chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mon 7/16/18 at about 1200: Pt rec'd SHINGRIX vaccine to left deltoid without incident. Pt describes local injection site pain that started later in the day following the vaccination. Tues 7/17/18: Pt describes more pronounced pain at injection site as well as swelling, erythema, warmth, tenderness and general malaise. Febrile at 101F that evening requiring ibuprofen. According to pt her normal body temp runs about 97.8. Wed 7/18/18: Symptoms continue at approximately the same severity. Pt describes low grade temp about 100F requiring ibuprofen. Thurs 7/19/19: Pt describes slight improvement in her symptoms. Afebrile. Less redness, swelling to site. Warmth and tenderness continues. Pt notes margin of local reaction has expanded and extends distally and medially from injection site. Margin is less well defined and part of the affected area is blanched in appearance. RXN area is greater than 5cmin diameter. Fri 7/20/18 at about 1130: Pt describes slight improvement in most symptoms. Afebrile. Area remains tender, slightly red/pink with an expanded area of local reaction remaining blanched and not well demarcated. Pt denies numbness of tingling to left extremity. Wed 7/18/18: Pt calls pharmacy and speaks with pharmacist to describe RXN. Thurs 7/19/18: Pharmacist calls pt to F/U. Fri 7/20/18: Pt to pharmacy. Pharmacist observes injection site reaction and documents. Patient to clinic for evaluation. Pharmacist completes VAERS form. Clinic prescribed short course of ABX and steroids.
Vaccine was given at Medical Center prior to resident transfer on 12/12/18 - Developed a Red area size of a quarter upon admission on 12/12/18 and on 12/15 had a red area 7 inches x 3 inches in length over the same site. PCP here (Dr. notified and asked if a VAERS report should be completed by Nsg. Supervisor - RN - he wishes us to proceed with VAERS report).
Patient called the pharmacy 5/6/21 to question a rash on her arm where she received her COVID vaccine.  She stated that she did have a red wheel around the injection site and mild pain after her 4/22/21 vaccine but the redness faded after 5 days.  She said that she woke up this morning (5/6/21) and noticed a rash on both arms and redness around the injection site.  I told her that I wouldn't know if she was experiencing hives unless I saw the rash.  She said that she needed to stop by the store today and would stop by the pharmacy.  A few hours later, patient presented to the pharmacy. I observed her rash.  She has a large wheel of redness on her left deltoid the size of a lime.  She has a red, spotted rash on her bilateral arms and states that she does not have the rash elsewhere on the body. Patient states the rash does mildly itch.  I told her I did not believe that she was experiencing hives but referred her to her physician to determine if it could be a delayed reaction to the vaccine. Patient visited her physician this afternoon and returned to the pharmacy with a prescription for triamcinolone cream.  She also had a letter in hand from her physician stating she was medically cleared to receive her second dose of Moderna vaccine.
rash on my arm where I had the shot between my wrist and my elbow and my left hand; My arms a little bit tired; My chest is little bit tight; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER2613), via an unspecified route of administration, administered in arm on 21Mar2021 as Dose 2, Single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: ENG202), via an unspecified route of administration on 25Feb2021 as Dose 1, single for COVID-19 immunization. On 30Mar2021, the patient was feeling like the patient did a little bit of lifting of couple of boxes the patient normally do the work and his arms a little bit tired and he had rash on his arm where he had the shot between his wrist and his elbow and his left hand little bit of he don't know it was allergy and his chest is little bit tight, the patient don't had any cough or anything. The patient don't had trouble breathing the patient think I was under the weather and I think went through all possible side effect, the patient don't know why it was suddenly just notice the rash today. the patient need to go to professional or medical doctor if he had any kind of reaction he don't know. The patient left arm between his elbow and his wrist had some dark rash. Would the patient had to go to doctor or don't feel like going to emergency room. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Arm pain. Pain worse with shoulder movement.  Advised heat, ibuprofen 400-600 mg tid x 5 days, avoid lifting.
