chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a pharmacist via a company representative, regarding to a female patient of unknown age. The patient's concurrent condition, medical history, drug allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, route of administration, anatomical location of vaccine and dose were not reported) for prophylaxis. On an unknown date, the patient developed shingles "across" her arm after vaccination. At the reporting time, the outcome of herpes zoster was unknown. The causality assessment between the event and ZOSTAVAX was not reported.
First vaccine received 3/31/2021,second vaccine received on 4/28/2021, 24 hours after both injection had swelling, hardness, redness, and pain around injection site that went away after 24 hours. July 12 and to date there has been redness, hardness to touch, swelling, and extreme pain around in a area of about 3 inches surrounding the vaccine injection site. My PCP ordered a MRI to see if anything  would explain the issues I am having
This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, (lot# and expiration date not reported), 0.65 ml, subcutaneous. The pharmacist reported that the patient developed an unspecified rash on their stomach near their belly button a "week" after receiving ZOSTAVAX. The outcome of the event was reported as not recovered. The patient was seen by the physician on an unspecified date. Additional information has been requested.
Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: NUMBNESS IN LEFT ARM
redness; swelling; This spontaneous report was received from a nurse concerning to herself.  The patient's concurrent conditions, medical history was not reported or allergies were not reported.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); and varicella zoster vaccine rge (cho) (SHINGRIX),  (strength, formulation, dose description, lot #, expiry date, route of administration, and indication were not provided).  On an unknown date, the patient experienced swelling and redness (erythema). The patient stated she experienced de adverse reaction after had received the vaccine zoster vaccine live (ZOSTAVAX) or  zoster vaccine rge (cho) (SHINGRIX). At the time of reporting, the outcome of both events was not known. No more information was reported.   The causal relationship between both adverse events with zoster vaccine live (ZOSTAVAX) and  zoster vaccine rge (cho) (SHINGRIX) was not reported.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-2204USA001371:
Pt arm had significant swelling that required oral steroid treatment; MD thought pt had an allergic reaction to vaccine; as of 11/6/13 this issue has resolved.
This report was rec'd concerning a pt who on 10/5/01 was vaccinated with MMR. Concomitant therapy that same day included one dose of varicella. On 10/6/ the pt developed septicemia streptococcal and was hospitalized. This was originally reported by a physician. Additional info has been requested. Follow-up information from the physician noted that he was only notified through adverse reaction reports that the patient had an event. It was noted that all available data has already been forwarded. The physician noted, "I did not admit this patient to hospital and am unsure if they even were hospitalized". No further information is available. Follow-up information noted that no further diagnostic data or work-up was available.
COVID arm, redness, itching, heat, at the injection site, starting about day 7, now receding about day 10.  I have a picture I can forward from day 9, if needed.
Abdominal pain; This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced abdominal pain. On an unknown date, the outcome of the abdominal pain was unknown.   It was unknown if the reporter considered the abdominal pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient did not want to provide demographic details. The patient asked call center representative to suggest over the counter treatment for abdominal pain post vaccine. The patient just want to know whether it was motrin or antacid. The reporter stated follow up not required.
hot injection site; itchy rash on hands; Rash on her hands; Fever; chills; injection site swollen; Red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot injection site), PRURITUS (itchy rash on hands), RASH (Rash on her hands), PYREXIA (Fever) and CHILLS (chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot injection site), PRURITUS (itchy rash on hands), RASH (Rash on her hands), CHILLS (chills), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (Red at injection site). 23-Mar-2021, the patient experienced PYREXIA (Fever). At the time of the report, VACCINATION SITE WARMTH (hot injection site), PRURITUS (itchy rash on hands), RASH (Rash on her hands), PYREXIA (Fever), CHILLS (chills), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (Red at injection site) outcome was unknown.            No treatment was reported.
Vaccines received 9/13/16 pm. Rash was present morning of 9/14/16. Rash worse morning of 9/15/16 and 9/16/2016. Hands swollen, lips swollen, slight tingling of lips.
