chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is one case out of a cumulative total of 230 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 25 July 2014. These 230 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 25 July 2014 from the Investigator participating in a post-marketing study under reference number M5A16. A case of pertussis disease in a four-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) database. The subject had received 3 doses of PENTACEL (dose one lot number not reported; dose two lot number C3421AA, dose 3 lot number C3599AA) on 07 January 2010, 20 April 2010, and 15 July 2010, (routes and site of administration not reported). She also received a dose of DAPTACEL, (lot number C3192AA) on 06 June 2011. The subject developed a cough on 05 July 2014, approximately three years after the last dose, and on 06 July 2014 developed a paroxysmal cough. A chest x-ray was negative; PCR test results were not reported. Corrective treatment included azithromycin for 5 days beginning 09 July 2014. The subject was not hospitalized. At the time of final contact on 21 July 2014 the subject's cough had been ongoing for 16 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per the protocol. Documents held by sender: None.
pt brought to ED with generalized malaise, increasing weakness, and SOB; O2 sats 55% on O2 via NC; placed on high flow O2 via NC with sats 92%; positive for COVID; condition worsened; pt placed on BiPAP; O2 sats still 84%; transferred to CCU and was intubated; pt's condition deteriorated despite treatments; O2 sats 80%; condition continued to worsen and pt died in the CCU
This spontaneous report as received from a pharmacist technician refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 22-SEP-2015, the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # K004483, expiration date: 16-AUG-2015, 0.5 ml, intramuscularly. No adverse effects were reported and there was no Product Quality Complaints (PQC) involved. Additional information has been requested.
The patient reported a history of sycope after vaccines.  She said she usually gets light headed and needs to lay down after receiving the vaccine.  Patient began taking deep breaths prior to administration and upon receiving the vaccine she started to lose consciousness. She then became pale, rigid and moaned.  She then relaxed and awoke.  I refused the second scheduld vaccine and the patient moved to the other chair in the immunization room and lost consciousness again and lost bladder control.  Patient then awoke again and remained conscious for the remainder of her time at the pharmacy.  EMS was not allerted as the patient reported that is was her normal recation to receving vaccines.  Patient remained in the pharmacy for a total of 25-30 minutes total post vaccine.  She was accompanied by an adult who sat with her during the episode and left with the patient.  The patient reported no further episodes and was doing well as of 11/28/2022 when I placed a follow up call to check on the patient.
fever; flu-like symptoms; cough; This is a spontaneous report from a contactable consumer (patient) reported herself. A 76-years-old female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: unknown), via an unknown route of administration on 11Mar2021 (at the age of 76-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On 18Mar2021, the patient experienced fever for two days, has had flu-like symptoms and a cough, ask if those symptoms may be associated to the vaccine. The outcome of events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Cellulitis of left arm-treated in emergency room next day with prescription of KEFLEX next day.  Seen in office 2 days later arm still red and swollen.
04/06/09 Rash on Rt leg above knee- both feet - rash is spotty and puffy, worse in AM - better in PM. Took Benadryl 4/09 rash still present -not as red or puffy - Has not spread. Psychiatrist said rash not thought to be from Lamactil - stopped it for 2 days + resumed without problems. 4/13 - rash gone - decided aginst JE #2.
Janssen COVID-19 Vaccine EUA  Rib and abdominal pain for the first 2 weeks Periodic numbness and tingling to extremities x1 month Mild headache everyday since vaccination   I experienced right posterior mid thigh pain as well as numbness and tingling to my right foot 4 days after getting the vaccine. I went to the walk-in clinic and had blood work done including D Dimer test which showed no abnormalities. No further treatment.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018) (route: intramuscular) (incorrect product storage). The vaccine was store at a temperature of 32 F for 15 minutes and at 31 F for 15 minutes. There was no previous temperature excursion. Digital data logger was involved. No symptoms were reported. The outcome of the events was unknown. This is one on three reports received from the same reporter. Additional information has been requested.
No additional adverse effects reported; one patient was administered improperly stored PROQUAD; Information has been received from a vaccine coordinator in charge of vaccine storage referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 11-JUN-2020, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) (strength, dose detail, anatomical location and route of administration were not reported) (lot # S030214, expiration date 25-MAR-2021) for prophylaxis (product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) was reconstituted with properly stored sterile diluent (lot S038697, expiration date 10-AUG-2022).  The administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced a temperature excursion of 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (14 degrees Fahrenheit) for 20 minutes and from 15 degrees Fahrenheit to 46 degrees Fahrenheit (18 degrees Fahrenheit) for 20 minutes. There were no previous excursions reported. The digital data logger was involved. No adverse effects were reported.
