chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chest tightness; Shortness of breath; Yawning a lot; This is a spontaneous report from a contactable other hcp. A 16-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8729) intramuscular, on 12Apr2021 (at the age of 16-years-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient may have taken some over the counter congestion medication. Investigation assessment was performed. On 12Apr2021, the patient was waiting the 20 minutes after receiving the vaccine and he was yawning a lot. On 13Apr2021, the patient experienced chest tightness and shortness of breath. Chest tightness was reported as worsened. The patient was having a harder time catching his breath, no need for an emergency room visit, it was not severe. The patient yawned a lot but was fine 2 hours later because he went to football practice. The patient's oxygen saturation was 97 percent and spirometer was normal. The patient underwent lab tests and procedures which included oxygen saturation: 97 percent and spirometry was normal on Jul2021. The outcome of the event yawning a lot was unknown. The outcome of the events chest tightness and shortness of breath was not recovered.  No follow-up attempts are needed. No further information is expected.
Patient was given Pfizer Mono-valent instead of Pfizer Bivalent due to pharmacist's mistake. Patient already notified and okay. Pharmacy apologized for the error and informed patient to come back after 2 months.
Why do I still get shingles after I had the vaccines?/Suspected vaccination failure; Why do I still get shingles; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingrix vaccine and still got shingles. 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 was received from a physician, via a company representative, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-OCT-2015, the patient was vaccinated with a dose of RECOMBIVAX HB, "10Pk 5 mcg/0.5 mL SDLLokCap Ped", lot # L016959, expiration date: 12-MAR-2018, (dose number and route of administration were unknown), which was improperly stored. On unspecified date, the RECOMBIVAX HB vaccine had a temperature excursion of 1.11 Celsius Degrees (34 Fahrenheit) for 24 hours. The vaccine status was reported as in excursion and the type of excursion and storage criteria were reported as refrigerator (R). No adverse effects were reported and no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Site: Redness at Injection Site-Mild, Systemic: BUMP AT FOREARM-Mild
Pt developed  lightheadedness, and diaphoresis shortly after vaccination. She has a history of similar reactions with injections in the past. HR72, BP 110/80, SP02: 98%. Pt improved without intervention. No signs to suggest anaphylaxis. Pt elected to drive home.
After administered vaccinations sitting in chair - became limp - pale- fainted - assisted onto floor by nurse and mom - v/s taken - propped up legs - 93  and B/P 98/66 P66 93.8 and 100/60 P60 - color returning to normal, can hear when nurse spoke to him - knows name - where he is at - sat up 94 100/68 P60 sat up in chair - soon assisted to waiting area.
Patient complained of pain in her knees following covid booster vaccine. Reported that pain started soon after vaccine and was still there (although much reduced) 1 week later at time of this report. Just pain, no inflammation or swelling present. Patient also states that she does have arthritic pain for which she undergoes physical therapy for, but had not had pain like this before.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as DOSE 5 (BOOSTER), SINGLE (batch/lot number: unknown) at the age of 74 years old for COVID-19 immunization; Covid-19 vaccine (COVID-19 VACCINE), as DOSE 1, SINGLE (batch/lot number: unknown), as DOSE 2, SINGLE (batch/lot number: unknown), as DOSE 3 (BOOSTER), SINGLE (batch/lot number: unknown) and as DOSE 4 (BOOSTER), SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "high BP" (unspecified if ongoing), notes: Other medical conditions. The patient had no known allergies. Concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19 Treatment." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
shoulder blades were hurting and that pain goes all the way to his lower back of; felt nauseated; fever of 102. degrees; did not have any balance and fell on the bed; lower back pain that shot up to his upper back; Felt dizzy; lower back pain that shot up to his upper back; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), DIZZINESS (Felt dizzy), the first episode of BACK PAIN (lower back pain that shot up to his upper back), BALANCE DISORDER (did not have any balance and fell on the bed) and the second episode of BACK PAIN (lower back pain that shot up to his upper back) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 01-Jan-2021, the patient experienced DIZZINESS (Felt dizzy), the first episode of BACK PAIN (lower back pain that shot up to his upper back) and the second episode of BACK PAIN (lower back pain that shot up to his upper back). On 02-Jan-2021, the patient experienced BALANCE DISORDER (did not have any balance and fell on the bed), NAUSEA (felt nauseated) and PYREXIA (fever of 102. degrees). On 07-Jan-2021, the patient experienced ARTHRALGIA (shoulder blades were hurting and that pain goes all the way to his lower back of). On 02-Jan-2021, PYREXIA (fever of 102. degrees) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurt), DIZZINESS (Felt dizzy), BALANCE DISORDER (did not have any balance and fell on the bed), the last episode of BACK PAIN (lower back pain that shot up to his upper back) and NAUSEA (felt nauseated) outcome was unknown and ARTHRALGIA (shoulder blades were hurting and that pain goes all the way to his lower back of) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2021, Body temperature: 102 °F (High) 102 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The reporter was patient's husband. The age at vaccination was not reported. The reporter did not consent to follow-up. The case has been linked to US2020222174, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222174:same reporter
6 days after vaccination she said redness, warmth, slight swelling and pain appeared in the general area of the vaccination site. She saw her physicians P.A. and was prescribed minocycline.
