chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash on upper body (arms and chest); injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on upper body (arms and chest)) and VACCINATION SITE PAIN (injection site soreness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash on upper body (arms and chest)) and VACCINATION SITE PAIN (injection site soreness). At the time of the report, RASH (rash on upper body (arms and chest)) and VACCINATION SITE PAIN (injection site soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Fever with fatigue and headache on 5/14 , getting worse.  Chest pain on 5/16. Admitted to hospital 5/17 with  Myocarditis probably vaccine related
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "Depression" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Hashimoto's Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "Known allergies: Lisinopril", notes: Known allergies: Lisinopril. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Home test with an extremely, barely visible, faint positive line that only showed 10 mins; (29Aug2022) Positive, notes: Line appeared immediately as it had when I tested positive on my first bout on 29Aug2022; (Sep2022) Positive, notes: a clear positive retest 7 days after competition of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medication in 2 weeks: unknown. I had a reoccurrence of COVID symptoms and a clear positive retest 7 days after competition of Paxlovid and feeling fully recovered and having had a home test with an extremely, barely visible, faint positive line that only showed 10 mins into waiting (also on day 7 post Paxlovid). At this testing the line appeared immediately as it had when I tested positive on my first bout on 29Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I woke up 2 days later and my tongue was a little swollen.  I took a Benadryl and it went away.
Upon returning from break at 11:30am, RN, went back to the mixing room and grabbed two Pfizer vials that were in a clear bin with no orange UB dot on them. I mixed the vials and drew doses of vaccine in preparation to administer them to TMs coming in for their booster doses of Pfizer vaccine.  At around 1:30pm Vaccine Clinic RN team lead, RN reported to my desk and asked if I knew where the two vials of Pfizer that were in the bin had gone; I acknowledged that I took the vials to dilute them and use them to administer doses to TMs.  He advised me that those doses were empty vials of used vaccine.    I acknowledged the information and let RN know that practice at this vaccination site since opening of the site Feburary 2021 has been to place wasted/empty vials in a clear zip lock bag so they do not get mixed with vials to be used for dilution and to place an orange dot on the pharmacy tag once mixed with the BUB (Best Used By) time; he acknowledged same.  I notified Dr., medical director occupationl medical services, and manager occupational medicine, of incident.  Patient called back to clinic and inoculated with correct dilution of Pfizer vaccine with lot number EW0176
30 April 2021: I had slight soreness at the site of injection that morning that gradually got a little worse overall by the evening... no other noticeable symptoms. Had a protein bar and cold brew coffee for breakfast prior to vaccination. Approx. 45 min after the vaccination I ate a donut, then an hour later a ham & swiss sandwich for lunch. For diner approx. 8 hours later, I ate a KFC chicken sandwich and an order of popcorn chicken.  01 May 2021:  I woke up with it feeling a bit more sore than in the evening... still very tolerable though... 3/10 overall on a pain chart... throughout the morning through mid-afternoon I felt no other noticeable symptoms. Ate a protein bar and some cold brew coffee for breakfast that morning, but nothing else before my AE.  At 17:05 Pacific I get a work-related phone call from a client (I work in IT as an executive support specialist) and assist them for approx. 30-40 minutes. At that point I'm working on my laptop sitting cross-legged in bed.  Adverse event: During that call, I start to notice that I'm slightly more sensitive to motion as usual, making me dizzy if I move around too much. By the end of the call, I'm feeling dizzy but I attribute it to hunger. Some time around 18:30 Pacific, I go downstairs to eat. However, by the time I get downstairs and try to prepare some sushi, I feel so dizzy I need to sit down on the couch to stop the room from spinning. I go upstairs a couple minutes later to try and sleep it off. I'm laying on my back at that point. I think I rested for about 25-35 minutes with my room dark. I then get up slowly to see if things got better but everything is still spinning and is getting worse. I try to rest in bed more, alternating laying on my back and my right side but it's still getting worse. Sometime around approx. 20:00 Pacific, I go to the bathroom to puke but nothing really comes out since I hadn't eaten since the morning. I go back to my room to try and sleep it all off.  From that evening on 01 May 2021 to 04 May 2021, I'd sleep 12-15 hours on average each day to get rid of the nausea and dizziness. I normally sleep 6-7.5 hours (bad sleeping habits due to work/surfing the web on phone - never resulted in these symptoms before though). It gradually went away until going away almost completely by the 04 May. However, as of 10 May I still feel like the potential for the nausea is there... just ever so slightly lingering as a slight heavy feeling in my head that feels like it will spiral out of control if I start spinning around too much. I'm not sure if that's just due to my relative lack of sleep since 05 May (more bad sleeping habits). Otherwise, I feel back to normal.
pt recv vax JUN97 & a few wk post vax pt exp alopecia areata;
2 cm, erythema and induration 10 days after Varicella vaccination.
