chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shivers; This case was reported by a consumer via interactive digital media and described the occurrence of shivers in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shivers. On an unknown date, the outcome of the shivers was unknown.   It was unknown if the reporter considered the shivers to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got really bad shivers after Shingles shot, but the patient would do it all over again as it was still better than getting shingles.
she is still experiencing a lot of pain in her head/ also her neck and her head; she is still experiencing a lot of pain in her head, her ears and her arm and arm pit; she is still experiencing a lot of pain in her head, her ears and her arm and arm pit/ her armpit area is giving pain; Her arm pit is swollen like a gland might be flared up; pain in the arm; her armpit area is giving pain, also her neck and her head; pressure in her ears/ eardrums are cold; her ear are giving her discomfort; she's having chills that come and go; hasn't eaten anything since Saturday; fever; Ache; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6205, Expiration date: Jun2021), via an unspecified route of administration in the right arm on 27Feb2021 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization. The patient medical history included surgery- hole in ear drum from previous surgery and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9264, Expiration date: May2021), via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunization. The patient stated, she would like to check on some side effects that she was experiencing and how long they were supposed to last. Yesterday (27Feb2021) the fever broke, she had a lot of pain in the arm, her armpit area was giving pain, also her neck and her head, she also stated that it was not a headache it like, if your brain was hitting your skull, rattling, her ear were giving her discomfort and also her eardrums were cold, she was having chills that come and go but nothing compared to what it was. She also had not eaten anything since Saturday (27Feb2021). She further stated that, she got it on Saturday and since then Saturday and Sunday she spent in bed with fever, aches, and normal stuff of what was to be expected but now it was Tuesday and she still had really bad aches, she was over the fever, that broke yesterday morning she would say but she was still experiencing a lot of pain in her head, her ears and her arm and arm pit. Her arm pit was swollen like a gland might be flared up. Her arm, her neck and her head hurt. Her head was like not like a headache, it was a feeling as if she could feel her brain hitting her skull type of pain. She had a hole in ear drum from previous surgery but she had never had this much pressure in her ears. The clinical outcome for event prexia was resolved on an unspecified date in 2021, not resolved for aches, she is still experiencing a lot of pain in her head/ also her neck and her head, she is still experiencing a lot of pain in her head, her ears and her arm and arm pit/ her armpit area is giving pain, pain in the arm and unknown for all other events.  No follow-up attempts are possible. No further information is expected.
nose tickling; spasming in sinuses; unusual side effects with throat; swollen gums; breathing was inflamed; This is a spontaneous report from a non-contactable consumer.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunisation. Medical history included Lyme's disease, inflammation/high sed rate (inflammation/high sed rate).  The patient's concomitant medications were not reported.  The patient received vaccine last Saturday and within an hour developed nose tickling, spasming in sinuses, unusual side effects with throat, not sore throat and not swollen lymph nodes, swollen gums, breathing was inflamed for a few days.  He states its "not anything like anaphylaxis." The outcome of the event was breathing was inflamed was not resolved, while the outcome of the other events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
7/4/23 - fever 100-102F, stopped Thursday  7/6/23 Everyday since 7/4/23 +sleeplessness every night +emotional and irrational +confusion with tasks that he didn't have issues with before +repetitive behavior (unable to move on from certain topic, repeating phrases "pick up daddy") - new behavior +anxiety (new behavior)  7/11/23 first time seizure at swimming lessons (not first swimming lesson)
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old female patient who received unknown volume (reported as 0.5 ml) of vaccine FLUZONE QUADRIVALENT (lot UJ035AB and expiration date 30-Jun-2019) via intramuscular route in the left arm on 16-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Underdose and Syringe issue. It was also reported that some of the medication came out through a crack or where the needle attaches, unknown exactly how it came out. "It squirted out" was the term used for description. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. List of documents held by sender: none. Follow up information received from nurse on 16 Oct 2018. No new information reported.
