chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAIN AT THE SITE OF INJECTION, CANNOT USE ARM CANNOT LIFT AND HAD TO CUT CLOTHES OFF WITH SCISSORS BECAUSE CANNOT EXTEND ARM TO GET CLOTHES OFF.  HAVE  FLU  LIKE SYMPTOMS, WAS COMPLETELY HEALTHY BEFORE VACCINE, ABLE TO DRIVE AND WALK AROUND AND SHOP AT CVS NOW 24HOURS LATER I CAN'T. FEEL EXTREMELY TIRED COULD NOT SLEEP CANNOT USE MY LEFT ARM!
decreased appetite; Sweats; Chills; fever (101.3); headache; Body aches; This is a spontaneous report from a contactable Other-HCP (patient) and another other-HCP. This 26-year-old female received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL0142, intramuscular in left arm on 11Jan2021 at 07:00 as single dose (at the age of 26 years) for Covid-19 Immunization.  Relevant medical history was reported as none and concomitant medication was not reported.  The patient had historical vaccine on 21Dec2020 at the age of 26 years of BNT162B2 for Covid-19 immunization and experienced Onset of body aches 12 hours after vaccination and lasted for 24 hours. (Lot Number/Expiry Date: EH9899, Route: intramuscular).  The patient experienced Body aches, headache, fever, chills, sweats on 11Jan2021 18:00 and recovered on 13Jan2021. Patient received Tylenol extra strength 100mg on 11Jan2021 for symptoms.  Patient experienced decrease appetite on unspecified date with outcome of unknown.  The other HCP consider the Pfizer product had a causal effect to the adverse event.
p/vax pt exp h/a, joint ache, back pain, neck pain, kidney pain;h/a was described as being @ the base of the neck & whole head;no tx given;pt seen by MD office & had blood work done (results not available @ time of report);tx doxycycline;
pt recv vax & exp a maculopapular, pruritic rash on neck & abd for 3 days post vax;
Pt stated she was on birth control to health care partner. Was vague on LMP. Pregnancy test done to restart B.C. (Depo) and report of test confirmed pt pregnant. After further investigation LMP ? April (1st trimester)
Individual was vaccinated on Jan 21, 2011 with the FLUMIST vaccine. She began to develop a redness and swelling on her upper lip with 4 pustules. She went to see her PCM. She did not miss any work and the condition resolved after one week.
swelling, hot to the touch, painful, headache, nausea, dizziness, achy, unable to lift arm
Patient vomited and would not take her bottle.  Her heart rate felt faster than normal.  The doctor informed me that they made a mistake and gave her one extra dose of DTaP and one extra dose of polio.
Heart palpitations. 2-4/hr. vaccinated 13 days ago and still occurring.
This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 16-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Pt/child was given flu nasal vaccine that expired 12-3-12 (on 12-6-12). No adverse reaction per mother - revaccination advised/offered.
This spontaneous report was received from a medical assistance regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated improperly stored with RECOMBIVAX HB lot # L010595, expiration date 12-NOV-2016. No adverse event was reported. The outcome of the event was unknown. Temperature was 28 F, time frame 185 hours. Yes it was administered and no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Repeated Headaches treated with tylenol. Began 4 days post shot and continues.   Shortness of breath (not explained by other activity) upon waking each morning. Also began 4 days post injection.  Use of albuterol inhaler provides little relief. Symptom comes and goes
Sore throat; Chest tightness; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and CHEST DISCOMFORT (Chest tightness) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In October 2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and CHEST DISCOMFORT (Chest tightness). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and CHEST DISCOMFORT (Chest tightness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   In October 2021, the patient experienced sore throat and tightened chest. Moderna vaccine was also considered suspect.   No treatment medication 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.
