chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"Patient presents today [23FEB22] for Palpitations (He sometimes experiences chest tightness to the left side of his chest, which is intermittent.  Symptoms have been more frequent over the past 2-3 months. He has lightheadedness upon standing.  Palpitations and fluttering intermittently as well)." HPI: "Patient is a 30 y.o. male who presents with palpitations for about 2 months [FEB22].  They come and go.  Can occur at anytime. The palpitations last no longer than a minute.  Denies associated symptoms.  Resolves spontaneously.  Only consumes 1 cup of caffeine per day.  Also has been experiencing left-sided chest discomfort for about a month.  Not associated with his palpitations.  Feels like tightness. Can occur at anytime. Lasts a few minutes.  Resolves spontaneously. Denies respiratory symptoms.  Denies heartburn, belching, nausea, and vomiting.  Occasionally feels lightheaded on occasion which is unrelated to his chest pain and palpitations.  The lightheadedness can occur any time and lasts for seconds.  Drinks alcohol on occasion. Denies tobacco use.  Denies use of illicit drugs.  States he keeps hydrated.  Patient states his sister who lives out of state is experiencing palpitations and chest discomfort also.  She is also going through a cardiac workup and so far the results have been negative.  Father who is deceased had a heart problem.  Denies depression and denies suicide and homicide thoughts." Orders: ECG 12-lead Comprehensive metabolic panel CBC TSH Magnesium Holter Monitor - 48 Hour; Future Stress Echocardiogram; Future Lipid panel  -  CRNP, health care facility, 23FEB22  ---  "Palpitations: Started approximately  1 month after receiving Covid vaccine. Had workup at a HCF (negative 48h holter, TTE, and stress test). Currently, has rare symptoms but does have intermittent palpitations/chest tightness (improved since last year). Likely SVT or PVCs causing intermittent symptoms. seems to be improving - ordered CBC, CMP, TSH - ordered 2 week event monitor (pt states he will wear after January 1st) - f/u in 6 months to discuss results" - HCP 29NOV22.
Pt received wrong age group vaccine so received what he needed but extra. Pt had no adverse side effects.
felt like acid reflux; nausea; vomiting; felt pain between shoulder blades; A Spontaneous report was received from consumer concerning a 66-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced acid reflux nausea then vomited, felt pain between shoulder blades.  The patient's medical history and concomitant medical history reported unknown.  On 20 Jan 2021 at 01:30 PM, the patient received their one dose of the two planned doses of COVID-19 Vaccine (mRNA-1273) intramuscularly in the right arm for prophylaxis of COVID-19 infection and experienced acid reflux and on 21 Jan 2021 felt nausea then vomited and pain Between Shoulder Blades.  No laboratory tests were provided.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event is unknown. Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
30 hours after receiving T/D-unable to lift arm x 24 hours. The following day-able to lift arm 10 degrees. Entire R upper arm red and edematous up to 72 hours after receiving injection. It then gradually improved.
urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection). At the time of the report, URINARY TRACT INFECTION (urinary tract infection) had not resolved.            Patient mentioned being with UTI and under antibiotics, her Urine test is negative but her doctor gave her more antibiotics..Patient received the two shot vaccination series of Moderna COVID-19 vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Apr2023 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: first symptoms and positive test; Negative, notes: negative tests 5; Negative, notes: negative tests 5 and 7 days. Therapeutic measures were taken as a result of drug ineffective, covid-19 which Paxlovid treatment was provided from 12Aug2023 to 16Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt came in with hot, swollen arm. Sent to ER 1/10/13. Abx treatment. Saw ER again 1/11/13 & rec'd more meds. Saw us 1/14/13 - no s/s of cellulitis anymore.
I had a sore stiff arm for a few days. The doctor advised me to rub it with alcohol and stop lying on that side for a while. The symtpoms subsided within a week
Information has been received from a physician concerning a female with a history of hidradenitis suppurative who on 30-MAY-2007 was vaccinated IM with the first dose of Gardasil.  Concomitant therapy included ACCUTANE and YASMIN.  On 30-MAY-2007 the patient experienced pain at the injection site.  On 31-DEC-2007 the patient was vaccinated IM with the second dose of Gardasil.  Subsequently, the patient experienced pain at the injection site and inappropriate schedule of vaccine administered.  The second vaccine was given at a clinic.  The patient sought unspecified medical attention in the physician's office and subsequently recovered from the injection site pain and inappropriate schedule of vaccine administered.  No further information is available.  Additional information has been requested.
