chrisvoncsefalvay/vaers-outcomes huggingface dataset:
81 year old male who presented to Medical ER 6/4/21 with possible seizure like activity at home after having his second dose of COVID vaccine on 6/3/21. His first dose of COVID vaccine was given on 5/4/21. After the patient arrived to the ED he was able so my questions.  The patient had an EKG performed was not concerning for ACS.  He was given a total of 1 mg of Ativan IV.  CT head CTA head and neck were negative for any acute findings.  He was started on IV lactated Ringer's.  CBC was reassuring.  CMP showed a sodium of 125 and potassium 3.3.  The patient was started on a liter of NS.  Magnesium was found to be 1.7 was given 2 g of magnesium IV.  Ammonia level blood alcohol level were negative.  Initial lactic acid level was 5.9.  Repeat lactic acid level is down to 1.9.  I had spoke with on-call neurology felt that seizure is most likely due to the patient's electrolyte abnormalities.  Did not recommend antiepileptics at this time.  I spoke with Dr. who is willing accept the patient for admission to the ICU.  When Dr. came down and spoke with the patient he started having another seizure.  After the seizure he continued to not breathe.  The patient was bagged and started having some spontaneous respirations however continued to have a low O2 sat if he was not bagged.  We were able to speak with the neurologist again who recommended giving Keppra 1500 mg IV.  Dr. was able to speak with the patient's next of kin his son and the patient's brother who both recommend the patient not be intubated or any other life-saving measures.  Would like the patient be kept comfortable.  The patient passed away shortly thereafter time of death was 2044.
Received both FLUZONE influenza vaccine and PNEUMOVAC 23 injections on the same day, same arm (left) on 10/1/14. By 10/2/14 she developed swelling and pain in the left arm with limited mobility of that arm. She also developed fever, diarrhea and overall weakness- unable to get out of bed. Was admitted to the hospital for possible left arm cellulitis. PNEUMOVAC 23 lot = K009107, FLUZONE lot= U5041DA.
pt recv vax against chicken pox on 4APR96;had heart attack sx that turned out to be shingles;chest pain went away p/rash broke out on 10APR96;
This spontaneous report as received from a healthcare worker refers to a 1 year old female infant. On 08-APR-2014 the patient was vaccinated with a dose of PEDVAXHIB, 0.5 ml, intramuscular in the left thigh, that had been improperly stored. There was no adverse effect. Additional information has been requested. This is one of several reports from the same source.
Pt recvd vax & w/in 1 hr p/3rd vax exp h/a, nausea, vomiting, general flu like sx & arm tenderness; remained ill over the weekend but flu sx have resolved & pt returned to work 22DEC92; rash;
COVID MULTIPLE TIMES; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced covid multiple times. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid multiple times was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000264468. This case, from the same reporter is linked to 20221255553.
Pt. states "a few hours after TDAP, I started to get hives on my stomach and my arms and then I started with a fever." When questioned she stated that her fever got as high as 101.2. She states she tried lotion on her hives. Patient report adverse event on 6/10/16 at 10:15 AM.
Severe itching, welps, lips and eye swelled slighty.  Most of my body was red. Looked like I was subnurnt.
pt recv vax & devel an inj site rxn characterized by redness & a hard knot;
Paid on administration. Returned at 5PM. Loss of range of motion. Intermittent pain, patient had physician appointment schedule for 12/22/15 and 11/25/15.
PATIENT CAME IN COMPLAINING OF PAIN, AND HAD FLUID BUILD JUST ABOVE THE ELBOW.  PATIENT SAID PAIN STARTED LATER THAT AFTERNOON. HE HAD PAIN RUNNING DOWN HIS FINGERS AND THRU OUT HIS BODY. AFTER PUTTING ICE OVER THE AREA THE PAIN HAS COME DOWN SIGNIFICANTLY BUT NOT GONE AWAY. PAIN IN HIS BODY IS GONE AFTER 2 DAYS. BIG CONCERN WAS THE FLUID BUILD UP IN HIS ARM. SUGGESTED TO KEEP ICING, TAKE IBUPROFEN AND TAKE BENADRYL AT BEDTME.
weakness; aching flu like symptoms; Aching flu like symptoms; Headache; general tiredness; This is a spontaneous report from a contactable consumer (patient herself). A 32-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EL3248) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced weakness, aching flu like symptoms, headache and general tiredness on 09Mar2021. No treatment was received for the adverse event. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The outcome of the events was recovering.  Information about lot/batch no. has been requested.  Follow-up attempts are completed. No further information is expected.
