chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STOMACH ACHE; NAUSEA; THROWING UP; DIARRHEA; This spontaneous case report (PVX2019-2796) was received from a consumer on 12-Nov-2019. It described a 32-years-old female consumer who started "throwing up" (PT: Vomiting) and also developed "stomach ache" (PT: Abdominal pain upper), "nausea" (PT: Nausea) and "diarrhoea" (PT: Diarrhoea), after administration of oral Vivotif for typhoid fever.  Case report: It was reported that the consumer did not experience any adverse event with first dose of Vivotif but after taking the second dose, she started throwing up. Eight to ten hours after taking the third dose, the event did not resolve. She also developed stomach ache, nausea and diarrhea. It was reported that these adverse events were not that bad after the second dose but got worse after taking the third dose of Vivotif.  Action taken with Vivotif with respect to the reported events was dosage maintained.  The clinical outcome of the events was unknown.  Company's Comment: In this case, it was reported that a female consumer started throwing up and developed "stomach ache", "nausea" and "diarrhoea", after administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, the vaccine has potential to cause these events. Hence, the causality of the events with Vivotif is assessed as possible. ; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer started throwing up and also developed "stomach ache", "nausea" and "diarrhoea", after administration of oral Vivotiff. There seems to be a temporal association between the intake of the vaccine and the events. Also, the vaccine has potential to cause these events. Hence, the causality of the events with Vivotif is assessed as possible.
Atrial fibrillation; Vaccination site pain; Diarrhea; Nausea; Sores mouth; Weight loss; This case was reported by a consumer via other manufacturer and described the occurrence of atrial fibrillation in a elderly male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Co-suspect products included ELASOMERAN (COVID-19 VACCINE MODERNA) for prophylaxis, TOZINAMERAN (PFIZER COVID-19 INJECTION) for prophylaxis and ibrutinib (Imbruvica) for chronic lymphoid leukemia.   Additional subject notes included Medical history- None.   On an unknown date, the patient received Hz/su + AS01B, COVID-19 VACCINE MODERNA (intramuscular) and PFIZER COVID-19 INJECTION (intramuscular). In April 2018, the patient started Imbruvica (oral) 420 mg once daily (420 mg daily). On an unknown date, unknown after receiving Hz/su + AS01B, the patient experienced atrial fibrillation (serious criteria GSK medically significant), injection site pain, diarrhea, nausea, sores mouth and weight loss. Imbruvica was continued with no change. On an unknown date, the outcome of the atrial fibrillation, diarrhea, nausea, sores mouth and weight loss were unknown and the outcome of the injection site pain was recovered/resolved.   The reporter considered the atrial fibrillation, injection site pain, diarrhea and nausea to be possibly related to Hz/su + AS01B. It was unknown if the reporter considered the sores mouth and weight loss to be related to Hz/su + AS01B.   Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comment: The patient had Moderna covid-19 vaccination and the shingles shot, one in each arm. There was no reported medical history. No known Allergies. No concomitant drugs taken. On an unknown date, the patient had Moderna covid-19 vaccination and the shingles shot, both were painful but resolved. It was unknown if patient was enrolled in a Covid-19 vaccine trial. an unknown date, unknown after receiving Covid-19 vaccine moderna, Pfizer covid-19 injection and Ibrutinib, the patient experienced atrial fibrillation (serious criteria GSK medically significant), diarrhea, nausea, sores mouth, weight loss and injection site pain. The primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for the event(s) of mouth sores and weight loss was not provided. The reporter considered the atrial fibrillation, diarrhea, nausea and injection site pain to be possibly related to Covid-19 vaccine moderna, Pfizer covid-19 injection and Ibrutinib. It was unknown if the reporter considered the sores mouth and weight loss to be related to Covid-19 vaccine moderna, Pfizer covid-19 injection and Ibrutinib.
Patient states that starting on 11/9/17 at 3pm ish she started to feel aches and significant pain in her core area, she took an aspirin and TYLENOL powder at 3:15ish it helped but did not take her pain away completely. She contacted me at 9:15 am on 11/10, and said she has been taking the aspirin/TYLENOL powder every 4 - 6 hours but still having some pain.
