chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Aches; Diarrhea; Headache; Fatigue; Muscle pain; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Muscle pain) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN (Aches), DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), PYREXIA (Fever) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 13-Mar-2021 for Adverse event, at a dose of 500 milligram, every 5 hours. At the time of the report, PAIN (Aches), DIARRHOEA (Diarrhea), HEADACHE (Headache), MYALGIA (Muscle pain) and PYREXIA (Fever) outcome was unknown and FATIGUE (Fatigue) and NAUSEA (Nausea) had not resolved.            No concomitant medications reported by investigator
Patient should never have had a immunization. He had Hypogammaglobulinemia and was given immunizations that had to be given to him a second time. He would never have received any if I new what I now know. He was diagnosed with Pertussis after receiving the DPT he was hospitalized at that time. He had fever with all of his immunizations. Julius also has been diagnosed with Autism and  sever stomach illness he is currently on Chemo treatment for his stomach illness at this time. God Bless my son  Prevention for my son and other children with Hypogamnaglobulinemia is a simple blood test. I feel all children should be tested before giving immunizations.
1:05 pm Post vaccination reports "feeling anxious w/palpitations"; medical monitoring x 30 min, BP 109/72  P69  O2 sat 98%RA No additional complaints / symptoms reported; released from facility to home.
About 15-20 minutes after vaccination, the patient began to feel chest heaviness and chest tightness. She then felt like she had postnasal drip and her throat began to feel like it was closing. She was short of breath until Epi pen was administered. She did not notice any swelling.
Patient received HPV #2 @ 4 pm 6/29/09. Developed generalized urticarial rash 6/30/09 @ 8 pm.
swelling, heat, erythema lt upper arm & swelling, pain of supraclavicular & axillary nodes;swelling, tenderness to pectoral muscle;vaccine was given correctly into center of deltoid muscle;tx med;
Same day post vax, this pt awoke from a sound sleep with sudden severe chills and severe stabbing pain in the chest, on the right side of the right shoulder, the right side of the back, and the right side of the neck. The pain continued throughout the night. The pt also experienced pain and chills with a low-grade fever. The pt also experienced frequency of urination (every 1-2 hours) and right earache. There was also a rapid heart rate; 'approximately 100' palpitations were felt. By 6:00 AM, the stabbing pains and chills had lessened. The pt experienced low-grad fever, flushing, lightheadedness, lethargy, and weakness of the right arm. The pt also experienced chest tightness, shortness of breath, and cough. The heart rate was rapid.  The shortness of breath improved by 01/30. The cough and pain in the right neck, arm and shoulder continued. By 02/03, the pain was 'more like an ache.' Some right arm weakness remained and the pt was still coughing. By 02/09, most of the symptoms had improved. The pt recovered from the symptoms. The pt had not  seroconverted after 3 doses of hepatitis B vaccine recombinant in 1979. No further information is available.
Information has been received from a physician concerning an 1 month old male who on an unspecified date was vaccinated with a dose of VAQTA (Lot #666030/1397Y) instead of hepatitis B vaccine. No information was provided as to how the patient was presently doing. No further information was provided. No medical attention was sought. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 12 years old female patient with no pertinent medical history or drug reactions/allergies. The patient was vaccinated with first dose of 0.5 ml GARDASIL (lot#0420AE, expired date:01-DEC-2014) intramuscularly on 04-FEB-2013. No other co-suspects were reported. There were no concomitant medications. On 05-FEB-2013 the patient experienced dizziness, headache and syncope. The patient had taken office visit for medical attention. No treatment information was given for the adverse events. The patient was recovered on 05-FEB-2013. The relatedness for syncope, dizziness and headache was unknown for GARDASIL. No lab diagnostics studies performed. Additional information is not expected.
CC:PATIENT PRESENTS WITH FEVER, CHILLS AND SOB SINCE LAST NIGHT. HPI:PATIENT STATES PRIOR EVENING, SHE SUDDENLY STARTED HAVING SHAKING CHILLS AND FEVER AND HER SOB GOT WORSE. IN FACT, THIS HAS BEEN INCREASINGLY WORSE OVER THE PAST COUPLE OF DAYS. NO REAL COUGH OR PRODUCTIVE SPUTUM NOTED. SHE ALSO DROVE HERSELF TO PHARMACY AND GOT A FLU SHOT YESTERDAY. SHE DENIES ANY OTHER SYMPTOMS.
she was hallucinating; didn't know where she was; her sugar dropped to 73/ she never had sugar so low; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's  mRNA-1273 and was hallucinating, didn't know where she was, and blood sugar dropped to 73.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included Insulin 4 times a day, heart medication, cholesterol medication and  high blood pressure medication.   On 08 Mar 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08 Mar 2021, the patient was hallucinating, didn't know where she was, and her sugar dropped to 73, which never reached this low before.   Treatment for the event included sugar.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events; hallucination, didn't know where she was, and blood sugar dropping to 73, were reported as recovered on 09 Mar 2021.; Reporter'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.
Erythema to upper chest, diffuse bibasilar diminished breast sounds with subjective chest tightness requiring diphenhydramine IM once and albuterol  nebulized treatment once with complete resolution of symptoms.
