chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intense headache; Shivering/chills; Horrible stomach ache; Muscle cramps; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shringrex (1st dose received on an unknown date).   On 8th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, 12 hrs after receiving Shingrix, the patient experienced headache, shivering, stomach pain and muscle cramp. On an unknown date, the outcome of the headache, shivering, stomach pain and muscle cramp were unknown.   It was unknown if the reporter considered the headache, shivering, stomach pain and muscle cramp to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Age group was captured as adult as per vaccine indication. The patient received 2nd dose of Shingrix vaccine at noon yesterday from the date of reporting.  12 hours later the patient began an intense headache, shivering/chills, horrible stomachache, and muscle cramps.
Patient fainted several minutes after getting the shot.  In the fall, the patient tore his ear and the doctor used glue to repair it.
24 hours after: sudden diarrhea, nausea, headache , fever- 100-101, dizziness, extreme body aches, chills, fatigue. Lasted through the evening but by the following day I was fine.  also- I had weird black spots in my vision immediately after the vaccine but they went away within 30 minutes.
2hr p/vax pt arm became swollen from the shoulder area to the finger tips;pt was sent to ER: 2 days p/vax the swelling was almost gone;
Within 5 minutes I felt severe tightness pressure in lungs area & chest. It has been 24 hours and I?m still feeling the same.
COVID-19; COVID-19; This is a spontaneous report from a contactable physician reporting for his sister. An 80-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, in 2021, as single dose, for COVID-19 immunisation. Medical history included diabetes mellitus and hypertension. Concomitant medications were not reported. The patient experienced COVID-19 in 2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive in 2021.   The information on the lot/batch number has been requested.; Sender's Comments: The information provided is limited and does not allow for a complete medical assessment.   It is unlikely  that the  reported COVID-19  was causally  related to BNT162B2.   This was probably an intercurrent  condition.  Case will be reassessed if additional information is  received.
Initial solicited report received from a physician in the study on 21 April 2016. This case involves a 14-year-old female subject who developed influenza post vaccination. The medical history and concomitant therapy details were not reported. The subject experienced influenza on an unspecified date, after receiving a dose of Flu Vaccine (date of vaccination, site and route of administration and batch number were not reported). The subject received a dose of the above mentioned vaccine (flu vaccine) and then got the flu with serious complications. According to the physician the event of influenza was considered as life threatening. The lab data and corrective treatment details were not reported. The outcome of the event was unknown at the time of report. Relationship to investigational product according to company: not associated. List of documents held by sender: none. Sender's Comments: A 14 year-old female subject received flu vaccine (date, lot are unknown). She developed influenza infection (number of days post- vaccination is unknown) with life-threatening complications. Due to lack of details of influenza infection, medication history and patient immune status at the time of vaccination, the sponsor assesses this event as not related to the study product.
This spontaneous report as received from a practitioner refers to a female patient of unknown age.  There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 10-DEC-2010, the patient was vaccinated with a dose of M-M-R II for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 24-DEC-2017, the patient was inadvertently vaccinated with a dose of VARIVAX for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Subsequently, in January 2014, the patient was vaccinated with the second dose of M-M-R II for prophylaxis and in January 2015 the patient was vaccinated with the second dose of VARIVAX. The vaccines were mostly reconstituted with sterile diluent (MERCK). No adverse effects were reported.