Pain and tenderness of left axillary region (left armpit). No swelling or nodules noticed by patient.
Pneumonia; Meningitis; Sepsis; Probable lupus; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia), MENINGITIS (Meningitis), SEPSIS (Sepsis) and SYSTEMIC LUPUS ERYTHEMATOSUS (Probable lupus) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization prolonged and medically significant), MENINGITIS (Meningitis) (seriousness criteria hospitalization prolonged and medically significant), SEPSIS (Sepsis) (seriousness criteria hospitalization prolonged and medically significant) and SYSTEMIC LUPUS ERYTHEMATOSUS (Probable lupus) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized on 24-May-2021 due to MENINGITIS, PNEUMONIA, SEPSIS and SYSTEMIC LUPUS ERYTHEMATOSUS. At the time of the report, PNEUMONIA (Pneumonia), MENINGITIS (Meningitis), SEPSIS (Sepsis) and SYSTEMIC LUPUS ERYTHEMATOSUS (Probable lupus) had not resolved.            Concomitant medication were not reported. No known allergies for the patient. No treatment information was provided. The reporter stated that the patient is currently admitted in a hospital on a critical condition. The patient was first hospitalized last month on 14 May 2021, and was discharged on 18 May 2021. The patient was re-admitted on 24 May 2021 under critical condition. The patient doesn't have the vaccination card and was unable to provide some important details.  Very limited information regarding these events have been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.
sick to stomach; Achy,hurt all over; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (sick to stomach), PAIN (Achy,hurt all over) and HEADACHE (headache) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CETIRIZINE, MELATONIN, MELOXICAM, CITALOPRAM, FISH OIL, VITAMIN D NOS, ZINC and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (sick to stomach), PAIN (Achy,hurt all over) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ABDOMINAL PAIN UPPER (sick to stomach), PAIN (Achy,hurt all over) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.   Reporter did not allow further contact
24FEB93 feverish, chills all day; 25FEB93; felt bad noted 3" annular ring around inject site; headache pain in rt arm & breast; 26FEB93 redness dec arm to just above elbow; cont soreness of rt axilla & rt breast;
Chills, low temperature, shivers, weakness, headache.  Happens every time flu shot has been administered for the past 6 years.
Information has been received from a Registered nurse concerning to a patient (age and gender not reported) who on 13-APR-2016, was vaccinated with dose 1 (reported as "this is the only dose of PROQUAD this patient has ever been administered) of PROQUAD (lot No. K013867) subsequently. The nurse noticed that the patient was inadvertently vaccinated with an expired dose. No adverse effect reported. Additional information has been requested.
patient called and notified us that the was having symptoms of headache, fatigued, weakness, and chest heaviness a day after receiving the Janssen COVID immunization.  Symptoms present for 4 days.  Patient sent to ER for evaluation of chest heaviness on 4/13/2021 when patient called office.
rash at site, fever, chills, dizziness, body ache and cellulitis
Heart arrhythmia and palpitations 96 hrs post-vaccine; Heart arrhythmia and palpitations 96 hrs post-vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection) dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 09:00 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunization. Medical history of the patient was reported as none. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 16Jan2021 09:00 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunization. On 14Feb2021 14:00 patient experienced heart arrhythmia and palpitations 96 hrs post-vaccine. Treatment included EKG, cardio. Consult, Holter Monitor, stress test. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency. Patient did not had COVID prior vaccination and didn't tested covid post vaccination. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected
Pain, redness, swelling around injection site. Hot to the touch.  Patient will take diphenhydramine by mouth and use cold packs. Seek further treatment if condition worsens.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 02-SEP-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (unknown strength, route and dose) lot # L019997 with expiry date of 02-DEC-2016. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Mother reported today that 4 to 6 hours after getting the second men B injection patient became pale, dizzy, nauseated, felt achy and felt fatigued. Denied any fever.  This occurred in the evening and she continued to feel some dizziness the next couple of days with some back pain.  Patient apparently did not go to work the next day, but did the second day of receiving the injection.