Improperly stored vaccine adminstration; shipment was received a day late; This spontaneous report was received from a an administrator via a field representative referring to a 80 years old female patient. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown.   On 22-OCT-2020, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shipment was received a day late (expected arrival date was 21-OCT-2020, product shipment delay) to the reporter's practice, they were not viable for use, and someone in the office mistakenly placed them in the vaccine fridge (confliction information: the box of vaccines got placed into a refrigerator at recommended storage range once received).   On 27-OCT-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # T020638, expiration date 26-FEB-2022; route was not reported) for prophylaxis (improper storage of product in use).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020638; expirationdate: 26-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2011USA015360: US-009507513-2011USA015361: US-009507513-2010USA011251: US-009507513-2011USA015359: US-009507513-2011USA015363: US-009507513-2011USA015357: US-009507513-2011USA015358:
Numbness on face and lips left side.  Strong metallic taste in mouth.  Immediate swelling injection site and in arm pit of left arm.  Stiffness in right leg, left arm.  Brief Pain (as heartburn but sharper) in center chest Stiffness in neck.
pt recv vax; SOB; chest pain; apprehension; nervousness; "can't get my breath" per pt;
Highly suspect positive case; Highly suspect positive case; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: FF2589) as dose 3 (booster ), single, administration date 17Feb2021 (Lot number: EL3247) as dose 2, single and administration date 27Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "recovering" and all described as "Highly suspect positive case". The event "highly suspect positive case" and "highly suspect positive case" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: oxygen saturation: 92-93 %. It was unknown if therapeutic measures were taken as a result of vaccination failure.  Clinical course: The reporter reported that the patient as exposed to sick daughter with Covid who is nonverbal, 10Jan, then she got sx 15Jan of coughing, headache, wheezing, low O2 (92-93%) by night starting last Saturday 15Jan2022, loss of smells for the last 3 days. PND PCR TEST tomorrow but highly suspect positive case. The information related to treatment, covid prior vaccination, and covid tested post vaccination was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded.
Pt recvd vax & exp pruritis following vax 14DEC92; No further details were provided;
SOB, Fevers, Chills, Cough Productive of thick white sputum.
Patient developed a rash on arm approximately 3" by 4" in size. He also had a hard lump approximately the size of a dime and discomfort in the upper arm. He was treated with Benadryl.
pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (pain in the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AXILLARY PAIN (pain in the arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, AXILLARY PAIN (pain in the arm) outcome was unknown. Unknown    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
If he could receive the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (If he could receive the second dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021c4a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (If he could receive the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (If he could receive the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The reporter was calling on behalf of their husband who received their first dose of the Moderna vaccine on the 02-May-2021 and wanted to know if the patient could receive the 2nd dose of the Moderna vaccine.
9/20- arm soreness at injection site 9/21- runny nose and cough  self administered homeopathic treatment
Red and swollen LT after Varicella vaccine. RT red and swollen after MMR vaccine.
Fever - chills. Myalgia. Headache. Gastric upset. Red raised hot at area of injection.
Redness, swelling, itching (entire back arm) started next day. Pt took APAP and BENADRYL - swelling slowly subsiding - seeing Dr. on 4/1.
Lacy rash; Mild sunburn appearance; Numbness/At 5+ weeks I still experience a kind of numbness; Tingling/tingling in my arms, legs, lips and face; Unable to sleep for 3 days straight; Fatigued; Brain fog; Joint pain; Pain at injection site; Positive ANA after history of negative; This is a spontaneous report from a contactable consumer or other non-health care professional. A 57-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0173), dose 1 intramuscular, administered in Arm Left on 14May2021 09:00 as 1st dose, single for covid-19 immunisation. Medical history included known allergies to Penicillin, casein, nickel, thimerosal and PABA, Immune thrombocytopenia (ITP) and antinuclear antibody negative. Concomitant medications included ergocalciferol (VIT D), Glutathione and MVM. It was reported that patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks. On 17May2021 at 08:00, the patient experienced lacy rash which started 3 days after vaccine, numbness all over body positive ANA which is rising pain at injection site and joint pain. It was reported that patient underwent lab tests and procedures which included antinuclear antibody Positive ANA after history of negative ANA. 2 weeks post vaccination ANA was 1:640 and 5 weeks post vaccination ANA was 1:1280. Both showed the dense fine speckled pattern. ANA was tested because she developed a pronounced lacy rash all over 3 days post vaccination which disappeared after a day or two. That was followed by having a mild sunburn appearance all over with significant numbness and tingling, she was unable to sleep for 3 days straight, was fatigued, and had brain fog. At 5+ weeks she still experienced a kind of numbness and tingling in her arms, legs, lips and face, have fatigue and some brain fog. Also, patient tested positive for sars-cov-2 test on 17Jun2021. On an unknown date, patient was recovered from lacy rash and was not recovered from all other events.  Follow attempts are needed. Additional information is expected.
