chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient was tested positive for COVID-19) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045BZ1A) for COVID-19 prophylaxis.     Concurrent medical conditions included Osteoarthritis since 1985 and Hypothyroidism since 1995. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, CELECOXIB for Osteoarthritis, RALOXIFENE for Prophylaxis, VITAMIN C [ASCORBIC ACID] and NIZATIDINE (PROTIN) for an unknown indication.    On 18-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced COVID-19 (Patient was tested positive for COVID-19). At the time of the report, COVID-19 (Patient was tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, SARS-CoV-2 test: (Positive) Yes, patient was diagnosed or tested positive for COVID-19.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that patient had not had acute illness at the time of vaccination and up to one month.  No treatment medications were reported.  Company Comment: This is a spontaneous case concerning a 63-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19. SARS-CoV-2 test yielded a positive result 10 days after the first dose of the mRNA-1273 vaccine, no further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event was unknown. The current COVID-19 pandemic of remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-324206 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 63-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19. SARS-CoV-2 test yielded a positive result 10 days after the first dose of the mRNA-1273 vaccine, no further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event was unknown. The current COVID-19 pandemic of remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Pt developed hives, looked like poison ivy. No medical treatment at this time. Had previous rash on other arm before vaccine.
pt recv vax; gen myalgia, arm felt feverish swollen;myalgia localized near lt shoulder; unable to use lt arm due to discomfort;
The pt had an onset of a erythematous, nodule, lesion at the site of the injection progressing to vesicular eruption about 24 hours, post vax. The lesion lasted for a week. It was treated with cool compresses. He has received Influenza vaccine yearly since 1992. No known egg allergy.
This was my second Covid -19 Vaccine but my first dose of the Pfizer vaccine. My first dose was the J & J vaccine, I also had a very severe and extended adverse reaction to the J and J vaccine ( previously reported in VAERS).  I had the vaccine around 4 pm. I felt a bit lightheaded and dizzy immediately after the injection but felt ok after 45 mintues of waiting at the facility.   Around 1 AM I develped a very rapid hearbeat, sweating , feverish feeling with intermittent chills, headache, followed by nausea and diarrhea several hours later. By 9 am the next morning the nausea was so bad that I contacted my PCP's office who told me it was a common  side effec from the vaccine. By noon the nausea was so bad that  I could not eat or drink  and had developed abdominal pain . By 2 pm I was vomiting and had severe abdominal pain. After speaking to my PCP's office staff,  I proceeded to go to the ER at Hospital as they ecommended.  I had severe abdominal pain on both sides of my stomach and severe nausea and  could not swallow water without vomiting. The pain was a 8 or 9 out of 10 at its worse.  I was evalulated and following an abdominal CAT scan I was diagnosed with Acute Diverticulitis.  I was admitted to the hospital and was there for a total of 5 days for treatment. This included IV fluids , IV pain meds ,  nothing by mouth for several days and monitoring of my blood count.  I had to follow a special post Diverticulitis diet for two weeks following my discharge and had a follow up colonscopy. These symptoms occured within 24 hours of receiving the Pfizer Covid 19 vaccine. I had no abdominal symptoms the day I received the covid vaccine.
Left upper arm chronic pain many months (3+) prescription: Diclofenac sodium topical gel.
Information was received on 01-SEP-2017 from a lawyer regarding case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 06-SEP-2011 at a pharmacy, as recommended for route adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-DEC-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by a weakened immune system, which was diagnosed as severe herpes zoster or shingles. The patient has been prescribed famciclovir (FAMVIR) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient 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.
itching & erythema rash all over legs, arms, trunk;minimal wheezing noted;DPh given;
The day after her vaccine patient went to the bathroom and passed out. EMS came, but she started to feel better and did not go to the hospital.
outbreak of shingles in the face, right ear, and neck; ear pain; rash; This is a spontaneous report from a contactable physician. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced outbreak of shingles in the face, right ear, and neck, ear pain and rash on an unspecified date. Outcome of the events was unknown.  Follow-up (18Aug2021): This is a Follow-up spontaneous report from a contactable Physician.  Information about lot/batch number has been requested.
When the nurse the nurse pulled siringe out,  blood abs assuming vaccine squirted out.  A lot.   Should I get revaccinated?
