chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm- local infection with pain and redness at the injection site. OTC Hydrocortisone 1% cream and Tylenol recommended as per Provider.
This spontaneous report as received from a healthcare worker refers to a 5 months old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 05-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
0.25 ml dose  for a booster dose, to two patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (0.25 ml dose  for a booster dose, to two patients) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A, 021C21A, 066H21A and 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (0.25 ml dose  for a booster dose, to two patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (0.25 ml dose  for a booster dose, to two patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No Allergies with medications, food and other products.   patient ever had COVID positive test or diagnosis was reported as unknown.  No medical history was reported with AE and both Acute and Chronic illnesses at the time of vaccination.  The patient did not experience a similar event in the past.  No treatment medications were reported.   This case was linked to MOD-2022-607752, MOD-2022-607755 (Patient Link).
Atypical varicella rash 2 weeks after being exposed to a boy with wild type varicella.
Bilateral lower leg edema and swelling reported by the nursing home. Taken into the Clinic for evaluation. Past medical history: Hypertension, alzheimers dementia without behavioral disturbances, probable recurrent transient ischemic attack. Physical examination: Vital signs stable. 2+ to 3+ edema from her knees down bilaterally. Minimal redness. There are swelling and blisters bilaterally, left more than right. She is currently wearing tubipgrips.
Flu like symptoms after administration of flu mist lasted for about one week. Progressed to bronchopneumonia the following week, lasted for two weeks. Was given Avalox for treatment and followed up with pulmonary provider.
Progressive slight numbness in my left arm follow day. Most noticeable in fingertips. Just didn?t feel right through day and took blood pressure at approx 5pm. Reading was 171/108.  Took a clonidine (which I have on hand in emergency. This was only the 2nd time I?ve ever taken it) I emailed my doctor a short time later. Doctor advises if symptoms progressed to go to ER(although sent following morning, I did not see until Thurs evening) Friday morning met with Doctor.  Fingers still feel peculiar but BP ok.
Ear Drainage, swollen ear, crusted blisters, continued extreme ear pain and down through neck on right side; Diagnosed Shingles in ear and super bacterial infection in ear; Ear Drainage, swollen ear, crusted blisters, continued extreme ear pain and down through neck on right side; Ear Drainage, swollen ear, crusted blisters, continued extreme ear pain and down through neck on right side; Extreme ear pain and down through neck on right side; Diagnosed Shingles in ear and super bacterial infection in ear; Fever; Chills; Exhaustion; Vertigo; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A 48-years-old non-pregnant female patient (non-pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 (Batch/Lot Number: ER8731, Expiry date was not reported) (at the age of 48-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was reported as none. There were no known allergies reported. Concomitant medications included vitamins. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8730, Expiry date was not reported), via an unspecified route of administration, administered in Left arm on 23Mar2021 (48-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 15Apr2021, the patient experienced chills, fever, exhaustion, Extreme ear pain and down through neck on right side, Ear Drainage, swollen ear, crusted blisters, continued extreme ear pain and down through neck on right side, Vertigo, diagnosed Shingles in ear and super bacterial infection in ear and vertigo. It was reported as within 12 hours, the patient had chills, fever and exhaustion, on day 3- Extreme ear pain and down through neck on right side, on day 4-7- Ear Drainage, swollen ear, crusted blisters, continued extreme ear pain and down through neck on right side and on day 8-Vertigo and diagnosed Shingles in ear and super bacterial infection in ear. The events resulted doctor or other healthcare professional office/clinic visit. Treatment included antibiotics, ear drops, nausea and dizziness medicine. The clinical outcome of the events was reported as recovered on an unspecified date in Apr2021.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
headache, chills / shivering, fever, body aches. symptoms   lasted about 36 hours. took no medications.
A report was received from an observational study. A male, patient, 19-24 years of age, experienced other anaphylactic shock, NEC (serious, since 25-Jan-2012, until 25-Jan-2012), within 42 days of vaccination, while enrolled in the study, a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. The patient was an active recruit. Patient received Adenovirus Vaccine on 21-Dec-2011. At the time of the report the outcome of the AEs were: other anaphylactic shock, NEC: unknown. Patient began Prednisone 20 mg PO on 25-Jan-2012 which stopped 30-Jan-2012, and Cetirizine 10 mg PO from 25-Jan-2012 until 24-Feb-2013. The medical history of the patient was not specified. The patient's concomitant medication included DTP (since 21-Dec-2011); Meningococcal Vaccine (since 21-Dec-2011); Hepatitis B Vaccine (unknown; since 21-Dec-2011); Influenza Vaccine (since 21-Dec-2011); Ranitidine (since 12-Jan-2012). Lab tests were not reported. This case was considered serious based on the following criteria: (Disability or Permanent Damage). The medical monitor's causality assessment: no reasonable possibility, unknown severity.
