chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 55 year old male patient. On 06-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K008409, expiry date 04-MAR-2016, dose 0.5 ml, intramuscular). Concomitant medications were not reported. In approximately November 2014, the patient experienced rash and cellulitis at the injection site. Patient sought medical attention-he was assessed by a physician on 11-NOV-2014 and no treatment was prescribed. No laboratory studies were performed. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. This is one of the several reports from the same reporter. Additional information has been requested.
CLIENT EXPERIENCED SORENESS AROUND INJECTION SITE DEVELOPING SEVERAL HOURS AFTER THE VACCINATION. THE SORENESS CONTINUED TO ESCALATE. REDNESS AND WARMTH  DEVELOPED AROUND THE INJECTION SITE  AND INCREASED IN  SIZE AND INTENSITY. THE CLIENT CALLED ON  MONDAY, SEPT. 25 TO ASK IF THIS WAS UNUSUAL. PT STATED THE WARM  REDNESS  WAS SLOWLY INCREASING IN SIZE AND THE DISCOMFORT WAS NOT IMPROVING. I WENT TO VISIT WITH HER IMMEDIATELY AT HER PLACE OF EMPLOYMENT. THE AFFECTED ARM IS NOTICIBLY  RED AND SWOLLEN. THE REDDENED AREA IS VERY WARM TO TOUCH. THE INJECTION SITE IS PURPLY IN COLOR. THE REDNESS IS A SOLID COLOR AND IS BLANCHABLE. THE RED AREA EXTENDS FROM THE TOP OF HER SHOULDER TO JUST ABOVE THE ELBOW JOINT AND HAS A DEFINITED LINE OF DEMARCATION.. THE CLIENT REPORTS NO SYSTEMIC SYMPTOMS. SHE SAID SHE WOULD TAKE AN OTC ANALGESIC AND WAIT A COUPLE OF DAYS MORE TO SEE WHAT HAPPENS. I CALLED HER ON 9/27/2017 AND PT STATED THE SYMPTOMS WERE SLOWLY RESOLVING. SHE DID NOT SEEK MEDICAL ATTENTION.
Like a severe migraine; Achy; Miserable; Was in bed for 3 days; Throwing up; Had a fever; Chills; headache across her forehead was so severe; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Like a severe migraine), PAIN (Achy), FEELING ABNORMAL (Miserable), BEDRIDDEN (Was in bed for 3 days) and VOMITING (Throwing up) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus systemic (Lupus mostly in joints and skin).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced MIGRAINE (Like a severe migraine), PAIN (Achy), FEELING ABNORMAL (Miserable), BEDRIDDEN (Was in bed for 3 days), VOMITING (Throwing up), PYREXIA (Had a fever), CHILLS (Chills), HEADACHE (headache across her forehead was so severe) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Nausea, at an unspecified dose and frequency and TRAMADOL for Migraine, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Like a severe migraine), PAIN (Achy), FEELING ABNORMAL (Miserable), VOMITING (Throwing up), PYREXIA (Had a fever), CHILLS (Chills), HEADACHE (headache across her forehead was so severe) and NAUSEA (Nausea) outcome was unknown and BEDRIDDEN (Was in bed for 3 days) had resolved.            No relevant concomitant medications were reported. Treatment includes some pills for nausea
Sore at injection site and swelling on bisep below injection site. I had fever of 100.5 four hours after vaccine that lasted from 10PM until 6 AM. On Sunday morning I noticed that my left elbw is very swollen,red and sore.
Sever cheat pains began in early may, increased blood sugar level; somewhat uncontrollable with normal insulin dose, became anemic, and incurred high cholesterol. Was put on iron supplement, and statin.  Severe chest pains, arm pain, back pain, presenting like a heart attack contined for 3 months when on 8/9 i suffered an actual heart attack and am now on 9 different medicines to control yhe cheat pain and deter future heart attacks.  I had ZERO heart, iron or choleaterol issues prior to getting yhe vaccine.
