chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed bilateral facial swelling over cheek area with blisters that broke and bled. No fever. Began night of vaccination day. Patient also developed bilateral leg swelling from hips down. Cheek swelling diminished over 2 days and blistering took 1 week to heal. Leg swelling decreased over 4 days. Patient called MD (PCP) but did not go in.
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (received expired dose of the Moderna COVID-19 vaccine) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 068H21A) for COVID-19 immunization. No medical history reported. On Feb 17, 2022, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 17, 2022, patient administered expired product (received expired dose of the Moderna COVID-19 vaccine). At the time of the report, administered expired product (received expired dose of the Moderna COVID-19 vaccine) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, the vaccines were placed in the refrigerator on Jan 13, 2022. The vials expired on Feb 12, 2022 (based on the stickers/labels). HCP was not sure and did not have the exact expiration date of the vial itself.
Felt jittery; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING JITTERY (Felt jittery) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced FEELING JITTERY (Felt jittery). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, FEELING JITTERY (Felt jittery) 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 reported by investigator   This case was linked to MOD21-041846, MOD21-041951 (E2B Linked Report).; Sender's Comments:  MOD21-041846:same reporter MOD21-041951:same reporter
Vaccination @ 10:28 am, pre-syncopal, parasthesias episode @ 10:43am. Patient's vitals were monitored for an hour, ice packs on chest. Blood pressure monitored and blood sugar check. Patient was alert and stable prior to discharge.
severe dizziness morning after vaccine, had to leave school and go home and still  dizzy in afternoon
On 8/23 This patient's history began with an earache and the diagnosis of strep upper respiratory infection.  A day later the patient developed a Bell's palsy of the right side.  Within days the patient was being admitted to the hospital with neurological compromise, dysphagia, sepsis, right-sided hemiparesis
Received the seasonal flu shot.  2 days later, red patches that itched slightly appeared on my arm about 5 inches below the injection site.  The size of the "rash" is approximately 3 inches long  and 2 inches wide.  Slight itch from time to time but the strange thing is that the area under the skin where the patches are is painful when touched, kind of like a bruise would be, but there is no bruise there.  I should also note that the actual injection site had no blood, no swelling and no pain.  The patch has now been there for 2 full days and has not lessened, changed or given me any reason to believe that it is going to go away any time soon.
QUITE FEW SYMPTOMS; This spontaneous report received from a parent via a company representative 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced quite few symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of quite few symptoms was not reported. This report was non-serious.
Patient 60yr old Male. A&Ox3. Denied receiving Bivalent upon arrival to clinic during screening process. Stated the last time he was vaccinated was in May 2022. Pt showed his Docket app to both me and educator which showed last vaccine was received on May 9, 2022.  Pt stated, " i have received a vaccine in about one year" Screening process was completed and pt was vaccinated.  Pt received PFizer Bivalent as requested.  Upon inputting information into data it was noted that the pt was vaccinated in November 2022 with Bivalent. He had two charts in data-  -First name was different.  This was found to be a medication error. Pt is not approved to receive second bivalent vaccine r/t age and requirements.  Pt was in observation and informed of medication error.  He was educated and expressed understanding.    11/02/2022  GJ6739 PHARMACY   05/09/2022 FK9893 HEALTH CENTER
sore arm; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (chills) and FATIGUE (fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.            Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   This case was linked to MOD-2021-051329, MOD-2021-051329 (Patient Link).
face is a little swollen; couldn't breath and was gasping for air; allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of SWELLING FACE (face is a little swollen), DYSPNOEA (couldn't breath and was gasping for air) and HYPERSENSITIVITY (allergic reaction) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 016M204) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Heart disease, unspecified. Concomitant products included OMEPRAZOLE for Oesophageal reflux, ACETYLSALICYLIC ACID (BABY ASPIRIN), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT), ALBUTEROL [SALBUTAMOL], FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and PREDNISONE for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (face is a little swollen), DYSPNOEA (couldn't breath and was gasping for air) and HYPERSENSITIVITY (allergic reaction). At the time of the report, SWELLING FACE (face is a little swollen), DYSPNOEA (couldn't breath and was gasping for air) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.            This case was linked to MOD-2021-214523 (Patient Link).
Developed a red ring/rash that was 2 inches diameter around injection site. The ring was about 1/4 inch thick. Was hot to touch. Doesn?t itch or hurt really, although I did scratch it at one point and that was very painful. I did not notice the rash until my mom saw it yesterday, so I?m not sure if that was the first day or not. It has faded significantly overnight but is still present. The day before my mom noticed the rash on me, I had sore shoulder muscles (both sides) and do not remember lifting anything. However, my back has been in pain so could be related to that. The only other side effects I had with the injection were a slight headache the day after and nausea/pooping more frequently (but not diarrhea) 4 days later, which I know are not unexpected side effects.
patient contacted clinic, informed staff that she had a rash breakout around her chest and back, not at vaccine site. No difficulty breathing or fevers reported. informed pt that will submit a Vaers report. Furthermore, informed pt that if she experiences any shortness of breath or difficulty breathing that she should report to the ER or call 911.
