chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via sales rep and described the occurrence of pain in a 62-year-old female patient who received SHINGRIX. On 24th February 2018, the patient received SHINGRIX. On 24th February 2018, less than a day after receiving SHINGRIX, the patient experienced pain, local reaction and drug administered at inappropriate site. The patient was treated with NOS Steroid Injection. On an unknown date, the outcome of the pain and local reaction were recovered/resolved and the outcome of the drug administered at inappropriate site was unknown. It was unknown if the reporter considered the pain and local reaction to be related to SHINGRIX. Additional details were provided as follows: The physician stated that the SHINGRIX vaccine was administered at a weird spot inside the left arm of the patient, which led to vaccine administered via inappropriate site. The patient experienced a very large local reaction that went from her upper arm down to her elbow that measured 5 to 7 centimeters within 24 hours of receiving the SHINGRIX injection. It caused significant pain and the reaction worsened over 72 hours. The patient was concerned and she went to urgent care where she was given a steroid injection and the local reaction resolved within a week. There were no residual symptoms.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Bloody nose possibly caused by the fall-Mild, Systemic: Shakiness-Mild, Additional Details: Patients parents had yelled that he had fallen. Once pharmacy staff went to check on him, the mom was already on the phone with 911. Parents became belligerent and threatened bodily harm the pharmacy staff, so we retreated to the pharmacy for our own safety. Patient was at that point sitting up against a chair so we then waited for paramedics to arrive.
patient was given the pediatric dose of the Covid vaccine; no known adverse side effects; spoke with Department of Public Health 1/3/22
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates in May 2016, reported as starting on or after 05-MAY-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. The call was made because of a data logger. The reporter stated that the doses of the vaccine were exposed to a temperature of 1.4 degrees Celsius for a time frame of 138 hours. The vaccine was not exposed to any previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Had typical symptoms within 24 hrs - low grade fever (101F), body aches and arm pain.  On second day developed mild headache that went across forehead.  On 5/15/21, developed right ear pain - pressure in ear and headaches continued.  Intermittently the left ear would also have pain.  Started developing stiffness on the right side of neck that accompanied the ear pain.   Went to urgent care on 5/20/21.  Doctor said both ears were visibly full, especially the right ear.  Prescribed Azelastine nasal spray.  Called PCP in morning of 5/21/21, and was prescribed prednisone for 5 days to control inflammation.  Prednisone worked after a few days but was still run down and pain developed in my abdomen and along the right side of back/leg.  Went to ER on 5/24.21.  Doctors performed tests for blood clots.  Was told I was weak and dehydrated and given IV and pain meds. Was negative for blood clots but my IVC was dilated. Pains persisted for about 2 weeks - especially in the right abdomen.  Went to cardiologist on 6/4/21 and had a normal EKG but low BP.  Doctor believes abdominal pain is gastrointestinal and put me on proton pump inhibitor.  I am getting echocardiogram on 6/10./21 to check IVC.  Since then most pains have subsided except weak, right sided abdominal pain.  The right ear pain is back.  Starts in the morning with outer cartilage of ear getting inflamed, followed by pressure/pain in right ear, then pain in right neck.  Has been going on for a month now.  100% related to vaccine - came after vaccination and never had before.
This spontaneous report as received from a nurse via a company representative refers to a male patient of unknown age. At an unknown date, the patient was vaccinated with ZOSTAVAX lot # H019042. At an unknown date, the patient developed blisters and redness on the upper half of the harm he got the vaccine in. The outcome of blisters and redness on the upper half of the arm he go the vaccine in was not reported. No action was taken regarding the ZOSTAVAX. Relatedness for blisters and redness on the upper half of the arm he got the vaccine in and ZOSTAVAX was not provided by the reporter. The case was cross referenced with case 1302USA009579. Additional information has been requested.
Generalized itching and red blotches on scalp, trunk and legs 3-4 hours after flu vaccination.
arm soreness; dizziness; an unusual smell; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), DIZZINESS (dizziness) and BREATH ODOUR (an unusual smell) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII. Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for Hypertension, MULTIVITAMINS;MINERALS, VITAMIN B COMPLEX, VITAMIN E [VITAMIN E NOS], ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE VIT) for Supplementation therapy, LEVOTHYROXINE for Thyroid activity decreased.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness), DIZZINESS (dizziness) and BREATH ODOUR (an unusual smell). At the time of the report, PAIN IN EXTREMITY (arm soreness), DIZZINESS (dizziness) and BREATH ODOUR (an unusual smell) had resolved.            No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up received contains relevant medical history, event and event outcome updated.
Herpes Zoster in a vaccinee.  Laboratory confirmed vaccine strain reactivation. No complications.
5 minutes after receiving vaccines, while sitting in my office, patient passed out and had a few seconds of tonic clonic movements. Patient regained consciousness within seconds. No neurologic findings on exam. Blood pressure was low. Patient diagnosed with vasovagal syncopal event.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-OCT-2015 12:13, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 7.9 and 1.6 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Received FluLaval IIV4 .5mg lot NY927   NDC 19515-816-52  On Oct 17, 2020. On or about Nov 01,2020 Shingles developed lower Left back and side. Pain, Blisters.  I wonder: Vaccinate about two weeks before Shingles developed. Related?
Patient reported pain through the entire arm vaccine given in and unable to lift arm. No redness reported though injection site slightly swollen. She took acetaminophen and applied heat and muscle rub. Symptoms began later in the day after receiving vaccine.
SWELLING, HIVES AND REDNESS AT SITE OF INJECTION, EXTENDING TO SHOULDER AND BACK.
3/17/21 63 y.o. male who presents with sudden onset of chest pain and palpitations, which occurred while patient was exerting himself.  Pain is substernal, radiated to the left arm, associated with lightheadedness.  Denies diaphoresis or nausea.  Per EMS there were short runs of nonsustained ventricular tachycardia  3/18: - remains inpatient admission as of 3/18/21 @ 0900 63 y.o. male with a past medical history of nonsustained ventricular tachycardia.  He states he was lifting a couch yesterday and his heart started beating fast.  He did not really have any chest pain, but felt a little bit lightheaded.  He called an ambulance and they brought into the ER.  In the emergency room his EKG did show some frequent PVCs.  However, he did not really require any intervention.  He was given 3 nitro, but it really did not make any difference in the way he was feeling.  The patient denies multiple times that he actually had chest pain.  He states he just felt like his heart was beating funny.  The patient's most recent stress test was a nuclear stress test in May of 2019.  Overnight, the patient has felt very well.  He denies any significant chest pain.  He denies any further heart palpitations.  On the monitor he would occasionally going to bigeminy, which is not abnormal for him.  EKG this morning was unremarkable.   After speaking with the patient's wife, she told me that he has had a several month history of very limited exertion.  She states every time he exerts he becomes extremely dyspneic and has heart palpitations and sometimes almost passes out.  She states last night he was extremely diaphoretic and very nearly passed out.
Small pox spread on left arm in deltoid area, one questionable papule on forearm, no pustule there. D/W Dr.
3/12/13 Left arm very sore also soreness in up in neck and in back. That evening, at injection site knot in arm red & swollen. Took Ibuprofen - low grade fever. 3/13/13 Arm & pain the same and continued Ibuprofen. Started BENADRYL in the evening with moist heating pad. 3/14/13 Injection site swelling decreased "little uncomfortable" continues BENADRYL & Ibuprofen. 3/15/13 No S & S per pt.
Client given expired Rotavirus, waited 15 min after meds given, no problem noted. Inform Dr. & supervisor. Will call or send letter to revaccinate.
Information has been received from a health professional concerning a patient who was vaccinated with a dose of Varivax. Subsequently the patient experienced chickenpox. Additional information has been requested.
The pt was due for her immunizations of :  Dtap, MMR, Varicella, and Polio Unknown that we had ordered PROQUAD in the office, as we never had this before. The patient was given Varicella, Kinrix, and Proquad.  Double dose of varicella
Moderna COVID-19 Vaccine EUA - significant pain on left arm.  Pain started to subside by noon on 1/30/21.
Pt received flu vaccine at med ctr, where she works, on 9/17/09 at Approx 08:00.  Pt had flushing of face, neck and upper chest, some tingling in lips, anxiousness.  No SOB.  No history allergy to flu vaccine but pt has history multi drug allergies; sulfa, BETADINE, LIDOCAINE, E-MYCIN, TCN, peanuts.  03 mg EPI X 2 DEXAMETNASONE 4 mg X 1.
