chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Provider: MD Primary Care Provider: DO Admission Date: 1/31/2023 Discharge Date: 2/4/2023   Clinical Narrative: Generalized weakness on admission was felt to likely be due to COVID infection and this has much improved, he was evaluated by PT/OT with recommendation for subacute rehab placement.  Case manager assisted with making placement available.  For COVID-19 infection patient had no respiratory symptoms he has remained on room air saturating at 95%, he has been afebrile no chest pain no cough no shortness of breath no diaphoresis. Dizziness much improved with Antivert, he will be discharged with Antivert p.r.n..  Workup done includes MRI of the brain which did not show any acute abnormalities, but showed crowding of the cerebral sulci vertex resume possibility of normal pressure hydrocephalus.  I discussed this with the patient and family, and patient is to follow with his family physician who will arrange for further workup with neurologist
Within 10 minutes of receiving first dose of Pfizer covid vaccine began to have "shakiness, lightheadedness, dizziness and fast heart rate". States that she has a history of anxiety and believes it is that. Initial VS of BP 180/100, HR130, RR 18, O2Sat 100%.  Patient was observed for ~40 minutes, given water, juice and position of comfort (sitting) with only had mild improvement of symptoms in that she felt her heart wasn't racing. Repeat VS BP 180/88, HR 90, RR 18, O2sat 100%.  EMS called and patient was transported to  Hospital ER for further evaluation/treatment.
redness is rectangular 1/4 by 2 inches in size; Swelling; Achiness; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), PAIN (Achiness), TENDERNESS (Tenderness) and ERYTHEMA (redness is rectangular 1/4 by 2 inches in size) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced SWELLING (Swelling), PAIN (Achiness) and TENDERNESS (Tenderness). On 12-Feb-2021, the patient experienced ERYTHEMA (redness is rectangular 1/4 by 2 inches in size). On 11-Feb-2021, PAIN (Achiness) had resolved. At the time of the report, SWELLING (Swelling), TENDERNESS (Tenderness) and ERYTHEMA (redness is rectangular 1/4 by 2 inches in size) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Narrative: Patient received two doses of covid vaccine. Patient was end stage COPD on hospice. No other cause of death reported. Reporting per network instructions.
A non-serious spontaneous report of a we gave expired H1N1 to several patients was received from a registered nurse/health professional concerning a seven-year-old female out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date 12-Feb-2010, had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
This case was reported by a physician and described the occurrence of sweating in a 82-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included osteoporosis. Concurrent medications included LEXAPRO and FOSAMAX. On 21 September 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route and site). On 21 September 2011, less than one day after vaccination with FLULAVAL, the subject experienced sweating, confusion, agitation and lethargy. The subject was discovered by a neighbor to be confused and lethargic the next morning. An ambulance was called and the subject was taken to the hospital. The physician considered the events were disabling. At the time of the reporting the events were unresolved. The physician considered the events were probably related to vaccination with FLULAVAL. The physician reported administering over 100 flu vaccinations and had 8 subjects report very unusual adverse events. This is case 1 of 8 (see case IDs A0946060A, A0946062A, A0946073A-A0946077A for details of the other reports).
Patient received one dose of MMR on 12/18/07. She reports she had a minor URI at the time without fever and chills at the time of administration.  She reports joint pain starting on 1/9/08, with joint swelling and pain that is transient and migrating.  On 1/16/08, she reports to Occupational Health Services stating she had 2-7/10 pain of the right wrist.  Pain was achy and did not radiate.  Pain was exacerbated by lifting objects.  She denied any rash or other issues.  She had full range of motion of shoulders, wrists, fingers, hips, knees, and ankles at 1/16/08. Ibuporfen 600mg PO TID with food was prescribed.  On 1/18/08, the patient reported that her symptoms had subsided.  No residual findings referrable to vaccination were found during exam on 1/18/08.
