chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bit swollen/My arm is bit swollen; arm is red; itchy/My arm is itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (bit swollen/My arm is bit swollen), ERYTHEMA (arm is red) and PRURITUS (itchy/My arm is itchy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (bit swollen/My arm is bit swollen), ERYTHEMA (arm is red) and PRURITUS (itchy/My arm is itchy). At the time of the report, PERIPHERAL SWELLING (bit swollen/My arm is bit swollen), ERYTHEMA (arm is red) and PRURITUS (itchy/My arm is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On unspecified dates, the patients were administered improperly stored GARDASIL (lot # K005881, expiration date: 14-JAN-2017) (dosage, strength and route were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
This medically confirmed spontaneous report (initial receipt 01-Sep-2015) concerns a 43-year-old female patient. On 01-Sep-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA (batch number T53909, expiry date: 30-Jun-2015) at a dose of 0.5 ml, once for protection against seasonal influenza. (Medication error). No adverse reaction occurred after the administration. The outcome was reported as recovered.
PARENT PRESENTED WITH CHILD TO CLINIC WITH A LEFT SWOLLEN RED AND PAINFUL TO TOUCH LEFT THIGH.  MOTHER STATED SHE NOTICED IT YESTURDAY 06-12-2008 BUT WORSENED TODAY.  DR.  WAS CALLED TO ROOM NO FURTHER TREATMENT WAS GIVEN ONLY INSTRUCTION FOR SUPPPORTIVE CARE.
Gave Patient 2nd moderna dose too early. It had only been 17 Days between doses.
pt states vision dark and dizzy, feeling racing HR, and feeling warm all over, staff lowered pt to floor   pt assisted self to stretcher laying down and taken to OBS.  pt given water   feeling better once laying down, VS as noted   pt evaluated and feeling better  pt concerned due to  12 yr old daughter outside in car by herself  pt requesting to leave as soon as she can due to feeling better and her daughter in car, pt sitting up and then dangling at side of bed then standing and denies feeling dizzy or other symptoms as previously stated. discharged from OBS area ambulated to car without diffiuclty at 1011.  VS 0959 bp 122/84 hr 66 rr 18 o2 100, 1004 sitting bp 131/83 hr 72 rr 18 o2 100  1007 dangling bp123/84 hr 70 rr 18 o2 100  1010 standing bp 110/89 hr 71 rr 18 o2 100
1 1/2" X 2" area of redness, swelling, warmth, and tenderness at posterior upper left arm. Mom noticed redness and swelling after lunch on 8/26. No action taken at the time. (Instructed to apply ice)
faints when she gets up; Yesterday started to get itch and rash around the injection site; Yesterday started to get itch and rash around the injection site; Was sick for days; joint pains; fatigue; headache; muscle pain; chills; sore arm; A spontaneous report was received from a consumer who was an  82-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, was sick for days, fatigue, headache, muscle pain, joint pains, chills, itch and rash around the injection site and faints when I get up.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03-Mar-2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 013A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 03-Mar-2021, the patient experienced the events sore arm. She reported that she was sick for days, suffered fatigue, headache, muscle and joint pain and chills.  On 06-Mar-2021, she stated that her vaccination site started to itch and a rash developed around it and that she felt tired all day.  On 07-Mar-2021, she reported that the redness and itchiness at the injection site was gone and that she felt better but still like when she had Covid in the past.  Additionally, patient reported that she fainted when she got up (date unknown).     Treatment included paracetamol 2 tablets on 06-Mar-2021 in the evening.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, itch and rash around the injection site, was considered recovered/resolved. The outcome of the events, sore arm, was sick for days, fatigue, headache, muscle pain, joint pains, chills and faints when I get up, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Severe skin reaction; 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 SKIN REACTION (Severe skin reaction) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (Severe skin reaction). At the time of the report, SKIN REACTION (Severe skin reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
A non-serious spontaneous report of a 16 week pregnant girl got H1N1 LAIV was received from a non-health professional concerning a pregnant female. The patient's medical history included smoking, mild asthma, cardiac murmur and promiscuity. As stated by reporter, the patient had never undergone testing for asthma and cardiac murmur. The patient's obstetrical history included gravida three, para one and two spontaneous abortions which occurred in first trimester. The patient was in her 15th week gestation at the time of the vaccination (second trimester) and the estimated date of delivery was 29-May-2010. The patient was diagnosed with placenta previa (sic). The patient was a troubled teen with a criminal history. The concomitant medication included prenatal vitamins. On 08-Dec-2009, the patient was vaccinated with H1N1, Intranasal and on the same day, the patient also had taken following vaccines: varicella, combination of DTP and GARDASIL. There was no problems with the pregnancy. On 14-June-2010, patient delivered a baby boy. Baby's labs reports were fine. Patient and baby were discharged within 24 hours of delivery. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The outcome of vaccine exposure during pregnancy was resolved. Additional information was received on 17-Dec-2009 and incorporated into the narrative: Details of vaccines given on same day and estimated date of delivery added. Additional information was received on 07-Jan-2010 and incorporated into the narrative: Medical history, obstetrical history and concomitant medication. Additional information was received on 09-Aug-2010 and incorporated into the narrative: Outcome of pregnancy, Reporter changed.
