chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEADACHE; FEELING TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and feeling tired was not reported. This report was non-serious.
Flublok Quadrivalent was administered to a 12 year-old child, no AE; Initial information received on 09-Dec-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1959 and expiry date: 30-Jun-2020) via intramuscular route in the right deltoid, on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation.  It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that Flublok Quadrivalent was administered to a 12 year-old child.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
On 11/21/2021, at 6 PM, I developed a rapid and irregular heartbeat of 120 (as per at home blood pressure machine).  I went to the local Medical Center ER at 9 PM. An IV was started, I was placed on a heart monitor, a Lovenox injection was given, a chest X-ray and blood work was done. When my heart rate did not slow on its own, I was place on a Cardizem IV drip. I was admitted to the hospital at approx. 2 AM. I remained on the Cardizem drip until mid-morning, when it was determined that my heart rate had slowed. I was started on Eliquis 5 mg on Monday, 11/22/2021. I remained in the hospital until 6 PM on 11/23/21 when I was discharged. I am to remain on Eliquis for the foreseeable future.
Patient now has breast cancer and lymph nodes increased in size 3 months after 3rd pfizer in September
Patient reports discomfort directly at injection site at first and had trouble lifting arm. Pain moved up to the shoulder and it persists. He reports that it is getting better but still has occasional pain in the shoulder area. Two shots were given in the deltoid. PNEUMOVAX was higher and SHINGRIX was lower, separated by greater than 1 inch.
about 6 hours after vaccination her right arm became red, hot and swollen (to size of a baseball). she exercised her arm and drank. These symptoms lasted ~ 6 days. About 14 days after vaccination, her right arm became red, hot and swollen again (to size of a baseball), and then continued to get more swollen (to grapefruit size). Then she felt nauseated and tired. she applied a Benadryl topical cream, which helped to lessen the hot and itchiness. 22 days after vaccination, her right arm is becoming less swollen and less red.
Pfizer vaccine was diluted with NS 0.9% Bacteriostatic which is not recommended for use with this vaccines. Reported to Pfizer and CDC. As per recommendation from CDC, affected dose should be repeated. Pt was notified and all questions answered. Pt refused to repeat dose 1 due to side effects he experienced with the vaccine.
long COVID; became very ill; developed COVID after being vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (developed COVID after being vaccinated), POST-ACUTE COVID-19 SYNDROME (long COVID) and ILLNESS (became very ill) in a 23-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. In January 2022, the patient experienced COVID-19 (developed COVID after being vaccinated). On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (long COVID) and ILLNESS (became very ill). At the time of the report, COVID-19 (developed COVID after being vaccinated) had not resolved and POST-ACUTE COVID-19 SYNDROME (long COVID) and ILLNESS (became very ill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  Company comment: This spontaneous case concerns a 23 year old female patient with no reported medical history, who experienced the unexpected non serious AESI of COVID-19 after receiving a dose of COVID -19 vaccination with mRNA-1273 vaccine (latency unknown). The patient also experienced Post-acute COVID-19 syndrome. No further information on clinical course, management of the event, vaccination schedule and its details were available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2022: Follow-up received and contains no new information; Sender's Comments: This spontaneous case concerns a 23 year old female patient with no reported medical history, who experienced the unexpected non serious AESI of COVID-19 after receiving a dose of COVID -19 vaccination with mRNA-1273 vaccine (latency unknown). The patient also experienced Post-acute COVID-19 syndrome. No further information on clinical course, management of the event, vaccination schedule and its details were available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Child noted L arm reddened and painful last eve. Went to school today teacher called mom to pick child up at school due to painful, swollen arm. Applying ice, Advised to give Benadryl 25 mg now, may repeat at bed time Ibuprofen PO at 4 hour PRN, erythema 1 1/2 x 1 1/2".
Pain in right shoulder joint that has not gone away. The pain varies from mild to severe ever since vaccination.
(L) arm red the afternoon vaccine given, began to get larger. When evaluated at appt. on 7/3/18, (positive) 10 cm area redness (L) arm. (Positive) warm/tender/hard. 10mL BENADRYL TID and KEFLEX 250/5 1 1/2 tsp TID x 7 days for cellulitis. Evaluated today, on 7/8/18 - good prognosis.