Extremely painful swelling of lymph node and got to the size of a large golf ball. Pain did not go away even with medication. Pain slowed down after about 36 hours but the swelling is still very large golf ball.
Dizziness, Arthralgia, Fever, injection site arm pain, fatigue, chills Narrative:
This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder pain/ the pain in his shoulder is still there/ his left shoulder hurts, around he deltoid muscle) and MYALGIA (muscle pain) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination. 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 an unknown date, the patient experienced ARTHRALGIA (shoulder pain/ the pain in his shoulder is still there/ his left shoulder hurts, around he deltoid muscle) and MYALGIA (muscle pain). At the time of the report, ARTHRALGIA (shoulder pain/ the pain in his shoulder is still there/ his left shoulder hurts, around he deltoid muscle) had not resolved and MYALGIA (muscle pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medication was reported. Patient has not taken any medication just applied some ice on it.
Fever with hallucinations (temperature unknown), pneumonia-like symptoms; was seen by urgent care on 10/4.  No pneumonia.  Intermittent shortness of breath; difficulty in taking a full breath intermittently.
This 26-year-old male subject was participating in A Study and experienced an adverse event of special interest (AESI) of pericarditis. The subject's medical history, as provided by the investigator, included seasonal allergies, unspecified. No concomitant medications were reported. Prior to event onset, the subject received intramuscular mRNA-1273.213 (Dose 1) for SARS-CoV-2 vaccination on 08 Nov 2021, approximately 9 months and 17 days before onset of the event. On 24 Aug 2022, the subject experienced pericarditis. The subject was diagnosed by his primary care provider (PCP) and was referred to a cardiologist for follow-up and treatment. Further treatment information was not provided. The subject received the scheduled dose of study drug prior to the event; therefore, action taken with study drug in response to the event was not applicable. The event, pericarditis, was reported as not resolved. The investigator assessed the event, pericarditis, as not related to study drug and not related to study procedure. Company Comment: This case concerns a 26-year-old male subject with medical history of seasonal allergies, unspecified, who experienced the listed non-serious adverse event of special interest (AESI) of pericarditis. The event occurred approximately 9 months 17 days after the first dose mRNA-1273.213. The event was reported as not resolved and was assessed as unrelated to the study drug in agreement with the investigator. Further information was requested.
Patient became flushed and hot.   Cheeks, forehead & nose became red.   Nervous.   Pulse 102.  Resp 20.   Administered Benadryl. "
skin redness; chills; fever; vomiting; intractable nausea; headache; left arm soreness; abdominal pain/cramping; fatigue; deltoid rash; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (intractable nausea), VOMITING (vomiting), ABDOMINAL PAIN (abdominal pain/cramping) and PYREXIA (fever) in a female patient of an unknown age 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 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 HEADACHE (headache), NAUSEA (intractable nausea), VOMITING (vomiting), ABDOMINAL PAIN (abdominal pain/cramping), PYREXIA (fever) and CHILLS (chills). At the time of the report, HEADACHE (headache), NAUSEA (intractable nausea), VOMITING (vomiting), ABDOMINAL PAIN (abdominal pain/cramping), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This case was reported by a healthcare professional and described the occurrence of vaccination site pain in a subject of unspecifie4d age and gender who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On or about 7 February 2014 the subject received a dose of BOOSTRIX (unknown). On an unspecified date in February 2014, less than one month after vaccination with BOOSTRIX, the subject experienced vaccination site pain. The reporter stated the subject received BOOSTRIX 14 days prior to this report and was experiencing pain at the injection site. At the time of the report no other information was provided. At the time of reporting the event was unresolved.
