chrisvoncsefalvay/vaers-outcomes huggingface dataset:
abdominal pain; constipation; very severe headache; joint pain; fast heart rate; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation), HEADACHE (very severe headache), ARTHRALGIA (joint pain) and HEART RATE INCREASED (fast heart rate) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation), HEADACHE (very severe headache), ARTHRALGIA (joint pain) and HEART RATE INCREASED (fast heart rate). At the time of the report, ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation), HEADACHE (very severe headache), ARTHRALGIA (joint pain) and HEART RATE INCREASED (fast heart rate) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Upon internal review on 21-May-2021, the age was corrected to unknown.   Reporter did not allow further contact
Fever, severe joint pain, burning on left arm, chills, headache, nausea, severe light headedness, kidney pain.
Patient was seen 5/23/13 with Dx: Torticollis. He had neck pain/spasm as well as a stiff neck. He also had some swelling at vaccine site.
Patient reports heart racing at 9:13am, c/o headache behind her eyes.  On exam, rapid rate, regular rhythm, lungs clear.  Patient reports symptoms resolved at 9:32am
Admission Date: 3/20/2023 Discharge Date: 3/21/2023  PRESENTING PROBLEM: Orthostatic hypotension  Hypotension    HOSPITAL COURSE:  Patient is a 75 y.o. male with past medical history of syncope, paroxysmal atrial fibrillation, OSA, idiopathic hypotension, BPH, urinary incontinence, migraine headaches, hypertension, COPD and GERD. Follows with cardiology and urology. He was admitted to hospital 6/2022 after a syncope and collapse- at discharge cardiology consulted with midodrine increased from 2.5 mg BID to 5 mg BID. He has had several syncopal episodes over the last 6 years.   Patient presented on 3/20/2023 with lightheaded and generalized weakness. Reports he took his morning medications around 5 am then checked his blood pressure around 7 am in the bathroom. States SBP 40s-50s with heart rate 60s. He then stood up where he became lightheaded and generally weak that led to a fall. Denies racing heart rate or flutters. Reports he was COVID positive last week and still feeling weak. He was given antiviral medications which he was unable to tolerate due to side effects. Denies chest pain. Denies fever or chills. Denies abdominal pain. Denies nausea or vomiting. Reports using marijuana/CBD monthly.    In the ER, patient arrived hemodynamically stable. Orthostatic vitals- laying 98/73, sitting 88/66, standing 70/41. 500 ml IV fluids given. CMP and CBC unremarkable. EKG:Sinus rhythm with 1st degree AV block. Expressing abdominal discomfort to ER physician- KUB no significant findings. UA small leukocytes, negative urine bacteria. Denied urinary symptoms, Urine culture sent. History of chronic UTI, on Macrobid nightly. The patient was admitted and placed on IV fluids. HIs home dose of midodrine was increased from 5mg BID to 5mg TID. His BP remained stable on this regimen and he was still able to continue taking entresto for underlying heart failure. His symptoms resolved entirely prior to discharge. A limited echocardiogram was obtained but was a very poor study so unable to assess valves or LVEF. Would recommend being outpatient appointment for complete echo in April.  The patient worked with physical therapy and occupational therapy note that he is at his baseline and appropriate to discharge home.
Provider note: Pt received 1 yo vaccines on 6/7/13. Since the time of shots, mom noted redness at injection site, but since then it has been growing in size, with incr swelling, and a discrete induration in the center of an oval area of erythema. No fever, decr PO/UOP. No meds. Moving arm around.
Received Shingrix vaccine on 4/24, developed small shingles or shingles-like rash on left side, itchy and tender, on 4/28. Reported to office on 4/30 and determined to be shingles on 5/1
the patient was administered an improperly stored dose of ROTATEQ on 5/26/20; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions, concomitant medications, and drug reactions/allergies was not provided.   On 26-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S013890, expiration date: 14-FEB-2021 (strength, dosage schedule and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to a temperature of 12.1 degrees Celsius (C) for 16 hours and 11 minutes (as recorded by digital data logger). No previous excursion was noted. No additional adverse event information was provided.
