chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US024354, is an initial spontaneous report received from a nurse on 02 Dec 2014 and with a follow-up from a nurse received on 22 Jan 2015. This report refers to a 76-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 13 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow-up from a nurse received on 22 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Chills; Fever; Elevated resting heart rate; Stomach ache; Partial constipation; Injection site soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 28Apr2021 at 16:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included stents due to prior heart attack. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); both from unknown start date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 07Apr2021 at 16:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 09:00, started next day to vaccination, the patient experienced chills, 101 fever, elevated resting heart rate (110+ instead of 75), stomach ache (due to partial constipation) and injection site soreness. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. On 29Apr2021, the patient underwent body temperature test and the result was 101 (unspecified units) and underwent heart rate test and the result was 110+ (unspecified units) instead of 75 (unspecified units). Therapeutic measures were taken as a result of fever and included treatment with 3 acetaminophen (MANUFACTURER UNKNOWN) 500 mg to manage fever from an unknown start date to an unknown stop date. The clinical outcome of the events chills, fever, elevated resting heart rate, stomach ache (due to partial constipation) and injection site soreness was resolved on 30Apr2021, after the duration of 1 day.  No follow-up attempts are possible. No further information is expected.
Awoke that night to a pounding, racing heart around 100 beats per minute that would not stop after 30 minutes of waiting. Rose from bed and felt faint, like I would pass out, so I lay back down. Considered calling an ambulance, but the faintness and racing heart improved after another 30 minutes and resolved by the next morning.
The day after the vaccine was given, the parent called and sent pictures, saying he's having a dermal reaction. He had redness and minor swelling. Next day it doubled in size. Mom said he gets a reaction after every vaccine which is why they only do one at time. I offered an office visit, but she declined and decided to do home care.
Immediately upon receiving the Meningococcal vaccine, after already receiving the Influenza, she had a vasovagal response and passed out and her face went pale. Patient's body then began to tense up and spasm while eyes rolled all over. She after about 5 seconds of the spasms, she lost control of her bladder and urinated on the exam table.
This spontaneous report as received from a registered nurse refers to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 12-DEC-2017, the patient was vaccinated with improperly stored dose of PROQUAD therapy type of recombinant human albumin (rHA) (exact dose, dose number, route of administration were not reported; lot # N020010 with the expiration date of 13-JAN-2019) for prophylaxis. The administered vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). The administered dose of PROQUAD underwent a temperature excursion between minus 14 and minus 10 Celsius degrees for 1 hour, and between minus 9 to 8 (also reported as minus 6) Celsius degrees for 1 hour and 30 minutes. Digital data logger was involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported.
4yo male received PROQUAD and KINRIX in clinic at approx 16:40. At around 16:45, patient was noted to be anxious and started vomiting. Patient brought back to exam room at 16:55 when hives were noted on face. Vitals (BP 90/61, HR 165, SpO2 on room air 82%). Supplemental O2 started via mask-- >3L and SpO2 at 98%. Wheezing on exam in mid lung fields Hives on face and arms Epinephrine 0.15 mg IM and Benadryl 20 mg IM administered at 17:06 and patient transported to ED via EMS at 17:20. In ED patient was given prednisoLONE 15 mg/5 mL oral syrup (Order): 21 mg, PO, ONE TIME and Pepcid pediatric (Order): 11 mg, IVPush, ONE TIME. Admitted overnight to general pediatric floor for observation and had no recurrence of symptoms. Discharged 4/25/2019.
Information has been received from a physician concerning a female who on 06-JAN-2011 was vaccinated IM (also reported as submuscularly) with a 0.5 ml dose of GARDASIL (lot # not provided). "In the past few days", the patient experienced swelling, redness and pain at injection site for GARDASIL. Therapy with GARDASIL was reported as not to be reintroduced. Patient did not seek medical attention. At the time of reporting, patient's status was not provided. Follow-up information was received and it was reported that the patient had recovered by the time of reporting. Additional information is not expected.
Began with intense soreness around the left arm's injection site then the soreness began to get worse & worse & went throughout my whole body. I threw up 3 times throughout the night & my symptoms did not improve. I had a fever of 101.6 degrees.
Information has been received from a licensed practical nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history. Concomitant therapies included sterile diluent (MRK). On an unknown date, the patient received an improperly stored dose of M-M-R II, lot # reported as N045390 and expiry date 14-NOV-2018 (anatomical location, dose and route of administration were not reported). No adverse effects reported. It was reported that on an unspecified date, the vaccine was exposed to a temperature between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 1 hour and 30 minutes. The licensed practical nurse reported that there was no previous temperature excursion. The call was placed because of a Digital Data logger report. Lot number N045390 is an invalid lot number for M-M-R II.
no adverse even took place. Pt was given 0.2ml of  non-diluted dose.
