chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was contacted post vaccination when the error was discovered she was 17 years of age vs 18 years for approved Moderna vaccination. She reported NO adverse events, treatment or outcomes. She provided her medical doctor and we contacted the doctor to relay the information and the patient reporting.  (was told to submit report by our corporate as no adverse effects happened to patient - no field to put that)
The patient came and reported that she got Moderna vaccine in her country but could not get records of the immunizations because they would not give it to her. Her PCP recommended for her to restart series. Family wanted her to get Moderna vaccine. The patient was observed and had no complications.
Hemorrhoids; Stomach cramps; Osteoarthritis; Pain; Diarrhea; Tiredness; Rheumatoid arthritis; Swelling; Hand pain; CARPAL TUNNEL OF BOTH HANDS; This spontaneous case was reported by a health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    The patient's past medical history included Hip discomfort in 2019 and Alcohol use in 1959. Concomitant products included BUDESONIDE (ENTOCORT) for Crohn's disease, VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2020, the patient experienced CARPAL TUNNEL SYNDROME (CARPAL TUNNEL OF BOTH HANDS). In February 2021, the patient experienced SWELLING (Swelling). On 12-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant). In April 2021, the patient experienced FATIGUE (Tiredness). In 2021, the patient experienced PAIN IN EXTREMITY (Hand pain). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), HAEMORRHOIDS (Hemorrhoids), ABDOMINAL PAIN UPPER (Stomach cramps), OSTEOARTHRITIS (Osteoarthritis) and PAIN (Pain). The patient was treated with COLESTIPOL at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis), CARPAL TUNNEL SYNDROME (CARPAL TUNNEL OF BOTH HANDS), ABDOMINAL PAIN UPPER (Stomach cramps), SWELLING (Swelling), PAIN IN EXTREMITY (Hand pain) and FATIGUE (Tiredness) had not resolved, DIARRHOEA (Diarrhea) and HAEMORRHOIDS (Hemorrhoids) was resolving and OSTEOARTHRITIS (Osteoarthritis) and PAIN (Pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the event swelling was prior to 1st dose of vaccine administration and it is unlikely related to vaccine. Humira may remain as risk factor.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the event swelling was prior to 1st dose of vaccine administration and it is unlikely related to vaccine. Humira may remain as risk factor.
Arm started itching aroung 7pm 2/17/21. Became red and slightly swollen. No treatment after talking to pharmacist 2/20/21
Information has been received from a pharmacist referring to a 22 year old female patient. The patient was a chronic every day cigarette smoker and she was allergic to cephalosporins and penicillins (reaction unspecified). The patient was hospitalized on an unknown date for an uncomplicated vaginal delivery on 06-AUG-2015. On 07-AUG-2015, first day postpartum, the patient was vaccinated with a dose of PNEUMOVAX23 injection (lot #, dose and route were not reported) by an unspecified healthcare provider. There were no concomitant therapies. On 07-AUG-2015, the patient experienced a fever of 102.9F with redness, warmth, and swelling at the unspecified injection site within 12 hours of receiving the vaccine. A blood and urine culture was taken on an unknown date in August 2015 and both cultures came back negative. The patient was treated with the antibiotics gentamycin and clindamycin. The events improved with antibiotic treatment on an unspecified date and the patient recovered from the events on an unknown date in August 2015. The patient was discharged at the normal length of stay on an unknown date in August 2015 for the uncomplicated vaginal delivery (length of stay and discharge date was unspecified). This is one of several reports received from the same reporter. Additional information has been requested.
Sepsis; hair loss; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Sepsis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L10A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced ALOPECIA (hair loss). On an unknown date, the patient experienced SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in April 2021 due to SEPSIS. At the time of the report, SEPSIS (Sepsis) and ALOPECIA (hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.  Very limited information regarding the events has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-216554 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
No adverse event; Administered a dose of the 5-11yo monovalent moderna vaccine as Additional Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administered a dose of the 5-11yo monovalent moderna vaccine as Additional Booster) and NO ADVERSE EVENT (No adverse event) in an 8-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1415B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer monovalent (lot number SK5127, dose 1) on 10-Nov-2021, Pfizer monovalent (lot number SL0007, dose 2) on 02-Dec-2021, Pfizer monovalent (lot number SK5618 and dose 3) on 21-May-2022. Past adverse reactions to the above products included No adverse event with Pfizer monovalent, Pfizer monovalent and Pfizer monovalent.    On 20-Apr-2023, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Administered a dose of the 5-11yo monovalent moderna vaccine as Additional Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administered a dose of the 5-11yo monovalent moderna vaccine as Additional Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Administered a dose of the 5-11yo monovalent moderna vaccine as Additional Booster).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication were reported.  No reported symptoms. No treatment information was provided by the reporter.
pt recv vax & devel inj site swelling which extended from the shoulder to the elbow;
From telephone contact received at manufacturer on 2/21/02 it was reported that a 33 year old female patient received a YF-Vax dose given on 2/14/02 SQ in left arm. Patient also received Typhim VI also administered in left deltoid, a Hepatitis A vaccination and a Measles vaccination. Reportedly the patient developed a large local reaction 50mmx60mm, red, induration, hard and very warm and painful of the left arm. The local reaction started 2 days after dose was received. Four days after injection the reaction started to subside but then flared up again and is getting larger.