Patient was given an undiluted dose of vaccine. As a result patient has experience nausea, chills, body aches, had blood on tissue when blowing nose, and worsening neck pain. Symptoms are resolving.
her arm was a little sore; This is a spontaneous report from a contactable consumer (patient) from Pfizer sponsored program and Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 15Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient's arm was little sore in Apr2021 from receiving the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
weak; lack of appetite; Body aches; felt tired; temperature of 99.7; Diarrhea; Nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ASTHENIA (weak), DECREASED APPETITE (lack of appetite), MYALGIA (Body aches) and VOMITING (vomiting) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING (vomiting) and NAUSEA (Nausea). On 08-Mar-2021, the patient experienced ASTHENIA (weak), DECREASED APPETITE (lack of appetite), MYALGIA (Body aches), FATIGUE (felt tired) and PYREXIA (temperature of 99.7). At the time of the report, DIARRHOEA (Diarrhea), ASTHENIA (weak), DECREASED APPETITE (lack of appetite), MYALGIA (Body aches), VOMITING (vomiting), FATIGUE (felt tired), NAUSEA (Nausea) and PYREXIA (temperature of 99.7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Body temperature: 99.7 (Inconclusive) Patient had a temperature of 99.7..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient were not provided. Treatment information was not provided.
The patient received a FLUCELVAX vaccine which is intended for 4 years and older and the patient is 14 months. The patient did not have any side effects or adverse reactions.
Nose bleeds; This is a spontaneous report from a contactable Pharmacist reported for consumer (Patient). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was unknown), via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization (age at vaccination was 54 years). The patient medical history included Penicillin allergy. Concomitant medication was none. On an unknown date, after receiving first dose patient had a minor nosebleed that night and then had 3 nose bleeds in the days after. The event was considered as non-serious. Upon the latest nosebleed the physician drew blood work, and everything was normal. The patient is worried about the 2nd dose. The patient underwent lab tests and procedures which included blood test: normal   on unspecified date. Follow-up (11May2021): Follow-up attempts completed. No further information expected. Upon follow up on 24Mar2021new information has been updated. This is a follow up spontaneous report from a contactable consumer. This consumer reported for a female patient about drug information (Pfizer Biontech covid 19 vaccine, dosage text about 1st dose, action(s) taken with drug was unknown, dates, NDC number, Expiry Date for Pfizer was unknown), reason for no lot number of Pfizer covid19 vaccine states student pharmacist who was calling on behalf of patient female he has no lot, expiry date or NDC for the patient's Pfizer COVID19 Vaccine. Patient history was not provided. Investigation assessment was not provided. The outcome of the event was not recovered.  Follow up (24Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported for a female patient that This is a follow up spontaneous report from a contactable consumer. This consumer reported for a female patient about drug information (Pfizer Biontech covid 19 vaccine, dosage text about 1st dose, action(s) taken with drug was unknown, dates, NDC number, Expiry Date for Pfizer was unknown), reason for no lot number of Pfizer covid19 vaccine states student pharmacist who was calling on behalf of patient female he has no lot, expiry date or NDC for the patient's Pfizer COVID19 Vaccine. Patient history was not provided. Investigation assessment was not provided.  Follow-up attempts are completed. No further information is expected
Within 10 minutes my pulse increased and I felt dizzy. They took my blood pressure and it was high. I had weird metallic taste in my mouth. They monitored and released me in about half an hour. That evening is when I started to vomit, diarrhea, headache and fever. I also broke a crown from having the chills so badly that I cracked a crown. I was hot and col d. From sweating and freezing. The symptoms. I treated the symptoms with ibuprofen and Tylenol. After 72 hours all the symptoms dissolved.
This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. This Physician reported similar event for 3 patients. This is first of three reports. A male patient of an unspecified age received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced oval shaped red patch with red dot under injection site on an unspecified date. The outcome of the event of oval shaped red patch with red dot under injection site was unknown. The information on the lot number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018223259 same reporter and suspect drug, similar event in different patients;US-PFIZER INC-2018225881 same reporter and suspect drug, similar event in different patients.
