chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A spontaneous report was received from a consumer who was a 79-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced intermittent headache, crushing feeling in her chest between her breast, red, swollen arm and had pain shooting down to the elbow and felt very fatigued.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Lot # 037N20A) on 23-Dec-2020 in the left deltoid intramuscularly for prophylaxis of COVID-19 infection.   The consumer called to report she had received the Moderna Covid-19 vaccine on 23-Dec-2020 in her left deltoid. She stated she did not have any reaction until 30-Dec-2020. She began to experience intermittent headache, a crushing feeling in her chest between her breast. She stated the crushing feeling was not pain, only lasted 10-15 seconds and was intermittent. She stated her arm began to get red, swollen and had pain shooting down to the elbow. She stated she felt very fatigued. Her son took her to Urgent care where she had a chest x-ray, blood work, an electrocardiogram and her vitals were taken. There were no specific results of these tests reported, but the patient reported that everything "checked out good."  She reported that on 02-Jan-2021, all of the symptoms went away except for the red, sore arm. She stated that that continued. The consumer reported her symptoms online through VAERS system.  Treatment included a topical steroid cream on the injection site which was not prescribed.  Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events, intermittent headache, crushing feeling in her chest between her breast, swollen arm, pain shooting down to the elbow, and felt very fatigued, were considered resolved as of 02-Jan-2021. The outcome of the event, red, sore arm, was considered unknown.; Reporter'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
Mom states day after immunization she noted that pt has what she thought was a "diaper rash". it began to spread down her legs and now its on her arms, back and stomach. Mom states pt had fever 09/28/2001 of 101 degrees gave some Tylenol and no further fever. Said temp today at PMW was 97 presented here with note from PCP to look at rash. Rash has some blister looking areas and is worse on lower extremities. Pt still had rash at last visit 10/01/2001.
Within 4 hours of receiving the PNEUMOVAX patient had swelling in her left arm from elbow to shoulder, tenderness, redness, hot to touch, fever 99 degrees.
Patient got a PNEUMOVAX 23 vaccine in the left arm on 4/2/16. He experienced redness/swelling around injection site. The inflammation improved after a few days.
I had a sore throat, slight fever, fatigue on 01/10/22. I took rapid and PCR lab test on 01/11/22. Both came back negative. I had fatigue, a fever, sore throat and started coughing on 01/15. I lost my voice and had trouble breathing. I tested positive for Covid 19 on 01/21/22. I continued coughing and had trouble breathing through 02/19/22. I was only worked two 8 hour shifts from 01/11 through 02/19.
L arm started swelling around 7:30 08/21/12 a.m.  Swollen to the size of silver dollar.
02/12/2021 I woke up with eye irritated but on 02/14/2021 I woke up with swollen eyes and hives all over, that lasted for just that day, I went to the ER, they gave me Benadryl, oral steroid, Maalox. It took at least a day for the swelling to go down and I was on the medications for three weeks.