DRY COUGH; BREAKAGE HAIR; THINNING HAIR; RASH TO ABDOMEN/LARGE FLAT, PINK BLOTCH TO LEFT SIDE OF ABDOMEN/HIP AREA/BLOTHCH RETURNED AND MORE RED/SMALLER BLOTCHES ON RIGHT SIDE OF ABDOMEN; TIRED; LITTLE RASH ON HER STOMACH FROM COVID-19 VACCINE/NEVER GONE AWAY/FADES SOMETIMES AND GET DARK AGAIN; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (DRY COUGH), TRICHORRHEXIS (BREAKAGE HAIR), ALOPECIA (THINNING HAIR), RASH MACULAR (RASH TO ABDOMEN/LARGE FLAT, PINK BLOTCH TO LEFT SIDE OF ABDOMEN/HIP AREA/BLOTHCH RETURNED AND MORE RED/SMALLER BLOTCHES ON RIGHT SIDE OF ABDOMEN) and RASH (LITTLE RASH ON HER STOMACH FROM COVID-19 VACCINE/NEVER GONE AWAY/FADES SOMETIMES AND GET DARK AGAIN) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Ulcerative colitis.    Concurrent medical conditions included Crohn's disease and Ulcerative colitis. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 14-Dec-2021 to 14-Dec-2021 for COVID-19 vaccination.   In June 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2021, the patient experienced RASH (LITTLE RASH ON HER STOMACH FROM COVID-19 VACCINE/NEVER GONE AWAY/FADES SOMETIMES AND GET DARK AGAIN). On 01-Jun-2022, the patient experienced FATIGUE (TIRED). In July 2022, the patient experienced RASH MACULAR (RASH TO ABDOMEN/LARGE FLAT, PINK BLOTCH TO LEFT SIDE OF ABDOMEN/HIP AREA/BLOTHCH RETURNED AND MORE RED/SMALLER BLOTCHES ON RIGHT SIDE OF ABDOMEN). On an unknown date, the patient experienced COUGH (DRY COUGH), TRICHORRHEXIS (BREAKAGE HAIR) and ALOPECIA (THINNING HAIR). The patient was treated with FOLIC ACID at an unspecified dose and frequency and BIOTIN at an unspecified dose and frequency. At the time of the report, COUGH (DRY COUGH), TRICHORRHEXIS (BREAKAGE HAIR), ALOPECIA (THINNING HAIR) and FATIGUE (TIRED) had resolved and RASH MACULAR (RASH TO ABDOMEN/LARGE FLAT, PINK BLOTCH TO LEFT SIDE OF ABDOMEN/HIP AREA/BLOTHCH RETURNED AND MORE RED/SMALLER BLOTCHES ON RIGHT SIDE OF ABDOMEN) and RASH (LITTLE RASH ON HER STOMACH FROM COVID-19 VACCINE/NEVER GONE AWAY/FADES SOMETIMES AND GET DARK AGAIN) had not resolved.            In June 2022, the patient received second booster dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular).   This case was linked to MOD-2022-658218 (Patient Link).
Received 1st dose of J&J and 2nd dose of moderna vaccine; Received 2nd dose more than 35 days after receiving 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received 1st dose of J&J and 2nd dose of moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose more than 35 days after receiving 1st dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jun-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 INTERCHANGE OF VACCINE PRODUCTS (Received 1st dose of J&J and 2nd dose of moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose more than 35 days after receiving 1st dose). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received 1st dose of J&J and 2nd dose of moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose more than 35 days after receiving 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
red splotchy rash; CHILLS; soreness at the injection site; body aches or feeling horrible; joint aches or feeling horrible; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red splotchy rash), CHILLS (CHILLS), VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches or feeling horrible) and ARTHRALGIA (joint aches or feeling horrible) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030LZOA?) for COVID-19 vaccination.    Co-suspect product included non-company product IBUPROFEN for Symptomatic treatment.    No medical history reported by the reporter.  Concomitant products included METOPROLOL SUCCINATE for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBUPROFEN (unknown route) 1 dosage form(s). On 10-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red splotchy rash). In March 2021, the patient experienced CHILLS (CHILLS), VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches or feeling horrible) and ARTHRALGIA (joint aches or feeling horrible). At the time of the report, RASH ERYTHEMATOUS (red splotchy rash), CHILLS (CHILLS), VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches or feeling horrible) and ARTHRALGIA (joint aches or feeling horrible) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Reporter did not allow further contact
Pt  had received the BEXSERO vaccine at approximately 3:14 PM on June 7, 2018. That evening pt began to show mental status changes specifically expressing suicidal ideations. Pt stated that he "wanted to go to sleep and not wake up". Pt  had been completely psychologically stable and had not expressed suicidal ideations since November 2016 when lithium carbonate was administered. The suicidal ideations, mental status changes and agitation continued the next day on June 8, 2018. Pt  was admitted to the acute psychiatric adolescent unit. During his admittance which is still happening at present date (July 4, 2018) he has degraded in his mental status. His mental status degraded on the weekend of June 16-17, 2018 that he was called "psychotic" and "paranoid" by staff. To attempt to stabilize pt. He was given clonazepam and Latuda daily addded to his current medication regime with little success. Pt is not stable psychologically. He attempted suicide / cutting his arms and legs on June 25, 2018.
chills; Body aches; Fever of 104; Bone aches; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone aches), CHILLS (chills), MYALGIA (Body aches) and PYREXIA (Fever of 104) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for an unknown indication.     The patient's past medical history included No adverse event (No historical condition reported.).    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced BONE PAIN (Bone aches). On 11-Apr-2021, the patient experienced CHILLS (chills), MYALGIA (Body aches) and PYREXIA (Fever of 104). At the time of the report, BONE PAIN (Bone aches), CHILLS (chills), MYALGIA (Body aches) and PYREXIA (Fever of 104) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact