chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.; I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.; I was tired, more than usual; I had a  sore arm; A spot on my right shoulder was itching. It looked like dry skin.; A spot on my right shoulder was itching. It looked like dry skin.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I had a  sore arm), PRURITUS (A spot on my right shoulder was itching. It looked like dry skin.), DRY SKIN (A spot on my right shoulder was itching. It looked like dry skin.), RASH ERYTHEMATOUS (I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.) and RASH (I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 013A21A and 002821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, the patient experienced PAIN IN EXTREMITY (I had a  sore arm), PRURITUS (A spot on my right shoulder was itching. It looked like dry skin.), DRY SKIN (A spot on my right shoulder was itching. It looked like dry skin.) and FATIGUE (I was tired, more than usual). On 13-Dec-2021, the patient experienced RASH ERYTHEMATOUS (I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.) and RASH (I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (I had a  sore arm), PRURITUS (A spot on my right shoulder was itching. It looked like dry skin.), DRY SKIN (A spot on my right shoulder was itching. It looked like dry skin.), RASH ERYTHEMATOUS (I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.), RASH (I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.) and FATIGUE (I was tired, more than usual) outcome was unknown.            No concomitant medication was reported
PT STATES SHE HAS A MASSIVE, SEVERE HEADACHE UNRELIEVED WITH OTC MEDICATION.  STATES AFTER VACCINE SLEPT ALL DAY AND TOOK TYLENOL AND WOKE UP WITH HEADACHE AGAIN.   PREVIOUSLY REPORTED REACTION TO 1ST DOSE OF PFIZER:  PT C/O Numbness, states he feels like "like hand fell asleep and feel like I am drunk"
Fainted at a party at an outside BBQ on the day after the shots (for a baby shower in early evening)
I was having trouble breathing on 5/19/22 and i went to see the nP at my doctor's office. She started me on antibiotic that didn't help because i was still having trouble breathing the following monday on the 23rd. they said to go to the er. At the ER they said I was having congestive heart failure. they then started me on some medications
patient had no history of allergies & had previously received flu vaccines historically without incident, patient developed severe hives on back, legs, & abdomen. There was no lips, face, tongue involvement. PCP ordered Benadryl 50mg stat dose then started Medrol dosepak.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 11th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 11th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 12th December 2018, the patient experienced tiredness, muscle pain, headache, shivering, fever and upset stomach. On an unknown date, the outcome of the injection site pain, tiredness, muscle pain, headache, shivering, fever and upset stomach were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, tiredness, muscle pain, headache, shivering, fever and upset stomach to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. On 12th December 2018, 1 day after receiving SHINGRIX, the patient experienced tiredness, muscle pain, headache, shivering, fever and upset stomach. The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up.
Treatment of COVID-19; Treatment of COVID-19; vaccine brand=Pfizer / BioNTech, vaccine dose number=4/ vaccine brand other=Moderna, vaccine dose number=5,; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Jan2021 as dose 1, single (Batch/Lot number: unknown), on 31Jan2021 as dose 2, single (Batch/Lot number: unknown), on 19Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: DESCOVY; TIVICAY; LISINOPRIL; MOBIC; CONTRAVE. Past drug history included: Sustiva for known allergies :Sustiva, notes: known allergies :Sustiva. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Feb2022, outcome "unknown", described as "vaccine brand=Pfizer / BioNTech, vaccine dose number=4/ vaccine brand other=Moderna, vaccine dose number=5,"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2022) positive, notes: Initial positive test on 26Dec2022; (31Dec2022) Negative, notes: Previously tested negative on 31Dec2022; (Jan2023) Positive, notes: Tested positive on rapid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient tested positive on rapid. Previously tested negative on 31Dec2022. Initial positive test on 26Dec2022 and started Paxlovid on 26Dec2022. Other medication in 2weeks: Yes. Patient received COVID 19 Treatment with Paxlovid, treatment start date on 26Dec2022, treatment stop date on 30Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events INTERCHANGE OF VACCINE PRODUCTS, DRUG INEFFECTIVE, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
vaccination site swelling, soreness, redness (remained swollen/sore even after using icepack for 2 hours)
General fatigue the next day. Saw doctor, getting depression and irritable to family members and mom noticed. No motivation to do anything. Went over symptoms and survey. Doctor also noticed my doctor who knows me for a few years. On medication now and feel more or less better now.
