chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around 7 pm on 3/13, I developed brain fog, trouble walking, and then fever, severe muscle pain worse in legs, and chills.  Most of these symptoms seemed to improve on 3/14, but then on 3/15, I developed new onset of shortness of breath and chest discomfort.  On 3/16 around 1 pm the shortness of breath worsened and I went to the emergency room.  I felt that I couldn't take a deep breath in and I had chest discomfort on the left side of my chest worse when taking a deep breath.  My legs were hurting as well, especially my left leg.  I had sinus tachycardia (heart rate 106-120) and increased respiratory rate (rate of 20)  with O2 sats 100% on room air.   My breathing and heart rate improved somewhat with 1 liter oxygen therapy, 1 liter of IV fluids, albuterol inhaler, and decadron 6 mg orally.  It was thought that I had a delayed asthmatic/allergic reaction to the vaccine.  I do not have a history of asthma.  I was prescribed a Medrol dose pack and albuterol inhaler.  My hands and feet are very cold and tingling on 3/18.  Shortness of breath and chest pain seems to have improved but not completely gone as of the time of this submission on 3/18.
Decedent is a 7 day old neonate who was given the hepatitis B immunization at birth (Energix B). Lot # AHBVB663AA. Decedent discharged on March 27, 2009 without complications. On March 30, 2009 decedent was taken to pediatrician mild jaundice. Labs taken and was told to come back in two weeks. In the evening of March 31, 2009, the decedent was very fussy, vomiting, and not taking formula. The mother tried comforting the baby all evening of March 31, 2009 and in the early morning hours of April 1, 2009. At approximately 6 AM, the mother felt the baby to be cold (the mother was sleeping with the baby in a possibly compromising position). The mother got up with the baby and walked her around and then when she was going to bed again, she saw the neonate take two deep breaths and become unresponsive. Autopsy revealed a normally developed female neonate with extensive necrotizing eosinophilic myocarditis. I did a literature search and found that hepatitis B vaccine maybe associated with this type of myocarditis and that is why I am reporting it. The cause of death for the death certificate reads "necrotizing eosinophilic myocarditis." I am not including the vaccination because I do not believe there is a direct correlation, but I felt I should report the case for potential correlation. The neonate was never given any prescription medications that I am aware of. Not sure if mother gave anything. 8/26/09-autopsy report received-COD-Necrotizing eosinophilic myocarditis.
This is for the MMR. She almost immediately started to feel tired and drained. There was a significant amount of soreness not just in the shot area but about the entire body. She ran a fever for 2 days and could not move hardly for 3 or 4 days. Her coloring is just now starting to come back after more than a week and a half. She complained the entire time of being so tired and was not in a good place. Till this day the injection spot is still sore.
Shortness of breath, difficulty breathing, hard time catching my breath, can?t take a full or deep breath, lightheaded and dizzy
pt began throwing up right p/taking OPV & threw up all day of the shots;the next day leg was red & mottled & extremely sore;could not walk on it at all & had a fever of 100;took pt to clinic;
Lot # expiration date had been extended and vaccine remained frozen until date of administration.  Vaccine was given 2 days past expiration date.  Moderna consulted and deemed the vaccine viable so revaccination was not necessary.  No adverse side effects were reported by patient.
Initially, myalgias and fatigue.  This was soon followed by acute chest pain.  The symptoms all completely resolved by 6/24/21.
Rash on arms, chest and abdomen. Patient given Depo-Medrol 40 mg IM.
Patient administered an expired vaccine.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Oct-2021 and was forwarded to Moderna on 20-Oct-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine.) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Oct-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 16-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine.). On 16-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications are provide by the reporter.  On 15-oct-2021 vaccine moved to refrigeration, used by on 13-oct-2021.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Non significant follow up received
This spontaneous report as received from a company representative who reported that a physician's office had stored ZOSTAVAX in the refrigerator since 13-JUN-2013. Reporter stated that they had administered one dose to one patient, lot#, dose, frequency and route unspecified. No adverse effects reported. No temperature conditions provided, therefore unable to evaluate ZOSTAVAX at this time. Additional information has been requested.
Extreme: Nausea, Vomiting, Fatigue/Lethargy, Stomach Pain Moderate: Diarrhea, Muscle/Body Aches, Joint Pain
Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium, Additional Details: entire left arm and hand. It was clear to me the shot was administered much too low on the arm and likely hit radial nerve.
Mom reported infant received Prevnar vaccine on 10/17/01. On 10/21/01 she noticed her infant had a mild case of hives on extremities and trunk and face. Approximately 15 hives all total. took infant to PMP on 10/22/01, no treatment indicated. Hives no longer in visible on 10/24/01. No further complications noted.
The pt experienced a light rash on stomach and back of neck and a few on the face. The pt also experienced a slight fever.
Patient developed light headedness and nausea/vomiting shortly after receiving Hep B vaccine.
