chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She has inflammation around her heart and has been seeing a doctor for about a month now.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "not recovered", described as "She has inflammation around her heart and has been seeing a doctor for about a month now.". The event "she has inflammation around her heart and has been seeing a doctor for about a month now." was evaluated at the physician office visit. Therapeutic measures were taken as a result of myocarditis. It was unknown that, if other vaccine received or not in four weeks. It was unknown that, other medications received in two weeks. It was unknown that patient had covid prior vaccination and covid tested post vaccination or not. It was unknown patient had allergies.   The lot number for bnt162b2 was not provided and will be requested during follow up.
pt recvd vax 18oct94; exp v & fever; on 20oct94, was noted to have fever of 104 & has projectile v; to hosp for v; recovered but episode has worsened stomach problems; hx of unk stomach problem; pt had no problem w/ vax previous yr;
5 hours after shot around midnight blood sugar has been high won?t come down no matter how much insulin I give myself. Ketones and glucose in urine. Specific gravity in urine was high as well. Chest tightness.
brain fog; forgetting common things; fatigue; upper arm got hard; itchy; swollen; rash; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (upper arm got hard), PRURITUS (itchy), FEELING ABNORMAL (brain fog), MEMORY IMPAIRMENT (forgetting common things) and INJECTION SITE SWELLING (swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced INDURATION (upper arm got hard), PRURITUS (itchy), INJECTION SITE SWELLING (swollen) and RASH (rash). On an unknown date, the patient experienced FEELING ABNORMAL (brain fog), MEMORY IMPAIRMENT (forgetting common things) and FATIGUE (fatigue). On 17-Apr-2021, FEELING ABNORMAL (brain fog), MEMORY IMPAIRMENT (forgetting common things) and FATIGUE (fatigue) had resolved. At the time of the report, INDURATION (upper arm got hard) and INJECTION SITE SWELLING (swollen) outcome was unknown and PRURITUS (itchy) and RASH (rash) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information was provided.
Fuzzy; Dizzy feeling; Swollen lymph nodes; "Swollen tongues"; Mouth ulcers; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 19Mar2021 at 08:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and asthma. Concomitant medications included "B-12". The patient stopped taking other medications before and after "shot (s)". The patient previously received HUMIRA and SIMPONI for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 at 09:30, the patient felt fuzzy, dizzy feeling followed by swollen lymph nodes, "swollen tongues" and mouth ulcers. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fuzzy, dizzy feeling, swollen lymph nodes, "swollen tongues" and mouth ulcers were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
The day after my vaccine, 07/09/2021, I started itching around my ankles, my chins and knees and arms. I was scratching harder than normal. It felt better to dig in than just touch it. It was like a crazy itch. My skin started bleeding, I started getting watery blisters from scratching too hard. Over a period of  a week it started spreading all over my legs, elbows, arms, and thighs. On 07/13/2021 I went to see the doctor diagnosed me with dermatitis. He prescribed the Prednisone 20 mg,  2 x day, Doxycycline 100 mg, 1 by mouth every 12 hours. I still have itching, and scabs on my forearm, lower legs, knee, upper thighs, chins, ankles, and feet. I have an appointment to see the doctor for a follow up on 07/27/2021 and he will let me know if I should get the next dose. I will probably get the 2nd dose.
Local Cellulitis; red, swollen, hot. 24 to 48 hours after injection.
