chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Provider: Primary Care Provider:  Admission Date: 10/4/2022 Discharge Date: Oct 7, 2022  PRESENTING PROBLEM: Shock (HCC) [R57.9] Fever, unspecified fever cause [R50.9] Hypotension, unspecified hypotension type [I95.9] Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (HCC) [A41.9] Acute hypoxemic respiratory failure (HCC) [J96.01]   HOSPITAL COURSE: 86-year-old female with asthma, chronic diastolic heart failure, history of complete heart block status post dual-chamber pacemaker, RA on chronic steroids presented to BW ED 10/4 due to weakness and confusion.  On arrival to Emergency Department she was found to be febrile with temperature 39° C, hypoxic with oxygen saturation 88% on room air requiring 2 L nasal cannula supplementation. Patient remained hypotensive after receiving 1.9 L of NS and was started on NE. Chest x-ray revealed mild pulmonary vascular congestion.  Complete blood count, BMP, urinalysis, and lactic acid were unremarkable.  Found to be COVID positive. CT angio negative for PE; bibasilar atelectasis. Repeat CXR revealed hazy left lung base opacity. Patient started on antibiotics for possible bacteria pneumonia. Patient started on stress dose steroids, given on chronic steroids for her RA. Blood pressures improved, weaned off vasopressors.  Increased pacemaker rate to 80bpm.  Transferred out of ICU to Internal medicine service. Weaned off oxygen to RA. PT/OT evaluated patient and initially recommended SAR, but given improvement recommended home with HHC. Patient medically stable for discharge 10/7.
Admitted with cervical spondylosis and cervical radiculopathy failing medical management. Procedure: Anterior discectomy and fusion. At time of Dc tolerating general diet, ambulating safely in corridors, voiding without difficulty, and pain acceptably controlled with oral pain medications. Hospital admission within 6 weeks of receiving the COVID vaccine.
a knot appeared just to the right of the bruise about the size of a silver dollar/about a size of a nickel; bruise on my inner elbow; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 50 years old via an unspecified route of administration, administered in Arm Left on 18Mar2021 11:00 (Batch/Lot Number: EN 6207) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; liothyronine taken for an unspecified indication, start and stop date were not reported; and varenicline tartrate (CHANTIX) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, (lot number: EL 9266), at the age of 50 years old, dose 1, single on 25Feb2021 11:00AM in the left arm for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was in the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 24 hours 19Mar2021 11:00 AM after the injection, the patient stated, "I woke up with a bruise on my inner elbow, 24 hrs after that on 20Mar2021 a knot appeared just to the right of the bruise about the size of a silver dollar. 24 hours after that on 21Mar2021 another knot appeared just below the bruise about the size of a nickel. Still have the large knot as of 28Apr2021." The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was given steroid shot and antibiotics as treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The events did not result in death and was not life threatening. The event did not cause hospitalization and was not disabling and was not a congenital anomaly. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
I received 2 does of the Moderna vaccine (1st in February and the 2nd exactly 4 weeks apart in March.) I was told to wait exactly 4 weeks between doses for the full effect of the vaccine to take place. On April 13th / 14th I woke up in the middle of the night nauseous, with a fever and feeling awful. I thought it was food poisoning or something that I ate. I went to work and as the day progressed felt worse. I had to leave work and come home. I was doubled over in pain in my lower right side. I had diarrhea, felt awful and went to bed. I wanted to go to the hospital but out of fear of COVID and it was less than 4 weeks from my last injection, I did not. I laid in bed all the next day and finally went to the doctor Friday morning April 16th. I was examined at an urgent care clinic by a PA who sent me for a CT scan which determined it was my appendix and I later that day / evening had an emergency appendectomy as my appendix had ruptured.