Severe jerking and shaking intermittently for 18 hours. Also extremely tired for 7 days.  Anxiety attacks prevalent still happening.
she had a very sore arm; This is a spontaneous report from contactable pharmacist (patient). This female pharmacist reported that: A female patient of unspecified age received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications were not reported. The clinical Pharmacist (patient) stated that she had a very sore arm for several days since an unspecified date after receiving the first dose of Pfizer COVID 19 vaccine. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The night of 4-4-21 I became very ill with fever (102), nausea, stomach pain and cramping, diarrhea, and headache. I remained in bed unable to eat or drink for 2 days and had to rest with continued but lessened symptoms the 3rd and 4th day. During these days I developed severe bloating, acne, headache, difficulty sleeping, and alternating constipation/diarrhea with stomach/gut pain and symptoms. As I had an Auto-immune disease in the past that had been cured called SIBO, I recognized these symptoms and was tested. The SIBO had returned (as shown in SIBO breath test) worse than it had ever been before I was cured. In addition I developed an H Pylori Stomach infection which I had never had before.  The night of 4-2-21 I became very ill with fever (102), nausea, stomach pain and cramping, diarrhea, and headache. I remained in bed unable to eat or drink for 2 days and had to rest with continued but lessened symptoms the 3rd and 4th day. During these days I developed severe bloating, acne, headache, difficulty sleeping, and alternating constipation/diarrhea with stomach/gut pain and gut dysbiosis symptoms. As I had an Auto-immune disease in the past that had been cured, called SIBO- Small Intestinal Bacterial Overgrowth, I recognized these symptoms and was tested. The test showed SIBO had returned (as shown in SIBO) breath test) worse than it had ever been in previous tests. In addition, I developed an H Pylori Stomach infection which I had never had before. With my Doctor's help we began several protocols to treat the SIBO and H. Pylori-expensive antibiotics, anti-viral medications, anti-fungal medications, herbs, diet, colonics, and appointments. The treatment of Xifaxin, an Eubiotic that cost thousands of dollars and cured me in the past was repeated twice with no healing effect. To date, I still have SIBO and H. Pylori infection that are unable to be treated since 4-2-21, the day I received the second Covid Vaccine by Pfizer. The suffering and cost has been immense and continues to this day over 6 months post Vaccination.  Medications: Rifaximin 550mg (2 week treatment and then a repeat 1 month treatment) Nystatin 5000 units Valacyclovir 1 g Fluconazole 200mg (2 rounds) Low Dose Naltrexone 2.5 Neomycin 500mg
Racing heart, nervousness,  severe fatigue,  chills, body aches, fever of 101.6, headache,  loss of appetite,
pt recvd vax & devel a wheal & flare @ the inject site which was described as white welts in a flat red area;
Case number PHEH2014US010196 is an initial spontaneous report from the medical assistant (other health care professional) received on 16 May 2014. This report refers to a 13-year-old male patient. The patient was vaccinated with MENVEO (batch number: M13015) intramuscularly on 13 May 2014. It was reported that the MENVEO vaccine administered to the patient was exposed to the temperatures between 33 F and 44 F for up to seven days before vaccination. No adverse event reported following this medication error (incorrect storage of drug).
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 10-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
01/24/2022 Covid symptoms started with sore throat, body aches, fever, and cough. They are still ongoing and for the past two days I haven't eaten anything and yesterday was the first time I ate something. I tested positive at a Doctor's office on 01/26/2022. My back side where kidney's are are also hurting and that started a few days ago. I haven't made it to the Doctor for that yet.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent conditions and medical history were not provided. Pharmacist reported 8 patients received their second and third doses of RECOMBIVAX HB (strength 2.5mcg/0.5ml, dose, lot# and route not reported) at not the recommended schedule on an unspecified day described as "the second dose was given after 1 month and the 3rd dose was given after 6 months"(Inappropriate schedule of vaccine administered, captured in 1602USA001304). Pharmacist reported one of the patients also received RECOMBIVAX HB and the second dose was ENGERIX-B (dose, lot# and route not reported) and third dose was RECOMBIVAX HB (Interchange of vaccine products). No adverse effects reported. The outcome of the event was not reported. This is one of several reports received from the same source. Additional information has been requested.
Hospitalization: 4/11/2023 - 4/19/2023 (8 days) Presentation to the ED: progressive SOB and generalized weakness for the last couple of days COVID + date: 4/11/2023 Treatment: Daptomycin  Discharge to: HOME.   PFIZER EJ1685 12/23/2020 PFIZER EL3249 1/13/2021 MODERNA 004F21A 11/10/2021
15 minutes after receiving second dose of Pfizer COVID vaccine patient complained of headache, dizziness and itching.