Arm pain after about 2.5 hrs.  Chills, fever, overall body aches, nausea after about 12 hrs.  Treatment: ibuprophen, tylenol PM, immodium.
About 5 min after receiving the injection, throat and tongue began feeling numb and tongue felt thick. 30 minutes after injection, sudden need for BM. Oral, liquid Benadryl taken. BP 120/96, HR 93, SpO2 96%.
severe allergies; Stuffed up nose; scratchy throat; This is a spontaneous report from a contactable consumer reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient had the first dose and had severe allergies. She had three different reactions since the shot, stuffed up nose and scratchy throat. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Information has been received from a registered nurse concerning a female with no known drug allergies who on approximately 1/15/03 was vaccinated with MMR II. There was no concomitant medication. The RN reported that in January 2003, the pt developed a fever of 103-104. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional  info has been requested.
Employee indicated that his vision was blurry later that evening for roughly a couple hours. He also indicated that it may have been contributed to stress and it self resolved without treatment. No longer is effecting him at this time.
Hives appeared as small clusters on the arms,torso and tops of the legs; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives appeared as small clusters on the arms,torso and tops of the legs) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced URTICARIA (Hives appeared as small clusters on the arms,torso and tops of the legs). On 26-Mar-2021, URTICARIA (Hives appeared as small clusters on the arms,torso and tops of the legs) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported No treatment medications were reported
Information has been received from a physician concerning a 6 month old female (also reported as 8 months old) with a history of reactive airway disease and umbilical hernia and no allergies who on 18-APR-2006 was vaccinated with Vaqta (Lot # 652090/1070R) 0.5 ml intramuscularly. No concomitant medications. On 18-APR-2006, the patient inadvertently received 3 doses of Vaqta of 0.5 ml. No other other vaccines were administered at the visit. No labs were required. No adverse reaction noted at the time or today (19-APR-2006). No further information was available at the time of reporting. Additional information was received from the physician. On 18-APR-2006, the patient received Vaqta (lot number 652508/1194R previously reported as 652090/1070R) IM in left and right thigh at 1600 hours. The patient had not received previous doses of hepatitis A virus vaccine inactivated. On 21-APR-2006, the child experienced mild nausea and vomiting lasting approximately 48 hours. On 22-APR-2006, the patient recovered. No additional information is expected.
Hyper, heart-racing, off-balance, foggy-mind, nausea.
Seizure with clonus, lasting 5 seconds x2, one 15min after vaccine, another 45 min after vaccine. Patient sent to the emergency room for evaluation.
Could barely stand; feels like she has the flu; feel really sick; body was fatigued; muscles were so achy, body aches; fever; Chills; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (feel really sick), DYSSTASIA (Could barely stand), INFLUENZA LIKE ILLNESS (feels like she has the flu), FATIGUE (body was fatigued) and MYALGIA (muscles were so achy, body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced MALAISE (feel really sick), DYSSTASIA (Could barely stand), INFLUENZA LIKE ILLNESS (feels like she has the flu), FATIGUE (body was fatigued), MYALGIA (muscles were so achy, body aches), PYREXIA (fever), CHILLS (Chills) and HEADACHE (headache). At the time of the report, MALAISE (feel really sick), DYSSTASIA (Could barely stand), INFLUENZA LIKE ILLNESS (feels like she has the flu), MYALGIA (muscles were so achy, body aches), PYREXIA (fever) and CHILLS (Chills) outcome was unknown and FATIGUE (body was fatigued) and HEADACHE (headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Headache added, outcome of fatigue updated.
On 10/12 at 0230 i had chest pain that woke me up from sleeping. I thought it would go away but upon arrival to work my co worker asked what was wrong and I explained I was having chest pains. She notified one of our doctors and he ordered an EKG and it was bone by 0830ish. Dr did not like what he seen on the EKG and ordered me to the ER. While in the ER I had blood tests and more EKG's done and was admitted. While admitted a CTA was ordered and I was kept over night. I was discharged on 10/13 in the evening and ordered to follow up with Dr at Cardiology for further testing.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
ongoing menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (ongoing menstrual cycle) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (ongoing menstrual cycle). At the time of the report, HEAVY MENSTRUAL BLEEDING (ongoing menstrual cycle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient informed that She is on birth control and has a very regular cycle. No treatment information was provided by the reporter. No Concomitant medicines were reported.
