chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed high fever, erythema at injection site, and cellulitis which resulted in an office visit to the pediatrician as well as an ER visit and a course of antibiotics.
Very sore upper right arm at the injection site; Sore shoulder/ very sore upper right arm/shoulder; Muscle aches on the right side; Shivering; Had a very restless night; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included tadalafil (Cialis).   On 22nd August 2019, the patient received the 1st dose of Shingrix. On 22nd August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, shoulder soreness, muscle pain, shivering and restlessness. On an unknown date, the outcome of the injection site pain, shoulder soreness, muscle pain, shivering and restlessness were unknown.   It was unknown if the reporter considered the injection site pain, shoulder soreness, muscle pain, shivering and restlessness to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. On the day before the reporting date, the patient received Shingrix in the right upper arm.  The patient took usual dose of adalafil 20 mg (Cialis) yesterday after dinner, before bedtime. No other medications were taken. The patient was fine throughout the evening until bedtime and then started to have symptoms including a very sore upper right arm or shoulder at the site of the injection, muscle aches on the right side and shivering through the night and into the morning. The patient had a very restless night. The patient wore winter layers in the office on 23rd August 2019, which helped. The patient did not reported fever.
24 hrs after the shot, 05/17/2021, I had  fever, chills, headache, stomach ache, diarrhea, fatigue, migraines, lump on the arm of injection, I could not lift my arm, I could not work until Thursday, 05/20/2021. The fever and chills subsided by Wednesday., 05/19/2021.  I still had trouble lifting my arm, and I still had a headache on 05/20/2021.  From the elbow down to my left hand, I have a pulsing in my hand. It's a weird pulsing feeling in my left hand and that still happens till this day, daily.  On 04/25/2021 I had my 1st Dose of Pfizer.  On 04/27/2021- I saw Dr. for the 1st time, I went in for a  wellness visit. I told her I was having minor heart palpitations, tingling in my hands, arm and my left foot was numb.. I have a  family history on  my maternal side,  my grandfather and his brothers died before the age of 52 of coronary. She sent me to cardiology for a stress test on 05/03/2021. Then on 05/16/2021 I went for my 2nd Dose of  Pfizer.  Dr. on 06/18/2021  did an EKG and a halter monitor. Since 05/24 I have been short of breath and it's been getting worse. Dr. wants me to get pulmonary function test but I am not able to get an appointment until November. I have  respiratory test on 08/05/2021. Dr. said my symptoms may be caused by GI, and vocal chords since my chest x-rays were normal. She is suggesting me to see an ENT because my vocal chords may be causing my symptoms. We are at a loss of what could be causing the problem.   I would consider it to be a disability if I am going to be having trouble breathing for the rest of my life.
It has been over 1 week and I have developed a raised, red, warm to the touch, circular bump around the injection site.
Patient showed no noticeable side effects the day after vaccination. Starting on 10/7, she had very thick, green snot for approximately one week. Starting on 10/12, she started getting a serious diaper rash after multiple bouts of diarrhea. She experienced at least 6 diarrhea episodes each day until 10/21. We took patient to the doctor on 10/18 to get her checked out and to ensure that she was as healthy as possible despite the diarrhea and diaper rash. The doctor saw no other issues and told us to come back in one week if she was still experiencing the same amount of diarrhea. Dr. gave us a prescription for some medicated diaper cream, although it was mainly to treat diaper rash due to a yeast infection, which was not observed.
product expired was given to a patient inadvertently, with no reported adverse event; Initial information received on 05-Oct-2021 regarding an unsolicited valid  non-serious case from a other health professional and non health care professional via regulatory authority.  This case involves a 70 years old male patient who was vaccinated inadvertently with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], which was expired (expired product administered).  The patient's past medical history, medical treatment, vaccination, concomitant medication and familyhistory were not provided.  On 05-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Once, lot UJ514AA; expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination..  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "FLUZONE HIGH DOSE was given to a patient inadvertently today, but the product expired on 06/30/2021. Lot: UJ514AA NDC: unavailable" Caller states that the pharmacy buyer is calling to report the event and ask what they should do from here. Pharmacy buyer transferred from Caller. Pharmacy buyer, states the following: Yes, I am calling about a patient who received a dose of FLUZONE HIGH DOSE today (05Oct2021) that had expired on 30Jun2021. I do not have the patient's initials or date of birth. The patient is 70 years old and is a male patient. I am wondering if the patient needs to be revaccinated. No further information was provided."  At time of reporting, no adverse event was reported and the outcome of the event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This case was reported by a consumer via sales rep and described the occurrence of suspected vaccination failure in a adult female patient who received Influenza vaccine Quadrivalent 2017-2018 season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent 2017-2018 season at an unknown dose. In March 2018, less than a year after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced pneumonia (serious criteria GSK medically significant). On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure, pneumonia and influenza were unknown. It was unknown if the reporter considered the vaccination failure, pneumonia and influenza to be related to Influenza vaccine Quadrivalent 2017-2018 season. Additional details were provided as follows: The age at vaccination was not reported. In winter 2017-2018, the patient took flu shot. She later got both types A and B influenza at separate times in the early months of 2018. This case was considered as suspected vaccination failure because the time to onset for influenza was unknown at the time of reporting.
