chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lymph nodes in both arm pits; large rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes in both arm pits) and VACCINATION SITE RASH (large rash around the injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in both arm pits) and VACCINATION SITE RASH (large rash around the injection site). The patient was treated with HYDROCORTISONE for Rash, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes in both arm pits) outcome was unknown and VACCINATION SITE RASH (large rash around the injection site) had not 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.   Concomitant product use was not provided by the reporter.
Nose bleeding; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleeding) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced EPISTAXIS (Nose bleeding). At the time of the report, EPISTAXIS (Nose bleeding) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Nonstop, high pitch screaming for 5 plus hours... unconsolable... screamed for 3 plus hours after 2 month vaccines.
Initial misuse report received from healthcare professional on 30 October 2013. The cases were received on 21 March 2014 at agency. A 02-month-old patient received 0.25 ml dose of FLUZONE QIV (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions, and concomitant medications were not reported. On 01-FEB-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (dose not reported) (lot # L039095 and expiration date 08-JAN-2017) subcutaneously for prophylaxis. There was not known adverse effects. Additional information has been requested.
Patient was given Meningococcal Liquid Conjugate Component only and not the mixture.
Patient states that since the evening of 1/16/21 she has had a fever, a red, sore and hard left arm, and body aches.  Tylenol helps but it still continues to happen, such as fever, and body aches return.  The tylenol is not helping her sore arm she states.
Received vaccine on 10/30 or 10/31. Patient has never had problems with flu vaccine in the past and has never received the high dose before.  The reaction was the same as with the TB skin test.  Within the hour after the vaccination started feeling faint. Patient was walking to couch and fell down.  Patient reports sweating, rapid heart rate, rapid pulse, ringing in the ears and high blood pressure (~190).  After episode laid on couch for 1 day and half.  Patient felt lousy; symptoms continued.  Patient contacted pharmacist but not sure, if doctor was contacted since was so out of it. Patient's nurse comes every other Tuesday and housekeep comes every day.  Symptoms continue but not as bad.
Noticed pain to (L) arm (achy) 6 hours later and then roughly 10-11 hours after injection entire arm was swollen. Swelling and aching decreased around 17 hours after injection. Still mild swelling noted today at 10:00.
Rash on the chest, back and Rt wrist after 12 hours from receiving the flu vaccine. Patient came back to clinic 3 days later preventing herpetic rash. Tx ACYDOVIR 800 mg 5x/day x 7  days.
subauricular & axillary lymphadenopathy, fever, redness, swelling @ inj site, diarrhea;
On 4/20/09 pt came to my office - her VARICELLA vaccine site had a 3 inch circle that was red, hot, painful and hard. Call to mom, ice applied, BENEDRYL 25 mg given po. Mom said it had occurred 4/18/09 after the vaccine had been given.
I received the moderna covid-19 vaccine eua on 12/30/2020 first dose. On jan 6 2021  i experienced itching and slight firmness 2cm below injection site. The next day jan 7 2021 I experienced redness 2 cm below inkjection site which was 9cm long by 5.5cm wide. Presently today jan 10, 2021 the redness is fading and I am not experiencing any itching anymore.
My period came a week early. After my first vaccine, My period started one week earlier than expected (22Mar2021) and was lighter/didn't last as long.; Period was lighter; Fatigue; Headache; This is a spontaneous report from a contactable other healthcare professional (Patient). A 32-years-old non-pregnant female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6205) via an unspecified route of administration in the left arm on 06Mar2021 (at the age of 32-years-old) as dose 1, single for Covid-19 immunisation. Medical history included eczema. The patient did not receive any concomitant medication within two weeks of vaccination. The patient did not have any known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for Covid-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 the patient experienced irregular periods and it was reported that period came a week early and was not on birth control and have had a regular period for lifetime. After first vaccine, period started one week earlier than expected (22Mar2021) and period was lighter and did not last as long. After two hours of vaccination (06Mar2021) the patient experienced fatigue and headache. On 07Apr2021, patient underwent lab tests and procedures, which included pregnancy test and tested negative. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient took second dose on 31Mar2021 and had no symptoms. The clinical outcome of the event irregular periods, fatigue, period was lighter, and headache were unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a RN concerning an 8 yr old female with no allergies who on 17Feb99 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (lot626960/0847H). On 03Feb06, the pt developed about 50 vesicular lesions and a low grade fever. No other symptoms were noted. Unspecified medical attention was sought. No diagnostic lab tests were performed. At the time of the report, the pt was recovering. A product quality complaint was not involved. Additional information has been requested.
