chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had shingles 4x. Had the shots in between /Suspected vaccination failure; shingles 4x; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingles 4 times and had the Shingles shots in between too. The patient enquired how about those vaccines and asked if they worked. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Extreme chest pain. Inflamed and swollen area under left arm pit. Fever. Headache. Malaise. Whole body muscle aches and pain. Nausea. Exhaustion upon exertion. Bed bound for 36 hours. Swollen and painful nodule formed in left hand. Felt as if my heart was going to quit. Truly terrifying experience. Continue to feel compromised in terms of stamina, even to this date. Heart feels like it "jumps" inside my chest at times and beats irregularly.
Persistent fatigue, body aches, sleep onset, sleep-maintenance insomnia, random brief and sharp body pains.
Patient started with redness on left arm and swelling.  Advised to use cold compress on the arm and Tylenol for pain.
Vaccines given at 0900. Fever, chills, nausea, vomiting started at 1100. Presented to clinic at 1200. Given Tylenol, Zofran and IV fluids. Discharged from clinic around 1500.
Chills; Fever; Patient developed fever and chills for 3 days after receiving Tdap.
bruise showed up on the calf muscle of the back of her left leg and oddly enough it showed up after the vaccine; feels like knot is in that left leg and it is painful; feels like knot is in that left leg and it is painful; This is a spontaneous report from a contactable consumer or other non hcp. This report is in reference to the reporter's mother. This is report 2 of 2.  A 64-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EN6207, Expiry Date: unknown), via an unspecified route of administration, administered in Arm Left on 19Mar2021 13:00 (at the age of 64-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No prior vaccinations within 4 weeks. On 20Mar2021 the patient experienced bruise showed up on the calf muscle of the back of her left leg and oddly enough it showed up after the vaccine, feels like knot is in that left leg and it is painful. On 15Mar2021, the patient underwent lab tests and procedures which included Covid 19 virus test, sars-cov-2 test: Negative. The outcome of events recovering.   No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 16Oct2023 to 20Oct2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350724 same patient, different drug/event;
BUMPS; ACHE; ITCHING; RASH; HIVES; SORE MUSCLES; TIRED; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. Concomitant medications included lorazepam for diabetes, and metformin for diabetes. On APR-2021, the subject experienced bumps. On APR-2021, the subject experienced ache. On APR-2021, the subject experienced itching. On APR-2021, the subject experienced rash. On APR-2021, the subject experienced hives. On APR-2021, the subject experienced sore muscles. On APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itching, rash, hives, ache, sore muscles, tired, and bumps. This report was non-serious.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a elderly male patient who received SHINGRIX (batch number 424A7, expiry date 18th April 2021) for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site pain, general body pain and fever. On an unknown date, the outcome of the injection site pain, general body pain and fever were unknown. It was unknown if the reporter considered the injection site pain, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. These symptoms began the day after vaccination and lasted 24 hours. The patient was symptom free up until 6 days later where the patient began experienced the same symptoms again. The reporter did not consent to follow-up.
red blotch on her shoulder; tired; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotch on her shoulder) and FATIGUE (tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 006B21A) for COVID-19 vaccination.     The patient's past medical history not included . Concomitant products included OMEPRAZOLE and HYDROCHLOROTHIAZIDE, Cartia XL  for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) . On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .  On 10-Mar-2021, the patient experienced RASH MACULAR (red blotch on her shoulder) and FATIGUE (tired). On 10-Mar-2021, RASH MACULAR (red blotch on her shoulder) and FATIGUE (tired) had resolved.    The patient received both scheduled doses of mRNA 1273 before the events, therefore Action taken with mRNA-1273 in response to the events was not applicable.
Patient reports feeling fatigued 6-8 hours post injection, lasting 3 days. He reported this to the pharmacy 7 days later. He is fine now.
Information has been received from a healthcare worker (immunization official) referring to a 3 year old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 10-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K015970 (expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Joint aches, especially in fingers/hands/feet; fatigue; flu-like "not feeling well", some nausea/upset stomach - about 2 days.
Localized erythema to injection site.  Suspect cellulitis.  Prescribed Keflex 800mg 1 pill three times a day for 10 days.