Ever since I got it (medication), it is red and swollen. It is like hard in that spot and warm; Ever since I got it (medication), it is red and swollen. It is like hard in that spot and warm; Ever since I got it (medication), it is red and swollen. It is like hard in that spot and warm; The site where vaccine is given is hard; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER2613), dose 2 via an unspecified route of administration, administered in Arm Right on 27Mar2021 (at the age of 74-years-old) as dose 2, single for covid-19 immunization. Patient medical history included cancer in right breast (cancer in right breast, this year) from 2021 to an unknown date. Patient also had high blood pressure from an unknown date and unknown if ongoing. Patient took other products as well. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), dose 1 via an unspecified route of administration on 05Mar2021 as dose 1, single for covid-19 immunization. On 27Mar2021, the patient reported that ever since the (medication), it was red and swollen. it was like hard in that spot and warm, the site where vaccine was given was hard. It was reported that patient was putting ice on it as a treatment but can't sit all day putting ice on it. Patient stated that with the first medication there was no problem at all, this second one was problem. Patient wanted to know what she can do about the swelling, the hardness, the heat and the hard where it was and was asking can she put some ice on it, she did not know what to do. On an unspecified date, the patient underwent lab tests and procedures which included weight as 170. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
night sweats; low grade fever; not good appetite/ appetite does not seem to be very good; headaches; low energy/feels with low energy; lethargic; leg weakness; achy/ overall achy feeling; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of lower extremities weakness of in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2019, the patient received the 1st dose of Shingrix. On 22nd April 2019, 3 hrs after receiving Shingrix, the patient experienced lower extremities weakness of, pain and influenza-like symptoms. On an unknown date, the patient experienced night sweat, low grade fever, appetite disorder, headache, energy decreased and lethargy. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the lower extremities weakness of, pain, influenza-like symptoms, night sweat, low grade fever, appetite disorder, headache, energy decreased and lethargy were not recovered/not resolved.   It was unknown if the reporter considered the lower extremities weakness of, pain, influenza-like symptoms, night sweat, low grade fever, appetite disorder, headache, energy decreased and lethargy to be related to Shingrix.  Additional details were provided as follows: The patient reported received the first Shingrix vaccine. Three hours after the vaccine he started experiencing the following symptoms: leg weakness, overall achy feeling, flu-like symptoms. The patient also experienced night sweats and low grade fever (up to 102 degrees) for the past 2 weeks. The patient had low grade fever was not as high anymore, but he still had it. The patient appetite does not seem to be very good. The patient was also having mild headaches, feels with low energy and lethargic. The patient said that all the symptoms come and goes in waves during the day. The patient had visited his physician twice since he started having these symptoms. The physician had given him steroid shots. The reporter consented to follow up.      Lab Comments: In 2019, body temperature was up to 102.
Information has been received from a registered nurse concerning a 59 year old white female professor with an allergy to vancomycin (hives) and erythromycin (nausea) and no medical history who on 11-OCT-2007, was vaccinated IM into right deltoid with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included influenza virus whole virion 3v vaccine inactivated (FLUZONE (influenza virus whole virion 3v vaccine inactivated)) (lot # U2443AA) administered IM into left arm, levothyroxine Na (SYNTHROID) and bupropion SR 150. On 11-OCT-2007, the patient developed cellulitis in the right shoulder at the injection site with erythema and tenderness 2 inches around the injection site. It was reported that the patient required 2 different antibiotics, cephalexin (KEFLEX) 500 mg QID and amoxicillin (+) clavulanate potassium (AUGMENTION) 875 mg BID. It was reported that she was not treated with medication. Subsequently, the patient was recovering. No product quality complaint was involved. Injection site cellulitis was considered to be life threatening and an other important medical event. Additional information is not expected.
This patient presented with her family and brother whom both needed four immunizations.  We added on the brother to our schedule but when it was time to give patient her vaccines we recognized that she was given her brothers (2 of them - PCV and Hib instead of the DTaP and IPV).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Dec2022 as dose 4 (booster), single (Lot number: 9J6738) at the age of 68 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 was not reported. Concomitant medication(s) included: CORICIDIN COLD & FLU. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid started from 12Jan2023 to 17Jan2023.   No follow-up attempts are possible. No further information is expected.
Dull pain in injection muscle 3rd day from injection. Numbness tingling extended to elbow. Though the 9th the numbness/tingling spread down forearm to left hand. Went to urgent care on advice of physician for assessment. Dr reviewed symptoms and diagnosed arm paresthesia suspected from soft tissue swelling post vaccination. Given instruction to monitor for worsening symptoms.  Arm stayed the same through the 14th with tingling limited to 4th and 5th finger of left hand (and elbow etc). As of today, the 16th, numbness receded to elbow. Dull pain in muscle decreasing, but still noticeable.
Hardness at injection site, lump / hardness about 2 inches to the side of injection site. Redness, warm, very slight itching.  Hardness began within a couple of days of shot.  Slight itching began 5 days after.  Redness and warmth began 8 days after.
Fatigue; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of   in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for Allergy, SIMVASTATIN for Cholesterol, CENTRUM.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Caller received Moderna vaccine last Jan 13th and experienced the following symptoms: Jan 13th Arm soreness Jan 17th on and off Fatigue 17JAN2021 TDS; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
pt recvd vax & devel lump (4-5) at inject site; biopsy revealed mild dermal fibrosis;
allergy; itching all over her body; welts; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergy), PRURITUS (itching all over her body) and URTICARIA (welts) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (Batch no. 037B21A/10/1/20) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Quinolone). Concomitant products included PANCREATIN (CREON), APIXABAN (ELIQUIS), FUROSEMIDE, POTASSIUM, SPIRONOLACTONE and APIXABAN for an unknown indication.    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced ALLERGY TO VACCINE (allergy), PRURITUS (itching all over her body) and URTICARIA (welts). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, ALLERGY TO VACCINE (allergy), PRURITUS (itching all over her body) and URTICARIA (welts) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
don't know if my issues are related to vaccine  Feb 1 - 5 days after shot - intense headache, pressure , fuzzy head, slight visual disturbance - lasted about 15 min.  - then subsided  Feb 2   strong headache  - approx 10-15 min Feb 3   strong headache - pressure  approx 10-15 min  Feb 4   mild headache  Feb 5   slight headache  -
Significant chills began while sleeping 15 hours after the injection, frequent urination--every 45-75 minutes from 3am to 9am.  No sweating, checked temperature at 9am, it was 99.5.  Significant muscle and joint aches, neck and shoulders especially on right side,  both hands, lower back, knees, and feet.  Sharp ear ache lasting for 3-4 hours, but only intermittant.  I tested positive for Covid-19 in March, 2020.  Very sick for 5 days, but not hospitalized.  The last time I donated plasma, on February 2, 2021, I still tested positive for Covid-19.
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Ache and pain all over her body, muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (A few days later she felt tired all the time, A few days later she felt tired all the time) and SARS-COV-2 TEST POSITIVE (She took two at home COVID test, which came out positive both times) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No Medical History was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced MYALGIA (Ache and pain all over her body, muscle pain). On 24-Aug-2021, the patient experienced ARTHRALGIA (Joint pain) and HEADACHE (Headache). On an unknown date, the patient experienced FATIGUE (A few days later she felt tired all the time, A few days later she felt tired all the time) and SARS-COV-2 TEST POSITIVE (She took two at home COVID test, which came out positive both times). The patient was treated with IBUPROFEN for Myalgia, at a dose of Unknown. At the time of the report, MYALGIA (Ache and pain all over her body, muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (A few days later she felt tired all the time, A few days later she felt tired all the time) and SARS-COV-2 TEST POSITIVE (She took two at home COVID test, which came out positive both times) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. On 07-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
DEMAND ISCHEMIA 8/25/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION  ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/25/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION  DEMAND ISCHEMIA 8/25/2022 ANEMIA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/25/2022 ANEMIA
Patient had a 4 day hospital admission for right upper arm cellulitis following administration of vaccines. Symptoms started about 6 hrs after vaccine administration.
It was reported that she cannot take the Moderna vaccine again due to a reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (It was reported that she cannot take the Moderna vaccine again due to a reaction) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (It was reported that she cannot take the Moderna vaccine again due to a reaction). At the time of the report, IMMUNISATION REACTION (It was reported that she cannot take the Moderna vaccine again due to a reaction) outcome was unknown.            No relevant concomitant medications were reported.   No treatment medication reported.
Excessive Sleepiness. Nausea/vomiting - 2-3 days duration. Occurred after 2nd, 3rd, 4th, and 5th vax.  Follow up 05/17/2000: "Patient partially recovered from adverse event.  Sinus and inner ear inflammation.  Nausea and vomiting stopped after 3 days."
Fever 32 hours after 1st dose.  Spotting 4 days after 1st dose for 4 days.
Headache, Myalgia, Arthralgia, Fever, CoughWheeze, NauseaVomiting, Syncope, fatigue,chills Narrative: 1/21 - Received the second dose of the COVID-19 vaccine. Started to feel sick later that day. 1/22 -1/23- Body aches, headache 1/23 - nausea and vomiting 1/26 - fever to 101.6 and sore joints and body aches. 1/27 - tested negative for COVID-19. He has a cough, headache, and fatigue. His symptoms have improved since Monday though. Advised to see his PCP tomorrow if his symptoms have not substantially improved. 1/28 - all symptoms resolved and he has returned to work. He has some mild residual fatigue.