severe body aches; Headache; Chills; Fever of 100.3; Cold sweats; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 30Mar2021 at 11:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to peanuts, cashews and walnuts. Concomitant medications included hydroxyzine (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and bupropion hydrochloride (WELLBUTRIN), all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 10Mar2021 at 14:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 20:15 (reported as night after booster shot), the patient experienced headache, chills, cold sweats and fever of 100.3. On 31Mar2021 (reported as day after booster), the patient experienced severe body aches, 100.3 fever, chills and headache. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events headache, chills, cold sweats, fever of 100.3 and severe body aches which included treatment with ibuprofen (MANUFACTURER UNKNOWN), acetaminophen; dextromethorphan; phenylephrine (DAYQUIL) and NYQUIL. The clinical outcomes of the events headache, chills, cold sweats, fever of 100.3 and severe body aches were resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Vertigo chronic all day for month unbalanced high heart rate fatigue blurred vision ear ringing
Expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
I have a fever, it maxed of this morning at 101.5; Nauseous; Body ache; Arm hurts; Chills; This is a spontaneous report from a contactable nurse (patient).  This 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK9231), via an unspecified route of administration, on 06Jan2021 at 5:15 at single dose for COVID-19 immunisation. Vaccine location was left shoulder.  The patient was vaccinated at hospital, age at vaccination was 50-years-old. Medical history and concomitant medications were none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE an unknown date.  Nurse stated she was just reporting some side effects from COVID Vaccine. She had second one last night at 5:15 and she is a nurse and she worked over night which she would never do that again. So, she has a fever, it maxed of this morning at 101.5 and chills, body ache, and she feels nauseous, and her arm hurts. Nausea was first at about 1:30 in this morning (07Jan2021) and then chills and then fever by about quarter to 6 this morning (07Jan2021), she started to check her temperature.  Outcome was not recovered.  No treatment was received for the events. She just didn't wanted to mask the fever. She wanted to see how it developed and her highest temperature was 101.5, then it came down a little bit, it's tolerable.  About causality, nurse stated Yeah, most definitely.
Patient came into clinic to update vaccines. Vaccine reviewed by RN and she gave verbal order to give, not realizing that it was Kinrix and thought it was Pediarix on injection tray. RN reviewed vaccines that were prepared by MA prior to vaccinating patient and gave authorization to vaccinate patient. MA immediately went to patients exam room and administered Kinrix. Patient left clinic with father. MA went to input data in CAIR and realized that Kinrix was not supposed to be given to children under 4 years of age. Informed RN of this immediately. RN spoke to pediatric nurse, and called public health nurse for information.
Approx 24 hrs p/receiving 2nd DTP & 2nd OPV, broke out in large hives; no resp problems reported; hives receded w/dose of DPH & reappeared when dosage wore off; had hives x 3 days MD advised tx w/DPH only;
Dizziness, Headache, Arm sore and painful. C/O feeling eye pressure
Bacterial bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS BACTERIAL (Bacterial bronchitis) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BRONCHITIS BACTERIAL (Bacterial bronchitis). At the time of the report, BRONCHITIS BACTERIAL (Bacterial bronchitis) had resolved.            Concomitant product use was not provided by the reporter.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-080097 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Significant followup received on 26-May-2021. Event outcome details updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-080097:Brother case
numbness in the arms,numbness in the feet , numbness in the hands; difficulty breathing.; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in the arms,numbness in the feet , numbness in the hands) and DYSPNOEA (difficulty breathing.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Dec-2021, the patient experienced HYPOAESTHESIA (numbness in the arms,numbness in the feet , numbness in the hands) and DYSPNOEA (difficulty breathing.). At the time of the report, HYPOAESTHESIA (numbness in the arms,numbness in the feet , numbness in the hands) and DYSPNOEA (difficulty breathing.) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-404773 (Patient Link).
Roughly 36 hours after the injection I experienced external swelling of my nose. Swelling went down, though not entirely, after I woke up and went about my day. Sent a photo of my nose with notes to my general practitioner who suspected it was a delayed reaction to the vaccine and instructed me to take an antihistamine that evening.