Numbing/cramping on my right toes & foot. Becoming evident on my right hand-spreading through my right side of my body. Woke up 02/02/2013 with a lock-jaw sensation & cramping spreading through my left side off my body. 02/05/2013, back pains occurred - progressing the following day. 02/08/2013, facial paralysis. 02/09//2013, Tongue & throat numbness (bar). I was diagnosed with GBS on 02/09//20133 -confirmed through a spinal lumbar puncture. 02/10/2013 at 2:00 am Immunoglobulin was administered (3 times daily, for 5 days). So far, recovering nicely.
The pt complained of pain in his neck approximately 20 minutes post vax as he was getting into his car. 24 hours later he still experienced pain associated with movement of his head. Has had similar pain in the past, but not this bad.
14JUL92 noted hives on face w/in 1 hrs of inject; returned to office & noted hives on abd arms, legs & feet; tx w/Epi;
7 days following Measles vax @ 9 mo of age -high fever (102 to 103) all day & night called MD & report it. Sz convuls on 24AUG65. Pt runs on tip toes w/stiffest in body to this day & walks on the side of feet.  Child healthy until shots
a left sided exotropia of the eye witness on exam; left sided facial swelling; Patient experienced left sided chills; left sided headache; This is a spontaneous report from a contactable physician. This physician reported for a female patient.  A non-pregnant female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EW0198, Expiry date was not reported), via intramuscular route, administered in Arm Left on 12Jul2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced left sided chills, left sided headache, left sided facial swelling and a left sided exotropia of the eye witness on exam on an unspecified date 2021.  The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Needle slipped and some of the content was lost on her arm; needle slipped and some of the content was lost on her arm; A spontaneous report was received from a nurse concerning a female patient who received Moderna's COVID-19 vaccine and received less than a full dose due to the needle slipping and some of the content was lost on the patient's arm.  The patient's medical history was not included. Products known to have been used by the patient, were not provided.  On 26 Jan 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On 26 Jan 2021, after she received the mRNA-1273 vaccination, the nurse notes that the patient did not receive the full dose as the needle slipped and some of the content was lost on her arm. Treatment information was not provided.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the event, not receiving a full dose due to the needle slipping and some of the content was lost on her arm, was considered resolved.; Reporter's Comments: This case concerns a female patient of unknown age who received one of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection and after she received the vaccination, the nurse notes that the patient did not receive the full dose as the needle slipped and some of the content was lost on her arm. There were no reported adverse events associated with this case of device connection issue and incorrect dose administered
NO ADVERSE REACTIONS. PATIENT WAS GIVEN EXPIRED VACCINATION (EXP DATE 9-21-21)
Patient received one of two doses of Moderna vaccine on 7/15/21. Patient presented to ED on 7/31/21 with complaints of worsening SOB x 3 days. Patient was exposed to a COVID positive person.
Sunday evening 5/9/2021 - Extreme nausea.  (Vomited 2x).  Body aches started in lower back but moved around to different parts of body.  Extreme fatigue.  Headache (Left side of head), Earache (Right Ear).  Soreness at injection site.   Loss of appetite.  Some disorientation. Monday am - Nausea, vomiting, dry persistent cough, loss of appetite, extreme fatigue (stayed in bed all day).  Appetite returned around 11pm.  Headache (intermittent).  Muscle aches moved around to different parts of body.  Used heating pads and ice-packs.  Tuesday am - Fatigue, still sore at injection site, winded when walking slowly, some disorientation, overall body tiredness. Wednesday noon - Fatigue, soreness at site, winded during light short swim, appetite depressed. Thursday - Fatigue, disorientation, loss of energy.   After the 1st shot in the series I had nausea and vomiting.  Also experienced extreme fatigue.   One important factor is that I had TKR surgery on right knee February 18, 2021.  Maybe it was too soon after surgery to receive the vaccination?  My husband had same shot, same day, same Lot#.  His side effects only lasted 1 day but were isolated to soreness at injection site and overall fatigue and muscle pain but only in lower back.
