chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was a pinkish color; Arm started to Itch; arm started to itch and became red; red splotches on her arm which were little puffy but not painful; arm was a little puffy but not painful; On a pain scale of 1-10, the pain was 0.5.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (arm was a pinkish color), PRURITUS (Arm started to Itch), ERYTHEMA (arm started to itch and became red), RASH MACULAR (red splotches on her arm which were little puffy but not painful) and PERIPHERAL SWELLING (arm was a little puffy but not painful) in a 71-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 14-Apr-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 16-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (arm was a pinkish color), PRURITUS (Arm started to Itch), ERYTHEMA (arm started to itch and became red), RASH MACULAR (red splotches on her arm which were little puffy but not painful), PERIPHERAL SWELLING (arm was a little puffy but not painful) and PAIN IN EXTREMITY (On a pain scale of 1-10, the pain was 0.5.). At the time of the report, VACCINATION SITE DISCOLOURATION (arm was a pinkish color), PRURITUS (Arm started to Itch), ERYTHEMA (arm started to itch and became red), RASH MACULAR (red splotches on her arm which were little puffy but not painful), PERIPHERAL SWELLING (arm was a little puffy but not painful) and PAIN IN EXTREMITY (On a pain scale of 1-10, the pain was 0.5.) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No concomitant and treatment medications were reported.
Insomnia, pain at injection site, muscle aches, bone aches, extreme fatigue, headache
Received DTAP on Thursday morning and daughter experienced sore throat the following day with 4 days of fever, sore throat and runny nose. Also very lethargic - napping for 2 hrs a day for 3 days straight even though she hadn't napped for over a year. Today is Tuesday, she still has a slight runny nose but seems to be doing better.
The patient reported that she had normal flu-like symptoms the day following the shot (12/22/2021). The following day, 2 days after getting the shot, she developed multiple blisters in her mouth.
Patient felt light-headed and was not responding to questions. She was lowered to the ground by the pharmacist and technician. She became responsive and was confused. EMS was contacted. Blood pressure measured 110/68.  Patient remained on the floor until EMS arrived and took over care.
First 36 hours: Soreness at injection site, severe headache, head pain (jaw), tiredness, chills/shivering, muscle aches, slightly elevated temperature. Took ibuprofen and aspirin as needed.   About 72 hours after: Developed redness and sharp pain on left arm near but not at the injection site. Painful to the touch and when moving and bending arm. Hasn't gotten bad enough to take medication yet, and still experiencing this as I submit this report (8:30pm on 1/27/20).   NOTE: This was the 2nd of 2 shots for Shingrix, and with the first one I only experienced soreness at the injection side for about 3 days.
both feet sore; Rash on his hind quarters; Red feet; face got a little red; redness in neck; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red feet), ERYTHEMA (face got a little red), RASH (redness in neck), PAIN IN EXTREMITY (both feet sore) and RASH (Rash on his hind quarters) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced ERYTHEMA (Red feet), ERYTHEMA (face got a little red), RASH (redness in neck) and RASH (Rash on his hind quarters). On an unknown date, the patient experienced PAIN IN EXTREMITY (both feet sore). On 03-May-2021, ERYTHEMA (Red feet), ERYTHEMA (face got a little red), RASH (redness in neck) and RASH (Rash on his hind quarters) had resolved. At the time of the report, PAIN IN EXTREMITY (both feet sore) outcome was unknown.        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.   No concomitant medication were provided. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow-up received on 01-Apr-2021 included added both feet sore On 09-Jun-2021: Follow-up received on 01-Apr-2021 included no new information. On 08-Jul-2021: Non-significant follow up-IRMS document with no new information
Patient came into pharmacy on 8/10/21 to receive 2nd dose of Pfizer Biontech vaccine.. During screening process patient mentioned he had chest discomfort and chest pain after the first dose that lasted 2 weeks. Patient stated he did not consult a PCP. The patient states it did resolve now but lasted for 2 weeks post vaccination.
Fever & chills for 24 hrs Headache, body aches for +36 hrs Injection site red, swollen,  warm, painful for +36 hrs
redness and swelling. The redness is continuing to expand, now approximately 3 inches in diameter
Client states she experienced nausea, vomiting, diarrhea, dehydrated and had fever.  Saw Dr on 11/23/05 who stated to increase intake and questionable flu shot prescription.
