chrisvoncsefalvay/vaers-outcomes huggingface dataset:
of ACTHIB that was expired by two days with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 14 months old female patient who was given act-hib that was expired by two days with no reported adverse event , after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Oct-2022, the patient received a  once dose of suspect HIB (PRP/T) VACCINE( lot UJ594AAA and expiration date: 28-Oct-2022) at a dose of 0.5ml at an unknown route  in the left thigh. as prophylactic vaccination.  On 28-Oct-2022 (latency: same day) ,the patient was administered acthib that was expired by two days with no reported adverse event (expired product administered).   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Bilateral cataracts; Flu like symptoms; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not Aplicable). The reporter is the patient. Other Case identifier(s): 22K-163-4297958-00 (Agency).  A 79 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Route of Administration: Intramuscular), administration date: Jan2021, when the patient was 79 years old, for Covid 19 immunization. The following information was reported: CATARACT (medically significant), outcome "unknown", described as "Bilateral cataracts"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Flu like symptoms". The action taken for adalimumab was unknown. The reporter considered "bilateral cataracts" and "flu like symptoms" related to bnt162b2.  Clinical course: On unknown dates, the patient experienced cataracts in both eyes and second vaccination and booster for covid-19 made felt like having flu. On an unknown date, second vaccination and Booster for covid-19 made felt like having flu resolved. Pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect. Patient had began cataracts in both eyes on her 06Jan2022 visit. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of Cataracts in both eyes and second vaccination and Booster for Covid-19 made felt like having flu was not provided. for the drug Humira. there is no reasonable possibility that the events of Cataracts in both eyes and second vaccination and booster for covid-19 made felt like having flu are related to Humira (Adalimumab). The reporter's causality for the events of Bilateral cataracts and Flu like symptoms was possible for the drug bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events Influenza like illness , Cataract  cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER_INC-202200363826 same patient/drug, different vaccine dose
Pt reports fever and chills  same evening as injection lasting from about 0830pm- 10:00 pm for which he took acetaminophen with success.  Also reports muscle aches in back the following morning that continued to report date.
Janssen vaccine received by patient on 3/24/21, no immediate symptoms. As of 4/14/21 started having petechia and non-traumatic ecchymosis. PLT count of 2. Hospitalized for severe thrombocytopenia, thought to be ITP.  Currently admitted as of 4/16/21, report made on day 1 of hospitalization.
my lower jaw and teeth began to hurt; my lower jaw and teeth began to hurt; my legs got hives for a couple of days; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0171) via an unspecified route of administration in the left arm on 22Apr2021 at 11:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included having her jaw rewired in 2001, reported as 20 years ago. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in four weeks. The patient received unspecified concomitant medications in two weeks. The patient reported she had her jaw rewired 20 years ago and after she got her first dose, her lower jaw and lower teeth began to hurt. She also reported that her legs got hives for a couple of days. It was reported no treatment was received for the events. The patient received her second dose of BNT162B2 (lot EW0168) on 14May2021 at 09:15. The clinical outcomes of her lower jaw and lower teeth began to hurt, and her legs got hives for a couple of days were not recovered. It was also reported the patient had not been tested for COVID-19 since vaccination.
Ultimate diagnosis:  acute disseminated encephalitis  Event Details July 1, 2019, 9:20 PM ? Headache behind left eye came on over the course of about 10 minutes, followed by intense nausea, beginning about an hour later.  About mid-way through the nausea, left facial numbness began, starting at left tip of tongue, and progressing over the course of less than an hour to the left upper palate, upper and lower left teeth, nose, check, forehead, scalp, and jaw, to the front of the left ear.  Sense of taste on the left side of the tongue disappeared, as well.  Headache abated at or before start of numbness.  No loss of coordination, loss of strength, confusion, slurring, drooping of muscles or other symptoms beyond those described above.  Went to urgent care after finding that the numbness persisted into the following morning.  Urgent care staff directed me to the emergency room.  Will begin a course of 4 days of IV steroid.  Currently pending insurance coordination and facility scheduling.
In lt arm: Fever, rash, swollen, whole lt side body in pain. Nausea, dizziness, flu like symptoms, fever extreme pain in whole arm. Took about 7 days for red rash to go away & pain to be totally gone.
Moderna COVID-19 Vaccine EUA. Rec'd Moderna COVID Vaccines on 1/21/2021 and 2/26/2021. Arrived to ED for subdural hematoma and AMS, COVID + but relatively asymptomatic. ID consulted. Persistent AMS and confusion. Hospital course c/b hypernatremia 2/2 central DI. Nephrology consulted DDAVP started w/improvde NaCl. course c/b Covid PNA w/hypoxia req intubation, cont to decline. Transitioned to comfort care, expired 7/24/2022. Given cefepime, vancomycin, dexamethasone, and remdesivir.