A spontaneous report was received from a 83-years-old female patient concerning herself  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event back ache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 8 Mar 2021, the patient experienced the event back ache.  Treatment details included Ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, back ache,  was unknown.
Light Headed; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light Headed) and PAIN IN EXTREMITY (Sore Arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event .     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (Light Headed) and PAIN IN EXTREMITY (Sore Arm). At the time of the report, DIZZINESS (Light Headed) and PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
5MAY mild sx, body aches, chills, sore throat, cough, fatigue-progressive; 7MAY seen by MD for increasing severity all tests neg; (Mono spot, sed rate, viral & bact throat cultures;
Child began vomiting 1/2 hr after IMZ administration. Parents took child to OPD at 4:30 P. T 101 degrees. Transferred to ER for IV hydration. Given 220 cc IV fluids and responded well.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided          No concomitant medication provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-091772, US-MODERNATX, INC.-MOD-2021-092231 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-091772:case for daughter US-MODERNATX, INC.-MOD-2021-092231:case for mother
I lose my balance when I walk; sore arm; Fever; headache; Sick like flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Sick like flu), BALANCE DISORDER (I lose my balance when I walk), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced INFLUENZA (Sick like flu), PYREXIA (Fever) and HEADACHE (headache). On 29-Jan-2021, the patient experienced BALANCE DISORDER (I lose my balance when I walk) and PAIN IN EXTREMITY (sore arm). At the time of the report, INFLUENZA (Sick like flu), BALANCE DISORDER (I lose my balance when I walk), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
I experienced extreme pain in my left arm 03/20/2010 and could not lift it (spanned a period of 10-days and still comes and goes randomly). I went to the ER and the doctor explained that possibly the clinician struck a nerve while administering the 2nd dose of the vaccine. I was asked a series of questions and directed to move my arms in different directions so they could properly diagnose me. Once I left the ER and arrived home the pain was gone.
Pain in arm not in the same spot but around where the shot was given'; This case was reported by a consumer and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included non-alcoholic steatohepatitis (stage 4 NASH a hereditary liver disease), renal disease (stage 3), diabetes, fibromyalgia and sleep apnea.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient was 68 years old at the time of reporting. The age at vaccination was not reported. The patient had so many physician appointments, etc. due to having "Stage 4 Nash"(a hereditary liver disease), a "Stage 3" kidney disease, diabetis, fibromyalgia, sleep apnea, among other things, she needed medicine for, so it was hard to remember when she had the shot or when she got the letter. The patient was wondering if there was any solution for the pain in her arm. The patient requsted response. The patient thought that she received Shingrix 3 years ago from the physician and then at one of follow up visits, the patient told the physician that since vaccination, the patient's arm hurt every day, not in the same spot but around where the shot was given. The patient thought that the physician contacted GSK and GSK response (she believed) was a letter from GSK to the patient. When the patient received the letter she could not think what it was about and did not finish even reading it and what it concerned, due to the fact of receiving so much junk mail.
C/O Mid sternum CP present for 8 hours, non exertional, had gas mask on apprx 10 min. Impression angina Temp 99.2 degrees
This spontaneous report as received from a medical assistant refers to an unspecified number of unspecified patients. On an unspecified date in 2015, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB (lot # K026666, expiration date 22-OCT-2016). No adverse effects have been reported. This is one of several reports received from the same source. Additional information has been requested.