Large, painful lump at injection site size of an orange, raised, warm, very painful, small red area also located above large area.
pain in both arms; headaches at the front and back of my head, more headaches than usual; pain on the injection site; still feels fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in both arms), HEADACHE (headaches at the front and back of my head, more headaches than usual), VACCINATION SITE PAIN (pain on the injection site) and FATIGUE (still feels fatigued) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 037Ac13) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Neuropathy.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced PAIN IN EXTREMITY (pain in both arms), HEADACHE (headaches at the front and back of my head, more headaches than usual), VACCINATION SITE PAIN (pain on the injection site) and FATIGUE (still feels fatigued). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (pain in both arms), HEADACHE (headaches at the front and back of my head, more headaches than usual), VACCINATION SITE PAIN (pain on the injection site) and FATIGUE (still feels fatigued) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) both arms.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up information was received on 29-jun-2021 contains Significant information. Added new events Pain in both arms and Fatigue. Anatomical location of vaccine updated.
When giving the injection, the syringe needle malfunctioned and more than half the dose spilled down the patient's arm. The patient was given a full dose in the right arm on the same day. No adverse reactions were reported.
pt recv vax 20APR97 & 21APR97 pt exp nausea, diarrhea & fatigue;
Heart racing,  feeling hot,  feeling like world is closing in.  10:49  improved and discharged home.
5/18/05 Parents here with child reporting called health department this morning as Mom noticed child had redness and swelling to right upper arm and it felt warm. Instructed per RN to use ice pack and Tylenol and if not better to notify MD. Mom says it got worse and they took to doctor and she said it was infection and started Keflex TID for 7 days and instructed her to report to health department. Noted right upper arm slightly swollen, warm to touch, and redness to entire right upper arm.
Itching and redness  Pt was given diphenhydramine 50mg and watched for 45 minutes.  Itching and redness was reduced and pt was counseled to watch carefully and seek medical assistance.
Patient was given a dose from a Pfizer Bivalent Vial on 11/21/2022 that had originally been opened on 11/20/2022 but was not wasted at the end of the day.  The patient receiving the dose on the morning of 11/21/2022 received it from  the already punctured vial that had been sitting since the day prior on 11/20/2022. Called Pfizer and they said stability data at room temperature was okay for 24 hours. Per Pfizer information and professional judgement, do not need to repeat the dose according to CDC data.
COVID-19/ Rebound of COVID symptoms and positive antigen test; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19/ Rebound of COVID symptoms and positive antigen test) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to unspecified drug).    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19/ Rebound of COVID symptoms and positive antigen test). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 25-May-2022 to 30-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19/ Rebound of COVID symptoms and positive antigen test) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was reported. From 25-May-2022 to 29-May-2022, other medication Zithromax was administered. From 25-May-2022 to 31-May-2022, other medication Prednisone was administered. On 03-Jun-2022, the COVID symptoms was rebound and positive antigen test. Device Date was reported as 04-Jun-2022.  Company comment: This spontaneous case concerns a 45-year-old female patient with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred on unspecified day after the third dose of mRNA-1273 vaccine The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 25-May-2022 to 30-May-2022  for COVID-19 treatment. It was reported 25-May-2022 to 29-May-2022, Zithromax and 25-May-2022 to 31-May-2022 Prednisone was administered. COVID symptoms was rebound and positive antigen test ( SARS-CoV-2 test) as on 03-Jun-2022.Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 45-year-old female patient with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred on unspecified day after the third dose of mRNA-1273 vaccine The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 25-May-2022 to 30-May-2022  for COVID-19 treatment. It was reported 25-May-2022 to 29-May-2022, Zithromax and 25-May-2022 to 31-May-2022 Prednisone was administered. COVID symptoms was rebound and positive antigen test ( SARS-CoV-2 test) as on 03-Jun-2022.Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
lymphedema in her left arm; her left arm that will become red and blotchy at times; slight redness on her arm; her left arm that will become red and blotchy at times; sick; The first two doses of her Moderna COVID vaccine; The first two doses of her Moderna COVID vaccine; she had the flu for about a day and a half; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (Solution injection; Batch/Lot number was not reported), dose 3 via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation and received influenza vaccine (FLU VACCINE VII; Batch/Lot number was not reported), via an unspecified route of administration from an unspecified date to an unspecified date, at DOSE NUMBER UNKNOWN, SINGLE for immunisation. Medical history included that she gets an injection for her bones every three months. The patient's concomitant medications were not reported. Patient previously received first and second dose of Moderna COVID-19 vaccine via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation which caused slight redness on her arm but no other reaction. The patient stated that when she received her booster shot she also got her flu vaccine. Patient stated she had quite the reaction to the combination of the two and felt like she had the flu for about a day and a half. Patient has lymphedema in her left arm that will become red and blotchy at times when she was sick. She thinks this was due to the flu vaccine or the combination of the two. The outcome of all the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
FAINTING. RECOVERED SOON WHEN WE HAD HIM LYING DOWN.  CALLED 911, THEY TALKED HIM AND CONFIRMED THAT HE WAS CONCIOUS AND DIDN'T COME.  BP CHECKING (80/42)..REALLY LOW. HE STAYED AT OUR LOCATION FOR 1 HOUR AND LEFT. CHECKED ON HIM ON 4/14/21, HE STATES HE IS FINE.