Pediatric  dose of Pfizer vaccine  inadvertently  given to 12 year old  patient. No reaction at this time after observation of 30 minutes.
This medically confirmed spontaneous report (initial receipt 02-May-2012) concerns a female patient with a medical history of chronic inflammatory demyelinating polyneuropathy and allergy to flu vaccine. On an unspecified date many years ago, the patient received a flu vaccine and she became ill after receiving the vaccine. The patient was hospitalised as a result of this. The event outcome was recovered. Reporter's comments: On 02-May-2012, the reporter considered events serious due to hospitalisation.
pt devel pain in rt deltoid area w/t99.2 the day p/vax;was told to apply ice & APAP, but pt did not comply per stepmom;area cont to inc in redness;23JUL97 pt came to office area was 6x4cm erythema, very sl elevation;
pt recvd vax 2JUL95 & 12SEP95 pt devel a generalized rash; No further details were provided;
This spontaneous report as received from a medical assistant concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, concurrent conditions, concomitant medications or drug allergies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (Lot # L048849, Expiry date : 04-FEB-2018, NDC# 0006-4995-00, expiry date 31-MAR-2018) (Strength, dose and route of administration were not reported) for prophylaxis (incorrect product storage). Other suspect therapies included sterile diluent(MERCK STERILE DILUENT) as prophylaxis. There was previous temperature excursions on 23-FEB-2016 to 24-FEB-2016, 27-FEB-2016 to 29-FEB-2016, 01-MAR-2016 to 04-MAR-2016, 08-MAR-2016 to 09-MAR-2016, 15-MAR-2016 to 20-MAR-2016, 23-MAR-2016 to 26-MAR-2016, 30-MAR-2016, 02-APR-201 to 04-APR-2016, 19-APR-2016 to 21-APR-2016 and 23-APR-2016 to 24-APR-2016 for 24 hours each. Data logger was involved. On 27-APR-2016,12-MAY-2016, 24-OCT-2016, 13-NOV-2016, 06-DEC-2016 and 04-APR-2017 there was temperature excursions of -0.12, -0.46, -0.14, -0.24, +9 and -20.18 to +14 degree Celsius for 1 hour 15 minutes, 1 hour, 30 minutes, 45 minutes, 1 hour and 3 hours 30 minutes respectively. There was no product quality complaint involved. No adverse effects were reported. This is 1 of 6 reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA007802:
SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-SEP-2021, the patient experienced sore arm. The action taken with covid-19 vaccine was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Pt said she developed a red rash at injection site and it was down her arm about half way.   she noted the rash lasted about 3-4 days.  Pt also stated that after the first injection that she missed her menstrual cycle for the month.
My arm was a little sore. My blood test went from 2.9 to 1.9 (protime INR) Had a regular appointment with my cardiologist and he said to report it.
My daughter had the flu shot given to her on 9-16-09 at 4:45 pm, she had severe pain in the arm and at 8:00 pm she developed a low grade 100.3 fever. She also had a headache nasal congestion and a cough. In the morning of 9-17 she still had a low grade fever but in the evening the fever went up to 101.3-(ear thermometer
Patient received Pfizer vaccine on 04/28/2022.  Vaccine expiry date as per manufacturer was 05/31/22  but beyond use date was 04/21/22.  Talked to patient they had no adverse reaction.  There was no temperature excursion during storage of vaccine after receiving in pharmacy.