On 8/15, patient woke up unable to walk. At hospital he was diagnosed with myositis. Although a clear link could not be connected to the vaccine, patient had not been sick for months, and has never had myositis before. He was given saline solution and sent home when he could walk better, but he woke up on Monday morning incapacitated again. Thankfully he quickly regained his ability to walk on Monday and since then his muscles have slowly built back up. There have not been any neurological symptoms, so we do think it was myositis.
Developed pain in left leg and numbness in left foot on 3/19/2021.   Went to ER on 3/20/2021 and was admitted for blood clots.  Spent 4 days in the ICU and clot busters were performed over the course of these days.   Unable to bust clots and amputation was proposed due to no blood flow back to left foot.   On 3/25/2021 bloodflow returned and I was discharged on 3/26/2021.   I am still on a medical LOA from work after seven months due to numbness and severe nerve damage to my left foot.  Difficulty walking, driving, and performing daily routines.   Another procedure to perform an angiogram is pending scheduling at the time this  is being written.
Left arm was swollen, red and warm to touch 2" above elbow and 1" below site injection.
Wheezing; Can't breathe/short of breath/gets short of breath during the walks and that has gotten worse; Has been sick; Feels weak; Sore throat; Feeling like she is about to get the flu; Had a cold; Ttired; Nausea; threw up last night; could not get out of bed for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Wheezing), DYSPNOEA (Can't breathe/short of breath/gets short of breath during the walks and that has gotten worse), ILLNESS (Has been sick), ASTHENIA (Feels weak) and OROPHARYNGEAL PAIN (Sore throat) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, the patient experienced VOMITING (threw up last night). On an unknown date, the patient experienced WHEEZING (Wheezing), DYSPNOEA (Can't breathe/short of breath/gets short of breath during the walks and that has gotten worse), ILLNESS (Has been sick), ASTHENIA (Feels weak), OROPHARYNGEAL PAIN (Sore throat), INFLUENZA LIKE ILLNESS (Feeling like she is about to get the flu), NASOPHARYNGITIS (Had a cold), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not get out of bed for 2 days), FATIGUE (Ttired) and NAUSEA (Nausea). At the time of the report, WHEEZING (Wheezing) and DYSPNOEA (Can't breathe/short of breath/gets short of breath during the walks and that has gotten worse) had not resolved, ILLNESS (Has been sick), ASTHENIA (Feels weak), OROPHARYNGEAL PAIN (Sore throat), INFLUENZA LIKE ILLNESS (Feeling like she is about to get the flu), NASOPHARYNGITIS (Had a cold), FATIGUE (Ttired), NAUSEA (Nausea) and VOMITING (threw up last night) outcome was unknown and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not get out of bed for 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac function test: results not reported Results not reported. On an unknown date, Electrocardiogram: results not reported Results not reported. On an unknown date, Myocardial necrosis marker: results not reported Results not reported. On an unknown date, SARS-CoV-2 test: negative (Negative) Tested negative for COVID 6 times since her 2nd dose.         No concomitant medication was reported. No treatment medication was reported.  Patient  went to a local urgent card in September or October after her 2nd dose and  they told patient had a cold. Patient went to her doctor five or six weeks ago and they told her she had a cold as well. It was reported that the patient goes for walks of up to seven miles they take longer than usual, gets short of breath during them, & that has gotten worse. The breathing problems did not start immediately after the second dose and some days are worse than others.
I am having bad rash all over; I started getting in middle in my back and now it just everywhere; This is a spontaneous report from a contactable consumer reporting for herself.  A 48-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in the right arm on 03Jan2021 at single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient experienced bad rash all over; she started getting in middle in her back and now it just everywhere on 03Jan2021 shortly after vaccination with outcome of unknown. The patient was doing anti-histamine and hydrocortisone cream as treatment.  Information on the Batch/Lot number has been requested.
Pt reported tightness in chest immediately following vaccination. Pt transported to Med Obs 1 at 09:17. Vital signs taken and BP slightly elevated at 168/97. Lungs clear bilaterally. Pt reported history of HTN, anxiety and that she had not slept much and did not eat breakfast. Oral fluids and crackers administered. Repeat vital signs stable. BP improved. Pt asymptomatic and released to husband at 09:35. Encouraged to follow up with PCP about HTN.