Information has been received from a registered nurse concerning an approximately 46 year old female with a history of Tetralogy of Fallot repair at age 9, bundle branch block right, mitral valve regurgitation, unspecified thyroid disorder and fibromyalgia who on 11-OCT-2010 was vaccinated intramuscularly with a 0.5ml dose PNEUMOVAX 23 (lot#667912/0933Z). On 12-OCT-2010 the patient returned to the practice complaining of swelling and tenderness below the injection site. Nurse reported that examination of the arm revealed a 4.5 cm erythematous area, slightly raised, with well defined borders. There were no laboratory diagnostics studies performed. At the time of this report, the patient's outcome was recovering. Physician's office would like a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 667912/0933Z were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from the registered nurse concerning the 46 year old female patient with no illness at time of vaccination, no preexisting allergies, birth defects or medical conditions and no adverse events following prior vaccination. The nurse reported that on 12-OCT-2010, the patient experienced local erythema. On 16-OCT-2010, the patient recovered from local erythema. There were no laboratory tests or diagnostic studies performed. This is one of several reports from the same source. No further information is available.
Vaccinated and I still have an outbreak/Suspected vaccination failure; Still have an outbreak; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had complications from years ago and stated that shingles were terrible.  The patient reported that shot was not available when he/she got shingles. The patient was vaccinated with Shingles vaccine and still had an outbreak for time to time. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous report as received from a physician and healthcare worker refers to a 18 years old male patient. It was reported that a second dose of GARDASIL was administered to the patient exactly 4 weeks after the first dose. The patient was vaccinated with the first dose of GARDASIL (lot# unspecified) on 04-JAN-2013 and the second dose of GARDASIL (lot# unspecified) on 01-FEB-2013. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. The outcome of the event was unknown. Additional information has been requested
Information has been received from a physician concerning an 1 yea old male with no past medical history and no known drug allergies who on 09/07/2001 at 13:15 was vaccinated SC in the right leg with the first dose of varicella vaccine. Concomitant vaccination the same day included a first dose of MMR vaccine given SC in the left leg. There was no illness at the time of vaccination. On 09/11/2000, "four days later," the pt developed a temp of 103 deg F, rectal. On 09/19/2001, it was reported that the temperature decreased, "but has not resolved totally at present." There were no other symptoms noted. Follow-up information reported that on 09/16/2001, the pt developed the increased temp of 103 deg Rectally and on 09/19/2001, the pt was seen in the office. Subsequently, the pt recovered.
The patient was pregnant while receiving this shot. I would estimate 7 or 8 months.  Adverse events were reported to the board of pharmacy. the patient did not report them directly to us, but it is known that some kind of prolonged joint/muscle pain occured, for an unknown period of time
After receiving the shot on 7/23 a round solid bump formed at the injection site. Two inches in diameter. Baby did not want his leg touched. On 8/8 baby developed fever of 104, followed the next day by lower 100 and vomiting and diarrhea. Baby was screaming continuously, and louder than he ever had prior. Unable to console. Screaming would go on and off for several hours until he was exhausted. Loss of appetite, regression in motor skills (walking stopped), less verbal.  8/13 slight body rash.
The symptoms I had were coughing, and stuffy nose. It was like a bad cold. I would have taken cold medication at that point. I wasn't that hungry, so I didn't eat that much. I didn't sleep well but that's not unusual for me. I did take Paxlovid.
The pt's skin in the area around the shot is turning yellow. No pain or inflammation in shot area.
Brachial neuritis 2-3 weeks post vaccine onset. Tx: Analgesics, steroids, MRI, upper plexus distribution. Severe pain, muscle atrophy (c 5-6 distribution), weakness 3 month duration. 70-80% recovery of muscle strength.
