chrisvoncsefalvay/vaers-outcomes huggingface dataset:
intermittent bleeding/ intermittent spotting/ bleeding is very light spotting now; stomach started cramping; she was not expecting her cycle until 16Nov2021; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left deltoid on 02Nov2021 11:05 (batch/lot number: FG3527 and expiration date: 31May2022) at the age of 49 years old, as DOSE 2, SINGLE for COVID-19 immunization. The vaccine was administered at a university vaccination facility.The patient's medical history included very regular menstrual cycle. Patient can tell what day her cycle is supposed to come and has never had intermittent bleeding even when she was pregnant with her children. There is no family medical history relevant to events reported. There were no concomitant medications and no prior vaccinations (within 4 weeks). The patient previously received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm, on 07Oct2021 (batch/lot number: FE359 and expiration date: 28Feb2022) at the age of 48 years old, as DOSE 1, SINGLE for COVID-19 immunization and experienced sore arm, menstrual pain, heavy menstrual bleeding, throwing up, crying, mobility decreased, and sweating profusely. Patient reported that she is one of those people with very regular menstrual cycle and never had intermittent bleeding. She has an appointment to see her doctor next week as she has had intermittent spotting. She has never in her life had spotting. The bleeding began the same date she had the 2nd dose of the vaccine on 02Nov2021, and the bleeding began a few hours after, about 5:00pm. The bleeding was very light, spotting now. When it first began, she thought her cycle was coming. Her stomach started cramping and just started to feel her cycle coming on and her cycle came down and she thought that was odd because she was not expecting her cycle until 16Nov2021. For her to have her cycle on 02Nov2021 really concerned her and she had never been off like that. Patient has had spotting ever since 02Nov2021. She asked herself did this happen because of the vaccine. Her cycle was not due until the 16th of the month and this form of her cycle with spotting was not like a normal cycle and she is not a person to spot. It never happened before, and people need to know so she wanted to report this, and cycles would not necessarily be tested. Some women seemed to have disturbed cycles or issues with it, and she wanted to make sure she was adding to it because it happened to her. The events did not require a visit to the Emergency room and no relevant tests were performed. The outcome of the events was not reported.  Follow-up attempts completed. No further information is expected.
Systemic: Death-Severe, Additional Details: Patient's wife called and told us that on the day that he passed (6/13/21), he did yard work all morning, then came in for a meal and to watch the soccer game. He then went to their bedroom to lay down and about 15 mins later she heard a strage noise and went check on him. Upon entering the room is when she found that he had passed. Cause of death is unknown
This spontaneous report as received from a medical assistant refers to a 2 month old patient. On 10-MAR-2014 the patient was vaccinated with ROTATEQ (oral, dose#1, 2 ml; lot number unknown). The Medical assistant reported that on 10-MAR-2014 the patient spit up after being administered a partial first dose of ROTATEQ. Patient had just eaten and was crying piror to the administration of partial dose of ROTATEQ. Remainder  of ROTATEQ dose was administered. The outcome of the events was unknown. Additional information has been requested.
Encephalitis; Seizure; Chronic autoimmune issues; This case was reported by a consumer via interactive digital media and described the occurrence of encephalitis in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced encephalitis (serious criteria GSK medically significant), seizure (serious criteria GSK medically significant) and autoimmune disorder (serious criteria GSK medically significant). On an unknown date, the outcome of the encephalitis, seizure and autoimmune disorder were unknown.   It was unknown if the reporter considered the encephalitis, seizure and autoimmune disorder to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero in 2002. It was reported that this was one of the four vaccinations that the patient received for work in 2002 (it was not FDA approved until 2005, so patients were used as test subjects) and the patient experienced encephalitis and seizures. The patient also experienced chronic autoimmune issues. The patient visited the emergency room for the events. The patient had not experienced the events within 15minutes of receiving Bexsero, that the reporter could not record it as such and ended up in the data used for adverse reaction reports during the testing phase. This case has been linked with case US2019GSK107338 reported by the same reporter.
Hepatitis A given IM on 1/19/2010 patient stated been rubbing and itching arm since she got the shot. Reddened, warm & firm area on R upper arm measuring 80 cm x 70 cm.
