chrisvoncsefalvay/vaers-outcomes huggingface dataset:
difficulty walking/limping; fatigue/she felt tired; soreness of the arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (difficulty walking/limping), FATIGUE (fatigue/she felt tired), PAIN IN EXTREMITY (soreness of the arm) and CHILLS (chills) in a 31-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031283) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Oct-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) at an unspecified dose. On 06-Oct-2023, the patient experienced GAIT DISTURBANCE (difficulty walking/limping), FATIGUE (fatigue/she felt tired), PAIN IN EXTREMITY (soreness of the arm) and CHILLS (chills). On 07-Oct-2023, GAIT DISTURBANCE (difficulty walking/limping), FATIGUE (fatigue/she felt tired), PAIN IN EXTREMITY (soreness of the arm) and CHILLS (chills) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.
Patient notified pharmacy on 10/29/18. When she received the vaccination on 9/7/18 the next day she stated that she had deep body aches not relieved by acetaminophen or ibuprofen that lasted for about 3 weeks, then resolved, then 3 weeks later developed the same muscle aches but not more confined to her arm(s).
Polymyalgia rheumatica; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2022 at 12:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, other vaccine same date product= Pfizer,, other vaccine same date lot number= 5318,, other vaccine same date vaccine location= Right arm), for COVID-19 immunization; Bnt162b2 (DOSE 2, other vaccine same date product=Pfizer,, other vaccine same date lot number= 6199,, other vaccine same date vaccine location= Right arm), for COVID-19 immunization; Bnt162b2 (DOSE 3, other vaccine same date product= Pfizer,, other vaccine same date lot number= 3182,, other vaccine same date vaccine location=Right arm), for COVID-19 immunization. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant) with onset 20Apr2022, outcome "recovering". The event "polymyalgia rheumatica" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jun2022) Negative, notes: Nasal swab. Therapeutic measures were taken as a result of polymyalgia rheumatica.  Clinical Course: The patient did not receive any other vaccine in four weeks. No other medications received in two weeks. Prior vaccination, the patient not had covid vaccination. Post vaccination, the patient had tested for covid.   Follow-up attempts are completed. No further information is expected.
Next appointment is scheduled past 42 days of first dose/had to delay his second dose; His knee had to be drained of fluid; Fall; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Next appointment is scheduled past 42 days of first dose/had to delay his second dose), JOINT EFFUSION (His knee had to be drained of fluid) and FALL (Fall) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included INSULIN GLARGINE (LANTUS), LISINOPRIL, METFORMIN, DILTIAZEM, OMEPRAZOLE, ROSUVASTATIN, DOXAZOSIN, GLIMEPIRIDE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and RIVAROXABAN (XARELTO) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Next appointment is scheduled past 42 days of first dose/had to delay his second dose), JOINT EFFUSION (His knee had to be drained of fluid) and FALL (Fall). The patient was treated with Surgery (On 19-Mar-2021, the patient had a surgery due to a fall the patient had.) for Fall. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Next appointment is scheduled past 42 days of first dose/had to delay his second dose) had resolved and JOINT EFFUSION (His knee had to be drained of fluid) and FALL (Fall) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.  The reporter was calling on behalf of their husband who received their first dose of Moderna vaccine on 18-Feb-2021. On 19-Mar-2021, the patient had a surgery due to a fall the patient had, so they had to delay their second dose. The patient's knee had to be drained of fluid and now that the patient was recovering well their surgeon stated that the patient was able to receive the second dose on 08-Apr-2021.
SLEEPY; A spontaneous report was received from a consumer concerning her friend, a female patient in her 80's who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sleepiness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) through unknown route in the unknown location for prophylaxis of COVID-19 infection. On unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) through unknown route in the unknown location for prophylaxis of COVID-19 infection.  On an unknown date, after receiving second dose of vaccination patient experienced sleepiness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event sleepiness was unknown.
site redness, little warm and itchy about dime size for couple days after, felt a little sluggish for 1 day or 2 after. Last Wednesday 12/30/20 injection site came back with itching, redness about a dime size again, never gone away. Last night it was bigger about a size of a quarter, warm, red and itchy, took Zyrtec. This morning 1/6/21 it is about the size of my palm, warm, little itchy. I had headache and neck stiffness last week, but none as of yesterday. Forgot to mention on phone this morning.
Patient received vaccine on 9/16/20. Patient then presented to pharmacy on 9/18/2020 with itchy, red rash at injection site and on the trunk area- under breast, across abdomen, and from middle back down to gluteal area.
Kinrix given, but patient is not 4 years old.  No incident at time of vaccine. Unable to get call back from parent on any adverse effects.
Rash all over arms, legs, feet, stomach lasting about 2 1/2-3weeks started on 4-20-12 went to urgent care.
This spontaneous report as received from a pharmacist refers to a female patient of over 65 years of age. In August 2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. In August 2017, the patient experienced injection site pruritus and injection site erythema. The outcome of injection site pruritus and injection site erythema was reported as recovered/resolved. Sender's Comments: US-009507513-1708USA013436.
