chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills/but she got chills; injection site pain of the left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 10:45 (Lot number: EW0151, Expiration Date: 11Apr2021) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TURMERIC + taken for phytotherapy (ongoing); ZINC taken for phytotherapy (ongoing); OMEGAN taken for phytotherapy (ongoing). The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills/but she got chills"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site pain of the left arm".  Additional information: NDC number of Pfizer-BioNTech COVID-19 Vaccine was unknown. Reason for no lot number was other she can't really read it because they put a sticker overlapping the handwritten Lot number on the CDC vaccine record card but she thinks it is EN6207. She got her first dose of Pfizer-BioNTech COVID-19 Vaccine on 18Mar2021 and had some side effects after that which were manageable and went away. Onset time unknown other than closer to the night time. Further described as she did not get fever; but she got chills and injection site pain of the left arm; the injection site did not get red or anything. Her menstrual cycle and symptoms were not affected by the first dose. she is a very healthy individual. No any vaccines administered on same date with the Pfizer vaccine considered as suspect. AE(s) not require Emergency Room and Physician Office. Patient was not hospitalized. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No any relevant Tests.  No follow-up attempts are possible. No further information is expected.
Patient felt sluggish and tired after covid vaccine #1 on 02/23/2021. After covid vaccine #2 on 03/23/2021, the patient suffered a cardiac event with weakness and lack of concentration resulting in frequent absence from work until June. On 06/15/2021, the patient attempted to return to work, but the lack of concentration and headaches caused by the cognitive effort progressively worsened.  09/21/2021 the patient went to a neurologist for help with executive function deficits. MRI of the brain done 12/12/2021 showed white matter issues. Headaches and processing issues worsened. After the covid booster on 12/22/2021, the headaches worsened to involve the eyes, ears, and sinuses, diagnosed as TAC-PH headaches,
Patient stated on second day her arm got increasing sore and  experienced flu-like symptoms but her main concern/complaint was that she was experiencing tremors up and down the arm that the injection was given.
The patient received ZOSTAVAX for shingles prevention called the clinic reporting severe injection site swelling requiring prednisone for swelling.
presented shingles in 3 different occasions/ suspected vaccination failure; shingles in 3 ocassions; This case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 13-FEB-2023 and 15-FEB-2023 Reporter's Comments: The patient completed Shingrix series, then presented shingles in 3 different occasions. The nurse inquired about the possibility of giving a third dose of Shingrix to a patient with a complete series of Shingrix vaccination. The nurse gave information regarding the patient but did not have information about the vaccine. The nurse reported that third dose was not yet administered. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Caller reported AE for inadvertent administration of VAXELIS and ROTATEQ after TE. No symptoms reported. No additional AE/PQC.; This spontaneous safety report, with reference number, was received by the partner on 19-JUL-2023 and forwarded to agency on 19-JUL-2023 and 20-JUL-2023, from a health professional on behalf of a physician s.  A 8 week old neonate experienced an inadvertent administration of Vaxelis and Rotateq after TE (temperature excursion) No symptoms were reported. No additional adverse event/product quality complaint.   Due to the nature of the event, the causality between the events "Inadvertent administration of Vaxelis and Rotateq after TE" and Vaxelis was not applicable.  Companion Cases: MCM-005053, MCM-005054, MCM-005055, MCM-005056, MCM-005058.  FOLLOW UP INFORMATION as received by the partner on 10-AUG-2023 and forwarded to agency on the same day:   This case is maintained as non-serious. Patient's first dose of Vaxelis was administered on 01-MAY-2023.  Due to the nature of the event, the causality between the events "Inadvertent administration of Vaxelis and Rotateq after TE" and Vaxelis was not applicable.   No further information is expected.
Swollen lymph node in left arm pit, beginning 12/3/21.  Arm pit is swollen toward lower area.  Taking naproxen sodium for pain.
p/2nd dose vax had sweating, itching, skin rash & chills; bitten by a bat while visiting Guatamala; 29OCT92 f/u 1st dose of vax given @ ER, 2nd dose was provided in IReland & no other info is available;
Fatigue, body aches, headaches, chills, lymph node soreness.  Took Tylenol for the headaches and slept as much as possible for 2 days.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 17-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Case number PHEH2012US014893 is an initial spontaneous report received from a medical assistant on 24 Jul 2012. This report refers to a 12-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that he received only the MenCYW-135 liquid component of MENVEO (batch number: X10065) through unspecified route and site on 23 Jul 2012 and did not receive the Men A lyophilized component. No adverse event was reported.