Narrative:  Patient received Tdap and PPSV23 on 2/16/22 and developed rash on right arm where PPSV23 was administered the next day then on second day began to be SOB and was advised to go to ED outside the facility. Patient was treated for pericarditis and cellulitis. CRP and Sed rate were elevated but heart cath normal. Patient was treated with colchicine with good benefit and for cellulitis was treated with Keflex. Pt was hospitalized from 2/19 to 2/21 and on d/c was doing well, recovered, and no complications.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 23-AUG-2013 (lot # H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
she did have a minor flare up or event about 36 hours after the dose and another about 48 hours after the dose; She had a headache; She had a headache, nausea, and felt like she was running hot all day; From time to time, she would get the low grade fever, running hot; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318, Expiration date not reported), via an unspecified route of administration, administered in left arm on 12Feb2021 at 15:15 as 1st dose, single for COVID-19 immunization.The patient's underlying medical conditions included, asthma, slight hypertension controlled by medication and was overweight.On an unspecified date she got pneumonia and a flu shot. Her blood group was reported as Type A. No history of all previous immunization with the Pfizer vaccine was reported. No vaccinations were reported within four weeks prior to the first administration date of the suspect vaccine. There was no family medical history relevant to AE. Concomitant medications included Montelukast, Budesonide Formoterol Fumarate (SYMBICORT) and an unspecified rescue inhaler indicated for asthma from an unspecified duration. She received Aleve, the night before getting her first dose of vaccination.On 13Feb2021, (after 1 day 8 hrs 45 min) the patient experienced nausea, headache and felt like she was running hot all day. She clarified that she just felt warm, (usually she was cold) didn't know if she had a fever because she didn't take her temperature and just assumed that it was related to the vaccine. She decided to take the ibuprofen because she didn't think she would be driving when she wasn't feeling well. It was reported that 4 hours later when the ibuprofen wore off, she didn't need to do anything else.  After the first dose of vaccination, the patient experienced 2 asthma flare ups on 14Feb2021 about 12 hours apart. She was an asthmatic and well under control, on Symbicort and Montelukast, but she did have a minor flare up or event about 36 hours after the dose and another about 48 hours after the dose. She rated that on a scale of 1-10, it was less than a 1; she used her rescue inhaler and within about 10-15 minutes she felt fine, and it resolved the problem. The symptoms were very minor and lasted a total of 6-8 hours, and she still managed to do all her housework and go to the stores. From time to time, she would get the low grade fever, running hot, aches and pains, and feeling funky like had the flu after, she got the pneumonia and the flu shot. She did take an Aleve about 6 hours after the 1st dose for lower back pain which she believed was from standing in line. She did also take Ibuprofen about 24 hours after the dose. The patient's oxygen saturation was reported as 96-97%, so she wasn't worried. On 14FEB2021, outcome of event Exacerbation of asthma was recovered, and other events were recovered on 13Feb2021.  Follow-up attempts are completed. No further information is expected.
I got really thirty at first. Then lips, tongue, throat swelled. Talked funny. Lips tingled. Whole left arm and hand felt weird. Tired.
Left arm erythema (4x3 cm), edema, and pain below the injection sites.
PT EXP PAIN AND STINGING AT SOI AFTER VAX WITH ENGERIX-B.  TREATMENT:  PT COUNSELING.
Information regarding PREVNAR  was received from a healthcare professional regarding a patient who was administered the vaccine that was stored at 34 degrees F. The patient received a dose on an unspecified date. The patient was administered the PREVNAR vaccine that was stored at 34 degrees F. No adverse events were reported. No additional information was available at the time of this report.
C/O just feeling "queasy for 2 days" is not vomiting, no diarrhea, no rash, headache, no fever.
Information has been received on 23-MAR-2018 from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 08-OCT-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the patient was treated by a physician for an outbreak that was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Breakthrough case. Developed a sore throat, and had been feeling bad and started having a coughing fit in the middle of the night. When coughing it felt like I was coughing up sand. Tested positive with a home test. Called Dr. at 08:00AM. Called Dr. and was prescribed PAXLOVID and told to take MUCINEX and TYLENOL and increased vitamin C. I'm still feeling most of the effects with a sore throat.