pt recv vax 23APR96 & pt tonic clonic, + eyeball rolling lasted 3min x 2;1hr apart
Patient appeared to be a normally developing child until approximately the age of 15 months.  Over the second year of his life patient's development slowed and eventually regressed (e.g. no longer remembered things he previously mastered such as names of objects or characters, reduced and eventually stopped speaking to and interacting with others, etc.).  Medical professionals initially suggested speech therapy which we expanded to include occupational therapy at age 3.  At age 4 we consulted a well respected Doctor group who explained how immunizations may be a cause for autism, and that the years of intense speech and occupational therapy are the only reasons why patient has not fallen substantially further behind his peers in his development.  We have also completely changed patient's food intake and diet, as well as that of the rest of our family as it is impossible for a four year old child to understand why the rest of the family is able to eat certain foods that he is not, which has been a substantial undertaking financially and personally for each family member.  7/11/08 Reviewed PCP medical records of 2005-2008.  Vax records included.  Received MMR #1 & Prevnar #3 on 1/15/2005(age approx 12 mos);  Received Hib #3 & Varicella #1 on 3/30/2005 (age approx 15 mos); Received DTaP, IPV, & Prevnar 6/29/2005 (approx 18 mos).  Many lot #s missing on vax record & unavailable in office. FINAL DX: metabolic disorder, encephalopathy, bacterial enteritis Records reveal patient was well on 1/15/2005, 3/30/2005, 6/29/2005.  Hospitalized 5/23/2005 for croup & severe respiratory distress.  10/2005 hospitalized for respiratory distress & had chest tubes at that time.  7/25/2006 referred for ST & OT.  Recurrent croup episode 3/2007; impetigo & urticaria 1/2008.  Began DAN protocol w/gluten & casein free diet 3/2008; chelation 5/2008; dx w/yeast & clostridium 6/2008.   10/14/08 Reviewed additional PCP medical records of 1/04-1/2008.  Also received flu vaccine 11/30/05, lot # U178764, RT.
The whole night after the injection I was sweaty, couldn't get comfortable. Woke up feeling sore and dizzy with a terrible, painful headache. When I attempted to take a shower, I fainted for a few seconds and it was a struggle to move. Only felt comfortable when I was laying down. My muscles all felt painful and sore, had a painful headache, felt very disoriented and woozy. It was a struggle to walk or move, and couldn't talk loud or for a long time at once. Had to go home from work and spent the rest of the day sleeping. Around 4pm, 24 hours after the injection, my muscles felt less sore and was feeling better. The next morning, I was back to being completely normal.
This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. On multiple unspecified dates, the multiple unspecified patients were inadvertently vaccinated with improperly stored doses of VARIVAX (lot # M005971 and expiry date: 02-FEB-2018 or lot: M009766 and expiry date: 23-FEB-2018) (dose, frequency and route of administration is not reported for the both lots). The vaccine was exposed to temperature of 29.3 Fahrenheit for 5 hours 24 minutes. No previous temperature excursion was reported and data logger was reported as yes. No product quality complaint (PQC) reported. Additional information has been requested.
This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients received doses of improperly stored VARIVAX (dose and route of administration were not reported) for prophylaxis. Data Logger was involved. No adverse effects reported. A product quality complaint was not involved. The following lot number and temperatures were reported: M005972 expiration date 02/FEB/18 -14.9C for 15 minutes -14.6C for 15 minutes -14.3C for 05 minutes -14.7C for 05 minutes -14.7C for 05 minutes -14.6C for 05 minutes -14.6C for 05 minutes -14.7C for 15 minutes -14.8C for 15 minutes -14.9C for 15 minutes -14.1C for 07 minutes -14.5C for 15 minutes -14.8C for 15 minutes -10.7C for 10 minutes - 9.4C for 01 minute -14.5C for 15 minutes - 9.4C for 11 minutes -10.3C for 03 minutes -14.8C for 15 minutes - 9.6C for 01 minute -13.0C for 14 minutes -14.9C for 05 minutes -14.6C for 05 minutes.This is one of the two cases reported for the same contact.  Additional information has been requested.; Sender's Comments:  US-009507513-1612USA005638:Original Case : 1612USA005638.