Received vaccine 3/29/21. Symptoms started on 3/30/21. 13 days duration so far. Neuropathy
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In January 2011, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 15-JUL-2016, the patient was treated by a physician's assistant at a hospital facility for a blistering vesicular outbreak, which was then diagnosed as herpes zoster. The patient has been prescribed prednisone and hydrocortisone for management of her painful symptoms and chronic pain.  As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
I got an inflammation in my elbow in the opposite arm of my injection. I went to an urgent care and ER.  they gave me an antibiotic (Keflex) and then two days later they switched me to a different antibiotic (Augmentin). The Augmentin gave me an adverse reaction that hospitalized me for less than a day. I'm expected to deliver on March 21, 2022.
Information has been received from a physician concerning a 5 year old female with no medical history who on 7/19/99 was vaccinated with a dose of varicella virus vaccine live. The physician reported that on approximately 4/5/04, while visiting relatives, the patient developed a mildly pruritic rash characterized by 13 pink spots on her body. The patient was seen by a pediatrician, but no laboratory/diagnostic tests were performed. On 4/9/04, the patient's rash resolved. No further information is available.
sensory neuropathy, circumurol neuropathy w/numbness in hands; very mild & comes & goes; has seen several MD; no obvious pathology dx;
This report was received from Pfizer and was assigned manufacturer report number 2016496457 for PNEUMOVAX 23. This was originally reported by a pharmacist via Pfizer company representative referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. Approximately in April 2016 (reported as "six months ago"), the patient was vaccinated with PNEUMOVAX 23 (anatomical route of vaccination, dose number, lot number, lot number and expiration date were not provided). The patient concomitant medications were not reported. On the same date, after being vaccinated by a pharmacist, the patient was hurt with limitation of the ram movement and pain when the patient moved the arm. The reported stated, that in June 2016 (reported as "about 2 or 3 months after the patient was vaccinated, there was still limitation in the arm movement and when moved the arm it still hurt. At the time of the report, the outcome of pain in extremity, injected limb mobility decreased and pain was reported as not recovered. Additionally, the reporter considered injected mobility decreased to be related to PNEUMOVAX 23. The reporter did not provide for a causality between pain and pain in extremity and vaccination with PNEUMOVAX. Additional information has been requested.
Moderna vaccine administered on 1/20/22 had expired on 1/19/22. There was no temperature excursion
Narrative: COVID infection following COVID vaccine series 01/14, Moderna, dose #1 (non-Facility) 02/11, Moderna , dose#2 (non-Facility) 08/16 pt cc: cough, fatigue, fever, headache, myalgais, dyspnea, sore throat exposure: unknown 08/18 COVID swab, result: detected
PT complained at 10 minutes post vaccination of itchiness on the arm that later extended to the right arm and legs.  No hives observed during assessment.  No difficulty breathing, PT is talking normally and is alert.  O2 sat 100 and HR 74  PT  stated she has seasonal allergies and is allergic to spider bites and stated she took a decongestant in the a.m.  No other history of chronic disease reported.  RN provided a tablet of Diphenhydramine (Benadryl) 25 mg at 0900 hrs. and educated about the possible side effects of the medication.  PT stayed until 0940 hrs. when symptoms started to cease.  PT was educated to seek medical help if symptoms return or get worse or if difficulty breathing occurs.
When she passed out; feeling real dizzy; since her leg and knee feel bruised; right eye was swollen; felt unwell; weak; This is a spontaneous report from a contactable consumer (patient) reported that a 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 as a single dose (at the age of 59-years-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the Pfizer-BioNTech COVID-19 Vaccine first dose on Saturday, 13Mar2021, and was fine after the shot but had a reaction on Sunday, 14Mar2021. On 14Mar2021, she got up to make breakfast and started feeling real dizzy and the next thing she knew, she was on the floor; this happened twice. When she passed out, she must have hit something on her right side, since her leg and knee feel bruised and right eye was swollen. She felt unwell, dizzy and weak; no dizziness today (15Mar2021). She planned to discuss further with her physician. The outcome of the event dizziness was recovered on 15Mar2021 and unknown for the rest of the events.   Information on the lot/batch number has been requested.
Information has been received from a physician assistant concerning a 27 year old male with amoxicillin allergy who on 13-NOV-2008 was vaccinated with his first dose of VARIVAX (Oka/Merck) (lot number 661641/1152X) 0.5ml SQ into his right deltoid. On an unknown date, after receiving vaccination, the patient developed a single lesion on his inner thigh. The patient called to notify the office of the lesion but was not examined at that time. Follow-up information was received from the physician assistant who indicated that no 13-NOV-2008 the patient also was vaccinated with MMR II (lot number 660019/0503X rHa; route not reported) into his left deltoid. On approximately 16-NOV-2008, 3-4 days after injection the patient developed a single lesion on his left inner thigh with area flat, red, dry and itch. The patient recovered on 21-JAN-2009. The second dose of VARIVAX (Oka/Merck) (lot number, route and site not reported) was administered with no repeat of additional lesions. Additional information is not expected.
Information has been received from a health professional concerning a 9 year old female who on 8/31/95 was vaccinated with 1 dose of varicella virus vaccine live (site unk) (lot 608665/0425B). Subsequently, it was reported that in 6/01, the pt was dx'd with "a mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. The reporter also indicated that the pt was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the pt recovered. No further information is available.
BNT162B2: Paxlovid:Treatment of COVID-19; BNT162B2: Paxlovid:Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Apr2022, stop date: 15Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "BNT162B2: Paxlovid Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported as no for the Serious, Seriousness criteria-Results in death, Seriousness criteria-Life threatening, Seriousness criteria-Caused/prolonged hospitalization, Seriousness criteria-Disabling/Incapacitating, Seriousness criteria-Congenital anomaly/birth defect. Anti-viral details reported as COVID 19 Treatment, Paxlovid Treatment start date was 02Jun2022, Treatment stop date was 06Jun2022, Indication was treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Unexplained menstrual Bleeding for 3 months.  Passing  large pieces of blood clots
I had mild symptoms when I woke up and as the day progressed, they got worse. Extreme joint pain from the waist down. It was beyond pain, and I didn't want to live. It lasted about 3 days. I also had pain above my waist, but the debilitating pain was from my back down. I took TYLENOL and it was not effective. I took an old prescription of gabapentin on the 3rd day and that's when I started to feel better. The symptoms started to subside after day 3. That night I was able to sleep. The 2 nights prior, I kept ice packs on my back and legs to help with the pain and I was not able to sleep. All of the symptoms have gone away. I normally have a slight back pain and sciatica, but this was much more severe than that and was constant over a 3 day no matter what position I was in. I have a future appointment with a nurse practitioner on Monday October 17 and I will be discussing these symptoms with them at that time.
After the second dose, beginning about 14 hours later, developed rapid heart rate, shortness of breath, chest discomfort for 5-6 days. Lightheadedness, near syncopal episodes and fatigue for 8 weeks, beginning about 12 hours after the second injection.  Body aches and whole body chills for 3 days beginning 12 hours after injection.
Information has been received from a nurse concerning her 15 year old daughter with no pertinent medical history who in October 2008, was vaccinated with the first dose of GARDASIL. The patient was vaccinated with the second and third dose of GARDASIL in December 2008 and August 2009 separately. There was no lot number reported. Concomitant therapy included YAZ. The patient experienced nausea, vomiting and diarrhea after receiving the second dose and the symptoms were resolved (date unspecified). On approximately 17-AUG-2009, the patient experienced nausea, vomiting and diarrhea after receiving the third dose of vaccine. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
chills; headache; nasal congestion  treatment: Benedryl  outcome: felt better next day
JOINT PAIN, CFS, INSOMNIA, DIZZINESS, HEADACHES, COGNITIVE MEMORY IMPAIRMENT, NIGHT SWEATS, RASH, IRREGULAR HEART BEAT & ARTHRITIS.
Case previously recorded as MA2009-3977. Initial case report received from a physician via MedCom on 10 NOV 2009. A patient 3-year-old female was vaccinated with S-OIV FLUVIRIN (batch no. unknown) i.m on 13 OCT 2009. No adverse event was reported. MedCom reference no.: NA09-007907.