Also developed rashes on both upper arms a day after.; IV due to low bp.; felt tired/weak.; felt tired/weak.; itchy throat; experienced shortness of breath; hoarseness; This is a spontaneous report from a contactable consumer(patient). A 46-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date: Not reported), via an unspecified route of administration, administered in Arm Right on 16Aug2021 (at the age of 46-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included polycystic ovaries, Known allergies. Other medications (in two weeks) included iron (IRON) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported; colecalciferol, menaquinone (D3 plus K2) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; glutathione (GLUTATHIONE) taken for an unspecified indication, start and stop date were not reported. Facility type vaccine was Pharmacy or Drug Store, the patient took no other vaccine in four weeks, had no COVID prior vaccination, was not COVID tested post vaccination. The patient stated that 10-15 minutes after shot on 16Aug2021, she felt tired/weak, shortness of breath and itchy throat, hoarseness and was rushed to the ER after an hour as, also developed rashes on both upper arms a day after (17Aug2021). Adverse event resulted in Emergency room/department or urgent care. Treatment was taken IV due to low bp. The patient underwent lab test and procedure which included bp: Low IV due to low bp on an unspecified date. The outcome of events IV due to low bp, felt tired/weak, also developed rashes on both upper arms a day after was unknown and of other events was not recovered. The patient stated that she was still experiencing shortness of breath, itchy throat and hoarseness.   The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
JANSSEN COVID-19 VACCINE EUA  I HAD A TEMPERATURE BETWEEN 101 AND 102.3 FOR APPROXIMATELY 24 HOURS.  HEADACHE, MUSCLE PAIN. EXTREMELY WEAK AND TIRED.  SOME DIZZINESS. FEELING OF TINGLING ALL OVER MY BODY ABOUT 4 HOURS AFTER THE VACCINE
This is a spontaneous report from a contactable nurse. A 9-month-old male patient received the first and second doses of PREVNAR, intramuscular on 06Jan2010 (Lot Number: E13861; Expiration Date: Sep2013) in the left thigh and 01Mar2010 (Lot Number: D94433; Expiration  Date: Apr2012); and the first dose of PREVNAR 13, intramuscular on 19May2010 (Lot Number: E44527; Expiration Date: May2011) in the left thigh; all at 0.5 ml single doses as part of the vaccine schedule. Relevant medical history included unspecified issues in the ear and ongoing at event onset. Relevant sibling information included the patient had two siblings. The patient's concomitant medications were not reported. The patient previously received the first and second doses of ACTHIB intramuscularly on an unknown date, first dose of ACTHIB intramuscular injection on left thigh, and first and second doses of ENGERIX; all on unknown dates. In Aug2010, the patient had a cochlear implant in right ear. In Dec2010, he had mastoiditis. On 04Jan2011, he was given the second dose of PREVNAR 13 (Lot Number: 915192) as part of the vaccine schedule. Relevant lab data included unspecified blood work in Mar2011 and the results were found to be normal. The clinical outcome of the events, cochlear implant in right ear and mastoiditis, was unknown.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 24-AUG-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally, lot # K020181, expiration date 24-JUN-2016 (strength and dose were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
On 13-NOV-2001, the pt received a Fluvirin injection IM on the left deltoid muscle. On the morning of the next day, the pt experienced an asthma attack on 15-NOV-2001. The reporter provided no information on the inpatient therapy regimen. The pt was discharged from hospital on 19-NOV-2001 and has recovered. The reporter assessed the relationship of study medication to the event as possible. Also stated event may have contributed to by the pt's medical history.