Pt began having body aches and temperature on 7/31/17 after receiving the vaccine on 7/28/17. Pt's arm started becoming red, swollen, and itchy on 8/3/17.
More than 35 days since the first shot was given; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot was given) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (patient  take medication for high blood pressure).    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot was given). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot was given) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment  was provided. Concomitant Medication provided was Medication for high blood pressure      Nurse Practitioner called to ask if a dose could be given to a patient after 53 days from the first dose.    More than 35 days since the first shot was given   Reporter did not allow further contact
Arm sore; arm being a little swollen; took breath away / shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), PERIPHERAL SWELLING (arm being a little swollen) and DYSPNOEA (took breath away / shortness of breath) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, MONTELUKAST SODIUM (SINGULAIR) and Breo Inhaler 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 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), PERIPHERAL SWELLING (arm being a little swollen) and DYSPNOEA (took breath away / shortness of breath). At the time of the report, PAIN IN EXTREMITY (Arm sore), PERIPHERAL SWELLING (arm being a little swollen) and DYSPNOEA (took breath away / shortness of breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-076350 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076350:Dose 2
Exhaustion; muscle soreness; lack of sleep; This is a spontaneous report from a contactable consumer (patient).   This 54-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left arm on 08Feb2021 09:15 for COVID-19 immunisation. Medical history included allergy to Sulphur derived antibiotics. There were no concomitant medications. Previously the patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. On 08Feb2021 19:00, the patient experienced exhaustion, muscle soreness, lack of sleep with outcome of recovered on an unspecified date in Feb2021. No treatment required. The vaccine was administered at Workplace clinic.   Information on lot number/batch number has been requested.
Pt reported back to me on 10/20/14. (Left arm pain) Stating left arm pain has not gone away since after she got shot. Can not raise arm above shoulder level. Called MD got her appt for the next day.
Pt got shot on 3/30/2022.  Noted more rash like hives on injection site left upper deltoid on 3/31/2022 in AM.  Noted more redness and swelling.  Site location felt sore.  Tried ice compresses which made it worse he felt.    No meds taken.  Sought treatment at Health Center on 4/2/2022.  Saw Dr. , D.O.  He was given allergy pack (Loratadine 10mg one tab po daily x 7 days, and Benadryl as needed.  Short ice compresses with towel buffer advised 5 minutes 3 times a day.  Ok to shower with soap and water.  Pat dry.  Rash marked with purple been to see if rash spreads.  Pt will follow up with appointment on 4/4/2022 to check on rash status.   In the mean time, if any worsening pain/rash/change in symptoms, advise for ER evaluation here locally.
Vaccines given at 1344 BP at this time 123/80, HR 82, Temp. 98.8. Patient verbalized feeling dizzy and nausea at 1348. Patient was asked to lay down on exam table. B/P 89/46 left arm, HR 74, RESP 22, Temp. 98.8. PT was oriented x3, visibly pale and sweating, @ 1351 BP 102/64, HR 76 laying down left arm. Pt sat up drank water, at 1355 BP 116/82 left arm sitting, HR 88, SPO2 99%. PT was evaluated by the Nurse Practitioner and cleared to go home.
