chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 80 years old male patient. The patient's medical history included colitis. The patient did not have any drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, lot # was unknown) 6 months ago (approximately in May 2012). No other co-suspects were reported. Concomitant medications included: ENTOCORT and Statins. The patient developed shingles after receiving ZOSTAVAX 10 days ago (approximately on 02-NOV-2012). The physician also reported that the patient had an irregular heart rate and collapsed at some unspecified time after receiving ZOSTAVAX and was admitted to hospital. The shingles was considered as Significant Disability or Incapacity. The outcome of events were reported as not recovered/not resolved. The treatment of VALTEX and topical steroids were given for adverse events. No lab diagnosis studies performed. The patient sought medical attention via contacting physician. Additional information has been requested.
Noted some redness on the thigh right;inflammatory morning after immunization. Low grade temp 48 hours after immunization.
Injection site pain Extreme tiredness  Headache  Muscle, body aches Chills Fever  Nausea No appetite  Swollen lymph nodes Feels horrible
After receiving a Td injection - pt complained of localized reaction at injection site. Pt complained of hematoma, redness, and skin warm to touch.
5 days after receiving HPV 9, pt started with soreness in R deltoid muscle.
swelling and pain around the place were shot was done same day of administration 12/22. Pain started to come down and I noticed the swelling never went away but yesterday pain came back. For the first time I noticed how big the bump is (inflammation?) which is a bit hard, pinkish and itchy. Moderna COVID-19 Vaccine EUA
12 minutes after injection felt sick/weird. Started getting pale, circles under eyes, nausea, vomiting, several hrs later heart racing, several hrs later "distant", limp.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (Vaccination adverse reaction) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Ongoing. On an unknown date, the patient experienced DRUG INTERACTION (Vaccination adverse reaction). At the time of the report, DRUG INTERACTION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medication use information was not provided by reporter.  On an unknown date, the patient experienced not saw best results from humira/humira was helping and felt it should be doing more.   It was unknown if patient was enrolled in a covid-19 vaccine trial.   Treatment Medication use information was not provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Pt developed auto immune celiac disease about a year after receiving vaccine. And hypothyroidism about five years after.
Pt called saying that her lips are swollen, she can't talk and that her arm hurts,
rash at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than 3 weeks after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. Till the time of reporting, the patient still had the rash at the injection site. The patient asked when that would go away. The follow-up would not possible as no contact details were available.
Had flulike symptoms for 4 days then cramping muscles Charlie horses in legs bout week later started getting red marks on legs and arm emergency room on 08/30/2021 had thrombophlebitis in leg and arm went for scan next morning and found multiple bloodclots started on Eliquis no history of clots before and no family history they couldn't say what caused it
Vaccinee noted mild soreness at injection site on day of vaccine. Next day vaccinee noted fever to 101.5 and tender axillary adenopathy, fatigue and malaise. Two days after injection noted headaches with come and go
Patient had an injection site reaction and had swelling and redness. He went to the dr about it and was prescribed KEFLEX as a precaution to rule out and/or treat possible cellulitis.
After the second dose of the vaccine I had a rash around the shot and a headache the day after but no other side effects. Ten weeks after the vaccine I got a bladder Infection. I have gotten bladder infections in the past but this was more severe. I had urgency, discomfort and blood in my urine. I took one course of antibiotics but the symptoms returned. I returned to the doctor when the discomfort returned and I had a lot more blood in my urine. I received a second course of antibiotics and those seem to have worked. I got the first dose of the shingles shot one month before the first dose of the vaccine. I got the second dose of the Shingles vaccine two months after the second dose of the Covid-19 vaccine.
Received pneumonia shot 9/13/2010, reports 9/14/2010 achy, malaise, arm red & warm 9/16/2010 arm continues with extreme redness small blister. Treated with CIPRO and Hydroxyzine.
Bone aches; Headache; Fatigue; Nausea; Muscle aches; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via unspecified route of administration in right arm on 21Mar2021 at 1200 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included dysautonomia. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration in right arm on 26Feb2021 at 1200 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. On 21Mar2021 at 1500, the patient experienced headache, fatigue, nausea, muscle aches and bone aches. The events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of headache, fatigue, nausea, muscle aches and bone aches was recovering at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
red, hot, swollen, painful and itchy patch left arm surrounding injection site. Prednisone 20 mg daily on 2/22/2021   and Keflex 500 mg TID and 2/23/2021.  Neither helped.
sick. really tired, diarrhea, nausea, muscle aches, fever  dry mouth, Trouble  reading, possible fever, no appitite,, red, very sensitive  and swollen arm
Swelling, redness and pain over right deltoid, developed by next AM fever to 102.6 CXR showed pneumonia on 11/09/06.
On 1/7, patient experienced ADRs including generalized weakness, nausea, and dizziness. On 1/8 and 1/9, patient experienced dizziness On 1/10, symptoms worsened and patient fell and hit head On 1/11, patient went to urgent care with complaints of generalized weakness, nausea, and dizziness On 1/12, symptoms persisted On 1/13, symptoms got slightly better- patient only experienced dizziness.