Patient is a 68 y.o. female with PMHX of COPD, afib on eliquis, DM2, HTN, HLD, chronic anemia, HFpEF, OSA presented to ED on 8/5 with complaints of worsening SOA x4 days with associated fever, cough, dizziness.  Constitutional: Positive for diaphoresis, fatigue and fever.  HENT: Positive for congestion.   Respiratory: Positive for cough, chest tightness and shortness of breath.    Hospital Course: Upon admission, patient required escalating oxygen requirements and was admitted to the ICU. She was intubated on 9/8 due to worsening hypoxia. She was treated with 10 days of IV dex and an empiric course of antibiotics with 2 days of Vanc and 7 days of Cefepime. CT PE was obtained which showed no PE. Her course was complicated by mucus plugging on 9/10 requiring bronchoscopy. She was found to have aspergillus at that time and started on voriconazole for a 6week course. She was unable to be weaned from the vent and tracheostomy was performed on 9/27 by ENT.   She also experienced Afib RVR during her hospitalization which required beta-blockade, diltiazem gtt, and amiodarone.   On 10/1, she underwent bronchoscopy for BAL sample as concern for new VAP. That night, her O2 saturations decreased to the mid 80s sustaining. She also became hypotensive, requiring vasopressors.  Patient is DNR/DNI and passed away on 10/02
Joint pain in feet, ankles, knees, hands , elbows, back shoulders.  fatique, nausea, lethargy.  fever over 100 - 102. low blood oxygen level which fell into the 70's at some points.  Pain at injection site
right upper arm was really sore; my stomach, all around to my back, all on the right side was really sore, to the point where it hurt to walk; my stomach, all around to my back, all on the right side was really sore, to the point where it hurt to walk; my stomach, all around to my back, all on the right side was really sore, to the point where it hurt to walk; This is a spontaneous report from a contactable consumer or other non hcp.     A 52-years-old non-pregnant female patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; Batch/Lot Number: EN6202), via an unspecified route of administration, administered on Arm Right on 26Feb2021 11:30 (age at vaccination: 52 years) at single for covid-19 immunisation. The patient medical history included COPD/Asthma and had allergies(drug hypersensitivity) to Floxin that is used in antibotics. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. Medical history included chronic obstructive pulmonary disease. Concomitant medications in two weeks included apixaban (ELIQUIS), levothyroxine sodium (SYNTHROID) taken for an unspecified indication. On 27Feb2021 04:00 ,the patient experienced, right upper arm was really sore which was to be expected, but my stomach, all around to my back, all on the right side was really sore, to the point where it hurt to walk and still pretty sore and it has been 4 days now. The patient did not receive any treatment for the events. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
On 11/08/2022 Patient was administered a booster dose that had a BUD of 11/02/2022.  Patient had no reports of adverse events.  Moderna was notified and stated the dose administered maintained the activity necessary to provide protection.
Redness, swelling of deltoid that spread to triceps area with decreased rom of arm that lasted 3 days. Pt applied ice.
pt recv vax; c/o numbness for a few minutes;next am , arm felt different and that night, pain arm; intermittent sharp pain stabbing pain in lt arm; pain and stiffness worsen w/ immobility at night;
This spontaneous report as received from a pharmacist via a company representative refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with ZOSTAVAX 0.65 ml, subcutaneously (lot #, expiration date and anatomical location were not provided). The reporter stated, that the patients had an increase in injection site reactions during the summer months after ZOSTAVAX administration on multiple unspecified dates. It was unknown if the treatment was given for adverse events. The outcome of the events and causality assessment were not provided. Additional information has been requested.
Patient presents to clinic on 8-20-2020 due to adverse reaction to recent Shingrix vaccine. She received the vaccine at 0930  on 8-17-2020 in her right deltoid. No immediate reaction observed. On the evening of 8-17-2020 patient does report feeling feverish and having chills. On 8-18-2020 she does not report any symptoms. On 8-19-2020 she reports hives all over body but her thighs and raspy/hoarse voice. She denies swelling of throat or face. Denies fevers.  Treatment to be completed at patient home after medication picked up from pharmacy. Medications ordered: Prednisone 20 mg BID x5 Benadryl: 25 mg 1-2 every 6 to 8 hours Patient is discharged from clinic. Outcome unknown and it is too early to determine. Will follow-up with patient on 8-21-2020.
4/2/2021: Right side of face went numb around 4:30 pm. Took blood pressure at 5:19 pm 151/98. Took additional half dose of Atenolol to lower blood pressure.  As I had already taken my blood pressure dose in the morning prior to the appointment. Took blood pressure at 6:43 pm 130/92. Took blood pressure at 8:20 pm 126/94. Took another half dose of Atenolol to lower blood pressure. Took blood pressure at 9:46 pm 119/85.  4/3/2021: Feeling started to return in face by about 90%. Blood pressure had improved. 7:44 am 121/81. 11:30 am 130/88. Took additional half dose of Atenolol. 3:25 pm 117/76. Arm was sore. 4/4/2021: Right side of face was feeling sore.  4/5/2021: Right side of face was still feeling sore. Went to Urgent Care. They prescribed 50 mg Prednisone for 10 days. Said potential case of bell's palsy and to follow up with neurologist. 4/7/2021: Seen neurologist. Possible mild case of bell's palsy or migraine that affected the facial nerve. Continue steroids and follow up with her in one week.  Still recovering from this but everyday has been improving so far.