On 4/11/01, the pt received his 1st IM dose of Engerix-B. Post vax, on 4/11/01, the pt experienced weakness and fatigue. The reporter stated that these adverse events were moderate in severity and possibly related to Engerix-B. No drugs were used to treat the adverse events. They resolved on 4/12/01. Engerix-B was stopped. As of 6/12/01, the adverse events had resolved.
Passed out the following morning, muscles paralyzed, severe leg tremors, slight fever, severe pain in right arm, dizziness, weakness, shivering.
Patient did not realize that she was pregnant when she completed the screening tool prior to receiving the Intranasal vaccine. EDC July 27, 2010 per sonogram. Date of conception Nov 4.
- Arm Sore at injection site from 4-6-21 to 4-9-21 - Passed out at 1:00am 4-6-21, and fell to floor with disorientation.  - Severe Chills, uncontrollable shaking of body/teeth, 4-6-21 to 4-7-21 - Feverish 04-6-21 to 4-8-21 - Heart Arrhythmia, causing abnormal breathing and inability to breath and sleep 04-6-21 to 4-7-21 - Dizziness 04-06-21 to 04-09-21 - Food/Water/mouth tastes of metal 04-7-21 to 4-8-21 - Loss of Appetite 04-06-21 to present  - Bloating, feeling full when haven't eaten 04-06-21 to present  - Brain fog, not able to concentrate - 04-06-21 to 04-09-21 - Excessive sweating 04-06 to 04-08-21 - Tired 04-06 to 4-10-21 - Irritability, 04-09-21 to 04-10-21 - Emotional, crying for no reason sporadically 04-06 to 04-9-21
This spontaneous case, initially received from other health professional (pharmacist) on 10-Oct-2018, concerns a 71-year-old, elderly, female patient. On 31-Aug-2018, the patient was administered FLUZONE HD (dose, route of administration, anatomical location, batch number, expiry date: not reported). On 10-Oct-2018, the patient was administered FLUAD (TIV) (both vaccine received in the same year) [route of administration: intramuscular, anatomical location: left deltoid, dose: 0.5 ml, batch number: 250795 and expiry date: 30-Apr-2019] (explicitly coded as inappropriate schedule of vaccine administered). It was reported that, no adverse events were reported after vaccination. The reporter assessed the case as non-serious.
right arm numbness/tingling   chest tightness  dry heaving   passed out  lips and tongue tingling then swelled. 50mg IM Benadryl administered, vitals monitored, RR called and I was transported to the ER and given more medications.
Having hives; Itching; Blisters; They got in their pubic area, like an bacterial infection; Shortness of breath; Rapid heart bit; Experienced a allergic reaction that is still going on to these day; Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Having hives), PRURITUS (Itching), BLISTER (Blisters), BACTERIAL INFECTION (They got in their pubic area, like an bacterial infection) and DYSPNOEA (Shortness of breath) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 804f21a and 091d21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CARVEDILOL, APIXABAN (ELIQUIS) and FUROSEMIDE for an unknown indication.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced URTICARIA (Having hives), PRURITUS (Itching), BLISTER (Blisters), HYPERSENSITIVITY (Experienced a allergic reaction that is still going on to these day) and HYPERSENSITIVITY (Allergic reaction). 09-Sep-2021, the patient experienced BACTERIAL INFECTION (They got in their pubic area, like an bacterial infection), DYSPNOEA (Shortness of breath) and HEART RATE INCREASED (Rapid heart bit). At the time of the report, URTICARIA (Having hives), PRURITUS (Itching), BLISTER (Blisters), HYPERSENSITIVITY (Experienced a allergic reaction that is still going on to these day) and HYPERSENSITIVITY (Allergic reaction) had not resolved and BACTERIAL INFECTION (They got in their pubic area, like an bacterial infection), DYSPNOEA (Shortness of breath) and HEART RATE INCREASED (Rapid heart bit) outcome was unknown.            Treatment included they have been prescribed with two types of antibiotics and nothing has work for an allergic reaction.
I experienced heart palpitations, dizziness, light-headiness, a bit of nausea and for only two days I broke out in sweats around the 12th and 13th day after the vaccine. The episodes have lessen as far as the heart palpitations. I spoke with the telephone triage nurse at the hospital and was told to report to the nearest ER and I did. The ER Doctor said that he couldn't rule it in or out that the symptoms were brought on by the vaccine. He consulted the records that were sent from the hospital and some follow up was set up. All medical records were sent back to the hospital to have them follow up on my symptoms.