Tinnitus developed two days after vaccine. No evidence of Tinnitus before vaccine. Ringing has not stopped in both ears since March 13.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 14-SEP-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Lethargy; Headache; Muscle weakness; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 12Apr2021 at 15:15 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. Concomitant medications included pregabalin (LYRICA), duloxetine hydrochloride (CYMBALTA), butalbital, caffeine, paracetamol (FIORICET) and norethisterone acetate (NORETHINDRONE) on unknown date for unspecified indication. The patient had no allergies to medications, food or other products. 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. On 12Apr2021 at 23:00, the patient experienced lethargy, headache and muscle weakness. No therapeutic measures were taken as a result of all the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events lethargy, headache and muscle weakness were recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Guillain-Barré Syndrome; initial symptoms started ~30 hours after shot (28/29 October). Ongoing symptoms for 7 days, admitted to hospital Treated w/ IVIG. Recovery ongoing.
Recurrent chills, headaches, confusion and breathing difficulties. Breathing difficulties and headache improved with use of albuterol inhaler. Symptoms lasted for 2 months then resolved. This happens every year she gets vaccinated.
This spontaneous report as received from a pharmacist refers to a 64 year old female patient. Medical history and current conditions were not reported. On 16-DEC-2014, the patient w as vaccinated with a dose of ZOSTAVAX lot # K012924, expiration date: 29-NOV-2015 int he right arm. Concomitant medication was not reported. 15 minutes after vaccination the patient developed a small red area at the injection site. On 18-DEC-2014 after two days from vaccination, the patient returned and reported that the adverse event had progressed, it was inflamed and swollen down to her elbow, also reported as a hard, dark and irregular area the size of a silver dollar around the injection site. Patient did not seek medical attention. Patient used ice to treat the events. The outcome of events was reported as not recovered. Additional information has been requested.
Myalgia, Arthralgia, Fever, NauseaVomiting, chills Narrative:
Patient started to develop itching all through the bottle, little red spots all over the body, warm spots where the welts started to form.  Has not done anything for it yet but called the physician and was told to report to the pharmacy. Started getting better on its own 1 week after vaccination, but still not completely reversed
This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-month-old female patient who received KINRIX (batch number 9EA47, expiry date 17th April 2016). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information was provided. RN reports that KINRIX was inadvertently administered to a 19 month old.
When driving home , I felt like my right side of my neck was swelling but it wasn?t and then it felt like my right side of my throat was sweet and then my asthma kicked in , I used my inhaler and I few hours all my symptoms went away.
Fever, rigors, nausea, vomiting, severe headache, diffuse myalgias.
1. Soreness in left arm from neck to fingers, started around shoulder within 5 minutes of injection, continued to worsen over the day and into next day.  2. Slight sleepiness and minor headache on and off through day 1 and 2. Not sure how long either will last, can report back if needed.
Extreme Flu-like symptoms. Massive headache, nausea, muscle aches. Coincidently, happened to have a previously scheduled blood draw for the next day at my doctor, listed previously. I got extremely nauseous, began sweating profusely and passed out right after the draw (have never had a blood draw reaction). 56 hrs since my shot and I still feel poorly, but better.
