chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on the arm of the injection and back; Felling winded; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on the arm of the injection and back) and DYSPNOEA (Felling winded) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE RASH (Rash on the arm of the injection and back) and DYSPNOEA (Felling winded). At the time of the report, VACCINATION SITE RASH (Rash on the arm of the injection and back) and DYSPNOEA (Felling winded) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-089559 (Patient Link).
Employee states she began having itching to her neck, chest, back and stomach in the evening on 7/5/2018. The next day she noticed red raised patches to her neck, chest, stomach and her back along with increased itching and thought it was eczema. She treated her skin with a paste of Turmeric powder and olive oil twice a day for several days with no relief. On Monday 7/9/2018 she also began having diarrhea that persisted for a couple days, subsided and returned for a couple more days. When she noted that the rashes were no longer raised but red and flat, she thought this is not eczema. Itching to rash became severe and on 7/13/2018 employee took a one time dose of OTC BENADRYL and states it helped with the itching but the rash was still there. She reported the event to employer on 7/14/2018 as she now knows it was not a bout of eczema but a reaction to the vaccine she had been given 7/5/2018.
allergic hives all over body; This is a spontaneous report from a contactable consumer via Pfizer representative. A 17-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was healthy and on an unspecified date, the patient experienced allergic hives all over body 4 days after 2nd dose of COVID-19 vaccine and went to the emergency room (ER). Day five after vaccination and hives have not resolved. Treatment prescribed by ER  doctor (MD) was Benadryl. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Significant swelling in right upper arm, around where shot was given.  Am applied cortisone and Benadryl topical creme, taken antihistamine tablet.
Diarrhea; Headache; Fatigue; Temperature of 99.2; Chills; Nausea; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Temperature of 99.2) in a 67-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.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 07-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Temperature of 99.2), CHILLS (Chills) and NAUSEA (Nausea). On 07-Jan-2021, PYREXIA (Temperature of 99.2) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore), DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication includes: Tylenol and Mylanta.  Company Comment: 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.
11 days following Smallpox vaccination, patient developed acute pericarditis.  Treated with Motrin, aerovac'd home. 02/13/07-records received and reviewed for DOS 12/24/06 and 10/25/06 DX:probable acute myocarditis associated with small pox vaccination. Symptoms: awoke with chest pain radiating to back, pain decreased one hour later and increased when lying down and decreased with sitting upright.  Week prior to admission experienced upper respiratory symptoms to include cough, then noted onset of chest pain which occurred at night two days ago. Some chest pain associated with SOB.
No adverse outcome or reaction. Patient was given MMRV instead of separate MMR and Varicella vaccines.
Got really sick; Had a reaction after the 2nd dose; It was rough; High fever; Body aches; Sweating; Bottom of feet hurt; Was real weak; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick), VACCINATION COMPLICATION (Had a reaction after the 2nd dose), MUSCULOSKELETAL STIFFNESS (It was rough), PYREXIA (High fever) and MYALGIA (Body aches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02B21A, 013AZ(2)1A and 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart valve operation NOS (Patient had open heart surgery last year prior to moderna vaccine,) since an unknown date. Concurrent medical conditions included Diabetes mellitus insulin-dependent, Thyroid disorder and Hypertension. Concomitant products included INSULIN LISPRO (HUMALOG) for Diabetes mellitus insulin-dependent, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Heart valve operation NOS, BENAZEPRIL for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, BRINZOLAMIDE (AZOPT) and DULOXETINE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got really sick), VACCINATION COMPLICATION (Had a reaction after the 2nd dose), MUSCULOSKELETAL STIFFNESS (It was rough), PYREXIA (High fever), MYALGIA (Body aches), HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Bottom of feet hurt) and ASTHENIA (Was real weak). At the time of the report, ILLNESS (Got really sick), VACCINATION COMPLICATION (Had a reaction after the 2nd dose), MUSCULOSKELETAL STIFFNESS (It was rough), PYREXIA (High fever), MYALGIA (Body aches), HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Bottom of feet hurt) and ASTHENIA (Was real weak) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-307315 (Patient Link).
No additional AE; inadvertently administered after its labeled expiry date; This spontaneous report was received from a pharmacist and refers to a younger aged male.  The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 31-MAR-2021, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rha) (M-M-R II) lot # R036581, expiration date 17-DEC-2020 (dose, route, vaccination site were not provided),  for prophylaxis. No adverse event was reported.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mildt
Out of Temperature Range Product Administered; Initial Report Received on 06-DEC-2022  This is a spontaneous report, received from a registered nurse in the regarding a 47-year-old male patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 01-SEP-2022, dose 1 of HEPLISAV B (Lot #937782, expiration date 25-SEP-2023, NDC # unknown) was administered intramuscularly in the left deltoid for hepatitis B immunisation.    The vaccine was out of temperature range. The amount of time it was out of temperature range is unknown. The reporter denied any other adverse effects reported by the patient.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Firm & rash. Pain at injection site 1.0 cm firm red warm at reaction site.
