chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills and felt feverish; chills and felt feverish; This is a spontaneous report from a non-contactable consumer. A 59-year-old male patient (reporter's husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264) via an unspecified route of administration in left arm on 28Jan2021 at 08:30 at single dose for COVID-19 immunization. Medical history included high blood pressure and diabetes. Patient has no allergies to medications, food, or other products. Concomitant medications included amlodipine besilate, atorvastatin calcium (CADUET) and escitalopram oxalate (LEXAPRO), both received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 29Jan2021 at 14:00, the day after the shot, which was the 1st shot, reporter's husband had chills and felt feverish. He took 2 ADVIL then he felt fine. No treatment and no seriousness criteria was reported. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovered on 29Jan2021.  No follow-up attempts are possible. No further information is expected.
mom stated pt c/o got shots 23FEB92 & exp stiff neck & eyes rolled up in head; had sz;
Red rash, pain, inflammation. Saw doctor for assessment. RICE, NSAIDS, KEFLEX for 7 days.
This spontaneous report as received from a pharmacist refers to a unspecified number of patients of unknown age and gender. Patient's medical history, concurrent conditions and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # M015930 with expiration date on 29-MAR-2019, (route and anatomical location were not provided). The time frame was reported as 10 hours with a temperature between 0 degrees C and 1 degree C. A first excursion of 14 degrees C had occurred previously which lasted 2 hours on an unspecified date. The pharmacist reported no adverse effects. There was a data logger issue involved. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse Event; Patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
Initial report received on 05 October 2011 from a company representative and a healthcare professional. A 63-year-old male patient with no concurrent illnesses, but allergy to cobalt had received an intramuscular left arm injection of FLUZONE (lot number UH469AB) on 04 October 2011 at 16:00 pm and 2 hours later the patient complained of headache, weakness, insomnia and vomiting. Concomitant medications included oxycodone, OXYCONTIN, and a "H2O" pill (indications not provided). It was not reported whether the patient required any treatments. The patient had received a FLUZONE vaccination last year. He had not experienced any adverse events with prior vaccinations. At the time of this report the patient had not recovered. Documents held by sender: none.
Woke with intermittent but very sore left knee pain. Might have been a little warm to touch but not sure.  No past h/o of knee pain or injury. To date, still experiencing intermittent left knee pain - not red, warm or swollen. Today (3/23) left shoulder is also very sore - couldn't open her vitamin jar and feels like she's been shoveling sand. No noted redness, swelling or warmth. Also noting intermittent bilateral hand and ankle pain. No other associated symptoms. Patient states she doesn't feel she needs to be seen by PCP at this time. Writer recommended Ibuprofen as directed every 6-8 hours as long as she has no contraindications to taking Ibuprofen (denies h/o kidney or GI issues). Recommend f/u with PCP for further evaluation if no improvement w/i 24-48 hours or if symptoms worsen. She is in agreement. Recommend discuss with PCP whether she should have 2nd vaccine.
Information has been received from a health professional concerning a 15 year old white female who on 27-MAR-2008 at 14:00 was vaccinated intramuscularly into the left deltoid with the third dose of GARDASIL (Lot # 660387/1967U). Concomitant therapy included a first dose intramuscularly given into the left deltoid on the same day at 14:00 of HAVRIX (Lot # AHAVB256AA). On 27-MAR-2008 at 14:10 the patient experienced nausea. On 27-MAR-2008 the patient recovered. No further information is available.
12/20/06 12:15 a.m. patient had generalized seizure lasting 1 minute. Temperature noted to be elevated to 104 degrees at this time. Paramedics called and child taken to Emergency Room for evaluation.
Abdominal pain, diarrhea, pain in joints, tiredness, nausea, pain in the chest, chills, nasal congestion and discomfort in the throat.
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a four years old female patient who received a dose of FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. On 10-Oct-2018, the patient received a 0.1 ml dose of suspect FLUZONE (lot number: UI998AC and expiry date: 03-June-2019) (dose in series and route was not reported) via intradermal route in the left forearm. It was a case of actual medication error due to inappropriate route of vaccination and vaccine underdose. It was reported that the child was administered FLUZONE QUAD intradermally yesterday because the MA thought she grabbed a PPD vial. Only 0.1 mL was administered. It was not reported if the patient experienced any 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 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. List of documents held by sender: none.
fever of 104 for 12 hrs, inconsolable crying x 14 hrs;
Information has been received from a physician, via a company representative, concerning a 26 year old female patient with Crohn's disease and a history of "passing out" when blood is drawn, who on 06-JUN-2007 was vaccinated with the first dose of Gardasil (Lot # not provided). Concomitant therapy included unspecified medication for Crohn's disease and hormonal contraceptives (unspecified). On 06-JUN-2007, "within 5 minutes" after she had received the vaccination, the patient had a seizure. The physician then confirmed that the patient was completely "lucid" and conscious, and was oriented to the time, the date and her name, however it was not specified whether the patient had recovered from the event. The physician, "does not believe" the seizure was related to therapy with Gardasil. The patient sought unspecified medical attention. Upon internal review, had a seizure was considered to be serious as an other important medical event. Additional information has been requested.
