chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient's height, and weight were not reported. The patient's concurrent conditions included mildly bad asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, The batch number was not reported and has been requested and Expiry: unknown) dose was not reported, administered on 05-APR-2021 12:00 noon on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the subject experienced generalized muscle aches. On 05-APR-2021, the subject experienced headache.  On 05-APR-2021, the subject experienced nauseous. On 05-APR-2021, the subject experienced injection site pain.  On 05-APR-2021, the subject experienced body temperature increased. Laboratory data included: Body temperature (NR: not provided) 100.6 F (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalized muscle aches, headache, nauseous, injection site pain, and body temperature increased. This report was non-serious.
Information has been received from an individual concerning a 13 month old Hispanic female pt who on 3/28/95, 5/23/95 and 7/25/95 was vaccinated with a 1st, 2nd, and 3rd dose of haemophilus b conjugate vaccine and the pt developed pneumonia and bacteremia. Additionally, it was noted that the pt had a blood culture which revealed Haemophilus influenza type B. Upon internal review, the pt's experiences were considered to be 'Other Medical Events'. The pt's outcome status was reported as 'yes'. This was reported as a case of vaccine failure.
19 y.o. female who arrived to the emergency department for 19-year-old female with history of COVID infection several months ago was receiving her COVID vaccine this morning when she developed nausea and tightness in her throat about 15 minutes after the injection.  Epinephrine was administered prior to transfer to the ED.  She denies any rash.  She does feel slight shortness of breath.  She denies headache earache sore throat or rhinorrhea cough vomiting diarrhea fever chills or abdominal pain.  She has had hives and tightness in her throat from several medications in the past including Prevacid Prilosec Zantac and iodinated contrast media. No new medications.  Anaphylactic type reaction and patient advised to not receive the 2nd vaccine.  PMH: Diabetes mellitus  Initial Vital Signs Blood Pressure 01/25/21 0902 132/85 Heart Rate 01/25/21 0902 92 Respiratory Rate 01/25/21 0902 16 Temp 01/25/21 0925 36.6 °C (97.9 °F) Temp Source 01/25/21 0925 Oral SpO2 01/25/21 0902 99 %
Both shots made me feel like I had Covid all over again; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 19:15 (Batch/Lot number: unknown) as dose 2, single and administered in arm left, administration date 08Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 30Sep2021, outcome "not recovered", described as "Both shots made me feel like I had Covid all over again". Therapeutic measures were not taken as a result of influenza like illness.  Additional information: patient reported that She set off the beepers when she walks in and out of facility. It happened right after her second dose at facility. She went the next day and it only went off when she walked out. But she went last night with only her wallet, and it went off when she walked in the store and when she walked out of the store as if she stole something. Both shots made her feel like her had Covid all over again. the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This subject is a 83 year old female who died 6/15/03 in the hospital while enrolled in the RSV 1I study with RSV vaccine. The subject received a dose of RSV vaccine or Placebo and Influenza vaccine on 10/03/2002. The subject developed congestive heart failure and COPD with acute exacerbation 254 days post immunization and was admitted to the hospital 254 days later on 6/14/03. The subject died 255 days post immunization on 6/15/03. The investigator has assessed the events as unrelated to the study products. Medical Certificate of Death: Immediate cause resulting in Death - Congestive heart failure. Further information has been requested.
there was no adverse event, when we went to the database we realized that pt. had already received a full course of Shingrix in 2019  Vaccination Dates: 05/30/2019, 07/31/2019, 12/07/2021 and 02/08/2022
No adverse event; 5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine) 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. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine).    Concomitant medication details not reported by the reporter. Vial was initially stored in refrigerator on 07-JUL-2023. Vial size was reported as 2.5 ml. Dosage text was reported as unknown. Vial did not undergo any temperature excursion. Treatment details was not reported by the reporter. This case contains information about patient 1 out of 5.   This case was linked to US-MODERNATX, INC.-MOD-2023-732779, US-MODERNATX, INC.-MOD-2023-732776, US-MODERNATX, INC.-MOD-2023-732777, US-MODERNATX, INC.-MOD-2023-732778 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732779:case for Patient 5 US-MODERNATX, INC.-MOD-2023-732776:case for Patient 2 US-MODERNATX, INC.-MOD-2023-732777:case for Patient 3 US-MODERNATX, INC.-MOD-2023-732778:case for Patient 4
3 hrs p/recvd vax devel fever of 103 w/APAP, stiffening & screaming; 1st 24 hrs p/vax needed constant walking & bouncing to stay quiet; 24 hrs p/vax had vomiting which lasted for 24 hrs, fever cont, then fussy x 1 day;
continues vomiting; developed Migraine headache and is gotten worse ever since; This is a spontaneous report received from a contactable consumer (patient's husband). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 25Jan2021, at single dose, for COVID-19 immunization. The patient medical history concomitant medications were not reported. It was reported that the patient got the COVID-19 shot in the morning of 25Jan2021 (yesterday) which developed into a migraine headache that has done nothing but gotten worse and on 26Jn2021, she had continued vomiting. The reporter asked if these were normal and how long will these last. The outcome of the events was not recovered.   Information on lot/batch number has been requested.
