chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness extending past injection site on left arm antibiotics started 4 days after initial reaction to 2nd dose of vaccine despite abx/elevation, redness/pruritis extendend on upper arm patient being admitted for abx/vancomycin/rocephin pending cx's for possible cellulitis.  allergy specialist consulted - recommended zyrtec  20mg bid
Patient tested positive for COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient tested positive for COVID) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 17-May-2022 and Moderna COVID-19 Vaccine on 14-Jun-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Blood pressure high. Concomitant products included HYDROCHLOROTHIAZIDE for Blood pressure high, ASPIRIN [ACETYLSALICYLIC ACID] and ATENOLOL for an unknown indication.    On 14-Nov-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient tested positive for COVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient tested positive for COVID) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         Height of the patient was reported as 5 feet and 1 and a half inches or 5 feet and 2 inches.  It was reported that the patient got Moderna shot in arm twice.  The patient tested positive for COVID and doctor prescribed Paxlovid. The patient had been sick for few days and the patient was also sick at the time of reporting.
This spontaneous report as received from a healthcare worker refers to a 4 months old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 12-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2015, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Saturday 7/29/2023 the vaccination provided was not diluted. Monday morning 7/31/2023 the vial was found on a tray with less than one dose left in it, when there should have been 9 doses left. When MA who administered vaccination was asked about circumstances she reported that she thought she diluted the vaccination and threw away the dilutent. The dilutent was not found. No other patients received this vaccination on Saturday 7/29/2023 or Monday 7/31/2023.
Patient presented with redness and swollen upper arm on the same day of administration. The next day her mother noted some blisters also in her upper arm.
Information has been received from an employee health registered nurse concerning a 48 year old female anesthesiologist with a history of anemia, arthritis, asthma, hay fever, and kidney disease, who on 4/27/04 was vaccinated SC on the left side with a 0.5cc dose of VARIVAX (lot # 645044/0207N). Prior to vaccination, on 4/19/04, an antibody titer for varicella was negative. By 5/23/04, the patient had developed a rash on the hairline of her scalp, then on the scalp, and then on the rest of her body. The patient reported that it looked like chicken pox and she went to a dermatologist. The patient had no history of chicken pox and no recent exposure to chicken pox or herpes zoster. The patient was treated with steroids for the inflammation. On 5/26/04, a biopsy of a lesion confirmed herpes zoster. The patient was treated with a prescription anti-viral medication. The rash had a duration of one to two weeks and subsequently, the patient recovered. A product quality complaint was not involved. The reporter considered herpes zoster to be an other important medical event (OMIC). Additional information is not expected.
18 MIN AFTER HPV VACCINE WAS ADMINISTERED, PT STARTED SMILING AND TWISTED HER FACE AND MOM VERBALIZED THAT SHES STARTING TO HAVE A SEIZURE. NOTED SYMPTOM LASTED FOR 3 MINUTES THEN PT STARTED LOOKING SPACED OUT AND STARTED DROOLING. PT WAS PLACED ON THE FLOOR FOR SAFETY, VS RECORDED, O2 @ 3L/MIN STARTED. MANDOWN CALLED. MOM ADMINISTERED DIASTAT 2O MG/RECTUM (HER EMERGENCY SUPPLY FROM HOME) @ 6:55PM. DR RESPONDED CALL AND EVALUATED PT/CALLED PER; MANDOWN TEAM ARRIVED @ 7:10PM. PT BROUGHT TO DEM @ 7:18PM BY MANDOWN TEAM.
no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 28-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034394, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
4 month old male had had upper extremity movements 2-3 wks prior. He received vaccines 7-21-09 in AM. He had a generalized seizure 16-20 hrs after vaccine administration. He needed intubation after administration of anticonvulsants.  8/17/09 Hospital records received DOS 7/22/09 to 7/23/09. Assessment: Seizure disorder. Patient presents with seizure activity lasting 40 minutes. Started on left arm, progressed to left leg, continuing to generalized seizure. Post admission left sided focal seizure of 5 minutes duration.  ICD-9 Codes: 780.39 Other Convulsions, 345.10 Gen Convul Epilepsy w/o Mention Intract Epilepsy.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 9:40 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 9:40 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 74.46. No concomitant medication was reported by reporter. Batch number 041L20A underwent temperature excursion on 11-Jan-2021 with temperature 35 degrees Fahrenheit at 02:00 PM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 11-Jan-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken by using a  traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
Information has been received from a company representative concerning a 13 year old female who on 10-APR-2008 was vaccinated IM with her first dose of GARDASIL (lot# unknown, site not reported). Concomitant therapy included VARIVAX. The patient was given the vaccination standing up and subsequently fainted. She was sent to the hospital emergency room because she fell but was not hospitalized. The patient recovered. No further information was available. Additional information is not expected.
