chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hair loss; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of hair loss in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced hair loss (Verbatim: hair loss).  The outcome of the hair loss was not reported.   It was unknown if the reporter considered the hair loss to be related to Shingles vaccine.     It was unknown if the company considered the hair loss to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that one could had hair loss and the patient had hair loss after the booster. The follow-up could not be possible as no contact details were available.
Arm numbness. Patient's agent stated the patient was fine after the immunization.  Onset of symptoms were 2.5 weeks later.
This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 16-OCT-2013 at 11:00 the patient was administered with M-M-R II (lot number J002505, expiry date 28-FEB-2015) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date the M-M-R II was exposed approximately for 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17:14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13.26 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7 degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
Information has been received from manf and assigned manf report number A050841A. It was reported that a 13 year old female whose past medical history included being fine prior to immunization on an unspecified date was vaccinated with a first dose of hep b virus vaccine rHBsAg (yeast) (Engerix B) (lot EG5353B2). There was no concomitant medication. Subsequently, the pt developed an increased aspartate aminotransferase level and chronic pain were unresolved. This report was originally reported by a consumer who is a relative of the pt. A physician or other health care professional has not verified this report. Additional information has been requested.
This is a spontaneous report from a contactable nurse reporting for himself via a Pfizer sales representative. A 67-year-old male patient of unspecified ethnicity started to received TRUMENBA (Lot Number J28923, Expiration Date Jun2016) via intramuscular route of administration into the right deltoid muscle on 25Sep2015 at 11:00 hours at 0.5ml, single, for asplenia (initially reported as for immunization). Medical history included asplenia from an unknown date and unknown if ongoing (in his 20's (1980)) and inflammatory bowel disease. The patient experienced mild erythema little bit lower than the injection site/erythema right bicep/deltoid on 25Sep2015 with outcome of recovered and "indication: asplenia" on an unspecified date with outcome of unknown. The events were reported as nonserious. According to the reporting nurse, the vaccine was to be administered again in 2 months, then in 4 months. The action taken for meningococcal group b rip2086 was not applicable. The nurse reported that there was a reasonable possibility that the event was related to meningococcal group b rip2086. Follow up (09Oct2015): New information from a contactable nurse includes: reporter details. Follow-up (09Nov2015): New information reported from the same contactable nurse includes: drug data (lot number, expiration date, start and stop date and time), medical history, concomitant medication, reaction data (added event: drug use for unapproved indication and reaction details), seriousness (nonserious), and causality (related). Follow up attempts completed. No further information expected.
Headache 2 hours after injection later that evening pt. with nausea, chills, stomach ache, lethargic.  Symptoms lasted 2 days.  Pt. felt better the next day (one day) then symptoms returned again x1 more day.  Pt. advised not to get further vaccine doses.
pt recv vax 12FEB99 & seen by MD 15FEB99 for c/o pain, swelling & redness @ site;pt was told it was probably an allergic rxn;had taken advil per PMD instruction;pt had some swelling w/red blotches;
Patient reports left arm redness, swelling, warm to touch, joint pain on left side. Taking ibuprofen every 4 hours and BENADRYL was ineffective. x 2 weeks.
Diarhhea and anorexia beginning the day after the vaccines and lasting for 6 days; tactile fever on first day of sx; no other family memebers were sick or became sick.
Mom reports patient seemed more tired than usual x4 days and developed rash x1 day. Initial rash to face, most prominent on left cheek, now spreading to trunk, arms and legs. Eyes appear more puffy than usual. Child also developed loose stools on day of assessment (11/02/18). Mom had been giving Tylenol at home. Child given Benadryl at PCP office- 11/02/18 at 11:00 AM.