Narrative:  COVID infection following COVID vaccine series 02/11, Pfizer, dose #1 03/04, dose #2 08/01 pt cc: poor appetite, nausea, fever, SOB, and a nonproductive cough exposure: unknown 08/03 COVID swab, result: detected 08/09 clinically resolved
Myocardial Infarction resulting in death Narrative: Myocardial Infarction resulting in death, unknown if correlation to the vaccine report entered as a precaution.
Patient was given the first dose of the Pfizer COVID-19 Pediatric 6M-4Y vaccine (3 mcg/0.2 mL) on his Right Arm. The patient pulled away during the administration and approximate 1/2 of the dose was still remaining in the syringe. Father also reported he felt some droplets on his finger  but they were not observable by the nurse. According to the Interim recommendations for COVID-19 vaccine administration errors and deviations, an additional 1/2 dose (1.5 mcg/0.1 mL) of the same Lot Number was given into the Left Arm.
Information has been received from a consumer concerning a young baby who on an unknown date was vaccinated with a dose of MMR II. Subsequently, the baby died locally. No further information is available.
Flu like symptoms, pains hands and feet, blood shot eyes, low grade fever, fatigue, night sweats, joint pain, dry eyes, poor grip. Pressure on chest and throat.
Information has been received from a physician via an email from a consumer concerning the consumer's 16 year old daughter who on 20-MAY-2008 was vaccinated with the third dose of GARDASIL (lot no. and route not reported). The consumer reported that in the summer of 2008, the patient started to complain of constant fatigue, had fainting spells and random bouts of aches and pains. On 11-SEP-2008, she was sent home from school with complaints of headache, spine pain, confusion and symptoms of bladder infection. She was given antibiotics by the gynecologist and was sent home. The consumer reported that the next day (12-SEP-2008) the patient woke up screaming for help as she couldn't feel her arms and legs, was gasping for air, vomiting, had severe back pain and fever. The mother reported that at the emergency room (ER) the patient was given antibiotics and sent home as she was told she "may have passed a kidney stone". It was reported that over the next two weeks her health was deteriorating and after her fourth visit to the ER she was finally hospitalized for the next ten days. Over the course of her stay the patient was seen by teams of doctors from Neurology, Rheumatology, Infectious disease, Endocrinology, Adolescent medicine, Urology, and Cardiology. The consumer reported that the patient endured two spinal taps, many MRI, CAT scan, sonograms, ultrasound and blood workups until "her body could no longer emit any blood". The patient was on morphine drip for severe headaches, liquids for rehydration, PERCOCET for allover pain and two and nausea medication for severe vomiting and acid reflux. The patient was checked for Lyme disease, meningitis, lupus, fibromyalgia chronic fatigue Hoshimoto's disease kidney disease and multiple sclerosis and everything showed up negative. The patient became so sleep deprived because her heart rate was in the 30 range that a monitor constantly kept her awake. The patient started hallucinate and was developing blood clot in her legs from lack of use. The mother stated that since there was no diagnosis, the doctors decided to send her home to be in her own environment. The patient returned home using wheelchair, unable to walk and was referred to a physical therapist. The patient's mother reported that out of desperation she continued to go to specialist hoping to get some kind of answers. The patient was taken to a highly recommended Rheumatologist and after a short physical exam, the physician told the patient she was showing signs of "pain amplification syndrome" and that she needed to "throw away her crutches" and "go see a psychiatrist to get better because there was nothing physically wrong with her". The mother indicated that the patient had continued to recover, six months after she felt ill. The physician reported the patient recovered "6 months after the patient had the reaction with GARDASIL". The physician felt the patient's experience was disabling and life threatening. This is one of several reports from the same source. Additional information has been requested.
