chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe left lower quadrant abdominal pain; Awakened me from sleep; Flatulence; Received moderna vaccine as dose 1 and BNT162B2 as dose 2; Off-label use; This is a spontaneous report from a contactable physician, the patient. A 64-year-old female patient received the second dose (initial Pfizer dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Feb2021 at 14:00 (at the age of 64-years-old) and third dose (reported as the second dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 14:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension-controlled, diverticulosis, and allergies to certain plastics or blue dye during childhood. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) in the left arm on 11Jan2021 as a single dose for immunisation. Concomitant medications included nifedipine (MANUFACTURER UNKNOWN) at a dose of 60 mg, hypericum perforatum (ST. JOHN'S WORT), colecalciferol/apoaequorin (PREVAGEN), and colecalciferol (VIT D3); all were taken for an unknown indication from an unknown date and unknown if ongoing. On 07Feb2021 at 00:30, after the 1st dose of Pfizer vaccine, the patient developed severe left lower quadrant abdominal pain which awakened the patient from sleep at 00:30, lasting 1.5 to 2 hours. The pain was rated 8-9/10 with no nausea, vomiting, or fever. The pain improved associated with flatulence and somewhat relieved with bowel. The patient had developed the same events on 2nd dose of Pfizer vaccine as well and recovered. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with a modified diet and no medications were accepted. Since the vaccination, the patient had been tested for COVID-19. On 11Mar2021, the patient underwent a SARS-CoV-2 antigen test via nasal swab and the result was negative. The clinical outcome of the events severe left lower quadrant abdominal pain, awakened from sleep, and flatulence was recovered on an unknown date in Feb2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 30-JAN-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M029598, expiration date 10-DEC-2017, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
her left arm is still sore at the injection site; an area about "a quarter of an inch" was burning on the left side of her arm; entire arm felt like it was going to fall off "it was so sore"; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose  of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Jan2021  as a single dose in the left arm for COVID-19 immunization. Medical history included a tooth had been bothering her from an unknown date and was ongoing. Concomitant medications were not reported. In Jan2021 (since her first vaccination), the patient experienced her left arm was still sore at the injection site, an area about "a quarter of an inch" was burning on the left side of her arm and on Saturday her entire arm felt like it was going to fall off "it was so sore". The clinical outcome of the events vaccination site pain, skin burning sensation and pain in extremity was not recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with improperly stored VARIVAX lot # M038856, expiry date 14-SEP-2018 for prophylaxis. No adverse event was reported. The vaccines were stored at a temperature range of -14°C to-10°C for 483 hours and in the range of -9°C to 8°C for 28 hours. Digital data logger was not involved. There was no previous temperature excursion. No product quality complaint was involved. No additional information was available. Sender's Comments: US-009507513-1707USA010627.
pt recvd vax & awakened w/t102 which by noon was 104 unable to bring down w/APAP; devel diarrhea & Thurs vomiting x 2 days; spoke w/MD on phone several times but no office visit needed;
Myalgia, Tachypnea, hx reactive airway disease. Can't move L shoulder, pain entire LLE & LUE  Narrative:  Advised going to ER if no improvement after taking Albuterol MDI personally at home (has for hx reactive airway disease, used prn illness only; no prophylactic MDI. Also advised use of Benadryl).
Chills and joint pain in the evenings from day 3 through day 7.  Mild to moderate Headaches from day 3 through day 9.  Shortness of breath, twice between day 5 and 7.  Chest pain on the evening of day 6, lasted 3 to 4 minutes.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ oral (dose and frequency were not reported). No adverse events were reported. Additional information has been requested.
