chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vomiting; headaches; nausea; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 56 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Dec2020, stop date: Jan2021. Concomitant medication(s) included: IBRANCE taken for breast cancer, start date: 08Mar2021 (ongoing). The following information was reported: VOMITING (non-serious) with onset 2021, outcome "recovering", described as "vomiting"; HEADACHE (non-serious) with onset 2021, outcome "recovering", described as "headaches"; NAUSEA (non-serious) with onset 2021, outcome "recovering", described as "nausea". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: cycle Ibrance 100mg take one tablet daily for 21 days, 7 off with letrozole daily as prescribed by md. patient reports occasional missed doses, amount unknown. no side effects reported due to missed doses. reports missed doses due to side effects and at times due to md order to delay start of therapy cycle. patient reports after start of therapy, therapy hold (previously reported) due to having covid-19 from December 2020-beginning of January 2021, now resolved. patient reports after start of therapy, having covid-19 vaccine 1 and experiencing headaches, nausea, vomiting, all resolving after three days (dates unspecified). reported holding doses (unspecified amount) due to vaccine side effects. patient reports after start of therapy, since January decreased red blood cell count, white blood cell count, and platelet count and improved begging of May. md aware of all side effects and missed doses (as reported).  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Abdominal pain and GI bleeding increasing in frequency, intensity, duration over 3 weeks. Rapid increase in bleeding led to emergency hospitalization Apr 20, 2021 - Apr 22, 2021. Ongoing treatment consists of: (1) pantoprazole 40 mg tablet, delayed release daily, (2) mesalamine 1,000 mg rectal suppository daily.
This literature report (initial receipt 10-Apr-2012) concerns a 50-year-old female patient. The patient had no clinical or laboratory evidence suggestive of any precipitating conditions. In 2010/2011 the patient received H1N1 influenza vaccine (manufacturer is unknown). 10 days after receiving H1N1 influenza vaccine the patient developed her first symptom of Guillain-Barre syndrome (GBS). Sensory symptoms included numbness of both upper and lower extremities, and lower lip. Motor symptoms included generalized ophthalmoplegia. A neurological examination revealed bilateral ptosis, bilateral vertical and horizontal ophthalmoplegia, remarkably hypoactive vestibulo-ocular reflex, generalized areflexia, motor weakness in both upper and lower extremities with left side worse as compared to the right and decreased perception of sharp sensation, touch and vibration. The patient's cerebrospinal fluid (CSF) protein was 86mg/dl which was considered elevated. 4 weeks after receiving H1N1 influenza vaccine electrodiagnostic findings revealed absent sural, median and ulnar responses which were highly suggestive of acute inflammatory demyelinating polyneuropathy (AIDP), reduced motor response, absent motor units. At week 8 there was a mild improvement. Clinical history, neurological exam, imaging studies, and serological and CSF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. At time of discharge from hospital or rehabilitation facility there was a slow improvement in eye movements, motor and sensory response but persistent areflexia. At 4 months the patient had slow and incomplete recovery, she had bilateral facial and distal lower extremity weakness and sensory loss. Reporters comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient fulfilled level 1 diagnostic certainty criteria outlined by the work group. A relationship between the vaccine and GBS was not necessarily established.
This spontaneous report was received from a nurse practitioner concerning to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 05-MAR-2015, the patient was vaccinated with an improperly stored M-M-R II (dose, strength, dose number, route af administration and lot number were not provided). No co-suspect or concomitant therapies were reported. Previous to administration, on an unspecified date, the vaccine was exposed to temperatures of 14.0 C for 4 hours and 30 minutes. This is one of several reports from the same source. Additional information has been requested.
Headache; Chills; Body ache and little bit congested; Body ache and little bit congested; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history included high blood pressure, seizure disorder. Concomitant medication included metoprolol, aripiprazole (ABILIFY). The patient experienced headache, chills, body ache and little bit congested on an unspecified date with outcome of unknown. No treatment was received for events.  Information about Lot/Batch number has been requested.
expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 52-year-old female patient who received HBV (Engerix B) (batch number HN5BE, expiry date 16th September 2021) for prophylaxis.   On 27th September 2021, the patient received Engerix B. On 27th September 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The nurse reported that female patient received expired dose of Engerix-B, which led to expired vaccine used.  The reporter consented to follow up.
Pt. became pale & diaphoretic post vaccination.  Also c/o nausea.  VS @ 08:44AM BP: 80/40, HR 59, OxSat. 99%.  VS @ 08:46AM BP 131/87, HR 66.  VS @ 08:51AM BP 134/84.  VS @ 09:02AM BP 134/68, HR 67.  VS @ 0904AM BP 159/86.  Pt recover from the adverse event.