Blood in urine; Pain in their arms; Little bit dizzy; Urine test showed extreme blood and protein; This is a spontaneous report from a contactable consumer. This consumer reported for a 52-year-old male patient that. A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 31Jul2021 (Batch/Lot Number: FA7484) as DOSE 2, SINGLE for covid-19 immunization(Age at vaccination 52 years) The patient past Medical history included ongoing hypertension, myocardial infarction from 22Jun2021 to an unknown date Verbatim: Heart attack , stent placement from 22Jun2021 to an unknown date , renal failure from an unknown date and unknown if ongoing Father:  third stage renal failure , blood cholesterol from an unknown date and unknown if ongoing Cholesterol , ongoing angina pectoris  Angina , myocarditis from an unknown date and unknown if ongoing  States she doesn't know if it is from dye or if it has to do with myocarditis that has been spoken about. Concomitant medication(s) included atorvastatin (ATORVASTATIN) taken for blood cholesterol from an unspecified start date and ongoing; isosorbide (ISOSORBIDE) taken for angina pectoris, amlodipine (AMLODIPINE) taken for hypertension from an unspecified start date and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication from an unspecified start date and ongoing and lisinopril (LISINOPRIL) taken for an unspecified indication from an unspecified start date and ongoing. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. Caller states she is calling more about her boyfriend than herself. About 2 weeks after the second shot, he started having blood in his urine on 15Aug2021. States she doesn't know if it is from dye or if it has to do with myocarditis that has been spoken about.  States she does not know if the vaccine helped bring this about. Caller states they are testing her boyfriend for Glomerulonephritis and Hematuria. Caller states she doesn't know if it is an interaction from the dye he had during his stent, or if it is an underlying condition coming up. Caller states that so far, she is doing good after her vaccines. States that her and her boyfriend had pain in their arms that lingered for days. Says so far that is the only side effect she knows of.  States they were a little bit dizzy also after the second vaccine, but that only lasted about an hour or so.  States otherwise they are doing good. The patient underwent lab tests and procedures which included urine analysis: extreme blood; protein on 17Aug2021. The event outcome was Not recovered for Blood in urine, Unknown for Pain in their arms and Urine test showed extreme blood and protein and recovered for Little bit dizzy on an unspecified date in 2021.
*extreme* fatigue.  could not awaken for more than few seconds. When briefly awake she was coherent and not confused.   slept deeply from 4pm and could not wake to eat or drink.  No fever, bp normal, blood oxygen ok.  Blood sugar at 11pm was 230.  Gave her 15u lantus at 11pm (normally 25u).  Was sleeping at 2:30am but had died at next check at 3:30am.
1 day after DPT shot, mother noted swelling around injection site that had increased by today. 10x15cm area of erythema, swelling, heat. No fever, limitation of movement noted. Has been a bit fussier than usual.
Patient received varicella , hepatitis A, and pneumococcal (PREVNAR) vaccines 11 days prior to one year birthday (12 mos). No adverse event or reaction occurred.
Information has been received from a physician concerning an 18 year old female who was vaccinated with the first dose of GARDASIL. Subsequently the patient expired breathing problems after the vaccine was administered. Subsequently, the patient recovered from the breathing problems after given Benadryl. Additional information has been requested.
Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included Infertility, Spontaneous abortion on 21-Jul-2020 and Alcohol use (1 to 4 drinks a week).    On 29-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-Aug-2020 and the estimated date of delivery was 03-Jun-2021. On 29-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 29-Jan-2021, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Nov-2020, Prenatal screening test: normal (normal) Normal. On 21-Dec-2020, Aspartate aminotransferase: normal (normal) Normal. On 14-Jan-2021, Ultrasound foetal: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitantly, on 01-Jan-2020, patient started taking Nature Made Prenatal  orally once a day as prenatal vitamin. No treatment related information has been reported.  On 15-Nov-2020, genetic test came with normal results.
On 11/08/20 the client had symptoms of fever up to 103.5 F, chills tachycardia 117 bpm, O2Sat nadir of 85%, respiratory rate 22, development of hypotension with BP 85/55 bpm with weakness, drowsiness, chills, flushed skin, bilateral edema both lower extremities with wheezing and rhonchi throughout both lungs and was sent to a local medical hospital for treatment where he tested positive for COVID and was returned to the psychiatric hospital after a 3 day stay and 2 administrations of remdesivir on 11/09/20 and 11/10/20  improved.  The client subsequently received the Pfizer COVID19 vaccinations on 12/29/20 and 01/19/21 from different lot numbers noted above.  On 5/16/21 the client began to have respiratory symptoms including temp of 99.5, pulse 103 O2 Sat of 85% with rhonchi responsive to albuterol inhalation and subsequently albuterol nebulizer treatment; however the following day symptoms progressed with weakness, wheezing, cough, shortness of breath, pallor and O2 saturation 77% unresponsive to albuterol nebulizer treatment.  He was was transferred to a local medical hospital for treatment of severe respiratory symptoms and tested positive for COVID a second time and after the complete Pfizer COVID19 vaccination series approximately 4 months prior.  He is still hospitalized at the medical hospital at the time of this report (2 days).
