chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up at 4am feeling nauseous after taking the vaccine at 4:45 pm the day prior.  Lack of appetite, body aches, chills in the morning and nausea.  At around noon, I started feeling very nauseous and my ear started ringing, I had shortness of breath, and thought I was going to pass out.  My heart was racing  My legs were pumping and I laid down on my back.  The feelings dissipated shortly.  Then, at 8pm, all symptoms disappeared and i felt 100%
I starting jaw pain and inflammation.  My doctor determined that it was musculoskeletal pain.  I started having tendonitis in my right elbow.
BLOOD CLOTS; HEART TROUBLE; HE WAS DYING; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency time 1 total administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, after vaccination the patient had blood clots, (heart trouble) his heart didn't want to work and he was dying. Heart had to be shocked- stimulated heart. It was reported that every couple of days tests was being ran. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots, heart trouble and he was dying was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210832975; Sender's Comments: 20210832472-Covid-19 vaccine ad26.cov2.s-Blood Clots, heart trouble. This event(s) is considered unassessable. The event(s) 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(s).
Extreme pain in right hand from wrist to end of little finger.  No pain with hand relaxed extreme pain when flexing. On scale 1-10 about 8. Starting at 5:30. Gradually subsiding until the morning of 2/6  Extreme pain in left foot from heel several inches up the back of leg. No pain when relaxed but extreme pain if I tried to Stand or walk. 0n scale 1-10 a 10. Gradually subsiding until midday 2/5.  Pain in lower back mostly toward the left. Starting gradually late 2/4 increasing through 2/5 then decreasing through 2/6. No pain when relaxed increased pain when standing up. On scale 1-10 about 4.  Diarrhea for several days.
Ringing in both ears. It was light raining after first shot. And louder ringing after second shot.
Patient started feeling arm stiff and numb, and started with fevers of 104F about 1 1/2 hr after getting vaccinated. Later that night she developed a red large hot bump around the injection site. C/O running nose and cough, still not better.
1st dose 2 years ago, 2nd not yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who did not receive Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (2 years ago received 1st dose.).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after not receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 2 years ago, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-MAY-2023 The patient received 1st dose 2 years ago, not able to remember the date and did not think that ever got a second shot. The patient did not have any further information about his first Shingrix dose. No further information was provided for second dose. The reporter consented to follow up with the health care professionals. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 67 patients of unknown age and gender. Patient's medical histories and concurrent conditions were not provided. On unspecified dates between August 2014 and October 2014, 67 patients were vaccinated with improperly stored doses of ROTATEQ oral (dose, lot number and expiry date were not reported). ROTATEQ, Oral was found to be unsupported excursions with in-house stability data. No adverse symptoms reported. Product quality complaint (PQC) was not involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Follow up information has been received on 06-JAN-2015 from the nurse concerning 60 unspecified patients of unknown age and gender vaccinated with improperly stored doses of ROTATEQ between August 2014 and October 2014. This is one of several reports received from the same reporter. Additional information has been requested.
Upper stomach had real funky feeling everyday, diarrhea 4-5 times day till the 25th then stomach felt 85% better.
Her tongue and throat started tingling; Her tongue and throat started tingling; Dizzy/Lightheaded; Jittery which she described as "like she had too much caffeine"; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Her tongue and throat started tingling), PHARYNGEAL PARAESTHESIA (Her tongue and throat started tingling), DIZZINESS (Dizzy/Lightheaded) and TENSION (Jittery which she described as "like she had too much caffeine") in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history information was reported.  Concomitant products included AIRBORNE for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced PARAESTHESIA ORAL (Her tongue and throat started tingling), PHARYNGEAL PARAESTHESIA (Her tongue and throat started tingling), DIZZINESS (Dizzy/Lightheaded) and TENSION (Jittery which she described as "like she had too much caffeine"). On 11-May-2021, PARAESTHESIA ORAL (Her tongue and throat started tingling), PHARYNGEAL PARAESTHESIA (Her tongue and throat started tingling), DIZZINESS (Dizzy/Lightheaded) and TENSION (Jittery which she described as "like she had too much caffeine") had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported
terrible headache; chills; fever; A spontaneous report was received from a consumer concerning a 46-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, pyrexia, headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) via unknown route in the right arm  for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced chills, pyrexia, headache.  No Treatment details were included.  Action taken with mRNA-1273 in response to the events was not reported.   on an unknown date the outcome of chills, pyrexia, headache was unknown.
administered 7 booster doses from a vial initially stored in the refrigerator on 16Nov2021/  (beyond the 30 use by date); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 7 booster doses from a vial initially stored in the refrigerator on 16Nov2021/  (beyond the 30 use by date)) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 027B21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021 at 1:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 7 booster doses from a vial initially stored in the refrigerator on 16Nov2021/  (beyond the 30 use by date)). On 16-Dec-2021, EXPIRED PRODUCT ADMINISTERED (administered 7 booster doses from a vial initially stored in the refrigerator on 16Nov2021/  (beyond the 30 use by date)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. The vial was initially stored in the refrigerator on 16-NOV-2021 at 10:00am. No Treatment information was reported.
