chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDSAIL 9 (lot # L007560, expiration date 15-JUN-2017; strength, dose and frequency were unknown; intramuscular) and GARDASIL (lot # K007828, expiration date 02-MAR-2017; strength, dose and frequency were unknown; intramuscular) (interchange of vaccine products and overdose), which were exposed under temperature of 34.5  degrees Fahrenheit for 5 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Patient left deltoid red and hot. Lines drawn around the area and parent informed to contact the clinic if the red area grows outside the drawn lines and/or if the area becomes hotter to the touch.
gave 2nd shot at day 23 not day 24.  miscalculated days.
Patient reported feeling light headed with a dry throat.  We checked her blood pressure and pulse.  BP was 138/89  and Pulse was as high as 133.  EMS was called, she wanted to go to ER to be monitored.
Pfizer-BioNTech Covid 19 Vaccine EUA Tight throat about an hour after vaccine injection. Tight throat lasted 14 days. Took ibuprofen . Itchy all over after 24 hours. Lasted 14 days
Severe headache, body aches, slight nausea,, complete fatigue unable to function, chills, fever101.6 (highest) total feeling of unwell
Pt was given a Flublok vaccine at 17 years old. This vaccine is only indicated for 18 years and older. No known reactions occurred.
patient was given an expired dose of Adacel with no adverse event; Initial information received on 08-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient (age and gender not reported) who was given an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL) (lot U5898AA expiry date-30-Mar-2020) for prophylactic vaccination.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U5898AA exp date-30-Mar-2020) for prophylactic vaccination.  It was an actual medication error due to expired vaccine used. (expired product administered).   At the time of reporting, the patient had no adverse 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 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.
Systemic: syncope-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: syncope
I discussed with patient's parent that the vaccine may not be as effective given the expiration, and therefore it would need to be repeated.  They have scheduled a follow up appointment for next week when the new vaccine arrives to repeat the vaccine.
Subjective fever began the night following vaccine administration. The following morning, patient had several episodes of vomiting. He was noted to be increasingly sleepy and lethargic as the day went on.
One month after second dose she started with Idiopathic hives, and urticaria all over body; Rash comes and goes after 2nd dose, Rash comes randomly in random places on the body after 2nd dose, Not sure if the rash is related to the vaccine; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of URTICARIA (One month after second dose she started with Idiopathic hives, and urticaria all over body) and RASH (Rash comes and goes after 2nd dose, Rash comes randomly in random places on the body after 2nd dose, Not sure if the rash is related to the vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced URTICARIA (One month after second dose she started with Idiopathic hives, and urticaria all over body) and RASH (Rash comes and goes after 2nd dose, Rash comes randomly in random places on the body after 2nd dose, Not sure if the rash is related to the vaccine). The patient was treated with PREDNISONE from April 2021 to May 2021 for Adverse event, at a dose of 2 courses; LORATADINE (CLARITIN [LORATADINE]) ongoing since an unknown date for Adverse event, at a dose of 10 mg once a day; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at a dose of 10 mg twice a day and MONTELUKAST SODIUM (SINGULAIR) ongoing since an unknown date for Adverse event, at a dose of 10 mg once a day. At the time of the report, URTICARIA (One month after second dose she started with Idiopathic hives, and urticaria all over body) and RASH (Rash comes and goes after 2nd dose, Rash comes randomly in random places on the body after 2nd dose, Not sure if the rash is related to the vaccine) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Patient was referred to an allergist whom did blood works, tested for allergies. All tests were normal..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   At the time of report, patient has a follow up appointment to see the allergist again next week.  No relevant concomitant medications were reported.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported similar event for 3 patients. This is the first of 3 reports. A patient of unspecified age ethnicity and gender received on the same unspecified day PREVNAR 13, at single dose and influenza vaccine both for immunisation. The patient medical history and concomitant medications were not reported. The patient previously received flu shot. The patient was sick after getting the flu shot plus pneumococcal 13-val conj vac (dipht crm197 protein) on an unspecified date with outcome of unknown. Information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018080774 same drug event different patients; US-PFIZER INC-2018080773 same drug event different patients.
patient developed autism after M-M-R II was administered; This spontaneous report was received from a nurse via company representative, and refers to a 7-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, after measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was administered, the patient developed autism. The patient did not recover from the event.  The causality assessment between autism and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.  Upon internal review, the event of autism  was considered to be medically significant.
