chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extremely fatigue; pain in my arm; I couldn't get from one room to another.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory authority. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Feb2021, outcome "unknown", described as "extremely fatigue"; PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "pain in my arm"; ASTHENIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "I couldn't get from one room to another.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021418724 same patient/drug, different dose/AE
Pt recv vax on 8/2/83;on 8/16/83 pt newborn, nursing son exp German measles rash, limp muscles, unable to suck x 3-6 mon, encephalitis; pt son at age 2 yr had strangulated hernia surgery
This spontaneous report was received from a licensed practical nurse and refers to a 9-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 27-SEP-2016, the patient was vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916:
discoloration, rash 6 1/2 x 4 cm on rt arm;
FACE FELT VERY HOT; CHEEKS AND FOREHEAD TURNED RED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAY-2021, the subject experienced face felt very hot. On 12-MAY-2021, the subject experienced cheeks and forehead turned red. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from face felt very hot, and cheeks and forehead turned red. This report was non-serious.
sore arms after the 1st shot; some soreness at the injection site for a couple of days after the injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 86 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Jan2021 14:45 (Lot number: EL9261, Expiration Date: 31May2021) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arms after the 1st shot"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "some soreness at the injection site for a couple of days after the injection". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The vaccine was administered at the left deltoid (reported as Left shoulder). The patient had no prior vaccinations within 4 weeks. The patient reported that he experienced sore arms after the 1st shot and got no absolute reactions after the 2nd shot. He's had just an uneasy feeling all along on what level immunity should he has had he gotten the 2 shots properly. The patient was querying what was the quantitative test to determine level of antibodies of Pfizer covid-19 vaccine during the clinical trial.    No follow-up attempts are possible. No further information is expected.
No adverse event; Given the same booster they received last year; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Given the same booster they received last year) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Given the same booster they received last year). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Given the same booster they received last year) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. Patient received the same booster that they got exactly one year ago. They want to know how long they should wait before they can get the new bivalent dose. No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2022-658062 (E2B Linked Report).   Reporter did not allow further contact, Sender's Comments:  MODERNATX, INC.-MOD-2022-658062: Wife case
Pt arrived with failure to thrive. Pt was found to be COVID-19 positive with symptoms of fatigue, generalized weakness, nausea, increased confusion, and a non-productive cough without hypoxia for 2 weeks. Pt was admitted to the hospital.
My son started vomiting violently. He has not been exposed to any viruses and has not traveled snd has been in virtual school. Symptoms onset about 2 hours after pediatric Pfizer Covid vaccine
Autoimmune adrenal insufficiency.  Dx: Aug 08.  Several months severe fatigue, myalgia.  9/12/08 Reviewed endocrinologist medical records of 6/10-8/18/08. FINAL DX: adrenal insufficiency Records reveal patient experienced episodes of excessive fatigue beginning 2/2007 which progressed.  Included dizziness, lightheadedness, overheated with activities, pale, hair loss, nausea, diarrhea for 2 mos, weight loss.  Was on oral contraception which was d/c 6/08.  9/16/08 Reviewed ER medical records of 2/20/07 & 9/12/07. 2/20/07 Final ER Dx: gastroenteritis w/mild dehydration Records reveal patient exprienced N/V/D, chills & abdominal discomfort x 24 hours.  Tx w/IVF & antiemetics.  Responded well & d/c to home. LABS: UA WNL.  9/12/07 Final ER Dx: sore throat secondary to mononucleosis Records reveal patient recently dx w/mono had increasing throat swelling & difficulty breathing, decreased appetite, nausea, difficulty swallowing, abdominal pain, slight SOB.  Exam revealed enlarged & red tonsils, cervical lymph node enlargement.  Tx w/steroids & pain meds.  D/C to home.  9/19/08 Reviewed PCP medical records of 10/3/07-8/5/08. FINAL DX: adrenal insufficiency, hypothyroidism, ADHD, anxiety/depression, OCD.  Records reveal patient experienced  anxiety/depression, OCD, fatigue, lower abdominal pain & fever when see 10/07.  Only able to attend school for 1/2 days.  Referred to neuro & admitted 10/26/07 for questionable seizure, w/u neg.  Had shotty cervical nodes bilaterally.  1/2008 referred to rheumatologist.  Hosp d/c summary, neuro consult, eye exam, rheum consult, sleep center consult, endocrine, psychiatric consult all included.  D/C summary of 10/26-10/29/2007 states final dx: anxiety, depression, s/p inf mono.  LP done.  Had episodes of staring & RLE shaking.  Neuro exam revealed asthenia, slow mentation, HA, possible seizures, ankle clonus.  Rheum consult for chronic fatigue, recurrent mouth sores, joint aches/pains & muscle aches/pains.    1/26/2010 Follow-up: Adreral Insufficieny-which will be lifelong.
Immediately after withdrawing needle, patient reported feeling dizzy and nausea and then experienced syncopal episode.