got very sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Tdap Vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received TDAP several years ago and would never again. The patient got very sick for several days. The follow up would not be possible as no contact details were available. This case is linked to the case US2021AMR172350, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR172350:Same reporter
PATIENT RECEIVED COVID VACCINE FROM US AND CAME IN THE FOLLOWING EVENING WITH A SWOLLEN FACE.  SHE WAS GIVEN BENADRYL AND STATED SHE WOULD LET US KNOW IF IT DIDN'T HELP OR HER CONDITION WORSENED
NEAR SYNCOPAL EVENT APPROX 2-3 MINS AFTER INJECTION.  PT REPORTED MUFFLED HEARING AND BLURRED VISION DENIED CP, SOB, ITCHINESS,   INITIAL VITALS UPON ENTERING OBSERVATION UNIT: BP-79/43 HR-46  RR-18  SPO2-100%--AOOX4 REPORTED A HEADACHE APPROXIMATELY 10 MINS INTO OBSERVATION  PT DISCHARGED WITH CAREGIVER ASYMPTOMATIC WITH NEGATIVE ORTHOSTATICS. LAST SET OF VITALS: BP 109/76  HR 70  SPO2 99%  RR18
Patient developed a rash that was bright red, hot, itchy, and mildly erythematous and approximately 10 cm long and 5 cm wide. This was treated for approximately 24 hours with an oral antihistamine x 3 doses and ibuprofen x 3 doses. The rash did not full resolve for approximately 72 hours.
Flu like symtoms, body aches , joint pain. sleepy, chills, slight headache, enough to keep in bed all day
Patient c/o dizziness. Patient sat for 5 min. felt like her eyes were itching. Gave pt orange juice. BP 143/94 P-95. 10 min later orthostatic BP-lying 156/90 sitting 147/88, P-79. Pt seemed stable and went home.
On 5/20, I started experiencing severe right-side pain in my lower back, right-side rib cage, right- side under breast and right-side skin (overall was painful to the touch). By 5/22, I had a burning sensation on my back and several tiny clusters of blisters appeared on a reddened area. Pain worsened and more tiny blisters appeared with additional on right-side breast area discovered by doctor in urgent care on Monday morning 5/24/2021.
Received 4 shots (flu, & standard 6 month shots), two in the left thigh. Dtap upper L thigh.. large red welt for 5 days with hard lump. Lump persists for 8+days. Low grade temp & double ear infection 5+ days after injection.
Within 8 hours, post vax, pt's arm became painful, red and swollen which progressively increased from should to elbow.
pt recv vax 4FEB97;13FEB97 devel flu-like sx w/post auricular adenopathy;21FEB97 swelling of hands & feet;23FEB97 heart fibrillations requiring inj of adenocard;
This spontaneous report as received from a health care worker refers to a patient of unknown age. Medical history and current condition of the patient was unknown. On an unknown date the patient was vaccinated with (Merck) VARIVAX lot # K009756, expire date reported as 09-JUL-2016, 0.5 ml, subcutaneous. Concomitant medication was unknown. On an unknown date unspecified amount of doses of (Merck) VARIVAX went temperature excursion were administered to an unspecified amount of patients and no adverse effect reported. The outcome was not reported. This is one of the two reports from the same source. (Same reporter link) (MARRS# 1412USA002940). Additional information has been requested.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 18-JUL-2013 (lot # and exp date no reported). This is one of the report from the same source, linked reports. Additional information is not expected.
fever, nausea and vomiting every 2-3 hours for ~ 12 hours,   Soreness at the injection area.  Fatigue.
some pain at the injection site tiredness headache body aches joint aches I felt bad for around 18 to 24 hours the folling day i didn't feel great, but not bad either
Received 1st of 2 vaccinations on 3/31/21. Received immunotherapy Keytruda on 4/1/21. On 4/3/21 started with fatigue and muscular pain. By 4/4/21 muscular pain level 10/10 especially of neck and chest. Creatine Kinase level drawn and found to be severely elevated at 1279 U/L (normal high 182 U/L). Patient is being admitted to hospital for possible myositis.
Information has been received from a 64 year old female consumer with no known allergies and a history of shingles which started "four years ago" who on 19-DEC-2006 was vaccinated SC with a dose of Zostavax. There was no concomitant medication. On 19-JAN-2007 the patient brokeout with blisters between L2 and L3 on her back. After the blisters popped she was in extreme pain. The patient reported that she had been getting these blisters for a about a year once a month. However, previously the outbreaks were very mild and did not cause her great discomfort. Since vaccination, the "outbreaks are significant and painful". At the time of the report, the patient had not recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Information has been received from a Registered Nurse (R.N.) concerning a female patient who was vaccinated with a dose of Gardasil at another practice. The patient developed an outbreak of genital warts after receiving the Gardasil. The time frame was unknown between the vaccination and the outbreaks. Unspecified medical attention was sought. The patient's outcome was unknown.
