chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day after the vaccine, on 10/06/2021, I started getting a moderate headache around noon and felt very tired. Tylenol helped the headache a little. That evening I had chills but no fever 98.7. I was weak and felt like I had the flu. The next morning 10/7, I felt tired and had a headache but no chills until the afternoon and it continued into the evening, adding muscle aches and joint pain. My lymph nodes in my arm pit on my left side (vaccine arm) started to swell and become uncomfortable.  10/08 My arm pit became painful and swelling went into my neck and a lymph node on my left collar bone was swollen and painful. It was effecting my ability to concentrate at work. I emailed my primary care doctor and she told me this was a normal immune reaction to the vaccine and recommended using heat and tylenol to control symptoms, which I tried and did improve comfort. 10/9 I still had a headache and tired, moderate to severe joint pain, somewhat weak, and lymph nodes swollen. 10/11 both sides of my neck were mildly swollen, but not painful. All discomfort was mild for all symptoms. 10/12 mild head ache and joint pain. 10/13 just tired.
felt yucky; Chills; fever; fatigue; body aches; headache; golf balls sized red circle at injection site; swollen injection site; hard at injection site; Booster; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 15Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Hypothyroidism (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included Bnt162b2 (dose 1), for covid-19 immunisation; Bnt162b2 (dose 2), for covid-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome unknown; FEELING ABNORMAL (non-serious) with onset 16Nov2021, outcome unknown; CHILLS (non-serious) with onset 16Nov2021, outcome unknown; PYREXIA (non-serious) with onset 16Nov2021, outcome unknown; FATIGUE (non-serious) with onset 16Nov2021, outcome unknown; PAIN (non-serious) with onset 16Nov2021, outcome unknown; HEADACHE (non-serious) with onset 16Nov2021, outcome unknown; VACCINATION SITE ERYTHEMA (non-serious) with onset 16Nov2021, outcome unknown; VACCINATION SITE SWELLING (non-serious) with onset 16Nov2021, outcome unknown; VACCINATION SITE MASS (non-serious) with onset 16Nov2021, outcome unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Patient originally received Janssen vaccine and was here for Moderna booster. The vaccine was administered and she developed ?itchy tongue and throat.? She didn?t have trouble breathing just very dry mouth and ?weird? feeling.  I gave her diphenhydramine 25mg and symptoms did not progress. She sat here for 45 minutes and she started feeling better. No other side effects were found.
Direct Email from the Patient-Thursday I took my second SHINGRIX vaccination. The side effect from the first was simply a sore arm. The second was more severe. For a 12 hour period I experienced a fever, uncontrollable chills, nausea, fatigue and muscle breakdown. I literally couldnt walk due to pain in the legs. I called up the patient and he said he is ok now. It was just a 12 hour span of feeling extremely terrible. I have known this patient a long time. He is never sick nor is he a complainer. For him to send me an email it had to be bad.
A 19-year-old female patient received intramuscular (in the left arm, deltoid) TRUMENBA, NDC number 005-0100-01) first dose on 25NOV2015 at 2:00 PM (lot. J29203) and second dose on 18JAN2016 at 11:00 AM (lot. M13066), both at single dose. On 18JAN2016, the patient received also Tdap, Lot U5243AA) intramuscular in the right arm. The vaccines was administered at the private physician's office/hospital. The reporter did not know of any illness at time of vaccination. Medical history and concomitant medications were not reported. After first dose of TRUMENBA, the patient experienced chills, fatigue, dizziness, myalgia, and generalized malaise on an unspecified date. After the second dose, she felt the same symptoms. She has recovered completely from the symptoms on an unspecified date. Follow-up (07APR2016): Follow-up attempts completed.. No further information expected. Follow-up (03MAY2016): New information received from a contactable physician includes: suspect drug details and reaction data.
The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date; No adverse event; received doses from the same lot number #015h22a administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2022, 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. In December 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date).    This case contains information for the 4 of 6 adult patients described by the reporter. No concomitant information was reported. The vial size reported was 2.5 milliliter. The vial was initially stored in the refrigerator on 01-Nov-2022. The vial did not undergo any temperature excursion.  No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2022-692559 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-692559:master case
10jun70,@ 18 mo pt toddled & fell & had flat & outward turned feet;12jun70 refused to stand;23jun70 pt dx as having juvenile rheumatoid arthritis, pos ANA, polyarthritis persisted w/ deformities;
Client reported her "arm in pain" around the injection site at 2:00PM. The client was provided a cool pack and placed it over the injection site. The client was alert and oriented to person, place, time, and situation. The client denied any other symptoms at that time. At 2:05PM the clients reported the pain was getting better. Around 2:10 PM the client reporting feeling light headed. Vitals obtained at 2:11PM were as follows: BP 121/89, HR 64, O2 98%. The client stated she last ate at noon. Reported clear vision. The client denied any current medications or known allergies. RN responded and provided education to the client regarding signs and symptoms of anaphylaxis and when to seek EMS. The client voiced understanding of this education. At 2:22PM the client declined repeat vitals and stated, "I feel fine." The client stated she was ready to leave the vaccination site. The client stood up, and denied felling light headed. The client left against medical advice at 2:22PM ambulating unassisted with a steady gait.