Recent travel.   Developed facial pain, congestion, low grade temps and nonproductive cough 7/29 COVID neg 7/31 at urgent care   COVID + 8/4 CXR with multifocal pneumonia    Fully vaccinated with Pfizer 4/1/2021   Currently requiring 2L NC, continue decadron, will start Remdesivir and monitor  8/9 O2 requirements increasing and currently on 6L O2. Currently on IVF's for nephrolithiasis- D/W IM, plans to HL given increasing O2 needs. Will ck BNP, repeat CXR, increase Decadron to 20mg. Encouraged proning, will order IS to bedside. Will continue to monitor  still in patient as of this writing
Sunday 11/21 had bad headache, Monday 11/22 had bad migraine
Dose administered at 10:38. Patient observed due to past Shingrix Vaccine adverse reaction. Patient sat for 10 to 12 mnutes, then patient presented to counter and stated she felt nauseous and hot at 10:50. I had my tech call for assistance team and got the patient an ice pack. Assistance team arrived, took her blood pressure. She then felt fine. Team left, she stayed for about 10 minutes more, felt fine and left. I followed up via phone call at 12:05 and she was out walking with her husband and felt fine.
Watery eyes, chest tightness, hoarseness, runny nose, coughing, eyes became very bloodshot, chills.
Woke up feeling very nauseous. Tried to go back to sleep, around 8 am still very nauseous my throat, ears, and joints were aching. Felt very tired and weak. No appetite all day. Continued feeling all over joint pain and sore throat all day, took a five hour nap until my husband woke me up to eat and drink water. Felt a little better after eating soup, but my joints were still hurting and around 7 pm a headache started. Pulse rate 100 just sitting on the couch, my resting pulse is normally around 62. I was in touch with my Midwife who informed me to take Tylenol and see how I felt the following day. Woke up 08/27/2014 with mild headache, but feeling much better.
On December 14, 2021, at approximately 7:00 a.m., I experienced tachycardia, which woke me up out of my sleep. My pulse rate was 135 beats per minute while laying in bed, as measured on a pulse oximeter. This event lasted 30 to 60 minutes. Since the vaccine, I have experienced severe ongoing shoulder pain in my right shoulder where the vaccine was administered. I also have severe pain which travels down my arm, and pins and needles sensation in my fingers. I have also lost range of motion in the arm. This is my dominant arm, and it has been very difficult to use for daily activities. The pain has been consistently disruptive to normal daily activities as well as sleep. I saw my primary care physician virtually on 1/4/22, and she has diagnosed adhesive capsulitis (frozen shoulder). My doctor has advised physical therapy exercises, topical anti-inflammatory medication (Voltaren), Tylenol, heat, and ice.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Vomiting-Mild
Admitted to ER 6/26 after generalized rash faded and bulls eye rash appeared 3 days later.  ER MD diagnosed as viremia.  Primary MD diagnosed as MMR allergy.
Information has been received from a health professional concerning her 4 year old healthy daughter with no medical history who on 06-MAY-2004 was vaccinated with her first IM (previously reported as SC) dose of varicella virus vaccine live (Oka/Merck) (lot# 647709/1247N) in the left thigh. On approximately 07-APR-2007 at the age of 3 years, the patient developed breakthrough chickenpox with more than 50 lesions all over the body after being in contact with a child who had chickenpox. Unspecified medical attention was sought. The physician states it was definitely chickenpox. Subsequently, the patient recovered as she was noted to be fine. There was no product quality complaint. Additional information has been requested.
about 5hr p/vax pt exp intermittent resp distress that lasted about 1hr & self  resolved by the time arrived at the ER;pt was observed for about 1hr in Er w/o reoccurrence;no epi or DPH needed;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 11:00 as dose 4 (booster), single (Lot number: GH9697) at the age of 46 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EH9899), on 25Jan2021 as dose 2, single (Lot number: EL3302) and on 01Nov2021 at 10:00 as dose 3 (booster), single (Lot number: ff2593), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac dz" (unspecified if ongoing); "reactive airway dz" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 21Nov2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Nov2022) Positive. Therapeutic measures were taken as a result of covid-19, treatment failure. On day 1 took PAXLOVID 5 days (from 21Nov2022 to 25Nov2022) as COVID 19 Treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to its Lack of efficacy cannot be ruled out.