Bulky painful axillary lymphadenopathy each 1-2 cm on the same side as the injection, erythema and warmth around the injection
ringing in my ears  hearing loss  tinnitus I never had these until the shot now I am worried Thank You
Had light headache; nausea; pain in left hand; This is a spontaneous report from a contactable consumer (patient herself). A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL1283, expiry date: unknown) via unspecified route of administration, administered in left arm on 23Jan2021 (age at vaccination: 33-years) as dose 1, single for Covid-19 immunisation. Patient medical history and concomitant medications were not reported. Patient reported she saw the form, someone gave her the form and she saw Pfizer's number on it to call to report she was having side effects from the Covid vaccine. She had the second shot yesterday and has come down with side effects so bad and she coundnt go to the emergency room due to no insurance. She was unable to provide primary care provider details, had no insurance and needed new provider. After first dose, on an unspecified date, patient experienced as reported: had light headache, nausea, pain in left hand. Patient had no history of problems with vaccines in past. Mentioned she had already missed work and looked to see what Pfizer can do to help her with side effects, looked for medical advice. Talked about a form she saw with help for medical care. Recommended caller for further medical advice to seek medical care, Pfizer was unable to provide medical advice. Vaccination facility type was clinic. No additional vaccines was administered on same date of the Pfizer suspect. There was no history of all previous immunisation with the Pfizer vaccine considered as suspect. The outcome of the events was unknown.   Follow-up (07May2021): Follow-up attempts completed. No further information expected
pt recv vax 16JUL96 & 30JUL noticed blood in uring grossly;saw MD 31JUL UA showed no infect;wk & half later occult blood in urine;seen by MD cystoscopy 1SEP96 negative x/small irritation;bruises easily;mild glomerulonephritis;hematuria;
With the first two vaccines, she felt a lot of fatigue; tiredness, just the regular sort of side effects.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 (Lot number: ER8734) at the age of 44 years as dose 1, single and administered in arm left, administration date 19Apr2021 (Lot number: ER8737) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "With the first two vaccines, she felt a lot of fatigue"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness, just the regular sort of side effects.".  No follow-up attempts are possible. No further information is expected.
pt received dose 1 2-23-21 and dose 2 on 3-22-21
Patient was given her first dose of the Covid vaccine that should have been Pfizer due to patient age but Moderna was given in error
Within minutes after the vaccine I felt hot, removed my jacked but then I got chilled, my right hand begin itching which moved to the left hand.  I was taken to the ER and was administed benedryl.  I was transported to the hospital via ambulance because my mouth and throat was extremely dry and my voice got hardened.  During the ride I regurgiatated because my stomach got queezy and was administered Zofran.  My right hand turned completely white and I was administered another med to help turn my hand back right.  My baby was checked and she was fine and was released after about 3 hrs.  At that time I was 31 week gestation.  Until about 3 days ago my body was still very very itchy all over which seemed to worsen when I was sleep.
Flu-like symptoms started within hours of receiving the second injection and persisted for more than 72 hours. Fever, chills, headache, body aches and pains. Treated with rest, alternating Motrin and Tylenol, and fluids.   I had minimal reaction to the first dose - some tiredness, nothing else notable.
Patient: 12 year old receiving Tdap, MCV4, and HPV.  Administered Tdap and MCV4 in the right deltoid.  After administering the HPV vaccine in the left deltoid patient went immediately pale, eyes became unfocused, was not able to respond to verbal questions, jaw and left leg twitched a few times. Gently laid patient on the carpeted floor, continued to ask her questions to observe her level of consciousness. Put cool wash clothes over her forehead and neck. This lasted approximately 30-60 seconds.  Patient came around quickly but had never had an experience like this before.  Parents decided to take her to the ER later that day just to make sure she was okay and she checked out with the Attending Physician just fine.
2 days p/inject pt devel hives then diarrhea & nausea w/body aches; pos resp exaccerbation of COPD; pt hosp for SOB & grand mal sz; in ER:
Severe swelling injection site over few days. Pain, redness. Progressed to swelling upper torso, LUE as well. Some numbness LUE. Nausea. No fever. Symptoms not resolved today at D14.
I had a rash that started on my chest that went to the front and back of my legs, before spreading randomly on my body. I went to my doctor, they said it looked like an immune response. I was given an ointment.
w/in 10min of vax pt broke out in hives;no other sx;DPH given;
PATIENT REPORTS ITCHING IMMEDIATELY AFTER VACCINATION 3/12/21. SYMPTOMS PROGRESSED INTO SWELLING OF RIGHT UPPER ARM, TENDERNESS, WARMTH, REDNESS. PATIENT PRESENTS TO CLINIC FOR EVALUATION 3/20/21.