3-4 hours after vaccination she developed migratory hives on her upper extremities. No facial swelling or difficulty breathing. Lingered off and on for 1 week.
This spontaneous report has been received from a physician via a company representative referring to a patient of unknown age and gender. Information regarding medical history, drug reactions, allergies, concurrent conditions and concomitant therapies was not reported. On an unknown date, approximately in  2015 "reported as about a year or two ago", the patient's spouse was vaccinated with ZOSTAVAX. This patient was not vaccinated but developed a bad case of shingles (secondary transmission). A the time of reporting, the outcome of shingles and secondary transmission was unknown. It was unknown by the reporter if the patient sought medical attention. The relatedness between the events and ZOSTAVAX was not provided. MARRS: 1702USA009259. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009259:
Chest tightness for approximately 1-2 months. Contracted COVID-19 in June 2022 (06/22) , and ever since experiences intermittent sharp pain in chest starting pain starting October 1st 2022, (10/1/2022).
Began with general malaise, growing fatigue, then progressed over next 12 hours to nausea, vomiting, non-localized abdominal pain, low-grade fever and headache. Vomiting abated quickly, but nausea persisted through subsequent 12 hours as did malaise, fatigue and abdominal pain. During this 2nd 12 hours particularly alternate chills and sweats occurred.  Symptoms largely abated after 36 hours.
This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient. A 63 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Patient had a hard case of covid" (unspecified if ongoing) and getting the vaccines threw her back into those symptoms. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunization, reaction(s): "COVID symptoms". The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passed off 3 times". Patient asked for advice if ever she can get the booster shot. She said that she had strong reactions to the two (2) vaccines unable to transfer to Covid19 line because there was a long wait time. Patient did not report until she called yesterday (as per report), stated that she was put through and passed off 3 times. She complained that didn't get to speak with anyone regarding this but only heard recordings about the Pfizer covid vaccine. The lot number for bnt162b2 was not provided and will be requested during follow up.
pt recvd vax & devel leukocytosis (30,000 WBC's/cmm w/eos (20%); cxr demonstrated an infiltrate, pt c/o aches & pains; ca of breast; diffuse bony metastatic disease from metastatic breast cancer;
Patient developed shortness of breath on 4/6/2021 after getting the Moderna vaccine #2 on 3/26/2021.  He saw me (his doctor) on 4/22/2021 for this and had positive D dimer and we did CT angiogram of chest showing pulmonary emboli.  He was put on Eliquis and is now feeling better.  He has never had DVT or PE in the past.
ADACEL were administrated post excursion with no adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 58 years old male patient to whom diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was administrated post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Aug-2022, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (lot U7461AA; expiry date: 12-Jul-2024) via intramuscular route in the left arm for immunization  On 29-Aug-2022 on same day the Adacel were administrated post excursion with no adverse event (poor quality product administered).  Action taken : not applicable.  Outcome : 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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 case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the Moderna Bivalent Covid-19 vaccine 1 day after 30 day expiration date in the refrigerator), PRODUCT STORAGE ERROR (Patient received a dose of the Moderna Bivalent Covid-19 vaccine 1 day after 30 day expiration date in the refrigerator) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.   No Medical History information was reported.     No concomitant medications were reported.  No treatment information was provided.
