chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is an 80 year old female with PMH of CHF, HTN, afib, MI, and COPD who presents to the ED c/o weakness x1 week. Patient also reports having loose stools for a couple days which she felt was related to eating too much fruit because that's all she "desired". Patient denies chest pain, shortness of breath, nausea, vomiting, body aches, and fevers. Patient reports that she tested positive for Covid with a home test on 1/1/22 but was negative 4-5 days ago. Patient is full vaccinated with Moderna including a booster which she received 3 weeks ago.
Five (5) minutes after receiving vaccines, patient started with a facial rash. Patient with erythematous, blanching, papular eruptions over face and upper chest. No hives. Lungs CTA, no increased respiratory effort. Observed in office x 20 minutes with spontaneous fading of the rash.  Family was called 3 hours after discharge to follow up and parents had reported that the rash had completely resolved without any further invention (ie: oral or topical medications)
This spontaneous report was received from a pharmacist via a company representative concerning unspecified number of patents of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. The patient individually reported to the pharmacist that on an unknown date, they experienced "redness and swelling at the injection site". No product quality complaint (PQC) was involved. The outcome of injection site erythema and injection site swelling was unknown. Additional information has been requested.
This spontaneous report was received from a physician, via Pfizer (2016164188) refers to a 78 year old male patient. Information about the patient's medical history and concurrent conditions was not provided. On an unspecified date in March 2008, and again in 30-SEP-2014, the patient was vaccinated with a dose of PNEUMOVAX 23. (dose, route of administration, anatomical location, lot number and expiration date were not provided). Some time after this last vaccination, on 02-OCT-2014, the patient was also vaccinated with PREVNAR 13 (dose, dosage number, route of administration, anatomical location, lot # and expiration date were not reported). Follow up information was received from the physician on 29-APR-2016. The patient had received the PNEUMOVAX 23 and PREVNAR 13 within three days of each other, carried out in an "outside" pharmacy. However, no adverse reaction was reported. Additional information has been requested.
Patient received HEP B3 vaccine on 7/20/06.  A few days later she had a severe nose bleed, blood pouring out of nose and mass coughing up blood with clots.  After 20 minutes of holding pressure bleeding stopped.
This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a 70-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and pain in arm. On an unknown date, the outcome of the influenza-like symptoms and pain in arm were recovered/resolved. The reporter considered the influenza-like symptoms and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 69 or 70 years old. The patient experienced pain in arm for 3 days and he was able to use without restriction. The patient experienced flu-like symptoms for 24 hours. The reporter thought these events were related to the SHNGRIX. The reporter did not agree to be followed up.
1) Major rash on face, chest and stomach. Very painful, swollen, itchy and uncomfortable. Started day of vaccine. Still present, 4 days later. 2) Lots of vomiting. Started day after vaccine. Lasted 1 day. 3) Abdominal pain. Started day after vaccine. Lasted 2 days. 4) Lots of diarrhea. Started day after vaccine. Lasted 2 days.
this is in f/u to a report submitted on 8MAR94;it has been determined that WAES93080955 through 93080962 are duplicate reports of WAES93090648 through 93090655;therefore, WAES93080955 through 93080962 are being deleted from file
Information has been received from a nurse practitioner concerning a 17 year old female patient who on 10-MAY-2007 was vaccinated with a dose of Gardasil. On 10-MAY-2007 the patient experienced a rash on her legs and dizziness. The day after she developed a rash on her arms. The patient also had a colonoscopy performed on that day. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions and medical history provided. Concomitant medications included sterile diluent (manufacturer unknown). On 14-FEB-2023, the patient was vaccinated with improperly stored doses of VARIVAX subcutaneous injection, lot #W008904 has been verified to be valid, expiration date was reported as 15-MAR-2024; and M-M-R II subcutaneous injection, lot #W007180, expiration date: 01-MAR-2024, albumin status has been verified as recombinant human albumin (rHA) (strengths, doses, anatomical locations, and routes of administration were not provided) for prophylaxis. On 11-FEB-2023, VARIVAX was stored at temperature 7 Fahrenheit degrees (F) for 1 hours; and M-M-R II was stored at temperature 57.0 F for 2 hours (product storage error). No additional adverse events were reported.
This spontaneous report as received from a consumer refers to the 24 year old daughter. Patient's pertinent medical history included diabetes. Drug reactions/allergies were reported as none. On 17-SEP-2013 the patient was vaccinated with the first dose of GARDASIL. Concomitant therapies included NOVOLOG, LEVEMIR and Influenza Virus Vaccine (manufacturer unknown). On an unknown date in 2013 the patient experienced muscle weakness, bruising, leg pain, fatigue and bad left arm pain after receiving her first dose of GARDASIL. On an unknown date the patient underwent Doppler test and no negative effects observed. The outcome of muscle weakness, fatigue, bad left arm pain, leg pain and bruising was reported as not recovered/not resolved. The patient sought medical attention and visited the physician but no treatment was rendered for the events. It was unknown if whether the patient will continue on to get the rest of the doses in the GARDASIL series. Additional information has been requested.