Potential Guillain-Barre; A spontaneous report was received from a pharmacist concerning an unknown patient who received Moderna's COVID-19 vaccine and potentially developed Guillain-Barre Syndrome.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 19 Jan 2021, the patient is in the hospital for potential Guillain-Barre Syndrome.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, potential Guillain-Barre Syndrome, was unknown/ not reported.; Reporter's Comments: This case concerns a patient of unknown age and gender, who experienced a serious unexpected event of potential Guillain-Barre Syndrome which required hospitalization. The event occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Treatment details were not provided. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
had an excursion with refrigerator problem then had another excursion and since it wasn't taken out of circulation/no AE; Initial information received on 21-Dec-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involved an unknown age female patient who was administered IPV (VERO) [IPOL] (lot R1B252M and expiry date: 31-Mar-2021) on 24-Nov-2020 via an unknown route at an unknown administration site for prophylactic vaccination, which had an excursion due to refrigerator at the end of August then kept the vial which had another excursion then someone gave a dose from the same vial (Product storage error).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included NA (NA).  It was an actual medication error case due to incorrect product storage (latency same day).   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Symptoms - Difficulty breathing, chest pain, fever, headache Diagnosis - Pulmonary embolism Treatment -  Xarelto and pain medications (Narco, Tylenol)
patient has heavy breathing and eyes goes up breathing sounds like snoring for about 2 minutes. patient feel dizzy for about 1 hour under observation
Patient returned to the pharmacy stating that she had had continuing arm pain several days after the vaccine on 10/13/17 and continues to have pain. She has seen her physician and has started physical therapy.
bad as well; fatigue; injection site pain; pain; This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc (Case Number: 01893875).   A female patient of an unspecified age received BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 18Feb2021 as dose 2, single for covid-19 immunization; pembrolizumab (KEYTRUDA, Batch/Lot number was not reported) via an unspecified route of administration from 10Mar2021 to an unspecified date, at unspecified dose and frequency for an unspecified indication. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunization. The patient experienced fatigue on 11Mar2021 with, bad as well on 22Mar2021, injection site pain and pain on an unspecified date in 2021. It was reported that patient had her 2nd Pfizer COVID vaccine on 18Feb2021 "she did well", and on 10Mar2021 she received her "4th or 5th" treatment with keytruda. Patient has not had any problems with keytruda however, experienced fatigue on 11Mar2021, extreme fatigue on Friday 19Mar2021 and yesterday 21Mar2021, and today 22Mar2021, was bad as well. she has experienced injection site pain and intense pain all over however, could not recall when these symptoms started. since the Keytruda therapy on 10Mar2021 patient "has gone downhill" and was unsure which medication caused these side effects. The action taken in response to the event for pembrolizumab was unknown. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
2 urticarial lesions 10 and 20 minutes after vaccine. (R) preauricular and (L) forearm. No other symptoms. Known allergies to milk, egg, peanut, tomato and wheat.
CHILLS Narrative:  HEADACHE MILD RESOLVED TODAY CHILLS STARTED EARLY AM AND CONTINUE
Patient reported arm redness, swelling, and soreness that lasted 4 days. She was most concerned with whole body aches and sickness that that kept her down for 2 full days and continued for 2 more days. No treatment mentioned.
Presented to office with significant submandibular lymphadenopathy (left sided) and surrounding soft tissue swelling
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant medication was reported.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.    It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
A couple days after the first shot i started having bouts of vertigo, ?bed spins? ,  feeling off balance when walking, dizziness and tinnitus, later after the 2nd dose i started getting ear infection like sensations and my doctor has reported fluid buildup in my ear drums.  I have had ringing in my ears and have experienced some hearing loss.  Just taking flonase to try to open up the ear canal
Was fine on Sunday, while at work on Monday, starting to feel a little dizzy, her eyes became blurry.  By the time that she looked in her rear view mirror her face was swelling up.   Her face started to burn, fast heart beat, and dizziness.  Her neck started to burn as well.  She looked at the side effects.  She called her doctor and took 2 Benadryl as she recommended, and took a nap.  Her doctor told her to continue taking the Benadryl and to call us to report the reaction.  She still has the swelling and the burning sensation in her face, and is still getting a little dizzy but it comes and goes.  The fast heartbeat comes and goes as well.
Mother noticed swelling to (R) eye & pt c/o urticaria 24 hours post vaccine, rash noted from face to trunk. 1300 - swelling to (R) eye decreased per mother.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:14 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:14 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.91.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM temperature was 34 total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Slight indigestion,  headache, and arm ache turned to raging arm pai, dry heaves, constipation, massive headache and unable to get out of bed for a day.  Incoherent some of time.  Extreme weakness (had a hard time cutting an apple) and dizziness.  Was able to sit up after 36 hours after shot.  It's been 3 days since the shot and I'm still not right.  Still have tinge of nausea, tiredness, and my head just feels off, disconnected, with occasional full dizzy spells.  Have been taking many OTC medicines to combat headache.
sick/not feeling well; ache; diarrhea; headache; dehydration; hasn't been able to eat and she is only eating popsicles; nausea; vomiting; muscle pain and aches; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on 07Aug2021 (at the age of 62 years) as dose 1, single for covid-19 immunisation. The patient medical history included Covid-19 on an unspecified date. The patient concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced very sick, having muscle pain and aches, diarrhea, headache, not feeling well, experienced dehydration, has not been able to eat, nausea and vomiting. This was the patients first day out of bed, she reported being very sick, having muscle pain and aches, diarrhea, headache, not feeling well, experienced dehydration, has not been able to eat and she was only eating popsicles. Patient said her main concern has been her nausea and vomiting. Patient said that she did not experience coughing or shortness of breath, like when she had covid. Patient asked how these side effects will last. Patient stated that she was terrified to get the second dose of the vaccine and was thinking about not taking the second dose. Patient added that she contacted her doctor about her symptoms from the first dose and was informed that she could not be seen because of the risk. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Secondary inoculation approx 1/2" inferior to the patients left lower lip from the vermilion border. Eschar appears to be healing at the same stage as the primary vaccine. Patient first noticed sore, self applied pro activ cream (thinking it was acne) then the following morning sore was scabbed and appeared healing normally.
Patient received IPV, HIB, DTAP and Hep B.  Within 5 minutes of shots, became apneic, bradycardic and required 3L 100% of O2 with prolonged vigorous stimulation.  This occurrec 3 times again in a 30 minute time period before the patient returned to baseline with a needed increase in O2 requirement.