At 7 days after administration of Varivax and MMR pt developed runny nose, cough, fever to 103 deg F x 2-3 days. Then 14 days after vaccination pt developed macular papular blanching rash starting on 600 progressing to trunk.
2 doses of PREVNAR were administered on the same day. Patient's Dr. notified @ 11:30am 3-25-09.
Patient developed a tic disorder after the first vaccine, appeared shortly after receiving the first vaccine and tics gradually became more pronounced over 5 weeks. Tic disorder worsened after second vaccine, less than 24 hours after the second vaccine the patient went back to the clinic where the vaccines were administered with severe tics located mainly in the face and neck. Doctor at the clinic was unsure of the cause of the tic disorder.
Day 1 - 7/3/23 3pm until Day 3 - 7/5/23 8pm:  nausea, extreme fatigue, soreness all over body, muscle aches & joint pain, fuzzy brain, loss of appetite, irritability
Daily severe migraine headache unresponsive to prescription meds.  Onset 10/08.  Abdominal pain and some dizziness.  Treated by pediatrician and neurologist.  5/18/09 MR received from PCP including vax rec.  HPV#1 8/20/2007 1060U. HPV#2 11/12/07 1265U with Hep A #1 1258U.  HPV#3 7/14/08 1279X with Hep A #2 AHAVB284DA. OV 11/21/07 with c/o H/A, upset stomach x 5 days. Dx:  Viral syndrome.  Otitis externa and OM 12/2007. Multiple OVs for H/A, sore throat, fatigue and malaise.  By 10/2008 H/As are more persistant and not responsive to meds. Assess:  Sinusitis. Pt reports not sleeping well. Getting PT for H/As. By 2/2009 c/o transverse mid-abdominal pain with now daily H/A. Assess:  H/A. Abdominal Pain. Now seeing neuro.  Neuro consults dated 12/30/08 to 5/4/09 with impression Primary Headache Syndrome with new daily persistant Headache.  H/A constant since 10/2008 which consist of painful pressure with phonophobia and difficulty concentrating. Had to quit swimming 2' to H/A and has missed many days of school. Multiple meds ineffective. 31# weight loss. Getting Accupressure.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of varicella virus vaccine live. The infant had become dizzy and could not walk or crawl. This was reported to a neurologist for cerebellar ataxia. Unspecified medical attention was sought. It was also noted that this case was reported to the reporting physician on 6/27/03. As of 7/11/03, the reporting physician has not heard differently. Upon internal medical review cerebellar ataxia was considered an other important medical event (OMIC). Additional information has been requested. A 15-day follow up report received 8/12/2003 adds: Follow-up info indicated that the pt experienced cerebellar ataxia on 06/27/2003. A CT scan performed and no results were reported. As of 07/31/2003, the pt's recovery status was unknown. Upon internal medical review cerebellar ataxia was considered an other important medical event. Additional info has been requested. The follow up received on 8/6/03 from the physician indicated that developed cerebellar ataxia and her symptoms included difficulty crawling and dizziness. The physician reported that the parents were very concerned and the pt was referred to a neurologist. The neurologist reported to the physician that he "is 99% sure that the vaccine caused the cerebellar ataxia and the cerebellar ataxia could take up to 2 months to resolve." The pt's CT results were negative. Upon internal medical review cerebellar ataxia was considered an other important medical event (OMIC). Additional info has been requested.  A 15-day follow up report received 8/25/2003 adds: Follow-up info received on 8/15/2003 indicated that the pt was seeing a neurologist for her cerebellar ataxia which was still ongoing. Upon internal medical review cerebellar ataxia was considered an other important medical event. Additional info has been requested.
I have been menopausal with no bleeding events in the past 2 years. On 8/22/2021 I started having vaginal bleeding and cramps which lasted for 7 days and became very heavy with clotting at times. I was seen in the emergency room and by an ob/gyn. I had diagnostic tests and a full exam which ruled out any underlying medical conditions that could explain the bleeding. I learned by doing my own research and speaking within my social and professional circle that other women have also experienced unusual and untimely menstrual bleeding post Covid vaccinations. Ruling out anything else, I am suspicious that there could be a connection between my vaccinations and my post menopausal bleeding event as well. I also noticed unusually tender and sensitive nipples as well in weeks prior to the beginning of my bleeding event. After 7 days the bleeding stopped and has not returned as of yet.