he got herpes breakout; little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HERPES VIRUS INFECTION (he got herpes breakout) and PAIN IN EXTREMITY (little sore arm) in a male 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.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES VIRUS INFECTION (he got herpes breakout) and PAIN IN EXTREMITY (little sore arm). At the time of the report, HERPES VIRUS INFECTION (he got herpes breakout) and PAIN IN EXTREMITY (little sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
01/05/ 2021 Received the Moderna Vaccine Left arm. approx 1 hour later developed Blisters in mouth, lip swollen, itching on entire left arm.    Later that evening sore throat, headache, nausea.
raised, red, warm warm to touch rash starting around injection site and continuing aprox 6 inches down arm
ARM STARTED OUT SORE, AS THE NIGHT AND NEXT DAY WENT ON IT BECAME MORE SORE AND STARTED SPREADING.  THERE WAS ALSO REDNESS AND SWELLING AROUND THE SITE AND MOVING DOWN HER ARM.
Administered dose of Proquad underwent a temperature excursion; No known adverse effects; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, historical drugs, drug allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S017255 and expiration date 01-DEC-2020) (dose, frequency and route of administration was not reported) for prophylaxis. On an unknown date, the patient administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) that underwent a temperature excursion on 27-DEC-2019 prior to being administered to one patient on 30-DEC-2019. There was no temperature excursion occurred previously. The call was because of data logger of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) which was stored at a temperature -12.94 Celsius for 90 minutes. Product quality complaint was not involved in the case.
Syncopal event x 2 the morning after patient received flu vaccine.  Seen in ED and given IVF.  Unclear if EKG was done at that time.  BP was low per patient. Seen by PCP 12/4/2020 and will refer to cardiology
Patient had physical and IZ's on 1/27/12. He developed swelling at injection site. Patient given KEFLEX & applied warm compress. Sibling has similar reaction - same DTAP lot.
12OCT95 AM got the flu & teeth chattering 13 & 14OCT fever, vomiting, t102, diarrhea extreme sweats;17OCT saw MD who found massive blood in urine & treated for urinary infect-cystitis-Macrobid prescribed
Patient reported swelling in his face as well as fever blisters on his body approximately 4 days after his vaccination. Patient reported he went to the ER  and received treatment there with steroids and antihistamines, as well as was given a prescription for the same thing to take for a few days after. Event was reported by the ER to the CDC when they were aware, and patient informed us at the site he was vaccinated on 5/20/21 of this reaction
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. On multiple unspecified dates, the patient were inadvertently administered with improperly stored VAQTA, (lots and expirations were unspecified) (route: intramuscular). The vaccine was stored at a temperature of 33 F for a time frame of 84 hours. There was no previous temperature excursion and data logger was not involved. No adverse effect reported. This is one of the four reports received from the same reporter. Additional information has been requested.
1st dose 13 months ago, 2nd not yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received first dose 13 months ago ).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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: 29-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient was wondering if he/she waited 13 months between doses if it was ok to just give the second dose. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
This spontaneous case, was received from other non-health professional on 27-Sep-2017, concerning a female patient of an unspecified age. It was stated that, the patient stayed away from the flu shots for the last 3 years. In the first 2 years, the patient could sustain herself, but in the last year she caught the flu which was bad so, the patient went to pharmacy, and the pharmacist gave her the NDC for the vaccine. On an unspecified date, the patient was administered with INN Flu Vaccine (route of administration, anatomical location, dose, trade name, batch number, manufacturer: not reported). On an unspecified date, after receiving the vaccine, the patient experienced severe breakouts. It was reported that, the patient wanted to vaccinate her with the FLUCELVAX, as it protected her from the flu, but still the patient did not know if she was going to take the vaccine. It was reported that, the patient did not experience any breakouts whenever she was not vaccinated with the flu shot. Outcome of the event was not reported. The reporter assessed the report as non-serious. Significant correction received with IRD 27-Sep-2017: The event coding was updated from no adverse event NOS to dry skin aggravated, prior history was checked yes, the reporter causality was updated from not reported to related and the company causality was updated from not related to related.
Cotton ball and ban aid stained but not solid blood and unsure if he got the full vaccine or it came back out with the blood; This is a spontaneous report from a contactable consumer.   This consumer (patient's wife) reported for a 73-year-old male patient that received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL9262, via unspecified route of administration in upper left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included high cholesterol, high blood pressure and he was overweight and had a large gut like most men his age. He had previous lung surgery. No further details provided. Concomitant medications were not specified but the patient had high cholesterol and high blood pressure and took medications for those.  The consumer reported that when the patient took cotton ball and band aid off, it was stained and it was not solid blood.
swelling under his groin; swelling under the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling under his groin) and AXILLARY MASS (swelling under the arm of injection) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 SWELLING (swelling under his groin) and AXILLARY MASS (swelling under the arm of injection). At the time of the report, SWELLING (swelling under his groin) and AXILLARY MASS (swelling under the arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication use was reported.