Chronic fatigue with intermittent headaches, so much so that it's been difficult to function. This began the day after receiving the first vaccine.
Swelling, redness left arm and chest wall. Pain and numbness left arm for 2-3 days.
1350 - after receiving the shot, pt reports feeling light headed and hard to breathe. Pt. was helped to cot by friend and biosafety personnel. 1401 - BP 109/69, pulse 112, pt calm and conversational. RN explained the vasovagal response to the patient, who explained that this has happened to him in the past "every time he got a shot". Pt reported feeling much better while lying on cot with a cold compress. MD recommended not drive, friend offered to drive pt home with family. Pt. given water to drink, advised to seek care as needed.
Sweaty hands and feet, tingling right hand, headaches, nausea, dizziness, mental disassociation, anxiety.   All these symptoms persist 10 days after vaccination.
Day of vaccination: R arm soreness, (3rd day of menstrual cycle) 9:30pm heavier menstrual flow than normal Day after: 8am feverish/chills  12pm muscle aches, still feverish/chills,  fatigue 5pm 99.8 (norm 97.6) fever continued chills and muscle aches and fatigue, headache, 600mg ibuprofen and recreational marijuana  6:30pm 99.7 fever continued chills and muscle aches, fatigue, headache 9:30pm 99.2 fever continued chills and muscle aches, fatigue, recreational marijuana. Heavier flow of menstruation.  2 days after: 9am 97.7 chills, fatigued 12pm: 97.7 fatigued, recreational marijuana 2pm: fatigued, menstrual flow very light My menstrual flow is usually heavy only the first couple days. It was heavier than normal on the 3rd night and continued heavy until over.
Had a slight fever and muscle aches and was fatigued. Treatment was taking tylenol and woke up next day fine
Patient walk in to pharmacy to request her first dose COVID vaccine, she has a history of fainting from immunization from needle injection pain. Pfizer covid vaccine was prepared and administered per manufacturer procedures. Immunizing technician noticed patient's change in behavior/voice and color of face, offered water and patient accepted, she fainted shortly after. Husband and technician was transitioning patient to recovery position as patient became alert and aware. She sat back down, vomited, and recovered, she left store on her own with husband.
Within 6 hours of flu vaccine he became agitated, restless, anorexic, had headache. H/A resolved, still restless, anorexic.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: fk9894), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Sep2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up (20Sep2022): Follow-up attempts are completed. No further information is expected.
Patient received second dose of HAVRIX on 03/28/2007 at 11:00. Patient complained of extreme fatigue, headache unrelieved with OTC analgesics, low grade fever and diaphoresis lasting less than 24 hours. All symptoms resolved spontaneously without medical treatment. Patient had received the first dose of HAVRIX on 08/28/2006 without incident.
3 episodes of syncope. Heart rate and blood pressure dropped and fainting occurred between 7-8am.   Minor symptoms- Fatigue, fever, chills, sweating
Patient began feeling ill approximately 4 hours after receiving seasonal flu vaccine injection. She report nausea, vomiting and fever up to 100.0, cold shakes, and lethargy lasting 18 hours. She then slept for 10 hours and felt somewhat better.
Headache & Fever Narrative:  Headache weak subjective fever on 1/24/21
Observed for 30 minutes. Flushing, arm heaviness reported, nausea, heat in thighs.  Reports similar reaction with first dose.  Requested to rest on a stretcher. BP 140/71, HR 93.   Nausea and arm heaviness reported at 1605.  BP 150/81, 10015sats; HR 87.  At 1610 Heat in thighs.  BP 125/66, HR 82 100% sats on oxygen.  1628: No further symptoms.  Released home.
Patient said she experienced littles bumps on her chest and both arms. She said it first started on her chest on Saturday then it has increased in number and is on the arms now. She also has swollen lymph nodes under both arms.
Patient did not have any adverse reactions. Patient was given the 2nd booster for Moderna with a Moderna vaccine vial which was not stored within CDC guidelines.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 14-NOV-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # K011004 and expiry date: 07-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a patient who was vaccinated with a dose of Varivax (lot number not available). Subsequently the patient developed a minor rash on the arm. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint. No additional information is expected.
Severe lower back ache appeared two days after each dose, sufficient to restrict ordinary movements. Pain abated slowly over following weeks. At time of reporting, two weeks after second dose, significant improvement noted but not full recovery.
Shortly after receiving the influenza vaccine and pneumococcal vaccine the patient began to have severe abdominal cramping with radiation to his lower back. Patient also became very pale. - Abdomen was rigid and distended. EMS/911 was called - symptoms lasted about 15 minutes and subsided prior to EMS arrival.
Red papules sparsely dispersed with concentration in groin, neck, and axilla. Received varicella vaccines on 07/24/2006 and 01/22/2010.