Pt admitted to hospital on 3/4/2021 with Extensive DVT to the LLE.  No history of cancer or thromboses.  History of redness and swelling to entire left leg starting on 3/1/2021.  Received Heparin infusion in hospital.  Currently receiving Eliquis p.o.  Pt also underwent trombectomy with iliac stent placement by IR.
My father received a Tdap on 7-2-15. On 7-3-15, he reported feeling "out of it" and vision changes. He says these possible side effects were listed on his VIS. They are not on the VIS I have. Regardless, he said a cold shower and nap resolved the sx.
Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 19-MAR-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
no adverse event; An improperly stored dose of MMRII was administered to a patient; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies.   On 20-FEB-2020, the patient received an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot number S013415, expiration date 01-MAY-2021 for prophylaxis (dosage schedule, anatomical location and route of administration were not reported) (product storage error).  The administered dose of the vaccine experienced a temperature excursion of 10 C for 16 hours, as recorded by a data logger. No previous temperature excursion was reported. No additional adverse effects reported.
1st vaccine skin reaction at vaccine site; double vision; balance issues; Itching; had a rash that looked like a mosquito bite that was flat, hard and hot; couple of days of aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (1st vaccine skin reaction at vaccine site), DIPLOPIA (double vision), BALANCE DISORDER (balance issues), PRURITUS (Itching) and RASH (had a rash that looked like a mosquito bite that was flat, hard and hot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (1st vaccine skin reaction at vaccine site), DIPLOPIA (double vision), BALANCE DISORDER (balance issues), PRURITUS (Itching), RASH (had a rash that looked like a mosquito bite that was flat, hard and hot) and MYALGIA (couple of days of aches). At the time of the report, VACCINATION SITE REACTION (1st vaccine skin reaction at vaccine site), DIPLOPIA (double vision), PRURITUS (Itching), RASH (had a rash that looked like a mosquito bite that was flat, hard and hot) and MYALGIA (couple of days of aches) outcome was unknown and BALANCE DISORDER (balance issues) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-132988 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Vaccination site reaction, myalgia, diplopia and balance disorder were added. Action taken was updated.
Large red, firm, tender area on right thigh at site of DTaP, started about 20 hours after vaccination, got progressively larger and more tender over following 6-8 hours.  The following morning the redness was larger, but much less tender, so they brought her to the office for evaluation.  I felt it was most likely an aggressive local response rather than cellulitis or allergic reaction.
I developed shingles on my back and waist. Went to my family doctor and to the pharmacy where it was administered. I had originally had the first shingles vaccine five years previously.
Day after vaccine patient experienced itching body wide. The next day itching continued and welps/hives developed. Patient took oral BENADRYL to treat the reaction and it helped reduce the hives but not the itch itself. Reaction resolved after aproximately 3 days. This was the first shot of the series and she will not be taking the 2nd.
a 9 year old patient received Flublok quadrivalent/no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was linked to cases 2019SA304487 and 2019SA304462 (same reporter).  This case involves a 9 years old male patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient did not have any concomitant therapy.   On 10-Oct-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in the left deltoid.  It was of actual medication error case due to Inappropriate age at vaccine administration.  It was unknown whether adverse event was experienced or not.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Pediatric dose was not diluted prior to drawing up dose of 0.2 ml into a syringe. Volume of 1.3 ml diluent was also pulled into same syringe and all administered to patient. No report for adverse reaction by patient/caregiver.
moderna red arm rash appeared after a week and lasted another week, swelling, itching, and burning , fatigue.    arm is still swollen and sore.   Had the second shot today in the other arm. Called my doctor and she said it was not uncommon.
Patient felt unwell and looked pale within 2 minutes of immunization. I elevated his legs and applied cold pack to neck.  Patient's symptoms resolved within 10 minutes
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date the patient's husband was vaccinated with ZOSTAVAX (lot number, dose, strength and injection site were not reported) subcutaneous for prevention of shingles. On an unknown date the patient's husband was transmitted shingles to her after he received ZOSTAVAX. The patient was going through chemotherapy treatments when shingles were transmitted to her. The outcome and action taken was not provided. This is one of several reports received from the same source with Patient/Partner Link to case 1308USA008132. Additional information has been requested.