Left arm in pain; headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 15th November 2022 and experienced pain in arm, refer case US2023AMR021808).   On 8th February 2023, the patient received the 2nd dose of Shingrix. In February 2023, unknown after receiving Shingrix, the patient experienced pain in arm and headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and headache were unknown.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingrix.     Linked case(s) involving the same patient: US2023AMR021808   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comment: The case was self reported by the patient. The patient received the second dose of Shingrix yesterday (the day before reporting) into left arm and had left arm pain and a headache.   The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2023AMR021808:Same reporter
Itchiness; Redness; Inflammation; Rash; Pink; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), ERYTHEMA (Redness), INFLAMMATION (Inflammation), RASH (Rash) and SKIN DISCOLOURATION (Pink) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PRURITUS (Itchiness), ERYTHEMA (Redness), INFLAMMATION (Inflammation), RASH (Rash) and SKIN DISCOLOURATION (Pink). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PRURITUS (Itchiness), ERYTHEMA (Redness), INFLAMMATION (Inflammation), RASH (Rash) and SKIN DISCOLOURATION (Pink) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided
Anaphlylactic reaction; booster; Aches and pains; This is a spontaneous report received from a contactable reporter, Consumer.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Dec2021 15:15 (Lot number: FD7218) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergies: Seafood" (unspecified if ongoing); "Allergies: Iodine" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6206, Route of Administration: Intramuscular, Location of injection: Arm Left, Vaccine Administration Time: 08:45 AM), administration date: 24Mar2021, when the patient was 57 years old, for COVID-19 Immunization, reaction: body aches; Bnt162b2 (lot number =EN5318,, administration time=09:30 AM,, vaccine location =Left arm., dose number=1), administration date: 02Mar2021, when the patient was 57 years old, for COVID-19 Immunization. The following information was reported: anaphylactic reaction (medically significant) with onset 13Dec2021 15:30, outcome recovered (Dec2021); immunisation (medically significant) with onset 13Dec2021 15:30, outcome recovered (Dec2021); pain (non-serious) with onset 13Dec2021 15:30, outcome recovered (Dec2021), described as "Aches and pains". Therapeutic measures were not taken as a result of anaphylactic reaction, immunisation, pain.; Sender's Comments: Linked Report(s) : PFIZER INC-2021325756 Same patient, different dose and event.
Fever, Rash, FATIGUE, GENERAL WEAKNESS, RASH ON CHEST < DIFFICULTY CLIMBING STAIRS /  Narrative:
Brief resolved unexplained episode BRUE  infant stopped breathing at home. Had to call 911.
Fully vaccinated (including booster). COVID-19 infection breakthrough. Inpatient hospital stay.
This is not a serious case from a nurse in the USA of involving accidental exposure. The reporter causality is not reported to FluMist. The case qualifies for accelerated reporting. This case is a case of possible accidental expoure to the FluMist vaccine. A parent called to report that she had developed sore throat, cough, weakness, and fatigue with onset beginning the same day of administration (see MEDI0002477). While reporting her own adverse event she also stated that her 14 year old daughter also experienced sore throat, cough, weakness, and fatigue beginning four days after the mother was vaccinated on 11/10/04. The child did not receive the vaccine, and was fully recovered on 11/20/04.
Headache, Myalgia, Diarrhea, CHILLS, SWEATS, FATIGUE, HEADACHE, BODY ACHES, DIARRHEA Narrative:
Noticed all dairy had different metallic taste. Drank milk at approx 2:30pm same day of vaccine, and noticed a very metallic taste. Also ate macaroni and cheese at approx 6:30 pm same day, and metallic taste was still prevalent. All other foods tasted normal.
Patient didn't have a reaction to the first dose in the series but she did to the second dose: swelling and redness (4 x 3 inch band circling arm), flu-like symptoms (chills, nausea, thirsty, fatigue)blisters in the mouth.
2nd day-soreness at injection site & slight headache on left side, 7th through 11th days-itching at injection site, 8th through 11th days-swelling & redness at injection site and surrounding area measuring 4" wide x 10" long and about 1" high.  By 12th day all reactions subsided.