Within 1 minutes after receiving FLUZONE QUAD, the patient fell forward. The patient regained consciousness within a minute and did not remember the episode of fainting. The patient got bruise his forehead due to the hitting on the cabinet door. Ice pack was provided for his forehead. I and his father observed patient in the consultation room for 20 minutes. The patient is recovered completely and was able to walk out with his father.
from about 9 p m on 01/04/2021  to 10 a m on 01/05/2021 I felt very sick with headache, sore throat and All-over aches
Patient is a 60 y.o male with a history of arthritis who presents to the ED with numbness for the last two months. He was seen at the neurology clinic earlier today from where he was referred to the ED because of concern myelitis. He states that the numbness started in her toes and has been gradually radiating upward into his upper thoracic area. He denies cough, fever, chills, CP, or SOB. Patient states his sx started after receiving an injection in his neck for arthritis by orthopedics on 2/16/21. Additionally, he states that he received his first covid-19 vaccine (Moderna) on 2/17/21. He was evaluated in the ED for paresthesias on 4/11/21, where he was worked up with an MRI of the Lumbar spine that showed no acute processes, so he discharged with return precautions and instructions to follow-up with spine outpatient.  Patient is currently admitted to the hospital and latest Assessment and plan are below: Possible Vaccination induced Transverse myelitis versus cord neoplasm Multifocal CNS white matter inflammatory process -possibility of post vaccine autoimmune myelitis.  Received Moderna vaccine 2/17, 3/20 -Repeat MRI of C and T-spine with and without contrast post plasma exchange (per neurology 2 to 3 months after completion of treatment)  and if no improvement in the lesion, would need spinal cord biopsy
Swollen under the arm pit. Lymph nodes from what I read.  Fatigued and muscle soreness in right arm.
pt recv vax 8APR97 & 10APR(7 pt exp diffuse disseminated papular vesicular rash & was febrile;
Patients mother called on-call nurse to report a rash (hives) after immunizations. Rash began on pt's (R) side, spread to chest, spread to back, spread to bilateral arms. Rash is now gone, no treatment.
1st dose approx 2 years ago, not yet received 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received, 2 years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter called on behalf of patient. The patient received did not yet receive the second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up. The reporter would not provide any patient demographics.
lupus; Shingles; inappropiate schedule of vaccine; This case was reported by a physician via sales rep and described the occurrence of systemic lupus erythematosus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, mepolizumab (Nucala) powder for solution for injection for drug use for unknown indication and prednisone for drug use for unknown indication.   On an unknown date, the patient received the 1st dose of Shingrix, the 2nd dose of Shingrix, Nucala 100 mg at an unknown frequency and prednisone at an unknown dose and frequency. On an unknown date, less than 2 years after receiving Shingrix, Nucala and prednisone and not applicable after receiving Shingrix, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant), shingles and incomplete course of vaccination. The action taken with Nucala was unknown. The action taken with prednisone was unknown. On an unknown date, the outcome of the systemic lupus erythematosus, shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the systemic lupus erythematosus and shingles to be related to Shingrix. The reporter considered the systemic lupus erythematosus and shingles to be unrelated to Nucala.  Additional information was reported as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrx but never received booster, which led to incomplete course of vaccination. The patient was on Nucala 100mg per 4 weeks for approximately 8 months. The patient experienced Shingles. The reporter told that, the patient had other comorbidities like lupus and was on frequent courses of prednisone. The reporter did not think it was related to Nucala since was in presence of other factors, but did discontinue Nucala. It was unknown if the reporter considered the systemic lupus erythematosus and shingles to be related to prednisone.
Woke on 6/24/05 with red area around injection site on left arm.  Itches, hot to touch. 2:15 pm seen in office, DIAGNOSIS: Allergic Reaction and started on Zyrtec 10mg daily.
Arm severely sore by 5:00 pm on Friday 3/22/2019. Body aches and muscle cramps by night. Temp 100.4 w/chills. Fatigue and soreness all weekend. Took Ibuprofen on Friday and Saturday for pain. Rested all day Sunday.
On evening after received vaccination, she experienced difficult to swallow, enlarged tongue., and muscle aches. She went to outpatient clinic and received Benadryl. She had fewer symptoms in the morning.
