chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lymph node; pain in left arm; tiredness; chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 11:30 (Batch/Lot number: unknown) at the age of 33 years 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: LYMPHADENOPATHY (non-serious) with onset 01Apr2021 13:00, outcome "unknown", described as "Swollen lymph node"; PAIN IN EXTREMITY (non-serious) with onset 01Apr2021 13:00, outcome "unknown", described as "pain in left arm"; FATIGUE (non-serious) with onset 01Apr2021 13:00, outcome "unknown", described as "tiredness"; CHILLS (non-serious) with onset 01Apr2021 13:00, outcome "unknown", described as "chills". Therapeutic measures were not taken as a result of lymphadenopathy, pain in extremity, fatigue, chills.  Additional Information: No other vaccine in four weeks. No covid prior vaccination. Covid was not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Round red welt on left arm around site of vaccination.  First noticed about 24 hours after injection.  Onset of mild fatigue around the same time.
Patient stopped in to report adverse response on 6/26/23.  Patient experienced swelling from shoulder to knuckles, itching and hard lump at site of injection later that day after receiving injection.  She contacted prescriber and was told to take Benadryl 25mg twice daily.   Patient stated she has been taking  once or twice daily dosing for 10 days.  Hard lump has been dissipating , swelling almost entirely gone and itching subsiding.  Patient stated she has tons of allergies and wasn't surprised with reaction.  Patient is doing well.
Information has been received from a certified medical assistant concerning a 6 month old female patient who on 07-MAR-2007, at 9:30AM, was vaccinated IM into the right thigh with a first dose of Pneumovax 23 (Lot# 655290/0959F).  The medical assistant reported that the wrong vaccine was given.  It was supposed to be PREVNAR.  There were no problems reported.  The medical assistant also noted that steps were taken to correct the problem.  The person who gave the vaccine was counseled/re-trained and visual aids were implemented.  No further information is available.
This case was reported by a consumer via call center representative and described the occurrence of chronic pain in a 76-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (In 2004). Previously administered products included ZOSTAVAX (In 2007). Concurrent medical conditions included fibromyalgia (In 1991, due to trauma to the spine and she was treating her condition with alternative therapies). On 28th July 2018, the patient received the 1st dose of SHINGRIX. On 28th July 2018, less than a day after receiving SHINGRIX, the patient experienced chronic pain and tiredness. On an unknown date, the outcome of the chronic pain and tiredness were unknown. It was unknown if the reporter considered the chronic pain and tiredness to be related to SHINGRIX. Additional details were reported as follows: The night after the patient received the vaccine, she had pain from her head to her toes that was a 10 level. She could not open her eyes due to tiredness and rested all day on Sunday and Monday.
Narrative: Patient experienced nausea, fatigue, and alternating hot/cold flashes after receiving the second COVID-19 dose.
PT EXPERIENCED INCREASED HR AND BP. HEART BEATING HARD AS WELL COMPLAINED OF TINGLING LEGS AND FEET DIFFICULT TO FEEL FEET
Minor tightness of breath, dry cough, headache, leg joint ache, fever 101 degrees @ 2:00 AM.
pt recvd vax;cried non stop x 40 mins;rt thigh swelled approx 4 hr p/ vax;mom called MD;he recommended Ibuprofen, pt better the next day; had fever but mom did not measure;
Initial misuse information was received from a healthcare professional in on 23 Sep 2013. A patient whose demographic details, medical history and concomitant medication were not reported received a dose of FLUZONE on an unspecified date. Route, site, dose and batch number not reported). It was reported that on an unspecified date patient received expired dose of vaccination. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: none
Red, Swollen, itchy  injection site which spread to become an area measuring 4 inches by 2 inches lasting 5 days. Low grade fever, nausea, dizziness, chills, muscle aches, lasting 1 day.   Took OTC Acetaminophen and benedryl as needed.   Low grade fever, nausea, dizziness, chills, muscle aches resided after one day. Swelling/redness lasted longer.
Initial information and follow up has been received from a nurse and consumer for the Pregnancy Registry for GARDASIL concerning a 17 year old female who was born three months premature was vaccinated on 22-AUG-2007 intramuscularly with her first dose of GARDASIL (lot# 655618/0186U). on 25-APR-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot# 659655/1486U) and was pregnant. Concomitant therapy on 25-APR-2008 included HepB (duration and dose not reported). The patient's LMP was estimated to be 24-MAR-2008. She had a positive urine pregnancy test. The patient sought medical attention on an unspecified date in the physician's office. Subsequently the patient experienced no symptoms. The patient has had no previous pregnancies. Follow-up information was received from the registered nurse. On 13-JAN-2009 the patient, with no significant past medical history and no concurrent medical condition, gave birth to a live, normal female baby with birth weight 6 lb 5 oz, length 19.2 inch, head circumference 13 and passed Apgar score and all testing. The baby was delivered by c-section due to mother's blood pressure dropping. There was no other complication. There were no congenital anomalies and other complications or abnormalities. Upon internal review, delivered by c-section due to mother's blood pressure dropping was determined to be an other important medical event. Additional information is not expected.