4/17/2022- Presents to ED, had exposre to Covid ,started to feel ill on Friday, fell this monring in bathroom, awoke on floor does not recall what happened.  Went to UC was advised to go to ED. Covid + test. C/o cough, fatigue, weakness and SOB. CT Head: no acute intracranial hemmorage. CXR: Mild subsegmental atelectasis.  D-dimer 1585. CTA no pulmonary embolism. Admit syncopal episode s/t dehydration with underlying Covid-19. Start bebtelovimab, fluids and potassium EQ one dose.  4/18/2022- Discharge to home with inhalers, advised pcp visit for adjustment to amlodipine and HCTZ.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 09-JUL-2016, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. About two weeks after being vaccinated, the patient broke out in severe blistering lesions. The patient was treated by a physician for the vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Case number PHEH2014US025149, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 19 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 28 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration (incorrect storage of drug).
Adverse event of fatigue and moderate chills with fever of 100.4 degrees F. Subject treated with acetaminophen. Subject went to bed early with plenty of covers for the chills.
Narrative: COVID infection following COVID vaccine series and after previous COVID infection 03/09, Pfizer, dose #1 03/31, Pfizer, dose #2 11/02, Pfizer, dose #3 12/30 COVID swab, result: detected 1/8 COVID swab, result: detected 02/24 pt cc: Cough, Upper/mid back pain, exposure: unknown 01/03 pt cc: no symptoms exposure: unknown 02/24 pt admit to ED cc: Cough, Upper/mid back pain, dx COVID 19, upper back pain, LOS: 1 day 2/24 cxr impression: No acute cardiopulmonary process.
2AUG91 PT admitted w/febrile szs & abnormal EEG (a definite sz disorder w/spike & wave discharges in temporal lobe); 19AUG91 report recd from MD recommends that PT not receive pertussis immun, but to receive DT, polio, mumps, & rubella;
Information has been received from a Registered Nurse referring to a 19 month old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 25-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K026532, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I became dizzy, transient vertigo type dizziness. Last about 15 min at a time for the whole day of administration and on Tuesday Wednesday it started to relief itself but, today is Thursday and so far no episodes. No treatments were needed.
the night of the 18th my right eye was bothering me so I was itching it in my sleep, when I woke up on the 19th my eye was red and I thought I had injured it in the night and  it bothered me all day but I didn't get it checked, I went to urgent care  the 20th because  I noticed there were vesicles on my right eye. they gave me eye drops and diagnosed me with HSV keratitis, Valtrex was also prescribed trifluridine. I feel almost completely recovered
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The reporter was not sure of the  number of patients involved but she thought 3 patients were vaccinated with the improperly stored (Oka/Merck) VARIVAX. Patient's medical history concurrent conditions and concomitant therapy were not reported. On an unknown date, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (lot # L001334, expiry date: 13-JUN-2017; lot # L004655, Expiry date: 11-FEB-2017), (dose and route were not reported). No symptoms were reported. Additional information has been requested.
administered QUADRACEL to a 16-year-old patient with no reported adverse event; Initial information received on 01-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA270585.  This case involves a 16 years old female patient to whom administered diphtheria-15/tetanus/5 Hybrid Ac Pertussis/IPV (Mrc5) Vaccine [Quadracel] to a 16-year-old patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Aug-2023, the 16 year old female patient received a unknown dose of suspect diphtheria-15/tetanus/5 Hybrid Ac Pertussis/IPV (Mrc5) Vaccine Suspension for injection (Frequency: once, Strength: standard, expiry date: 14-Apr-2025 and lot: 07632BB) via intramuscular route in the left deltoid as Immunization and (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recv vax 3MAR97 & on 29AUG97 pt devel mult zoster like eruptions on the rt buttock & L3 dermatome, lt buttock & inner aspect of rt leg confirmed as shingles;
Staff nurse review consent and no record .  Mom documented wrong dob on consent . I got vaccine ready that were marked (Tdap, MCV, HPV and MenB ) . Mom denied any allergies, no medical condition, no previous reaction to previous vaccines. After vaccination instructed mom, they had to wait 15 min post injection. no complaints only was sore from left arm . I advice  to move arms , recommend she can put icepack wrapped in towel and can take tylenol or any analgesic of her choice  She asked me to write vaccine on copy she had of vaccine printed record Public Health Office and noticed dob from that record and form mom filled out was different and inquired from mom, she stated she had documented the wrong dob, she had documented her son dob instead of daughter. so, notify parent we administered vaccine not on schedule.  Vaccine would probably not count and at age  16 she would need to get re vaccinated, she voiced understanding.