Light headed; Nausea; fatigue; Sore left arm and neck for 2 days; Sore left arm and neck for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 11:00 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fatty liver" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN; MELOXICAM; OMEGA 369 [BORAGO OFFICINALIS OIL;FISH OIL;OLEA EUROPAEA OIL]. Past drug history included: Tramadol, reaction(s): "Known allergies". Vaccination history included: Bnt162b2 (Dose 1, Light headed within minutes), for Covid-19 immunization, reaction(s): "Light headed"; Bnt162b2 (Dose 1, Nausea and fatigue for 2 1/2 days), for Covid-19 immunization, reaction(s): "fatigue", "Nausea"; Bnt162b2 (Dose 1, Slightly sore arm.), for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: DIZZINESS (non-serious) with onset 06May2021 13:00, outcome "not recovered", described as "Light headed"; NAUSEA (non-serious) with onset 06May2021 13:00, outcome "recovered" (May2021), described as "Nausea"; FATIGUE (non-serious) with onset 06May2021 13:00, outcome "recovered" (May2021), described as "fatigue"; NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 06May2021 13:00, outcome "recovered" (May2021) and all described as "Sore left arm and neck for 2 days". Therapeutic measures were not taken as a result of dizziness, nausea, fatigue, neck pain, pain in extremity.  Additional information: Patient did not receive any other vaccine in four weeks. Other medications in two weeks were Tamsulosin, meloxicam, Multi vitamin, omega 369, c. Light-headed continuously since 5/6. Slight nausea and fatigue for 1 day. Sore left arm and neck for 2 days. It was reported as AE resulted in none of the above. If COVID prior vaccination and if COVID tested post vaccination was reported as No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt developed ringing in her ears and loss of hearing within an hour of receiving the vaccine. She also had swelling in the arm the vaccine was given in.
Tested positive for Covid 19 after 4 Doses of the Covid 19 Vaccine; Tested positive for Covid 19 after 4 Doses of the Covid 19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Aug2022, outcome "not recovered" and all described as "Tested positive for Covid 19 after 4 Doses of the Covid 19 Vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (Lot number: 6D8819. (nirmatrelvir tablets; ritonavir tablets) 300 mg; 100 mg) started on 29Aug2022 3 pills in the morning and 3 pills in the evening.  Clinical course: Tested positive for Covid 19 after 4 Doses of the Covid 19 Vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A month after my medically coerced Tdap vaccination, I went into pre-term labor at 33 weeks on Sep 23rd 2018. I was rushed to the emergency room with heavy bleeding and cramping. I was admitted for 24 hours for observation and was given medication to stop the contractions. The cause of the bleeding was a partial abruption of my placenta and I was told that I had to be in bed rest for the remainder of my pregnancy. I had to stop working and subsequently lost thousands of dollars. I continued to bleed throughout the rest of my pregnancy. In addition, after the vaccine my baby stopped growing at a normal rate. She was healthy but small so they allowed me to go to term. I gave birth on my due date to a full term baby weighing only 4.8lbs. My placenta was heavily calcified and blanched.
Injection site pain; She developed chills; Stomachache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included acetylsalicylic acid (Aspirin) for injection site pain.   On 6th June 2022, the patient received the 2nd dose of Shingrix (intramuscular) and Aspirin at an unknown dose and frequency. On 6th June 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, chills and stomach pain. The action taken with Aspirin was unknown. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the chills and stomach pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, chills and stomach pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-JUN-2022 Reporter's comment: The reporter was the patient. She received her second Shingrix dose in arm the day prior to the reporting. She had injection site pain that resolved after she took two aspirin.  She developed chills and stomachache that had continued for about twenty-four hours. It was unknown if the reporter considered the chills and stomach pain to be related to aspirin. She had nothing else to report. The reporter might follow up with primary doctor. The reporter consented to follow up.
Patient states she started feeling bad approximately 1 to 2 hours post-injection. She complained of increasing confusion and disorientation over the next two days. She awoke each of the next two nights on the floor beside her bed. A family member called for EMS on Sept 9 for transport to Hospital. She was admitted and kept overnight for observation. She states the EMS told her her blood sugar was 53. The hospital also stated she had low blood sugar levels. She was discharged from the hospital on Sept 9 with instructions to monitor blood sugar.
Severe pain in back, Left hip, knee, and leg. Onset of incontenence and constipation, loss of appetite. The only treatment I received from either ER's Was Morphine for pain and Xrays. Patient went to ER on 2/7/10 & went to hospital 2/8/10.
Patient had vasovagal reaction after injection at the office. Patient was examined by doctor after incident and was okay to go home afterwards. There was no other harm to patient.
