chrisvoncsefalvay/vaers-outcomes huggingface dataset:
change of behavior; Brain bleed surgery; Subdural Hematoma; 2 separate pools of blood and clotting; 2 separate pools of blood and clotting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 11:30 (Lot number: EW0167) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sleep Apnea" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "PTSD" (unspecified if ongoing). The patient's concomitant medications were not reported. No other vaccine in four weeks. Vaccination history included: Bnt162b2 (Dose Number: 1, lot number=EW0161, administration date=15Apr2021, administration time=01:30 PM, dose number=1, vaccine location=Right arm), administration date: 15Apr2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: SUBDURAL HAEMATOMA (hospitalization, disability) with onset 15Jul2021 12:00, outcome "recovered with sequelae", described as "Subdural Hematoma"; CEREBRAL HAEMORRHAGE (hospitalization, disability) with onset 07Oct2021, outcome "recovered with sequelae", described as "Brain bleed surgery"; ABNORMAL BEHAVIOUR (hospitalization, disability), outcome "recovered with sequelae", described as "change of behavior"; BLOOD DISORDER (hospitalization, disability), COAGULOPATHY (hospitalization, disability) all with onset 15Jul2021 12:00, outcome "recovered with sequelae" and all described as "2 separate pools of blood and clotting". The patient was hospitalized for subdural haematoma, cerebral haemorrhage, abnormal behaviour, blood disorder, coagulopathy (hospitalization duration: 4 day(s)). The events "subdural hematoma", "brain bleed surgery", "change of behavior", "2 separate pools of blood and clotting" and "2 separate pools of blood and clotting" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Oct2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of subdural haematoma, cerebral haemorrhage, abnormal behaviour, blood disorder, coagulopathy. Treatment included Surgery and blood drip. Subdural Hematoma. Brain bleed surgery on 07Oct2021. Symptoms started on 01Sep2021 but family described a change of behavior a few months before that. Surgeon described 2 separate pools of blood and clotting. One pool was a couple of months old while the other was of newer blood.   Follow-up attempts are completed. No further information is expected.
A nurse reports the occurrence of an 18 month old female who did not respond to the Hep B vaccine recombinant (Engerix-B) immunization series. The subject was born to a mother, who at the time of the subject's birth, tested positive for Hep B surface antigen. Concurrent conditions and concurrent medications were not specified. The subject received her first and 2nd injections of Hep B vaccine (mnft'r unknown) on 4/13/01 and 6/20/01, respectively. "Titers (NOS)" were obtained on 2/26/02 and results revealed a level of less than 2 (> 10 normal range). On 3/9/02 and 6/27/02, the subject received injections of Engerix-B subcutaneously (lot ENG5253C9). On 6/15/02 and 10/11/02, "Titers (NOS)" were obtained and results revealed a level of less than 2 (>10 normal range).
Patient called to let us know that today  9/13/21 he has started to have pain on his arm. He also states that his arm is yellow.  Called primary care and made them aware of the adverse events that were relayed to me. I asked the patient if he could call his primary care MD.
Patient received ADACEL, GARDASIL, and MENACTRA on 12/8. Shortly after became nauseated and pale. Rested and took juice-felt better. On 12/10 parent called- patient feel her arms and legs feel "gooey". Had fever on 12/9. Achy muscles-not true weakness. Also has persistent nausea.
Dizzy; vertigo; Feeling week; Tested positive for Covid-19; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), VERTIGO (vertigo), ASTHENIA (Feeling week), COVID-19 (Tested positive for Covid-19) and HEADACHE (Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy), VERTIGO (vertigo), ASTHENIA (Feeling week), COVID-19 (Tested positive for Covid-19), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizzy), VERTIGO (vertigo), ASTHENIA (Feeling week), COVID-19 (Tested positive for Covid-19), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Redness around tender and hot. Pt c/o of itching. Prescribed HC .25%.
Pt complained of feeling dizzing with a tight and scratchy throat. Pt took oral Benadryl 25mg at 6:20pm.
Rash 7x7 cm, swelling to injection site, warm, redness.
pt exp sl throat retraction, difficulty swallowing & difficulty breathing shortly p/recvd Engerix-B; seen in ER recvd IV DPH & IV Solu-Medrol & oxygen;
PATIENT REPORTED WITHIN 24 HOURS STARTING HAVING TERRIBLE HEADACHE, FELT WEAK AND THEN 10 DAYS AFTER SHOT DEVELOPED ITCHY RASH.