Approximately 20 hours after took 2nd vaccine, I was lighheaded. This was approx. 9AM on 02/28/21.  I continue to be lightheaded when get up every morning.  One morning around March 2nd was also a little Dizzy.; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left on arm 27Feb2021 at 12:45 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included vertigo from 2009 and labyrinthitis from 2018. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL926S) via an unspecified route of administration in the left arm 03Feb2021 at 10:45 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 28Feb2021 at 09:00, approximately 20 hours after the vaccination, the patient was light headed, he continued to be lightheaded when he get up every morning, one morning around 02Mar2021, the patient was also a little dizzy. The patient had less lightheaded as day goes on. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with special exercise to improve. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event light headed/dizzy was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
flu like symptoms; fever; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms and fever. On an unknown date, the outcome of the influenza-like symptoms and fever were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient took one dose of Shingrix and developed flu like symptoms and fever. This happened a few months ago and the patient was fine.  The patient had the dose at a pharmacy, it wasn't at reporter's office. The reporter gave permission to follow up.
Fever of up to 104 degree Fahrenheit. Redness, swelling, hardness, heat-at the area on the leg-thigh. Lethargic, loss of appetite. Treated with BENADRYL and TYELNOL.
This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On unknown dates, the patients were vaccinated with 4 improperly stored doses of VARIVAX (lot # M034583 with an expiration date of 27-JUL-2018, and  lot # reported as M373008  with an expiration date of 25-AUG-2018; strength, dose and route of administration were not provided) for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 56 minutes at a temperature between 14 and 46 degrees Fahrenheit on an unspecified date. No previous temperature excursion was reported and a data logger issue was involved. Additionally, a product quality complaint (PQC) was not reported. Additional information is not expected because there was no consent to contact the physician.
Patient (10 yo) received an adult Pfizer vaccination. Pt was observed and no reaction occurred
Information has been received regarding a case in litigation from a lawyer and a female patient referring to herself. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The female patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2010, the patient was administered the ZOSTAVAX by a healthcare provider at a medical office (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at a medical office for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to self and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
FEVER; LOWER BACK ACHE; FEELING UNWELL; CHILLS; ABDOMINAL PAIN RADIATING TO BACK; BODY ACHE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 16:00:00 for prevention of covid-19. No concomitant medications were reported. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced abdominal pain radiating to back. Treatment medications included: paracetamol. On 08-MAR-2021, the subject experienced lower back ache. On 08-MAR-2021, the subject experienced feeling unwell. On 08-MAR-2021, the subject experienced chills. On 09-MAR-2021 02:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 degree F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, lower back ache, and feeling unwell, and had not recovered from chills, body ache, and abdominal pain radiating to back. This report was non-serious.
Pt called stating that she developed redness, swelling, and warmth on the arm where she received her vaccine. Redness and swelling started developing about a week after receiving her vaccine and extended from her shoulder to her elbow. She went to urgent care on 4/4/21 where the provider told her that he believed she had an infection and prescribed antibiotics (Bactrim). Pt called the pharmacy on 4/6/21 to report her reaction and stated she had seen some improvement since taking the antibiotics.
Pt received her 1st dose of the COVID19 Moderna vaccine. After sitting in observation for about 15 min she reported feeling pain and stiffness in her neck. BP 117/86 HR 78. Pt is post meniscus surgery 2 days prior in a wheel chair. Pt was repositioned by  RN and instantly felt better. Pt declined EMS evaluation.
small red itchy bumpy rash on chest and arms; small red itchy bumpy rash on chest and arms; small red itchy bumpy rash on chest and arms; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL1284) via an unspecified route of administration in the right arm on 02Jan2021 at a single dose as Covid vaccine. Medical history included hypothyroid. The patient had no known allergies. Concomitant medication included thyroid (ARMOUR THYROID) (other medications in two weeks). The patient had no other vaccine in four weeks. It was reported that the next day after receiving the vaccine, the patient developed a small red itchy bumpy rash on chest and arms on 03Jan2021. Treatment was not received for the events. She had no Covid prior to vaccination. She did not have Covid tested post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects) on Jan2021.
I had a fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (I had a fever) and CHILLS (chills) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (I had a fever) and CHILLS (chills). At the time of the report, PYREXIA (I had a fever) and CHILLS (chills) outcome was unknown.            No concomitant medications and no treatment medications were reported.     Reporter did not allow further contact
Medication given wrong route. Given intranasel. Person was given correct vaccine, correct route 10/27/22
1/17/21 L/Arm sore at injection site.  1/18/21 woke up during the night with stomach pain result -- loose bowel movement and stomach cramps.  Started with severe chills, body shaking, achy all over, head felt like it was going to implode, started to sweat and felt flushed.  Woke up my spouse to get me something to take for headache, etc.  Later that morning could hard lift the Arm, felt a golf ball size lump at injection site and warm to the touch. Was in bed 2 days bcuz it exacerbated my MS.  After that the injection site started itching, with redness.  Lump finally getting smaller.  I took a photo of the injection site which has a red circle the size of my hand.