Lingering lower back pain /My back hurts; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 11Mar2021 (at the age of 37 years old) at a single dose for COVID-19 immunization.  Vaccination was done in a hospital. Medical history was reported as none. Concomitant medications included acetylsalicylic acid, caffeine (BC), biotin, vitamin d [vitamin d nos], zinc, selenium and cyanocobalamin (B12), all taken for an unspecified indication, start and stop date were not reported. On 12Mar2021, the patient experienced lingering lower back pain/my back hurts. It was reported that the patient's back hurts and she did not want to get up to get her card. She experienced lingering lower back pain. Today was 5 days later. Still painful. It was also reported that the event has caused disability/permanent damage. No treatment was received. There was no other vaccine in four weeks, no COVID prior vaccination, not COVID tested post vaccination, and has no known allergies. The outcome of the event was not recovered.  Information about lot/batch number has been requested.
Pt w/hx of COVID positive (5/3) in the setting of an exposure and onset of symptoms including arthralgias, body aches, non-productive cough, loss of taste/smell sensations, shortness of breath upon exertion despite receiving Moderna vaccines (2/12 & 3/12/21).  Pt presented to ED w/worsening SOB upon rest and was admitted for management of acute hypoxemic respiratory failure due to COVID-19. Was treated w/dexamethasone, remdesivir. She was ultimately discharged on 5/12 after significant improvement with follow-up.
Heart palpitations, sinus tachycardia with heart rate up to 151, and premature ventricular contractions resulting in ER admission. 14 days later EKG still showed irregular rhythms.
Day of vaccine arm was very sore and next day was even worse; used cold pack.  Next day felt extremely ill, had slight fever, joint muscle pain was so severe that could hardly walk to the kitchen.  It felt like it was the worst case of flu you can have and she has never had.  Patient felt fatigued and was sleeping most of the timealmost bed ridden. Patient had limited activities for 2 days; felt fatigued and sleeping most of time almostwas bedridden.  Monday patient felt better but could not drive, felt too lethargic and sleepy.  For the pain, patient took Tylenol but also current medicine is supposed to help with pain.  On Saturday morning, patient contacted pharmacy to see what type of compresses to use. On Monday, contacted pharmacy again reporting that vaccine area was very red like a pale strawberry; there was a rash and swelling.  Monday afternoon felt alert enough to drive to grocery store.  By Monday night, arm was swollen and fiery red; rash was extreme. Patient did not contact the doctor on Monday.  Next day patient contacted pharmacist and was told to give it a few more days.  On Tuesday, rash was so bad, itchy and swollenarea expanded 3 inches from vaccination site; patient was using Cortaid.  In terms of progression, first, area was sore, then it was sore/rash, and then sore/rash/itch--as itch came rash came down.  On 3/10, patient went to dermatologist because of rash and sent back to her doctor.  Dermatologist concerned that there was an infection because symptoms were going backwards; since patient had been on antibiotics recently doctor checked for other things. The medicine the dermatologist prescribed did not work as well as doctors.  Next day 3/11, patient went to doctor, and rash had subsided quite a bit.  Patient told that if there is no improvement to call back.  Yesterday, was the first day that there was a tiny itch, continues to use Cortaid and energy came back.  Today still has itch, small red area and still using Cortaid.   Per internist, it is not unusual with 2nd shot to get rash while dermatologist said it was.  Patient had Zostavax vaccine with no problems.
Inflammation 3 x 3cm, tenderness x 2 days - improving on own
This spontaneous report as received from a pharmacy student refers to a currently 78 year-old female patient with contrast dye allergy and iodine allergy. Other medical history was not reported. On an unknown date, the patient was vaccinated with Hepatitis B vaccine (manufacturer unknown) (Batch#, Lot#, dose and frequency not reported) also reported as an unspecified Hepatitis B vaccine. Concomitant therapies included letrozole, furosemide (manufacturer unknown), atenolol, atorvastatin, warfarin sodium (manufacturer unknown), potassium chloride (manufacturer unknown), Lactobacillus (unspecified), senna and docusate. On an unknown date the patient experienced unspecified allergy. The outcome of unspecified allergy is unknown. The relatedness between the event and suspect therapy was not reported. Additional information is not expected.
Extreme pressure in her head, which gave her a headache; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events extreme pressure in her head, which gave her a headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 29 Jan 2021, 50 minutes later the patient experienced an extreme pressure in her head, which gave her a headache. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, extreme pressure in her head, which gave her a headache was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event,, a causal relationship cannot be excluded.