Case not medically confirmed. Case received from a patient 16 Nov 2005. A 34 year old female patient had received a 1st dose of Fluzone (lot unknown) in her left arm on 07 Nov 05. 30 minutes later, she had hot, dizzy, headache and flushed. Within 24 hours, she developed sinus and urinary tract infections (urinalysis was performed). On 07 Nov 05, after infections occurred, she visited physician. The initial symptoms lasted half hour. Patient's recovery status: not reported. Follow up information received on 07/Feb/2006 from a health care professional. Per the reporter, the lot number of the Fluzone wa U1805AA and the vaccination was given on 04/Nov/2005 not 05/Nov/2005 as previously reported. After review of this case by the reporter there was no additional information available to add at this time. Follow up information received on 13/Mar/2006. Per reporte, the injection was given with a 5/8"needle which was a medication error. The size of the patient and intramuscular route required a 1" needled. There were not cultures performed. The patient was followed up at a clinic. Reporter will be forwarding further follow up information. Follow up information received on 27 Mar 2006. Per the reporter, the case was reviewed, and there is no additional information at this time.
Client complained vision went dark and hearing was like she had cotton in her ears, experienced feeling hot. Initial vital signs during episode 98/66 pulse 62. Denied dizziness, pain or nausea. Cooled patient down by fanning her, symptoms subsided a few minutes later. Vital signs before leaving and feeling better, 100/68 pulse 62.
Hives developed on arm, face, chest and back within 1 minute of administration. Treated with 2 tsp of liquid benadryl with good effect.
Friday noticed a lump on  left arm where shot was given, had a rash on my abdomen area - only on the left side.   On the following Saturday, Feb. 13th the lump was still there but much more noticeable, I had a big red ring around the shot area and a rash back on my abdomen - left side again.  I contacted my primary care physician and spoke to the on call nurse they have set up.  She recommended I take a marker to mark the area to make sure it did not get bigger and to take a Zytec to see if that would help.  On Sunday, the lump was almost gone, the red ring was gone and the rash was as well.
pt recvd vax; severe itching; 28dec93 no response to f/u request;
flu like symptoms; joint pains; extreme tiredness; muscle aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), ARTHRALGIA (joint pains), FATIGUE (extreme tiredness), MYALGIA (muscle aches) and NAUSEA (nausea) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), ARTHRALGIA (joint pains), FATIGUE (extreme tiredness), MYALGIA (muscle aches) and NAUSEA (nausea). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), ARTHRALGIA (joint pains), FATIGUE (extreme tiredness), MYALGIA (muscle aches) and NAUSEA (nausea) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. No Relevant concomitant medications were reported. Treatment information was not provided
"Polymyelitis rheumatica"; Re-visitation of pain from her neck injury; Fibromyalgia; Re-visitation of mono; Horrible headaches; Chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA ("Polymyelitis rheumatica") in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Polymyalgia rheumatica ("polymyelitis rheumatica"), Infectious mononucleosis, Neck injury (car accident) in 1980, Headache, Fibromyalgia and Chronic fatigue.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced POLYMYALGIA RHEUMATICA ("Polymyelitis rheumatica") (seriousness criterion medically significant), NECK PAIN (Re-visitation of pain from her neck injury), FIBROMYALGIA (Fibromyalgia), INFECTIOUS MONONUCLEOSIS (Re-visitation of mono), HEADACHE (Horrible headaches) and FATIGUE (Chronic fatigue). At the time of the report, POLYMYALGIA RHEUMATICA ("Polymyelitis rheumatica"), NECK PAIN (Re-visitation of pain from her neck injury), FIBROMYALGIA (Fibromyalgia), INFECTIOUS MONONUCLEOSIS (Re-visitation of mono), HEADACHE (Horrible headaches) and FATIGUE (Chronic fatigue) outcome was unknown.            Treatment information included a tapering dose of 60mg of prednisone for past 7 day. Patient was taking unspecified concomitant medications.  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. Further information has been requested.; 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. Further information has been requested.
Fatigue, severe headache, fluid found in lungs, was diagnosed with Pneumonia.
Pt recv vax on 12/17/98; within 1 hr pt exp swollen/ achy vax site, flu-like body aches, headache  6 days; tx=migraine medicine
Patient had vaccine administered on 2/01/13. Seen in office 2/4/13. Low grade fever since administration and erythema and centralized blisters at the injection site.