two individuals received the Moderna vaccine dose #2 at day 21; received a Johnson & Johnson shot on 27/May/2021 and their first Moderna shot on 09/Jul/2021; first Moderna shot on 09/Jul/2021, lot 039K20A (expired vaccine 21/Jun/2021); This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received a Johnson & Johnson shot on 27/May/2021 and their first Moderna shot on 09/Jul/2021), EXPIRED PRODUCT ADMINISTERED (first Moderna shot on 09/Jul/2021, lot 039K20A (expired vaccine 21/Jun/2021)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two individuals received the Moderna vaccine dose #2 at day 21) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced WRONG PRODUCT ADMINISTERED (received a Johnson & Johnson shot on 27/May/2021 and their first Moderna shot on 09/Jul/2021) and EXPIRED PRODUCT ADMINISTERED (first Moderna shot on 09/Jul/2021, lot 039K20A (expired vaccine 21/Jun/2021)). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two individuals received the Moderna vaccine dose #2 at day 21). At the time of the report, WRONG PRODUCT ADMINISTERED (received a Johnson & Johnson shot on 27/May/2021 and their first Moderna shot on 09/Jul/2021), EXPIRED PRODUCT ADMINISTERED (first Moderna shot on 09/Jul/2021, lot 039K20A (expired vaccine 21/Jun/2021)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two individuals received the Moderna vaccine dose #2 at day 21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 27 May 2021, patient received the Johnson & Johnson COVID-19 vaccination. Concomitant information was not provided. Treatment information does not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: updated event two individuals received the Moderna vaccine dose #2 at day 21 On 09-Sep-2021: non significant Follow-up document received .
possible side effects regarding neuropathy; possible muscle fasciculation; This spontaneous case was reported by a health care professional and describes the occurrence of NEUROPATHY PERIPHERAL (possible side effects regarding neuropathy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     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. On 24-Feb-2022, the patient experienced NEUROPATHY PERIPHERAL (possible side effects regarding neuropathy) (seriousness criterion medically significant) and MUSCLE CONTRACTIONS INVOLUNTARY (possible muscle fasciculation). At the time of the report, NEUROPATHY PERIPHERAL (possible side effects regarding neuropathy) and MUSCLE CONTRACTIONS INVOLUNTARY (possible muscle fasciculation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported No treatment medications were reported  Company comment: This spontaneous case concerns a male patient of an unknown age with no a medical history reported, who experienced the serious (medically significant)  unexpected event of Neuropathy peripheral in association with a dose of mRNA- 1273 vaccine (unknown dose number). Temporal association cannot be assessed due to lack of information on the vaccination date. Involuntary muscle contractions were also reported. No further information is available. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of an unknown age with no a medical history reported, who experienced the serious (medically significant)  unexpected event of Neuropathy peripheral in association with a dose of mRNA- 1273 vaccine (unknown dose number). Temporal association cannot be assessed due to lack of information on the vaccination date. Involuntary muscle contractions were also reported. No further information is available. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
redness over armpit area; itching over armpit area; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness over armpit area) and PRURITUS (itching over armpit area) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness over armpit area) and PRURITUS (itching over armpit area). At the time of the report, ERYTHEMA (redness over armpit area) and PRURITUS (itching over armpit area) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I was having very strong headaches that were mild to very strong throughout the day with dizziness.  These headaches were happening for over a month  even after my second Covid-19 vaccine.   I was also having a hard time breathing but this happen after a few weeks and lasted several weeks.  I was given strong meds for my headaches (Nortriptyline 10 mg)
I started having vision issues 3 days after vaccine.  I hadn't had vision issues from my Multiple Sclerosis (MS) in over 10 yrs.  I went to urgent care and was referred to the emergency room.  Emergency room doctor referred me to neurologists.  The neurologists think the vaccine was interacting and fighting w/ my MS causing the optic neuritis. I am still seeing the neurologists now.  I'm now taking Ocrevus. I have since lost vision and have been told that it will never return.  Vision in my right eye was 90/20 and is now 50/20.