Itching at injection site immediately following second dose; the following morning a Red, swollen and itchy rash around injection site developed and lasted 72 hours; fever and fatigue set in around 24 hours after injection and lasted another 24 hours. Chest pain and tightness occurred about 36 hours after injection and was treated with ibuprofen.
At arm pain at 11:00 pm. The following day, my left arm swelled up from wrist to shoulder - three times it's size. I couldn't move my arm for 24 hours. Arm pain was gone after 24 hours. Two days after - I was freezing cold, on the couch. Following day, I called my doctor. He told me to rest. I had a high fever and I had body aches. I was really cold. I felt like I had the flu for about a week - missed a couple days of work.
Arm began itching.  Later in the day I noticed a red spot, about 3" across, raised and warm to the touch.
Pt recvd DTP/OPV/MMR/HOBC 19AUG91 & devel blue streak, looks like vein below knee & slight blue streak above knee;
no adverse effects; An 18 year old patient inadvertently received unspecified dose of PROQUAD instead of MMR II and VARIVAX due to human error in selection; An 18 year old patient inadvertently received unspecified dose of PROQUAD instead of MMR II and VARIVAX due to human error in selection; An 18 year old patient inadvertently received unspecified dose of PROQUAD instead of MMR II and VARIVAX due to human error in selection; This spontaneous report was received from a nurse referring to an 18 year old patient.  No information was provided regarding the patient's medical history, concurrent conditions or past drug history.  Concomitant therapies included sterile diluent.  On 08-JUN-2020, the patient inadvertently received an unspecified dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S021325, expiring on 05-JAN-2021, for prophylaxis (dose, route and site of administration were not reported), outside recommended age range.  The nurse stated it was human error in selection as patient needed  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) immunizations. There were no symptoms or additional adverse effects reported.
On Tuesday morning school noticed redness on injection site of (L) arm contact mom and applied ice. Tuesday afternoon mom noticed redness spreading down arm. Patient was seen in Dr. office on Thursday AM treated for cellulitis. Prescribed SEPTRA for 5 days and prednisone for 3 days. Advise to use MOTRIN and cool compress.
Pt felt dizzy, light-headed, and pale. Fainted/loss of consciousness.
Patient stated she felt soreness and redness at site of injection. Felt Flu-shot was administered differently (SQ) than recommended (IM)
Approximately 10 cm red patch on the left thigh at the injection site, 1.2 cm hard knot .
BLOOD CLOTS; NUMBNESS IN BOTH OF THE KNEES; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. 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 and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots, and numbness in both of the knees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness in both of the knees and blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210919371 -covid-19 vaccine ad26.cov2.s- blood clots. 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).
Sign/Symptoms: vomiting, nausea, and diarrhea. Took one bite of sandwich and pickle from Wendy's prior to vaccine and she vomited prior to getting the vaccine.
pt recvd vax 17JUN94 & mom called 23JUN94 stating pt had lump to lt leg, turning balc, hot & painful to touch; pt brought to clinic that afternoon-lump was palpable, but not black, not very red, not hot to touch;
At 11:06am the pt vomited and became pale, diaphoretic, dizzy. Placed head between knees. Pulse was 72. The pt was moved to a table to lie down. At 11:08am BP was 86/48, pulse was 72 the pt was still pale, dizzy but responsive. At 11:10am, BP was 104/60, pulse 72, color is better, stated feeling better. At 11:15, the pt sat up, became pale and dizzy, laid back down. Pulse was 76. At 11:30am. BP 110/60, pulse 80. Color is now normal and when she sat up was ok. At 11:40 the pt walked to waiting area. After a 3:00pm phone call home. All is well.
Fever 100.7 for 2/6 and 2/7 dates.  Severe headache 2/6 2/7 and 2/8 Swelling and redness at injection site Severe body aches 2/6 and 2/7
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date, the patient was vaccinated with VAQTA for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. Additional information has been requested. Sender's Comments: US-009507513-1708USA011860: US-009507513-1708USA011858: US-009507513-1708USA011859: US-009507513-1708USA011856: US-009507513-1708USA011857.
Three days post vaccination, the patient developed "chickenpox with 75 to 100 lesions". The patient sought unspecified medical attention. Additional information has been requested.