Patient stated she had suicidal thoughts and severe depression within 3-5 days after first vaccination of Pfizer.
Information has been received from an office manager concerning a kindergarten age patient who on unspecified dates were vaccinated with a dose of VARIVAX (Merck) (lot#s not reported) in the lateral thigh, MMR II (lot#s not reported) in the lateral thigh and KINRIX in the deltoid all at the same time. She stated that these are the three standard immunizations given for children of kindergarten age. In the process of trying to narrow down which inoculation was causing the reaction, they moved the injection site of the KINRIX to the deltoid. Subsequently the patient developed cellulitis at the injection site. The office manager stated that it didn't appear that the patient previously reported had a reaction to VARIVAX (Merck), the patient had a reaction to the KINRIX. No medical attention was sought. At the time of this report, the patient had recovered from cellulitis at the injection site. This is one of several reports from the same source. Additional information is not expected.
tenderness; pain on the left arm; swollen lymph nodes of left hand; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness), PAIN IN EXTREMITY (pain on the left arm) and LYMPHADENOPATHY (swollen lymph nodes of left hand) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain on the left arm) and LYMPHADENOPATHY (swollen lymph nodes of left hand). On an unknown date, the patient experienced TENDERNESS (tenderness). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, TENDERNESS (tenderness), PAIN IN EXTREMITY (pain on the left arm) and LYMPHADENOPATHY (swollen lymph nodes of left hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: Follow-up information included patient demographic details. causality updated and treatment details were updated.
Patient developed hives on the Left elbow about 5 minutes after injection given.  Benadryl 25 mg given, hives resolved
THREE DAYS AFTER VACCINE STARTED GETTING HEADACHES.  NOW THEY ARE DAILY YESTERDAY ALL DAY AND LAST NIGHT WAS VERY SEVERE.  WOKE UP WITH HA TODAY.  TOOK IBUPROFEN YESTERDAY BUT DIDN'T HELP MUCH.
No ADR, timing ERROR, 2nd dose given 56 days after 1st  Narrative: Timing ERROR only
About 2 weeks after I got vaccine I was driving and started having vision problems & my neck became very stiff no pain but just couldn't turn my neck then months later I started having muscle spasms about 100 a day or more.
12/1/08 patient received tetanus/diptheria injection.  Returned 1/19/09 with complaint of injection site swelling - left deltoid- Reported increased reddening over 3 weeks.  On 1/17/09 area burst wit greenish drainage.  Complained of pain at site, decreased swelling.  Complained of chills and fever for 1-2 days.  Treated conservatively:  TYLENOL for pain, no antibiotics.
Started a headache about 12:00 pm progressed to brain fog unable to concentrate but still all able to manage, at about 10:30 pm I started to become nauseous, unable to form sensible sentences for about 5 minutes, extreme pain feeling like pins and needles on the entire surface of my body which pain increased with any touch, chills and rigors began and lasted for 2 hours, nausea become very bad, severe back and flank pain, abdomen felt as though insides were being squeezed, I was unable to stand due to weakness and pain, hands and feet turned purple, felt extremely dizzy, heart was racing and had some tightness in chest, ended up with 102.2 fever after taking Tylenol 45 minutes prior. I needed help to get up as I was so dizzy, weak and in so much pain, I was able to get into bathroom and at that time had pain with urination.  I was able to eventually fall asleep and woke in the morning (1/21) with severe back and flank pain, pain on entire skin surface that increased with touch, fever 100.2, chills, severe nausea, extreme dizziness, weakness, exhaustion, brain fog, left foot numbness, and pain with urination. I slept most of day unable to function normally at all, did call my MD office to get a script for zofran which did help the nausea, later this evening I started to get what appeared like a heat rash across my trunk, I took Benadryl 50 mg and went to sleep.  Next day (1/22) fatigue, nausea, pain was less just now low back and flanks, temp 100.1, left foot and bilateral hands numbness, ears were hot ad itchy but no rash on trunk until evening took Benadryl again.  Today 1/24  dizzy, some fatigue and left foot remains numb and tingly, some low back pain
Presents for fever, sore throat, fatigue, & SOB x 4days. Positive home COVID test x2. Admit for respiratory tract infection/sepsis due to COVID & hypoxemia. Tx: abx, tylenol, O2, dexamethasone, remdesivir. DC to home on oral abx & steroids.
CC: Nausea, H/A, dizzy. 6/29/10 22:19 presented to ER "not feeling well" ROS - c/o weakness E.D. Dx generalized weakness status post immunizations. Pt received req. immunizations with 9d appoint. ER consulted Peds hospitalist and ok'd to DC home - stable - 7/1 Phoned better per mom.
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.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 80 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; METFORMIN; TRAZODONE.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative; Positive, notes: then tested positive again after a couple of days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxlovid for COVID-19 from May2022 to May2022. The patient was on other medications in 2 weeks.
first two doses of Imovax Rabies for pre-exposure prophylaxis received by patient with 10 days interval, no AE; The patient has yet to receive a third dose of Imovax Rabies event if second dose received in 2019, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00313449) and transmitted to Sanofi on 13-Oct-2020  This case involves a 45 year old female patient who was vaccinated with a 1 ml first dose of RABIES (HDC) VACCINE [IMOVAX RABIES] in the left deltoid on 23-Aug-2019 and 1 ml second dose of same vaccine on 03-Sep-2019 in the right deltoid (batch number P1C852M and expiration date 25-SEP-2020 for both the doses) 10 days apart (Inappropriate schedule of product administration) via an unknown route for pre-exposure prophylaxis and yet not received the third dose (Product dose omission issue).   The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient was concomitantly vaccinated with a dose of TYPHOID VACCINE POLYSACCH VI (TYPHIM VI) and YELLOW FEVER VACCINE LIVE (17D-204) (STAMARIL) for prophylactic vaccination with the first dose of IMOVAX RABIES.  This was an actual medication error due to drug dose administration interval too long and missed dose. At the time of reporting, the patient yet to receive a third dose. The nurse wanted to know how to proceed with administering the remaining dose.  At the time of reporting, no adverse event was reported to the patient.  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 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.
Pt received flu vaccine 9/29/17 in R deltoid. Came into office today complaining of adverse reaction to vaccine. States when he woke up on Saturday morning, he fell and was unable to walk "I was practically crawling." Reports no change in normal routine (medications, new foods etc) except for flu vaccine on Friday. Did have consultation with dentist on Friday but states no med admin. Has history of sciatica in R lower extremity but states his last flare-up was years ago. Has been taking 600 mg ibuprofen due to feeling he has inflammation. Reports that each day his walking is improving. No reaction at injection site, denies fever, chills, nausea/vomiting, difficulty breathing, hives, racing heart rate.
Received dose at 0800. By 1730 was nauseated and achy. Fever of 104 by 2330 with vomiting, severe joint pain, shortness of breath, tachycardia, BP 174/110.  Fever down to 101.8 in Emergency Department. Received nausea medicine and Tylenol. Chest X-ray negative. MD felt it was a severe hypersensitivity reaction. Fever continued through today (12/24 low grade, 99.8). I had severe Covid-19 the last week of March and was hospitalized. I'm just resting and waiting for the reaction to pass and have stayed off work.
Patient reports it was too painful to raise arm above shoulder height. Pain started the night of vaccine administration and started to subside two days later. Patient stated it has resolved.
Right arm - almost whole upper arm, dorsal aspect: red, indurated, with mild tenderness. Redness and swelling ofright upper arm resolved 3 - 4 days later per mom.
Diarrhea the following day (only for one day). Severe nausea / vomiting (since vaccination). Severe weakness. Has never happened with FLUAD or FLUZONE from pervious yearly vaccinations.