This spontaneous report was received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). On an unknown date, the patient experienced patient developed a mild case of shingles. The outcome of patient developed a mild case of shingles was unknown. The reporter did not provide the causality between the event and the suspect drug. This case is linked to the case 1402USA011857 (same reporter link). Additional information has been requested.
received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination.   No Medical History information was reported. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product was provided by the reporter. No treatment medication was provided.
Dizziness, nauseous, headache, symptoms felt worse later in the day, chills. Went to ER same night and was given Tamiflu after testing positive for Flu.
Right upper arm became swollen, indurated and warm following administration of vaccine. Is now resolving 72 hrs after vaccine admin, No generalized symptoms. No Treatment.
Has not gotten the second dose; swollen face; Severe pain behind her eyes; Itching from head to toe including the bottoms of her feet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not gotten the second dose), SWELLING FACE (swollen face), EYE PAIN (Severe pain behind her eyes) and PRURITUS (Itching from head to toe including the bottoms of her feet) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced PRURITUS (Itching from head to toe including the bottoms of her feet). On 27-Jan-2021, the patient experienced SWELLING FACE (swollen face) and EYE PAIN (Severe pain behind her eyes). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not gotten the second dose). On 27-Jan-2021, PRURITUS (Itching from head to toe including the bottoms of her feet) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not gotten the second dose) had resolved and SWELLING FACE (swollen face) and EYE PAIN (Severe pain behind her eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8733), in left arm, on 23Apr2021 as dose 2, single (Lot number: EW0169), in left arm and on 28Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: patient received Anti viral COVID 19 Treatment, Paxlovid, from 25Apr2023 to 30Apr2023 as Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
no adverse effect; patient received improperly stored pneumovax23; This spontaneous report was received from a pharmacy technician refers to a patient of unknown age. Information on pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 14-AUG-2019, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R010724, expiry date: 13-JUN-2020, anatomical location and dose were not reported) via intramuscular route for prophylaxis (product storage error). The vaccine was exposed to a temperature of temperature above 470F/90C (70 F) for a time frame of 4 days which was recorded in a digital data logger. There was no previous temperature excursion noted. No adverse effects reported. No PQC involved.  This third of three cases received from same reporter; Sender's Comments:  US-009507513-1908USA007080:
18 hours post vaccination, presented with debilitating full body itching. 24 hours post vaccination., itching continued  and a rash presented from hips up. 4 days later, there is still no relief. Antihistamines not effective. Cold showers followed by peppermint oil provide limited relief. Ice packs provide limited relief.  Trying calamine lotion.
9-3-09 Rec'd T/C from MGM, advised client developed enlarged node Left side of her neck,close to the clavicle on 8-21-09. States client has been very tired but has been going to school. MGM stated client did not have any fever, sore throat or headache. PHN advised MGM to take client to Urgent Care, as she does not have a PCP.
mom who two children recv vax & mom exp a classic case of chicken pox & secondary transmission;
Patient suffered a massive hemmorahgic stroke 3 days after Covid Booster.  Ambulance picked him up around 10 am the morning of 01/13/22 and transported him to the Emergency Room.  He was in the ER for over 24 hours waiting on a bed in the ICU.  He spent 5 days in the ICU as they tried to get his blood pressure under control.  The next 5 days were spent in a regular hospital room.  He was then discharged to a rehab facility.  His issues were Expressive Asphasia, and Receptive Asphasia.  About 6 days later he was discharged and local Home Health started making visits to him at home.  RN came once per week and the Speech Therapist came twice a week.  He is still receiving treatment from the speech therapist.
2/4 first dose 2/13 itchy rash appeared around injection site. 2/19 ... getting much better.   spoke with PA who suggested I fill this form.                    approved my getting second dose, scheduled for 3/4.
hard; Fever; Fatigue; Swelling arm of injection; Red; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE INDURATION (hard), PYREXIA (Fever), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling arm of injection) and VACCINATION SITE ERYTHEMA (Red) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE INDURATION (hard), PYREXIA (Fever), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling arm of injection) and VACCINATION SITE ERYTHEMA (Red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Feb-2021, PYREXIA (Fever) and FATIGUE (Fatigue) had resolved. At the time of the report, VACCINATION SITE INDURATION (hard), VACCINATION SITE SWELLING (Swelling arm of injection) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
states having pain in right arm where vaccine was given.  Denies shoulder pain,   Denies redness at site, but states has mild edema. Sought care at Urgent Care without resolve or any orders, was told to take Tylenol. Called MD who sent to another MD who completed ultrasound completed to rule out blood clots.  Gave Rx for Prednisone (reducing dose which ended 10-31-21).  Still complaining of arm pain at site of injection.  Referred back to MD.
Patient complained of headache after receiving first dose; blood pressure monitored  and was elevated.  Patient was evaluated in the urgent care department and later discharged.