Day 1 (May 10) Extreme Fatigue, Deep arm pain in shoulder (not just injection site) Day 2 (May 11) Same as Day 1 Starting October 15:  Intermittent sharp chest pain.  Central to slightly right of center.  Deep inside chest.  Pains started generally mid-day to early afternoon and lasted for 3-4 hours (intermittently).  Symptoms occurred 5-6 days / week for 3-4 weeks.  Have not had them over the past week.
Admitted to hospital for vomiting/AGE. Small bowel intussusception noted on ultrasound (2.7cm in length). Self resolved but required long 14 day hospital stay for vomiting/post infectious enteropathy/dehydration.
itchy rash all over;MD said was d/t hep b rash appeared w/in wk & lasted a week or more;
The patient/employee presented with a rash covering her face, all extremeties, and trunk on the morning of 11/12/2019.  She reported the rash and associated itching, low grade fever, and headache started around 6 pm on 11/11/2019.  A visit to the local Occupational Health provider for our office was recommended, but the employee refused.  Instead, she stated she had started taking Benadryl at onset of symptoms with slight relief.  She continued to have the rash and itching for three more days, but the fever and headache subsided by the second day.  The employee reported that she was still taking Benadryl at night, but plans to stop now that the rash resolved.  She never saw a physician for the problem, just myself, who is an RN in charge of our in-house occupational health, including administration of the annual flu vaccines and associated monitoring of potential side effects/reactions.
pt recv vax 24SEP96 & mom called 15OCT96 to report to nurse that pt had t102 ear responded w/APAP;high pitched crying resembling a cat lasting 5hr;no local rxn;
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 04-JAN-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336 (dose, route and the expiration date were not reported). The total cumulative hours out of range were 24 hours with 34 degrees C as the lowest recorded temperature and the storage was a refrigerator.  There was no concomitant medication provided nor no Product Quality Complaint(PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
aches, chills and headaches after the second COVID-19 vaccine but those symptoms are mild to moderate. the symptom were for about two days.
Mild flu like symptoms: muscle aches, headache, arm swollen at site. Began the following morning and lasted 1 day. Had similar reaction for first shot. Took VANQUISH for the headache. No further problems.
Patient presented to the ED and was subsequently hospitalized for pulmonary embolism, esophageal cancer metastatic to liver within 6 weeks of receiving COVID booster vaccination. He died on 12/19/21.
Rc'd shot and had no problems until AM of 4th day. Red and hard area (10 mm) over injection site. Tenderness and rapidly spreading swelling down arm towards elbow (about 1" from elbow) came to HD 9/3/08 and arm still red and swollen.
Information has been received from a physician concerning a 12 year old female with no drug reaction/allergies and no pertinent medical history who on 15-OCT-2007 was vaccinated with 0.5 mL HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 658556/1060U). The patient received a simultaneous injection of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX) that same day. On 17-OCT-2007 the patient experienced urticaria (area unspecified) for which the physician prescribed diphenhydramine hydrochloride (BENADRYL). No lab diagnostic studies were performed. Upon examination on 22-OCT-2007 the urticaria was resolved. No other symptoms or treatment were reported. Additional information has been requested.
This is a spontaneous report from a contactable other health-care professional.  A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number FD8448), via intramuscularly, in Left arm on 19Aug2021 13:00 PM (at the age of 54-years-old) as DOSE 1, SINGLE for covid-19 immunization. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number FC3182), intramuscular, administered in Arm Left on 09Sep2021 11:00 AM (age at vaccination 54years) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 21Aug2021, the patient test (+) for covid/ he tested positive for COVID. On 23Sep2021, the patient underwent lab tests and procedures which included computerized tomogram resulted as negative, electrocardiogram resulted as possible enlarged, full blood count resulted as negative, Left Atrium, metabolic function test resulted as negative and on 21Aug2021 sars-cov-2 test was positive. The outcome of the event was unknown.  Follow-up attempts are completed. No further information was expected.
covid 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid 19) in a 27-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In July 2023, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2023, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that patient received Moderna vaccinations. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-741650 (E2B Linked Report).   Reporter did not allow further contact.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741650:Husband case
Myalgia, Fever, CHILLS, SORENESS, LUMP, REDNESS AT INJECTION SITE Narrative:  Other Relevant History:
Received 1st dose Pfizer  Lot # En6206 Covid Vaccine at HD 3/12/21 Right Deltoid R Received 2nd dose Covid Vaccine at unknown Pharmacy And received Dose of Janssen lot # 203A21A, Returned to HD 2/22/2022 received booster dose ok'd by clinic manager to receive booster Pfizer booster dose Lot number EN6206 left deltoid.