Client began to experience some tingling in left fingertips after receiving the COVID-19 vaccination in her left deltoid. Client's vital signs were taken (below). The report done by the healthcare staff who responded to the event does not indicate whether or not the client's symptoms resolved, but it does say that EMS was not initiated for the client.
It's hard to say if this was due to shot #1 or #2, but I have only had one period since beginning the vaccination series 7 months ago.  I regularly have a period for 3-4 days every 28-30 days and after the 1st vaccine, I didn't have one for 5 months (Jan 2022).  Then, it was heavy and lasted for a week and I haven't had another one since.  I am not in menopause and have no family history of early menopause.    Here is the info for shot #1:  Lot: fc3184, pharmacy #1480 for both vaccines
vaccine had been in the refrigerator for more than 30 days; No adverse event; patient received monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator), PRODUCT STORAGE ERROR (vaccine had been in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013B22A and 013B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine had been in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator), PRODUCT STORAGE ERROR (vaccine had been in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator) and PRODUCT STORAGE ERROR (vaccine had been in the refrigerator for more than 30 days).    Concomitant medications were not reported. Patient received vaccine past 30 day use by date in refrigerator. On 06-Sep-2022 vial was initially stored in the refrigerator. The vial size was 2.5ml. There was no adverse reactions for dose 1. No treatment information was provided by the reporter.
Broke out into rash covering entire body.  Redness, welps, itching and blotchy.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient got very light headed and dizzy and might have passed out.  We called 9-1-1 since she fell to the floor but i dont believe she fully lost conciousness.  She was repsonsvie right away to me. We called 9-1-1 and they responded.  All of Patient's vitals were normal and they said she was ok.  It was the first time she had a flu shot and the first time she recieved 2 vaccines at once. Patient also stated that she had passed out as a child from vaccines and had been fine
pt was forced to get vaccine due to work. Pt was very nervous about the vaccine. stated she was forced and didnt want to get the vaccine. pt said she had to get vaccine. After the vaccine was administered pt was in the waiting area due to her allergy she needed to wait 30 min. She got up and came to the drop off window stating she was dizzy and wanted to lay down. We got a mat, pillow and blanket for her. Offered her water and juice. She had no itchy throat. She said she had a heaviness in her chest and her left arm was numb. She could move her left arm and felt my touch when I was helping her. She didnt want me to take her blood pressure. She said she wanted us to call 911 and call her husband. I believe she was having a panic attack. I asked her if she had experienced one before and she said probably. we call 911
Arm pain; Chills; Fever; Severe body aches; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Oct2021 at 13:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) and eletriptan (MANUFACTURER UNKNOWN); both for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on unknown date and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 01Nov2021 at 03:45, the patient experienced arm pain, chills, fever and severe body aches. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain, chills, fever and severe body aches was resolved on an unknown date in Nov2021. The lot number for BNT162b2 was not provided and will be requested during follow up.
Woke up in the middle of the night on 12/20 and noticed that the left side of tongue felt like he had bit it. He woke up again on 12/21 at 1:10 AM with a swollen tongue. He also had left sided unilateral edema. NKDA or significant past medical history. No past allergic reactions. Went to the ED and was treated with benadryl and a methylprednisone. Sent home with additional medications in case condition worsened again.