Twitching in upper left arm where the shot was administered, the muscle started twitching as soon as the needle was removed; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old-male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 08Mar2021 at 13:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 08Mar2021 at 13:15, the patient experienced twitching in upper left arm where the shot was administered. The muscle started twitching as soon as the needle was removed and had continued since then. The twitching was not constant but had been persistent since 08Mar2021. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was reported that the patient did not receive any treatment for the event. The clinical outcome of the event muscle twitching was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Felt bad the day after the vaccine; This is a spontaneous report from a non-contactable consumer (patient). This is the 2nd case of the two cases. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date, as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced felt bad the day after the vaccine. The patient did not know about the injection site though and she did not feel well, that was the day after her second inoculation. The outcome of event was unknown.
Patient received GARDASIL 9 vaccine at approximately 11:45 am on 5/29/15. Immediately after injection was given patient began to complain of dizziness then passed out. Per patient's mother, patient began to come to after a few seconds. Patient was monitored and vitals were taken. Patient reported that he was feeling better within a few minutes. Around 12:15 pm on 5/29/15 patient reported that he felt like "he might get lightheaded". EMS was contacted at that time and patient transported to the emergency room. Patient discharged from ER same day. Patient's mother contacted our office 5/30/15 advised staff patient was doing better.
Muffled hearing; Loud ringing in right ear; This is a spontaneous report from contactable consumer, the patient. A 16-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW01076) via an unspecified route of administration in the left arm on an unknown date in May2021 at 18:15 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. 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. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for an unknown indication from an unknown date and unknown if ongoing. On 05May2021 at 07:00, the patient experienced muffled hearing and loud ringing in right ear. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events muffled hearing and loud ringing in right ear were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
dizziness,dizziness is worse; can't stand up; cannot eat; very weak; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness,dizziness is worse), BALANCE DISORDER (can't stand up), EATING DISORDER (cannot eat), ASTHENIA (very weak) and VOMITING (vomiting) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced BALANCE DISORDER (can't stand up), EATING DISORDER (cannot eat), ASTHENIA (very weak) and VOMITING (vomiting). On an unknown date, the patient experienced DIZZINESS (dizziness,dizziness is worse). At the time of the report, DIZZINESS (dizziness,dizziness is worse), BALANCE DISORDER (can't stand up), EATING DISORDER (cannot eat) and VOMITING (vomiting) outcome was unknown and ASTHENIA (very weak) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient were not provided. Patient had experienced dizziness on 16 Mar 2021 ant the dizziness was worse on 17 Mar 2021. Treatment information was not provided.
Patient received second Materna vaccine 5/28/2021 around 630 pm.  Around 10 PM felt fatigue and headache.  Felt very fatigued and unwell and slept most of 5/29 - 5/30. On 5/31, began experiencing chest discomfort radiating to left arm and palpitations.  Presented to hospital which was notable for abnormal EKG with diffuse ST elevations and PR depressions, troponin peak of 25.  TTE revealed low normal systolic function with EF 50%, no valvular disease or wall motion abnormalities.  Cardiac MRI revealed subepicardial delayed myocardial enhancement in the mid, apex lateral wall of the left ventricle and adjacent pericardium consistent with myopericarditis.  Patient was treated with colchicine and improved.  Infectious work-up for cardiotropic viruses were sent, viral swab was notable for positive rhinovirus/enterovirus.  Patient's presentation and timing of vaccine should be looked into as it is unclear wheter this presentation can be entirely due to presence of virus as above.  This is notably at least the second presentation of teenager with myopericarditis on this cardiology service in the past 2 weeks in setting of recent Covid vaccination.
I had a severe headache daily. I had fatigue and chills that eventually went away. On Jan 1st, the symptoms returned with a fever of 104, muscle aches and achy joints. Tylenol and Ibuprofen would only help it to go down to 101 or 102, but it would go back up. I went to urgent care around the 3rd, where they tested me for COVID but it was negative. I was still having symptoms days later, so I called my PCP. My doctor decided to do another COVID and a flu test, but both were negative. I gradually improved and then once I was fever free for 72 hours, I returned to work. I still had the headache, though. I am continuously completing my vsafe checks, but I was scared about getting the 2nd dose.  I went ahead and got it.  I had fever, chills, body aches and joint pains, but it only lasted two days.