Client received the 1st COVID vaccine (Pfizer Lot # EW0183 expiration date 08/14/2021) at 1647. At 1652 client reported to PHN that, "I feel like I'm going to faint in about 15 seconds." RN and PHN responded and helped transfer the client into the zero gravity chair. Client was alert and oriented times four. Client's skin was pale and dry. Patient stated, "my left foot and leg feels tight. When I get anxious I get this feeling and my body feels weak like this." PHN removed client's shoe and sock, there was no swelling or discoloration. Client denied any tightness in his chest or swelling in his throat or mouth. At 1657 client's oxygen level was 98% and heart rate was 74. At 1658, the injection site did not have any redness or swelling.  RN took the client's blood pressure at 1659 (141/88). The client stated, "I am very nervous about the vaccine. My wife is against getting the vaccine and says that it's not safe. I wanted to get the vaccine for my daughter since she starts kindergarten in two weeks. Now I am scared that I got the vaccine and I don't know what's going to happen. I am starting to think about every part of my body and I'm getting scared. My daughter was crying and begging me not get the vaccine before I left. She listens to the things that my wife says about it, but I did my research before coming and the risks are better than if I got COVID." PHN instructed client to focus on his breathing and performed breathing exercises with the client. RN offered the client water, juice or a snack, and client refused.  Client has a medical history of palpitations and GERD. The client takes Omeprazole for his GERD and vitamins. The client has no history of allergies. At 1700 client stated, "I'm feeling a weird sensation on the right side of my chest. I don't know how to describe it." PHN investigated the area and found the client's necklace lying in that area. The client stated, "oh it's just me necklace. I am starting to make myself feel things that aren't there." RN took blood pressure at 1703 (142/88). Client's wife called at 1705. After client hung up the phone, he appeared more calm. At 1709, client's skin was appropriate to race. Vital signs taken at 1710 (blood pressure 150/92, oxygen 99%, heart rate 91). At 1717 client stated, "I'm starting to feel worse again. It's all a panic attack. I feel this way when I'm very nervous." At 1720, client started to shiver and stated, "I keep thinking about it all. I wish I had a way of telling that I was fine." PHN offered to call EMS and the client refused. At 1722, client's wife called him again. After the client hung up the phone, he appeared more calm and stated, "when I talk to my wife, it makes me snap out of it." Vital signs taken at 1726 (blood pressure 138/90, oxygen 98%, heart rate 73). At 1733 client stood up and started walking around the vaccine room and stated, "My leg feels heavy but don't feel like I'm going to feel any better than this. I want to go home." PHN provided education to client on when to seek emergency services, and advised the client to follow up with his primary care provider. Client left the facility at 1735 unassisted and with a steady gait.
1st dose May 2022, 2nd 25Jun2022.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 83-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 25th June 2022, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On 25th June 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-Dec-2022 The pharmacist called and reported that the patient was administered a second dose of the Havrix vaccine 1 month after receiving the first one. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter. This case was 2 of 2. Additional supportive information: The patient received 2nd dose of Havrix, earlier than the recommended interval, which led to shortening of vaccinations schedule. This case is linked to the case US2022181960, reported by the same reporter.; Sender's Comments:  US-GSK-US2022181960:Same reporter
Injection site warm, raised, and red; Injection site warm, raised, and red; Left arm felt bruised after she got the injection; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL9262, first dose) solution for injection intramuscular in the left arm on 08Feb2021 at 12:00 (at the age of 60-years-old) at single dose for COVID-19 vaccination. Medical history included obesity, arrhythmia (that was fairly under control, and was not life threatening) and palpitations (palpitations from time to time, but this medication did not cause that). Concomitant medications included escitalopram oxalate (LEXAPRO) and lisinopril. Historical vaccine included flu vaccine in Oct2020 and experienced bruised after the injection. After the vaccination, the patient experienced injection site warm, raised, and red on 08Feb2021. The patient experienced left arm felt bruised after she got the injection in Feb2021. The patient has had no treatment for her arm yet. The outcome of the events injection site warm, raised, and red and left arm felt bruised after injection was unknown.