Flair up of tendentious and upper arm pain in my right arm (the opposite arm from the one I had the shot in).  This is still ongoing. (I have had a few limited periods where I have had tendentious/bursitis in the past, but it as not been an issue in over a year and reoccurred immediately after the shot.) Significant fatigue the  day after injection with ongoing fatigue following.   Elevated heart rate for at least the day following the injection.  Pain at injection site for 3 days
get my walking properly which I haven't been able to do for 9 months because of this shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 14Jan2022 at 11:00 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (booster dose, manufacturer unknown), for COVID-19 immunisation. The following information was reported: GAIT DISTURBANCE (non-serious) with onset 15Jan2022 at 09:00, outcome "unknown", described as "get my walking properly which I haven't been able to do for 9 months because of this shot". Therapeutic measures were taken as a result of gait disturbance.  Additional information: when the patient was walking slowly around the back of the car, patient said it was March of this year, when patient  was still on physical therapy to get patient's walking properly which patient hadn't been able to do for 9 months because of this shot.  Patient had shot on arm on 14Jan2022. Less than 24 hours later after patient had shot at 11 O' clock in the morning, patient knew the exact date that when the lousy shot was put in patient's arm. Patient didn't have any problem with them, covid 1, covid 2, booster, not the problem in the world, not a problem with the vaccine that all covid1. covid2 and the booster but since they gave the patient that Prevnar 20 bronchial pneumonial Flu shot, the next morning when patient woke up at 9 O' clock, patient couldn't get out of the bed, get up the dog, patient could not even walk.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Chills, aches, nausea, vomiting, headache for approximately 36 hours.
Patient received J&J from outside location and did not inform us of this or provide a vaccine card.  He was given Pfizer on 2/17/2022 and returned 3/19 for 2nd Pfizer shot. We are reporting his 2nd Pfizer shot from 3/19.
Allergic reaction-lingering  hoarseness & excessive throat clearing starting  shortly after initial doses & has become chronic. Condition worsened after 9/15/22 2nd booster
This case was reported by a pharmacist and described the occurrence of needle injury in a neonate patient who received ENGERIX B PEDIATRIC (batch number P7EE2, expiry date 9th March 2019). On 27th October 2017, the patient received ENGERIX B PEDIATRIC (intramuscular) .5 ml. On 27th October 2017, immediately after receiving ENGERIX B PEDIATRIC, the patient experienced needle injury and needle issue. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the needle injury, needle issue and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the needle injury to be related to ENERGERIX B PEDIATRIC. Additional details were reported as follows: The age at vaccination was not reported. The nurse administered dose intramuscularly to newborn baby, after removal of syringe, found needle had separated from prefilled syringe halfway in infant's injection site. Needle removed with no harm to patient. At the time of reporting, reporter had the defective product.
Vaccine was exposed to storage temperatures outside of the recommended ranges. The patient did not need any treatment and did not have any symptoms.
Tachycardia, Afib, Pounding, Flutter (Heart) Short of Breath, runnier nose, Weak & Shaky, no Apatite.
Mom noticed 15 small hives that appeared on him 10/6/10 in the morning.  Woke up at 0100 on 10/7/10 with hives from head to toe, facial swelling and vomiting.  Mom called our answering service and was advised by physician on-call to give Epi-Pen and present to ED immediately.  Mom brought patient into our office later in the afternoon, 10/7/10 for re-exam with Dr.  He wrote a prescription for Atarax syrup and discussed patient's case with Dr. before sending him to be evaluated in Dr's office immediately.  Per mom, Dr's office prescribed an oral steroid and anti-itch medication.  They will be performing RAST testing and planning to draw labs in 4 weeks.
This spontaneous report was received from a doctor of pharmacy concerning a 6 months old patient. On 07-JAN-2013 (yesterday), the patient was vaccinated with a dose of GARDASIL (lot number, expiry date, dose and route unspecified) instead of HIB VACCINE (manufacturer unspecified). No product confusion was discovered, just a medication error. The pharmacist did not know if the patient received HIB VACCINE (manufacturer unspecified) on 07-JAN-2013 (yesterday). No concomitant medications were reported. No adverse event was reported. Additional information has been requested.
Diarrhea & NauseaVomiting Narrative: Developed nausea 2x days after vaccination, resolved within a day. Not associated with vomiting. Also experienced 2-3x episodes of diarrhea at the same time w/o associated abdominal cramping. No other reported adverse effects. No medications or treatments trials.