First blanching red spots, then lacey red rash in same areas; Cheeks, back, wrist, ankles, still has rash today.
severe aching joints; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (severe aching joints) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Asthma and Kidney disorder.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ARTHRALGIA (severe aching joints) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (severe aching joints) had not resolved.            No concomitant medication was provided by reporter.  No treatment drug was provided by reporter.  Within 24-48 hours, patient began experiencing severe aching joints. it been almost constant.  Company comment: This is a spontaneous case concerning a 63 years old, female patient with no clinical history who experienced the unexpected event of ARTHRALGIA The events occurred unknown days after the third dose of mRNA-1273 vaccine The rechallenge is not applicable" as the events occurred after the third dose and no details were provided about the first dose The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-382423 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 63 years old, female patient with no clinical history who experienced the unexpected event of ARTHRALGIA The events occurred unknown days after the third dose of mRNA-1273 vaccine The rechallenge is not applicable" as the events occurred after the third dose and no details were provided about the first dose The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
On 4/3 consult noted Achy sore 2 days with some itching severe thrombocytopenia - plt coungt 175k on 4/3 18k 4/3 4pm  24k 4/4  4/7 41k  4/10 50k  Bone marrow transplant 10-29-22
5 migraines a week; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (5 migraines a week) and CONDITION AGGRAVATED (Condition aggravated) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (Patient has a medical history of 40 years of migraines.). Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for Migraine.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced MIGRAINE (5 migraines a week) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, MIGRAINE (5 migraines a week) and CONDITION AGGRAVATED (Condition aggravated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received on 09 Jul 2021 with event outcome updated and new event added.
Postural tachycardia syndrome - onset 2 weeks post vaccination Chest pain, shortness of breath, dizziness, syncope.
erthema, edema, ttp to vaccination site.  abx, steroids and antihist started
This spontaneous report was received from a medical assistant, refers to 12 months old patient of unknown gender. Medical history and current conditions were not reported. Concomitant medications include sterile diluent. On 25-JUL-2017, the patients were vaccinated with improperly stored VARIVAX (lot # M047660, exp. date: 02-DEC-2018) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccines were stored under temperature from -14 Celsius degrees (C) to -10 C with timeframe of 6 hours 31 minutes. Previous temperature excursion included: -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. Digital data logger was involved. No product quality complaint was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA001338: US-009507513-1709USA005542: US-009507513-1709USA006806: US-009507513-1709USA006807: US-009507513-1709USA006809: US-009507513-1709USA006813: US-009507513-1709USA006815: US-009507513-1709USA006816: US-009507513-1709USA006820: US-009507513-1708USA001467:
Patient woke up the next morning with a red, swollen face. Eyes swollen. Pt given BENADRYL & prednisone. Pt recovered & has some residual flaking skin. No reaction at injection site.
Spoke to patient, she broke out in a rash a day after receiving the flu shot has rash on breasts, arms and feet. She spoke to her wound care physician they told her it was still good she rec'd vaccine. I recommend BENADRYL if no relief to go to MD for follow-up.
All over hives on extremities including head and shoulders.  Received a round of hydroxyzine which helped after five days all hives gone but still have some rash and itchy spots in scalp.  My skin is still sensitive and I only take half s pill at night for itchy spots.
burning pain in back of legs; Painful lymph nodes under arms/swelling in armpit glands; Headache; Swollen and painful neck lymph node, supraclavicular; muscle pain; Pain in back and legs; pain in legs; Bad pain behind right knee/Joint pains; Fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain in back and legs), PAIN IN EXTREMITY (pain in legs), BURNING SENSATION (burning pain in back of legs), AXILLARY PAIN (Painful lymph nodes under arms/swelling in armpit glands) and ARTHRALGIA (Bad pain behind right knee/Joint pains) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Endometriosis.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Dec-2020, the patient experienced VACCINATION SITE PAIN (sore arm). On 29-Dec-2020, the patient experienced BACK PAIN (Pain in back and legs), PAIN IN EXTREMITY (pain in legs), ARTHRALGIA (Bad pain behind right knee/Joint pains), FATIGUE (Fatigue) and MYALGIA (muscle pain). On 07-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen and painful neck lymph node, supraclavicular). On an unknown date, the patient experienced BURNING SENSATION (burning pain in back of legs), AXILLARY PAIN (Painful lymph nodes under arms/swelling in armpit glands) and HEADACHE (Headache). At the time of the report, BACK PAIN (Pain in back and legs), PAIN IN EXTREMITY (pain in legs), BURNING SENSATION (burning pain in back of legs), AXILLARY PAIN (Painful lymph nodes under arms/swelling in armpit glands), HEADACHE (Headache) and VACCINATION SITE PAIN (sore arm) outcome was unknown and ARTHRALGIA (Bad pain behind right knee/Joint pains), FATIGUE (Fatigue), MYALGIA (muscle pain) and LYMPHADENOPATHY (Swollen and painful neck lymph node, supraclavicular) had not resolved.            concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-108110 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient demographics, medical history updated, therapy details of Moderna vaccine, additional events reported (burning pain in back of legs, muscle pain, Swollen and painful neck lymph node, supraclavicular).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
P/receiving a dose of Td, pt arm became hot & red from the shoulder to the elbow; An area of induration, about the size of a quarter, devel @ inject site; Pt also c/o sweating, pain & feeling hot; 4 days later pt recovered;
Pt recvd 1st dose of vax on 26JUN92 & 1JUL92 pt devel a swollen, red, & itchy rt upper arm; the arm was described as being 1 & 1/2 time larger than nl;sx persisted for 5 days; pt recvd 2nd dose of vax on 22SEP92 w/no noted problems;
Patient described symptoms - redness, swelling, tenderness, headache, diarrhea, pain, itching-at injection site of Flu shot. Symptoms began about 1 + hrs after vaccination. Patient is treating with OTC medications (TYLENOL/BENADRYL).