The 2nd dose of PROQUAD was given 1 month after 1st dose in error/Customer reporting a dose of PROQUAD being given too early in 2 patients.; This spontaneous report was received from an administrator, referring to a male patient (one of twins) of unknown age. The patient's historical condition, concurrent condition and concomitant medication were not provided.    On 25-SEP-2020, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# T016989, expiration date 11-NOV-2021; strength, route were unknown) for prophylaxis. Other suspect drug included sterile diluent. The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was given too early in the patient (also reported as the 2nd dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was given 1 month after 1st dose in error) (inappropriate schedule of vaccine administered).   This is one of two reports received from same reporter.; Sender's Comments:  US-009507513-2009USA010116:
Pt had shingrix vaccination a couple months ago in left arm. His left arm swelled and had pain to his spine. . Immediately after he had 4 lesions that showed up on right upper arm. Until the last couple days, the lesions had been bleeding and oozing. They have just dried up and started getting smaller yesterday.  Patient has been having pain in hips and low back. He is getting the pain up to an 8/10 mostly on his right side. When he shifts and puts wt on his left side his hip, knee and low back pain shifts to that side. Sometimes the pain on the right side lets up a little when he shifts to his left side but it never goes away. When the pain is really bad, his muscle tighten up. He has pain that starts in his left knee and then goes up to his hip. He states the pain is very sharp pain, denies burning pain. This has all happened since his shingrix
patient is reporting a burning sensation through the body. Patient has seen the doctor and is seeing an allergist
Expired vaccine administered to 11 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. No Medical History information was reported.On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients). On 16-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No concomitant medications were reported.No treatment information was provided.The vial was kept under Moderna's recommended temperature range the entire time. There was nothing else wrong except that the vaccine was administered beyond the manufacturer's expiration date.
Pt had localized reaction with induration 3.5cm x 5cm, erythema 7.5cm x 9.5cm - gradually resolved.
SOB, facial flushing, tachycardia, dizziness, cleared by EMS
Heat at the injection site; Slight bruise at the injection site; Feeling of inflammation; One small hive, fairly large, underneath the injection site; Swollen at the injection site; Soreness at the injection site/Tiny bit of aching at the injection site; Red with a slight wheel at the injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Heat at the injection site), VACCINATION SITE BRUISING (Slight bruise at the injection site), VACCINATION SITE INFLAMMATION (Feeling of inflammation), VACCINATION SITE URTICARIA (One small hive, fairly large, underneath the injection site) and VACCINATION SITE SWELLING (Swollen at the injection site) in a 58-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.     The patient's past medical history included No adverse event (No reported medical history.).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Heat at the injection site), VACCINATION SITE BRUISING (Slight bruise at the injection site), VACCINATION SITE INFLAMMATION (Feeling of inflammation), VACCINATION SITE URTICARIA (One small hive, fairly large, underneath the injection site), VACCINATION SITE SWELLING (Swollen at the injection site), VACCINATION SITE PAIN (Soreness at the injection site/Tiny bit of aching at the injection site) and VACCINATION SITE ERYTHEMA (Red with a slight wheel at the injection site). On 10-Jan-2021, VACCINATION SITE WARMTH (Heat at the injection site), VACCINATION SITE BRUISING (Slight bruise at the injection site), VACCINATION SITE INFLAMMATION (Feeling of inflammation), VACCINATION SITE URTICARIA (One small hive, fairly large, underneath the injection site), VACCINATION SITE SWELLING (Swollen at the injection site), VACCINATION SITE PAIN (Soreness at the injection site/Tiny bit of aching at the injection site) and VACCINATION SITE ERYTHEMA (Red with a slight wheel at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included betamethasone topically and fexofenadine.  No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: NNI; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. Injection site pain, injection site swelling and injection site redness are consistent with the known safety profile of the vaccine.
I noticed muscle spam, two weeks after, every day. Extreme fatigue, my face was no of my and my legs, arms, feet.  I felt a sharp pain in my upper part of my stomach. They stopped two months ago.  I had headache, strong palpitations, pain in the chest. My hands and my feet cramped up every day.  I can't open them, I had to use my other hand to do it. I had a burned sensation random in different parts of my body. Ringing in my ears and I have a constant tension in my neck.  I felt dizzy and I felt twice. I went to see a doctor in June, and he said everything was normal and he referred me to a Rheumatologist. I have seen him twice and he said everything is normal.
Rash on right side of my torso at the waist and under both breasts.  The rash resembles shingles for which I was vaccinated two years ago.  The rash first felt like pins sticking into my skin and then intense itching.  Regular application of a cortisone cream and Ibuprophen 800mg eased the discomfort temporarily.   Extreme fatigue.   No blisters or weeping after five days.