My daughter got the live Chickenpox vaccine and two weeks later, woke up with many small red bumps on her legs (thighs), back, torso. Some were raised, others were not. The redness went away but ever since, she has small raised skin-colored bumps all over skin. She had NEVER had any bumps on her skin prior to this shot.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 6-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
This spontaneous report was received from a 80 year old female patient. Current conditions of the patient included KEFLEX allergy, clindamycin allergy, cefuroxime allergy and cipromycin allergy. The medical history included stent in heart. On 02-JAN-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). Concomitant therapies included gabapentin, metoprolol, losartan potassium (reported as Losartan), chlorthalidone, ZETIA, LIPITOR, SYNTHROID, PEPCID, meclizine, RENEW LIFE ULTIMATE FLORA CRITICAL COLON (reported as ultimate flora), ersupoloate and ultra B12. On an unknown date in the third week of June 2013, the patient developed shingles, including blisters above the eye, the hairline and 3-4 inches down her face. She still feels pain and swelling in eyelids. Also, a week after developing shingles (approximately on an unknown date in June 2013), she was hospitalized for potassium and sodium level problems. Length of stay was not specified. The patient sought medical attention (went to eye doctor). Unspecified test was performed and her eyes were dilated. She was treated with eye drops (unspecified) and gabapentin. The patient had not recovered from the events at the time of report. In addition the patient mentioned that she was hospitalized for cold on an unknown date (length of stay was unspecified) at the same facility. Outcome of cold was unknown. Additional information has been requested.
Severe pain, especially in my left lower extremity, where I had a prior CRPS diagnosis, as well as my neck, back, and right upper extremity, where I got the injection. My CRPS had been in partial remission, but the vaccine caused it to flare and spread to my right upper extremity. I was diagnosed with CRPS of the right upper extremity on May 6, 2021.  In addition, I suffered from headaches, rashes, and gastrointestinal issues for several weeks, and I'm still having heightened allergic reactions as of September 2021. I started experiencing eye irritation and allergies in June 2021.
pt recv varicella vax 3/20/98 & approx 26 days later pt devel fever 104 lasting 3 day then 4/14/98 pt devel approx 30 pox & mom rpt pt devel rotavirus approx 2 wk p/vax
Every time I took it, got the flu; Initial information received on 31-Oct-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer) .  This case involved a patient of an unknown age and gender who every time took it, got the flu (Influenza), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, it was reported that every time patient took it got the flu (Influenza).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event of influenza was reported as unknown.  There will be no information available on the batch number for this case.
GARDASIL 9 was administered to 4 patients on 10/26/2020 after a temperature excursion; This spontaneous report was received from a health care professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 26-OCT-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, site and route of administration were not reported; lot# T007035, expiration date reported as 01-MAY-2022, was valid) for prophylaxis.  Administered dose of vaccine underwent a temperature excursion below 36 degrees Fahrenheit/3 degrees Celsius (0.9 to 1.9 degrees Celsius) for 10 hours an above 47 degrees Fahrenheit/9 degrees Celsius (9.1 degrees Celsius) for 30 minutes. There was no previous temperature excursion. No data logger was involved.  This is one of four reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA011190: US-009507513-2010USA011203: US-009507513-2010USA011367:
Kidney pain low back both sides, fatigue, upset stomach, no appetite, constipation, chills, full body ache, temperature, full body joint ache, very dark urine, low abdomen cramps
Hot at injection site; Swelling; Redness; Itching; Pain; Sore at the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE PAIN (Sore at the injection), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (Pain) and VACCINATION SITE SWELLING (Swelling) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SIMVASTATIN for High cholesterol, VITAMIN D2 from 25-Feb-2021 to an unknown date for Vitamin D low.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore at the injection). On 12-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (Redness). On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot at injection site) and VACCINATION SITE SWELLING (Swelling). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form and DICLOFENAC DIETHYLAMINE (VOLTAREN EMULGEL) at an unspecified dose and frequency. On 08-Mar-2021, VACCINATION SITE PAIN (Sore at the injection) had resolved. On 20-Mar-2021, VACCINATION SITE WARMTH (Hot at injection site) and VACCINATION SITE SWELLING (Swelling) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (Redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Benadryl, voltaren gel and ice.   This case was linked to MOD-2021-044218, MOD-2021-160917 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Follow up received on 22-May-2021 contains patient demographics, concomitant products and add new event and updated outcome.
A little tired; Headache; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis (MS)" (unspecified if ongoing); "Joint pain" (unspecified if ongoing); "Hip replacement" (not ongoing). The patient took concomitant medications. Past drug history included: Amoxicillin, reaction: "She is allergic to Amoxicillin". The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "A little tired"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Headache".  Additional Information: The reported age of patient was 59 with unspecified unit. The patient received her first dose of the Pfizer BioNTech COVID-19 vaccine yesterday (26Mar2021) and reported that she was a little tired from it and her headache went away. She stated that on Wednesday 31Mar2021, she was scheduled for a dental appointment and had to take 2000mg of amoxicillin one time beforehand due to a hip replacement. She mentioned that she was allergic to amoxicillin so she had to take diphenhydramine (BENADRYL) for 3 days beforehand or else she would break out into hives but this was her only antibiotic option as all other options cause joint pain. She would like to know if it was okay to take this amoxicillin after receiving the vaccine. She also mentioned that she had multiple sclerosis and was taking medication that suppresses her immune system.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.