Nausea, muscle pain, ringing in ears, red circular rash at site of injection
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.   The patient's past medical history included chickenpox (have had chicken pox).   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she had the Shingles shot and immediately got shingles not really, it gave him/her shingles immediately.  The patient reported that, the vaccine gave him/her shingles.
pt recv vax; mom noticed inc T several hrs later; pt cried & mom found him unresponsive w/ upward turning of eyes & brought him to er; gen sz; lasted for approx 40 mins;
Pain in every joint.  To where I wasn't able to do anything.  Throwing up for about 10 hours. Headache. Chills, hot flashes
Pt called today stating that yesterday she started to get a "welp", redness and itching at the injection site.  Pt states she will not be seeking any medical attention for this and just wanted to let us know her reaction to the vaccination.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Joint Pain-Mild, Systemic: Weakness-Mild
Information has been received from a 46 year old female registered nurse with no known allergies, depression and tendonitis and a history of herpes zoster who administered Zostavax (Oka/Merck) to multiple patients on 19-JUN-2007, 21-JUN-2007, 26-JUN-2007, and 28-JUN-2007.  Concomitant therapy included trazodone HCl, CELEXA and nonsteroidal anti-inflammatory drug (unspecified).  The nurse reported that on 29-JUN-2007, she developed a widespread red, raised, itchy rash.  The physician prescribed oral prednisone and BENADRYL.  On 02-JUL-2007, the nurse was examined at a local emergency room complaining of intense itching and was prescribed ATARAX.  The patient's widespread red raised rash and itchy rash persisted.  Additional information has been requested.
8 hours after Shot 1, fever, chills, headache and light sensitive. Fever lasted 2 days and got up to 101.  Headache and light sensitivity never got better. After consultation with my Primary Care MD, I went to the ER on May 23, 2018. I had a Spinal Tap and MRI. My doctor was concerned about Meningitis, but I tested clear. I was treated with Migrane injection which did not help at all. Then a Steroid injection which helped a good deal. I got major relief from the Steroid injection. My Dr. put me on Valtrex and a MEDROL pack (steroids). After finishing the oral steroids, the symptoms returned. My Dr. prescribed more steroids yesterday. So now I am taking 2 MG of Dexamethasone Twice daily. This Vaccine has changed my life for the worse.....I can not go out in the sun or keep my blinds open and have live in a darkened room since the original injection of SHINGRIX. I wrote to GSK, the manufacturer, but they offered NO help, other than telling me to see my doctor.
First, shortness of breath which was unreported while happening, resolved in 30 minutes.  Second: Over the 24 hour period following vaccine, all symptoms of Lyme disease appeared in a cycle: extreme fatigue, muscle aches, joint aches, cardiac pain, head ache, "brain fog", neurological pain.  All symptoms resolved abruptly 24 hours after vaccine.
I feel cold; have chills & body aches; body aches; felt really tired, like I've been playing football; temperature was 99.5°F,My temperature was 105°F; I was sweating a lot; I couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (temperature was 99.5°F,My temperature was 105°F), HYPERHIDROSIS (I was sweating a lot), INSOMNIA (I couldn't sleep), FEELING COLD (I feel cold) and CHILLS (have chills & body aches) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 17-Mar-2021. Previously administered products included for an unreported indication: SHINGRIX (Vaccine given for left arm). Concurrent medical conditions included Pneumonia.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced BODY TEMPERATURE INCREASED (temperature was 99.5°F,My temperature was 105°F), HYPERHIDROSIS (I was sweating a lot), INSOMNIA (I couldn't sleep) and FATIGUE (felt really tired, like I've been playing football). On 08-Jul-2021, the patient experienced FEELING COLD (I feel cold), CHILLS (have chills & body aches) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BODY TEMPERATURE INCREASED (temperature was 99.5°F,My temperature was 105°F), HYPERHIDROSIS (I was sweating a lot), INSOMNIA (I couldn't sleep), FEELING COLD (I feel cold), CHILLS (have chills & body aches), FATIGUE (felt really tired, like I've been playing football) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, COVID-19: positive (Positive) Positive. On 07-Jul-2021, Pyrexia: 99.5 High. On 08-Jul-2021, Pyrexia: 105 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were Provided. Med Info Agent: 118722 and MOD21-118748. Caller received a phone call from Moderna and was asked to provide an email address. Patient stated that he got both shots and he's "all good now." Patient didn't clarify which shots he got.  He said, "Don't worry about it" and then disconnected the call.  He declined providing his email address.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Event outcome updated
expired Flublok was administered to a patient with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient, expired influenza quadrivalent recombinant vaccine [Flublok QIV] was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 19-Jun-2023, the patient received an unknown dose of suspect influenza quadrivalent recombinant vaccine (form, strength, lot number: unknown) (expiry date: 14-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination. Information on batch number was requested  On 19-Jun-2023 the patient had a non-serious event of expired flublok was administered to a patient with no reported adverse event (expired product administered) (latency: same day) following the administration of influenza quadrivalent recombinant vaccine.  It was unknown if any lab data/tests available.  Action taken with quadrivalent recombinant influenza vaccine (Flublok QIV) was not applicable.  Outcome: unknown.  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 guidelines. 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 dose of Rotarix vaccine was administered past 15 weeks of age. Infant is not having any problems per Mom via phone conversation on 12-6-22. This was infants first immunizations outside of Birth Hepatitis B in hospital.