Onset of disorientation and epitaxis from the L naris 90 minutes after injection.  Resolved without medical intervention.
DTaP immunization was administered in the left arm/deltoid region. Within several hours, as to be expected with DTaP, the left arm became sore and remained so over the Thanksgiving weekend (11/22-11/25). Pain did not gradually diminish as expected and arm remained too sore for patient to sleep on side, raise arm to wash hair in shower, or carry light laundry basket. Pain partially resolved overnight, but would then resume in morning with activity and become progressively worse during the day. Motrin 600-800 mg bid provided minimal relief of pain, which at its worst, pt rated 6/10. On 12/3, the patient called PCP's office and reported sx to RN. RN advised that since the patient had no fever, redness, swelling, or other signs of infection, to continue monitoring for another week and take motrin around the clock to reduce inflammation/pain. Pain and limited mobility persisted and on 12/10, the pt again contacted PCPs office and was seen that day. Patient is herself a healthcare provider, and reported to her PCP that she suspected she may have SIRVA. Pt presented Dr. with links to peer-reviewed articles on SIRVA, who confirmed that pt's sx and physical exam findings were suggestive of this condition. Dr. offered referral to orthopedics for eval for cortisone injection. Pt declined, asking to increase Motrin to 800mg tid, alternate heat/cold compresses, and rest for 2 more weeks. Dr. concurred with this plan and indicated that she would initiate internal processes to determine if the vaccine administrator had a pattern of inadvertant injections and/or needed re-education and training on proper technique.
This spontaneous report as received from a other health professional. The primary reporter is a nurse who states the same expired GARDASIL lot #666595/0096Z) expiration date 14Oct2012, was administered to 3 clients. This was the second dose in the GARDASIL series for all three clients, and they were vaccinated on 30Nov2012. Client, vaccinated in right deltoid. No other co-suspects were reported. No treatment information was reported. All drop down boxes apply to all three clients. No concomitant medications were reported. No other information was provided.
Information has been received from a 25 year old female nurse practitioner with no medical history or allergies, who on 11-JUL-2007 in the morning, was vaccinated IM into the left arm with a third dose of Gardasil (Lot# 653735/0688F).  Concomitant therapy included hormonal contraceptives (unspecified).  Moments after receiving the vaccine, she became very lightheaded and experienced a near syncope episode.  No injury was reported.  She sat down to let the lightheaded feeling pass.  She did not completely pass out, but had a rush come over her to which she was not accustomed.  After one to two minutes the symptoms resolved.  It was reported that she felt fine after the experience was over.  It was reported that she did not have any symptoms with the previous two vaccinations.  Additional information is not expected.
pt says she started noticing that her hair was falling out.  Every day she would find hair in her hairbrush, sink and floor.  She could run her hand through her hair and it would come out by the handfuls.  After a couple of months she had to get it cut to about 1" since she had lost so much of her hair. She says it is starting to grow back now.
Fever of 102 - body aches, nausea. Site of administration very tender, but no swelling, redness or warmth.
Fever of 101, body aches (one day) Fever of 99, (2nd day) Night sweats (mild)
The pt experienced tiredness, nausea, vomiting, restlessness, hacking cough the same evening of the vax. The next day he started having migraine headaches.
Getting reaction headache from the second shot; It is like I have Migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; manufacturer unknown), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset Nov2021, outcome "not recovered", described as "Getting reaction headache from the second shot"; MIGRAINE (non-serious) with onset Nov2021, outcome "not recovered", described as "It is like I have Migraine".   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Lymph node under her left arm feels like a hard knot; Adverse reaction; Left arm pain/left arm soreness; There was a lump on top and bottom of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction), PAIN IN EXTREMITY (Left arm pain/left arm soreness), LIMB MASS (There was a lump on top and bottom of the left arm) and LYMPHADENOPATHY (Lymph node under her left arm feels like a hard knot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced VACCINATION COMPLICATION (Adverse reaction), PAIN IN EXTREMITY (Left arm pain/left arm soreness) and LIMB MASS (There was a lump on top and bottom of the left arm). On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph node under her left arm feels like a hard knot). At the time of the report, VACCINATION COMPLICATION (Adverse reaction), PAIN IN EXTREMITY (Left arm pain/left arm soreness) and LIMB MASS (There was a lump on top and bottom of the left arm) had not resolved and LYMPHADENOPATHY (Lymph node under her left arm feels like a hard knot) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided   This case was linked to MOD-2021-395644, MOD-2021-395622 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: New event lymph node under her left arm feels like a hard knot was added. On 23-Nov-2021: Follow up information included no new informaion
I received my moderna booster on 12/13/21. On 12/23/21 I noticed some hives on my hips. I treated with Benadryl and went to bed. On 12/24/21 I noticed the hives were getting worse and would travel (i.e would appear on my neck, then hand, then ears etc). Woke up 12/25/21 to hives on my face. Hives were not responding to Benadryl so I went to urgent care. I was put on a 6 day taper of steroids and instructed to take Zyrtec. Steroids ended on 12/30/21. I am continuing to take Zyrtec. Hives have improved but are still occuring regularly. I also use oatmeal baths and lotion to reduce symptoms.
p/vax pt exp swelling; redness & warmth to site of inj;no fever
Five days after receiving VARIVAX vaccine noted chicken pox type rash on trunk, arms and face.