I work at  medical center where patient is being treated for a new diagnosis of Acute monocytic leukemia.  I was able to that the patient was vaccinated with Moderna vaccine on 1/16/2021, patient does not have the vaccination card with the Lot number so this is unknown at this time.  Here are the details I see in the chart. Patient arrived on   1/30/2021 at 2100, per History and physican patient has not been feeling well for about a week and a half, and had received the moderna vaccine approximately 2 weeks prior to this time.  Doctors note states about a week after first COVID vaccine she noted chest and back pain, dyspnea, high grade fevers and for this went to the ER on 1/28/21 and found to have anemia Hemoglobin 10 with normal LFTs.  She was thought to have a reaction to vaccination and sent home.  When her symptoms did not get better she went to ER again on 1/30 and found to have Hemoglobin down to 8 and marked LFTs elevation.  Pathology evaluated elevated WBC and showed monocytosis and possible blast cells and patient transferred for further workup.      per oncologist patient went to primary care about 6 months ago and had a normal CBC.   Patient was started on chemotherapy for diagnosis of  AML during this admission, as of 2/9/2021 patient remains inpatient, is intubated in ICU with prognosis unknown at this time.
That day when I woke up, I had a headache, my eyes felt hot, I was 99.3 temp, had diarrhea , lessoned Sunday and Monday  and then on Tuesday , I had diarrhea and a headache again, I called my doctor and tele-med visit. Two weeks after that, the inside of my mouth felt irritated, faded away after four days and then it came back. I contacted my allergist, they ran test. She did not have an allergy to anything she has eaten. Then my tongue was raw.
no adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    Patient was over 18 years of age. No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 27 Jun 2023, 2 doses were administered at administration site 1. No treatment medication reported.   This case was for the 4th patient out of 47 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case (Patient 01)
pt expired approx 1 wk p/vax given; clinic reports pt's death was expected; pt was in end-stage liver disease, COPD, on 02
23OCT89 pt vax w/hepta B; devel numbness that shot down arm into fingertips, numbness & tightness in neck muscles & tingling in left cheek & right hand, shortness of breath.  Pt felt unwell for 3 days w/ nausea.
Heart flutter, palpitations, increased heart rate even at rest, feelings of weakness and just feeling unwell
Red splotches at and around injection site (approximately 2-3 inches around), hot to touch, itchy arm. Symptoms reduced with Benadryl and OTC topical steroid.
This case was reported by a nurse via other manufacturer and described the occurrence of passed out in a female patient who received MENVEO. Co-suspect products included TRUMENBA. In June 2016, the patient received the 1st dose of MENVEO (intramuscular) and the 1st dose of TRUMENBA (intramuscular). In June 2016, several hours after receiving MENVEO, the patient experienced passed out (serious criteria GSK medically significant) and lightheadedness. In June 2016, the outcome of the passed out and lightheadedness were recovered/resolved. It was unknown if the reporter considered the passed out and lightheadedness to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by a Pfizer Territory Manager and was not provided product information by the reporter. The patient's medical history was unknown. Concomitant medication were unknown by the reporter. On 17th June 2016, the non-GlaxoSmithKline sales representative stated that he was on luncheon at a pediatric office and a nurse and a physician shared adverse events for 4 separate patients who received MENVEO and standard 1st dose of TRUMENBA (non-GSK vaccine). They stated that at least 3 patients also received MENVEO on the same day. The reporting sales representative had limited information regarding patient's details (initials, date of birth, age, height, weight and ethnicity was unknown) and adverse events. In June 2016, few hours after vaccination with MENVEO and TRUMENBA on the same day, the patient experienced dizziness, lightheadedness and passed out. The patient went to the emergency department. The date of visit to emergency department and the duration of the visit was unknown. In June 2016, the patient underwent blood test and the blood work was fine. Other investigation was unknown. The reporting sales representative did not have reporting nurse's last name. The reporter email and prescribing email was unknown. The National Drug Code (NDC), lot number and expiration date was unknown for both TRUMENBA and MENVEO. The nurse did not have time to provide that product information at the time of reporting. The patient had not received another vaccine due to the 2nd dose was not due at the time of reporting. This case was not associated with product complaint and there was no medical information request. This case has been linked to cases US2016GSK116036, US2016GSK116037 and US2016GSK116035, reported by the same reporter.