I had lymph nodes in the front of my neck were swollen to the size of a grape.
took the Pfizer vaccine; Second Shot April 3; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second Shot April 3) and INTERCHANGE OF VACCINE PRODUCTS (took the Pfizer vaccine) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second Shot April 3). On 03-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (took the Pfizer vaccine). On 17-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Second Shot April 3) had resolved. On 03-Apr-2021, INTERCHANGE OF VACCINE PRODUCTS (took the Pfizer vaccine) had resolved. Not Provided          Patient administered first dose of Moderna vaccine and later administered second dose of Pfizer vaccine.  No concomitant medication information was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: 2nd dose information updated. This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021. The most recent information was received on 01-Jul-2021 and was forwarded to Moderna on 01-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second Shot April 3) and INTERCHANGE OF VACCINE PRODUCTS (took the Pfizer vaccine) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second Shot April 3). On 03-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (took the Pfizer vaccine). On 17-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Second Shot April 3) had resolved. On 03-Apr-2021, INTERCHANGE OF VACCINE PRODUCTS (took the Pfizer vaccine) had resolved. Not Provided          Patient administered first dose of Moderna vaccine and later administered second dose of Pfizer vaccine.  No concomitant medication information was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: 2nd dose information updated.
Nurse entered room patient was in PEA CODE BLUE called and patient expired on 8/13/2021
pt devel generalized hives w/in 45min of vax;no wheezing, no nausea/vomiting or dysphagia;treated w/DPH elixir & pediapred suspension & discharged to parents care;
Break through infection with COVID. Tested positive for COVID in april  2022 after receiving first booster October 29, 2021 (~6 months) Have not gotten second booster yet.  Original vaccination dates  April 7 and April 27, 2021
Swollen, Hot, red area at site of Daptacel (DAPT)
Swelling & redness, blister, pain lt upper arm, fever t103.2;
Information has been received from a nurse concerning a female pt who in approx June 2005 was vaccinated with her second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Concomitant therapy included varicella virus vaccine live and amoxicillin. Subsequently, the pt developed a rash. Medical attention was sought, and she was treated with diphenhydramine hydrochloride (Benadryl). Subsequently, the pt recovered. The reporter felt that the rash was an other important medical event (OMIC). Additional information has been requested.
pt recvd vax; lt leg began to swell;lt arm swelled w/ T 102.4; mom called ER then took to MD;
Pt recvd MMR vax 16SEP91 & on 18SEP91 pt exp afebrile sz w/ a ? tonic clonic episode; als exp vomiting, neck stiffness & petechiae; pt did not have a fever; pt was hospitalized for 1 day & lab eval revealed a WBC 11.6; CT scan & EEG nl;
I am experiencing a lot of arm/shoulder pain a week after the shot.  The pain was very acute right near the injection site the day after the shot, which I expected.  But then I started to notice more pain in my upper arm, farther away from the injection site.  A week later, I still have a lot of pain throughout my arm, between my shoulder and my elbow.
shingles; This is a spontaneous report from a contactable physician (patient). A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6200), via intramuscular route, administered in left arm on 14Feb2021 at 12:45 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history included crohn's disease, reflux gastritis, benign prostatic hyperplasia, arthritis and sulphur allergy. Concomitant medication(s) included mesalazine (PENTASA); Tamsulosin hydrochloride (FLOMAX); finasteride (PROSCAR); esomeprazole sodium (NEXIUM). On 01Mar2021 at 14:00, the patient experienced shingles. The patient received acyclovir as treatment for the adverse event. The patient visited physician's office for the event. The patient was not diagnosed with covid-19 prior vaccination and was not tested post vaccination. There was no other vaccine administered on the same day of the suspect vaccine. The outcome of the event was recovered on an unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.
Baby soon developed a generalized red, raised rash, cheeks became quite flushed, no respiratory difficulties.
That same evening I began to be more short of breath and just didn't feel good. I had lethargy and general malaise. I had pleuritic pain in my right upper back that was a sharp pain with inspiration. All of this continued to get worse over time and I developed pneumonia. I wasn't able to go back to work from 1/27/21 to 3/6/21.
Within two hours after shots were given experienced joint pain. When she woke up the next morning she had severe joint pain everywhere which she has to this day. Seen by rheumatologist 11/9/04 doctor.
CDC Reports:3 yo child developed fever 102, local rxn & rash on chest following DTP/OPV immunization, recovered in 5 days
Development of abscess at injection site starting 72-96 hours after infection; no fever; mild tenderness; prescribed Keflex PO and culture done of wound drainage.
Left arm swollen /red the whole top of left arm red and swollen. Pt  was given abx and steroids Pt Provider.
A company representative reported that a female child received an injection of Prevnar and subsequently, became irritable. The irritability resolved after 24 hours. The child also experienced pain at the injection site. She recovered. This is 1 of 3 pts from this facility who had an adverse experience following receipt of Prevnar.
This is a spontaneous report from a contactable consumer, who reported for herself. A 65-year-old female patient received the first dose of PREVNAR 13 , on 16Jan2017 at 8:30-9:30 am, at 0.5 ml single in arm, to not get pneumonia (immunization).  Medical history included right hip replacement on 13Jan2015, rheumatoid arthritis, blood pressure and arthritis. Concomitant medication included vitamin B12 taken for about a half a year and ongoing, tocilizumab (ACTEMRA) from Feb2016 and ongoing for rheumatoid arthritis , atenolol for blood pressure since years and ongoing , hydrochlorothiazide/ lisinopril for blood pressure since years, diclofenac sodium for arthritis from fall of 2016 and ongoing  and  cefalexin (CEPHALEXIN) due to  hip replacement from Jan2015 and ongoing.  The patient previously took methotrexate ,leflunomide, allopurinol and mometasone furoate (ASMANEX) and experienced drug hypersensitivity and shortness breath. The shortness of breath was during use of the products and once stopped , it went away completely. In late 2015 she received adalimumab (HUMIRA) every 2 weeks or twice a month (she only took 3 shots ) and experienced forgetfulness and shortness of breath. A couple years before the report (date unspecified) she took ciprofloxacin and had difficulty swallowing and shortness of breath. She had also  allergy to monosodium glutamate (MSG).In Jan2017, after vaccination,  the patient experienced headache and shortness of breath. Headache was mild and pressure. She took diphenhydramine hydrochloride (BENADRYL) off and on because she is allergic to MSG, but symptoms came back. Her rheumatologist suggested switching to loratadine (CLARITIN) and she took it last night.  The final outcome of the events was not recovered.
sore arm; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and MYALGIA (body aches) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002331) for COVID-19 immunisation.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and MYALGIA (body aches). On 15-May-2021, PAIN IN EXTREMITY (sore arm) and MYALGIA (body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment and concomitant medication reported.
This spontaneous report was received from a physician concerning a 55 year old male patient with hypercholesterolemia and hyperglycemia and no drug reactions or allergies. On 09-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J000783; expiration date 30-APR-2014), 0.65 ml, subcutaneous. Concomitant therapies included omeprazole (manufacturer unknown). The physician reported that after the patient received ZOSTAVAX on 19-OCT-2013, he developed shingles. The physician saw the patient on 25-OCT-2103 and diagnosed him with shingles. The patient reported to the physician that he had been using VALTREX for several days. The physician instructed the patient to continue to use the VALTREX but at and increased dose. No laboratory tests were performed. The patient sought medical attention. Patient outcomes was reported as not recovered/not resolved. Additional information has been requested.