Pruritus; Lip swelling; Case reference number BN-2022-000854, initially downloaded on 28-Mar-2022, is a spontaneous case received from a health professional via Health authority (ID: 2173543-1) and concerns a 35-years-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 18-Feb-2022, the patient was vaccinated with the second dose of RabAvert (inactivated rabies virus vaccine; batch number: yrba821a), at an unknown dose, intramuscularly, in the left arm, for unknown indication.  On 20-Feb-2022, two days after the RabAvert, the patient began experiencing itchiness on the arms and extremities followed by swelling of the lips and the patient took diphenhydramine (Benadryl) on Sunday.  At the time of this report, the patient's symptoms lip swelling and pruritus resolved on Sunday, as reported.  The reporter assessed all the events as non-serious. Causality for the events was not provided.  No further information was provided.; Reporter's Comments: A 35-year-old female patient experienced non-serious events of pruritus and lip swelling on the day 2 after the vaccination with the 2nd dose of RabAvert for unknown indication. The events of pruritus and lip swelling are listed according to the Datasheet v6. Time-to-onset was plausible. The patient's medical history and concomitant medication details were not provided. Reportedly, the patient recovered from the events. Considering plausible temporal relationship, known product safety profile and since the contributory role of the suspect vaccine cannot be excluded with certainty, pruritus and lip swelling have been considered as related to RabAvert. This case is considered as non-serious.; Sender's Comments: A 35-year-old female patient experienced non-serious events of pruritus and lip swelling on the day 2 after the vaccination with the 2nd dose of RabAvert for unknown indication. The events of pruritus and lip swelling are listed according to the Datasheet v6. Time-to-onset was plausible. The patient's medical history and concomitant medication details were not provided. Reportedly, the patient recovered from the events. Considering plausible temporal relationship, known product safety profile and since the contributory role of the suspect vaccine cannot be excluded with certainty, pruritus and lip swelling have been considered as related to RabAvert. This case is considered as non-serious.
Febrile seizures at 2400 4/27/04 went to ER. Temp 102.2 F.
Booster dose of Janssen COVID-19 vaccine was administered into left deltoid on 12/21/2021 at 1215. Reported feeling body aches, fever and chills next morning (12/22 AM). On the evening of 12/22/21 patient began to feel a sensation of tingling and cramping in quadriceps. Throughout the following day (12/23/21) the tingling and cramping sensation became more intense, progressed to numbness and weakness in legs, and spread to arms as well. Patient spoke to an acquaintance who is a neurologist who advised patient to go to ER because signs and symptoms were consistent with Guillain-Barre Syndrome. On Sunday 12/26/21 patient reported to ER as symptoms worsened. ER believed that he either has Guillain-Barre Syndrome or an acute autoimmune response to Janssen COVID-19 Vaccine. Patient received an IV corticosteroid while at the hospital and began a Medrol dose pack on Monday 12/27. Patient followed up with PCP office on Monday. His physician is currently out of town so he met with the nurse practitioner of an associated physician. Multiple sclerosis and tumor were both ruled out. He was diagnosed with an acute allergic reaction to Janssen COVID-19 Vaccine. Patient was told if symptoms have not subsided by the end of current Medrol Dose Pack he will repeat. As of today, patient is still experiencing neurologic symptoms in legs and arms which has started to spread to the face. Told patient to follow up with any further questions or concerns.
having pain in the Armpit, Elbow and Shoulder by clavicle; Pain in the Right Armpit, Elbow and Shoulder by clavicle; Pain keeps coming back; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (having pain in the Armpit, Elbow and Shoulder by clavicle), ARTHRALGIA (Pain in the Right Armpit, Elbow and Shoulder by clavicle) and PAIN (Pain keeps coming back) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced AXILLARY PAIN (having pain in the Armpit, Elbow and Shoulder by clavicle), ARTHRALGIA (Pain in the Right Armpit, Elbow and Shoulder by clavicle) and PAIN (Pain keeps coming back). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, AXILLARY PAIN (having pain in the Armpit, Elbow and Shoulder by clavicle), ARTHRALGIA (Pain in the Right Armpit, Elbow and Shoulder by clavicle) and PAIN (Pain keeps coming back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant drugs included
'15min episode of nausea then vomiting about 10 - 15min after receiving HAVRIX
Received one dose of Shingrix, have disabilities; one dose in 2019, never received second dose; This case was reported by a nurse via call center representative and described the occurrence of disability in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced disability (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the disability and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the disability to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient had received 1st dose of Shingrix vaccine back in 2019 and till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination and the patient had disabilities. The nurse stated that most of their patients were disabled and lives in residential houses. They live in group home settings and they all had disabilities. No information was available for lot number and expiration date at the moment of the call. The reporter consented to follow up by fax.
I had a rash on arm, migraines, itchiness around the mouth. Itchy and swollen throat. Shortness of breath.