received his first dose of Moderna COVID-19 Vaccine on 27Jan2021 , has not received the second dose yet; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received his first dose of Moderna COVID-19 Vaccine on 27Jan2021 , has not received the second dose yet) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received his first dose of Moderna COVID-19 Vaccine on 27Jan2021 , has not received the second dose yet). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received his first dose of Moderna COVID-19 Vaccine on 27Jan2021 , has not received the second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
Erythema multiforme-like rash, mid-to-distal extremities, involving hands/feet both aspects.  Not involving face/mouth/throat/lungs/eyes (no SJS severity or distribution). Occurred about 2nd or 3rd day after vaccination. Sx persisted 2 days before patient contacted medical by phone. I instructed him to go to ED and he was seen in ED and dxd with "allergic reaction" and "nonspecific skin eruption" by ED Dr., who Rxd prednisone and hydroxyzine. Rash plateaued and is gradually waning 3rd day s/p ED Tx.
Seen in office on 06-06-2002 with a 11 cm by 9 cm area of warmth and erythema on right deltoid where DTaP was given.  Treatment - cool compresses and Motrin. Re-check if worsens.
Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. Patient was scheduled to get second dose on 25-Feb-2021 and wanted to know should she get her second dose or whether was allowed to get second dose.  Company comment: This spontaneous case concerns a female patient of unknown age with no details on medical history, who experienced the unexpected non serious event of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 8 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding symptoms and clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no details on medical history, who experienced the unexpected non serious event of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 8 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding symptoms and clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Initial information received from another manufacturer (Reference number: 1-398530441) on 09 August 2012. The information was originally provided to the other manufacturer by a health care professional. A female patient born on 30 July 1998, whose concomitant medications and medical history were not reported, had received MENACTRA (Lot number, route and anatomical site of vaccination were not reported) on an unspecified date. On an unspecified date, the patient was dizzy, lethargic appeared ash grey, had eating disorder and was tired. Corrective treatment and outcome of the events dizzy, lethargic appeared ash grey, eating disorder and tired was not reported. List of documents held by sender none.
Patient called the office complaining of a nickel-sized area of swelling in her right arm at the injection site and pain in her arm that occurs with movement.  She denies fever, rash, difficulty breathing, or other complaints.  She was advised to try OTC ibuprofen and moist heat at the injection site and to follow up next week if her symptoms have not improved.
Information has been received from a nurse practitioner concerning a 14 month old female pt with no known medical history who on 20Apr2004 was vaccinated in the right anterior thigh at her well visit with a dose of varicella virus vaccine live. Concomitant vaccination on 20Apr2004 included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) at another site. On 03May2004, the pt was seen by the nurse practicioner with swelling and redness of the leg that had started 12 hours prior. It was noted that the pt developed a skin infection at the injection site. The pt was afebrile and could stand on her leg. The patient was treated with amoxicillin (+) clavulanate potassium (AUGMENTIN) for 24 hours. On 04May2004, the pt was seen again for a follow-up visit. The pt was febrile, very irritable when her leg was manipulated and could stand on her leg, "but really wasn't" The area was a 6.5 cm by 8.5 cm, "non-fluctuate", erythematous, slightly bluish and hardened area on the right anterior thigh. The area had increased in size from 3.5 by 6 cm the day before. At that time, the nurse arranged for admission to the hospital. On the evening of 04May2004 the pt was hospitalized for cellulitis at the injection site. The pt was treated with intravenous antibiotics. Two and a half days later, the pt was discharged and recovered. The nurse saw the pt for follow up and the pt was walking fine. A product quality complaint was not involved. The reporter also mentioned another pt who developed a skin infection at the injection site post vaccination with varicella virus vaccine live. The reporter was very concerned about this lot number and requested a lot check. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. Follow up information received from a nurse practitioner indicated that she had no further information to report. No additional information is expected.
Elevated heart rate during exercising; This is a spontaneous report from a contactable consumer (patient). A patient of an unknown age and gender received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0180) at single dose via an unknown route on 16Jun2021 for Covid-19 immunization. Historical vaccine included 1st of dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient experienced elevated heart rate during exercising on 20Jun2021. The clinical course was reported as follows:   just over a week ago (as of 22Jun2021), patient had 1st experience exercising after that and had an extremely elevated heart rate which was very unusual for him/her.  Patient stated, right now (as of 22Jun2021) other than the elevated heart rate during exercising there was no other side effect. No treatment for event. No investigation assessment. Outcome of the event was unknown.   Information about lot/batch number was requested.
Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a physician via phone. This case is linked to cases 2019SA082205, 2019SA082208, 2019SA082210 and 2019SA082211 (same reporter). This case involves a 6 months old female patient who experienced redness and swelling on left thigh from vaccine injections, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL PREVENAR 13 and ROTATEQ on an unknown date. On 13-Mar-2019, the patient received a 0.5 ml dose of suspect PENTACEL (lot number: UJ095AA, expiry date, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a non-serious redness and swelling on left thigh from vaccine injections (vaccination site inflammation) following the administration of PENTACEL. No lab data was reported. Final diagnosis was redness and swelling on left thigh from vaccine injections. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for redness and swelling on left thigh from vaccine injections. Documents held by the sender: none.