Covid-19 Positive test after the second shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid-19 Positive test after the second shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Covid-19 Positive test after the second shot). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19 Positive test after the second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   This case was linked to MOD21-074146 (E2B Linked Report).; Sender's Comments:  MOD21-074146:
"Side effects"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("Side effects") in a female patient of an unknown age 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 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.       Concomitant was unknown No Treatment were reported
I received the IM inj and walked out of the room to talk to billing and I was waiting a minute and started feeling dizzy while i was standing. So I decided to get my labs drawn in the other room while i was waiting so that i could sit down. I sat down, dizzy stopped, my blood was drawn and then I stood back up and dizzy returned. Then went back to billing and sat. Once I stood up after talking to billing the dizzy was worse. I was walking sideways to my car. I drank a latte for blood sugar, no difference. Dizzy got worse and it subsided after 6 hours.
SYNCOPE, fall, head contusion FATIGUE DIARRHEA Pneumonia due to SARS-associated coronavirus Diverticulitis Hyponatremia Hypoxia Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (CMS/HCC)
Tiredness, muscle pain, chills, fever, upset stomach, nausea, diarrhea from 11:00 am 1-27-20 until the following morning 1-28-20.  I still have moderate pain at the injection site.  Taking ibuprofen for the pain.
3-4 days after vaccine patient said she experienced swollen and painful lymph nodes in neck.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 20-MAR-2014, the patient was vaccinated with a dose of improperly stored PEDVAXHIB lot # reported as J005672, expiration date reported as of 05-DEC-2015 (dose and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This child mother states that she had not noticed the reaction x 1 1/2 days after the shot, but the child states it was there by the next day. His right upper arm was red, very hot, with a lot of swelling. The mother also noticed white spots under skin where are was swollen. The mother applied cold cloths, ice packs, and gave Tylenol every 4 - 6 hours. The patient states his arm was sore. All of this lasted about 8 days. Today 05/10/01, the patient's arm was "perfect" per mom.
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Information has been received from a medical assistant concerning a 17 year old female with no pertinent medical history and no drug reactions/allergies who on 18-SEP-1995 and 24-AUG-2011 was vaccinated subcutaneously with 0.5ml of the first and second dose of VARIVAX (Merck) (lot#665935/0157AA), a pregnancy registry product, respectively. The patient came to the physician's office on 11-AUG-2011 and the patient reported that she was pregnant (LMP: 21-AUG-2011, EDD: 27-MAY-2012). The patient's pregnancy was confirmed using a urine pregnancy test. The patient started on prenatal vitamins. No adverse effects were reported. Follow up information received from a pediatrician physician via a initial pregnancy questionnaire which reported that a multiracial 17 year old female patient with no previous pregnancies on 24-AUG-2011 was vaccinated with 0.5 ml of the second dose of VARIVAX (Merck) (lot#0157AA) (route not reported) at private MD office/hospital. The patient did not test for varicella antibodies before vaccinated with VZV containing vaccine. The patient had no local reaction at vaccination site, no varicella (chickenpox) symptoms post vaccination, and no herpes zoster (shingles) symptoms post vaccination. Follow up information has been received who reported that three attempts were made to obtain patient's pregnancy outcome and were unsuccessful. Case lost in follow up. Additional information is not expected.
Pfizer 3/31/21, 4/28/21. Positive on 2/12/22
hives around neck/ high fever/ rash/ took back to doctor/ she told me ear infection/ high fever and vomiting continued/ returned to doctor/ second doctor admitted allergic reaction
Patient came back 30 minutes after administered with a rash on opposite arm of injection site, applied cold compress and gave BENADRYL, Patient then declined TYLENOL. Pt recovered 30 minutes later, rash went away.
Short term: I was very faint walking the dog. I could barely breath and felt like my heart was in my throat. I also felt very foggy. I can just feel things was weird with my body. I had a rash located on my right arm and on my throat. Injection site also got very swollen, swelled, red and blotchy. Long term: I had a serious fall during a volleyball game about a month later. I also been having nerve issue in both feet. I almost fell down the stairs due to the foot pain and tingling. Just a tone of nerve damage and I am not unable to walk at the moment. I also had severe flu like symptoms.
Joint pain; Tiredness; muscle pain; swelling of face; swelling of throat; difficulty breathing; Diarrhea; This is a spontaneous report from a contactable consumer.    A 61-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 10:30 (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunization. Medical history included sjogren's syndrome, arthritis, fibromyalgia and systemic lupus erythematosus. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination, patient has not been tested for COVID-19. On 16Mar2021 at 18:30, the patient experienced Joint pain, tiredness, muscle pain, swelling of face, swelling of throat, difficulty breathing and diarrhea. The events were not treated. The patient was recovering from the events.   Amendment: This follow-up report is being submitted to amend previously reported information: Relevant Med History 2, the verbatim was updated from Arthritis NOS to Arthritis and Relevant Med History 4, the verbatim was updated from Lupus syndrome to Lupus and Narrative regenerated per original source document.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt was given vaccine at age 17. Minimum age is 18. Patient was monitored for 15 mins with no adverse effect.