T103.3;area of erythema & swelling below inj site rt arm = 5 1/2 x 5 1/2cm;
This spontaneous report as received from a medical assistant refers to an unspecified number of patients (age and gender unknown). On unknown dates the patients were vaccinated with improperly stored GARDASIL dose, route of administration and lot# were not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Child was given kinrix and proquad at approx. 09:50 am, child was walking with mom to car and said his tongue was itching and  child was scratching himself.  Mom brought back into clinic around 10:00 am, by this time  his face and eyes were swollen, he had a flat rash/welts on his face and body. At the proquad inj site he had welts the size of a BB all around site and the kinrix site has small bumps  around it.  Child was frantically scratching himself,  crying.  At 10:04 am I gave child epi 0.2ml to the right deltoid IM.  And at 10:07am  I gave him benadryl 2.5ml  by mouth. as ordered. by 10:30 child had calmed down, was still scratching, at 10:48 Swelling to face and eyes and significantly decreased.  At 11:00 am the provider had discharged the child to moms care.  No further swelling was noted and rash and subsided.
About 4-5 hours after my shot, my left leg was tingling (like if I sat on it wrong) for about a day and a half; then felt chest pressure; got muscle twitches; all subsided within the next few days.   About 10 days afterwards (on 6/28), I had to go to the ER because got a sharp pain in my left upper arm (felt like a nerve issue), pain was a 10/10, ibuprofen did not help, so had to press ice packs really hard which helped a little bit. The pain started in my left arm then the next day went to my left arm and left foot, then the next day went to left arm and foot and then my right upper arm in the same spot as the left; pain continued to decrease within 5 days. At the ER the did a blood test, ECG, chest xray, and urine test and said that all came back normal and blood pressure was fine.  I was fine for about a week and is now the pain started coming back (7/10) but the pain is a 1/10. This all happened after my 1st dose so I'm undecided on if I'm going to get the 2nd shot because I'm terrified of the initial pain coming back. Currently waiting for lab results from a local doctor.
Facial paralysis on right side; Inability to see or focus and many more serious conditions sppeared 20-30 approx; Inability to see or focus and many more serious conditions sppeared 20-30 approx; slurred speech; confusion; This is a spontaneous report from a contactable consumer reporting for himself. A 55-years-old male patient received the first dose BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, at School or Student Health Clinic, via an unspecified route of administration, administered in right arm on 29Mar2021, at 55 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included allergy to penicillin and sulfa since an unknown date. The patient was not diagnosed with COVID-19 prior to vaccination and he has not been tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. On 29Mar2021 at 12:00 the patient experienced facial paralysis on right side, inability to see or focus and "many more serious conditions appeared 20-30 approximately after injection", slurred speech and confusion, all assessed serious for disability. The patient visited his doctor and was prescribed with unspecified medications and a brain scan. The brain scan was performed on an unknown date and no result were provided. At the time of the report the reported events had not resolved yet.  Information on the lot/batch number has been requested.
side effect as grasshopper sound, it's likes hearing bugs at night; interrupted the normal sleeping cycle; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (side effect as grasshopper sound, it's likes hearing bugs at night) and SLEEP DISORDER (interrupted the normal sleeping cycle) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 026A21A and 006B21A) for COVID-19 vaccination.     The patient's past medical history included Upper respiratory disorder (have upper respiratory illness in the past).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (side effect as grasshopper sound, it's likes hearing bugs at night) and SLEEP DISORDER (interrupted the normal sleeping cycle). At the time of the report, TINNITUS (side effect as grasshopper sound, it's likes hearing bugs at night) and SLEEP DISORDER (interrupted the normal sleeping cycle) outcome was unknown.      Concomitant drugs were not reported.  It was reported that, following the booster shot first husband and later herself developed tinnitus. Caller described this side effect as grasshopper sound, it was likes hearing bugs at night. The caller stated that they experience tinnitus mostly at night. It had interrupted the normal sleeping cycle. She said it was very annoying. She said sometimes it was low and sometimes higher. It was usually ok during the day. Caller was yet to visit primary care doctor.   It was reported that patient did not have any allergies or prior COVID-19 diagnosis  Treatment medications were not provided.   This case was linked to MOD-2022-507719, MOD-2022-507166, MOD-2022-507293, MOD-2022-507717, MOD-2022-507720 (Patient Link).
PATIENT HAD J&J VACCINE ON 09/07/21 AND TESTED POSITIVE TO COVID.
Woke up the next morning and could hardly get myself out of bed.  Just dragging!  Showered and popped back into bed.  Arm was KILLING ME.  Very s?l..o?w?.  Did not feel well (stomach felt icky, body ached).  Temp was 99.8 this morning.  Went hiking after taking an Aleve.  Anything I ate the day after turned into diarrhea...  Still have fever at 3:03 p.m. ? 99.38  After I posted at 3:03 p.m., I was OK for about another 45 minutes, and then got freezing cold. Put on my heavy winter jacket over a vest socks and turn the heat up to 72. Still could not get warm, so went to bed with the vest and my robe on.  FREEZING!!!!  Slept or something for about four hours before I finally got hot enough. Once I cooled down, I felt pretty good.  10 pm and no fever!!!!!  Everything was fine after that nap. However, my arm hurts for at least a week and maybe a little diarrhea.