Swollen where shot was, itchy, hot to the touch and half way down arm is red. Going on 3 days.
Left arm erythematous warm/hot upper deltoid to bicep medially 8 inches x 7 inches at widest area. Tx for both cellulitis and drug reaction.
Information has been received from a pharmacist referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 27-APR-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K010630, Expiration date 30-OCT-2015; dose and route were not reported). No adverse effect was reported. Additional information has been requested.
Patient developed hives to his face, trunk and arms 30 minutes after receiving MMR, VARIVAX, QUADRACEL. Patient returned to our office and oral Benadryl 12.5mg was administered. Patient did not have any breathing issues or oral swelling. Patient was given a subsequent dose of Benadryl at home. After speaking with patients mother on 8/30/17 hives have resolved. No swelling or itching reported. Patient was not treated at any other medical facility for the above reaction.
This study case was received from the investigator in a trial on 05 February 2013. A 24-year-old male subject, who had a past medical history of asthma (included exercise induced), developed Guillain-Barre syndrome, 20 days after receiving a injection of ACAM2000 (lot number not reported) on 18 October 2012. On 07 November 2012, 20 days post vaccination, the subject was diagnosed with Guillain-Barre Syndrome. On 14 December 2012: a magnetic resonance imaging (MRI) of the brain was reported as abnormal and an MRI of the spinal cord was reported as abnormal. Troponin I result was reported as not performed; an ECG and echocardiogram were reported as not available. Magnetic resonance imaging (MRI) heart and lumbar puncture (spinal tap) were reported as not performed. Treatments and hospitalization were not reported. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Information was received from attorney regarding a case in litigation concerning a 64 year old female. It is being claimed that on 10-NOV-2014 the patient experienced retinal detachment of the right eye secondary to reaction from ZOSTAVAX, muscular palsy of the right abducens (sic) nerve, ocular nerve and trochlear nerve and hypertension. The patient displays loss of vision in her right eye. The patient is claiming permanent injuries. Post surgery of right retinal reattachment, the patient has remaining double vision with impairment of the movements of the right eye. The nerve damage may be permanent. Medical treatment is continuing and the patient has been treated from 10-NOV-2014 until 28-JAN-2015. The patient has not been hospitalized. As a result of the patient's employment, the patient was required to receive the ZOSTAVAX. The patient has been out of work since November 2014 until the present. The patient has a workers compensation claim for these injuries. Compensation: the judge found that the drug was the cause of her injuries. Her physicians have opined that the drug was directly related to the injuries complained of. Upon internal review, retinal detachment with surgery secondary to reaction from ZOSTAVAX vaccine, loss of vision and muscular palsy of the right abducens nerve, ocular nerve and trochlear nerve were considered medically significant. Retinal detachment with surgery secondary to reaction from ZOSTAVAX vaccine, loss of vision and muscular palsy of the right abducens (sic) nerve, ocular nerve and trochlear nerve  were disabling. Additional information has been requested.
Systemic: Fainting / Unresponsive-Severe, Additional Details: pt fainted and fell to floor, was bleeding from nose- was picked up by ambulance following
Information has been received from a physician concerning an 84 year old white female who on 13-OCT-2006 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX. Concomitant therapy included nifedipine, losartan potassium (MSD), albuterol and ipratropium bromide (ATROVENT). On 13-OCT-2006 within minutes to hours of the injection the patient experienced flushing and transient dermatitis on the face, arms and legs. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. 6/17/10 Additional information has been received by the physician indicating that the "reaction turned out to be from taking NIACIN, which the patient bought by accident instead of THIAMINE". No further information was reported.
p/ pt vax 4 days later pt exp diarrhea. pt sought unspecified medical attention
ACT-HIB was mixed with an expired diluent and was administered to a patient with no reported AE; Initial information was received on 12-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 8 months old female patient who stated act-hib was mixed with an expired diluent and was administered to a patient with no reported ae after receiving HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (Ipol [POLIO VACCINE INACT 3V (VERO)]) and pneumococcal vaccine 13V (PNEUMOCOCCAL 13 VALENT VACCINE) for Immunisation.  On 28-Mar-2023, the patient received a Dose 2 of 0.5 ml Total of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot U7251AA/UJ647AA, expiration date: 05-Mar-2023/30-Mar-2023) Strength: standard via intramuscular route in Left Quadracipe for prophylactic vaccination (Immunisation).  On 28-Mar-2023, the patient developed a non-serious event of ''act-hib was mixed with an expired diluent and was administered to a patient with no reported ae'' (Poor quality product administered) (same day) following the administration of HIB (PRP/T) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.