chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hit a blood vessel when administering the vaccine; lot more blood came out than expected; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (hit a blood vessel when administering the vaccine) and VACCINATION SITE HAEMORRHAGE (lot more blood came out than expected) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (hit a blood vessel when administering the vaccine) and VACCINATION SITE HAEMORRHAGE (lot more blood came out than expected). On 03-Apr-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (hit a blood vessel when administering the vaccine) had resolved. At the time of the report, VACCINATION SITE HAEMORRHAGE (lot more blood came out than expected) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
The vaccine was administered on 11-29-21 in R deltoid. Patient reports R upper arm swelling, red, and warm starting on 11-30-21
This initial spontaneous report was received from a male patient of unknown age. The patient refused to provide any information regarding his medical history, concurrent conditions, or concomitant medications. In June 2018, the patient was vaccinated with ZOSTAVAX and sterile diluent (lot # and route not provided). An unspecified duration after getting the shingles vaccine, the patient started developing some problems with his eyes. He described the problems as his eyes became severely irritated after getting the vaccine. Also, his eyes became very red and bloodshot all the way up to the pupils. He went to three different physicians to get unspecified treatment for his ocular related adverse reaction. The patient also mentioned that his eyes have gotten bad enough where he can't work or hardly drive anymore. He was not sure if he needed to pursue legal action because he was already out [amount] for medical expenses due to the adverse experiences. The events were not resolved.  Causality assessment was considered related. Eyes became severely irritated and eyes became very red and bloodshot all the way up to his pupils were considered disabling since the patient said he can't work or hardly drive anymore. The patient did not provide consent to be contacted for follow-up.
Had a sore throat, with coughing, fever and then a sinus infection. Went to doctor and was prescribed a prescription cough syrup and an antibiotic. Was given a COVID-19 test, RSV and Influenza test and was negative for each.
Patient reports that he has also been more short of breath than usual.  Reports that he has been using 2 pillows instead of 1 due to his shortness of breath.  Patient reports that she has also had some cough.  Reports chills however, has not checked his temperature.  His home nurse came to visit him and noted that his lower extremity swelling has significantly worsened and that he had crackles
Pain started 1 1/2 hours to (L) hip after getting injection. Vaccine given to (L) deltoid. Site intact. No bruises, no sign of cellulitis. Taking Ibuprofen PRN.
Information has been received from a physician assistant via company representative, concerning an 80 year old male patient. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On approximately 2012 (reported as: about 5 years ago), the patient was vaccinated with an unspecified dose of ZOSTAVAX (dose, dose number, anatomical location, route of administration, lot number and expiration date were not provided) for prevention of shingles. Other suspect therapies included sterile diluent (DILUENT MRK) (indication, formulation, strength, dose, route of administration, lot number and expiration date were not provided). On 03-MAY-2017, the patient was seen by the physician assistant in his office because, since an unknown date, the patient was experiencing one of the most severe cases of shingles the physician assistant had seen; there was a rash on the patient's left neck and chest area. Therefore, the physician assistant immediately started a course of antivirals, as treatment, to the patient during the visit,, but no intervention to prevent serious criteria was performed. At the time of the report, the outcome of the patient regarding the shingles and the causal relationship between the event and the ZOSTAVAX were not provided. Additional information is not expected because there was no consent to contact the reporter.
Hot became painful, swelling and hot to the touch which lasted a week. She had a fever over 101. Headaches 247 for months and still going on.  She spoke with the dr and he wanted her to only stand and walk on around for 10 mins at a time. Dizziness all day and night for months. Medicine head feeling which is still going on. Memory loss. Her thought process has slowed up. Dizziness has caused her to be off balance. Staring into space. Nausea. It has caused high/low blood pressure problem. Body pains. Sleeping 10 to 12 hrs a day. Caused an elevation in her thyroids which her medicine had to be up twice. Hoarseness and pressure on her neck. Weight gain. Constipation. Iron weakness. Swelling, tightness and stiffness in her hands which lasted for months. Shoulder, elbow, wrist and finger pain. Hands and feets burn 20 min after being outside in the cold. Flashes in the eyes. Getting winded easy, before taking the vaccine walked 8 miles a day.
covid vaccine breakthrough case  dose 1 Moderna 3/2/21 025A21A dose 2 Moderna 3/30/21 028A21A
Cellulitis left upper atm, treated with Amoxycillin 400 mg/ml, 1 tsp po bid x 10 days.