Swelling, redness, hot to the touch. Soreness. Hydrocortisone cream.
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 02/23/2009 with COPD Exacerbation. Vaccination took place on 10/10/2008. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.  7/9/09 Clinical Research Network summary received DOS 2/23/09 to 2/26/09. Assessment: COPD Exacerbation.
Irregular heart rate, tachycardia for about 4 hours (I really don?t think this is related to the vaccine but I guess we don?t know!)
Adverse event had NOTHING to do with vaccination and everything to do with my propensity toward kidney stones. But because I reported that I had to visit an ER, apparently I have to report now.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Additional Details: Pt has history of fainting to needles in the past; post injection in the observation area, pt felt lightheaded. We gave her an ice pack at which point she loss consciousness and shortly after started, what appeared to be, seizing.(RN)  I carefully moved her to the floor as she continued to shake. 911 was called. Shaking/seizing lasted roughly a minute (pt was still unconsious); she regained consiousness and waiting on floor until EMT arrived.
pt recv 2 doses of vax in 1995 & in 1996 pt exp lack of seroconversion;
Swelling and Redness around injection site about the size of a golf ball, Injection site was for the MMR + Varicella.
After seven days from vaccination (and currently as of now) mild pain upper left arm still exists when raising arm at and above shoulder height. The vaccinator told me to raise t-short sleeve as high as possible, I complied. The vaccinator entered shot very high on arm; I believe she entered shot too high on arm. I?m also not sure she washed her hands after she vaccinated a different person before me because vaccinator picked up coins prev person dropped on the floor and vaccinator afterward went inside pharmacy employee doorway, returning- at front counter I didn?t see any indication she washed hands. She did place new gloves on when she vaccinated me.
Left UE swollen, red, warm around vaccine site compared with immunization reaction vs cellulitis.
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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Dec2022) positive, notes: I tested positive on 18Dec2022; (15Jan2023) positive, notes: 15Jan2023 I tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 19Dec20022 to 24Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
red whelp-bigger than softball; sick w/h/a & fever x 2 days; feels like has been run over by a truck
Beginning the next day after immunization, the patient was unable to sleep for about 14 days.
nerves are crunching in my arm; spasm are little closer; not in pain; spasm of nerves from wrist to all the way up to her arm to site of injection; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (nerves are crunching in my arm), MUSCLE SPASMS (spasm are little closer), PAIN (not in pain) and VACCINATION SITE PAIN (spasm of nerves from wrist to all the way up to her arm to site of injection) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history not  included . relevant concomitant products usage were product related to blood pressure.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On an unknown date, the patient experienced NEURALGIA (nerves are crunching in my arm), MUSCLE SPASMS (spasm are little closer), PAIN (not in pain) and VACCINATION SITE PAIN (spasm of nerves from wrist to all the way up to her arm to site of injection).  At the time of the report, NEURALGIA (nerves are crunching in my arm), MUSCLE SPASMS (spasm are little closer), PAIN (not in pain) and VACCINATION SITE PAIN (spasm of nerves from wrist to all the way up to her arm to site of injection) outcome was unknown.        The patient received both scheduled doses of mRNA 1273 before the events, therefore Action taken with mRNA-1273 in response to the events was not applicable.
On 2/15/2020 my daughter developed eye conjunctivitis, since then she has had fever on and off and been extremely fussy. Today, on 2/21/2020 she has developed a rash over her body including her face and head. I was told it was a reaction to the vaccine she had 15 days ago. She is still feeling unwell and on and off fever with full body rash now. I was told not to worry.
GRANDMOTHER REPORTS EXCESSIVE SWELLING, REDNESS AND PAIN OF LEFT ARM.  SEEN IN ER 9/4.  APPLIED ICE PACKS, TOOK BENADRYL AND TYLENOL AND IBUPROFEN.  RESOLVED SUNDAY NIGHT 9/5-MONDAY MORNING 9/6.  LOCALIZED REACTION ONLY.  DENIES RASH, FACIAL SWELLING, OR DYSPNEA.
