chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included autoimmune disorder and post herpetic neuralgia.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: Age at vaccination was not reported. The patient received first dose of Shingles and still experienced shingles. The patient also has historic autoimmune condition, after effects of which were experienced even after 5 years called post hepatic syndrome. The patient received second dose of Shingles and had no recurrence. The reporter consent to follow up was not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR258508:Same reporter, same product, same patient - case for another dose
Pediarix dose #4 given to baby instead of intended flu vaccine. Grandmother reports child experienced mild fever the evening after the vaccination.  Today, child has a runny nose.
Extreme fatigue,  head ache, chills, severe generalized body aches, (temp 95.5 F).  Started the day after vaccine, 12/20/20, and lasted until 12/21/20. Tylenol was taken for immediately after vaccine and continued until 12/21/20.
left side of face red; eye lid droop; bumps left side face (breakouts); This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (left side of face red), EYELID PTOSIS (eye lid droop) and RASH (bumps left side face (breakouts)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced EYELID PTOSIS (eye lid droop) and RASH (bumps left side face (breakouts)). On 22-Apr-2021, the patient experienced ERYTHEMA (left side of face red). At the time of the report, ERYTHEMA (left side of face red), EYELID PTOSIS (eye lid droop) and RASH (bumps left side face (breakouts)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
I have been in Graves? disease remission since 2018. Since my second vaccine I have even thrown into a huge flare up. I have muscle aches, I can?t catch my breath, I have anxiety,  tremors, I am heat intolerant, and I can not sleep. I feel like my brain is in a fog and I can?t keep my thoughts.
Patient has developed rash on left side of back that was diagnosed by a doctor as shingles.; Patient has developed rash on left side of back that was diagnosed by a doctor as shingles.; This is a spontaneous report from a non-contactable consumer via Pfizer company representative. A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8736, Expiration date: not reported), via intramuscular on 22Apr2021 (at the age of 35-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included known allergies: Medical gauze. The patient received weekly allergy shot in two weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8737, Expiration date: not reported), via intramuscular on 01Apr2021 (at the age of 35-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, no other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 29Apr2021, the patient has developed rash on left side of back that was diagnosed by a doctor as shingles. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment medication included Valtrex (Valacyclovir). The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Headache, no treatment, lost of memory, no treatment joint pain, no treatment. 1/11/2010 Unexplained headaches, difficult to breath and memory lost.
pt recvd vax; started fever eve of 2nov94; t of 101.5-103.5 on 3nov94 & started twitching w/ body stiffenings; was given sponge bath & subsequent reduction of fever;
After administration of the vaccine, the patient got light headed and clammy. The patient never loaded consciousness. His heart rate is normally in the 80s according to his mom, who is a nurse practitioner. His heart rate dropped to 69. The mom did not want an ambulance called. Monitored the patient for 20 minutes. He was completely alert and held a conversation the entire time.
This is a spontaneous case, initially received on 29-Nov-2017, from other health professional (nurse), concerning a 02-year-old male child. The patient's medical history included GERD (Gastroesophageal reflux disease). On 02-Oct-2017, the patient was administered with FLUCELVAX QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left thigh, batch number: 195218, expiry date: 30-Apr-2018). It was reported that the patient had no adverse event. The reporter assessed the case as non-serious. Non-significant follow-up received from other health professional (nurse) received on 02-Jan-2018: The other health professional (nurse) confirmed that patient did not have any adverse event.
Pt came after 30 mts with hives, chocking & itching all over. In clinic Epipen & Albuterol nebulizer, & Depomedrol given & Pt still has hives & c/o headache & sent to hospital ER
Received Flu shot 11/22/10 - 1 hr later started to hurt, chest heavy (has fibromyalgia) pain warm (L) face went onto head & shoulder & whole body hurt pain mainly upper shoulders & ears "feel like on fire, no temp, says feel like has fever no temp - says arm hurts/no redness etc. -  refused to left me see dr says hurts to talk.