This initial non-serious spontaneous case received on 21-Nov-2017 was reported by other non-health professional and concerns a male patient of unspecified age. Patient's medical history and concomitant medications were not reported. On an unspecified date (2-3 years ago), the patient received INN Flu Vaccine Seasonal (dose, batch number, expiry date, route of administration, trade name, manufacturer: not reported). On unspecified date after administration INN Flu Vaccine Seasonal, the patient had a reaction on the right arm and chest was swollen. The outcome of the events was not reported. The reporter assessed the case as non-serious.
I Starting the next day when I woke up, I felt very awful and achy.  I was unable to move my left thumb.  My left thumb  was positioned touching my palm and I was unable to move it.  The only way to move it was to pry it with  my opposing hand. A few days later, my left  thumb was swollen.  My other fingers were not affected.   I had severe vertigo 2 months later. I went to see my doctor who commented seeing other patients with vertigo after the vaccine.  The doctor did not prescribe any medication and the vertigo resolved on its own after 3 weeks.  On 2/9/2021, I went for a routine appt  with my PCP and did a routine PAP and blood work.  The  blood work came back positive for hashimoto disease and I was referred to an endocrinologist.   On 2/12/2021, I went to a rountine mammogram, and my mammogram showed an enlarged lymph node and 2 calcifications on my left breast. On 3/5/2021 I went in for  2nd mammogram and ultrasound for my breast. The 2nd mammogram also confirmed the 2 calcifications on my left breast.  4/2/2021,  I did do 2 biopsies on the calcifications on my left breast, which came back normal.   I was able to finally get an appointment with an orthopedic doctor concerning my thumb.  I did received a cortisone shot at the orthopedic doctor's office.  The shot did help relieve the swelling and some of the pain.  I still have mild swelling and pain.   On 6/22/2021, I did go see my endocrinologist who changed my thyroid medication.  I am still being followed up with endo.
blood sugar dropped/their sugar and it dropped to 63 mg/dL; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE DECREASED (blood sugar dropped/their sugar and it dropped to 63 mg/dL) 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 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE DECREASED (blood sugar dropped/their sugar and it dropped to 63 mg/dL). At the time of the report, BLOOD GLUCOSE DECREASED (blood sugar dropped/their sugar and it dropped to 63 mg/dL) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Blood glucose: 63 mg/dl (Low) Blood sugar dropped, 180 mg/dl (Inconclusive) Blood sugar 180mg/dL and 238 mg/dl (Inconclusive) Blood sugar 238 mg/dL.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  Patient emphasized they were not a diabetic. Patient drank a sugary glass of juice and ate a sandwich.
Patient went directly to a gurney for her 15 mins observation because patient stated she had dizziness during her first dose of Pfizer.  Patient c/o dizziness, nausea. Patient stated has history of gastric issues and has sensitivity.  Patient verbalized that she gets nauseated.   Patient lying on gurney bed and given some snacks and water since patient stated her throat was dry. Also patient was monitored for 30 mins and taken vital signs: BP (127/81); HR: 80; RR: 16, O2 Sat 98%. Around 1:35 PM, no N/V no dizziness noted.  Patient discharged and patient stated feeling better, no more dizziness. Patient stated she has a ride home with accompanying husband.
vomited once home about an hour and half after vaccination. HX of car sickness. Mom is nurse and assures no continued concerns
mother received Abrysvo; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team.  An adult female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single  (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE TIMING UNSPECIFIED (non-serious), outcome "unknown", described as "mother received Abrysvo". The baby was delivered premature.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Information has been received from a nurse concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. It was reported that the patient had anxiety about receiving GARDASIL. No specifics known about the patient. At the time of reporting on an unspecified date the patient had recovered and continued in the series. The patient sought medical attention in office. This is one of several patients received from the same source. Additional information has been requested.
