONTINUING EVERY NIGHT SINCE (ABOUT 3 DAYS SO FAR). IT WAKES HIM UP IN THE MIDDLE OF THE NIGHT AROUND 2 AND 3AM EVERY NIGHT. PATIENT STATES HE DOES HAVE HIGH BLOOD PRESSURE AND EXPERIENCING SOME ANXIETY LATELY. I INFORMED HIM TO ALSO CONTACT HIS PHYSICIAN FOR FURTHER REVIEW.
Pain, redness, swelling and heat in the entire upper arm region. Started the next morning and lasted until the following Wednesday, Dec.14. Low grade fever 99's.
This spontaneous report has been received from a registered nurse refers to a patient who was vaccinated with the first 0.5 ml dose of GARDASIL IM in 2010 and did not received the second dose of GARDASIL on time. No adverse effects reported. It was unknown if the patient sought medical attention. At the time of report, the patient's status was unknown. Additional information has been requested.
Received full doses of Moderna COVID19 Vaccine/ the patient is not immunocompromised; Third dose less than 6 months after second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Received full doses of Moderna COVID19 Vaccine/ the patient is not immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose less than 6 months after second dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (Received full doses of Moderna COVID19 Vaccine/ the patient is not immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose less than 6 months after second dose). On 01-Apr-2021, ACCIDENTAL OVERDOSE (Received full doses of Moderna COVID19 Vaccine/ the patient is not immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose less than 6 months after second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
1/96 pt was vax w/1 dose of varivax & on 3/98 pt dx w/attenuated varicella
Tenderness @ injection site. Hot, itchy rash developed on 2nd day after injection. Lasted 15 or more days with decreasing intensity.