Patient called stating that she received the pneumococcal vaccine on 8/24/2018 and her left arm became very sore, swollen, red, and she could barely stand the pain that she had to take a pain pill; stated she also iced it several times. Myalgia and erythema multiform.
Developed tender red bump on 9/28/19 on right upper abdomen. Then felt pain on her right flank and saw a similar red bump posteriorly. Pain radiated around torso like "nerve is burning".
Diffuse pruritic rash; fever, agitation (rash: papular, round, 4-6 mm in diameter, some with vesicular centers)-ongoing. Prednisone 15mg/5ml, 3cc po x 5d.
Dizzy, light headed, pale, sweating, clammy - patient did pass out for ~30-45 sec.
Fever up to 101.2 for 24 hrs,  muscle aches, headache, rash and swelling at and around injection site, Sore arm and lymph node in same arm
YF VAX ADMINISTERED INTRAMUSCULARLY ON 5-1-2023 INSTEAD OF SUBCUTANEOUSLY  PT CAME BACK TO PHARMACY FOR TYPHIM VACCINE ON 5-4-2023 AND PHARMACIST DISCOVERED THE ERROR.   PT INQUIRE IF TINGLING IN HANDS IS ASSOCIATED WITH YELLOW FEVER. PHARMACIST INFORMED HIM "NO" BUT I CAN REPORT THESE SYMPTOMS TO HIS DOCTOR WHO ISSUED THE PRESCRIPTION FOR YELLOW FEVER  DR OFFICE INFORMED ON 5-4-2023 TO FOLLOW UP WITH PT  SANOFI WAS CONTACTED ON 5-5-2023 AND THEY INFORMED US THAT YF VAX IS STILL VALID DOSE AND DOESNT NEED TO BE REPEATED. PTS MOTHER WAS INFORMED
positive for covid; positive for covid; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), (Lot number not reported) via unspecified route of administration on 21Mar2021 as SINGLE DOSE for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. On unspecified date patient tested positive for COVID. Patient was about the Pfizer vaccine. Patient and his daughter (female, age 17) received their first dose on 21Mar2021. Caller was scheduled for his second dose today (18Apr2021). He and his daughter were tested positive for covid. He got negative test results last Friday on 09Apr2021. His daughter tested negative on 06Apr2021. Patient asked can I go for my vaccination today. I travelled outside the country so I may have gotten covid because of that. My daughter lives with me so she may have gotten it from me. Outcome of the events was unknown.  Information about lot/batch number has been requested.
It was reported that a patient (2 of 2) received a TD Adult vaccination on 08/28/2000. Reportedly that same day the pt complained of tightness in the throat. No specifics provided. Further info requested.
6 weeks postpartum. Severe pain. Went to ER. Confirmed appendicitis with CT scan with contrast and had appendectomy a few hours later.
This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in a 65-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history included heart transplant and hemodialysis. Concurrent medications included Epoetin alfa (Epogen), Paricalcitol (Zemplar), Venofer, Azathioprine (Imuran), Losarten potassium (Cozaar), Lisinopril, Cyclosporin (Neoral), Quetiapine fumarate (Seroquel), Diazepam, Clonidine, Docusate, Prednisone, Metoprolol succiante (Toprol) and Fioricet. On 04 September 2006, the subject received the 1st dose of Engerix-B. On 02 October 2006 the subject received 2nd dose of Engerix-B. On 04 October 2006, 2 days after vaccination with the 2nd dose of Engerix-B, a blood sample revealed that the subject was hepatitis B surface antigen positive and negative for hepatitis B core IgM, hepatitis B surface antibody, and hepatitis A virus antibody. A repeat blood test performed on 07 October 2006, again revealed that the subject was hepatitis B surface antigen positive and negative for hepatitis B IgM, hepatitis B surface antibody, and hepatitis A virus antibody. At the time of initial reporting, 09 October 2006, the event was ongoing. The healthcare professional considered the event was possibly related to vaccination with Engerix-B.