noted tingling under lt breast & on back by 2APR93, by 8APR devel redness & itchiness in same areas; 11APR devel pustules in these areas which broke open & contained clear liquid; suspected shingles;
Approximately 1 month later, severe joint flare up resulting in almost total disability patient now on a walker and physical therapy required
Sever cold; Severe cough; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0171), via an unspecified route of administration on 28Apr2021 at 09:15 (at the age of 46-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01May2021 at 17:00, the patient experienced severe cold and cough. On an unknown date in May2021 (one week after the vaccination), the patient still had fatigue. The adverse events did not result in doctor or other healthcare professional office/clinic visit or emergence room. No treatment received. The clinical outcome of the events severe cold, cough and fatigue was not recovered.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: patient information, Treatment Received updated to NO for all events, "The adverse events did not result in doctor or other healthcare professional office/clinic visit or emergence room. No treatment received" added in narrative.
4 Patients received their 1st dose from a vial greater than 12 hours post puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 Patients received their 1st dose from a vial greater than 12 hours post puncture) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 Patients received their 1st dose from a vial greater than 12 hours post puncture). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (4 Patients received their 1st dose from a vial greater than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.
Patient had some subjective tongue swelling after receiving the 2nd dose of Pfizer vaccine today. She also experienced this after the first dose from lot #EM9809 on 02/16/2021 but did not bring it to anyone's attention at the time. She pre-dosed with 25mg of Benadryl today before receiving the vaccine. She was observed for over an hour without worsening before being discharged from the observation area with instructions to take an additional 25 mg Benadryl after returning home.
No adverse events. Residnet rec'd pfizer on 1/7 and 1/28 and on 6/2 rec'd J&J
Pruritis and hives started aound 3pm to clients abdominal region. 6pm hives covered entire body. Oral Benadryl taken at 6:15pm. Several hours later client had no symptoms.
9/17/21 9:29 AM:    56 yof c/o nausea, diarrhea, HA, fatigue, dizziness, L arm at inj site pain/redness/swelling/warmth x 2d  Pt in no resp distress Pt speaking in clear and complete sentences Pt A&O x 4  Pt reports that she had chills the first day Started with the arm SXs 24h later; redness 1 in around inj site Pt reports inj site has gotten worse; 4 in bright red around inj site, bumpy, hot, hard, painful, itchy, swelling around site Current pain level: 6/10 L arm; 3/10 HA Last took Advil 2d ago; with relief   Denies difficulty breathing, difficulty speaking, sudden swelling in back of throat Denies CP, fainting, palpitations, confusion, agitation, dec LOC Denies fever, chills, drainage  Pt scheduled with nurse at 3:20 PM  9/17/2021 3:20 PM nurse visit:   56 yof c/o nausea, diarrhea, HA, fatigue, dizziness, L arm at inj site pain/redness/swelling/warmth x 2d Has been taking Advil with relief; last taken 2d ago   Pt in no resp distress Pt speaking in clear and complete sentences  Pt A&O x 4   Currently Dull HA; sides of head/frontal; 2/10 Mild dizziness; denies vision changes, room spinning, feeling faint; lasts less than 1 min; aggravating: denies; alleviating: denies   L inj site: Currently burning, itching, stinging, painful 2/10 3.5 x 2 in site Notes some improvement from yest Redness, swelling, warmth, firmness, pain on palpitation    Meds: Denies   Allergies: Denies    Consulted with provider NP whom saw pt: Benadryl 50 mg at home; 25 PO during the day Can also use topical Benadryl Pepcid  Cold compresses Arm should heal in 3-4d with using consistently OK to receive Shingles #2 that is scheduled for 10/2021   Pt states that she has above at home Home care instructions and ER precautions provided Instructed pt to advise if SXs worsen or new SXs arise Pt verbalized understanding and had no further questions Pt left clinic in stable and ambulatory condition
Extreme Fatigue for first 3 weeks, and downgraded to moderate fatigue, which still exists. The morning after the shot, I had a severe headache which has continued and has not improved since the onset. The morning after the shot I had severe muscle pain, Which continues to persist with moderate inflammation/muscle pain throughout my entire body. When I woke up the morning after the shot I also had a fever and chills that finally broke 3 days after the shot. When I woke up the day after the shot I also had a sore throat & congestion that has still not gone away. I've also experienced brain fog that continues to impact my ability to focus at work.