Hands, Arms, would not work. WAlking with help. Lack of memory for several hours
around 4AM of 01/06/21 (approximately 10 hours after receiving injection) I woke up with stomach cramps, feeling as if I needed to have a bowel movement which is extremely unusual at that hour. I went to the bathroom and ended up having extreme diarrhea. Went back to sleep, proceeded to wake up at 7am for work (I work at a hospital). Went to work, temperature upon arrival to work at 8am was 96.7. Didn't start to experience any other symptoms till around 10-11am. Developed a headache and thought, "hm this is weird, I haven't had a headache since I had COVID but I hope it goes away soon." Then I went to lunch at noon and everything hit me all at the same time - freezing and sweating profusely, headache became so debilitating that it was burning/hurting my eyes, uncontrollably shaking, felt so weak (body aches all over, everything hurt). Took my temperature while I was at home for lunch and it was 101.5 and my heart rate was 160 (my heart rate is usually high because I take a stimulant but it is never that high). Went back to the hospital because I wanted to go to the ER and needed to get the rest of my belongings anyways. The ER physician and staff found the same things when doing initial vitals - high fever and heart rate. I made the ER physician aware of the fact that I had just received the vaccine the night before while also just having had COVID less than one month prior. I was instructed to go home at that point to get rest and recover. For the rest of the day on 01/6/21 and all of 01/7/21 I had to take off work because of adverse symptoms and effects. For all of 01/7/21 I was extremely fatigued and the headache never went away until 01/08/21.  On 01/08/21 I returned to work and symptoms diminished.
pt recv vax 21JAN98 & 7FEB98 pt devel & rash & 24 skin lesions;
Pt recvd 3 doses of Engerix-B on 6DEC90, 23JAN91 & 25JUN91; 20AGU91 lab tests indicated did not convert; recvd a booster dose of Engerix-B 20AUG91; 17SEP91 lab tests indicated pt did not convert; recvd a 2nd booster of Engerix-B 18SEP91;
Needle malfunction resulted in most of the vaccine to be wasted; patient agreed to receive a full dose.
At 0840 am FLUMIST given. At 0850 student c/o headache to front part of head and around eye area stated history of sinus and allergy problem. BP taken 110/80 HR 85 Rep 20 - 0910 student report headache worse. Student given BENADRYL 10 ml PO strong orders. No other S/S, stated just felt weak. No problem breathing, no erythema, no urticaria, no wheezing, no angioedema. 1110 states feeling better - mom to pick up after test.
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 65 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Feb2021 as dose 1, single (Lot number: 032330a), on 03Mar2021 as dose 2, single (Lot number: 029A21A), on 21Oct2021 as dose 3 (booster), single (Lot number: o61e21a), in right arm and on 27Apr2022 as dose 4 (booster), single (Lot number: 048l21a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "HIV+" (unspecified if ongoing), notes: other medical history: HIV+. Concomitant medication(s) included: JULUCA; SYNTHROID; ROSUVASTATIN; TESTOSTERONE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Nov2022) Negative; (25Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti viral details: Product: COVID 19 Treatment brand: Pfizer treatment from 14Nov2022 to 19Nov2022.
Patient woke at 4 am with a fever, then began having unusual jerky movements, hitting herself, flapping hands, head turning or nodding.
Patient called hospital call center on 1/21/22 reporting symptoms of body aches, pain,  cough, and runny nose.  Fever and tender arm pain were noted the same day when she received teh booster shot.  Pt reported she had close contact(family members) testing positive for COVID. She found out of their positive covid test on the same day she got her booster shot.   Pt was scheduled for visit with urgent care 1/21/22. COVID test was ordered for patient by MD. ED precautions educated to patient.
Fever, red rashes, swelling, hives, fatigue & appetite loss were immediate.  After 24 hours staring spells began occurring several times a day, loss of speech, Decreased coordination & loss of eye contact.