BLOW-OUT DIARRHEA; TIRED; SWELLING AT SITE OF INJECTION; REDNESS AT SITE OF INJECTION; This spontaneous report received from a consumer concerned an 18 year old male. The patient's height, and weight were not reported. The patient's past medical history included encephalitis, and concurrent conditions included autism. The patient was previously treated with Hib vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced blow-out diarrhea. On APR-2021, the subject experienced tired. On APR-2021, the subject experienced swelling at site of injection. On APR-2021, the subject experienced redness at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blow-out diarrhea, tired, swelling at site of injection, and redness at site of injection. This report was non-serious.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA057733 and 2023SA057309.  This case involves adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It was unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (latency: unknown)  (poor quality product administered) (latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It was unknown if the patient experienced any additional symptoms/events   It was unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
first two doses given too close from each other with no reported adverse event; Initial information received on 31-Jul-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Caregiver).  This case involves an unknown age and unknown gender patient who experienced first two doses given too close from each other with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   the patient had first two doses of Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine suspension for injection with unknown strength, batch number & expiry date via unknown route in unknown administration site given too close from each other the first one on 06/05 and the second dose on 06/29 for prophylactic vaccination (Immunisation) with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  Information on batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
1/6/21  5:30 pm  Client was as her patients house and stood up to leave and was "walking like I was drunk."  Felt like her leg was asleep. Got to her car and drove to next patients house.  Noticed Rt. sided weakness and knee buckling. Drove herself home and went to bed.   1/7/21  Woke up to increased symptoms, Rt hand and Rt. leg weak, slurring speech.   hospital by rescue. Admitted X 7 days. CT SCAN with and without contrast showed no bleed. Telemed Visit,  MD ordered MRI to rule out Cerebellum Stroke. MRI showed cerebellum stroke. Transferred to A Rehabilitation X 7 days. Has regained most of her normal functions, continues outpatient therapy.
Patient's nose on the right side at the top has been hurting from 1-23-21, the day after she got the vaccine. It is painful to the touch and there is numbness that goes from the top of the nose down to the area above her top lip. Her 2 front teeth are numb as well. Her nose hurts to touch it, but just on the right side. This was reported to me on 2-3-21.
low grade fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) and FATIGUE (tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025b21a) for COVID-19 vaccination.     Concurrent medical conditions included Crohns associated arthritis (Patient takes Toradol injection during Crohn's flare up).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PYREXIA (low grade fever) and FATIGUE (tired). At the time of the report, PYREXIA (low grade fever) and FATIGUE (tired) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, SARS-CoV-2 test: positive (Positive) COVID-19 Positive, no symptoms just a bit tired. On 13-Apr-2021, SARS-CoV-2 test: positive (Positive) COVID-19 Positive, no symptoms just a bit tired.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided for the first dose events.   This case was linked to MOD-2021-138815 (Patient Link).
Day 8 I notice sweling , Red, and Itching and this is day 14 and I still have all the sympton , no fever
This was my booster shot. The 1st and 2nd shot caused arm pain and discomfort, but was tolerable.  This booster is different. It  has caused my entire upper arm to be progressively red, hot, swollen and has edema.  It also feels like the extreme heat of a really bad sunburn. Today on day 3, the severity drove me to see a doctor because of the intense, pervasive heat and  itchiness.  I also had 24 hours of fever and chills, but it went away quickly. The arm reaction is really bad and is lasting longer.  I am currently taking Mobic (already on this short-term for tendinitis. I?m a distance runner), Zyrtec, and Tylenol.  I pro-actively searched for this reporting system because my reaction to the booster  seemed more severe than I?ve seen or heard of from others. Tomorrow is day 4 and I am hoping for the pain, burning and itching to subside.
Sept 7th - diarrhea starts, in 3 days becomes violent and immediate (unable to hold more than 20 seconds from onset)  Sept 18th & 26th - follow-up visits with Doctor, having 12-16 bowel movements per day, lost 17lbs to this point,   Doctor has no idea what is wrong, can barely eat soft food at this point, perscribed antibiotic and sent to   hospital for fluids and testing, hospital mis-diagnosed and perscribed even stronger antibiotic Sept 29th - called Doctor's office 8:30am, ask to come in for fluids, extremely weak, still having severe diarrhea, cannot   stomach any food, was told by nurse to go to ER, they did not have time to give me fluid - they were closing at noon  (in Doctor's defense, he never received my request, the nurse acted on her own) he would have given me fluid Oct 2nd - appointment with Dr., lost 27lbs to this point, cannot eat anything, takes all I have just to walk between   the bed and toilet, sent to hospital for colonoscopy and endoscopy, hospital admitted me Oct 4th - diagnosed with Lymphocytic Colitis and discharged, put on Budesonide by Dr.  Oct 17th -  follow-up with Dr., stay on Budesonide for next 6 months  Continuous side effect to present day
Swelling  extending about 1.5 inches by 2 inches, on left arm (area of injection) painful, redness,  As a result can't use left arm. Pain radiating to entire left arm. Past 24 hours the pain and swelling have increased.