Administered incorrect dosage per Moderna vaccine guidelines. patient received 0.3 mL instead of 0.5mL.  Per CDC if more than half the dose was given, do not repeat the dose. If less than half the dose was given, then repeat the dose.   in this case more than half the dose was given based on CDC guidelines. Incident reported to patient by clinics Doctor.
Pt received Pfizer vaccine x2. Second dose in may 2021. Hospitalized with COVID PNA 1/4/2021
Information has been received from an office billing supervisor concerning her 22 year old daughter who on 04-OCT-2007 was vaccinated with the first dose of GARDASIL (Lot # 658560/1062U, expire date and route not reported). On 17-DEC-2007, the patient was vaccinated with the second dose of GARDASIL (Lot # 658488/1264U, expire date and route not reported) and on 11-JUN-2008, the patient was vaccinated with the third dose of GARDASIL (Lot # 660393/0067X, expire date and route not reported). Concomitant therapy administered, when the first dose of GARDASIL was given, on 04-OCT-2007, included influenza virus vaccine (unspecified) (manufacturer unknown). The office billing supervisor informed that on 11-MAR-2009 and on 09-APR-2010, her daughter had an abnormal PAP which resulted in multiple colposcopies (results not provided). The patient sought medical attention by an office visit. On an unspecified date, the patient recovered. Follow-up information was received from the office billing supervisor indicating that on 11-APR-2010, her daughter had the second PAP (previously reported as 09-APR-2010 by the office billing supervisor). Follow up information has been received from a nurse practitioner indicating that the 22 year old (currently 25 years old) female patient with no illness at time of vaccination and no preexisting allergies, no birth defects and no medical conditions who on 04-OCT-2007 at 16:03, was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly on the left deltoid (Lot # 658560/1062U). On 17-DEC-2007 at 15:16, the patient was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscularly on the left deltoid (Lot # 658488/1264U) and on 11-JUN-2008 at 23:27, the patient was vaccinated with the third dose of GARDASIL 0.5ml, intramuscularly on the right deltoid (Lot # 660393/0067X). On 16-APR-2009, was performed a "necessary" PAP smear reported as abnormal PAP. On 27-APR-2009, was practised a colposcopy that reported epithelial cell abnormality, reading endocervical/transformating zone component present. In December 2011, would schedule next PAP smear. The patient did not seek medical attention. This is one of several reports from the same source. Additional information has been requested.
Pt developed fever of 102 degree, swelling , redness and area was hot for 24 hours after vaccine administration. afterwards the symptoms subsided.
Symptoms include light headedness that was immediate; 30 minutes later had a headache and neck pain; 30 minutes later had a headache and neck pain; Diarrhea started 2 hours after the shot and now symptoms are improving.; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient had symptoms that include light headedness that was immediate, 30 minutes later patient had a headache and neck pain, and then diarrhea started 2 hours after the shot and now symptoms were improving. Clinical outcome of headache was not recovered while for the other events was recovering.  Information on the lot/batch number has been requested.
Itching, throbbing pain on Lt upper arm (entire) swollen (severe). Reddened area (spotty) on Lt upper arm & in clavicle area 5x5 cm.
Hives lasting 48 hrs.  Treated with Benadryl.   All of body was involved in episode.  My first experience with Hives.
8 Days after initial shot, experienced red swollen lump which is hot and itchy near injection site
Rash over arms, legs, body itching - slight SOB. Mom saw pharmacist -> BENADRYL given. Allergic reaction started next day after vaccines given. Child also used new soap and possibly this was the cause of the reaction. Child also c/o abdominal cramps. Unable to eat but able to drink fluids. Probable stomach virus. Vomited x 1 at home. When seen rash was resolving but still visible. No SOB noted. Mother instructed to continue BENADRYL PRN. Watch for SOB. Keep child hydrated. See MD or go to ER if symptoms worsen or if child unable to take fluids.