An improperly stored vaccine was administered; This spontaneous report has been received from a register nurse, concerning a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medication were not reported.  On 25-JAN-2021, the patient was vaccinated with improperly stored (Product storage error) doses of  hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (lot # T004378 has been verified to be valid, expiration date reported as 31-OCT-2021, but upon internal validation established as 01-NOV-2022 )1 injection (anatomical location was not reported) as prophylaxis; on that same day, the patient also received rotavirus vaccine, live, oral, pentavalent(ROTATEQ)  (lot number 1688504 has been verified to be valid, expiration date reported as 18-NOV-2021, but upon internal review, established as 19-NOV-2021), 1 injection taken orally for prophylaxis.   Moreover, it was reported that temperature for vaccines were above 9C (13.4C); with time frame 2 hours and 9 minutes, with no previous excusion.  The error was identified via a data logger.
Received injection at 5:50pm, patient noted the start of hive-like rash with increased heart rate and "feeling like I am going to pass out, my heart is racing".  Reddish, purple colored hive like reaction noted to neck, chest, lower face areas. No angio edema noted, no shortness of breath noted, did not become unresponsive.
Patient complained of headache and chest pressure (7/10) to daughter and MD was called to the car at 0950. Med Team activated for additional assessment and support at 0955. Vital signs at 0951: HR 74, BP 128/78, RR 18, O2 sats 90%, VS @ 1026 HR 70, BP 123/76, RR 18, O2 sats 98%.
Patient was given Moderna vaccine in error. She is not 18 years old. Also 1st dose was Pfizer.
About 3 days after the vaccination, both of my inner forearms developed a slight irritation that looked a bit like eczema, with light red lines following the lines in my skin. It was slightly painful and a tiny bit itchy. I also felt like the area was warmer than normal. The irritated area was about 6 inches long by about 2 inches wide on my right arm, and about 4 inches long by 1.5 inches wide on my left arm.  I applied hydrocortisone cream when I noticed the reaction and the following morning; then Benadryl cream four times a day for the next 3 days, then 3 times a day for the next few days, now only twice a day. I also took Extra Strength Tylenol when needed.  The reaction is less severe now, but it still requires application of Benadryl cream twice a day to keep my skin calm and less irritated.
pt recv vax & was fussy, was jerking in the middle of the noc & devel a rash;pt was taken to ER & was sent home;
11/10/21 Onset of symptoms which included runny nose, headache, cough, shortness of breathe and sneezing
Initial report received from a healthcare professional on 22 November 2013. An unknown age patient received dose of PENTACEL at left deltoid on 19-Oct-2013. On 22 October 2013, pain and swelling injections. It was reported that when she abducts the arm the area around the injection site pulls. Patient had swelling at left deltoid and slight indurated area. Event was not resolved at the time of report. List of documents held by sender: none.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 at 14:00 as dose 1, single (Lot number: El9269), in right arm, on 30Mar2021 at 14:00 as dose 2, single (Lot number: En6205), in right arm and on 14Jan2022 at 13:00 as dose 3 (booster), single (Lot number: FJ6369) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: After completing 5 days of paxlovid and testing negative on antigen test; (unspecified date) Positive, notes: COVID 19 Treatment; (2022) Positive, notes: symptoms returned and I tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient did not receive any other medication in 2 weeks. The patient received treatment with Paxlovid (Lot number: GD8744) from 26Jul2022 to 30Jul2022 for Covid-19.
