chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tuesday May 10th I had a TIA event, went to ER at Hospital. Wednesday afternoon and stayed there for 2 days doing all kind of tests. My primary doctor thinks it could be related to the booster I had 2 days prior on the May 8th, since I'm very healthy person.
RECEIVED DOSE @ 1:30 PM. No reaction until 7:30 PM at home: red rash and itchiness on neck with some stiffness of neck. AT 8:15PM THROAT WAS TIGHT AND PAINFUL WITH SOME DIFFICULTY SWALLOWING. Notified PCP WHO ADVISED TO GO TO ER. 9:30 PM IN ER RECEIVED BENADRYL 25MG PO AND PREDNISONE 60MG PO WITH RELIEF OF SYMPTOMS. THIS AM REPORTS RELIEF WITH SOME RT SIDED THROAT TINGLING. TAKING BENADRYL q6h.
Guillain-Barre; This spontaneous case was reported by a patient family member or friend and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 20-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient mentioned that patient nurse friend also took the Moderna booster shot and also came down with Guillain-Barre. The last four numbers of their lot numbers are exactly the same.   No treatment medications were reported. Company Comment: This is a spontaneous case concerning an adult female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI event of Guillain-Barre syndrome, which occurred on an unknown date and with unknown latency after a dose of mRNA-1273 vaccine (unknown COVID-19 vaccination schedule). It was reported patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine, and that patient´s nurse friend also took the Moderna booster shot and came down with Guillain-Barre. The last four numbers of their lot numbers are exactly the same. The outcome of the event was reported as not recovered. No further information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
by mistake injected 1 ml of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION ERROR (by mistake injected 1 ml of Moderna COVID-19 vaccine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION ERROR (by mistake injected 1 ml of Moderna COVID-19 vaccine). At the time of the report, VACCINATION ERROR (by mistake injected 1 ml of Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. no treatment medication was provided.
Rash to various locations:  knuckles, wrists, knees, ankles, toes.  OTC treatment of hydrocortisone cream, bendryl cream.  Rash has been present since 2 days after second dose on 1/19/21.  Rash waxes and wanes in severity.  Now trying prednisone tapering dose.   Continue to have rash today
VALID VACCINE DOSES WERE MIXED WITH EXPIRED VACCINE DOSES (WHICH WERE NOT DISPOSED OF APPROPRIATELY). ADMINISTERING TECH IS UNSURE WHICH PATIENT RECEIVED. OFFERED PATIENT TO REVACCINATE PER RECOMMENDATION FROM CLINIC TEAM.
No additional AE details available; Caller is a nurse who reports VARIVAX that experienced excursion 10/20/2023 was administered to one patient that same day; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.   On 20-OCT-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection after a temperature excursion of -10 Celsius degree (C) for 1 hour and 57 minutes, that occurred on that same date (product storage error) (lot number W025277 has been verified to be a valid lot number, expiration date reported and validated as 10-AUG-2024) administered for prophylaxis (strength, vaccination scheme, anatomical location and route of administration were not provided) . There was no previous temperature excursion and no additional adverse event.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Feb2022 as dose 1, single (Batch/Lot number: unknown), in Feb2022 as dose 2, single (Batch/Lot number: unknown) and in Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chron's" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Thyroid issues" (unspecified if ongoing), notes: Other medical history: Thyroid issues. The patient took concomitant medications. Past drug history included: Cephalexin, reaction(s): "known allergy: Cephalexin", notes: known allergy: Cephalexin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Nov2022 at 16:00, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Nov2022) Positive, notes: Covid Rapid test shows positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: 5 days after completing Paxlovid, Covid symptoms (runny nose, stuffy head, phlemy throat, head and neck ache, fatigue) began again. Covid Rapid test shows positive.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 at 14:00 as dose 1, single (Lot number: ER8727), in left arm, on 01May2021 at 11:30 as dose 2, single (Lot number: ER8731), in right arm and on 21Dec2021 at 15:30 as dose 3 (booster), single (Lot number: FJ1611) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mitrovalve prolapse" (unspecified if ongoing); "kidney donor (1 Kidney)" (unspecified if ongoing); "partial thyroidectomy" (unspecified if ongoing); "obesity" (unspecified if ongoing); "GERD" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "dust mites allergy" (unspecified if ongoing); "Pollen allergy" (unspecified if ongoing); "mold allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SYNTHROID; SERTRALINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jun2022 at 09:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jun2022) Negative, notes: Tested negative 19Jun2022 with home rapid antigen test; (26Jun2022) Positive, notes: On 26Jun2022 took another Rapid Antigen test at home and it was positive again. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts possible. No further information expected.
Right arm swollen bicep, elbow, red, hot, sore, fever (low grade), fever blister
On 03/12/2004 pt was given rabies vaccination Lot # W1419-2. One dose.  The last dose in a series of 5 doses.  04/02/04, CDC lists that Lot # within it's voluntary recall.  No adverse effect known.
Vaccine administration error.  It is suspected that a 1/2" needle syringe was used for administration instead of a 1" IM needle syringe .
