chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Parent reported on 5/22/2018, hives, vomiting, sore throat occurred two days after child was vaccinated.
Suspected vaccination failure; have them now; ZERO energy; headaches; bodyaches; no interest in doing absolutely anything; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, loss of energy, headache, general body pain and loss of interest. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, loss of energy, headache, general body pain and loss of interest were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, loss of energy, headache, general body pain and loss of interest to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received 2 doses of Shingles vaccine 2 years ago from the date of reporting. After receiving Shingles vaccine, the patient was diagnosed with shingles 3 weeks ago from the date of reporting. The patient had zero energy, headaches and body aches, and no interest in doing absolutely anything.  It really stinks him/her. Till the time of the reporting, the patient still had all the adverse events. The patient stated that, might be he/she would feel a lot worse if I did not have them. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation was not provided. This case had been linked with case US2019175353, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019175353:Possible same reporter/patient
Light Headed; A spontaneous report was received from a consumer, concerning himself, a 69-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lightheaded.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Feb 2021, one hour prior to the onset of the event the patient received first of two planned doses of mRNA-1273 (lot/batch: 014M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, one hour after vaccination,  the patient felt lightheaded. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event lightheaded was unknown.
WITHIN 5 MINUTES AFTER VACCINATION :SWOLLEN LIPS,DIFFICULTY SWALLOWING ,SENSATION OF THROAT CLOSURE, DI FUSE RASH (ARMS ,LEGS ,BACK) ,SWOLLEN NOSE AND FACE AREA AROUND.
Cellulitis - strep, staph. Arm sore, pain 6/10 left arm. Red 2 days after. Fever Sun night. 3 in x 2 in rectangle, red, increased size. TX ZITHROMAX. Radiating pain, numbness. TX - IV antibiotic, Doxy, PERCOCET.
pt coughing 2DEC98 during noc; pt found unresponsive in bed 0500 3DEC98;CPR initiated @home; pupils fixed & dilated, no spontaneous breathing, cool cyanotic skin; unresponsive, apneic, asystolic,cardiopulmonary arrest;
Tremor in hand developed within 24 hours. Change in gait and speech patterns developed over the next 6 to 8 weeks. Initial diagnosis PSP or Parkinson's like syndrome.
THS level unbalanced; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD THYROID STIMULATING HORMONE ABNORMAL (THS level unbalanced) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included THYROID (ARMOUR THYROID) for Hypothyroidism.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced BLOOD THYROID STIMULATING HORMONE ABNORMAL (THS level unbalanced). At the time of the report, BLOOD THYROID STIMULATING HORMONE ABNORMAL (THS level unbalanced) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Blood thyroid stimulating hormone: 0.51 or 0.52 (Low) 0.51 or 0.52 WNL. On an unknown date, Blood thyroid stimulating hormone: 1.5-2.2 (High) 1.5-2.2 and 5.72 (High) 5.72 - Latest.         TSH level 5.72 - Latest , Now taking 60mg , 7 days a week TSH level 0.51 or 0.52 , Retained 60mg dose but dropped to 5 days a week WNL Lack of effect No treatment medication details was provided. Cyanne maa Allergan armour thyroid Doctor wrote script for 6 days 60 mg , 1 at 30 mg or 15 mg 1 day nannayaa; Sender's Comments: This case concerns a 66-year-old, female patient, with medical history of hypothyroidism, who experienced the non-serious, unexpected event of blood thyroid stimulating hormone decreased. The event occurred  17 days after second dose of mRNA 1273 vaccine. The patient had her TSH level checked 2 weeks after second dose and revealed that it was lower than her baseline, although still normal. Her medication regimen was changed which led to a higher TSH level, she is still undergoing treatment to make her thyroid hormones balanced. The rechallenge is not applicable as there is no information regarding a third dose. The patient's history of hypothyroidism remains as a confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Terrible headache; A spontaneous report was received from a consumer concerning an 82-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed terrible headache.  The patient's medical history was not provided. Concomitant medications were not provided.  On 22 Jan 2021, the patient received their first of the two planned doses of mRNA-1273 (Batch number: 011L20A) intramuscularly in the left deltoid for the prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient received their second of the two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly in the left deltoid for the prophylaxis of COVID-19 infection.  Patient reported after the first dose that they had a terrible headache for a short time. Treatment information not provided. Lab tests not included.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the event terrible headache was resolved after a short time.