Vaccine admin 10/28/09. 10/29/09 dev a knot at injection site became red & hot Friday in swelling at site and painful. Saturday (10/31) pain in injection arm from elbow to shoulder with marks on neck & itching. Pt took Darvocet & Benadryl & is feeling better at time of call - 11/2/09 1315.
Narrative: Pt is a 97y.o. male who died on 01/26/2021 w/ h/o CAD and HLD. Pt received Moderna Covid-19 Vaccination 1/2 on 01/14/2021. Unlikely that Moderna Covid-19 Vaccine caused/contributed to pt death.
I tested positive for Covid-19 on January 12, 2023 I experienced  body aches and fatigue. I was prescribed Paxlovid for my symptoms.
Recieved COVID vaccination 10/4/23 _unsure where/ type;  Sxs began 10/5/23. Describes as constant / severe pain affecting sleep. radiating to Neck and interscapular ; Denies redness of area            Tried Tylenol, Topical CBD, and Tens unit.            Pt's daughter is a physical therapist. Has attempted some exercises no relief
Started experiencing back pain around 4/23/21, then experienced numbness in the feet on 4/26, was subsequently admitted to Medical Center on 4/28/21
TINGLING FINGERS AND TOES, LIGHTHEADED, INCREASE BLOOD PRESSURE
I was sick on my stomach; lethargic; pains; arthritis; myalgia; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (I was sick on my stomach), LETHARGY (lethargic), PAIN (pains), ARTHRITIS (arthritis) and MYALGIA (myalgia) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01FB21A and 030I21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (I was sick on my stomach), LETHARGY (lethargic), PAIN (pains), ARTHRITIS (arthritis), MYALGIA (myalgia) and FATIGUE (fatigue). At the time of the report, ABDOMINAL DISCOMFORT (I was sick on my stomach), LETHARGY (lethargic), PAIN (pains), ARTHRITIS (arthritis), MYALGIA (myalgia) and FATIGUE (fatigue) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.  This case concerns a 61-year-old, female patient with no medical history reported, who experienced the unexpected non serious events of abdominal discomfort, lethargy, arthritis and pain and expected events of fatigue and myalgia. The events occurred on the same day after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as events' outcome was unknown at the time of third dose administration. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-361796 (Patient Link). Sender's Comments: This case concerns a 61-year-old, female patient with no medical history reported, who experienced the unexpected non serious events of abdominal discomfort, lethargy, arthritis and pain and expected events of fatigue and myalgia. The events occurred on the same day after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as events' outcome was unknown at the time of third dose administration. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Hives and intense itching beginning 48 hours after injection and ongoing for greater than 10 days.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored dose of PNEUMOVAX 23, (dose, route of administration, lot# and expiration date were not reported). Administered dose of PNEUMOVAX 23 was exposed to temperature of -1 degree of Celsius for 16 hours and 35 minutes, on an unknown date. There was previous temperature excursion which took 8 hours with the temperature 14 degrees of Celsius, on an unknown date. Digital data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt devel fever of 105.6 R w/in 24 hrs of DTP/OPV/HIB/MMR; fever down to 102 R in office w/sponge bath & Pediaprofen; cont to have fever x 4 days & devel elevated WBC; fever was probably fr a concurrent infection;
No additional AE/no PQC.; Nurse called and reported VARIVAX which had a temperature excursion on 06/01/2023 and was short-dated with the outcome "Supported-Within 3 months" was administered on 09/14/2023 after the three-month time period. See information below per attached ar; This spontaneous report was received from Other Health Professional and refers to a patient of unknown ae and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-SEP-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, unknown by reporter/unknown by reporter, lot #W031812, expiration date: 05-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 14-SEP-2023, nurse called and reported VARIVAX which had a temperature excursion (Temperature: 47°F to 77°F for 2 minutes) on 01-JUN-2023 and was short-dated with the outcome "Supported-Within 3 months" was administered on 14-SEP-2023 after the three-month time period. See information below per attached article.  No additional AE/no PQC.