Prolonged type of diarrhea that I have never experienced before; Experienced stomach pain; Stomach rumbling; Diarrhea is strange, bad and explosive; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Prolonged type of diarrhea that I have never experienced before), ABDOMINAL PAIN UPPER (Experienced stomach pain), GASTROINTESTINAL SOUNDS ABNORMAL (Stomach rumbling) and DIARRHOEA (Diarrhea is strange, bad and explosive) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 18-Feb-2021, the patient experienced DIARRHOEA (Prolonged type of diarrhea that I have never experienced before), ABDOMINAL PAIN UPPER (Experienced stomach pain), GASTROINTESTINAL SOUNDS ABNORMAL (Stomach rumbling) and DIARRHOEA (Diarrhea is strange, bad and explosive). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Prolonged type of diarrhea that I have never experienced before), ABDOMINAL PAIN UPPER (Experienced stomach pain), GASTROINTESTINAL SOUNDS ABNORMAL (Stomach rumbling) and DIARRHOEA (Diarrhea is strange, bad and explosive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Pt came into office and never was immunized. She was going to camp and needed imms. Dr. Asked nurses to work on seeing what imms could be given due to ins. Dr. Put a box around DTap and checked off TDAP And put the order in the door with a flag up. Dr. didnt inform us (the Medical assistants) of what the nurses were doing. The Tdap was given by mistake when the pt should have got TD. Pt had no reaction to the immunization. Was explained to the mother. Problem was the lack of communication between the doctor, nurses, and medical assistants.No treatment was necessary.
redness, swelling with palpable firmness, and erythema (10-12cm) around site of injection
There were no symptoms until much later in the evening. Around 8:30 PM, I felt fatigued. A little later I had chills for about 30 minutes. Then I felt nauseous and went to the restroom down the hall (I was living in a dorm). I did not throw up, but I had a pounding headache which only got worse. I also felt very hot and the cold floor was welcoming. I laid on the floor in the bathroom but felt too awful to sit up. Someone found me in the bathroom around 10:00 PM and called campus safety, which came about 20-30 minutes later. She determined that she could not give me medication on the spot and that she had to take me to the hospital. We arrived at the ER around 10:45 PM. The nurses and doctor took my temperature and found I had a 103-degree fever. Because of my pounding headache, I couldn't hear very well. The doctor gave me a shot of 60mg of Toradol at 10:56 PM. He then gave me instructions to alternate tylenol and ibuprofen every 3 hours, increase my fluids, and only do activity as can be tolerated. I left the hospital around 11:25 PM with a huge headache, but better than when I initially walked in.
Within 10 minutes of injection, light headed feeling faint.  Lasted 20-30 minutes. Next day bad headache, flu like symptoms. No fever. Lethargic.
5/22/2021   Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  dizziness.   Assessment : Time of assessment 1218. Alert and oriented and voices that she has only had coffee today.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by juice, water and crackers given. . 1218- BP- 162/91, P- 60,  1234- BP- 156 /90, P- 63 1238- 158/94 , P- 64     Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 45 minutes. Discharged home. She has family with her and she is not driving.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 5/22/2021 11:55 AM 0.3 mL 2/25/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: EW0182
This spontaneous report as received from a medical assistant refers to a 17 year old male patient with ZITHROMAX allergy and Ampicillin allergy. No other pertinent medical history was reported. The patient was vaccinated with dose 2 GARDASIL (lot number, dose, frequency and route was unspecified) on 09-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 28-SEP-2012 the patient was diagnosed with intussusception. The patient sought medical attention and was admitted to the hospital on the same day. It was unspecified if the patient received treatment. The outcome of intussusception was reported as recovered on an unspecified date in 2012. The relatedness for intussusception is unknown for GARDASIL. Additional information has been requested.
Paralysis to the left side of face and tongue. Diagnosed with Bell?s Palsy. It started on April 8th 2021 and i still have paralysis on the left side of face. At the beginning I had strong nerve pains on left side of face and I was very sensitive to loud sounds. Left eye lid would  it close naturally and could only smile on right side of face. Had trouble with pronunciation of certain words. Could only eat and drink in right side of mouth.
6 hours after vaccination, patient was throwing up and had diarrhea. She had a low-grade fever and chills. Symptoms persisted throughout the night. I brought her to our regular doctor Tuesday morning. He gave her 2 bags of fluid via I.V. for dehydration. Fever of 101.4 continued through out the day along with diarrhea.
nurse administerd expired Daptacel to 30 months old maile patient, no AE; Initial information was received on 11-Feb-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 30 months old male patient who was administered with an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5366AA, expiry date: 07-Feb-2020) via unknown route in unknown administration site for prophylactic vaccination.  Medical history, medical treatments, vaccinations and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  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 Directive and Module VI of the 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.