Person began mild cold symptoms, could not identify date of onset; then on 3/23/22, wife noticed change in cognition, confusion, "wet himself" while sitting on couch, and BG level 200+, wife concerned with CVA, took Person to ED, admitted to hospital, given routine tests, including CXR, clear, MRI clear and no COVID treatments given.
Next morning after vaccine: fever of 103, exhaustion, high blood sugar not going down by insulin, extreme lower back pain. He said the pain is 9/10.
Arm was really sore for 2 weeks. No fever. Patient took 600mg Ibuprofen every 6 hours which help with soreness.
one diluent was remaining in a box of ActHib and assumes the powder half of the dose had been given to a patient with sterile water instead, no adverse event; Initial information received on 02-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA002810, 2020SA002811, 2020SA002812 and 2020SA002456 (same reporter).  This case involves an unknown demographic patient who was vaccinated with a dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] on 20-Dec-2019, (lot number UJ175AAA and expiration date 26-Nov-2020), other dosing details were not reported.  Medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong solution used in drug reconstitution as Act-HIB was accidentally mixed with sterile water instead of the diluent that came with product and had been administered to the patient.  No adverse event was reported at the time of reporting.  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 and Module VI of the 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.
Expired dose of vaccine Ipol was administered to the patient, no AE; Initial information received on 30-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a five years old male patient who vaccinated with an expired dose of vaccine IPV (VERO) [IPOL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Dec-2019, the patient received a expired 0.5 ml dose of suspect IPV (VERO) (lot number: N1K931M and expiry date: 18-Nov-2019) via intramuscular route in the left deltoid.  It was actual medication error due to Expired vaccine used.  At the time of report 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.
First vaccine dose administered 24-FEB-2021, second dose administered in Apr-2021; Muscle soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First vaccine dose administered 24-FEB-2021, second dose administered in Apr-2021) and MYALGIA (Muscle soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple allergies (Patient is allergic to so many things).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 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 experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First vaccine dose administered 24-FEB-2021, second dose administered in Apr-2021) and MYALGIA (Muscle soreness). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First vaccine dose administered 24-FEB-2021, second dose administered in Apr-2021) had resolved and MYALGIA (Muscle soreness) had not resolved.            No relevant concomitant medications were reported.  Patient visited doctor who recommended acupuncture for treatment.   This case was linked to MOD-2021-041363 (Patient Link).
body aches; fever of 101; chills; This is a spontaneous report from a contactable consumer. The consumer reported for a non-pregnant female patient of an unspecified age who received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if the patient was diagnosed with covid-19 prior to vaccination or tested for covid-19 since the vaccination. It was reported that 4 hours after the shot the patient experienced fever of 101, chills and body aches for 2 days on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on an unknown date. No treatment received for the adverse events. Explicit consent was reported. Pfizer receipt date was 18Mar2021. The outcome of all the events was resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12SEP92 flat, round dots on back, shoulder, stomach, feet (fading on 14SEP( & fever 105 (101); irritable, eyes puffy & running nose, while crying; 14SEP MD described rash as maculopapular; 15SEP generalized fine, red rash cont 16 & 17SEP;
2 weeks after receiving smallpox vaccine developed erythema at site and vesicular rash on back and chest, fever. Received Bactrim at ER for presumed cellulitis at vaccine site. Diagnosed cellulitis, generalized vaccina
WOKE UP WITH PAIN AND SWELLING IN THE LYMPH NODES UNDER THE LEFT ARM.
Had kidney stone problem; Urine test showed bacteria; Sore arm; A spontaneous report was received from a consumer  concerning a 76-years-old, female patient, who received Moderna's COVID-19 vaccine  (mRNA-1273) and experienced sore arm / pain in extremity, had kidney stone problem / nephrolithiasis and urine test showed bacteria / urinary tract infection bacterial.  The patient's medical history was not provided. Concomitant medications reported included potassium and nebivolol hydrochloride administered half a pill.  On 03 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 03 Mar 2021, the patient experienced sore arm. On 13 Mar 2021, the patient had kidney stone problem and urine test showed bacteria. The event kidney stone was found to be medically significant.  Treatment drug administered was amoxicillin and clavulanate potassium on 18 Mar 2021 and on 19 Mar 2021. On an unspecified date, treatment drug was switched to ciprofloxacin.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the events, sore arm, had kidney stone problem and urine test showed bacteria was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of sore arm, a causal relationship cannot be excluded. Very limited information regarding the events of nephrolithiasis and urinary tract infection bacterial has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Information has been received from a Medical Assistant regarding a case involving VAQTA lot # M001815, expiration date 20-SEP-2017 (MARRS # 1610USA001301) who refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were administered improperly stored doses of GARDASIL 9 lot # M007764, expiration date 30-JAN-2018 (dosing details were not reported). The vaccines were exposed to temperatures ranging from 33F to 35F for cumulative total time frame of 72 hours out of recommended storage range. There were no previous excursions reported. The data logger was reported as yes. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concomitant therapy, pertinent medical history, drug reactions and allergies provided. On an unknown date, the patient was inadvertently vaccinated with PNEUMOVAX 23 (lot#, expiration date, dose, site and route of administration, indication were not reported), which had been improperly stored. No adverse effects and no product quality complaints (PQC) were reported. Additional information is not expected, as the reporter does not wish to be contacted.