This child received the Pfizer covid vaccine intended for age 12 and up 0.3 ml, instead of the 5-11 year old covid vaccine which is reconstituted differently and a different dose of 0.2 ml
skin flaking around hair follicles; mild headache; joint pain; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162b2 (PFIZER COVID-19 VACCINE BIONTECH, lot number: unknown) via an unknown route of administration in the left arm on 28Feb2021 at 09:15 (at the age of 35-years-old) at dose 1, single for COVID-19 immunization. Medical history included Ehlers Danlos syndrome, POTS (as reported), high blood pressure, CACS (as reported), thoracic outlet syndrome, CFS (as reported), and OA (as reported). The patient was allergic to legumes and neoprene. Concomitant medication included tylenol (PARACETAMOL), ibuprofen, hydroxychloroquine, and meloxicam.  The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since having the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced skin flaking around hair follicles; most noticeably around facial hair occurred last around three days, mild headaches lasted only one day and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events.  The clinical outcome the events was recovered on an unspecified date in 2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Non-ST elevation (NSTEMI) myocardial infarction Acute kidney failure, unspecified SHORTNESS OF BREATH CHEST PAIN RESPIRATORY DISTRESS
pain at the shot site of the arm; some other muscle pain; felt lethargic; Aches in forehead and temples 2 hrs; This is a spontaneous report from a non-contactable consumer or other non hcp. A adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm on 17Feb2021 (Batch/Lot number and expiry date was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient pregnancy information was unknown at the time of vaccination. The patient was previously received bnt162b2 (PFIZER BIONTECH Covid 19, Solution for injection), dose 1, via unknown route on an unknown date (Lot Number: unknown) as dose 1, single for covid-19 immunisation. On 17Feb2021, the patient experienced aches in forehead and temples 2 hrs after shot, the events were alleviated after taking a Tylenol but she still felt lethargic. On 18Feb2021, the patient experienced pain at the shot site of the arm, and some other muscle pain and events were alleviated with a Tylenol. The patient not received treatment for the event lethargic. The clinical outcome of the event lethargic was not recovered whereas other events were recovering.  No follow-up attempts are possible. No further information is expected.
No adverse event; Received expired booster dose after 30-day Use By Date; Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (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 expired booster dose after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time).    Concomitant product use was not provided by the reporter. It was reported that there were total 2 vials and 8 doses were affected. The vials did not undergo any temperature excursion and were in refrigerator the entire time. The vaccine doses were administered to 4 patients on 22-Jul-2022 and to 4 patients on 02-Aug-2022. The vials were in refrigerator the entire time. Treatment information was not provided.
This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 69-year-old female patient who received Flu Seasonal QIV Dresden for prophylaxis. Previously administered products included PREVNAR 13 with an associated reaction of peripheral swelling (The patient also had a reaction to the PREVNAR 13 shot and that she had swelling to her left arm which moved down her arm and this happened 2 years ago). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced swelling arm, erythema of extremities and pain in arm. On an unknown date, the outcome of the swelling arm, erythema of extremities and pain in arm were recovered/resolved. It was unknown if the reporter considered the swelling arm, erythema of extremities and pain in arm to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient had an adverse reaction to the flu shot. The caller states that the patient left arm was swelled and became red and painful and its lasted a couple of days. The reporter did not consent to follow up. No HCP information was obtained.
Patient received second covid shot on 7/12 and second shingrix shot on 7/19. On 7/22 patient went to ER with signs of facial drooping that she believed to be a stroke. ER doctor diagnosed her with bell's  palsy and believes it was caused by her second shingles shot.
I became very ill; just like the flu; Chest pain; Body aches; low grade fever I mean like 100, 101.; Nausea; Diarrhea; Terrible headache; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EK9261), via an unspecified route of administration on 11Feb2021 17:30 as DOSE 2, SINGLE for COVID-19 Immunization at hospital. The patient's medical history was not reported. The patient's concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration as DOSE 1, SINGLE for COVID-19 Immunization. The patient experienced low grade fever, nausea, diarrhea, chest pain, body aches, patient became very ill, just like the flu and terrible headache. The patient also underwent the lab test and procedures included body temperature and resulted into 100, 101. The outcome of events were unknown.  Follow-up attempts were completed. No further information was expected. Information on the lot/batch number has been requested.
Full blown flu symptoms - within 10 minutes of shot arm swelled twice size in area of injection, sinuses swelled, mass produced mucus, sneezing fits all day, pressure headaches. 2nd day itchy throat, mass mucus production, coughing fits, fatigue, arm still swollen and very tender. 3rd day body aches, chills, foggy headed, pressure headaches, coughing, sneezing, arm still swollen and painful. 4th day is today and I really thought I would be feeling better but I'm still very cloudy headed, overly sleepy, fatigued, my arm is starting to go back to normal and the mucus production has slowed, which is a blessing, but the aches and chills are worse and I'm wondering how long this is going to go on for, I thought it was just supposed to be a day or two.
Second Moderna vaccine: I took Zyrtec and Zantac the day before and the day of the vaccine. I went to a hospital following the Publix pharmacist  and PCP recommendation. My PCP gave me a Rx for an epipen.  My throat tighten up suddenly right after I got the shot . I felt like it was very hard to swallow. No shortness of breath. No cough. No tachycardia or warmth sensation either. They took me to ER and they administered IV Solumedrol/Pepcid. I felt much better after 15 minutes but the sensation in my throat didn?t go away completely until 5 hrs later. Next morning I had a rash on my face and neck that went away with Benadryl 100 mg.