This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 19th February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, less than a week after receiving SHINGRIX, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was not recovered/not resolved. It was unknown if the reporter considered the enlargement of lymph nodes to be related to SHINGRIX. Additional details were provided as follows: At 12:22 pm, the patient was administered SHINGRIX in the right arm. The patient reported that within one week of getting the dose of SHINGRIX, he experienced large lymph nodes on his neck, under his arm and on his collarbone. He had a physical two weeks prior to the vaccination and no enlarged lymph nodes were noted at that physical. The patient would have a biopsy a week after reporting date for lymphoma. The contact details of the physician was provided.
severe stabbing pains in abdomen/colon; Within 5 hours i started having severe stabbing pains in my abdomen/colon; abdomen swelled; CT showed my colon to be swollen / An emergency colonoscopy showed it to be extremely inflamed; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 13Aug2021 at 12: 00 PM (Lot Number: FA7484) at the age of 77-year-old as single dose for COVID-19 immunization. Medical history included breast cancer twice, ovarian cancer from 2013 to May2021 and sulfa allergy. COVID prior vaccination was none. COVID tested post vaccination was none. The patient didn't received other vaccine in four weeks. Concomitant medication included niraparib tosylate monohydrate (ZEJULA), fexofenadine hydrochloride (ALLEGRA) and Multivitamin. The patient previously received Codeine and experience allergy. On 13Aug2021 at 05:00pm, within 5 hours, the patient started having severe stabbing pains in abdomen/colon and abdomen swelled to where he looked 7 months pregnant. The pain was so bad he doubled over every time it hit. 1000mg of Tylenol was necessary to help pain that subsided by midnight. Patient had to take Tylenol 2-3 times a day for 5 days. The swelling was gone by the end of a week. Patient had the same reaction with the same time lapse to Neulasta. A CT showed colon to be swollen. An emergency colonoscopy showed it to be extremely inflamed. The colonoscopy was done at (Name withheld). The patient was Terrified of Getting A Second Dose 3Sep21 and most likely will not. No treatment was received. The outcome of events was recovered.
Prior to vaccination, pt advised to wait 30 minutes due to self-reported anaphylactic allergies to non-vaccine-related substances. Covid vaccine administered approximately 12:45 PM. I went to check on patient at 12:58PM, she reported feeling well and trying not to be worried. After a couple minutes, she reported feeling nauseous and needing to vomit. She said her stomach and throat 'felt warm'. I brought a wastebin to her. She began retching, but only saliva was spit up.By 1:05 PM she said her throat was closing up and she couldn't breathe. She was in a pick-up truck and began kicking/writhing in her seat and clutching her throat in the universal choking sign. I administered 0.3mg epinephrine via auto-injector. She started to normalize breathing, calm down, and then lost consciousness. I brought her out of the truck with the aid of her spouse and one of my coworker RNs. She lay on the ground with but rapid but otherwise normal breathing. The RN and I began to take vitals but patient then started shaking. EMT was called immediately after epinephrine injection, so they had arrived on the scene by appromximately 1:20PM. Vitals stable, medic was called to scene, arrived and checked in with EMT and then left. Pt was transported to Hospital.
Low grade Fever for 11 Days Large Neck muscles sore for 2 weeks Nearly Locked up at times
At 245PM - Zoster vaccine administered on (L) deltoid. Pt. tolerated well. At 125pm - monitored patient; C/O mild itching on nose and arms, denies shortness of breath, no anaphylactic shock, no wheezing, no hives, throat not swollen. Patient able to swallow and speak. Respiration even and non labored. Non diaphoretic. No fever. AAOX4. Notified Provider at 0130 vital signs WNL and BENADRYL/25mg PO STAT ordered. At 210pm evaluated by Dr. At 220pm patient discharged in good condition in no acute distress.
FEVER/CHILLS, BACK PAIN, SAID SHE STARTED HER PERIOD 4 DAYS EARLY AND PASSED SEVERAL BLOOD CLOTS VAGINALLY
After 2nd dose, I looked like I had chicken pox. I was seen by allergy and immunology and internal medicine, and no one could figure out what was going on. I was given Doxepin and steroids, and Atarax at night.
Red itchy rash; Red itchy rash; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received first dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced red itchy rash/ rash pruritic and rash erythematous.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced red itchy rash.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event red itchy rash was unknown.
Appearance of shingles - rash, sharp pain.  Rash below waist from naval area to middle of back.
Received flu vaccine about 15 min. after developed throat tightness, difficulty breathing. Declined meds, resolved. Seen in ED.