Moderate swelling, 3" x 3" area of induration and erythema, mild to moderate pain on site of injection of right thigh; 102 fever, on day of vaccines administration. Treated with acetaminophen and warm compresses. Erythema subsided on day #3 post-immunization, patient continues with a 3" x 3" induration on right thigh, and 2" x 2" induration on left thigh. No more fever, no pain on affected areas.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "atrial fibrillation" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Mar2023) Negative, notes: symptom free; (14Mar2023) Negative, notes: symptom free; (18Mar2023) Positive, notes: re-developed symptoms. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 06Mar2023 to 11Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Some mild achy chest pain with exercise and deep breathing x 3 months after second pfizer dose, which has since resolved.
Information has been received from a nurse concerning a 60 year old male patient with an allergy to MACRODANTIN who on 26-FEB-2007 was vaccinated IM with a dose of Pneumovax 23, lot #655152/0889F.  Concomitant therapy included VICODIN, aspirin, atenolol, AVANDIA, glipizide, LIPITOR, lisinopril, MIRAPEX, vitamins (unspecified), carbidopa/levodopa (MSD), and VIAGRA.  On the evening of 26-FEB-2007 the patient experienced extreme pain in the right upper arm.  There was no redness or swelling.  The patient could not lift his arm.  Medical attention was sought.  At the time of the report the patient's symptoms persisted.  Additional information has been requested.
Presented to ED on 12/22/21 for generalized body malaise/aches and scattered rash following COVID vaccine. Workup revealed elevated inflammatory markers, acute on chronic kidney disease, and UTI. Diagnosed with acute interstitial nephritis post COVID vaccination.
Patient reports swelling and stinging pain at the injection site that has been spreading down her arm. Site of swelling had a red outline. Patient was instructed to take Benadryl and contact primary care provider who ruled out infection. Patient was instructed to contact doctor and pharmacy if it does not go away/gets worse.
Started 5am on 1/16. Upper lip felt tingly. Applied ice and fell asleep. Awoke at 9am to extremely swollen upper lip. Took Benadryl 25mg at 9:15 am and 1:15 pm. At 6:30 pm, has improved but not completely yet.
got diagnosed with COVID19; hasn't had her second dose of the vaccine and has missed it.; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (got diagnosed with COVID19) and PRODUCT DOSE OMISSION ISSUE (hasn't had her second dose of the vaccine and has missed it.) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (hasn't had her second dose of the vaccine and has missed it.). On an unknown date, the patient experienced COVID-19 (got diagnosed with COVID19). At the time of the report, COVID-19 (got diagnosed with COVID19) and PRODUCT DOSE OMISSION ISSUE (hasn't had her second dose of the vaccine and has missed it.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant details were provided no treatment details were provided   Reporter did not allow further contact
Tested positive for COVID/Treatment of COVID-19; Tested positive for COVID/Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Nurse) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EK9231), on 05Feb2021 as dose 2, single (Lot number: EL9261), on 03Nov2021 as dose 3 (booster), single (Lot number: 32030BD) and on 16Apr2022 as dose 4 (booster), single (Lot number: FM9992) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). Concomitant medication included: TYMLOS, start date: 02Dec2022. Past drug history included: Tetracycline, reaction: "known allergies: Tetracycline"; Hydromorphone, reaction: "Known allergies: Hydromorphone"; Iopromide, reaction: "Known allergies: Iopromide". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Dec2022, outcome "unknown" and all described as "Tested positive for COVID/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Dec2022) Positive, notes: Tested positive for COVID; (17Dec2022) Positive, notes: Tested positive for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient tested positive for COVID on 08Dec2022 and again on 17Dec2022. The patient was treated with Paxlovid from 08Dec2022 to 12Dec2022, indication: Treatment of COVID-19.; Sender's Comments: A contributory role of BNT162B2 to event Tested positive for COVID/Treatment of COVID-19 cannot be excluded based on temporal association and available information.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # L039659, expiration date 15-MAR-2017 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 48 degrees Fahrenheit for 89 hours. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow up.
Total fatigue and lack of energy; pretty motionless, could take a shower & read  but that was about it; sleeplessness; headache; recurring chills;  allover muscle & joint pains, nausea, appetite loss -- lost 6 lbs. in 6 days; blurred vision, dizziness.  On the 5th day was able to eat cheese sandwich; only chicken noodle soup & crackers & tea & toast prior to that.  Finally on the 8th day began to feel normal.
Mild aches and joint pain  all day. Didn't think anything of it. Then at 830 pm I very suddenly got the chills. Chills turned into  shakes.  My temp read 99.1. Normal is 97.4-97.7. Took Tylenol and went to bed.  Woke up  a few hours later sweating profusely.  Took temp again, was  101.6.  Was very unpleasant.  Fever broke a few hours later, though it went up and down throughout the next day, but not nearly as high. This was easily the sickest I've been in 10-15 years.