Covid19 breakthrough.  1st vaccine received on 08/17/2021.  40 y/o PMH of Traumatic brain injury and Hashimoto's thyroiditis presents to ED after PCP recommends he be evaluated due to worsening Covid symptoms.  Pt had positive home test on 1/13/2021.  On 1/18/2022 arrived to ED with c/o fatigue, polyuria, polydipsia, intermittent vomiting, cough and increased confusion.  Covid PCR + however blood glucose 800's.  CXR no acute process and room air sat 99%.  Blood sugars treated.
Pt recvd vax & devel red whelps on limbs, legs trunk-called MD told to give DPH went away back next Am; took to MD felt react to MMR;
Extreme armpit pain/breast pain on side of the injection that lasted 3 days. Lymph nodes were able to be palpated and a bit swollen.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of GARDASIL 9 (strength, dose, frequency, route of administration were not reported) lot # N021571 with an expiration date on 29-APR-2020 for prophylaxis. No adverse effects were reported.  The vaccines underwent temperature excursion of 32 to 35 degrees Fahrenheit (F) (34F) for 102 hours and 47 to 77 degrees Fahrenheit (F) (47F) for 18 hours. No previous temperature excursion was reported. A digital data logger was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1811USA001803:
pt recv vax 8MAY97 & pt devel what looked like chickenpox that consisted of several vesicles mostly on face & presented to ER;
Extreme pain at site of injection, unable to lift left arm, swollen redness at shot site about 3" diameter, lots of fatigue, headache, muscle pain all over like flu, fever and chills. Lasted about 24 hours. Next day arm still painful but able to touch and lift halfway. No more fevers or chills.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 01-FEB-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K019388, expiry date 20-JAN-2016; dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Fatigue, mild headache, joint pain. On day two, I developed a rash on the injection site. That rash went away today (day 3) but now I have another rash on my neck, above the collarbone. The headache is better but I am still very tired and still have joint pain.
2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated; Vaccine administered after date of expiry to 6 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 6 patients) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 6 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 6 patients) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported. It was reported that the 2 vials were placed in the freezer on 18-Jan-2022, and was never stored in the refrigerated. The total number of vials were 2. The vial was not initially stored in the refrigerator. The vial did not undergo any temperature excursions. It was reported that patient did not reported adverse event. No treatment were reported.   This case was linked to MOD-2022-582650, MOD-2022-582640 (Patient Link).
Rash - Information has been received from a reqistered nurse concerning a 39 month old male who on 29 Nov 2000 was vaccine with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second geneation.  Concomitant therapy included the first dose of hepatitits b vaccine recombinant yeast manufacturer unknown, one dose of varicella virus vaccine live (msd) hib conjugate vaccine manufacuturer unknown, and diphtheria
Vaccine was given after beyond use date but before expiration date.  Patient is aware on 12/29/22.
Information has been received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 19-OCT-2016, the patient was vaccinated with an expired dose of PNUEMOVAX 23 (lot # L001311, expiration date 06-JUL-2016; dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Persistent, daily, aching pain at left upper arm with tenderness at biceps muscle and biceps tendon. No bruising, mass, erythema or swelling. Normal neuro/vascular.
On the day of the vaccine, I immediately felt different. I went to dinner and a concert and was a zombie. I could not talk or do anything. My heart started palpitating the next day, and I had extreme bouts of vomiting. By June, I was in the emergency room with what appeared to be a heart attack accompanied by vomiting. This progressively got worse with no diagnosis. I was in bed, and it's 2023 and still happening. I haven't left my home in years. When I am remotely active, my heart literally explodes. I have extreme sweating, and crazy smells, I can't move. I am mostly from one chair to another. I went to all specialists with no answers but vitamin deficiency and trauma. I have (according to them) maybe a stomach virus and no one knows, anemia. I eat vitamins and it helps. My heart doctor says maybe I have too many beats and I just am in tune and feel them. My therapist says it's trauma even though I spend most days in meditation and I can yoga. I lost my life. Last year I became unhomed. I was so sick and had no answers and could do nothing about it. I would love to know if this is going on.
hot to the touch; swollen on her left arm; patch on her left arm; tired; sore arm/arm hurts when she lifts it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/arm hurts when she lifts it), VACCINATION SITE WARMTH (hot to the touch), PERIPHERAL SWELLING (swollen on her left arm), FATIGUE (tired) and ERYTHEMA (patch on her left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm/arm hurts when she lifts it) and FATIGUE (tired). On 17-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch), PERIPHERAL SWELLING (swollen on her left arm) and ERYTHEMA (patch on her left arm). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 200 milligram. On 07-Mar-2021, FATIGUE (tired) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (sore arm/arm hurts when she lifts it), VACCINATION SITE WARMTH (hot to the touch), PERIPHERAL SWELLING (swollen on her left arm) and ERYTHEMA (patch on her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       As a treatment patient applied a Cold Rag.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: No new information.