Appetite lost; Lethargic; diarrhea; little bit of shortness of breath at times; coughing up phlegm when using their CPAP machine at night; muscle pain; headache\ pain in the right temple; feeling like they are going to vomit; Fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Appetite lost), LETHARGY (Lethargic), DIARRHOEA (diarrhea), DYSPNOEA (little bit of shortness of breath at times) and PRODUCTIVE COUGH (coughing up phlegm when using their CPAP machine at night) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.     On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced DECREASED APPETITE (Appetite lost), LETHARGY (Lethargic), DIARRHOEA (diarrhea), DYSPNOEA (little bit of shortness of breath at times), PRODUCTIVE COUGH (coughing up phlegm when using their CPAP machine at night), MYALGIA (muscle pain), HEADACHE (headache\ pain in the right temple), NAUSEA (feeling like they are going to vomit), FATIGUE (Fatigue) and CHILLS (chills). The patient was treated with NAPROXEN SODIUM (ALEVE) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Appetite lost), LETHARGY (Lethargic), DYSPNOEA (little bit of shortness of breath at times), PRODUCTIVE COUGH (coughing up phlegm when using their CPAP machine at night), MYALGIA (muscle pain), HEADACHE (headache\ pain in the right temple), NAUSEA (feeling like they are going to vomit), FATIGUE (Fatigue) and CHILLS (chills) had not resolved and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment included ice packs, and rest to help with the symptoms.
Patient received the same vaccine twice on two different dates. She states she has not experienced any adverse effects.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient came in to pharmacy on 08-21-21 stating hives and cough started post moderna vaccination. Patient wanted report to be filed
Pt denied being given Covid vaccine before yesterday (7/19/21). After giving pt vaccine and entering it into our system, pt was noted to have received the same vaccine on 6/21/21.
This spontaneous report as received from a registered nurse refers to an unspecficied number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot number of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 6 months old infant patient of unknown gender. On 25-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Thrombosed superficial vein on outside of right shin indicative of a likely clot. Resolved on its own within 48 hours.
Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  BUD was reported as 16-Jan-2022
Hepatitis A #2 given too soon, on 3/1/10 at 1640. No treatment necessary.
fatigue; She could not get in out of her chair by herself, bathe, dress, or do any activities of daily living because the pain was so bad; the patient was administered with a first dose of PREVNAR 13 and a year later she received a second dose; pain in the administration site; She said that she had severe intense pain in her arm; she had large lump occur at the injection site about the size of egg; She could not lift her arm; This is a spontaneous report from a contactable consumer (patient) and contactable physician received via Medical Information Team.  A 66-year-old female patient received two doses of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), first dose on Nov2017 and second dose on Nov2018, both intramuscular at single dose for immunization. The patient medical history included paraplegia (T10-T11 ) from Sep1969 and ongoing, ongoing high blood pressure (diagnosed between 2005-2010), ongoing acid reflux (esophageal), ongoing Raynaud's syndrome (diagnosed in the 1980's), ongoing low grade bladder infection (the patient had a indwelling catheter), the patient has been diagnosed with limited scleroderma in 2010 unknown if ongoing (the patient said that she does not show any symptoms). There were no concomitant medications.  It was reported that the patient was administered with a first dose of PREVNAR 13 and a year later she received a second dose, on Nov2018 after second dose administered the patient experienced "a very bad reaction to PREVNAR 13", the patient reported "pain in the administration site, she had a large lump occur at the injection site about the size of egg. It traveled down her arm below the elbow. It started after receiving the injection and it was dissipated. The pain started subsiding late. She had severe intense pain in her arm. She could not lift her arm and could not reach across the sink to turn the faucet on. It was very debilitating. She could not get in out of her chair by herself, bathe, dress, or do any activities of daily living because the pain was so bad. She was really tired and after reading the side effects, she assumed it was part of the fatigue that comes with the shot. She stated that she does not remember any chills or fever or anything like that". The patient outcome of large lump and pain was recovered on an unspecified date, and the outcome of fatigue was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Continued Muscle Aches. Described as deep and dull as of today's date. Patient reports the aches/pains have not gotten better or worse since onset.
At time of injection, the needle site bleed and later bruised. No problems until rash on arm.  Rash on arm is below the site of injection.  It is itchy, red and hard.
My arm really hurts, it feels like I got beat with a bat. It swelled a little too and feels hard to touch. I cannot love my arm without it hurting. I?m also really tired
Severe Headaches (24/7) Felt like burning needles pushing through my head (Symptoms subsided after about 6 months to about once per month/30 min) Irregular Heart Beat /Tremors (constant)-Saw Cardiologist: CT Scan/Monitor/Ultrasound (Symptoms are less but continue after 8 months. Still very erratic & debilitating) Lungs-Burning/Pressure/Out of Breath. Testing done: Pulmonary Function Tests/CT Scan. Dr. Appt is in Jan. 2022. (Symptoms have very slightly lessened. Lungs still burning, unable to walk any distance or do any laborous chores Breasts-Feel engorged. Shock like feelings in arms & legs
3 hours after shot could feel every cell in my body,   had to sleep for 2 hours,  woke up with the beginning o allergic reaction of hives. I routinely get hives but this was different.  Normally one dose of hive medicine 5mg will stop the itching  instead I had to take a double dose and then another double dose four hours later.  The next day I was still having itching issues and had to repeat the same large soes of hive medicine.  Brought it under control.  Felt bad for an additional two days .