Body pain at the moment of injection; Numb mouth; Lips inflamed; Cheeks inflamed; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body pain at the moment of injection), HYPOAESTHESIA ORAL (Numb mouth), LIP SWELLING (Lips inflamed), SWELLING FACE (Cheeks inflamed) and OROPHARYNGEAL PAIN (Sore throat) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy (Patient was under treatment for 3 years until 3 months ago.).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (Body pain at the moment of injection), HYPOAESTHESIA ORAL (Numb mouth), LIP SWELLING (Lips inflamed), SWELLING FACE (Cheeks inflamed) and OROPHARYNGEAL PAIN (Sore throat). The patient was treated with PARACETAMOL (TYLENOL) on 24-Mar-2021 for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, PAIN (Body pain at the moment of injection), HYPOAESTHESIA ORAL (Numb mouth), LIP SWELLING (Lips inflamed), SWELLING FACE (Cheeks inflamed) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Extremely tired, fatigued; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Extremely tired, fatigued) in a 55-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Extremely tired, fatigued). At the time of the report, FATIGUE (Extremely tired, fatigued) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. It was reported that prior to November of 2022, patient was a healthy 55 year old male that jogged 5-6 days per week with no health issues. It was reported by the patient that after 2 MRI's noone could tell that what was wrong with him. No treatment medications were reported.   This case was linked to MOD-2023-711123 (Patient Link).
TASTE METALLIC; BODY ACHES; EXHAUSTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced taste metallic. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the taste metallic, exhaustion and body aches was not reported. This report was non-serious.
Nausea, vomiting, body aches, chills, fever, headache, lightheadedness, multiple rashes, strange metallic taste in mouth reduced food taste
Patient received vaccine in right deltoid. The following day noticed a lump underneath her arm with a red line from lump to lymph node in arm pit.
Invalid dose, vaccine exposed to temperature excursion. Patient notified that booster dose is invalid and should be repeated. Ms. stated that she developed the same side effects after the booster as she did the first 2 shots and did not desire to repeat the booster dose.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Feb2023 at 18:00 as dose 4 (booster), single (Lot number: GJ3270) at the age of 65 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 at 12:00 as dose 1, single (Lot number: EL9265), in right arm, on 25Feb2021 at 16:00 as dose 2, single (Lot number: EN6202), in left arm and on 11Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FF883), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 25May2023 to 30May2023.
I received the vaccine. I began experiencing acute flank pain/abdominal pain that has been persistent. I have nonstop pain on my left side that feels like an internal twisting or spasm that will not go away and that worsens when I eat.
that they administered an expired dose of MENACTRA vaccine over the weekend with no reported adverse event; Initial information received on 03-Jul-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and gender patient and it was reported that they administered an expired dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] over the weekend with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, they administered an expired dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] Solution for injection (batch/lot number, expiry date, strength, dose, route: not reported) in unknown administration site for prophylactic vaccination (immunization) over the weekend with no reported adverse event (expired product administered) (latency: same day). Information on the batch number was requested.  Reportedly, Pharmacist (vaccine specialist) called because another pharmacist from a sister pharmacy reported that they administered an expired dose of MENACTRA vaccine over the weekend. Caller is requesting guidance on re-vaccination.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Hives on back and injection site that lasted for approx. 1 1/2 hours. Mother gave him Tylenol.
eyes swollen shut; swelling face; body itching; Hives; skin feels like it is on fire; Puffiness/swelling of various limbs- right hand,arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (body itching), URTICARIA (Hives), SKIN BURNING SENSATION (skin feels like it is on fire), PERIPHERAL SWELLING (Puffiness/swelling of various limbs- right hand,arm) and EYE SWELLING (eyes swollen shut) in a 55-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.    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PRURITUS (body itching), URTICARIA (Hives), SKIN BURNING SENSATION (skin feels like it is on fire), PERIPHERAL SWELLING (Puffiness/swelling of various limbs- right hand,arm) and SWELLING FACE (swelling face). On an unknown date, the patient experienced EYE SWELLING (eyes swollen shut). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (body itching), URTICARIA (Hives) and PERIPHERAL SWELLING (Puffiness/swelling of various limbs- right hand,arm) had not resolved and SKIN BURNING SENSATION (skin feels like it is on fire), EYE SWELLING (eyes swollen shut) and SWELLING FACE (swelling face) outcome was unknown.
Rash occurring for 2 days. Rash described as vesicles with red rim in various stages of healing. PT instructed to use NEOSPORIN TID.
11:40 am Injection given, 11:45 pt felt dizzy/faint. Then pt ? vaso-vagal response - (30-45s) mouth open/eyes open, stiffened, unresponsive to ammonia capsules x 3, moaning. Then pt awakes feeling dizzy, mentions weird dreams - is coherent. 13:00 pt d/c; A+O x3.