This initial spontaneous case, was received from other health professional (nurse) on 31-Oct-2017, concerning a 41-year-old adult male patient. The patient had no any medical history or concomitant medications. On 31-Oct-2017, the patient was administered FLUVIRIN Thiomersal (dose: 0.5 ml, batch number: 1721501, expiry date: 30-Jun-2018, route of administration: intramuscular and anatomical location: left deltoid), that underwent first temperature excursion, at a maximum temperature of 23-degree Celsius for 3 hours. It was reported that the patient had no adverse events. The reporter assessed the events as non-serious. Follow-up received on 12-Dec-2017: Added vaccination details (route of administration: intramuscular and anatomical location: left deltoid). It was reported that the patient had no adverse events.
Information has been received from a physician concerning a 15 year old female who in May 2008, was vaccinated with her first dose of GARDASIL. Subsequently the patient developed numbness of her feet about 2-3 months later. Then the numbness spread to the hands and tongue. She had fevers of up 103F, body aches, sore throat, stomach aches and headaches. The numbness of the tongue had gotten better and the numbness in the hands were less. She was seen by several physicians including her primary physician and OB/GYN. Physician thought that this could be from other causes. Numbness of feet, hands and tongue, fevers, body aches, sore throat, stomach aches and headaches were recovering. Laboratory diagnostic studies performed include: CBC, SMA-12, basic metabolic tests, positive epstein barr virus antibody, thyroid test, liver function tests, urinary tests and chest x-ray. No further information is available. 2/23/09-records received for DOS 8/31/08-9/5/08 DC DX: Guillain-Barre syndrome. Left facial nerve palsy. Situational depression. Constipation. Muscle tension headache. Sore throat and fatigue and with continued fatigue developed numbness of right fifth toe. PE demonstrated positive left Bell phenomenon. Deep tendon reflexes suprressed throughout. Treated with IVIG/9/7-9/19/08-DC DX: Gait disturbance and disability to due recent Guillain-Barre syndrome event. Left facial nerve palsy. Situational depression. Constipation. Muscle tension headache. Presented with C/O headache, nausea and vomiting.
This spontaneous report as received from a physician and a nurse via a company representative refers to a 56 year old female patient. Concomitant medication and pertinent medical history were not provided. On 04-JUN-2014 the patient was vaccinated with PNEUMOVAX 23 (injection, lot # J011998, expiration date 12-FEB-2015, 1 shot, dose and route were unspecified). The injection was given above the normal injection site area, in the shoulder joint. On 04-JUN-2014, "within an hour or two" of receiving PNEUMOVAX 23, the patient had extreme pain in the injection arm. The patient experienced loss of movement in the right (injection) arm; she could not lift the limb and the pain gradually increased to where she couldn't sleep, movement was painful, and there was obvious swelling and a tingling and burning sensation up and down the arm. In addition, the patient had a fever of 102F-103F. The patient went to urgent care for medical attention and was put on an unspecified "prednisone pack" (manufacture unknown) (dose, route and frequency were not provided) for 6 days. When the pack was removed, the pain and fever returned. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered. Causality assessment was not provided by the reporter. The reporter considered the adverse events resulted in significant disability and incapacity. Additional information has been requested.
Severe headache, knot on my arm at site, redness at site as big as 50 cent piece and it is hot 4 days after  - you could feel the heat thru my clothes, bones & joints felt like they would break and muscles hurting, on the 3rd afternoon I was nauseated. It is 1/31/2021 and I have not called my Dr. to let him know, but will call him on 2/1/2021.
Left arm swollen hot to touch, can barely move arm.  received  vaccination 9:30  Headaches  started 1:30. No symptoms have resolved . Currently have 99.8 temperature
I TOOK A FLU MIST VACCINE IN COLLEGE AND IT RUINED MY LIFE, WHAT IS IT DOING TO MY NOSE, SO I CAN REVERSE IT?; I took a flu Mist vaccine in college and it ruined my life you. What is it doing to my nose, so I can reverse it?; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent: Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown), via nasal route, on an unknown date.     A Unknown administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.    On an unknown date, the patient experienced i took a flu mist vaccine in college and it ruined my life, what is it doing to my nose, so i can reverse it (preferred term: Nasal disorder).     At the time of reporting, action taken with Flumist Quadrivalent was not applicable.    The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
swelling & erythema @ inj site; fever & chills & arthralgia-arthus type rxn w/in 12 hrs treated w/Pred;
Extreme muscle pain started in neck and back by late Wednesday Evening. The pt could hardly lift arms over head. The pt experienced hip and buttock pain and then the legs were affected.