This spontaneous report was received from a pharmacist and refers to a 56 year old nurse female patient who had sensitivity to certain unspecified medications and unspecified medical history, drug reactions or allergies. On 10-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65ml, subcutaneous, lot number L027322, expiration date 21-OCT-2016, (anatomical location was not reported). There was no concomitant medication reported. On 11-NOV-2015, the patient emailed the pharmacist and reported that she developed "respiratory problems, she felt like she had a lump in her throat" and also a "knot and swelling at the injection site". The reporter stated that the patient went to an unspecified hospital, where she worked, on an unknown date and unspecified antihistamines were given to her while she was at the hospital. The patient was not admitted to the hospital. At the time of the report, the outcome of the respiratory problems was reported as recovered on an unspecified date in November 2015. The outcome of the she felt like she had a lump in her throat and a knot at the injection site was unknown. The outcome of the swelling at the injection site had lessened but had not yet resolved. The relatedness between the events and therapy with ZOSTAVAX, was not reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 lot # K021030, expiration date: 22-JUN-2016 (dose, route and site of administration were not reported). NO adverse effects were reported. Follow up information has been received from the pharmacist on 09-NOV-2015. On 03-SEP-2015, the patient was vaccinated with dose of improperly stored PNEUMOVAX 23. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Patient details, suspect therapy, event data and narrative were updated.
Wheezing, low o2 stats, tachycardia, severe pain, dizziness, severe nausea and vomiting
Fever 101.6, extreme fatigue, nausea, lack of appetite, headache, chills. Lasted approximately 24 hours. Onset was 7 days post vaccine.
COVID-19 pneumonia with hypoxia: improving, completed remdesivir. Doing well today on day of DC
pt recvd vax; T 104; was coughing before;PAR states MD felt, sxs not related to vax; pt sick & T 104 x 2 days, MD states no more DTP;
Moderna COVID-19 Vaccine EUA Red itchy rash on left arm above and below  injection site began on 3/11. Red splotches/rash in both armpits and underside of both breasts began on 3/12; left side symptoms more pronounced than right side.
Information has been received from a 43 year old female impatient with bipolar disorder, lupus erythematous, diabetes, hypertension, arthritis, regentive joint and disk disease, fatty liver, hypothyroidism, cardiomegaly, penicillin and COMPAZINE allergy who on "29-OCT-2009 or 30-OCT-2009" was vaccinated a dose of PNEUMOVAX 23. Concomitant therapy included CAMPRAL, VISTARIL, BUSPAR, ABILIFY, LAMICTAL, SEROQUEL, AMBIEN, lithiumC03, morphineSO4, DURAGESIC, SKELAXIN, NASONEX, PLAQUENIL, methotrexate, folic acid, prednisone, LYRICA, SALAGEN TABLETS, glimepiride, potassium chloride, BUMEX, TOPROL XL TABLETS, SYNTHROID, lisinopril, fenofibrate, triamcinolone acetonide, NEXIUM, VOLTAREN and MIRENA and an unspecified medication "NUMOISYN". On "31-OCT-2009 or 01-NOV-2009" while she was hospitalized, the patient noticed swelling and hotness around the injection site after receiving PNEUMOVAX 23. The patient also observed redness around the injection site. At the time of reporting the patient had not recovered. Additional information has been requested.
This spontaneous report has been received from a pharmacy technician via a company representative, concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication were unknown by reporter. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced Guillain-Barre syndrome and it was not known if the patient sought for medical attention or if laboratory diagnostics-studies were performed for the event. The reporter stated that the patient received plasmapheresis on an unknown date, due to Guillain-Barre syndrome. The outcome of Guillain-Barre syndrome was unknown. The causal relationship between the therapy and the adverse event was not assessed. Upon internal review, the adverse event of Guillain-Barre syndrome was determined to be medically significant.
No Additional AE/PQC reported; The patient was given PROQUAD instead of MMR II; The PROQUAD also suffered from a non supported temperature excursion; This spontaneous report was received from Pharmacist and refers to a patient of unknown gender or age. Information regarding the patient medical history, historical drug, current conditions or concomitant therapies was not provided.  On 28-JUN-2023, the patient was vaccinated by mistake (wrong product administered) with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #W029552 rHA, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided) patient should received instead measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II.)  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 8 degree celscius for 2328 hours on an unknown date; no previous temperature excursions were reported.  No adverse symptoms were reported.
Immediately post immun fell asleep slept deeply for 1-2hrs, then was listless the rest of the day. Also pale for 2 days; URI in family.