No additional AE information provided; Caller reported temperature excursion/Temperature -13.3C; This spontaneous report was received from a registered nurse concerning to a 7-year-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.   On 17-DEC-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), 0.5 milliliter (ml) for prophylaxis, lot number reported as T017688 and expiration date as 21-MAY-2022 (vaccination scheme, route of administration and anatomical site of vaccination were not provided).   The administered vaccine had a temperature excursion of -13.3 degrees Celsius (°C) for a time frame of 4 hours and 15 minutes (product storage error) on an unspecified date, and the data was recorded by a digital data logger. It was also reported there was not a previous temperature excursion. No additional adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA013584: US-009507513-2012USA013603: US-009507513-2012USA013596: US-009507513-2012USA013501: US-009507513-2012USA013603: US-009507513-2012USA013093: US-009507513-2012USA013539: US-009507513-2012USA013601: US-009507513-2012USA013532: US-009507513-2012USA013533: US-009507513-2012USA013524: US-009507513-2101USA000122: US-009507513-2012USA013592: US-009507513-2101USA000144:
A spontaneous report has been received from a Health Professional concerning a female patient. Patient relevant history, concurrent diseases and concomitant drugs were not provided. Patient had been receiving FLUMIST quadrivalent (intranasal), 0.2 milliliters, unknown, started during Oct-2015. The reporter stated that the patient had developed flu like symptoms and during Oct-2015 she had a positive nasal swab for influenza. FLUMIST quadrivalent was continued. The outcome of the events of positive for influenza and flu like symptoms was unknown. The company physician assessed the events of positive for influenza and flu like symptoms to be non serious.
mom called stating pt exp a 2' x 3' red raised hot area below inj site;sx started approx 1 day p/vax;
10-15 minutes after injection, paresthesia right arm, myalgia, arthralgia, HA, back pain. Benadryl 50, EPI .5, Solumedrol 62.5. Transported via ambulance to ED. Symptoms progressed; repeat some meds and Pepcid IV (Solumedrol, Benadryl). Admit overnight for observation. ED doctor consulted with manufacturer regarding reaction. Diagnosed as probable hypersensitivity reaction.
Can only describe as 'goose bumps' that itch - so am calling it a rash on arms, with more on upper arms and some on front of thighs.
Woke up with sore throat.  Stayed home to let flu shot run its course.  On Monday 11/22/2010 developed hoarseness.  Still have no voice for the last 3 days (11/22-11/24).  First time with this type of reaction to flu shot.
Feeling of "pins and needles" on left side of face, increasing headache as time went on for up to 3 hours after vaccine administered.  "Patchy numbness" on left side of face.
Vaccine administered to an underage patient.; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to an underage patient.) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to an underage patient.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to an underage patient.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sore arm; Red rash; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH ERYTHEMATOUS (Red rash) and PRURITUS (Itching) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), RASH ERYTHEMATOUS (Red rash) and PRURITUS (Itching). At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH ERYTHEMATOUS (Red rash) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
COVID19 VACINE CLINIC SHCE: 3/1/2021     4:57 pm: 1st Seizure 20 sec long      30 year old male, had a seizure 10 mins after receiving 1st dosage of pfizer.      History of Seizures per parents that are accompanying the patient, every 4 days. Dx of Epilepsy.      3 RN's attending   1. FIRST RN   2. SECOND RN  3. THIRD RN     MA attending:  1. ATTENDING MA      Note: First Vitals taken, 10 mins after 1st dosage of Pfizer given.      5:00 pm:   BP:147/82  HR: 74  O2: 96%  Notes: No complaints of pain        5:07 pm:   BP: 125/73   HR:76  O2:96  Notes: No complaints of pain     Outcome: 30 mins in  Observation area, 2nd Dosage for Pfizer appointment made for Hospital.    5:17 pm:  2nd Seizure 10 sec long      5:19pm: EMS called by NP      5:19pm:   BP:140/71   P: 69   O2: 96     5:24 pm: EMS Arrived      5:31 pm:  Vitals   BP:115/72  P:87  O2: 97        Outcome: Family refused EMS.   EMS released the patient to the parents due to history of epilepsy at 5:33pm, patient stable.      **Instructions were given to the parents by Charge RN and atttending RN, advised the family to take the patient to the ER if symptoms worsen. Family understood and agreed.     5:34 pm patient was able to walk out with parent to the exit.       Director, &  RN on site notified
Pt's husband said pt had hives. Pt was taken to emergency room and was kept there for 2 days and 1 night.