intense heart rate increase; blood pressure was elevated, 140/84, 132/86; increased heart rate and it spiked and then decreased; This is a spontaneous report from a Pfizer sponsored program  from a contactable consumer (patient)   A 57 year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 26Jul2021  at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history included allergies during seasonal changes and sometimes she had e a runny nose and difficulty breathing. Concomitant medications were not reported. On 26Jul2021 patient noticed an intense heart rate increase and feels different like something has changed and not like before (as reported). A few days after she was seeing her cardiologist and her blood pressure was elevated which she states is not normal for her and has not happened before. She states that it was 140/84 and 132/86. She recalled that after the dose of the vaccine she had an increased heart rate and it spiked and then decreased.  At the time of the reporting the patient had not yet recovered from the events.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
No adverse event; Received Bivalent booster from a vial with Red Cap instead of blue cap; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Bivalent booster from a vial with Red Cap instead of blue cap) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-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. On 15-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Bivalent booster from a vial with Red Cap instead of blue cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Bivalent booster from a vial with Red Cap instead of blue cap) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medications were not reported.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Sep-2022: Significant Follow up received contains patient age and lot number updated
pt recvd vax w/achiness that evening; on the following vax pt exp severe swelling of all joints, exp hands, fingers, feet & ankles; also exp under the skin, hive-like rash w/itching; MD prescribed Pred tablets x 10 days;
Shot given on September 29, 2004 around 4:00 pm, taken home and 2 hours later left arm started breaking out in red raised bumps circled in white. They spread down left side to other arm both groin areas. Kept getting worse; bumps turned in to red raised welts. Took him to emergency room, Benadryl shot administered waited 30 minutes, rash and welts continued to worsen. Doctor administered a shot of Vistiril, and a shot of Epi. We waited 30 minutes, breaking out appeared to be somewhat better. We arrived home by 10:30p.m.; welts had started getting bigger, but by 7:30am the red raised welts were larger and more pronounced and more of them. So I took him to our regular physican. He orederd predisone packet and advised us not to try another hepatitis b shot that the next one could be worse, and I agree. Today Friday, the red raised welts are now huge red raise blotches and larger. I have taken pictures that I will be sending you.  Now at 9:00 pm Friday, some of the centers of the huge raised welts are going down but are leaving dark blotches in the center. People this scares the hell out of me. We are not out of the woods yet if I see no improvement by saturday at noon, I will take him back to the emergency room, the red raised welts are hot to touch, his face is red and hot to touch also but no temperature.
Rash on face, ears, eyelids, neck, chest and back. Sudden dizziness.
Sore arm; Headache on the lower right side of head; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 31Mar2021 at 14:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, blood pressure high and arthritis. Concomitant medications included hydrochlorothiazide (+) olmesartan medoxomil (OLMESARTAN HCTZ), glimepiride (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. The patient was not allergic to food, medication or other products. 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 31Mar2021 at 16:00, the patient experienced sore arm (pain in arm) and headache on the lower right side of head. 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 as a result of reported events. The clinical outcomes of the event sore arm headache on the lower right side of head were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Decedent passed 06/05/2021 at 1042 hours. Exam showed bilateral pulmonary emboli.
Patient experienced rapid heart rate, chest tightness and pressure, shaking, heart pounding, and elevated blood pressure.  Patient spent 3 days in the hospital and will follow up with her primary care physician as well as her cardiologist
pt recvd vax; c/o tight feeling in throat; urticaria on arms, head & neck;
Rash on arms, hands, mid-legs - raised, itchy, painful Rash on torso, hips, torso, buttocks - splotchy Treated with antihistamine, Tylenol, and 1% hydrocortisone cream Rash is continuing to heal - now at Day 9
Headache chills fingers went numb up to knuckles shaking uncontrollably sick for three days, will never get vaccinated again.
Experienced chills, arm soreness, and fatigue initially, which worsened over the rest of the evening. Around 6:00 pm, I measured my temperature and it was 95.0 degrees Fahrenheit. I could not get warm for and experienced tingling and numbness in first my feet, then arms and hands, and finally my face. This passed and I was left feeling nauseous and still extremely cold. After tossing and turning for most of the night, so of these side effects have resolved, but I have a splitting headache and muscle and joint pain throughout my body. No treatment has been undertaken. Some side effects have resolved while others continue.
Client called health department on 3-15-04- states that 2 hours after getting shot her left arm was red, swollen & painful. On 3-13-04 had a fever of 100.0 and felt bad. Was advised on 3-15-04 to take Motrin & alternate hot/cold packs to arm. Went to sleep & woke feeling ok. On 3-17-04- states arm slightly sore.