RECEIVED ONLY 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 39 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) 2.5 ml, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-NOV-2021, the patient experienced received only 2.5ml of the janssen covid-19 vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received only 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219386, 20211219731, 20211219686, 20211220206 and 20211220552.
My arm was just swollen; I felt sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Lot number: ER8733, Expiration Date: 31Jul2021) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Hypertension/Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LANTUS taken for diabetes mellitus; HYDROCHLOROTHIAZIDE taken for hypertension; METFORMIN taken for diabetes mellitus. Past drug history included: Lisinopril for Blood pressure, reaction(s): "I am allergic to Lisinopril". The following information was reported: ILLNESS (non-serious) with onset 26Mar2021, outcome "unknown", described as "I felt sick"; PERIPHERAL SWELLING (non-serious) with onset 27Mar2021, outcome "unknown", described as "My arm was just swollen". Therapeutic measures were taken as a result of illness, peripheral swelling.  Additional information: Patient took paracetamol (TYLENOL) as treatment for the events.  No follow-up attempts are possible. No further information is expected.
Sore throat, coughing, chest pain, sneezing, runny nose,severe headaches,  soreness at injection site
Pt received booster on 10/6/22 and second booster 10/26/22.
Info has been received from a health professional concerning a 6 year old white, female, with a history varicella exposure, who on 12/9/99, at 09:30 AM, was vaccinated with a SC dose in left upper leg of varicella virus vaccine live. Concomitant vaccines administered on the same day included a 3rd, IM dose in the upper right leg of DTAP, a 3rd oral dose of poliovirus vaccine inactivated (IPOL), a 2nd SC dose in the upper right leg of MMRII. It was noted that at the time of vaccination, the pt was seen for well child care. On 4/2/05, the experienced 7 pox on the abdomen with no other symptoms. Medical attention was sought. No product quality complaint was involved. Follow-up info from a health professional indicated that on 4/5/05, at 08:20 AM, the pt broke out with 7-10 pox. On 4/8/05, the pt recovered and was doing well. Additional info is not expected.
Received 1st dose of vaccine at 17 yrs old; Low grade temperature; Chills; Sore arm at the injection site; A spontaneous report was received from a nurse  concerning her daughter, a 17-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) (product administered to patient of inappropriate age) and experienced chills, sore arm at the injection site (vaccination site pain) and  low grade temperature (body temperature decreased).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.    On 29 Dec 2020, the patient received 1st dose of vaccine at the age of 17 years and experienced chills, sore arm at the injection site (injection site pain) and low-grade temperature. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of the events received 1st dose of vaccine at 17 yrs old was considered resolved on 29 Dec 2020. The outcome of events chills, sore arm at the injection site and low-grade temperature were not reported at the time of this report.; Reporter's Comments: This case concerns a 17-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age and associated adverse events of chills, vaccination site pain, and  low body temperature decreased. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 14-FEB-2013 the patient was vaccinated with PNEUMOVAX23, 0.5 ml, intramuscular, lot number H014283. On 15-FEB-2013 the patient experienced feeling achy, fever of 102.7 and pain at injection site. The patient was seen in the ER and was discharged the same day. Treatment information was not reported. On 16-FEB-2013, 3 days after onset of therapy the patient experienced left leg cellulitis (hospitalization). Treatment included intravenous clindamycin. The outcome of left leg cellulitis, fever, pain at injection site and achy is unknown. The relatedness for achy, pain at injection site, fever and cellulitis of the left leg was not reported for PNEUMOVAX23. This case was linked to cases 1303USA005018, 1304USA002378 and 1304USA002385, based on same reporter. Additional information has been requested.