Headache; Diarrhea; bodyaches; chills; fatigue; Sinus pressure; This is a spontaneous report from a contactable consumer reported for herself. A 45-years-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration in right arm on 28Jan2021 at 04:15 PM (at the age of 45-years-old), as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. On 29Jan2021 at 04:00 PM, the patient experienced headache, diarrhea, body aches, chills, fatigue, and sinus pressure. Patient was not diagnosed with COVID Prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The patient was not recovered from the events at the time of this report.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Approx. 2 months, post vax, the injection site became red, swollen and hot. Approx. 2 days later, pt began experiencing substantial arthritic pain. This arthritic pain has shown no sign of abating in the approx. 3 weeks since its start. Further evaluation is being done by our family physician.
Patient had headache, fever, and upset stomach. Took Tylenol which helped with the fever but came back shortly but medicine helped with soreness and aches. Symptoms continued into next morning and then resolved. On follow days, patient started complaining of chest pain, especially tightness when going up and down stairs in dorm. Also had more stiffness, tightness in chest in the morning when wake up. By first days of September 9/1 or 9/2 for sure by 9/6 she started to complain of tingling and numbness on legs, sometimes while sitting down, didn't feel the legs at all. On 9/17 had a doctor visit and given Advair inhaler which was used for 2 days. A pulmonary test on 9/24 was normal. Patient will be seen by a ENT specialist on 10/27.
Patient came down with a fever of 102.6 on the sixth day after receiving a Varicella booster.  Fever responded to tylenol.
PATIENT RECEIVED 1ST DOSE OF MODERNA VACCINE ON 5/1 FROM A DIFFERENT LOCATION. PATIENT CHECKED MODERNA ON CONSENT FORM.   PFIZER WAS ADMINISTERED IN ERROR AS THE 2ND DOSE.
Tired; Weak; Minor swelling at injection site; Whole body felt like it was on fire; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Whole body felt like it was on fire), ASTHENIA (Weak), VACCINATION SITE SWELLING (Minor swelling at injection site) and FATIGUE (Tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced BURNING SENSATION (Whole body felt like it was on fire) and VACCINATION SITE SWELLING (Minor swelling at injection site). On 12-Mar-2021, the patient experienced ASTHENIA (Weak). On 13-Mar-2021, the patient experienced FATIGUE (Tired). At the time of the report, BURNING SENSATION (Whole body felt like it was on fire) was resolving and ASTHENIA (Weak), VACCINATION SITE SWELLING (Minor swelling at injection site) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment using ice pack was reported.
Arthritis aggravated; Knees were swollen; Fatigue; Headache; Pain in her bladder; Urine odor foul; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Urine odor foul), ARTHRITIS (Arthritis aggravated), JOINT SWELLING (Knees were swollen) and FATIGUE (Fatigue) in an 80-year-old female 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 06-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 BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Urine odor foul), ARTHRITIS (Arthritis aggravated), JOINT SWELLING (Knees were swollen), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Urine odor foul), ARTHRITIS (Arthritis aggravated), JOINT SWELLING (Knees were swollen), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, International normalised ratio (3.8-4.2): (High) High. INR normal range is 2-3..     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.   No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment.   This case was linked to MOD-2021-058249 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Follow up received on 25-MAR-2021.Date of birth, patient initials and outcome of events were updated,
@ 1525  Pt stated to this nurse that her throat felt like it was "burning a little".  Denies s/s of any breathing issues.  Water was given to her by this nurse.  @ 1528 she stated that it felt more like "an itchy feeling in her throat/chest".  Expressed to this nurse around 1533 that the issues had slightly resolved, and that she felt anxious upon receiving the vaccine.  This nurse gave Pt a Benadryl 25mg @ 1539.  States that her s/s are better.  Pt states she takes the following medications, Allegra po once daily, Flonase daily, and Flovent.  Does voice that she has chronic allergies/asthma.  Pt is still in observation @ present time 1552.  Left observation @ 1554, states that her s/s had improved.
Info has been received from a health professional concerning a 10 year old female with no known history or allergies who on 10/24/97 was vaccinated with a 1st 0.5 ml dose of varicella virus vaccine live (lot 621201/0082E). Concomitant vaccination the same day included 4th dose of poliovirus vaccine live oral (lot 771134). There was no other concomitant medication. On 12/27/05, the pt broke out in less than 50 lesions assumed by the physician to be varicella. No other symptoms were noted. Acyclovir was ordered for the child and at the time of the report, she was recovering. It was reported that on 12/14/05, the pt's 14 year old brother was dx'd and treated for shingles. The pt's brother never had varicella virus vaccine love or varicella. There was no product quality complaint involved. Follow-up info from the health professional indicated that on 12/27/05, the pt noticed a red bump on her abdomen. Three days later approximately 15 bumps were noted on her trunk, back, legs and arms. The pt was prescribed "acyclovir 420mg 5 X daily X 5 days". Subsequently, the pt recovered. No further info is available.