Information has been received from a physician concerning a 2-month-old male who on 11-OCT-2006 was vaccinated PO with the first dose of Rotateq. The physician reported that on 14-OCT-2006, the patient developed diarrhea. Unspecified medical attention was sought. The patients diarrhea subsequently resolved. The physician felt that the patients diarrhea was not related to Rotateq but due to exposure to other family members who had diarrhea at the time. Additional information has been requested.
PATIENT STARTED HAVING LOCAL INJECTION SITE PAIN SHORTLY AFTER RECEIVING THE SHOT . AFTER FEW HOURS, HER JOINTS AND BONES STARTED HURTING ALL NIGHT LONG . HER SHOULDER GOT REDDER AND HOTTER AND ON THE 6TH , SHE SAW SHINGLES LIKE RED SPOTS AND STARTED FEELING ITCHY  FROM ARM TO ELBOW AND THEN HER LEFT BREAST. AFTER 4 DAYS SHE STARTED FEELING BETTER AND IS FREE OF SYMPTOMS NOW.
soreness at the in jection site for 48 hours. Redness, swelling, and itchiness at the injection site about the size of a quarter for 7 days, which grew to 3 inches in diameter on days 8-9 (present time).
16 year old male with no past medical history, recently received 2nd pfizer vaccine on monday 6/28, here with chest pain since . EKG shows ST elevation: consistent with pericarditis. troponin 15.2. will admit to healthcare faciility.
Pt recvd 2 doses of Engerix-B & approx 1 wk following exp redness @ site sx resolved; approx 6 wk following dose 2 exp erythema nodosum; seen by MD;
Shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 02-NOV-2007, at age 64, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
PT was given MMRV (Proquad) at age 18.  Manufacturer recommendations are for pts up to 12 years of age Pt has had no reactions to vaccine.
Child followed mother out of room where vaccine was given  While mother was paying she passed out and hit her head on the floor. Approximately 5 minutes after receiving vaccines.  Child was given some soda to drink.  Mother sat in waiting room with child for 20 minutes after she fainted before leaving facility. Child seemed fine when she left.
persistant crying x 2 hrs; swelling of both legs, blotchy red skin, holding breath; frequently legs turned purple in color; no elevation in temp;
Irregular menstrual cycles (3 periods in 6 weeks); Irregular menstrual cycles (3 periods in 6 weeks) and extremely heavy bleeding; This is a spontaneous report from a contactable nurse reported for herself.  A 40 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) via an unspecified route of administration on 21Dec2020 02:45 PM at age of 40 years old in left arm at single dose for covid-19 immunisation. Medical history included there was no known allergies. No covid prior vaccination. And no other medical history. Patient was not pregnant. Concomitant medications were none. Previously there was no other vaccine in four weeks. No other medications in two weeks. Patient experienced irregular menstrual cycles (3 periods in 6 weeks) and extremely heavy bleeding with several clots starting one week after first vaccine. The adverse events started date was on 31Dec2020. Patient had the doctor or other healthcare professional office/clinic visit. There was no treatment. No covid tested post vaccination. Outcome of events were unknown. Patient received the second dose of BNT162B2 (lot number= EL1283) on 11Jan2021 09:15 AM in left arm for covid-19 immunisation.
p/vax pt exp knot & redness; hot to touch; rt thigh; scheduled for removal of sterile abscess
Temp 101.9 ax pre grandmother - on call phone call - Instructed to take to ER Temp increased 104 at ER - given ROCEPHIN, IV flds dx with UTI - urine cultures - negative.