Headache, Myalgia & Arthralgia Employee got the second dose 1/28/21, 1030am she claimed that 12pm started having headache fatigue, chills muscle soreness, body ache These progressed to second day , there is associated diarrhea she could not make it to work on 01/29/21 she stated that she took ibuprofen that helps with some reliefs Employee denied h/o previous allergy to vaccine
he 1st dose was Sputnik COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (he 1st dose was Sputnik COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (GAM-COVID-VAC) (SPUTNIK V (GAM-COVID-VAC)) injection for COVID-19 vaccination.    No Medical History information was reported.   On 15-Apr-2021, the patient started COVID-19 VACCINE NRVV AD26 (GAM-COVID-VAC) (SPUTNIK V (GAM-COVID-VAC)) (unknown route) 1 dosage form. On 13-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (he 1st dose was Sputnik COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (he 1st dose was Sputnik COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.
Pt called pharmacy 10/11/2018 says his arm hurts from the flu shot he got back on 9/26/18. Pt claims he was "injured by a flu shot at hospital few years ago and it feel the same". I advised him to see his MD right away to have his arm checked out, and call the pharmacy's risk management dept. to report the incident.
On 6/6/2021 during the Pfizer 2nd dose injection I experienced severe pain in my spine and dizziness. On 6/23/2021 I developed the following symptoms: vision problems/disturbance, spine pain, vertigo, nystagmus, muscle twitching, muscle spasms, myoclonus, internal vibrations, tremors, numbness in limbs, fatigue, dizziness, head pain, brain fog, head pressure, tingling in limbs, weakness in arms & legs, burning sensations. I was later diagnosed with the following disorders after a multitude of doctor visits, tests, & imaging: Vertigo:Diagnosed 8/13/2021, Visual Snow Syndrome:Diagnosed 9/15/2021, Nystagmus:9/23/2021, Functional Neurological Disorder & Vestibular Disorder:Diagnosed 7/15/2022   Vestibular Disorder includes Mal de Debarquement, Vestibular Migraine, and Benign Paroxysmal Positional Vertigo due to Bilateral Vestibular Disorder, Malaise, Imbalance. For Visual Snow Syndrome Diagnosis on 9/15/2021, per doctor visit and medical records indicate "there is no current effective treatment for visual snow".  Additional information for Item 19: Audiogram 6/14/22, Video Head Impulse Testing (vHIT) 6/14/22, Vestibular Evoked Myogenic Potentials (VEMPs) 6/14/22. Thyroid Disorder Screen, Infectious Encephalopathy, Screening for iron deficiency anemia, Diabetes Mellitus Screening 8/4/21. Protime & APTT STAT Blood Test 1/4/22. ECG & Chest x-ray 8/20/21. Intraocular Pressure Exam 9/15/2021.
red swelling on arm of the site of shingles injection (also got tdap but reaction was lower around the shingles injection)  roughly a circle the size the bottle of a water bottom
After IM (COVID -19) injection to Left arm experienced severe deltoid area pain as if bone was "fragmented" within days pain radiated to upper arm / shoulder and eventually neck area (left sided).  Pain continued and I started to have limited mobility of arm. Difficult to move arm backwards (limited)  Unable to fasten bra for my left arm currently is unable to extend backwards Limited with range of motion Still experience discomfort and on occasion arm goes numb. Unable to sleep on my left side due to excruciating pain
Had redness and soreness next day and healed within 3 days or so. 9 days from shot redness reappeared along with hot to touch and itchiness
Sore arm; Administration of second dose of vaccine past 36 days post first dose of vaccine; Administration of second dose of vaccine past 36 days post first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PRODUCT AVAILABILITY ISSUE (Administration of second dose of vaccine past 36 days post first dose of vaccine) and PRODUCT ADMINISTRATION INTERRUPTED (Administration of second dose of vaccine past 36 days post first dose of vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PRODUCT AVAILABILITY ISSUE (Administration of second dose of vaccine past 36 days post first dose of vaccine) and PRODUCT ADMINISTRATION INTERRUPTED (Administration of second dose of vaccine past 36 days post first dose of vaccine). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PRODUCT AVAILABILITY ISSUE (Administration of second dose of vaccine past 36 days post first dose of vaccine) outcome was unknown and PRODUCT ADMINISTRATION INTERRUPTED (Administration of second dose of vaccine past 36 days post first dose of vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: F/U received on 16-jun-2021 .No New Information reported.. Declined consent for follow up.
Within  minutes I became flush and very hot. My heart starting racing. I had blood pressure check and heart rate.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 29-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Fever around midnight that lasted until about 5 AM on 8/25/21. Muscle pain in legs first noticed around 3:00 a.m. Soreness at injection site. Severe headache first noticed around midnight on 8/25/21. Difficulty regulating body temperature has lasted from 5 am until present time. Very tired and feel weak.
Patient had seizure activity - eyes rolled back, clonic-tonic, muscular contractures, verbal grunting noise, voided on self. Nausea reported after seizure type activity. Lasted approximately 2 minutes. After history - child had done this at a concert 2 wks ago and at school. No app and follow up until today.