MD rpt pt recv 1dose varivax 1/26/96 & in 5/98 pt exp chickenpox
Swelling of right deltoid, warm and tender to touch. Mother denies any previous vaccine reaction in the past or any accompanying fever with this reaction.
Initial and follow up information has been received from a physician, via a company representative and a registered nurse, concerning a 18 week old white female infant with no illness at the time of vaccination and no medical history, who on an unspecified date was vaccinated with a first dose of COMVAX.  On 26-OCT-2007 the patient was vaccinated with the second dose, "7.5mcg," of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (lot # 657380/0377U) IM in the right leg.  There was no concomitant medication.  On 27-OCT-2007 the mother noticed that the injection site looked like a "spider bite" and advised the physician of this.  The redness lasted approximately 10 days (approximately 05-NOV-2007).  There was also a lump under the skin at the site.  Treatment included warm compresses.  At the time of this report, the infant continued to have a slight lump at the injection site.  The physician indicated that the infant was recovering from the lump.  This is a consolidation of two reports (WAES # 0801USA01136 and 0801USA03412) concerning the same patient.  No further information is expected.
Dizziness, Headache, Fever, NauseaVomiting,  headache, lethargic, vomiting fever, body soreness, light-headed
Patient with fever of 104 degrees. Parents brought child to ER no rash or redness at the sight of injection. Just fever.
I had a breakthrough COVID-19 case. I had extremely mild symptoms. I had received exposure from my wife. No medication or treatment have been necessary at this point. I did have weakness but that was followed from exercise and exhaustion.
@ <1 wk after 2nd covid shot (~4/2/21), extreme increased hearing sensitivity to all sounds including a person normally speaking - hurting ears/discomfort 4/24 - Sudden onset of major vertigo/dizziness, loss of balance, ringing in the ears, and sudden loss of hearing in left ear
Severe pain in joints. Supplements from holistic doctor. Lyme's disease diagnosis and after 8 months of supplements and electromagnetic therapy the pain has significantly decreased.
Total body muscle and joint pain High fever (103) Severe Headache Lasted about 55 hours
VERY sore left thigh and groin area, back and front. /could hardly walk. It has been 3 months. Still sore thigh. Awake at night from it.  Had an ultra-sound, found nothing.  Had an x-ray and was listed some strange stuff. Not a hip like my dr insisted.  Still thigh hurting to walk.  Groin pain is gone.  Where do I go from here.  Should I take pain pills  Why does it still hurt after 3 months.  The first shot I received on 2/24/21 had no problems? Moderna was the vaccine.
Chills, Fever, Vomitting, Headache, Muscle and Joint Pain, Fatigue, Rapid Heart Rate
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. On an unknown date in November 2014 the patients were vaccinated with doses of ROTATEQ (strength, dosage, route, lot number and expiration date were not reported), that were exposed to a supported temperature excursion since 05-NOV-2014. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy,Feeling dizzy (dizziness)), ASTHENIA (Weak,Weakness), TACHYCARDIA (Tachycardia/fast heart rate), HYPERTENSION (Hypertension/elevated Blood pressure) and HYPERSENSITIVITY (Allergic reaction) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 041L20A and 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Nov-2021 at 3:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSENSITIVITY (Allergic reaction). On 15-Nov-2021, the patient experienced DIZZINESS (Dizzy,Feeling dizzy (dizziness)), ASTHENIA (Weak,Weakness) and HYPERTENSION (Hypertension/elevated Blood pressure). In November 2021, the patient experienced HEADACHE (Headache). On 15-Nov-2021 at 7:55 AM, the patient experienced TACHYCARDIA (Tachycardia/fast heart rate). At the time of the report, DIZZINESS (Dizzy,Feeling dizzy (dizziness)), ASTHENIA (Weak,Weakness) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown and TACHYCARDIA (Tachycardia/fast heart rate), HYPERTENSION (Hypertension/elevated Blood pressure) and HEADACHE (Headache) had not resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 15-Nov-2021, Blood pressure measurement: 200/100 (High) High.On 15-Nov-2021, Electrocardiogram: normal (normal) normal.On 15-Nov-2021, Heart rate: 137 (High) High.No concomitant medications were provided.No treatment information were given.This case was linked to MOD-2021-389097, MOD-2021-389098 (Patient Link).
Very painful and a lot of swelling at injection site.  Then tiredness, achyness, headache, muscle aches, joint pain, vomiting.
This spontaneous report was received from a pharmacist referring to a 70 year old female patient. The patient did not have concurrent conditions, medical history or drug reactions. On 18-APR-2016, the patient was vaccinated in her left arm with a dose of ZOSTAVAX 0.65 ml, subcutaneously, lot # L033311, expiration date on 01-DEC-2016 (dose number was not provided). The patient did not take concomitant medications. On an unknown date, the patient experienced injection site rash, reported as: "2.5 to 3 inches oval rash on her left arm". NEOSPORIN was given for the adverse event. The outcome of injection site rash was reported as not recovered. Additional information has been requested.
First night, low energy, upset stomach, brain fuzz. Next day, chills and fever, nausea, heart pain, headache. 3rd day, same, but no heart pain. By 5th day all okay, except some cognitive issues (slower thinking, searching for words, poor memory) still with me on May 3, these are subtle changes, but it's obvious to me they began after this vaccine shot.  SERIOUS REACTIONS BEGAN AFTER 2ND COVID SHOT ON 2/26/2021: Pain in neck, hips, head, down left leg. Diagnosed as inflammation and bursitis in left hip, which still remains in May and limits my life in the extreme.
Sick after first shot for four days tired achy. Two weeks after second shot I begain having ear problems and ear aches and fluid in the ear. Ringing in the hear and minor hearing loss in right ear.  Coughing and extreme fatigue. Treatment has been pendi ng since Oct 13th.  Antibiotics, predisone, nasal inhalers given. Still in treatment.
Moderate to severe nausea, headache, fatigue day 2 through 7 after vaccine; intermittent nausea through present, worsened last week
diagnosed with Covid; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (diagnosed with Covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 COVID-19 (diagnosed with Covid). At the time of the report, COVID-19 (diagnosed with Covid) 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.
Developed hives all over body that got worse as week went on. Swelling of hand and feet as well.  After first week, symptoms got better but have not gone away. First week was taking a medrol pack along with Benadryl and Zyrtec to alleviate  symptoms.  Currently in week four of this affect but is controlled by taking Zyrtec daily to every other day.