Next day woke up with flu-like conditions--chills, sweats, and tiredness--, which lasted through evening.   Patient did not take any medicine or did any treatment other than resting and did not call doctor.   On 8/15 patient felt fine On 8/16 chronic stomach issues started: burning sensation and stool not normal.  Contacted GI doctor in the afternoon and requested to submit another stool sample; dropped it off on 8/17.    Patient submitting another sample because lab missed some tests.    Symptoms are on and off, achy stomach, and having sensation to have to go.   Has follow-up appointment with PCP on Monday.  Patient did not have problems after the first vaccine dose
Injection site is hot,  red, swollen to a 3" area at injection site.
The Pfizer (maroon cap) vaccine was administered to this patient who is 4 years old. However, the nurse used the incorrect volume of diluent to reconstitute the vaccine vial. 1.3ml of sodium chloride was used for reconstitution instead of the required 2.2mL for the maroon cap vaccine. The patient was given the vaccine and monitored during the observational phase. No adverse event was seen.  Contacted Pfizer representative for more information regarding future vaccination schedule. Pfizer representative stated that the patient should just continue the vaccination schedule normally as indicated by the CDC guidelines.
This spontaneous report as received from a pharmacist refers to a 76 year old non-pregnant female patient with no known allergies. IT was reported that the patient had an unspecified reaction to a flu shot, could not rule out ALFURIA, administered on an unspecified date in 2013 (also reported as "last year"). On 08-JUL-2014 the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (dose not reported, lot # J011882, expiration date 04-JAN-2015). On 09-JUL-2014 (also reported as "the following day") the patient complained of swelling, redness and pain at the injection site. On 09-JUL-2014 the patient visited an unspecified physician and was diagnosed with cellulitis. The patient was prescribed doxycycline for 7 days as well as an unspecified cream. The patient was not recovered as of 11-JUL-2014. The relatedness between ZOSTAVAX and the events was not reported. This is one of several reports from the same source. Additional information has been requested.
Patient developed fever of 101.3, body aches and had a 5 second syncopal episode then vomiting the day of the vaccine
Left deltoid area is minimally erythematous and indurated- 7x12cm. Not warm to touch, scabbed entry point of needle (teen says he "pick at it"). Local adverse reaction-topical only.
COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for herself. A 67-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 09Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 virus test positive on 18Jan2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 18Jan2021. She was still sick.  The information on the Lot/Batch number has been requested.
This case was reported by a physician and described the occurrence of swelling of arteries in neck in a 20-year-old female subject who was vaccinated with Havrix, for prophylaxis. The reporter is the parent of the subject. The subject's medical history included penicillin allergy. Concurrent medications included Advair. On 14 June 2006 the subject received 1st dose of Havrix in the left arm. On an unspecified date on or after 14 June 2006 and on or before 16 June 2006, less than one week after vaccination with Havrix, the subject experienced carotid artery swelling, "cervical puffiness" and arm pain. The subject was seen at a physician's office. At the time of initial reporting, 16 June 2006, the events were ongoing. The physician considered the events were possibly related to vaccination with Havrix.
8 hours after injection started with extreme fatigue, chills , sore arm. Over next 7 days experienced severe symptoms : fatigue, myalgias, chills, arm pain, nausea, vomiting , abdominal pain, mental fog, insomnia, anorexia, change smell.
approx 36hr p/vax pt c/o gen hives, inc swollen eyelids, no resp distress;took DPH on own;instructed to go to ER p/consulting primary care provider;in ER given IV solumedrol & DPH put on pred & DPH;
Not adverse reaction report: Administration error. Patient had requested Hi-dose Flu vaccine but instead received Moderna Bivalent dose.  Later discovered she had COVID 1 month prior to date of vaccination --(so we were told she should have waited 3 months per CDC/FDA.
Pt was given two doses of polio vaccine during well child visit. One dose in pentacel, one dose of IPOL. Pt did not exhibit any negative signs or symptoms while in office. Pt parent contacted by provider approx 2 hours after and no negative signs or symptoms were reported.
12-1 n on following dya, woke up with hives at injection sites (R and L deltoids) which have ? distally while clearing proximally on following 48 hours.