Felt dizziness and off balance when get up early morning about 4 am. First day experienced this was on 4/10/21, four days after vaccinated. Similar Simpson?s experienced for about 7 days anytime I get up from bed or when lying down in bed. Also felt tired and aches in legs during these days. These symptoms keep going lesser and lesser until disappeared after about 7-8 days.
Pt stated her arm felt super heavy before going to bed. She also stated her arm is red from her shoulder down to her elbow, also slightly warm to touch.  RPH instructed her to take benadryl and ice her arm. Please keep the pharmacy updated.
Staff, reds in puncture area. Patient evaluated clear lungs at scultation, in the observation area it began with itching and wheals on the left forearm, patient does not present refractions or effort to breathe. Doctor was consulted who ordered 50 mg BENADRYL IM patient after 10 min indicates that she feels better. After 30 minutes, the patient was reassessed, she does not present much itching and indicates that she feels well. Doctor is consulted and discharged.
pt. came in for vaccination, pt. turned pale & was unconscious, body was very tight. pt. Stated he felt dizzy.
with a severe rash; A lot of pain in all his joints; This is a spontaneous report received from a contactable consumer (patient himself) via Pfizer sponsored program. A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient reported being off Xeljanz for about 1.5 months. He was instructed by MD to stop Xeljanz while he received his covid vaccine. After he got the vaccine, he developed an adverse reaction with a severe rash. He was placed on prednisone for the rash which helped with his rheumatoid arthritis symptoms. While he was off of his Xeljanz, he reported having a lot of pain in all his joints. He has been back on Xeljanz now for about a week and his rheumatoid arthritis symptoms are back to normal. His primary MD was aware of the allergic reaction. Informed patient to update his rheumatologist when he sees them next. No additional information provided. The outcome of the events was unknown.   Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Entire arm became sore; deltoid muscle was inflammed; It was hot to touch (deltoid muscle); Arm puffed up and swollen; bright red like a sunburn (deltoid muscle); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Entire arm became sore), PERIPHERAL SWELLING (Arm puffed up and swollen), VACCINATION SITE INFLAMMATION (deltoid muscle was inflammed), VACCINATION SITE WARMTH (It was hot to touch (deltoid muscle)) and VACCINATION SITE ERYTHEMA (bright red like a sunburn (deltoid muscle)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Entire arm became sore), PERIPHERAL SWELLING (Arm puffed up and swollen), VACCINATION SITE INFLAMMATION (deltoid muscle was inflammed), VACCINATION SITE WARMTH (It was hot to touch (deltoid muscle)) and VACCINATION SITE ERYTHEMA (bright red like a sunburn (deltoid muscle)). The patient was treated with DICLOFENAC (VOLTAREN [DICLOFENAC]) at a dose of 50 mg. At the time of the report, PAIN IN EXTREMITY (Entire arm became sore) had not resolved and PERIPHERAL SWELLING (Arm puffed up and swollen), VACCINATION SITE INFLAMMATION (deltoid muscle was inflammed), VACCINATION SITE WARMTH (It was hot to touch (deltoid muscle)) and VACCINATION SITE ERYTHEMA (bright red like a sunburn (deltoid muscle)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-029752, MOD-2021-029752 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Feb-2021: Follow-up added on 27-Feb-2021 included: Additional AEs added. Outcome of pain in arm updated.
Starting about 2PM 20oct, I started to feel extremely fatigued.  I was falling asleep sitting down.  Through out the remainder of the work day, I struggled to stay awake.  Toward the end of the evening, 8PM or so, I developed a headache so I went to bed.  I woke up at 530AM on the 21st with an extreme headache.  I couldn't open my eyes longer than a few seconds, the room seemed to be moving in and out as if I was zooming in and out on a camera, and I was nauseous.  I called off work and went back to sleep. I woke up at 930am and the headache intensity had subsided.  I was still tired but got up and started moving around.  The headache gradually went away throughout the day and but the morning of the 22nd, was gone.
DTaP given (L) IM and Proquad given (L) sub 4/9/07. Pt came in 4/11/07 w/local reaction, red hot and hard, no itching, no fever. Dr said do warm compresses mother did. Pt came back 4/12/07 and reaction was bigger, harder, same redness w/blisters and itches now. Dr pres. Atarax and Prednisolone
Pericarditis. Had chest pain starting the 13th at 2 a.m.  The next day I woke up in extreme pain again and went to urgent care. Pain was 8/10. Got an ekg at urgent care and they sent me to the ER. Got an ekg at the ER and an X-ray and then a CT scan. Then was told it was Pericarditis potentially due to the COVID vaccine. I?m healthy and have no history of issues so my ER doctor told me to report it online to the CDC.
After receiving two vaccinations the morning of the incident at or about 0945. The patient returned to the Aid station at 1200 After suffering from an anaphylactic reaction. With the chief complaint of for hives that had broken out all over his head and around his neck and shoulders. The patient was also complaining of shortness of breath. The patient was treated for his shortness of breath and was given oral antihistamines, all medications and doses have been documented. EMS was contacted and patient was transported to hospital.