chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever  (101.7); Aches; chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown), via unspecified route in left arm on 26Mar2021 at 12:15 (at the age of 53-year-old), as single dose for COVID-19 immunisation. Medical history was reported as none. No concomitant medications were reported. The patient had no known allergies. The patient previously had received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), in left arm on 05Mar2021 at 1215 (at the age of 53-year-old), as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. On 27Mar2021, at 4:00 the patient experienced fever (101.7 degree F) up to 28 hours, chills, aches and nausea. The patient did not receive treatment for the reported events. The events neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The clinical outcome of the events fever, chills, aches and nausea was not recovered at this time of report.   No follow-up attempts are needed. No further information is expected.
ABOUT A MONTH AFTER THE BOOSTER I FELT REALLY NOT KNOCKED DOWN WITH WHAT I THOUGHT WAS A COLD. THIS IS LATE NOV, POSSIBLY EARLY DEC. I BEGAN TO WONDER IF I WAS HAVING A BREAKTHROUGH COVID EVENT BECAUSE WITHIN A DAY I WAS PRETTY MUCH LYING ON MY BACK FOR ABOUT 2 WEEKS WITH A VERY FRUSTRATING COUGH. HOWEVER I DID HAVE  A SENSE OF SMELL AND TASTE. HAD NO APPETITE, AND LOST 5 POUNDS IN 6 DAYS. NO FEVER. FOR 2 WEEKS ALL I COULD DO WAS LAY ON MY BACK AND READ, I HAD NO ABITION AT ALL. I'VE NEVER HAD A COLD LIKE THIS SO I TOOK A COVID TEST AND IT WAS NEGATIVE. AFTER 2-3 WEEKS I CALLED MY CLINIC AND THEY REPORTED THE EVENTS AND THEY DISCONTINUED LISINAPRIL DUE TO THE DRY COUGH SIDE EFFECT. MY DOCTOR STARTED ME ON LOSARTAN. AFTER  A FULL MONTH OF  LOW ENERGY AND PRODUCTION, WHEN I'M TYPICALLY A HIGH ENERGY PERSON, I FINALLY STARTED TO BE ABLE TO WORK A FEW HOURS A  DAY. I DON'T KNOW WHAT HIT ME. FOR A MONTH I WAS PRETTY WELL NEUTRALIZED AS A PRODUCTIVE HUMANBEING.
PAIN AND STIFFNESS WHEN LIFTING ARM ABOVE HEAD AND UNABLE TO PUT ARM BEHIND BACK
Information has been received from a pharmacy intern concerning a patient who in 2009, was vaccinated with PNEUMOVAX 23. The pharmacy intern reported that the patient developed local reactions after received PNEUMOVAX 23. It was reported that the reactions involved soreness and swelling that lasted 3 to 5 weeks and that the patient could not lift up the injected arm because of the soreness and had lymphedema. At the time of the report the patient had not recovered. It was unknown if the patient sought medical attention. Additional information has been requested. This is one of several reports received from the same source.
Typically i experience about 4 flare ups of HS per year. Since the vaccine I have had non stop infections. I have had approximately 5 now in the last 2 months. It could be unrelated but I felt i should let you know.
Clinician prepared vial with 1.3ml Normal Saline diluent rather than 1.8ml Normal Saline.  Pt stated his arm hurt for 2 days after injection (denied redness/swelling) and had a headache. Stated symptoms resolved on own after 2 days. No other clinical concerns reported
Stiffness in left arm started the 3rd day and continues. Arthritis has intensified  over whole body . unable to dress herself or comb hair. muscle pain
ACTIVATION OF TRIGEMINAL NEURALGIA FROM 04/16/2021 RESULTING IN DEBILITATING PAIN CONTINUING TO THIS PRESENT REPORT
Jaw and rough of mouth felt bruised, hip pain, lower back pain, ovaries and uterus felt bruised, left arm shoulder felt very tender and bruised, left hand felt arthritic and bruised, and it was hard to open and shut, left foot, ball of foot, felt bruised, could see bruise. Period started suddenly, heavy bleeding, came out in clots, soaked pads, period lasted longer than usual, 9 days.
Patient came to receive her vaccine. While in the monitoring area. Patient stated her mouth was experiencing numbness/tingling. Patient stated she never has adverse reaction to vaccines. V/S. B/P 130/99 P: 85 O2.98. Patient stated feeling lasted approx 3 mins. Patient was further observed for additional 15 mins. Patient stated feeling had stopped and she was feeling much better. Patient left observation approx 8:10 AM.
I started itching a little, then in the middle of the night got deathly ill. Fever, NO energy and could not function except to drink water and go to the bathroom. I cannot remember that ill. All I could do is sleep. And that is what I did. I would never had the shot if I knew what it would do to me. I could not even concentrate and could not have driven myself to a doctor.
A report was received from an health care professional on 11/26/01 concerning 3 patients who inadvertently received Fluvirin SC. The patient's did not complain of any adverse events at the time of administration. There was insufficient information to determine the reporter's causality.