Wiped out; She was Extremely tired and no energy; Father stated that she slept and stayed in bed for most of the day on Saturday and Sunday which; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ASTHENIA (Wiped out), FATIGUE (She was Extremely tired and no energy) and ARTHRALGIA (Father stated that she slept and stayed in bed for most of the day on Saturday and Sunday which) 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 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced ASTHENIA (Wiped out), FATIGUE (She was Extremely tired and no energy) and ARTHRALGIA (Father stated that she slept and stayed in bed for most of the day on Saturday and Sunday which). On 15-Mar-2021, ASTHENIA (Wiped out) and FATIGUE (She was Extremely tired and no energy) had resolved. At the time of the report, ARTHRALGIA (Father stated that she slept and stayed in bed for most of the day on Saturday and Sunday which) had not resolved.            No treatment was given for events.  No concomitant medications were reported.   This case was linked to MOD21-053529 (Patient Link).
Within hours of receiving these 2 vaccines in the same arm this patient developed temperatures up to 103 along with headache and severe pain and swelling and redness in his right deltoid area. He was treated with Tylenol and ibuprofen and ice packs.
2 days after receiving the Pfizer vaccine, I started experiencing a fever and tingling in the arms and legs with some shooting pains in the extremities and knees (with a general constant discomfort in the arms and legs). The following day, large painful unexplained blisters started to appear on my feet, particularly at the heels (both feet) and some smaller ones on my hand fingertips.  Due to the pain and fever, I visited a local urgent care center who recognized the symptoms as having occurred recently on some other patients receiving the same vaccine. I received a steroid injection and a prescription for an antibiotic. This treatment generally helped with the condition.
Redness around injection site. There is a blister as well. Patient believes blister is about an inch from where vaccine was given.
He got pretty sick; Expired booster dose administered; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (He got pretty sick) and EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced ILLNESS (He got pretty sick) and EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered) had resolved. At the time of the report, ILLNESS (He got pretty sick) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was unknown.  A nurse gave an expired booster. Physician would like to now if they should receive a new booster or if it was whether or not good to give another booster shot.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Significant follow up appended ( Patient Demographic updated ,event updated, reporter data updated); Sender's Comments: This is a case of Expired product administered for a patient of an unknown age and gender with no medical history provided. Reportedly, a booster dose of mRNA-1273 vaccine which was administered was actually an expired vaccine. No adverse events were reported. No further information regarding this event was provided at the time of this report. The company causality for the event Expired product administered is not applicable.
Patient was given an extra 0.5ml dose right after that; A spontaneous report was received from a Healthcare Professional concerning a 65-years-old, female patient who received Moderna COVID-19 vaccine (mRNA-1273)  who was administered an invalid dose, some of the content of the dose slipped through the syringe and the patient was given an extra 0.5ml dose.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the event, the patient received their first dose of the two planned doses of mRNA-1273 (Batch Number 042l28), unknown route in the right arm for prophylaxis of COVID-19 infection.   On 28 Jan 2021, the patient received an extra dose of the vaccine right after the patient received an invalid dose.  It was reported that the patient was administered an invalid dose on her right arm and 15 minutes later some of the content of the dose slipped through the syringe and the patient was given an extra 0.5ml dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event patient was given an extra 0.5ml dose was considered recovered.; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273. There were no reported AEs associated with this case.
Tenderness around injection site and "tightness" soreness of the muscles in that whole area - anterior chest wall/supraclavicular area/trapezius to the neck/midline. Extremely swollen and tender lymph node at supraclavicular area.
Information has been received from a registered nurse concernin a 15 month old female in a "good state of health' who was vaccinated with varicella vaccine SC in the right thigh. Concomitant vaccinations on 01/18/2001 included haemophilus B conjugate vaccine (+) hep B vaccine recombinant IM in the right thigh and IPOL vaccine SC in the left thigh. Concomitant therapy included Bactroban. On 05/15/2001, the pt experienced shingles. She was brought into the office with a "red blistery" rash of four lesion on her back. The rash spread in a continuing band over the left side to the front. The child was noted to be "clearly uncomfortable" but had no fever or other symptoms. The child was treated with Tylenol and Benadryl. At the time of the report, the pt's outcome  was unknown. In follow-up, the registered nurse reported that the pt recovered. No further info is available.