headache; joint pain; weakness in both hands to the extent I could not pick up a coffee cup; chills; fever; pain at injection site; Entire body aches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in both hands to the extent I could not pick up a coffee cup), CHILLS (chills), PYREXIA (fever), HEADACHE (headache) and ARTHRALGIA (joint pain) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Metabolic acidosis. Concurrent medical conditions included Type 2 diabetes mellitus since 01-Mar-2005 and Blood pressure. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Acid-base balance, LISINOPRIL (LISINOPRIL AL) for Blood pressure, METFORMIN from 06-Mar-2005 to an unknown date and EMPAGLIFLOZIN (JARDIANCE) for Diabetes.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced PYREXIA (fever), VACCINATION SITE PAIN (pain at injection site) and MYALGIA (Entire body aches). On an unknown date, the patient experienced MUSCULAR WEAKNESS (weakness in both hands to the extent I could not pick up a coffee cup), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (joint pain). At the time of the report, MUSCULAR WEAKNESS (weakness in both hands to the extent I could not pick up a coffee cup), CHILLS (chills), HEADACHE (headache), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown and PYREXIA (fever) and MYALGIA (Entire body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jun-2020, SARS-CoV-2 test: positive (Positive) Nasal Test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-101598 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up Received on 04-JUN-2021,Received Significant Information. Added Patient Demographics, Medical History, Lab data, Suspect Drug Information, Concomitant Product Information.
We started having temp about 4 hrs after the flu shot was given to our son.  We have had extremely high temperatures starting the next day (102-103). 2 days after flu shot still having temp of 103 (3 days after flu shot). Never able to break the temperatures since onset that started right after flu shot.  We have went to the pediatrician and to the ER which all tell us it's a viral type of infection.  We are now on day 4 of fighting high fever.  Definitely seems related to the flu shot to us but of course you will never get a doctor to admit that.  He had temp at ER of 103.7.
pt recvd Td 6JAN93 pt noticed swelling & pain 8JAN93; cont hurting & started draining bloody pus 13JAN93;
Cramps; Chills; Fever; Headache; Her arm hurts; This is a spontaneous report from a contactable consumer (patient) from a  sponsored Program  Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced cramps, chills, fever, and headache on Mar2021. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
rash at injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2021, the patient received the 1st dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix 4 days ago and had a rash at injection site.  The reporter asked did the patient need to report to a doctor.
This case was reported by a nurse and described a 37 year old male patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. On unspecified dates in 2004, the patient received three dose of Engerix-B (lot number not specified). Subsequently on 08 October 2004, a hepatitis B surface antibody titer was negative. The nurse considered the event to probably be related to the use of Engerix-B.
Information has been received from a physician assistant concerning a male patient (age not reported) who on 10-JUL-2006 was vaccinated intramuscularly with a 0.5mL dose of Pneumovax 23 (Lot # 651321/1036P). Subsequently, within 48 hours of vaccination (approximately 12-JUL-2006) the patient developed swelling, redness, warmth and severe soreness around the injection site. Additional information from the physician assistant also indicated that this patient had developed a fever of 102F on the evening of 13-JUL-2006 (outcome of fever not reported). She also noted that the patient was doing much better. He was still recovering and had only slight edema. The reporter indicata3ed that the patient was treated with anti-inflammatory medication for relief of symptoms. At the time of the report, the patient was recovering. The physician assistant requested a lot check. The reporter considered the patient's experience an other important medical event. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
first 24 hours felt run down and flu like, next numbness and tingling in hands, arm, legs, feet and face.  Went to ER due to numbness and tingling on 7/24/21.  Feeling worse each day.  History of Postural Orthostatic Tachycardia, but has been off medicine (metroprolol) for years.  Heart rate is elevated again - 150's and even 160's.  Difficulty standing.  Now like when first diagnosed with POTS when has been controlled for years. Interferring with activities of daily living, unable to go to work as must be on feet and not sitting.  Even sitting, heart rate is elevated.
On 13APR94 early AM parents found pt not breathing-attempted CPR-no response-rushed to ER by paramedics-no response to CPR in ER: pt pronounced dead; pt had not been ill;
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 27-JAN-2017 at 15:18, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000425: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Information has been received from a pharmacist concerning a 13 year old female with allergies who on 03-DEC-2007 was vaccinated with Gardasil.  Concomitant therapy included desloratadine (CLARINEX) and montelukast sodium (MSD).  On 04-DEC-2007 the patient developed a dry, persistent cough.  The patient was examined by her pediatrician and spirometry testing was normal.  The physician recommended the patient increase her montelukast sodium (MSD) dosage from 5 mg to 10 mg at bedtime and to switch from desloratadine (CLARINEX) to fexofenadine hydrochloride (ALLEGRA).  As of 28-JAN-2008, the patient's dry persistent cough persisted.  No further information is available.
weakness; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA, CHILLS, and HEADACHE in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced ASTHENIA, CHILLS, and HEADACHE. At the time of the report, ASTHENIA, CHILLS, and HEADACHE had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.