Triggered an autoimmune disorder Igg4; Swollen left eye; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Triggered an autoimmune disorder Igg4) and EYE SWELLING (Swollen left eye) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 04CB21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced EYE SWELLING (Swollen left eye) (seriousness criterion medically significant). On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Triggered an autoimmune disorder Igg4) (seriousness criterion medically significant). The patient was treated with PREDNISONE at a dose of 100 mg. At the time of the report, AUTOIMMUNE DISORDER (Triggered an autoimmune disorder Igg4) and EYE SWELLING (Swollen left eye) outcome was unknown.            No concomitant medications were provided. It was reported after her second dose the patient left eye had been swollen and was still in treatment. The vaccine triggered an autoimmune disorder Igg4. The patient had been taking steroid to treat the side effect, 100 mg Prednisone.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Itching like crazy at injection site; 3 inch redness at injection site; Itchy at injection site; Quarter size redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE ERYTHEMA (Quarter size redness at injection site), VACCINATION SITE PRURITUS (Itching like crazy at injection site) and VACCINATION SITE ERYTHEMA (3 inch redness at injection site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE ERYTHEMA (Quarter size redness at injection site). On 10-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching like crazy at injection site) and VACCINATION SITE ERYTHEMA (3 inch redness at injection site). On 29-Jan-2021, VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE ERYTHEMA (Quarter size redness at injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching like crazy at injection site) and VACCINATION SITE ERYTHEMA (3 inch redness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication and treatment provided
Vaccine administered at 7 AM symptoms began at 7 PM  by the next morning at 9 AM they started to subside and by 4:00 PM the symptoms were gone My symptoms were severe chills and the body aches were pretty bad, also slightly nausea, no temperature at any time
This is a spontaneous report  obtained from a contactable pharmacist through a Pfizer sales representative. This pharmacist reported the same adverse event for three patients. This is the first of three reports. A female patient of an unspecified age, race and ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pain and soreness of the arm where the vaccine was injected. Clinical outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017505508 Same reporter/drug/event, different patients;US-PFIZER INC-2017505482 Same reporter/drug/event, different patients.
Headache, Fever, Local Symptoms: Pain- discomfort , swelling, itching. General symptoms: chills, fever, headaches, joint pains, muscle pains, fatigue, nausea, swollen glands, chest pain-tenderness, fullness, left axillary pain- tenderness, skin -flushing, burn feeling.  Narrative:
pain on the right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Mar2021, outcome "unknown", described as "pain on the right arm".  Additional information: Caller had taken her first vaccine shot 18Mar2021 on left arm and when she woke up the next day, she was experiencing pain on the right arm and wanted to know if that was normal. Medical Information. Were any unaddressed medical questions referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Rec'd INFLUENZA vaccine approx. 9/30 onset of (R) facial weakness 10/3 - pronounced facial droop. Diagnosed with Bell's Palsy.
Patient received 2nd dose of Pfizer Covid-19 vaccine at 2:15 pm on April 30, 2021. Patient started having a reaction to the vaccine at 2:30 pm. She complained of her tongue feeling swollen or thick and feeling like she needed to clear her throat a lot. She was given a 50 mg (20 ml)dose of  liquid Benadryl (12.5 mg/5 ml) at 2:32 pm followed by famotidine 20 mg tablet. Her throat was examined with a flashlight and it did not appear to be swollen. Her blood pressure (135/87 mmHg), pulse (65 bpm), and pulse ox (98%) were measured at 2:40 pm. Patient was timed for 5 minutes to see if symptoms improved her worsened and her symptoms improved. She was given water and monitored until 3 pm where she continually improved. The patient left at that time and followed back up with the pharmacist via text at 3:30 pm and was feeling normal. She patient had an Auvi-Q with her if her symptoms returned or worsened.
Patient called the pharmacy and said she had a lump at the injection site that was inflamed and red. She mentioned that touching underneath the arm pit was tender. She is taking ibuprofen for the pain and inflammation and an antihistamine.
The Patient contacted the pharmacy the day after vaccination and complained about a very sore shoulder. She said she had trouble moving her arm without feeling pain, she also mentioned a sharp pain while putting on her clothes.
Systemic: Dizziness/Lightheadedness-Mild, Systemic: Fainting/Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Tachycardia-Mild. Additional details: About 5-10 minutes after vaccine given, patient fainted and fell. She complained of nausea and heart racing. We called the EMTs. They took her to ER.
A young person was given their first dose of the moderna covid-19 vaccine 20 days before his 18th birthday; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A young person was given their first dose of the moderna covid-19 vaccine 20 days before his 18th birthday ) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A young person was given their first dose of the moderna covid-19 vaccine 20 days before his 18th birthday ). On 03-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A young person was given their first dose of the moderna covid-19 vaccine 20 days before his 18th birthday ) had resolved.        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 concomitant medications were provided. The patient not experienced any known symptoms and not received any treatments.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up appended: Patient demographics added.