Pt c/o sore arm & had a sl fever evening recvd vax; next day devel 2-3in patch that was red & puffy but not sore to touch; had no fever; improved by evening; went to MD 2nd day later; MD stated this was result of vax; gave ATB;
nausea, vomiting, and diarrhea about 36 hours after vaccination; nausea, vomiting, and diarrhea about 36 hours after vaccination; nausea, vomiting, and diarrhea about 36 hours after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 09:00 (Lot number: EP7534) at the age of 48 years as 1st dose, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious), NAUSEA (non-serious), VOMITING (non-serious) all with onset 06Apr2021 19:00, outcome "recovering" and all described as "nausea, vomiting, and diarrhea about 36 hours after vaccination".  Additional information: No treatment received, no covid prior to vaccination, no covid tested post vaccination, no allergies, no other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-APR-2016, the patient was vaccinated with expired dose of M-M-R II which had lot# J006955, expiry date: 07-JUN-2015 (dose and route not reported). No adverse reactions were reported. No further information was provided. Additional information has been requested.
Case number PHEH2014US007021 is an initial spontaneous report received from a nurse on 04 Apr 2014. This report refers to a 54-year-old male patient. His medical history and concomitant medications were not reported. On 24 Mar 2014, he was vaccinated with MENVEO (batch number: A12002) by subcutaneous route. No adverse event was reported following this maladministration.
I95.9 HYPOTENSION 2/3/2022 SYSTOLIC HEART FAILURE, CHRONIC J96.00 ACUTE RESPIRATORY FAILURE 2/3/2022 SYSTOLIC HEART FAILURE, CHRONIC I95.9 HYPOTENSION 2/3/2022 ACUTE RESPIRATORY FAILURE    HX OF ACUTE KIDNEY INJURY J96.00 ACUTE RESPIRATORY FAILURE 2/3/2022 ACUTE RESPIRATORY FAILURE    HX OF ACUTE KIDNEY INJURY
Suspected vaccination failure/Got shingles shot, still got shingles; Got shingles; So painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shingles shot and still got the shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Vaccine is used for age 18 and up, patient was age 16 at time of vaccination.
Intussusception diagnosed at surgical team. Reduced surgically on 10/3/18.
This case was reported by a consumer and described the occurrence of increased liver enzymes in a 44-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health professional has not verified this report. Concurrent medical conditions included allergy to alcohol. Concurrent medications included Vitamin supplement. In May 2011, November 2010 and an unspecified date the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (unknown). Approximately 1 month after vaccination with the 3rd dose of ENGERIX B, in June 2011, the subject experienced increased liver enzymes. This case was assessed as medically serious by GSK. Bloodwork for a physical performed in June 2011 showed an increase in liver enzymes. The subject had two repeat liver enzyme follow-up tests which still showed an increase. At the time of reporting the event was unresolved.
Woke up with a fever over 101, arm was too sore to raise above my head, full body aches, pounding headache, weird tingling sensation going up and down the left side of my body (same as shot), nausea, heavy sweating, dizziness.  The fever lasted 3 days, and each night after taking acetaminophen, I would drench the bed sheets in sweat.  My head has been hurting since, today is May 1st.  I'm still weak but getting better.
Pt states heR Reaction started the evening she Recieved the Flu Imm. She was itchy. Red, Swollen and had hives all over heR body. Symtoms lasted a week she said. She was in the E.R. on 10/10/20 foR these symtoms. BenadRyl did not help and was given steRoids/antihistamines fRom E.R. DR. that helped
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
66 yo female with PMH of HTN, HLD, DM2, CKD (baseline creatinine 1.0-1.2), dementia (AOx 2-3), recently diagnosed metastatic lung adenocarcinoma (not yet formally seen by onc), hx of smoking (0.5pd x 30 years, quit 2013), COVID+ on 9/21/21 who presents 9/23/2021 with shortness of breath. Transferred to ICU on 9/25 for AHRF with likely in the setting of worsening COVID PNA and anxiety.   From July-Sept, patient reported increasing fatigue, weight loss, and SOB. Patient was diagnosed with metastatic lung adenocarcinoma, following confirmatory biopsy on 9/17.  Furthermore, patient tested positive for COVID on 9/21. Patient is vaccinated with pfizer (4/22/21 and 5/13/21). She was admitted on 9/23 with CRP of 13.2. While on the wards, patient was on 2-6 LPM O2. On 9/25, patient with desaturations and a rapid was called. Patient found to have accessory breathing and continual self-removement of HFNC/ NRB from anxiety. She was admitted to the ICU for escalation of O2 therapy in the setting of respiratory failure and precedex drip for agitation. CRP increased from to 25.9 (9/25). Empiric PE treatment with lovenox was started but CT PA was negative for PE. Despite treatment with remdesivir, decadron, and tocilizumab, patient's condition worsened and eventually required maximum settings on HFNC, NRB, and iNO. Per palliative meeting on 9/28, family would like patient to be intubated if necessary if no family member can be by her side. Their main goal is to get the patient home and they are open to home hospice if the patient can be transported home while alive. Patient is scheduled to be transported via ambulance with HFNC and NRB on 9/30. Grandson, who is vaccinated, is approved to be present throughout the transition from hospital to home hospice.
Woke from nap, about 4 hours after vaccinations and crying then pale, green lime looked like "in shock" but no LOC called the office and told to come in - fine in office and observed for 2 hours.