Fatigue, Dry Heaves, Slight Diarrhea, 101.8 fever,Throat Dryness. Remained in bed for 36 hours before I had energy to get out of bed.Fatigue lasted approx 72 hours. Drank water. Ate very,very little.
4 cm x 1 cm erythema.  Streak on right anterior thigh, painful to touch, warm.  Augmentin 400/5 4 tsp PO BID x 10 days.  HCTZ cream 2.5% BID; Bactroban ointment tid for 7 days.  Bromhist pdx 3/4 ml po every 6 hours prn.
Cramps & stuff; She's throwing up and having violent vomiting; chills; Body aches; headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MUSCLE SPASMS (Cramps & stuff), VOMITING (She's throwing up and having violent vomiting), CHILLS (chills), MYALGIA (Body aches) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 014F21A, 016M20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Gluten sensitivity, Lactose intolerant, Egg allergy and Seasonal allergy.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, the patient experienced MUSCLE SPASMS (Cramps & stuff), VOMITING (She's throwing up and having violent vomiting), CHILLS (chills), MYALGIA (Body aches) and HEADACHE (headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 03-May-2022 at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) on 04-May-2022 at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Cramps & stuff), VOMITING (She's throwing up and having violent vomiting), CHILLS (chills), MYALGIA (Body aches) and HEADACHE (headache) had not resolved.            Concomitant medication information was not provided by the reporter.  It was unknown if the patient ever had COVID positive test or diagnosis. It was unknown if the patient had any acute and chronic illnesses at the time of vaccination. It was unknown if other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.   Patient began vomiting about 45 min ago the call. It was reported that none of the events caused the patient to seek medical care. It was unknown if the patient had experienced similar events in the past. It was said that the patient symptoms had worsened. Patient never had any of the events with the other shots. Patient had took Aleve 1.5 hours before the call and patient had asked for Benadryl after the shot and got it.
patient asked for 2 immunizations in the same arm, immunizer performed the task.  A few days later patient developed redness and went to the local walk in to be evaluated on 11-3-21.  She was diagnosed with cellulitis and given antibiotic.
(L) arm swelling, pain, warmth- treated with KEFLEX for cellulitis.
Patient was accidently given a 3rd Menveo at his well visit. No adverse reactions noted. Mother of child, patient and Physician notified. He was also given a Tdap which he was due for.
Left calf pain and swelling , diagnosed with DVT left popliteal and posterior tibial veins, treated with Eliquis
Burning/discomfort in throat 10 minutes after vaccine administration. Elevated blood pressure and heart rate.
pain in arm since shot slowly went away the 7 days after my arm swelled and is very tender and painfull swelled entire muscle shot was given warm to touch pain to touch
While getting a dose of BioThrax had some come out and a drop or two went into her mouth; A spontaneous report was received from the other healthcare professional on 23NOV2022.  It described a female patient who "while getting a dose of BioThrax (anthrax vaccine adsorbed) had some come out and a drop or two went into her mouth" (PT: Accidental exposure to product). It was reported that a while ago, when the patient was getting a dose of BioThrax, she had some come out (not confirmed at the time of reporting if she said if it was from the needle or not) but a drop or two went into her mouth, which was open (due to talking) and it tasted bad. The outcome of the reported event was not applicable.  Action taken with BioThrax with respect to the reported event was not applicable.  The concurrent conditions, medical history, and concomitant medications of the patient were not reported.  No additional information was reported.  Company comment: It was reported that a patient while getting a dose of BioThrax (anthrax vaccine adsorbed) had some come out and a drop or two went into her mouth (accidental exposure to product). Further information is limited. Considering the case information, the causality of accidental exposure to product is assessed as not applicable with BioThrax. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient while getting a dose of BioThrax (anthrax vaccine adsorbed) had some come out and a drop or two went into her mouth (accidental exposure to product). Further information is limited. Considering the case information, the causality of accidental exposure to product is assessed as not applicable with BioThrax. The case is considered non serious as per medical assessment.