NOT POSSIBLE TO MAKE APPOINTMENT  WHY NOT SIMPLY STATE WHEN NEXT IS AVAILABLE????
pt recv vax; severe hives p/ 2nd dose of vax approx 3:15pm 10may95;18may95 had extended to up to neck;tx w/ atarax; no help;24may95; tx pred; instant relief 10 day course;2june hives returned;WBC sl elev,eosinophils 5 x nl;
MMR administered 10SEP91; devd rt parotitis & t101 fever 4OCT91; resolved w/out incident;
Injection site is red, swollen, hot. Muscle aches, feverish, headache general malaise.  I took Tylenol, Advil and used ice for the headache.. The side effects didn?t start until day after the vaccine. This is the third day post vaccine side effects are starting to subside.
Fever; Headache; Joint pain; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Waldenstrom's macroglobulinaemia.    No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, MIRTAZAPINE (MIRTAZEPINE TEVA), ONDANSETRON (ZOFRAN [ONDANSETRON]), TRAMADOL, CALCIUM, TESTOSTERONE, ROSUVASTATIN CALCIUM (CRESTOR) and TERIPARATIDE (FORTEO) for an unknown indication.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2021, Body temperature: 99.9 99.9 F.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event(s) of FEVER 99.9 F, HEADACHE, JOINT PAIN, NAUSEA and FATIGUE with IMBRUVICA(IBRUTINIB) was no reasonable possibility.   No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
left armpit and under arm became swollen and tender to the touch; left armpit and under arm became swollen and tender to the touch; arm remained somewhat sensitive to the touch; Patient was also extremely tired; This is a spontaneous report from a contactable pharmacist. A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL1284, on 06Jan2021 09:30 Intramuscular at single dose in left arm for COVID-19 immunization. Medical history included Anxiety and depression, Chronic pain in right foot, tendinopathy of right foot since 2015, Derangement of medial meniscus, Environmental allergies, Fatty liver H/O, hypothyroidism since 25Jan2013, Health care maintenance, Hyperlipidemia since May2016, thyroid nodule since 25Jan2013, Obesity, Prediabetes. Concomitant medications included salbutamol (ALBUTEROL), levothyroxine and omeprazole. The patient previously received first dose of BNT162B2 lot number=EH9899 on 16Dec2020 11:00 AM via Intramuscular at left arm at 56-year-old. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximately 24 hours after receiving the vaccine, left armpit and under arm became swollen and tender to the touch on 07Jan2021 08:00. Notified primary care physician during routine visit, PCP advised to notify her if symptoms did not resolve. Swelling resolved 4 days after onset, arm remained somewhat sensitive to the touch. Patient was also extremely tired for 2 days after the vaccine but otherwise fine. No treatment was received for all events. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The outcome of all events was resolved.
No additional AEs reported; a 5 year old patient was administered GARDASIL 9; This spontaneous report was received from a pharmacist and refers to a 5-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-AUG-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection in prefilled syringe, lot # T036812 (lot number was confirmed to be valid), expiration date: 28-APR-2023, 0.5 milliliter (injection site and route of administration were not provided) for prophylaxis (Inappropriate age at vaccine administration). No additional adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T036812; expirationdate: 28-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Patient reported feeling lightheaded, feeling hard of hearing, and having ringing in the ears. Patient was sweaty upon observation. Patient was given water and a snack and reported starting to feel better after about two minutes had elapsed. Patient remained in the pharmacy for about 30 minutes after he began to feel better to make sure he was ok. Patient left feeling ok, per patient.
Had Covid in April of 2020 and was in hospital for 5 weeks. not sure if this is why i experienced what i did After vaccine i kept a fever the night after shot and it got to 101.3 and remained for 48 hours  i had substantial  swelling that got worse with my fever and began going down after two days and by the 3rd day it was gone. Over all body ache, and splitting headache behind my eyes.
Case number PHEH2014US016081 is an initial spontaneous report received from a healthcare professional on 11 Aug 2014. This report refers to an 11 year old male child. His medical history and concomitant medication were not reported. On 10 Aug 2014, he was vaccinated only with the MenCYW-135 liquid component of MENVEO (batch number: not reported) via intramuscular route without reconstituting it with MenA lyophilized conjugate. On the same day, he was concomitantly vaccinated with BOOSTRIX (batch number: not reported). No adverse event was reported following this administration error (inappropriate preparation of medication).