Woke up with a headache the next day and I took 500 mg of Tylenol and it got worse so I took another 500 mg. I was able to sleep after that. I was taking 1000 mg of Tylenol twice a day to manage it. It relieved it but it was still there.  I finally talk to my  doctor and he sent me to get an MRI. I was still having the headaches and by the following Sunday (31st) it was gone.
Burning in the arm of injection. Slight red rash, itchy. Tingly lips, fever, headache. Went away in two days
Itchy bumps/rash on leg that MMR vaccine was administered.  Went away within a few days.  Same itchy bumps/rash then appeared on inner part of arm near the inner part of elbow area.
experiencing thrush since taking it.; This is a spontaneous report from a contactable other hcp from a Pfizer-sponsored program.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced "experiencing thrush since taking it." No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. It was reported that the patient took the Covid Vaccine and has been experiencing thrush since taking it.  The outcome of the event was unknown.    Information on the lot/ batch number has been requested.
Humira did not work as good as pre covid; First dose on 01Feb2021 and second dose on 20Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Humira did not work as good as pre covid) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 01Feb2021 and second dose on 20Mar2021) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Rheumatoid arthritis.    Family history included COVID-19 (Family covid). Concurrent medical conditions included Plaque psoriasis and Rheumatoid arthritis.   In 2020, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 20-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 01Feb2021 and second dose on 20Mar2021). On an unknown date, the patient experienced COVID-19 (Humira did not work as good as pre covid). At the time of the report, COVID-19 (Humira did not work as good as pre covid) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 01Feb2021 and second dose on 20Mar2021) outcome was unknown.            Concomitant medications were not reported.  It was reported that Humira did not work as good as pre covid (Drug effect decreased). The reporter's causality for the events of Humira did not work as good as pre covid with Adalimumab Solution for Injection was Not Provided. Treatment medications were not reported.
30 seconds after giving PEDIARIX child started crying then she was unable to breath approximately 45 seconds. Then child started sleeping. She opens eye when she wakes up. Patient was sent to Emergency room for further evaluation.
Having bad symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Having bad symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Having bad symptoms). At the time of the report, VACCINATION COMPLICATION (Having bad symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Fever  Chills  Severe Headache Nauseous Joint pain  Couldn?t sleep long periods
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received bnt162b2 (BNT162B2 NOS), on 01Oct2022 as dose 3(booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 03Aug2021 as dose 1, single (Batch/Lot number: unknown) and on 01Jan2022 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hi cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, patient took Paxlovid from 26Sep2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
temperature excursion with no reported adverse event; temperature excursion / administered to patient with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 36 years old and unknown gender patient who had temperature excursion with no reported adverse event and temperature excursion / administered to patient with no reported adverse event involving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TENIVAC).  On 29-Sep-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, formulation was unknown, lot UJ899AA and expiry date: 30-Jun-2023) via unknown route in unknown administration site for Immunization.  On 29-Sep-2022 the patient developed a non-serious event of temperature excursion with no reported adverse event (product temperature excursion issue) involving INFLUENZA QUADRIVAL A-B VACCINE. On 29-Sep-2022 the patient developed a non-serious event of temperature excursion / administered to patients with no reported adverse event (poor quality product administered) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken:  not applicable.  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.
injection site pain for 5 days; rednesss for 5 days; This case was reported by a consumer via other manufacturer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient experienced injection site pain and redness for 5 days after vaccination. The patient applied ice and it resolved. This case has been linked with case US2020AMR004282, reported by same reporter.
Patient reports feeling SOB of breath,  accompanied by tightness in neck and chest.  PT given Electrolit for rehydration and reports taking 50 mg before the vaccine administration and 50 mg after the vaccination. BP/02/RR/HR VS taken all WNL (129/89/98%/88/20) Pt observed for additional 30 minutes and discharged @ 1815.
Frequent urination (every half hour to an hour during the first night), nausea, diarrhea, headache, muscle aches, very tired (second day and morning of third day) My sister had the same reaction to her flu shot:  big hive at injection site, lasted for a week
feeling week; swollen arm where injected.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "feeling week"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swollen arm where injected.".  Additional information: Patient got first dose at clinic. And patient did get few side effects like feeling week and swollen arm where injected. Now it was invalid so she started revaccination and got first dose this Monday 19Apr with side effects like swollen arm , headaches. Patient second dose was on 10May. Based on the above observations patient had a feeling if dose with clinic was valid, 10May dose will be 3rd dose. But it was mentioned that clinical trials were going on to see what happens with 3rd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.