vaccines have been more than likely used since the excursion with no reported adverse event; Initial information received on 04-Oct-2022 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2022SA411401, 2022SA412043 and 2022SA412359.  This case involves a 12 years old male patient for whom IPV (VERO) [IMOVAX POLIO] vaccines have been more than likely used since the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included hepatitis A vaccine (Hepatitis A), measles vaccine, mumps vaccine, rubella vaccine (MMR) and varicella zoster vaccine (Varicella Vaccine) all for Immunisation.  On 21-Sep-2022, the patient received suspect IPV (VERO) at a dose of 0.5 ml total (lot U1C571M, expiry date: 17-Jun-2023) via intramuscular route in the left deltoid for prophylactic vaccination(immunisation).  On 21-Sep-2022 IPV (VERO) vaccines have been more than likely used since the excursion with no reported adverse event (poor quality product administered, latency: same day) .  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
rheumatoid arthritis; Was tired for a day; extreme pain in joints,hands,wrist,both knees/ debilitating pain in joints; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included HYDROXYCHLOROQUINE, PREDNISONE and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced ARTHRALGIA (extreme pain in joints,hands,wrist,both knees/ debilitating pain in joints). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis) (seriousness criterion medically significant) and FATIGUE (Was tired for a day). At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis), ARTHRALGIA (extreme pain in joints,hands,wrist,both knees/ debilitating pain in joints) and FATIGUE (Was tired for a day) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported/unknown. Patient reported that March, April and May was horrible, nothing worked heat, ice. Patient was put on steroid were reported.  Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Arthralgia and fatigue are consistent with the product known safety profile   This case was linked to MOD-2021-216022 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up contains secondary reporter details, patient demographic details and additional concomitant medication. On 10-Jun-2021: Upon internal review on 08-DEC-2022 non-significant correction performed to update "case received from  field" to blank.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Arthralgia and fatigue are consistent with the product known safety profile
This spontaneous report regarding to multiple unspecified patients of unknown ages and genders was received from a licensed practical nurse. The patients' concurrent conditions and medical histories were not reported. On multiple unspecified dates, the patients were vaccinated with unspecified and improperly stored doses of GARDASIL 9 which had a lot # reported as L044775 and an expiration date of 12-MAY-2017 (route, dose and anatomical place of vaccination were not reported). The aforementioned doses of vaccine were stored at 23 degrees F for a time frame of 576 hours. Nevertheless, no adverse effect was reported and no product quality complaint was involved. Information regarding concomitant therapies was not reported. Additional information has been requested.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the second dose of GARDASIL vaccine (yeast). The physician reported that the patient received the HPV vaccine and experienced red, itchy welts head to foot. At the time of the report the patient had not recovered. The patient sought medical attention by phone. No further information is available.
A round red erythematous area around the point w/center area of paler tissue; 6 days from when shot was given;
This case was reported by a nurse via call center representative and described the occurrence of burning lips in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced burning lips. On an unknown date, the outcome of the burning lips was unknown. It was unknown if the reporter considered the burning lips to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional stated that, the patient was suffering from burning lips 24 to 48 hours, following vaccination after SHINGRIX. The adverse event was submitted via Webform.
pt recvd vax & exp 3cm-raised redden warm w/8mm crusty center, 7cm node @ widest point; painful to touch states pt also states pus discharge was white, about 29DEC94 in AM; states blister then it popped; site was sore x 3 days; uncomfortabl
Patient received the vaccine on friday night and by the next morning a rash appeared that has now increased to the size of a baseball. Has taken Tylenol and used cold packs. Reporting on Monday and no resolution since. Rash appears a reddish-purple.
Had a severe allergic reactions: 12/21/2018. Arm swollen around 5 PM and complaining about pain in the arm and stiffness. 12/21/2018. At 11:30 PM noticed discoloration in skin, really red with white spots on Stomach, Chest, Arms, Back and Legs. Took an over counter allergy med and went to bed. 12/22/2018, Itching, burning, pain in arm, loss of appetite, chills, fever, hives, rashes and headache. 12/23/2018, Took over counter BENADRYL all day with no results. 12/24/2018  Went to emergency room.