Guillain-Barre Syndrome - mild case. Tingling, numbness up entire legs more prominent in feet. Mild back pain. No weakness. Some numbness and paresthesias hands. Restlessness.
Initial report received from healthcare professional on 16 October 2012. The female patient, over the age of 65 years) initials, date of birth were not reported) whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD vaccine (batch number, route and anatomical site of administration were not reported) on an unspecified date. After receiving FLUZONE HD vaccine, the patient had swelling of entire arm. The corrective treatments and laboratory investigations were not reported. The patient's outcome was not reported. Documents held by sender: none
mom states pt vomited x 6 evening 7JUL98 & had temp of 102, c/o malaise 8JUL98 5PM-mom states pt much better-no fever;no further vomiting 9JUL98 3PM;soreness in rt upper arm;
Pt recvd vax 15JUL92 & on 22JUL92 devel Bell's Palsy on rt side w/drooping on rt side of face;
Mom reports that around 10:00 PM patient just did not feel well. She gave him some water, put him to bed-he was OK. At 11:30, he awoke with temp of 102, blurry vision and said his arms and legs "felt funny". She gave him Tylenol and took him to ED. (around 1:00 AM 8/5/15) There temp was 34, his neuro sx had resolved, and his P.E. was normal. Sent home with no therapy and with Dx of post- immunization fever.
12-28-07 complained of pain in deltoid since receiving flu vaccine 11-20-07.  No edema, erythema, tenderness with palpation.  Pain with movement.  Referred to private physician.
Tightness  that traveled from the shoulder (site of the vaccine) to the wrist; numbness that traveledfrom the shoulder (site of the vaccine)to the wrist.; This is a spontaneous report from a contactable consumer. A 49 -year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP6955,) via an unspecified route of administration in the left arm on 22Mar2021 at 11.00 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included overweight and hemochromatosis. The patient did not have any allergies to medications, food or other products. Concomitant medication included ADDERALL, for unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 12:00, the patient experienced tightness and numbness that travelled from the shoulder (site of the vaccine) to the wrist which subsided completely after about three hours. The patient did not receive any treatment for the events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of tightness and numbness was resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
I was 34 weeks at the time of vaccination. Initially, I only had pain at the injection site. I woke up the next day with diarrhea that lasted about 6 days. I had no other symptoms besides dehydration and back pain. On Day 3, I was instructed to take Imodium, which I took for about 2 days, but it didn't help. Around Day 5, I was given fluids, my urine was tested and multiple GI tests were run. I was placed on antibiotics for a UTI. PVCs were also discovered at visit, but it's not connected to the vaccine.
PT CALLED PHARMACY AT 02:35PM ON 07/15/2023 COMPLAINING OF ARM SORENESS, REDNESS, AND SWELLING/LUMP IN AREA SURROUNDING INJECTION SITE (PATIENT STATES AREA THE SIZE OF GOLF- SOFTBALL)  DENIES ANY KIDNEY OR LIVER ISSUES, INSTRUCTED TO TAKE IBU/ TYLENOL PRN FOR PAIN/ SWELLING. MAY USE ICE IF NEEDED. FOLLOW BACK WITH US POST 3 DAYS OF INJECTION SHOULD SYMPTOMS NOT IMPROVE OR CALL BACK IF GETS WORSE, AND WE FOULD FOLLOW UP WITH PCP.
Patient stated that she had red, swollen and painful area near to injection site. On april 13th, patient went to the doctor office and seek medical attention, dr believed that she had infection at the site of infection so she was given antibiotic (keflex).
From initial info received on 7/15/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 43 year old female pt received a dose of TD ADS ADULT, lot U1000AA, administered in the left deltoid on 7/8/04. Route of administration was not reported. Four days later, on 7/12/04, the pt experienced painful lymphadenopathy in the left clavicular region. The reporter provided the event onset date as 7/12/04, but reported that the event  occurred 2 days after vaccination. No infection, redness, warmth or drainage was noted at the injection site. Pt's pre-existing medical condintions include allergies to multiple antibiotics. The pt has hypertension at the time of vaccination. Reportedly, she recovered from the events.