PERICARDIAL EFFUSION/MASSIVE PERICARDIAL EFFUSION/LARGER PERICARDIAL EFFUSION; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 43year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypothyroidism, hyperthyroidism, nonsmoker, and no alcohol use, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with cortisone, tetanus vaccine, and bupropion hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805002, and expiry: 25-MAY-2021) dose was not reported, (Dose no in Series: 1) 1 total administered for left arm on 03-APR-2021 for prophylactic vaccination. Concomitant medications included Armour thyroid for hyperthyroidism, and hypothyroidism. After receiving vaccine, On 04-APR-2021, the patient experienced fever, and patient couldn't lift head up (Headache). After 7 days on APR-2021, the patient experienced Pericardial Effusion, 2 months later another larger Pericardial Effusion which ended up in an Emergency room, 2 months after that patient had a massive pericardial Effusion where patient undergone a Pericardial window surgery on 20-SEP-2021 and Laboratory data included: Echocardiogram (NR: not provided) Not reported. The patient was re-hospitalized on 22-SEP-2021 and 14-OCT-2021 for Pericardial Effusion and discharged on 28-SEP-2021.  On 9-APR-2021 and 27-AUG-2021 the patient visited physician office and prescribed with Toradol(ketorolac tromethamine) and Steroids for Pericardial effusion. On 02-JUN-2021 the patient visited Emergency room and prescribed with the treatment drug Colchicine (0.6 mg). On OCT-2021, Heart rate (NR: not provided) Not up. On 11-OCT-2021, the patient visited doctor, Laboratory data included: Echocardiogram (NR: not provided) Clear. On 14-OCT-2021 patient was back to the Emergency room and readmitted the same day and discharged on the 20-OCT-2021. That's when patient put on the Arcalyst, Indomethacin and some Expensive medications. Indomethacin is 25mg three times daily. At this time patient couldn't get heart rate up and couldn't exert myself at all. And patient was seen on 29-OCT-2021 by physician and he was released from bed rest but still have to continue watching exertion, take his medicine and he says he won't be a marathon runner. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and headache on 06-APR-2021, and had not recovered from pericardial effusion/massive pericardial effusion/larger pericardial effusion. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211235471-COVID-19 VACCINE AD26.COV2.S-Pericardial effusion. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 17-MAR-2017, at 80 years of age, the patient was administered the ZOSTAVAX by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Vaccine was received on 02/19/2021 at 0738. Symptoms began on 02/19/2021 at 1000. She experienced diarrhea and fatigue.
headache; chills; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced HEADACHE (headache), CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 15-Mar-2021, CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea) had resolved. At the time of the report, HEADACHE (headache) had not resolved. Not Provided          No concomitant medications were provided by the reporter. Patient stated she received the 2nd dose of Moderna on 14Mar2021 to the left, non-dominant arm. She reported that on the same day she started to have chills, fever, nausea and a headache. All the symptoms stopped on 15Mar2021 except the headache.
Headache; sever body ache all over especially back and joints; upset stomach; dizziness; fatigue.
Developed fever, chills, severe frontal headache, expressive aphasia and unsteady gait with loss of appetite on 1/30/2020 that  lasted 5 days. Resolved completely by 7 days
Day 8 after the vaccination I had red spot develop over injection site, pain in bones, prickling pain in limbs, numbness in limbs, stabbing pains in torso and neck and leg and feet and hands (moving around like electrical shock), bad leg pain in left leg (causing me to wake up and jump around to get it to stop), stabbing pains in feet, burning in feet, frequent numbness in feet and arms during sleep causing me to wake up to get circulation going, stabbing pains in chest and torso causing me to wake up and worry about a heart attack, and worst of all...........rapid heart beat and fluttering (as if hyped up on caffiene) causing me to see cardiologist for ekg.    None of these symptoms happened prior to vaccine.   This all started the day the red rash showed up on left arm.  It felt as if my body was purging the vaccine.   On day eight I also had severe diahrrea resulting in bloody diahrrea (I have a recurring hemmorhoidd)  and vomited.   Then the scary fast heart beat started and the tingling pain.  I have been to five doctors for these various symptoms to make sure I'm ok.  They said to not take second dose.   The symptoms subsided after 6 weeks.  It was very scary.  I was fearful I would have lasting neurological issues.    My GP referred me to a neurologist who I will see next week to discuss, but the symptoms seem ok now so I am grateful and not sure what they can test at this time.