The next day, 3/26, had a golf ball size hard knot at inj. site with redness and swelling and soreness.
Woke up early Sunday morning with a temp of 101. Had chills and shaking, body aches, nausea, with a little confusion. Took medicine for pain.
lightheaded, dizzy; sudden weakness\felt very weak; I never felt like I had trouble breathing; This is a spontaneous report from a contactable consumer (Patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Not available/provided to reporter at the time of report completion), via an unspecified route of administration, administered in Right Arm on 03Feb2021 12:00 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications not reported. The patient previously took metronidazole and experienced drug allergy. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Hospital. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: None. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was in very good health/exercise - take no medications. The patient experienced lightheaded, dizzy, sudden weakness\felt very weak, I never felt like I had trouble breathing; all (non-serious) and on 03Feb2021 12:00. Patient reported that About 6-9 minutes after receiving the vaccine, patient felt very lightheaded, dizzy and sudden weakness. patient felt drugged. patient never felt like that patient had trouble breathing. It began to subside about 30 min later, but patient felt very weak for about two hours. Her doctor said she should not take the second dose. Treatment was not received for the adverse event. The outcome was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.
Patient passed out immediately after vaccine administered. Time 1235, room temp 79; Pt was out for appx 15 sec, small upper extremity contractions exhibited. Epinephrine not needed. Pt woke up before administered. Pt complained of hunger 56 gram of glucose given.
Nose Bleeds; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (Nose Bleeds) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 045B21A) for COVID-19 vaccination.     The patient's past medical history included Sinusitis and Cholesterol. Concurrent medical conditions included Hypertension.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced EPISTAXIS (Nose Bleeds). At the time of the report, EPISTAXIS (Nose Bleeds) outcome was unknown.            Treatment includes Ice and pressure locally to slow bleeding   Reporter did not allow further contact
severe pains in his stomach; nausea; vomiting; This is a spontaneous report from a contactable consumer or other non health care professional. This reporter was a caregiver reported for a 70-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on 04Mar2021 (at the age of 70-years-old) as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Mar2021, the patient experienced severe pains in his stomach, nausea and vomiting. Consumer reported about his partner who had a Pfizer shot on past Thursday, he stated on tonight he was experiencing nausea, vomiting, and some severe pain on the side and middle of his stomach. The outcome of all events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Injection site swelling, redness expanding in area to approximately four and a half inches in diameter, still present three weeks after injection.  Some swelling still exists and the area is slightly warm to the touch.
patient was very nervous before getting vaccine. I tried to reassure her, then she seemed ok to proceed. she was sitting in the waiting area after getting the vaccine when she started to feel faint. She told my tech that she is "passing out". I came out to check on her.....and her head was going back. I ran to then chair she was sitting in and held her by her shoulder in the chair so not to fall on the floor. she stiffened up and didn't respond to me calling her name . then suddenly she woke up. she asked ,"did I pass out?" She was ok to sit in the chair after that. we called 911. the EMTs checked her out. She told them that she has had a history of passing out after getting a needle. she also told them she had seizures as a child but that was over 25 years ago. she refused to go to the hospital. EMTs called her family and they came to get her. EMTs said that it seems that she had an anxiety attack. no anaphalactic reaction. They said her pressure normalized before she left.
Side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Consumer answered "Yes" when the chatbot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Information has been received from an 84 year old male consumer with no known allergies, a history of chickenpox and mumps who on approximately 20-FEB-2008 was vaccinated SQ with 0.65mL of zoster vaccine live (Oka/Merck) once. Concomitant therapy included primidone, isosorbide, benazepril HCL, LIPITOR, omeprazole (MDS), PAXIL and alprazolam. On approximately 21-FEB-2008 the day after he was vaccinated he developed shingles. Medical attention was sought and he was prescribed a topical cream, "halobetasol proportionate cream.05 (glades)." There were no lab studies performed. The patient stated when he applied the cream to his rash it would go away and reappear on a different part of his body. This happened each time he applied the cream to the rash whit it appeared. The patient also stated that he purchased the vaccine a week before it was administered and stored it in his freezer until it was administered. At the time of the report the patient's status was unknown. The patient stated he thinks that it is all gone, but there might be some on his back. There was no product quality complaint involved. Follow-up information from the physician's office indicated that patient was last seen in their office on 20-NOV-2007. The physician's office indicated they did not buy or administer the vaccine to the patient. Follow-up information from the patient indicated he has another "bout of shingles." He reported he has lesions on his back, abdomen, and both of his elbows. He indicated he has not notified his physician thus far about this latest event. Additional information is not expected.