Flu vaccine received 9/13/10. Patient contacted MD office 9/15/10 at 1030 stating on 9/14/10 he had chills, shivering, lethargy, low grade temp. and body aches. Did not take temperature. Slept from 4:00pm to 9:00 pm, woke up to eat supper, went back to bed at 9:30 pm and slept until 5:30 am on 9/15/10. Bed was soaking wet in the morning. Took Motrin 600 mg 9/14/10. Stated felt fine when called.    Pt. called back at 1500 on 9/15/10 stating he had a temperature of 101 (tympanic)and aches in legs and lt arm where injection received. Took 1 gram of tylenol 15 minutes prior to call and stated was starting to feel better.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the long-term prevention of shingles and zoster-related injuries. The vaccine did not prevent shingles or zoster-related injuries as intended. In 2016, the patient was treated by a physician for the onset of a rash which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. As a further proximate result of ZOSTAVAX, 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 not recovered. Causality assessment was related. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 15-AUG-2014 the patient was inadvertently vaccinated with a dose of M-M-R II (lot # H014977, expiration date 09-AUG-2014, 0.5ml) subcutaneous which had expired on 09-AUG-2014. No adverse events were reported. Additional information is not expected.
Headache; Chills; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6119) via an unspecified route of administration in the left arm on 04Mar2021 at 17:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications include spironolactone (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), vitamin B-12 (MANUFACTURER UNKNOWN) for an unknown indication. The patient was not tested for COVID-19 since the vaccination. On 16Mar2021 at 16:00, the patient felt chills. The patient felt fine until about mid-day and she felt she needed to take a nap. On the same day, the patient also felt exhaustion. On 17Mar2021 (reported as this morning), the patient had a slight headache. No therapeutic measures were taken for the reported events. The clinical outcome of the events chills, exhaustion and headache were unknown.  No follow-up attempts are needed. No further information is expected.
Approximately 10 minutes after injection the patient experienced increased Heart rate, rapid breathing, "body tingles". Injection site was unremarkable. Contacted EMS to evaluate Spoke w/Pt 10/1/20. Went to Hosp via EMS. in ER app. 6 hours. Per patient given Diphen in ER + cont'd FoR 2 days experienced rapid respirations, rapid HR dizziness + tingling in extremities. Feeling Better @ onset on phone call.
Given wrong dose for age.   Inadvertent temperature excursion, vaccine was stored in freezer temperatures (-50° C to -15° C)   beyond the allowable two-week excursion then administered to patient.  No patient issue to report from vaccine.
"Moderna Covid-19 vaccine EUA" The left side of my face, including nose and lips became numb and tingly for 4.5 hours. There was no swelling and I could breath and swallow fine.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included carvedilol, rosuvastatin calcium (Crestor), colecalciferol (Vitamin D3), ascorbic acid + carotenoids nos + copper + tocopherol + zeaxanthin + zinc (Areds 2), azilsartan medoxomil + chlortalidone (Edarbyclor) and acetylsalicylic acid (Low Dose Aspirin). On 2nd June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd June 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain. On 4th June 2018, the patient experienced local swelling, localized erythema and pain localized. On 3rd June 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the local swelling, localized erythema and pain localized were unchanged. The reporter considered the injection site pain, local swelling, localized erythema and pain localized to be related to SHINGRIX. Additional details were provided as follows: At 15:00, the patient received SHINGRIX on the left arm. The patient reported that, on the day of vaccination, in the evening, he noticed soreness at the injection site. At the time of this report, 2 days after receiving Shingrix, the patient after getting back from work, noticed that on the back of his biceps he had big red bump which was painful and it was about the size of 3 inches in width and 5 inches in height. The patient had denied permission to contact their physician. All questions were asked however no further details were provided.
This study case was received from the investigator on 27 September 2012. A 37 year-old female subject (medical history not reported) was found to have other and unspecified angina pectoris 24 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and TYPHIM VI (manufacturer, lot number, route and site of administration not reported) on 14 February 2012. Relevant laboratory data was not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
elevated liver enzymes; This is a spontaneous report from contactable consumer (patient). This consumer reported similar events for 3 patients. This report is for 1st of 2 other patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history included megoblastic macrocytic anemia. The patient's concomitant medications were not reported. The patient did not had other vaccine in four weeks. The patient did not had no COVID prior vaccination and not tested for COVID post vaccination. On an unspecified date, the patient experienced elevated liver enzymes (Hepatic enzyme increased). On an unspecified date, the patient underwent lab tests and procedures which included elevated liver enzymes: unknown. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I woke up the following morning with pain in my left side above my hip down in to my left knee, and as of today I still have the pain.
My vision became blurry.  My sugar levels dropped drastically.  And continue to fluctuate. This all started five days after I have received to shot.
Admitted for COVID pna. Fully vaccinated. Steroids, Ainc, Vit-C, Vit-D, ceftriaxone/azithro. Remained on RA and did not require O2. Discharge home.
within 24 hours Pt developed >101 degree fever that was present for 3 days. On the 3rd day she noted development of oral lesions consistent with herpes labialis and aphthous ulcers. Not responsive to OTC tx.