PT GIVEN BOOSTRIX VACCINE DUE TO INCORRECT ENTRY TO PHARMACY SYSTEM. PT CONFIRMED DESIRE TO RECEIVE BOOSTRIX DURING PRE-ADMINISTRATION PERIOD WITH PHARMACIST, BUT REALIZED THIS IS NOT WHAT SHE WANTED AFTER ADMINISTRATION. ROUGHLY 2 HOURS AFTER VACCINATION, PT REPORTED LEFT ARM SHOULDER-TO-WRIST PAIN/FAINT NUMBNESS. PT CALLED HER DOCTOR AND TOOK 2 TYLENOL AS ADVISED BY DOCTOR. VACCINES WERE APPROPRIATELY SPACED IN LEFT ARM DURING ADMINISTRATION BY PHARMACIST.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Since 23-JUN-2015, the patients were vaccinated with doses of ROTATEQ lot # K022990, expiration date: 26-JUN-2016 which were exposed to temperatures outside of the recommended range. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Immediately after the introduction of the vaccine, uncontrolled speech and dizziness appeared. I've talked a lot. I realized what I was saying. I couldn't control myself to be silent. She could only be silent when she turned her attention to reading the book. On the night of the same day as the vaccination, the temperature rose to 40. There were convulsions. Chills. Feeling that waves are rolling through the body and liquid is spreading. The muscles throughout the body felt as tightly squeezed into a ball with pain and sharply unclenched. Then there was a feeling that the body was paralyzed and the lungs also began to move with difficulty. It became difficult to breathe. In the morning there was a temperature of 38.5. Weakness. Dizziness. Nausea. Took paracetamol. On the second day after vaccination, there was a feeling that fluid had accumulated in the lungs and they hurt with every inhalation and exhalation. I couldn't get air into full lungs. The pain is similar to muscle pain. During the day, I took paracetamol 4 times to bring down the temperature, which rose above 38. On the second night, it was difficult to breathe. Today is the 3rd day. Dizziness remains. And the temperature remains up to 37, 3-37, 6.
So one day I noticed that my arm was itchy at the injection site which it had not been before. I noticed later that it was getting red and hot, so I drew a circle around it, to make sure it didn't spread more. The next day it was bigger so I went to the clinic.  The doctor saw it and said it was cellulitis and because of my history of allergies to anti-biotics she put me on bactrim.
Soreness at injection site the evening of the injection, the next day increased soreness, swelling and redness at site. On second day after, increased area of redness, increased discomfort enough to cause difficulty in raising arm. Warmth at injection site started the next day and continued for 3 days. By third day after injection, redness and swelling the size of a tennis ball. Painful  to move arm.
1/15/21  Chills a few hours later after vaccine 1/16/21  temp 99.9 despite Tylenol, nausea, shoulder, chest pain, cold sore call out sick on 1/16 and 1/17
Information has been received from a pharmacist referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 09-MAY-2016 the patient was inadvertently vaccinated with a dose of expired PNEUMOVAX23  (lot # K016294, expiration date: 28-APR-2016) (dose and route unspecified). No adverse effects reported. Additional information has been requested.
Patient had a seizure episode about 50.5 hours after receiving immunization shots. Father described episode: generalized tonic seizure with loss of consciousness, rolling of eyes and foaming mouth. Loss of consciousness for 2-3 minutes. No fever, no postietal period.
Bumps that appear in 3 first site right foot on top  2 nd location right arm  above elbow in back 3rd location left arm above hand in rear  4 th location stomach 5 th  location  left shoulder
SLIGHT HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (SLIGHT HEADACHE) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine headache. Concomitant products included RIZATRIPTAN for Migraine headache.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (SLIGHT HEADACHE). At the time of the report, HEADACHE (SLIGHT HEADACHE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
This case was reported by a consumer via call center representative and described the occurrence of blood pressure high in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 26th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced blood pressure high. On an unknown date, the outcome of the blood pressure high was not recovered/not resolved. It was unknown if the reporter considered the blood pressure high to be related to SHINGRIX. Additional information was provided as follows: The patient reported this case for himself. The reporter indicated that he had experienced high blood pressure since receiving SHINGRIX vaccine on the morning of 26th February 2019. The same day he received the vaccine, he had his yearly physical and his blood pressure was 118/74. In the morning of reporting day, blood pressure was 150/92. The reporter said it had been elevated at other times since having the vaccine, too. The patient had a new blood pressure monitor and did not feel that there was any wrong with it. The reporter consented to follow up. This case linked with US2019057155, reported by same reporter for his wife.