diagnosed with a skin condition dermatographia; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MECHANICAL URTICARIA (diagnosed with a skin condition dermatographia) in a 31-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MECHANICAL URTICARIA (diagnosed with a skin condition dermatographia). At the time of the report, MECHANICAL URTICARIA (diagnosed with a skin condition dermatographia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter.  She got a skin condition that came all down her neck after receiving the vaccine.  Patient was prescribed an antihistamine, to help with the skin condition.   This case was linked to US-MODERNATX, INC.-MOD-2022-643383 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-643383:MOD22-023007(Mother's Case)
chest is extremely heavy; right lung hurts more than the left lung/her right lung hurts more when she breathes deep; This is a spontaneous report from a contactable consumer.   This female consumer (Patient) reported that a female patient of an unspecified age received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), dose 2 via an unspecified route of administration in right arm on 05Feb2021 12:30 as single for covid-19 immunisation from pharmacy. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), dose 1 via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. the patient was diagnosed with Covid on 20Dec2020. The patient reported that, her chest is extremely heavy and the right lung hurts more than the left lung. Patient reported that it was definitely different than the first vaccine. Patient reported that she was alone and was freaked out a little. The patient reported that her right lung hurts more when she breathes deep. It was a tight, heavy hurt. She said that she feels constricted a little bit. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Started on 06/20/2022, I had symptoms. I took an at-home COVID-19 test (06/21/2022) which was positive. I called my doctor the same day and he prescribed me a steroid, an antibiotic to help with secondary infection and told me to take vitamin D and Vitamin C. The symptoms started as pain, chills and temperature swings. Then, I got a cough that lingered for a bit and fatigue that also lingered. The actual symptoms lasted for a few days and the cough lingered but by 10 days later I didn't feel sick anymore. 2 weeks after testing positive the first time, I tested positive again. At day 15, I finally tested negative. I was still having fatigue and some GI issues that my doctor thought was related to the antibiotic use. Then, I started having pain issues again and we just got the labs back that my liver enzymes were significantly out of range. So, we are looking into the cause of that.
Began having stomach pain 5 days after her 2nd vaccination dose.  She ran a low grade fever (up to 100.5) for approximately 48 hours.  We went to Urgent Care approximately 28 hours later on 1/7/22.   They ran urinalysis, strep test and Covid test.  Strep and Covid negative.  Urinalysis abnormal with hematuria.  Urine cultured and showed no infection.  Followed up with pediatrician on 1/10/22.  Urine test ran again and still showed some blood.  Other physical symptoms resided.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, chills, fever 102, headache, joint pain, body ache, fatigue, diarrhea Narrative:
Local reaction in right arm, redness, heat, inflammation at site of injection, had headache.
Child screamed uncontrollable f several hours mom stated then slept for 10 hours straight. Did not wake up to eat did not have wet diaper.
Sore arm, diarrhea, sever joint pain in both hands, and muscle cramping in right leg.  The diarrhea, joint pain, and muscle cramping all occured between 7:00 PM and 8:00 PM on Friday 9/10/2021.  The joint pain lasted for 3 hours.  Upset stomach lasted into the next day.
Child who recently immigrated, living elsewhere and visiting here for holiday. Received MMR vaccine 4-6 weeks ago, developed ITP.
Breakthrough case: I tested positive for COVID-19 on Saturday August 21, 2021 when I did a rapid test. I also received another confirmation that I had COVID-19 on August 24, 2021 when I did a PCR test. My symptoms: Fever, Chills, Cough, Congestion, Headache, Body aches, and Fatigue.
some of the dose spilled/leaked out either due to a defective needle or the syringe was not attached properly; administering only half of the dose; some of the dose spilled/leaked out either due to a defective needle or the syringe was not attached properly; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (administering only half of the dose), UNDERDOSE (some of the dose spilled/leaked out either due to a defective needle or the syringe was not attached properly) and DEVICE CONNECTION ISSUE (some of the dose spilled/leaked out either due to a defective needle or the syringe was not attached properly) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced ACCIDENTAL UNDERDOSE (administering only half of the dose) and UNDERDOSE (some of the dose spilled/leaked out either due to a defective needle or the syringe was not attached properly). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (some of the dose spilled/leaked out either due to a defective needle or the syringe was not attached properly). On 19-Feb-2021, ACCIDENTAL UNDERDOSE (administering only half of the dose) and UNDERDOSE (some of the dose spilled/leaked out either due to a defective needle or the syringe was not attached properly) outcome was unknown. At the time of the report, DEVICE CONNECTION ISSUE (some of the dose spilled/leaked out either due to a defective needle or the syringe was not attached properly) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient experienced facial flushing with a rash; immediately given 25mg of liquid siladryl and sent to ER for observation.  Later released to home where he is extremely tired. He feels like he has been lifting and moving things all day. Muscle aches. No report of temperature.
no AE; PNEUMOVAX 23 administered to a 16 month old instead of PREVENAR 13; PNEUMOVAX 23 administered to a 16 month old instead of PREVENAR 13; This spontaneous report was received from a medical assistant and refers to a 16-month-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 02-APR-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter, once (lot # T024557, expiry date 15-MAR-2022) for prophylaxis, instead of pneumococcal 13v conj vaccine (crm197)(PREVNAR 13). The reporter stated there was no confusion between the two products. No additional adverse event was reported.