Information has been received from a physician concerning a 60 year old female patient with diabetes and no drug reactions or allergies, who on 18-NOV-2011 was vaccinated with 0.65 ml single dose of ZOSTAVAX (Merck) subcutaneously (lot number 671596/1056AA, Exp. Date: 05-OCT-2012). Concomitant therapy included pravastatin Na, metformin (manufacturer unknown), loratadine  (MSD) and aspirin. The physician reported that on 21-NOV-2011, the patient returned to the practice with fever and redness and swelling of the arm, that started at the injection site and continued down the arm toward the elbow. No lab diagnostics studies were performed. KEFLEX, BENADRYL and ADVIL were given as a treatment for the experience. The patient was also instructed to elevate the arm. At the time of the report, the patient was recovering. Follow up information has been received from the physician concerning the female patient with no illness at the time of vaccination, no adverse events following prior vaccinations and no pre-existing medical conditions (previously reported as with diabetes) no pre-existing allergies and birth defects who on 18-NOV-2011 at 10:36 am was vaccinated subcutaneously with 0.65 ml second dose of ZOSTAVAX (Merck) (lot number 671596/1056AA, Exp Date: 05-OCT-2012). The physician reported that the patient was complaining of tingling, redness, swelling site of injection on 18-NOV-2011 at 10:36 (also reported as 24 hours on 19-NOV-2011). The physician also reported the following findings: in left tricep area, raised firm vesicular lesion the size of a lime with surrounding tissue erythema. On 22-NOV-2011 the patient had recovered from tingling, redness and swelling of the injection site and from left tricep area - raised firm vesicular lesion size of a line with surrounding tissue erythema. Tingling, redness and swelling of the injection site; and firm vesicular lesion with surrounding tissue erythema were considered to be other important medical event by the physician because required medical/surgical intervention. No further information is available.
Pt came in for 2nd Shingrix immunization.  Due to low supply I have not given a shingles vaccine in sometime.  Gave to pt subcutaneously instead of intramuscular.  Realized when doing my 2nd patient shortly after.  Contacted my supervisor. She advised that IM was preferred but that immunization should be effective and not harmful.  I came in contact with pt shortly thereafter and told her it should be fine.
fainting following day, muscle aches, headaches, nausea (no vomiting), tiredness, weakness
This spontaneous report as received via social media refers to a female patient of unknown age, who on an unspecified date was vaccinated with a dose of GARDASIL (dose and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The other reported that the patient died after vaccination. The relatedness for the adverse event was unknown for GARDASIL. This is one of the several reports from the same source. Additional information is not expected.
It was administered in her right arm but lower than the deltoid, it was not in the deltoid; This spontaneous report was received from a 69 year old female nurse referring to herself. The patient's vaccination history included pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) approximately a year ago. The patient's pertinent medical history was not reported.  On 02-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (lot# and additional dosage regimen information were not provided) in the right arm but lower than the deltoid. She mentioned that she knew that her vaccination was not in the deltoid. Additionally, she reported that her husband and several family members also received unspecified vaccinations that were also administered lower in the arm but close to the deltoid, therefore she could not say if they were correctly administered or not.
Flushing/sweating, dizziness, numbness on arm/lips. Rested and had water. BPs 158/100 (pulse 125), 171/105.
After 48 hours, mouth irritation on palate and lip corners, after 72 hours fever blisters, 2 on lips and 1 on hard palate.  I get them with sunburn, stress, etc. ( I had had the typical arm pain, headache, fatigue, muscle and joint pain and fever on day two).
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 female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) 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 Jan2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested negative for several days; Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in 2 weeks.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Chicken Pox Vaccine given to my son(6/6/07) on Upper Right Arm.  After Needle removed from his skin, a foreign body or black piece of rubber? remained under his skin.
Headache 2 1/2 days fatigue 3 days chills 2 1/2 days aches 2 1/2 days
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 8/31/2022 HX OF ACUTE KIDNEY INJURY
We administered 0.25 ML instead of 0.3 ML. We contacted Patient and Pfizer. Recommendation was by CDC to Repeat dose immediately or 8 weeks later. Patient is choosing to wait 8 weeks. She is okay that I know of.