Infant received immunizations. Approximately 5 minutes later, while still in office,  Mom was nursing infant when she noted that the baby had fallen asleep and was dusky around his eyes. Physician was alerted and noted that the baby was slightly pale. Vital signs were within normal limits and baby was moving around and responsive. Observation was continued, and app. 10  minutes later, mom reported that he was  "dusky" around his mouth. Physician was alerted again, and baby was noted to be alert, vital signs were normal but physician also noted a very slight dusky color that disappeared within a matter of seconds.  The baby was in no respiratory distress of any type, and would smile when prompted. Baby was observed for approximately one hour after this, and then parent went home. Baby was not pale and was comfortable. Mom reports 24 hours later that baby  is fine, happy and has experienced no further symptoms of any type.
Summary from hospital stay "On admit pt was febrile, tachypneic, Lactate 4.0 and AAOx3. UA showed infection and pt was started on Rocephin. Admitted for sepsis. Blood Cx showed streptococcus, with adequate coverage with Rocephin which was comntinued. Hx of chronic diabetic foot wounds, we considered this the likely source of his bacteremia. Wound care was consulted. Today, blood cx are still negative at 48 hrs so pt stable for discharge on oral antibiotics. Will need follow up for wound care and this has been set up both for at home as well as at the wound clinic. He will start Amoxicillin 500 TID for 13 days. "
Light headed, syncope, abdominal pain 1 day after the vaccines. No treatment needed.
Acute L Shoulder Pain when he woke up this morning- cannot use L Arm, can move fingers, radiates to Lower Back. Nausea, Headache. panic Attack. Missing work. Referred to PT. Unclear Outcome
Initial and follow up information has been received from a mother and 16 year old female patient for the Pregnancy Registry for GARDASIL. On 21-AUG-2007, the patient was vaccinated with her first dose of GARDASIL (Lot # 658222/0927U; site and route not reported). On 23-OCT-2007 (previously reported as approximately 26-OCT-2007), the patient was vaccinated with her second dose of GARDASIL (Lot #657737/0522U; site and route not reported). There was no concomitant medication. Subsequently, the patient found out she was pregnant (LMP approximately 15-SEP-2007).The patient sought unspecified medical attention. On 24-JUN-2008, The patient gave birth to a normal female infant (6 Lb, 2 oz; 18.5 in). There were no congenital anomalies, complications or abnormalities. There were no complications during the pregnancy or labor and delivery. Additional information was provided from the patients physician. Laboratory work from 25-JUN-2008 revealed a CAH (17 Hydroxy Progesterone) level of 75.8 ng/ml. The analysis revealed unsatisfactory specimen. Repeat levels were done on 29-JUL-2008 that were within normal range. At the time of this report mother and baby were reported to be doing well. Additional information is not expected.
Rash PAIN, SWELLING, ITHCING AT INJECTION SITE Narrative:
Vaccine was injected into my left arm muscle. I have a Nexplanon birth control implant in the same arm on the inside of my left arm. Within a few hours of getting the shot, the place on my arm where the implant is started burning and was blindingly painful to the touch. It felt like the implant was ripped out then re-inserted and was very tender. Symptoms persisted for 24 hours. I have no pain now. I assume it was from muscular swelling, but I think it is something to be aware of.
Mother reports that child started "screaming" when getting ready for bath on the day following the immunization.  The left arm was "swollen three times the size of the other arm".  She took the child to Emergency room. Where the mother reportedly was told that the child had an "allergic reaction" to the tetanus shot.  They started an IV and did some blood tests.  She reports that the temperature was 98.4 and that she was "cool and clammy". She also took the child to clinic on the following day 3/26.  Doctor gave her a shot to take down the swelling and also an antibiotic.  Mother reports that he told her that if she hadn't come in that she "could have lost her arm".  She was also seen by doctor on 3/27 and the arm remained swollen and discolored.  The child was given the OK to return to school where she is today 3/29.  Mother reports however that she is not fully recovered.  Doctor is out of the office today and won't return until 3/31.
Approx. 6 hours, post vax, child had a hypotonic-hyporesponsive episode.
shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a 60-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 16-JUN-2011, the patient was administrated zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis by unspecified provider at the clinic. On 29-MAR-2012, the patient suffered shingles, including any and all of its sequeale.. As a result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of zoster vaccine live (ZOSTAVAX), the patient required and/or would require more health care and services and did incur medical, health, and would in the future be required to obtain further medical and/or hospital care, attention, and services. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses, continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The outcome of the event was determined to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling.
ZOSTAVAX given at pharmacy. Pt woke up this morning and states the injection site is itchy. It is red and 50 cm x 55 cm when measuring the red and edematous area. Advised to apply ice.
Pain in right shoulder began 2/9/17 PM. Pain continued to increase each day to the point that I could not lift my right arm, operate my car, or wash my hair. Saw doctor 3/17/17 for steroid shot then went back on 4/7/17-prescribed PT and Naproxen.