After receiving the first vaccine on April 1, my ears started ringing just days after on April 6. I was dizzy and lost balance many times.  Less than 2 months after my second vaccine, my eye started to swell. I saw 20+ doctors who finally diagnosed me with GPA (Granulamatosis with Polyangitis--formerly known as Wegeners). I saw an ENT for the ringing (tinnitus) in my ears and they diagnosed me with Sensorineural Hearing Loss in both ears (irreversible) and I had to get hearing aids. I also will need to get Rituxan (infusion) for the GPA (two infusions two weeks apart) and am now immunocompromised. I was a perfectly healthy 35 year old until I received the first dose of the Pfizer vaccine, and then all my symptoms started less than a week after.
1/2/13 Shortly after Tdap vaccine about 2 hours, developed severe HA, low grade fever (997), generalized malaise & fatigue, joint aches, chills & swollen glands (per pt) & diarrhea. Taking FIORCET for HA, ibuprofen for body aches & BENADRYL at NOC for sleep. 1/4/13. All sx resolved except fatigue.
Redness, swelling, pain & itch around injection site, as well as mild rash on right side of upper body/face. Starting on day 8, lasting 36 hours so far.
1-1 1/2 day after vaccine child irritable, inconsolable cry. Today is day 4 of this. No sick contacts.
Red raised bumps on back. Slightly itchy.  Unilateral and somewhat symmetrical.
The nurse reports that the patient received an improperly stored dose of ROTATEQ; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 20-JAN-2020 the patient received an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (2 ml, batch/lot number 1658254; expiration date 17-NOV-2020, strength and route were not provided) for prophylaxis (incorrect product storage). The administered doses experienced a temperature excursion of 0.06 degree Celsius below zero for 4 hour and 59 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger.
THE INCIDENT HAPPENED ON FRIDAY 09/27/19. PATIENT HAD A VERY SWOLLEN LEFT ARM 30 MINUTES AFTER THE INJECTION . SHE WENT TO EMERGENCY ROOM AND HER PROVIDER ADVISED HER TO APPLY ICE PACK ON THE AREA AND GAVE HER AN ANTIBIOTIC.  WHEN SHE CAME INTO THE PHARMACY ON SUNDAY 09/29/2019 TO REPORT. THE SWELLING HAD GONE DOWN SLIGHTLY. I ADVISED HER TO TAKE IBUPROFEN AND TYLENOL TO HELP WITH SWELLING AND PAIN.
Vaccine given 6 days ago Pt noticed soreness in shoulder to elbow area.  Then spread to Flexor portion of Forearm only describes as "Arthritic. like pain". 0 numbness 0 tingling 0 loss of use of arm.  Recommend Ibuprofen & follow-up in next few days in office on by phone
Evening after second dose of Moderna, developed chills, body aches, fever 100.6, abdominal pain. Thinking it was a "normal"reaction I remained home. Abdominal pain worsened next day. Went to hospital. Diagnosed with a  perforated  appendix. After laparoscopic surgery and 4 days of recovery developed a small bowel obstruction requiring rehospitalization.
PATIENT STATED THAT SHE BROKE OUT WITH CHICKENPOX. HER PHYSICIAN CONFIRMED THAT SHE HAD A REACTIVATION (ORIGINAL CHICKENPOX OUTBREAK IN HER 20'S).
Pt recvd vax & exp fever (103), chills, clammy, dizzy, nausea, & muscle achiness;
Anthrax Lot # FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per agency direction.
Red, raised blotches on both cheeks and right leg. No fever and not fussy. 0.2cc Benadryl IM.
Patient presented to the ER with diarrhea. Patient tested positive for Covid-19. CT scan showed findings consistent with colitis and possible pneumonia. Patient received IV abx, steroids. Patient went into afib with RVR and was started on Lopressor, Lovenox/Warfarin. Diarrhea was improved at discharge. Patient passed walk study. Patient was discharged home.
Began having difficulty swallowing. Within the hour, tonsils were noted to be +4 by a dental hygienist. These symptoms were treated with 10mg Zyrtec and 50mg Benadryl. 6 hours later, the patient experienced fevers, chills and hives on the face, neck, and chest. Fevers (100.4-104.7 F) persisted on and off for 72 bites and hives (treated with daily Zyrtec, Benadryl, and topical triamcinolone) persisted for 8 days.