have soreness in her arms; she was dehydrated; legs have a rash,left one is slightly worse; more swollen than the right leg; left leg is also more red; warm than the right leg; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (have soreness in her arms), DEHYDRATION (she was dehydrated), RASH (legs have a rash,left one is slightly worse), PERIPHERAL SWELLING (more swollen than the right leg) and ERYTHEMA (left leg is also more red) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] and ESTRADIOL (ESTRACE) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (have soreness in her arms), DEHYDRATION (she was dehydrated), RASH (legs have a rash,left one is slightly worse), PERIPHERAL SWELLING (more swollen than the right leg), ERYTHEMA (left leg is also more red) and FEELING HOT (warm than the right leg). The patient was treated with NYSTATIN at a dose of 1 dosage form; GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) at a dose of 1 dosage form; COCONUT OIL at a dose of 1 dosage form; EUCALYPTUS OIL at a dose of 1 dosage form and CANNABIDIOL (CBD OIL) at a dose of 1 dosage form. At the time of the report, MYALGIA (have soreness in her arms), DEHYDRATION (she was dehydrated), RASH (legs have a rash,left one is slightly worse), PERIPHERAL SWELLING (more swollen than the right leg), ERYTHEMA (left leg is also more red) and FEELING HOT (warm than the right leg) outcome was unknown. Not Provided
vomiting; had a headache (ongoing); arm hurt; He also had fever; chills; A spontaneous report was received from a consumer concerning a 59 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, vomiting, had a headache(headache), arm hurt(pain in extremity). fever(pyrexia) and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On , 14 Feb 2021, approximately 1 day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: ) (route unknown) for prophylaxis of COVID-19 infection.  On 14 Feb 2021, patient experienced vomiting, had a headache, arm hurt, fever and chills  .No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, had headache is not recovered/resolved andnn  the outcome of the events,  vomiting, arm hurt, fever and chills is unknown
Patient presented to Urgent Care 3 days after his second dose of Pfizer COVID-19 vaccination.. He reported a 10 day issue of a left axilla mass (12 cm) with new onset of tenderness.
Pregnant patient received the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003b21a) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 01-May-2021. On 22-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the vaccine). On 22-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Diarrhea increased after the shot; lost taste; lost smell; was drenching/ drenching was just unbelievable/had massive hot sweat/just debilitating them/much worse than menopause hot sweat; felt like they were burning up but temperature was fine; Eyes hurt; arm still hurts/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm still hurts/sore arm), AGEUSIA (lost taste), ANOSMIA (lost smell), HYPERHIDROSIS (was drenching/ drenching was just unbelievable/had massive hot sweat/just debilitating them/much worse than menopause hot sweat) and HEAT ILLNESS (felt like they were burning up but temperature was fine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Irritable bowel syndrome (diarrhea worse.). Concomitant products included ZINC and VITAMIN D3 for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm still hurts/sore arm). On 21-Jan-2021, the patient experienced AGEUSIA (lost taste), ANOSMIA (lost smell), HYPERHIDROSIS (was drenching/ drenching was just unbelievable/had massive hot sweat/just debilitating them/much worse than menopause hot sweat), HEAT ILLNESS (felt like they were burning up but temperature was fine) and EYE PAIN (Eyes hurt). On an unknown date, the patient experienced DIARRHOEA (Diarrhea increased after the shot). The patient was treated with RIFAXIMIN (XIFAXAN) for Diarrhea, at a dose of 550 mg three times a day. At the time of the report, PAIN IN EXTREMITY (arm still hurts/sore arm), EYE PAIN (Eyes hurt) and DIARRHOEA (Diarrhea increased after the shot) had not resolved, AGEUSIA (lost taste), ANOSMIA (lost smell) and HEAT ILLNESS (felt like they were burning up but temperature was fine) had resolved and HYPERHIDROSIS (was drenching/ drenching was just unbelievable/had massive hot sweat/just debilitating them/much worse than menopause hot sweat) was resolving. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up received on 20 Jul 2021 contains updated event outcome - not recovered for diarrhea, sore arm, eye pain and recovering for hot sweats, updated patient demographics-DOB, height, weight, ethnic group, race info. medical history updated, second dose of vaccine updated.