Dizzy and nauseous.  EMS called and pt evaluated.  Pt refused transport. Sx resolved
Severe chest pain; breathlessness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 21Apr2021 (Batch/Lot Number: Ew0161) (at the age of 40-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: Er8733) on 31Mar2021 (at the age of 40-years-old) in the left arm for COVID-19 immunisation. On 04Jun2021, the patient experienced severe chest pain and breathlessness. The patient was not given any treatment for the events. The events resulted in ER visit and physician office visit. Outcome of events was recovered on an unspecified date.   Follow-up attempts are completed. No further information is expected.
Case became concern on 3/27/03 after not having menstrual cycle since 2/10/03. Took home pregnancy test, result was positive. Case if to follow up after OB.
Evening of day 1 chills, day 2 sore painful arm, day 5 hot tingling face advancing down to calves became blotchy with hives lasted about less than 1 hour.
Tingling left upper extremity and left lower leg, neck felt swollen on left side, general feeling of shakiness.  Cervical adenopathy present Supraclavicular adenopathy present Lymphadenopathy of head and neck region
Pt admit to hospital 6/12/22 and incidentally found to be COVID+. Pt previously received J&J vaccines on 6/15/21 & 11/4/21). O2 needs increased and started steroids on 6/15/22.
SX: Fever with violent shaking, cough, throat burning and felt like unable to breathe, stridor, severe eye itching/watering, sinuses with copious mucus drainage, voice very hoarse. Heart racing to the point of chest pain. Symptoms began about 4 hours after injection. TRX: Zyrtec 10 mg. po, Nasocort nasal spray 2 to each nostril, Tylenol 625 mg PO, Zicam 1 tablet dissolved in mouth all taken about 45 minutes after symptoms started and symptoms started to abate about 40 minutes after that.
Heavy, extremely painful menstrual bleeding began just over four hours after receiving the Moderna vaccine. Bleeding was atypical and arrived early on cycle day 25, whereas my cycles had previously lasted an average of 30-31 days throughout my then-seven years of menstruation. Bleeding was heavier with larger and more numerous clots, and lasted for four days. Previously, my menses were 6 days long. Menstrual cramping and heavier bleeding were in conjunction with nausea, weakness, diarrhea and pre-syncope. My menstruations that came after June 3rd - 6th, 2021, continued to increased in severity and unfamiliarity. I then contracted a sudden and severe UTI less than two weeks later, which spread  up into my kidneys within 3 days. I had to visit the ER to receive fluids and antibiotics. I continued to visit outpatient services for a few days to receive IV antibiotics with fluids before switching to an oral antibiotic. After a 28 day cycle, bleeding began again July 1st - 6th, 2021. I bled heavily and painfully, with post-menstrual spotting that continued from July 8th - July 11th.  After a 35 day cycle, my next period began August 5th, 2021 with the most intense cramping I had ever experienced. Over the 5 days my period lasted, August 5th-9th, I was unable to attend work, bathe myself, or get out of bed other than to use the restroom. I was weak, fevering, faint, and cramping severely. My next period arrived September 3rd, 2021 after a 29 day cycle. Again, I bled heavily for five days (09/03/2021 - 09/07/2021) with significant pain and weakness, diarrhea, and large clots. Over the next 13 months, my cycles and menstruation  continued to be painful, heavy and irregular. I became pregnant in November of 2022 so that is where my data stops.
This spontaneous report as received from a physician via a company representative refers to a male patient of unknown age. On an unknown date in October 2013 the patient was vaccinated with GARDASIL (dose, route, lot number and expiration date not reported). It was unknown if this was the patient's first, second or third dose in the GARDASIL series. There was no concomitant medication reported. The physician stated that the patient fainted 7 times and had high blood pressure since receiving GARDASIL on an unspecified date in October 2013. It was also reported that the patient was seen as an outpatient in a hospital in November 2013, and the cause of the patient's symptoms was not found. The outcomes of the events were unknown. Additional information has been requested.
1 hr after vaccination patient experienced dizziness then nausea/vomiting/dry heaving. 2 hrs later - patient took a 30 min nap and woke up feeling fine.