Approximately 8 hours after the first dose of Pfizer COVID19 my torso, arms, neck and face became itchy and my hands swelled slightly.  Rest and cool shower relieved the symptoms in a few hours.   Approximately 8 hours after the second dose of Pfizer COVID19 my torso, arms, neck and face became itchy and a rash covered all these areas.  Shortly after my hands swelled to twice the normal size.  Benadryl was taken and rest.  The itching subsided after 24 hours and the swelling went down a few hours after the Benadryl was taken.  A headache, body aches, and fatigue persisted through the next 48 hours followed by just body aches and fatigue now.
Complained of pain left arm, hot to touch, swollen left arm, left side of chest and left shoulder and left side of neck. Mother called ER and gave ibuprofen and iced area. Swelling resolved in 2 days.
Seizure after returning home from getting vaccination (Grand mal) 2 hours post vaccination She had an stressful episode with elevated HR and normal SPO2 5 minute after the shot which was controlled with clonazepam
65 years old female felt chest palpitations. Onsite Ems responded Vitals BP 161/103 HR 93. We gave herba few minutes to relax. She felt better & released to home, she did say she hadn't eaten yet.
Patient had 30 minutes of chest pain and presented to hospital, and was airlifted. He underwent emergent LHC finding a severe LAD lesion that received 1 DES. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Chronic Urticaria/break out in hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, Ever since taking all the COVID Vaccines I have developed Chronic Urticaria), for COVID-19 immunization, reaction(s): "Chronic Urticaria". The following information was reported: URTICARIA CHRONIC (non-serious), outcome "not recovered", described as "Chronic Urticaria/break out in hives".  Additional Information: Patient told this would resolve in time but patient's last booster was Sep2022. Will this indeed resolve, and will future vaccines cause the same issue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300239563 same patient, different dose/event;
Patient presented to pharmacy on 9/15/18 stating that he started experiencing erythema, swelling, muscle tenderness, and itchiness on his right arm on the night of 9/12/18. He stated that the arm was so sore that he could not lie down on his right side and it lasted for about 2 days. Today, 9/15/18, he states that he is feeling much better; the erythema and itchiness is gone, but there is a little swelling and muscle tenderness left.
High fever, aches, chills, dry mouth, uterine cramping, extreme soreness at injection site
fever, chills, & rigor for 24 hrs un resolved with ibuprofen muscle soreness and stiffness at injection site for 4+ days itching at injection site for 7 days
Patient's mom--a nurse--called to report that she was called by the school to pick up her child due to adverse effects apparently stemming from receiving COVID-19 vaccination yesterday. She said she was cold, had a temp of 98, heart rate that increased from 104-108-118-127 (based on an Apple watch reading--I advised the mom to take it manually since she is a nurse to verify), her nails turned purplish temporarily (reversed to normal by the time of the call), and she felt very sleepy. Mom and I agreed that she should seek medical attention so she said she would take her to an Urgent care facility as she was not wanting to go to the hospital due to a weakened immune system (the mother's).
VERY sore L shoulder, less than 90deg elevation for 2-3days due to pain.  Fatigue, chills, low energy level, "flu-like" symptoms.
mom states about 1 hr p/vax pt seemed to be staring in space & mom shouted to pt & seemed to come out of it; repeated this in a few mins & agian shouted pt's name & pt was ok; called MD but did not tkae pt to see MD; poss sl sz;
Swelling and redness of about 1" x 1" over the Rt. thigh at the site of inj - Varicella.
24hr p/vax twenty five cent size reddened area;48hr p/local rxn redness anterior thigh & 1x2cm posteriorly lateral thigh;
First night...Severe Chills. Day 2..Loss of appetite &  weakness. 3rd day Loss of appetite Headache.
reaction following day pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever
Injection site swelling and redness. Loratadine 10 mg prn.
delayed cutaneous hypersensitivity reaction Narrative:  onset 8 days; duration 1 day; size of grapefruit