PATIENT SCHEDULED FOR SECOND DOSE OF 5-11 COVID VACCINE ON 12+ COVID VACCINE DAY AND GIVEN 12+ IN ERROR
Covid-19 returned, two days after two negative at-home tests; Covid-19 returned, two days after two negative at-home tests; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL8982), in right arm, on 10Feb2021 as dose 2, single (Lot number: EU5318), in right arm, on 01Sep2021 as dose 3 (booster), single (Lot number: FC3184), in right arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Essential Thrombocythemia" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: Jan2019, stop date: 26Jul2022; HYDROXYUREA, start date: Feb2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19 returned, two days after two negative at-home tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: two days after two negative at-home tests; Negative, notes: two days after two negative at-home tests; Positive, notes: Covid-19 returned. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: If vaccine received: Yes. Other medication in 2 weeks: Yes. Anti viral details: Product: COVID 19 Treatment. Brand: Paxlovid. Treatment start date: 26Jul2022, Treatment stop date: 31Jul2022. Indication: Treatment of COVID-19. Other medication details: Other medication in 2weeks product: Prednisone. Other medication in 2weeks Brand: generic. Other medication in 2weeks Start Date: 15Jul2022. Other medication in 2weeks Stop Date: 22Jul2022. Other medication in 2weeks Brad: Rosuvastatin. Other medication in 2weeks Brand: generic. Other medication in 2weeks Start Date: Jan2019. Other medication in 2weeks Stop Date: 26Jul2022. Other medication in 2weeks Brad: Hydroxyurea. Other medication in 2weeks Brand: generic. Other medication in 2weeks Start Date: Feb2021. Adverse event: Covid-19 returned, two days after two negative at-home tests. Adverse event start date: 04Aug2022. Adverse event start time: 09:00 AM. Ae resulted in: [None of the above]. If patient recovered: Not Recovered. If treatment ae: No. Known allergies no. Other medical history: Essential Thrombocythemia, high cholesterol.
2 areas on bilateral thighs (injection site) with erythema/mild swelling. R thigh 4"x3" no drainage. L thigh 6"x5" small vesicle at injection site.
staff member complained of "freezing" and feeling "off" and dizzy, night sweats, body aches and nausea.  She took ibuprofen  last evening 1/12 around 7:30PM.  Today 1/13 c/o fatigue and "feeling like she hit a wall."
G40.309 GENERALIZED CONVULSIVE EPILEPSY 12/21/2021 ATHEROSCLEROSIS OF AORTA G40.909 EPILEPSY, UNSPECIFIED 3/9/2022 ATHEROSCLEROSIS OF AORTA
Breakthrough case admission after two vaccines Moderna 7/23/21 Lot# 018B21A;  Moderna 8/24/21 Lot# 048B21A
Fever, irritability, not eating, sleeping or playing as normal. Cries all day and night.
t103-104 fr 7AUG90 -10AUG90, listless off & on, dec po intake; Seen by MD 8AUG90;Not tx'd told to observe till 10AUG90; Mom PC 7AUG90 inc temp & told to call MD if no dec w/in 24hrs;
Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified Vaccine program Administrators.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministerd.  An email was sent from Pfizer with the following info to verify that there is 2 additional days for expire time but the vaccine over all expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured  to the vaccine receipent (patient) and all staff have met and will place visible expire labels on each box upon recieving and monitor expire dates daily to prevent further occurances.
Metallic taste within 5-7 minutes,  within 10 minutes redness in face, feeling of warmth,  coughing,  within 20 minutes more coughing and shortness of breath, wheezing increasingly getting  worse.   Taken to ER.   Seen immediately.   Received medications  via IV and oxygen.    Followed up with primary doctor.  Scheduled to see doctor again on 4/10.
rt deltoid- 24 hr p/vax, pt devel severe cellulitis w/T, inc WBC required 48hr;inpatient IV ATB;
At 18:45, pt had tactile temp followed by generalized tonic/clonic "shaking" of all 4 extremities, eyes deviated to right, tight facial muscles, drooling. Seemed to be alert off and on during event. Was lethargic, then very clingy. Episode lasted 12-15min. Was taken by private car to ER for eval. Vomited x1 in ER. Was given Ibuprofen prior to discharge.
Day 1-2 Headache, fever, chills, muscle pain, nausea, fatigue, loss of appetite, lips felt numb Day 3-4 Loss of appetite, tired, and still injection site soreness
Reports bilateral tinnitus that began about 36h after vaccine, worsened to a maximal symptom after 3 days. Ringing in ears as well as reduced hearing. Has persisted following the vaccine. seen by ENT with no resolution. Following  second vaccine had swelling  and stiffness of hands which has also persisted.
Immediately after the jab, pt developed chest pain. didn't notify the Corpsman. no SOB, palpitations. Pain was during inspiration and triggered by palpation. went to ER 9/24/21 and diagnosed with chostocondritis, rx with ibuprofen and discharged. no labs/xray/ekg done. patient seen by our clinic on 10/12/21 and CRP/ESR/Chest xray/ekg were all normal. clinically still with some tenderness to anterior chest wall palpation but better than initially. her PE was completely normal  and patient discharged with NSAID's.
never received the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 07-NOV-2019 and no reactions reported).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received the 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-OCT-2023 The reporter consented to follow up, email preferred. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
approx 13mos p/vax pt presented to MD less than 12 shingles & runny nose.
worst shot ever....better than shingles; This case was reported by a consumer and described the occurrence of malaise in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.  Additional details were provided as follow: The case was reported by the consumer itself. The age at vaccination was not applicable for this report.  The patient received shingles vaccine on an unknown date. The patient experienced malaise. No further information was provided.