Hurt badly when shot given. Shoulder sore for 48 hours. Neck sore 12 hours after shot. Injection site was hot to touch for 12 hours. Two days later and I still feel dragged-out and no energy
48 hrs after administration and 96 hrs after administration of 3 vax had choke up and stiffen up. ?GERD and SZ
Initial report received from a consumer on 08 October 2008. A 12-year-old male patient with history of seasonal allergies and sensitivity to medications may have received MENACTRA or MENOMUNE at the end of August, 2008. The reporter, the patient's grandmother, was not sure what vaccine her grandson had received, but indicated it was a booster dose. The reporter also indicated that her grandson may have received other vaccines at that time. A few days after the vaccination, the patient developed a cough and was diagnosed with pneumonia. The patient also experienced vomiting, headaches and decreased strength in his legs and by two weeks, he could not walk across a room. When the patient was hospitalized on 29 September 2008, he could not walk at all. Spinal tap, x-rays and labs were performed; results were not provided. At the time of the report, patient outcome was 'not recovered' and hospitalization continued. Documents held by sender: None  11/18/08 Reviewed hospital medical records of 9/30-10/11/2008 & 10/18/2008. FINAL DX: bilateral LE pain & weakness; recently dx w/pneumonia. Records reveal patient experienced URI x approx 1 mo w/croupy cough, discolored sputum.  Dx w/walking pneumonia 9/15 by PCP & tx w/oral antibiotics.  CXR 9/20 revealed persistent pneumonia & tx w/another round of oral antibiotics & steroid taper.  Developed N/V, HA & abdominal pain on meds.  Pulmo consult done 9/29 & admitted to hospital for weakness, difficulty walking, ataxic gait, poor trunk stability.  Neuro consult done.  Transferred to inpatient rehab & d/c to home 10/11/08 w/walker assist.  Admitted 10/18 for back pain & falls.  D/C to home to return for outpatient MRI.      11/18/08 Reviewed PCP medical records of 8/28-11/04/2008. FINAL DX: Records reveal patient experienced usual state of health on 8/28/08.  RTC 9/8 for pain right shoulder, clavicle & ribs after fall from top bunkbed.  RTC 9/15 w/complaints of feeling sick x 3 weeks w/anterior chest pain, cough, stuffy/runny nose & breathing difficulty.  FEV revealed mild obstruction & low vital capacity possibly due to restriction.  RTC 9/20 w/continued symptoms s/p completion of antibiotics, decreased activity, decreased appetite, bibasilar rales.  Dx w/RML pneumonia.  Tx w/oral antibiotics.  Cough improved but had chest tightness & tx w/steroid taper.  Developed vomiting & meds changed.  RTC 9/24 w/continued symptoms & weakness, dizziness.  Exam improved & to continue same tx.  RTC 9/26 w/HA, fatigue, rib pain to palpation.  Seen by pulmo 9/29, ortho 10/13 & neuro 10/17.  Continued back pain & difficulty walking, nausea w/riding in car.  W/U WNL & referred to psych & continued PT
Vomiting; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) via COVID-19 Reporting portal. The reporter is the patient.  A 34 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm left, administration date 19Mar2021 10:15 (Lot number: En6207) at the age of 34 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "Obsessive-compulsive disorder (Ocd)" (unspecified if ongoing); "complex post-traumatic stress disorder (ptsd)" (unspecified if ongoing); "known allergies to Nickel" (unspecified if ongoing). Concomitant medications included: citalopram hydrobromide (CELEXA); lorazepam. The following information was reported: VOMITING (non-serious), outcome "unknown," described as "Vomiting." Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are needed. No further information is expected.
After first dose: Palpitations, dizziness,  high blood pressure, tachycardia, bilateral lower extremity weakness, muscle spasms, goose bumps on Left leg, left arm weakness,  After second dose: above symptoms and signs and difficulty swallowing, ataxia like movement in both legs during ambulation,  heavy menstrual flow, menstrual cramps, facial numbness and tingling, photosensitivity, hypersensitivity to medications, swollen lymph node behind right ear and left axilla.
PEDIARIX and DTaP well given on same day. client had cold, no fever, IM 2 hotline called immediately. Advise that he might have more local reaction and a fever. CLT physician called.