Information has been received from a physician concerning an approximately 6 year old male who on 05-DEC-2001 was vaccinated with the first dose of VARIVAX (Merck) (lot number unspecified). On 12-JAN-2007 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot number 654526/1141F). After vaccination of the second dose (date unspecified, approximately in 2007) the patient developed chickenpox and was given BENADRYL and CALADRYL for treatment. The symptoms improved on therapy. On an unspecified date, the patient had recovered. Additional information has been requested.
pain radiating down to the index finger; Tachycardia; pain at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (pain radiating down to the index finger), TACHYCARDIA (Tachycardia) and INJECTION SITE PAIN (pain at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN (pain radiating down to the index finger), TACHYCARDIA (Tachycardia) and INJECTION SITE PAIN (pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (pain radiating down to the index finger), TACHYCARDIA (Tachycardia) and INJECTION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient takes an injection once in every 8 weeks for Psoriasis. Patient  body temperature also increased.
It was reported 11/05/01 that Fluzone was administered 11/01/01. Patient developed shortness of breath, diaphoresis, throat tightness and fainted, 10-15 minutes post vaccination. Patient was evaluated in an emergency department and treated with IV Benadryl. Symptoms resolved and patient was discharged. Patient is a known asthmatic and is on bronchodialtors as needed.
noc of inject poly arthralgias & diaphoresis; next morning pruritic urticarial rash, scattered all over; 6MAY swelling of hand & feet; 7MAY puffy neck; periorbital & hand edema;
HEADACHE, NAUSEA, CHILLS, BODY ACHE, DIZZINESS, FEVER, VOMITING, CHEST PRESSURE/PAIN.  ALL SYMPTOMS SUBSIDED WITHIN 36 HOURS.  TOOK MOTRIN FOR FEVER AND BODY ACHES.
This spontaneous report was received from a health professional referring to multiple patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # J010668, expiration date 29-APR-2016; K003520, 20-NOV-2016; K006124, 02-FEB-2017) dose and route of administration were not provided. No adverse effect reported. This service request was first opened on 30-JUN-2015, when a pharmacist called to report a vaccine temperature excursion but any adverse event was reported at that time. However, this adverse event was reported on 11-AUG-2015, during a call back by this healthcare worker. This is one of several reports received from the same source. Additional information has been requested.
It?s been 6 days since my first vaccination. I?ve had diarrhea for 5 days and for the last 4 days I believe there is blood. Outside of that, my arm pain has gone away, and I?m tired because I have to use the bathroom every 30min - 1 hour.  And while sleeping through the night I?ll get up ever 1-2 hours.
This spontaneous report as received from a registered nurse, via field representative, refers to a patient of unknown age and gender. Medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (route, lot number and expiration date were not reported) (specified dose in series unspecified). Concomitant medication was not provided. After receiving the vaccine the patient fainted. The patient sought medical attention, visited the office on an unspecified date. Additional information has been requested.
Itchy; Rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchy) and INJECTION SITE RASH (Rash at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INJECTION SITE PRURITUS (Itchy) and INJECTION SITE RASH (Rash at the injection site). At the time of the report, INJECTION SITE PRURITUS (Itchy) and INJECTION SITE RASH (Rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported. No treatment information was provided
MODERNA COVID-19 VACCINE EUA SKING BREAKOUT WITH ITCHING AND RASH OVER CHEST AREA, BACK AND LEGS
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 14-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication reported date of refrigeration 8/6/2021   This case was linked to MOD-2021-363737 (Patient Link).