Elevated heart rate within 30 minutes of shot, lasting for a few minutes and resolving on its own. No other adverse symptoms.
1:10  Received vaccine. Pt. alert, oriented,having no  health issues. 1:20  Became weak, diaphoretic, nauseated, near syncope. Placed  supine with cold compress to  head. B/P 140.80 P- 80 R-20 Sat 97%. FSB:105. Pt. admits has only eaten fruit today and no oral fluids. Water taken in sips. Peanut butter crackers given. Pt. reports his vision is blurred and he has a severe headache. 1 :30 Vital signs unchanged. Pt's color very pale. Denies any improvement. Now noticing numbness of face, chest, neck, and abdoman. Disoriented to time, place, and person. Unable to give any information for contacting family. Unable to sit up under own power.   EMS notified. No change in Vital signs. 1:55 EMS evaluated and transferred to Medical Center. Condition unchanged.
Soreness at injection site, Soreness under arm with injection, headache, chills, nausea
Redness, swelling, bruising at injection site, pain in armpit lymph glands, chills & body ache
Heart rate increased; Flushing on face; Tingling from face to thighs; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart rate increased), FLUSHING (Flushing on face) and PARAESTHESIA (Tingling from face to thighs) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Heart rate increased), FLUSHING (Flushing on face) and PARAESTHESIA (Tingling from face to thighs). At the time of the report, TACHYCARDIA (Heart rate increased), FLUSHING (Flushing on face) and PARAESTHESIA (Tingling from face to thighs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Heart rate increased: increased High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient did not use any treatment medications.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Case number PHEH2013US021175 is an initial spontaneous report from the consumer received on 10 Oct 2013. This report refers to an unknown age female pregnant patient. The last menstrual date of the patient was not reported. On an unknown date in 2009, while the patient was of 08-month pregnant she was vaccinated with FLUVIRIN (batch number: not reported). On an unknown date, days after vaccination she experienced life threatening urticaria, wheezing and respiratory problems. The patient received respiratory treatment and corticosteroids. Her dermatologist stated that she had a neomycin allergy, but it was hard to confirm. The outcome of the events was not reported. The patient was vaccinated with flu vaccine again in 2012 and experienced respiratory problems (see case: PHEH2013US021214). No other information was available.
diarrhea & vomiting sl fever but not taken;15 BM's last 24hr;
I seemed to be having intermittent heart palpitations mostly at night and sometimes during the day. Also my heart skips a beat dozens of time during the day. My PCP sent me to a Cardiologist. I'm now scheduled for a monitor to be placed on the 23rd.
Arm swelling, Red spot at site of vaccine. Diarrhea, Pain Scalp pain.
SECOND DOSE OF MODERNA GIVEN, PATIENT IS UNDER 18 YEARS. NO ADVERSE EVENT
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 05Oct2021 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hay Fever" (unspecified if ongoing), notes: Childhood hay fever (remission); "Prostate cancer" (unspecified if ongoing), notes: prostate cancer (remission). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), 7 months 6 days after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant), 7 months 6 days after the suspect product(s) administration, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (06May2022) Negative, notes: Tested negative on 06May on an antigen test; (11May2022) Positive, notes: Tested positive on 11May on an antigen test. Therapeutic measures were taken as a result of covid-19. Clinical course: Paxlovid treatment given for covid-19 from 01May2022 to 05May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Developed swelling of left lower leg on 1/24/2021, went to ED and was diagnosed with DVT of the L femoral vein. Placed on Xarelto and sent home.
08/23/2021 about 8:30 PM observed round/oval red rash 2 inches in diameter between left ankle and heel on outside of left leg. Saw doctor 08/24/2021 who prescribed DOXYCYCLINE HYC 100 mg twice a day if rash a bacterial infection and KETOCONAZOLE 2% Cream twice a day if rash a fungal infection.  Advised to go to the ER if the rash gets worse and fever develops.  Pharmacy counselled that there were no adverse drug interactions expected.
Severe L arm pain, L face tingling, numbness, and warm to touch including eye area and eye swelling
pt recvd vax & in th4 evening was weak & achy; treated in ER w/APAP; events subsided; next morning pt was achy, weak, feverish, & had alumpy feeling in throat; treated w/APAP & events subsided;