Background Trivalent inactivated influenza vaccine (TIV) is not licensed for use in infants <6 months old, the group with the highest influenza hospitalization rates among children. Methods. In this prospective, open-label study, 2 doses of TIV were administered to healthy infants aged 10-22 weeks. Adverse reactions were assessed, and hemagglutination inhibition (HAI) antibody titers were determined. Weekly telephone surveillance for influenza-like illness was conducted during the influenza season. Results. A total of 42 infants were enrolled and completed the study. Mild local and systemic reactions were noted. In the first season (2004-2005), post vaccination HAI titers > 1:32 were noted for 3 1.6%, 47.4%, and 21.1% of 19 subjects for H1N1, H3N2, and B strains included in the vaccine, respectively. In the second season (2005-2006), post vaccination HAI titers > 1:32 were seen in 45.5%, 58.1%, and 0% of 23 subjects for HIND, H3N2, and B strains included in the vaccine, respectively. In the second season (2005-2006), postvaccination HAI titers >1:32 were seen in 45.5%, 59.1%, and 0% of 23 subjects for HINI, H3N2, and B strains included in the vaccine, respectively. Infants who were seronegative before vaccination (titers < 1:8) were significantly more likely to have a 4-fold rise in antibody liter after vaccination, compared with infants who had prevaccination titers >1:8 (P < .001). Conclusion. Two doses of TIV were found to be safe and moderately immunogenic against some influenza strains. The presence of preexisting maternally derived antibody was associated with significantly lower zero response rates to vaccination. Whether vaccination with TIV will prevent influenza in three young children remains to be determined.
Super painful / burning hot Diarrhea. It's almost as if I ate a massive bowl of habanero chili peppers.; This is a spontaneous report from a contactable consumer (patient). This 30-year-old male patient reported that he received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08Feb2021 at 09:00 (Lot Number: EM9809, Age at vaccination: 30-years) as dose 1, single for COVID-19 immunisation. Medical history included obesity and smoking. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. On 12Feb2021 at 12:00 PM, the patient experienced super painful / burning hot Diarrhea. It's almost as if I ate a massive bowl of habanero chili peppers. No treatment received for the adverse event (AE). The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.  Follow-up (15Apr2021): Follow-up attempts are completed. No further information is expected.
About 1 week after she was giving the MMR she developed a low grade fever which lasted a couple days.  She then developed a red rash which started on her back and spread all over body and face.
felt sick for 3 days/ gets sad; muscle cramps from her knees to her thighs; couldn't walk as much; feels heavy feeling in her chest, a burden, tightness; she sometimes started to cry/crying has gotten worse/ gets sad and cries every day; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CRYING (she sometimes started to cry/crying has gotten worse/ gets sad and cries every day), MALAISE (felt sick for 3 days/ gets sad), MUSCLE SPASMS (muscle cramps from her knees to her thighs), GAIT DISTURBANCE (couldn't walk as much) and CHEST DISCOMFORT (feels heavy feeling in her chest, a burden, tightness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 114M20A and 013M20A) for an unknown indication.     The patient's past medical history included No adverse event (No medical history was provided).   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 20-Feb-2021, the patient experienced CRYING (she sometimes started to cry/crying has gotten worse/ gets sad and cries every day). On 19-Mar-2021, the patient experienced MALAISE (felt sick for 3 days/ gets sad), MUSCLE SPASMS (muscle cramps from her knees to her thighs), GAIT DISTURBANCE (couldn't walk as much) and CHEST DISCOMFORT (feels heavy feeling in her chest, a burden, tightness). At the time of the report, CRYING (she sometimes started to cry/crying has gotten worse/ gets sad and cries every day), MALAISE (felt sick for 3 days/ gets sad), MUSCLE SPASMS (muscle cramps from her knees to her thighs), GAIT DISTURBANCE (couldn't walk as much) and CHEST DISCOMFORT (feels heavy feeling in her chest, a burden, tightness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient has been taking fluoxetine HCL 10 mg, levalbuterol (Vurveroe xtl) 5mg and ibuprofen (Advil) to treat symptoms.   Reporter did not allow further contact
He reports he received the seasonal influenza and Td vaccines and the following day developed pain and swelling affecting the lymph nodes of his left axilla which lasted for one week prior to resolving. No constitutional or systemic symptoms. He sought care in the ER where he was told to use cool compresses.
7-year-old only had 2DTaP; This case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a 7-year-old female patient who received DTPa (DTaP vaccine) for prophylaxis.   Previously administered products included DTaP (received 2 dose of vaccine on an unknown date) and POLIO VACCINE (received 2 doses of vaccine on an unknown date).   On an unknown date, the patient did not receive the 3rd dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comment:  The case was received per after hours. The reporter had a 7-year old patient who the school was saying she needed shots. The school said that she needed to get a TDaP and polio, she only had 2DTaP and 2 polios. The reporter gave her the polio but couldn't give her the Boostrix because she's younger than 10 years old. Brand of DTAP and IPV were not provided in request/inquiry. Consented to follow up.  Additional supportive information: Till the time of reporting as patient did not receive DTap vaccine, which led to incomplete course of vaccination.