21 years old female called to report an adverse reaction after she received her second P-fizer dose on 05/07/2021 @1330. patiet reported that after 2 hour she developed numbness, tingling, loose sensation, and pain in her right arm. patient denies any allergies, patient reported no current medication. patient reported past medical history including: high blood pressure and anemia. patient was instructed to exercise her arm and apply cold compress to help with the symptoms. patient was instructed to seek medical attention if the symptoms got worse. Consulted with doctor
Swollen red area ranging from elbow to injection site, hot to the touch. Lasted 4 days.
Hives on chest near breast bone and on right shoulder.  First appeared two days following shot and continue presently.  Have taken antihistimine
Patient reported heavy menstrual bleeding beginning 24 to 36 hours after administration of both Janssen vaccines. Bleeding continued in intensity for 5 days then stopped after 9 days. This was 4-5 and 10-11 away from patient's normal cycle. Patient reported using heavy adult diapers to contain blood and presence of blood clots and cramping. Patient said she might have become anemic but did not present to clinic for testing.
Rashes on injection site;  appears bumpy hives;  skin itching;  claritin and famotidine ordered
administered a dose on 07Jul2022, which had an expiration date of 28May2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Infanrix.   On 7th July 2022, the patient received the 5th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 7th July 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK receipt date: 7-Jul-2022 Reporter's comment: The nurse practitioner reported that the patient was administered a dose of Infanrix, which had an expiration date of 28th May 2022. This was the patient's fifth dose in the series. At the time of reporting, the dose has not been repeated.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional supportive information: The patient had received an expired dose of Infanrix, which led to expired vaccine used.
Doppler showed a blood clot; Pain behind her cast; Really bad case of diarrhea; Swelling in her knee; Leg was swelling/right shoe was tight; Lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; It was tender on her right leg on the left side of the tibia/It is very tender to the touch; Red mark on her leg with a little nodule; Red mark on her leg with a little nodule; Calf pain; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7533; Expiration date was not reported) on the right arm on 30Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the clinic. Medical history included pain and headache. Concomitant medications included paracetamol (TYLENOL ARTHRITIS) for pain; hydrocodone for pain; amitriptyline for headache; and ongoing paracetamol (TYLENOL EXTRA-STRENGTH) for pain. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6208; Expiration date was not reported) on the right arm on 11Mar2021 (when the patient was 62 years old) for COVID-19 immunization. On 07Apr2021, the patient's doppler showed a blood clot. On 30Mar2021, the patient had a really bad case of diarrhea; swelling in her knee; and leg was swelling/right shoe was tight. On 02Apr2021, the patient had pain behind her cast. On an unspecified date in 2021, the patient's lower extremity venous ultrasound showed right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; was tender on the right leg on the left side of the tibia that was very tender to the touch; had a red mark on her leg with a little nodule; and had calf pain. The events had resulted into an emergency room visit and physician's office visit. The patient had received treatment for the events, 'blood clot', 'lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein', 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'tender on her right leg on the left side of the tibia that was very tender to the touch'. The outcome of the events was recovered on 30Mar2021 for 'really bad case of diarrhea'; was recovering for 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'red mark on her leg with a little nodule'; and was unknown for all the other events.
Received vaccine H1N1 at 1300 12-1-09. 1600 began itching on hips. 1900 hives on hips, Abd. 2030 Hives on buttocks- Applied HYDROCORTISONE oint. BENADRYL 25mg PO. 12-2-09 Hives to hips and stomach -> ZYRTEC 1 tab daily per MD.
Patient received vaccine 4/28/21 at 2:30pm husband reported 12:00pm 4/29/2021 her child called him stating she was on the floor with 104 degree fever vomiting and couldn't move. We advised him to call emergency services immediately and that we would report the symptoms.
I was in good health, had a breakthrough case of Covid, tested positive on 10/28/2022. Had fatigue, chill, and body ache for about 24 hours after injection. I have residual concentration issues and memory issues. I also got a concussion after bumping head.
Itching, soreness, and pains (body ache and  low energy); chest pain with shortness of breath and swollen lymph nodes. Incapable of doing typical house chores/work for five days.