89 y/o female complained of paresthesia in her arms and hands during her 15 min wait period after vaccination. Patient alert, oriented and vitals stable and WNL before being  transported to ER via ambulance for monitoring.
slight arm pain to begin with, four hours after injection had significant arm soreness and redness around injection site, then the following 48 hours consisted of aching all over, fever, chills, swelling around injection site and armpit, and a slight headache-as of today 2/16/2021 feeling tired but no other side effects
The night of my vaccine I had a slight fever and tiredness. I had a sore arm. I missed work for a day due to the tiredness. I then contracted COVID two weeks later around the 14th or 15th of March. I talked to the doctor he told me to get a lot of rest and drink a lot of fluid. I did end up going to the emergency room because I was having shortness of breath. They did a chest x-ray which came back normal and they said my oxygen was fine so they sent me home a couple of hours later.
04/22/2021 admitted through EC with fever (103.2 on admission) and chills that gradually worsened overnight.
Patient was seen in our office for his 2 mo well child exam on 2/11/08.  Mom reported 4 days of cough but no fever.  His exam was WNL including normal vital signs (afebrile, RR 40, SaO2 100% RA), and normal lung exam.  He received immunizations as listed below.  Later that day he was noted to be difficult to arouse and have increased work of breathing with retractions, possible eye deviation (no frank seizure activity) and decreased responsiveness.  He was taken to a local emergency department where he was found to have 20-30 second periods of apnea and was intubated and transferred to Hospital.  His laboratory evaluation (CBC, urine, CSF) was all normal and all cultures have been negative to date.  Nasal swabs for influenza, RSV, and pertussis were all negative.  CXR revealed bilateral infiltrates.  He was extubated on 2/15 and in completing 7 days of IV antibiotics for possible pneumonia.  There is concern that an unwitnessed seizure may have precipitated the apneic event and he is undergoing neurologic evaluation at this time.  To date a head CT was done and was normal.  He remains an inpatient in stable condition. 2/27/08-records received for DOS 12/11-12/18/07-DX DX: Seizures. Admitted with apneic spells, intubated, full sepsis workup negative.
Moderna Vaccine expired 10/20/2021 at 0600 at refrigerator temperature. Vaccine administered approximately 4.5 hours after expiration time on 10/20/2021. Moderna Manufacturing company consulted and stated: It is recommended that the vaccine be used by 30 days to the expiration date and time; however, it is ok to use by the end of the day on the 30th day. No treatment required.
About 30 post administration, I had injection site soreness which progressively worsened in severity as time went on. About 12 hours after the injection I had a pretty sudden onset of fatigue, headache and nausea.
About 5 minutes after getting his flu shot, the patient was standing near his mother when he started falling and almost lost consciousness. The patient was placed in supine position with his leg slightly elevate, still well conscious, for about 10 minutes. He was then seated and stayed seated for 5 minutes then after standing up, he felt well and went home.
First PEDIARIX given at age 2 m - 4/16/2008.  Cried high pitch cry with fever & irritability same night & with irritability > 24 hours after.
This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. This nurse reported for two patients. This is the second of two reports. A 17-year-old male patient of an unspecified race and ethnicity received, on 28Feb2017, TRUMENBA        (Lot. R94916, Expiration date: 01Jan2019) intramuscularly, into the arm, at 0.5 ml, single dose and MENACTRA intramuscularly, into the arm, at 0.5 ml, single dose, both  for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, in 2017, the patient's  arms were sore and he had weakness of both arms. The patient also was lethargic and he was very tired to the point that he missed a dentist appointment. The patient did not experience any fever. Clinical outcome was unknown at time of this report.
6in by 5in red, hot, hard, itchy raised area that lasted 11 days.
child broke out w/single vesicle on rt thigh @ inj site on 8/14/99;no temp-no other s/s;
injection site red after two weeks; injection site hot after two weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site red after two weeks) and VACCINATION SITE WARMTH (injection site hot after two weeks) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (injection site red after two weeks) and VACCINATION SITE WARMTH (injection site hot after two weeks). At the time of the report, VACCINATION SITE ERYTHEMA (injection site red after two weeks) and VACCINATION SITE WARMTH (injection site hot after two weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
This spontaneous report was received from a physician, via a company representative, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-NOV-2015, the patient was vaccinated with a dose of ROTATEQ, "2ml, 10 unit dose tube", lot # K020183, expiry date: 25-JUN-2016, orally, which was improperly stored at 1.11 Celsius Degrees (34 Fahrenheit) for 24 hours and 8.88 Celsius Degrees (48 Fahrenheit) for 32 hours. The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.