Two days after vaccination: Extreme pain, swelling, and tenderness in my left lower lip. Swelling turned into multiple pus pockets on both the inside and outside of my lip. It is now one month since my one vaccination and the pain is gone but some swelling still exists.
Severe headache, nausea, diarrhea, stomach pain,. Redness, swelling, heat, itching, pain at injection site about the size of a golf ball. Chills, causing pain @ injection site.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported, but was selected as adult as per vaccine indication. The pharmacist stated that she had 50 percent of the patients returning for the 2nd dose stating they had flu like symptoms with the 1st dose. She did not have any patients who refused the 2nd dose due to those events but she had not been reporting those to GlaxoSmithKline, as they were known events listed in the product information (PI). No specific number was shared with specific identifiers.
I had extreme fatigue. I also had joint pain that would come and go. Because of the severe fatigue, I had to have someone to come and live with me because I could not do anything.
Rash - all over the body x 4 days, red raised above the skin. No fever, painful welt looking lump right thigh - Scabies exposure.
I broke out in shingles, Herpes Zoster, with a rash across the right side of my chest and down my arm. I had never had a shingles outbreak before.  I had also started losing hair about two weeks before and it continues. I saw my PCP who prescribed Valacyclovir 1 gram three times a day for one week. The sores have scabbed over and are starting to heal after one week on medication.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 18-APR-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H020002, expiry date 08-AUG-2015), with the same lot of improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Area of facial numbness about 2 inches in diameter on left mandibular distribution. No motor loss. Persistent to present, unchanged.
Fine, flat red rash to lower arms and left cheek; patient denied itching; mother states rash occurred the same day after vaccine was received.
Pt developed severe monoarticular knee arthritis 10 months p/vax w/MMR;
My periods was late two months following my vaccine which is not typical. Also, I am no longer having my painful periods and nothing else changed with this. They were so painful that I had an ultra sound done earlier this year 2x to verify things were ok. Seems odd that the Pain & cramping has moved to very little to non-existent and later periods the first two months after the vaccine. I had a co-worker worried she was pregnant because her period was late for the first time since having her 6&4 year olds and this was right after the 2 doses of the vaccine. Just seems too weird of a coincidence that we both had this and makes me wonder why this would happen.
Information has been received from a nurse concerning a 43 day old patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot# unspecified). The nurse mentioned that on 02-MAR-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Additional information has been requested.
several canker sores in my mouth; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of APHTHOUS ULCER (several canker sores in my mouth) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 APHTHOUS ULCER (several canker sores in my mouth). At the time of the report, APHTHOUS ULCER (several canker sores in my mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided.  Treatment medications was not provided.   Reporter did not allow further contact
A report was received from a health professional on 05Dec03, concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 01Dec03. On 01Dec03 the vaccinee inadvertently received Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301247, PJP200400084, PJP200400085.
SEQUENTIAL USE WITH MODERNA COVID-19 VACCINE; This spontaneous report received from a health care professional concerned a 64 year old male. 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination. On 04-AUG-2021, the patient experienced sequential use with moderna covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sequential use with moderna covid-19 vaccine was not reported. This report was non-serious.
serious medical condition; A spontaneous report was received from a consumer female patient, concerning herself, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced serious medical condition/vaccination adverse event.  The patient's medical history was not provided. Concomitant medication was not reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, after the first dose of the two planned doses of mRNA-1273, the patient was said to have experienced a serious medical condition. Post second dose of the planned two doses of mRNA-1273, the event became severe. Treatment given was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The event serious medical condition was reported as resolved on an unknown date.; Sender's Comments: Very limited information regarding the reported event has been provided at this time.  Further information has been requested.
Patient's arm is red and swollen. It itches a little and is warm to the touch.
Administered vaccines to patient, she said she didn't feel well and asked for some water. I went to go get her a glass of water and she passed out briefly per her husband. Came back and got pt cold wet cloths, a cold pack, and a coke. She sat for about 20 minutes and then she was able to leave on her own accord.