Patient presents to ED on 1/12/21 with Allergic Reaction (pt received Moderna Covid-19 vaccine at hospital, and pt states about 10 minutes later she started to feel dizzy, sob, heart racing, and developed rash on hands and chest.) Pt seen by Dr.  Pt was ordered NS 500 mL IV x1, diphenhydramine 25 mg IV x1, famotidine 20 mg IV x1, methylprednisolone 125 mg IV x1, and ondansetron 4 mg IV x1. Symptoms resolved prior to discharge from ED.  She was given scripts for diphenhydramine and prednisone with instructions to follow up with PCP.
Feeling of fogginess; Dizzy; Fever of 102.0; Nausea; Vomiting; Chills; Moderate headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling of fogginess), DIZZINESS (Dizzy), PYREXIA (Fever of 102.0), NAUSEA (Nausea) and VOMITING (Vomiting) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling of fogginess), DIZZINESS (Dizzy), PYREXIA (Fever of 102.0), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Moderate headache). At the time of the report, FEELING ABNORMAL (Feeling of fogginess), DIZZINESS (Dizzy), PYREXIA (Fever of 102.0), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Moderate headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Headache, Myalgia, c/o fatigue,injection site sore. Told to follow up with primary care if no improvement. Narrative:
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 03/16/2023. I had extreme fatigue, diarrhea, headache and felt awful. I contacted my provider via telehealth and got a prescription for PAXLOVID. I tolerated the medication without any complications. As of today, I feel better but I'm not 100% better. I still feel the fatigue.
I have a nerve conditions in both feet. Doctor diagnostic me with having Neuropathy. I believed it to be arthritis.
pain, weakness, fever, shivering, sweating, headache, nausea, balance issues.
Pt was given 1cc of flu vaccine instead of 0.5cc vaccine.  Pt notified of possible vaccine response.    No adverse reactions known.
severe hypertension /his blood pressure was 190/125/very abnormal; This is a spontaneous report from a contactable consumer (father) received via Pfizer Sponsored Program and medical information team.  A 39-year-old male patient that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The caller stated that, two or three weeks after the second dose of vaccine, the patient went to doctors office and his blood pressure was 190/125, which was very abnormal for the patient. The patient took medications for the event and was getting it under control. The caller had a question, if Pfizer was aware of any reports that may suggest this hypertension could have been caused by the Pfizer BioNTech Covid-19 Vaccine. The outcome of the event was recovering at the time of this report.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021294684 Same reporter/diff patient/diff event
head ache (left side of neck; ); can't sleep; blurry vision; aches and pains; muscle aches; very shaky; memory problems; scared to drive; very nervous and shaky; very drained; went to the doctor, who advised her to let the pharmacy know that she was probably having a reaction to the shingles shot; This was her 2nd shot in the series, AND she had Zostavax back in 2009 (with no problems) - no problems with the 1st dose of shingrix
Few mins p/vax c/o nausea, vertigo, chest pressure, PB 170/100, p72 reg; given Epi-notified MD; assessed x30min BP 140/74, p-76;
Tingling and pain to left arm from elbow to hands that has been ongoing for 5 weeks Narrative:
Injection site small nodule and small red dot. Hives on face first noted 03/23/2005. Pt seen in our office 03/23/2005, Treatment with Benadryl 1/2 tsp Q6H and referred to allergist.
pt recv vax 26AUG98 & the morning p/vax pt exp a rash starting on  the palms of hands & soles of feet;by next day the rash had spread all over the body;@the time of vax pt had a temp of 100.7;
ErtythemaMultiform, arm swelling Narrative: Redness at inj site, arm swelling
Fever 101 on 12/19-12-20, neck swelling, itchy 12/21/12/22. Went to ER given Benadryl
Intense chills: 10pm, 12hrs; Intense joint aches (including knees, spine, fingers): 10pm, 12hrs; Intense headache: 10pm, 16hrs; Dizziness: 10pm, 24 hrs; Nausea: 10pm, 12 hrs.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and PEDVAXHIB (Lot number, expiry date, route and dose were not reported). Certified medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reports. Follow-up received. Certified medical assistant stated other 104 children received GARDASIL and other 18 children received PEDVAXHIB. Follow up information has been received from the certified medical assistant regarding a 17 years old, female patient with no pertinent medical history reported. On 21-AUG-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). Other suspect therapies included PEDVAXHIB (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). Concomitant medications included Hep A vaccine (manufacturer unknown) administered on 21-AUG-2012 (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Approximately 4 hours after injection, I developed a severe, one sided headache. Extreme fatigue developed the following morning,  headache less severe. Extreme fatigue continued for 6 days, headache for 5 days. OTC analgesic was not helpful.