Pt states her arm was red, swollen, and hot to the touch for 5 days after her booster dose.  She also states she was extremely lethargic for 5-6 days following her vaccine. She states that her arm is still sore when lifted.  She also states that she has been suffering extreme headaches only at night that have caused her to wake up.
Information has been received from a nurse practitioner concerning a 45-month old white male male with "EES" who on 16-Jun-2000, also reported as 06-Jun-2000, was vaccinated with a first dose in the right arm of varicella virus vaccine live (Lot #635205/0073K). It is unknow if the child was ill at the time of vaccination. Concomitant therapy that day included a first dose in the left arm of measles virus vaccine live (+) mumps virus live (+) rubella virus vaccine live (second generation) (MSD) (Lot # 634039/1714J) and a first dose in the left arm of tuberculin purified protein derivative (PPD Tine test). On 03-Apr-2003 the patient developed chickenpox, which was described as a maculopapular rash which started to develop on his left shoulder and left arm. It was also noted that the rash was pruritic and that the patient had a fever. The reporter indicated that the patient was treated with aceteaminophen (APAP). diphenhydramine, and calamine lotion. Unspecified medical attention was sought. Follow-up information indicated that on 04-Apr-2003 the patient developed a rash on his shoulders and arms that was described as red, itchy, and containing approximately 25 to 40 lesions. No fever was noted. It was noted the patient recovered. No further information is expected.
Marked swelling of hands, forearms, dorsum of feet/ankles a few hours after receiving immunization, No respiratory distress. Evaluated by ER physician. 9AM immunization given/approx. 11-noon swelling noted.
Observation 4/21/22-4/22/22 SOB, weakness, low back pain, dyspnea, lightheadedness,  DVT
Redness and lump to arm at site of injection. Nearly 2 weeks after pt states arm injection site is red, warm, itchy, and appears to be spreading. Pt has not tried anything OTC at this time. Pt does have a phone call out to her primary doctor at this time to discuss any treatment if needed.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2021 at 9:41 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 9:41 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 60.50 for dose administered on 07-Jan-2021. No concomitant medications were reported. Batch number 025L20A underwent temperature excursion on 07-JAN-2021 with temperature 34 degrees Fahrenheit at 09:00 AM to 10.00 AM. This vial was moved to fridge on 05-JAN-2021 and beyond use date for the vial was reported as 27-JAN-2021. Product moved to clinic on 07-JAN-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported.
No additional AE information provided.; she may have used the MENACTRA as the diluent when administering the PROQUAD; This spontaneous report was received from a registered nurse, referring to an 11-year-old male patient.  The patient's medical history and concurrent conditions were not provided. The concomitant medications included meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA).  On 08-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (OKA-MERCK) virus vaccine live rHA (PROQUAD) 0.5 mL subcutaneous (SC) (valid lot #U031561, expiration date: 06-APR-2023) as prophylaxis (also reported as Measles, Mumps and Rubella (MMR) and varicella vaccine); however medical assistant was unsure if she accidentally used the a/c/y/w conj (dip tox) (MENACTRA) vaccine as diluent, instead of the sterile diluent (strength, dose, lot #, expiry date, anatomical location were route of administration were not provided) (Product preparation error). Paracetamol (TYLENOL) was given prophylactically round the clock for 24 hours. On 09-JUN-2022, the patient had an appointment with the healthcare professional, and it was stated that the subject was fine, with no reactions, fever, or nothing (also reported as no issues). No additional adverse events were reported.
Patient ended up light headed and fainted in the pharmacy waiting area. she recovered within seconds and didn't need us to call 911.  She stated that she had just gone on a bike ride and hadn't eaten anything all day before she received her vaccination, which is what she thought was the cause of her fainting..  She waited in the area for at least 20 minutes before she said she felt ok to leave.  She was eating a protein bar while waiting, to help with the low blood sugar.
5 x 10 mm firm intramuscular nodule at injection site - not resolved after 3 wks from vaccination. Tx = warm compresses with massage (started today).
Information has been received from a consumer via the internet concerning her healthy toddler child who on an unspecified date was vaccinated with a dose of MMR II. Concomitant therapy included VARIVAX vaccinated at the same time. Subsequently, "after receiving the vaccination at the same time as the VARIVAX", the patient developed a seizure. The outcome was not provided at this time. it was not specified if the patient sought medical attention or not. Upon internal review, seizure was considered to be other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Runny nose within 3 hours. 104 degree fever within 36 hours. Significant pain at injection site within 12 hours. Headache within 4 hours - lasted 3 days. Body ache within 24 hours. Skin (upper arm) red and very swollen within 48 hours.
cherry color pin point papules v.s. every 4 hrs x 24 hrs O2 sats