Pt is a 24 year old gentleman who had a tetanus shot in his left arm on July 26th because of a superficial injury on his left ring finger. He developed arm or shoulder stiffness within 4 hours of that episode and it has gotten gradually and steadily worse since then. He has been using Tylenol 3 or 4 tablets twice a day. No other medications. Pt has a great deal of tenderness along the lateral superior edge of the rotator cuff at the edge of the AC joint. He has a positive impingement sing at 80 degrees of abduction and also with internal rotation. Assessment: rotator cuff tendinitis, possibly precipitated by his tetanus immunization. He is instructed in pendulum range of motion exercises. He is given Bextra 20mg to talke 1 po qd, #15 samples. He is to ice this if it is particularly bother ing him. He is to follow-up if this is not gradually improving.
I experienced numbness, tingling sensations and weakness in my arm starting on the day of my vaccination (01/04/2021). It is especially troublesome on my left hand/fingers. It is worse in the morning when I wake up, but it gets better with movement of my arm/hand to complete my normal day activities.
feel very tired on 29OCT-30OCT fever, chills, h/a, diarrhea had it 10-12 days; fever 100-101;flu shot given 25OCT95 still feel tired;nurse told pt that she had 'start of virus' when vaxed, made it 'twice as diff'
Persisting sharp to dull ache pain to shoulder joint area and difficulty moving left arm, up/down and left to right/right to left motion. No swelling/redness/rash/hives/drainage noted or any other symptoms. Still present today but improved with home treatments such as cold compresses, oral and topical inflammatory medications, brace and rest.
Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: cough-Severe
Information has been received from a registered nurse concerning a female (age not reported) who in approximately December 2006, was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast).  In approximately December 2006, when administering the vaccine with the prefilled syringe, the nurse release the spring before removing the syringe, therefore causing the patient pain at the injection site. No additional information was available at the time of reporting. No further information is available. This is in follow-up to report(s) previously submitted on 1/16/2007. Additional information was received from the registered nurse via telephone who reported that the patient received the full dose of the GARDASIL. No additional information is expected.
redness, arm was red; soreness, sore arm; chest broke out, rash on her chest, spine, ribs and pelvic area all on her right side; headache; diarrhea; achy joints; itching; This case was reported by an other health professional via sales rep and described the occurrence of erythema of extremities in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th January 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced erythema of extremities, pain in arm, rash, headache, diarrhea, joint pain and itching. On an unknown date, the outcome of the erythema of extremities, pain in arm, rash, headache, diarrhea, joint pain and itching were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, pain in arm, rash, headache, diarrhea, joint pain and itching to be related to Shingrix.  Additional details were provided as follows: The medical assistant reported that the patient received the 1st dose of Shingrix on an unknown arm.  The patient called the physician's office after the vaccination and reported that her arm was red and sore and her chest broke out and she had a headache, diarrhea, achy joints, rash on her chest, spine, ribs and pelvic area all on her right side.  The patient had no pain but only itching.  All of her symptoms resolved after two weeks. The reporter provided the consent to follow up.
Child was feeling nauseated, fever, myalgia after working a twelve hour shift. Call to dr after hours and sent to hospital.
Patient received 0.5ml of Moderna for booster instead of 0.25ml. Patient w/o any adverse symptoms on date of vaccination.
pt recv vax & devel a gen rash all over the body;f/u from MD office indicated pt was vaccinated on 22OCT96 & devel a chickenpox on 7NOV96;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 at 13:15 as dose 5 (booster), single (Lot number: GH9694), in left arm and on 22Apr2023 at 08:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300199940 Same patient, different product, different event;
Daptacel expired on 07-FEB-2020 and was given on 21-FEB-2020/no AE; Initial information received on 27-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a male patient (unknown age) who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 21-Feb-2020 which was expired on 07-Feb-2020 (expired product administered)  for prophylactic vaccination via an intramuscular route [ dosing details 0.5 ml , expiry date: 07-FEB-2020, lot number and site of administration not reported].  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event reported.  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 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.  Information on the batch number was requested.