After 30 minute observation, at 11:05 am patient voiced "i have a tingle in the back of throat". Patient was further assessed vital signs within normal limits. 02 via NC was administered at 6L/min. 911 immedetialy called and responded. sight lead supervisor immidetly notified.
LUMPS/BOIL ON GROIN AREA OUTSIDE VAGINAL SIDE; PAIN TO BOIL WHICH MAKES IT DIFFICULT TO WALK; CHILLS; TIRED; FEVER; FEELING OF THROWING UP; HEADACHE; SWELLING OF FINGERS; SWELLING OF TOES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included celiac disease, hashimoto's thyroiditis, and reactive arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced swelling of fingers. On 13-MAR-2021, the subject experienced swelling of toes. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced tired. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced feeling of throwing up. On 13-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced lumps/boil on groin area outside vaginal side. On 16-MAR-2021, the subject experienced pain to boil which makes it difficult to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of fingers, swelling of toes, chills, fever, feeling of throwing up, and headache on MAR-2021, was recovering from tired, and had not recovered from lumps/boil on groin area outside vaginal side, and pain to boil which makes it difficult to walk. This report was non-serious.
received the first dose of Havrix outside recommended schedule /  fist dose  was administrated on July 16 2018; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-month-old male patient who received HAV (Havrix) (batch number 334PA, expiry date 7th December 2018) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th July 2018, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 16th July 2018, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The patient received the 1st dose of Havrix outside recommended schedule at the age of 11 months, which led to inappropriate age at vaccine administration.  The vaccine was recommended to be administered to children and adolescents from 1 year of age up to and including 15 years of age. No known side effect were reported. The reporter consented to follow up.
pt recv vax @ 4wk instead of the recommended 2mo;DTP/HIB given together as one;vax not recommended by MFR package insert;
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 (Lot number: EN6203) as dose 1, single and administered in arm left, administration date 22Mar2021 (Lot number: ER8730) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hip arthroplasty" (unspecified if ongoing), notes: Verbatim: Hip replacement about 12 years ago. The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine, for Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "sore arm".  Additional information: NDC number was not reported. Investigation Assessment was not reported. She did not have problems.  No additional vaccines administered on same date of the pfizer Suspect. Emergency room visit and physician office visit was not required. No relevant tests reported.  Follow-up attempts are completed. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In January 2009, the patient was inoculated with ZOSTAVAX by a physician at the physician's office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 03-JUL-2016, the patient was treated by the same physician at the office for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
About four hours after injection, I experienced lightheadedness and chills; I experienced lightheadedness and chills; I decided to check my temp, assuming I would be feverish. Instead, one thermometer read 95.4 F and the other thermometer read 95.6 F; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the arm left on 27Feb2021 at 11:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, latex allergy and fruit allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), buspirone (MANUFACTURER UNKNOWN) and hydroxyzine (MANUFACTURER UNKNOWN) taken for an unknown indication in an unknown date and unknown if ongoing. The patient previously received hydrocodone (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Feb2021 at 17:00, about four hours after injection, the patient experienced lightheadedness and chills. The patient's husband (who did not receive the vaccine) noted that he felt warm, so the patient decided to check temperature, assuming would be feverish. Instead, one thermometer read 95.4 Degrees Fahrenheit and the other thermometer read 95.6 Degrees Fahrenheit. After wrapping up very warmly for a couple of hours, her temperature was normal again, but still experienced light headed for the rest of the day. On the same day, the patient underwent body temperature test and the result was 95.4 Degrees Fahrenheit and 95.6 Degrees Fahrenheit. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events lightheadedness, chills and feverish were recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Within two weeks of receiving the flu vaccine, I began noticing spontaneous, random muscle spasms/contractions throughout the major muscles of my body. For example, my leg or arm muscle would contract and move my limb without me causing it too. This continued for approximately three months and slowly got better over time.
General unwell; Chest cold; Lymph node swollen; Painful in right arm pit; A spontaneous report was received from a consumer who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced generally unwell, chest cold, lymph node swollen, and pain in the right arm pit.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Dec 2020, the patient received the first of two planned doses of mRNA-1273 in the right deltoid for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced being generally unwell, chest cold, swollen lymph nodes, and pain in right arm pit.    The treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, being generally unwell, chest cold, lymph node swollen, and pain in the right arm pit, was considered not recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.