After 12 hours of injection, severe agony flu occurred! 103 fever for 36 hours. Pain chills all over body! Deathly Ill for 48 hours. Shallow breathing. Red hot ring around injection site.
Hives - generalized & then local reaction to (R) thigh - 12.5mg BENADRYL given & discuss with allergist.
pt recv vax 19DEC96 no problems 20DEC or 21DEC @ 5AM 22DEC96 pt started screaming;pt had crying episode from 5AM-6AM & from 830AM to 1030AM;mom & child went to ER;had stomach x-rays & showed no stomach problems;
patient got the first dose of the Moderna vaccine on 18Jan2021 but still has not gotten the second dose.; A Spontaneous  report was received from a consumer concerning a 76-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and event is patient got the first dose of the Moderna vaccine on 18Jan2021 but still has not gotten the second dose   No medical history was provided/no adverse event.  Concomitant medications were reported.  On 18 Jan 2021, the patient received their  first  of two planned doses of mRNA-1273 (lot number 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  Pharmacist  called because a patient was asking to get their second dose of the Moderna vaccine but has gotten the first dose on18Jan2021.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event missed dose is considered Unknown.
Injection on patient's left deltoid began to swell immediately after administration. Patient was offered/given 25mg (10mL) or liquid oral Benadryl and asked to stay in the pharmacy area for 15 minutes for observation. Patient felt fine aside from the swelling.
Multiple aches and pains in various parts of the body, slight tremor for several months. Lost weight about a pound a month.
Nausea; exhaustion; vomiting (24 hours); swollen lymph nodes in head, neck, spine; headache; sore throat; rash on scalp; pain at injection site (48 hours). All symptoms except for injection site pain and vomiting have continued for eight days.
very itchy pimple like spot here and there on my body; pimple like spot; breakout; This case was reported by a consumer and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced pruritus, pimple-like rash, and skin breakout. On an unknown date, the outcome of the pruritus, pimple-like rash, and skin breakout were not recovered/not resolved.   It was unknown if the reporter considered the pruritus, pimple-like rash and skin breakout to be related to Shingles vaccine.  Additional details were provided as the case was reported by patient. The age at vaccination was not reported. The patient had both shots and shortly after started a breakout know on head with a very itchy pimple like spot here and there on body. The patient stated that it had been almost 2 months. The patient asked if it was shingles.
1st 28Jan2020, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th January 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-FEB-2023 Reporter's comment: The patient self-reported this case. The patient had not yet received the second dose. The patient received the vaccine at a pharmacy but the pharmacy had since closed.   The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case is linked with US2023028619, reported by same reporter. Details pertains to 1st dose of Shingrix in product tab; Sender's Comments:  US-GSK-US2023028619:Same reporter
MY EYE STARTED WATERING; I FELT SO SICK; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history and concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date.     It was reported patient had the FluMist and stated it was the worst decision ever made as soon as patient got done with eye started watering (preferred term: Lacrimation increased) and  felt so sick  (preferred term: Malaise). it? was a live virus.    The outcome of my eye started watering and i felt so sick was unknown.     The comapny physician identified my eye started watering as an event from source document. The my eye started watering and i felt so sick were considered non-serious by comapny physician.
C/O backache 2 hrs after she received Td and hep B; c/o muscle ache that night-went to class and could not drive home; c/o twitching and spasms in back. Saw MD 2/7/03 dx UTI. Prescribed Tequin, Celebrex pain and muscle relaxer off work for 10 days and school. Back to work on muscle relaxer only feeling better.
Information has been received from Registered Nurse concerning a 12 month old male (24 lbs. 11 oz.) who on 09-AUG-2007 was vaccinated with ZOSTAVAX (657764/0584U) instead of varicella virus vaccine live. No problems were reported. This was not a case of product confusion. No further information available.