Headache; Fever; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 17Jun2021 at 16:00 as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. The patient's past drug history was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Jun2021, the patient experienced headache and fever. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ibuprofen (ADVIL) and acetaminophen (TYLENOL). The clinical outcome of the events, headache and fever was recovering at the time of this report.
New skin lesion developed after second injection of COVID vaccine at site of needle insertion within 3-4 month window. Shave biopsy completed. Pathology report "Compound spitzoid melanocytic proliferation with immunohistochemical expression of ALK1, see microscopic description. Extending to the deep and peripheral margin. Re-excision is recommended to ensure complete removal.
Few red papules and blisters on left upper lip, chin, both cheeks. One of the vesicles on (L) abd is a small vesicle on a red base; scattered red papules on trunk.
raspy voice; delayed allergic reaction; fatigued; broke out on her face; sore throat; swollen eyelids; a lump in the lymph node under her nose; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (broke out on her face), OROPHARYNGEAL PAIN (sore throat), DYSPHONIA (raspy voice), HYPERSENSITIVITY (delayed allergic reaction) and EYE SWELLING (swollen eyelids) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced ACNE (broke out on her face), OROPHARYNGEAL PAIN (sore throat), EYE SWELLING (swollen eyelids) and LYMPHADENOPATHY (a lump in the lymph node under her nose). On 08-Apr-2021, the patient experienced DYSPHONIA (raspy voice), HYPERSENSITIVITY (delayed allergic reaction) and FATIGUE (fatigued). At the time of the report, ACNE (broke out on her face), OROPHARYNGEAL PAIN (sore throat), DYSPHONIA (raspy voice), HYPERSENSITIVITY (delayed allergic reaction), EYE SWELLING (swollen eyelids), LYMPHADENOPATHY (a lump in the lymph node under her nose) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I have attempted to complete this report 3 times, each time being cut off without warning. It is not possible to explain the entire course of events in the timeframe allotted. However, I will state I have never been so sick in my entire life as I was when I received the vaccine and the following day. I was deathly ill, with multiple symptoms. It progressed to all 4 extremities and tongue becoming weak, numb, and tingly with internal vibrations and tremors. I had difficulty walking, cognitive issues, and extreme generalized weakness along with many other symptoms which timeframe will not allow for listing.
1 day after taking vaccine, noted  stiffness on left side of the body, beginning on left buttock down left leg to the left foot; leg was swollen and stiff
Pt called to report that on 9/14/00, he had a temperature of 101.5F, body aches, worst headache ever, sore arm and redness at injection site. All resolved except sore arm, he stated on 9/15/00.
Per the wife she woke to what she described as tonic clonic seizure activity. She advised the seizure lasted about 1 minute prior to the decedent going unresponsive & not breathing. CPR was initiated. The spouse advised that this happened one time two weeks prior when the decedent went into a seizure. He was seen at the ED and not diagnosed, they were awaiting an appointment at a primary care facility. The spouse advised that the decedent has experienced unusual sensations since he received his booster shot 3 weeks prior. She stated the decedent has experienced memory deficits in addition to the seizure activity. EMS arrived today and completed resuscitative efforts unsuccessfully.
Hives on torso, arms, and legs - itching.  Next day throat closing.  Weak - heaviness in chest, back pain.  Hoarseness.  Took aspirin and benadryl.  Next day went to dr.'s office, from there by ambulance to ER for 3 hours.  More meds - sent home with prescription for EpiPen, Prednisone, and Famotidine.
Tightness in calves; Swelling in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Tightness in calves) and VACCINATION SITE SWELLING (Swelling in injection arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031220A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), METFORMIN, TRAMADOL, CEFIXIME (FLEXERIL [CEFIXIME]), METOPROLOL, CLOPIDOGREL and SERTRALINE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced MUSCLE TIGHTNESS (Tightness in calves) and VACCINATION SITE SWELLING (Swelling in injection arm). At the time of the report, MUSCLE TIGHTNESS (Tightness in calves) and VACCINATION SITE SWELLING (Swelling in injection arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Patient said she was feeling better.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Outcome of the events were updated as resolved.
Itchy, burning feeling across shoulder after vaccination generalized itching on trunk has had same S/S after using hot tub. Used hot tub pm 11/04/2005 broke in hives pt took Sudafed and felt better.
Hot/cold flashes, body aches, severe headache, fever up to 102, diarrhea lasted 2-3 days,  arm at injection sight extremely painful for over a week
On the 3rd day, post vax, he was very irritable and woke up many times, during the night. By the 5th day, he ran a temperature of 103.2F and screamed at any touch. Would not sleep or eat. He also became very congested. On 6th day, temperature rose to 104F and he was sent to hospital for blood work by doctor. Treated with Motrin and fever broke. Baby was still extremely irritable however for the 7th, 8th and 10th day after vaccination.
Systemic: Abdominal Pain-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient fainted about a minute and a half after booster dose of pfizer. A slight rash formed immediately around injection sight but dissapeared in a couple of minutes.  Patient had extreme fatigue and hot flashes.  Was very lethargic and pale. Dad was taking her to the ER and will follow up with me.