Close to 4:00PM I was waiting for my husband to leave work, I noticed that my throat was starting to swell and was becoming sore, I also started to feel weak.  My husband drove home, as the night progressed my throat became more swollen, my headache increased, I started to get a fever and chills, and I felt even more weak. Throughout the night my fever increased to 101, I was sweating and then I would get the chills, my throat continued to feel very swollen and sore, I had muscle aches and continued to feel nauseated.  It is now 12-5-09 and 12:20 pm, my fever is finally gone down, my throat is still very sore and swollen, my asthma is worse, but lucky no wheezing, I feel weak (muscle weakness) and I am extremely tired. I just called my doctor to see what I should do and I wanted to make sure that your organization was aware of my reaction.
Heqdache severe throwing up fatigue and outvof breathe alot having vision  Horroble headache  Chest pain  Shortness of breathe Pain all over body
On 12/4/13 this client received Tdap, Hepatitis B, MMR, IVP vaccines at 2:20 PM. After the vaccines were administered, he stood up and walked over to his father on the other side of the clinic room, passed out and slumped into his father. He was lowered to the floor and his feet were elevated. He regained consciousness several moments later. BP was 90/50, pulse 64. No other symptoms. He then sat upright on the floor for several minutes. He reported he was not dizzy and stood up to sit in a chair. A 2:42 PM, the client was talking and reported that he felt fine and he denied any other symptoms. BP was 94/70. He left at 2:45 PM.
Resident reported he was feeling Hot and requested for Air to be turn on and also requested for a Cup of Ice. All his request was Provided. At 8:52am Resident was checked and told writer he feels better and requested for Ice this time which was provided. At about 10:15am writer went to administer Resident meds and found resident on unresponsive. Pt is full code so CPR initiated,911 called and V/S during CPR was B/P, 218/161,175,BS 159.911 arrived at 10:25 and took over CPR.RP made aware of changes. Resident pronounced Deceased by 911 at 10:50pm.
No reaction until today, 12/31/2020 - Injection site is red, swollen and itchy I went to EH and advised to use a compress and monitor.
anaphylaxis; This is a literature report for the following literature source:  A 40-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "food and drug allergies" (unspecified if ongoing); "food and drug allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis".  The initial vaccination with COVID-2019 vaccines with emergency use authorization began in December 2020, less than a year after the SARS-CoV-2 RNA sequence was known. anaphylaxis suffered by two female healthcare workers aged 40 and 49 years after receiving the Pfizer- BioNTech mRNA vaccine, 24 hours after the start of mass vaccination. Both patients had a history of food and drug allergies and carried epinephrine auto-injectors.; Sender's Comments: Based on the limited information currently available, a possible association of the suspect drug administration with the reported event cannot be excluded, due to a plausible temporal relationship. This case will be reassessed when additional information becomes available.
I developed headache, low grade fever, and nausea at approximately 11:59 PM 1/11/2021. As of 05:42 AM 1/12/2021 these symptoms persist. Headache reduced via ibuprofen, fever and nausea did not respond.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruise the size of a half dollar at the injection site), VACCINATION SITE HAEMORRHAGE (bleeding at the injection site when the needle was withdrawn), VACCINATION SITE SWELLING (swelling at the injection site), FATIGUE (fatigue) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID, TOCOPHEROL (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]) for an unknown indication. On 07-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bleeding at the injection site when the needle was withdrawn), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). On 08-Apr-2021, the patient experienced VACCINATION SITE BRUISING (bruise the size of a half dollar at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE BRUISING (bruise the size of a half dollar at the injection site), VACCINATION SITE HAEMORRHAGE (bleeding at the injection site when the needle was withdrawn), VACCINATION SITE SWELLING (swelling at the injection site), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) outcome was unknown. Action taken with mRNA-1273 in response to the events was not Applicable. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up information received on 23-Jun-2021 and contains no new information.