p/vax pt devel some soreness in lt arm;arm remained sore but pain started on 5th day in muscle above bicep;pain progressed to whole arm & into neck in back of neck;pain head & wrist & muscle jerking;poss nerve was hit by needle per MD;
No additional AE reported; expired PNEUMOVAX 23 that was administered yesterday 2/26/2023.; This spontaneous report was received from a pharmacist and referred to a patient of unspecified age or gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reaction/allergies were not reported.   On 26-FEB-2023, the patient was vaccinated with expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter, lot #U022984, expiration date: 29-JAN-2023, administered for prophylaxis (strength and route of administration were not provided) (Expired product administered). No additional adverse event details available.
Information has been received from a nurse concerning a 17 year old female with a history of syncope after injections who on 13-AUG-2007 was vaccinated with a first dose of Gardasil (lot# unknown).  Concomitant vaccinations included MENACTRA and Tdap (manufacturer unknown).  On 13-AUG-2007 the patient fainted.  The patient fully recovered and was sent on her way.  Additional information has been requested.
5cm X 7cm erythematous, indurated, hot area at injection site. Also had chills, myalgias and headache.
NONE - REPORTING ERROR: PATIENT RECEIVED A 0.3ML DOSE OF PFIZER VACCINE THAT WAS MIXED WITH 0.8ML OF SALINE RATHER THAN 1.8ML OF SALINE, HUMAN ERROR ON PHARMACY PART OF PERSONNEL RECONSTITUTING VACCINE; PATIENT INFORMED ON 05/26/21 2:33PM OF VACCINE ERROR AND INSTRUCTED TO WATCH FOR ABNORMAL OR GREATER THAN NORMAL SIDE EFFECTS.
apparent sz (non febrile) x 2 day p/DTP adm to hosp, work up (CT, EEG, Ophth) neg discharged p/3 days; again sz (poss febrile) 3 days later began Phenobarb-awaiting MRI & neuro f/u;
I contracted COVID-19 with symptoms of headache, fatigue, runny nose, congestion, myalgia, and intermittent cough. I began taking Paxlovid 5/4/2022 antiviral which leaves me with a metallic taste in my mouth. I have had a mild illness/symptoms so far.
Could not turn head to left or look up , neck popping, shooting pain up into head, dizziness, forgetful (lost job), headaches 6 months. physical therapy helped (facet joint inflammation). still not 100% better
48-year-old female patient reports fever, severe body aches, chills, nasal congestion and severe headaches approximately 24 hours after the second dose administered on 4/14/2021. She currently presents with a bilateral severe temporal headache, nasal congestion and abdominal pain/indigestion on 4/21/2021.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 34 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "PCOS" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; SPIRONOLACTONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Conclusion of Previously Completed Investigation: The complaint for PFIZERBIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9693. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. Agency concluded that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to its Lack of efficacy cannot be ruled out.
sweat; Fever; body aches; Patient/Employee received a dose from an expired vial . Vial had also been punctured for more than 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (sweat), PYREXIA (Fever), MYALGIA (body aches) and EXPIRED PRODUCT ADMINISTERED (Patient/Employee received a dose from an expired vial . Vial had also been punctured for more than 12 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient/Employee received a dose from an expired vial . Vial had also been punctured for more than 12 hours). On an unknown date, the patient experienced HYPERHIDROSIS (sweat), PYREXIA (Fever) and MYALGIA (body aches). On 01-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Patient/Employee received a dose from an expired vial . Vial had also been punctured for more than 12 hours) had resolved. At the time of the report, HYPERHIDROSIS (sweat), PYREXIA (Fever) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.  Vial was punctured on 31-Jan-2022 around 4:30pm.   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2022: non-significant follow up appended: No new information
Lethargic, unable to concentrate, memory ok. Lasted approv 48 hrs then everything ok.
Pt recvd MMR vax on 19APR88 & 1MAR91 devel a cough, fever & had been vomiting; seen by MD found to be pos for coryza & for Koplik's spots; dx measles;
no additional adverse events; Expired dose administered; This spontaneous report was received from an other health professional and refers to a 34-year-old patient. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided.  On 03-MAY-2021, the patient was vaccinated with expired hepatitis a vaccine, inactivated(VAQTA), 0.5 milliliter, non-valid lot # T01590 with expiration date 14-APR-2021, for prophylaxis. There was no previous temperature excursions. There was no additional adverse events reported.