Pt recvd pneumococcal vax on 14NOV91 & devel a local reaction which resolved 2 or 3 days later; pt then devel ulnar numbness w/a shooting pain in shoulder & swelling of hand; MD dx reflex sympathetic dystrophy;
Oday of vaccination that p.m. had headache (9/16/05). On 9/23/ had heartburn took an antacid tablet.on 9/25/ diarrhea. On 9/28 called in sick and described a rash like prickly heat and itchy on face, neck, arm, abdomen, and back advised to see physician. Injection site swollen the size of a quarter and bruise had reddened. Saw M.D. who Dx is: Viral Exanthem 28 to mmr injection #2, Polyarthritis.
caller is disabled and has a bad back and stuff; have tons of ills because of the shot; felt soreness in the arm; Sleepiness; caller was tired; The initial safety information received was reporting only non-serious adverse drug reactions, upon receipt of follow-up information on 28Apr2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 22Mar2021 between 09:00-10:00 (Lot Number: EP6955) as 1st dose, single for COVID-19 immunisation. There was no medical history, no family medical history relevant to adverse events.  The patient's concomitant medications were not reported. There were no prior vaccinations within 4 weeks. The patient felt soreness in the arm and it made him sleepy after the first dose of the Pfizer COVID-19 vaccine in the evening of 22Mar2021. When he got back home the same day 22Mar2021 sleepiness began. The patient stated this was probably going to happen anyway, he was disabled and had a bad back and stuff on an unspecified date.  The patient had to drive 30 some miles, 31 miles to be exact to see the doctor to receive the Pfizer Covid Vaccination.  When he returned from the trip he was tired and would go to sleep anyway on 22Mar2021.  The patient stated soreness in the arm had been gone for maybe 3 or 4 days, he was good, no problem with arm, and sleepiness went away. The patient mentioned that he had tons of ills on unspecified date because of the shot. The patient was not experiencing any of this before having the Pfizer Covid Vaccine. The events did not require a visit to Emergency room or Physician office. There were no relevant tests.  The outcome of events felt soreness in the arm and Sleepiness was recovered, and of the other events was unknown.
Day 1 and 2 no redness or swelling at site.  Slight headache and chills day 1.  Day 3 swelling, redness and itching at site.  No improvement on day 7.  No pain associated or other symptoms.  Just red, itchy, and large lump above injection site.  Using Benadryl  cream on the site.
pt recv vax & 6 hr later pt devel diarrhea & flu-like sx & exp nausea, light headedness, hot flashes & pain in the arm where the inj was administered;
6 hours, post vax, pt began swelling in left leg at injection site to knee and into testicles. Saw MD next day because he had developed purple spots under the skin with a red border from injection site to foot. Was told that this was probably a vaccine reaction. 2 days, post vax, purple spots appeared in right foot. Spots resolved after approximately 4-5 days.
Patient is post menopausal and she began having periods  after the first and second dose of the vaccine
Itchy, red rash on stomach and back this morning. I feel fine, but the rash is a bit strange and I thought it was worth reporting, as when I googled it, others have had a rash as well.
PATIENT IS INFORMED THE PFIZER GIVEN WAS EXPIRED BY 1 DAY.  NO ADVERSE EVENT AT THE TIME OF THIS REPORT.
Vasovagal syncope approximately 5 minute post vaccination; normal breathing and color minutes after syncope (fall); patient was assessed by paramedics and send home.