Septic Shock, Respiratory Failure, Pneumonia with negative Blood and Sputum cultures. ICU admission with Central line, BIPAP and IV Vanco and Zosyn. Also IV fluids.  ID consults, Pulmonary Consults, Cardiology consults.
pain continued to elbow; arm of injection continued to feel sore and weak; Injection site was sore to the touch; injection site was sore to the touch; arm of injection continued to feel sore and weak; arm is weak and sometimes tingly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: FD0809) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, start date: 2021, stop date: 2021. Vaccination history included: Bnt162b2 (Prev dose product: COVID-19, Prev dose brand: Pfizer, Prev dose Lot number: ER8730,, Prev dose dose number: 2, Prev dose vaccine location: Left arm), administration date: 21Mar2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (Prev dose product: COVID-19, Prev dose brand: Pfizer, Prev dose Lot number: EM9809,, Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 28Feb2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Injection site was sore to the touch"; HYPERAESTHESIA (non-serious) with onset 17Nov2021, outcome "not recovered", described as "injection site was sore to the touch"; PAIN (non-serious) with onset 20Nov2021, outcome "not recovered", described as "pain continued to elbow"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021, outcome "not recovered", MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "not recovered" and all described as "arm of injection continued to feel sore and weak"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "arm is weak and sometimes tingly". Therapeutic measures were not taken as a result of vaccination site pain, hyperaesthesia, pain, pain in extremity, muscular weakness, paraesthesia.  Additional information: Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient was not been tested for COVID-19.  Follow-Up (07Dec2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Pt to ED 10/24 for possible syncope. Pt COVID+ 10/24, to start remdesivir for 5 days, denies shortness of breath. 10/26 pts oxygen sat, 78% on 5LNC. 10/17 Pt SpO2 was mid 80s while pt was laying flat in bed on left side. 10/28 pt with occasional non-prod cough. Pt discharged 10/31.
Patient is 51-year-old female with complains of large local reaction after Anthrax #4.  She complains of swelling noticed the evening after the injection.  She reports feeling sick.  She complains of being nauseated and vomiting.  She had episodes of chills and then feeling hot.  No diarrhea.  Complains of feeling itchy at the site.  Pain at the site and tenderness.  Some swelling that started the first day of the injection.  She reports feeling "like I had the flu"  and this lasted for approximately 48 hours.  She reports some difficulty "catching her breath" for the first day but no severe dyspnea or problems breathing.  No itching except at the site.  No hives on body.  No specific joint pain but generally just felt uncomfortable.  Did not check her temperature.  This was given on 29 Mar 04.
8 days after vaccination I developed itching, erythema, warmth and induration at site and distal to injection site.
3 mins post vaccination I felt left side face tingling and numbness for 2-3 mins. Followed by chest pain and tightness slight swelling of the face and throat. increase heart rate and possible irregular heart rhythm. 20 mins after vaccination felt increase in fever chills and general malaise, joint pain and increased difficulty for work of breathing.
Arm swollen up really large, swelling increased; Felt very hot; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen up really large, swelling increased), FEELING HOT (Felt very hot) and FATIGUE (Feeling very tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. lot no:048B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT TU) and PROPRANOLOL HYDROCHLORIDE (PROPANOL [PROPRANOLOL HYDROCHLORIDE]) for an unknown indication.    On 04-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced FATIGUE (Feeling very tired). On 06-Jun-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen up really large, swelling increased) and FEELING HOT (Felt very hot). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm swollen up really large, swelling increased), FEELING HOT (Felt very hot) and FATIGUE (Feeling very tired) outcome was unknown.            This case was linked to MOD-2021-213362 (Patient Link).