Reports that started having myalgias, fevers up to 102, white productive cough, loss of taste about 9 days prior to admission, tested positive for COVID 7 days prior to admission, came to the ER as progressive/not improving.  Main complaint is aches and pains almost unbearable.
The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022; The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 004B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date the vial was initially stored in the refrigerator on 11-Jan-2022. The vial did not undergo any temperature excursions. No patient has reported adverse reaction. No treatment medications were reported.
Information has been received from a physician concerning an approximately 19 year old female patient who on an unspecified date was vaccinated with first dose of GARDASIL (lot # 661044/0548X) into left arm. On an unspecified date when the patient arrived at home she got "dizzy". The patient sought unspecified medical attention. At the time on the report on 10-AUG-2009 the patient had recovered. Follow up information was received from a physician concerning a female patient with sulfonamide allergy and prior reactions to pertussis vaccine who on 03-AUG-2009 was vaccinated with the first dose of GARDASIL (lot # 661044/0548X) intramuscularly. There were no concomitant medications reported. It was reported that on 04-AUG-2009 (24 hours after injection), the patient experienced dizziness. It was reported that the patient recovered on an unspecified date. No further information is available.
Fever of 101.9, disorientation, pain in arm, ache red spot of 7 inches in diameter
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 28-JUN-2011, patient received improperly stored (Oka/Merck) VARIVAX  dose 1 from batch/lot# 669223-1564Z (expiry date, dose units, route and anatomical location were not specified), on 02-AUG-2011, patient received improperly stored (Oka/Merck) VARIVAX dose 1, from batch/lot # 669601/0138AA (incorrect product storage).  No adverse effect were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.  This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 14-JAN-2014, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX  dose 1 (dose unknown), from lot # H018451 with expiry date of 09-OCT-2014. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
On Friday March 15, 2019 at 4 pm had lower back pain accompanied with bilateral leg weakness. It progressed worsening by 3 am on March 16, 2019 and was unable to walk. Went to ER. By time arrived to ER was unable to move legs, had limited movement in bilateral arms with numbness and tingling of feet and hands. Was treated with IVIG starting on the evening of March 16, 2019 and received a dose every day for a total of 5 doses, so through March 20, 2019. Experienced severe back and upper leg pain and headaches. Was transferred to Rehab on Friday, March 22, 2019. On Sunday March 24, 2019 experienced nausea and vomiting. On Monday March 25, 2019 was transferred to Hospital for altered mental status changes and sodium of 119. Was admitted to the ICU for management of hyponatremia. Was discharged back to Rehab on Thursday March 29, 2019. Has continued currently at Rehab for intensive physical therapy and monitoring of sodium levels.
This spontaneous report was received from a nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates in the years 2015, 2016 and 2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. There were multiple temperature excursions but the temperature and the time frame were unknown by the reporter. No data logger was involved. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1705USA005384: US-009507513-1705USA005385: US-009507513-1705USA005386: US-009507513-1705USA005387: US-009507513-1705USA005388: US-009507513-1705USA005389: US-009507513-1705USA005390.
On 11/11/99, the pt received her 1st injection of Lymerix and in early December, 1999, the pt experienced a severe burning in her knees, shoulders and elbows. Relevant lab test results include a Western Blot that has tested positive for several strains as well as Erlichia. Treatment was not specified. The pt has never received the 2nd injection of Lymerix vaccine. The most recent information received on 2/17/200 reports the outcome of the adverse events as unknown. Additional information has been requested.
60 hours of prolonged fever ranging from 100.5 to 102.9.  60 hours of watery diarrhea.  Shivers, aches in joints and muscles, nausea, loss of appetite, lethargy, unsteady on feet, night sweats, confusion, fatigue.  Mostly confined to bed and bathroom for 60 hours.  My fever broke early this morning (June 3, 2023) thus I'm able to complete this form.  I still have watery diarrhea and loss of appetite.  Still fatigued.  Walking short distances in the house wears me out.
Information has been received from a RN concerning a 4 yr old male who on 13Jun04 was vaccinated at an unk time with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) . On 13Jun04 at an unspecified time the pt experienced an anaphylactic reaction. The child was referred to an allergist for follow up. Serum test were performed for porcine and bovine. The test was positive for porcine. The pt had received his first dose of the measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 635920/0826K) on 19Feb01 and did not experienced an adverse event at that time. Additional information has been requested.
Information has been received from a physician concerning his 72 year old wife with thyroid problems and no known allergies who on  approximately 18-FEB-2007 was vaccinated with an IM dose of zoster vaccine live (Oka/Merck). Concomitant therapy included an unspecified thyroid medicine. On the first three days after vaccination, the patient experienced induration and soreness. She recovered within three to four days of vaccination. No laboratory tests were performed and no medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
I received the first dose of Modera on 4/1/2021. accidentally gave me  the 2nd dose of the Pfizer vaccination for my second shot.