fatigue; patient cannot walk very well; barely get out of bed 5 days after it; This non-serious case was reported by a other health professional via call center representative and described the occurrence of bedridden in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chronic fatigue.   On 20-MAY-2023, the patient received the 1st dose of Shingrix. In MAY-2023, an unknown time after receiving Shingrix, the patient experienced bedridden (Verbatim: barely get out of bed 5 days after it). On an unknown date, the patient experienced fatigue (Verbatim: fatigue) and walking difficulty (Verbatim: patient cannot walk very well). The outcome of the bedridden was resolved (duration 5 days) and the outcome of the fatigue and walking difficulty were not resolved.   It was unknown if the reporter considered the bedridden, fatigue and walking difficulty to be related to Shingrix.     It was unknown if the company considered the bedridden, fatigue and walking difficulty to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-JUN-2023 The reporter reported that patient received a dose of Shingrix and can barely get out of bed 5 days after it. The patient could not walk very well due to fatigue. The vaccine was administered at an unknown pharmacy.
sore arm: first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Mar2021 (Lot number: ER8733) at the age of 49 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALEVE taken for headache. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Mar2021, outcome "recovered" (31Mar2021), described as "sore arm: first dose".  Additional Information; No prior Vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. Not visited emergency room and physician office. No relevant tests provided.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a 68  year old male patient with no medical history and no drug allergy. On 12-SEP-2014 the patient was vaccinated with ZOSTAVAX (reported as vial 19400 PFU, lot # K000726 expiry date: 09-JAN-2015, dose: 0.65 ml, route of administration: subcutaneous, arm). There was no concomitant medication. In approximately September 2014, after receiving the injection the patient experienced very swollen arm after receiving the injection/injection site was very swollen. No lab diagnostic was performed and no treatment was provided. The outcome of very swollen arm after receiving the injection/injection site was very swollen was not reported. The relatedness between ZOSTAVAX and very swollen arm after receiving the injection/injection site was very swollen was not reported. This one of several reports from the same source.  Additional information has been requested.
Vaccine was given 4 days past "use by" date. Called manufacturer & was advised "off label" use was 45 days in refrigerator so they did not recommend revaccinating.
pt arm was swollen the size of a quarter that noc;the next morning the swelling inc to the size of an orange;mom gave Ibuprofen;no fever or sz occurred;pt also has prev vax w/DTP in another hlth institution
Two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days; Two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) and EXPIRED PRODUCT ADMINISTERED (Two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) and EXPIRED PRODUCT ADMINISTERED (Two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days). At the time of the report, PRODUCT STORAGE ERROR (Two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) and EXPIRED PRODUCT ADMINISTERED (Two patients received a dose administered from a Moderna vial that was in the refrigerator longer than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was reported.   This case was linked to MOD-2021-279505 (Patient Link).
"covid arm"  10 days after 1st shot noted itchy area under injection site - rash type of aprox 3 inch in diameter - hot to touch but not raised - still continues lightly after a week - no other symptoms noted- checking in with primary Doctor today - 2 nd shot scheduled for Feb 22 2021
3/17/2023 I had a minor cough and not feeling quite right. The main symptom was just not feeling well. I took an at home COVID test and it was positive. I texted my doctor and went to bed early. Later I began feeling very nauseous and continued throughout the night feeling that way. I had trouble urinating. I just did not want to move. The next morning, I was terribly weak. The doctor called that morning and was going to prescribe Paxlovid and something for nausea. She called back and told me to go to the hospital I went to the hospital by ambulance. On the way, they said my oxygen level was about 86 and I was given something for nausea. After that, I was weak. After I got to the Emergency Room, they admitted me into ICU. They were watching my oxygen levels that fluctuated throughout my stay. I was given Paxlovid. While I was there I was given antibiotics for a UTI. I had a CT scan and an MRI and saw I had an abscess in my left buttocks. I was taken off Oxygen on 3/24/23. I was discharged on 3/26/23 with a walker because I was so weak.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: while observing the patient after administering the vaccine, he temporarily fainted.  He came to immediately and felt better within the following 5 minutes.
Patient stated that her arm was extremely sore for 6 days after receiving the vaccinations and she had to take APAP for relief.