chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chickenpox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chickenpox outbreak. The reporter notified the elementary school parents of the outbreak. Follow-up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated patients was a 6 year old patient (Grade 03 1Sa) who on 29-Apr-1997 was vaccinated with a dose of varicella virus vaccine live. On 27-Feb-2003, the patient developed chickenpox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other patients that developed chickenpox post vaccination with varicella virus vaccine live were also identified (WAES #0305USA00974, 0306USA00276, 0306USA00277, 0309USA01822 through 0309USA01824 and 0309USA01826-0309USA01846). Additional information is not expected.
Information has been received from a mother of an 11 year old female who on 31 Oct 2006 was vaccinated with Gardasil (yeast) (0.5 ml). On 31 Oct 2006, 30 minutes following vaccination, the patient's arm "felt heavy". Subsequently, the patient recovered from the event 30 minutes later. Medical attention was not sought. Additional information has been requested.
He got his vaccine, got it at 11:00 AM at pharmacy, came home and worked around the house, took care of the horse and came in the house about 7:00 PM, and wasn't in the house 15 minutes and started shaking violently with tremors.  Tried to make it stop and his muscles were jerking all of the place.  He then got real thirsty and would open a bottle of water and opened it and could not drink it due to the tremors, was slopping it on the floor, and unable to do so.  Went up the stairs and fell down twice trying to get to the bed, and got in the bed.  The shaking stopped about an hour later, his temp was 104.3.  He did not eat or drink anything and then went to sleep.  In the morning it was 104.1, and it took 4 days to get down below 100.  He was not able to do anything for days, muscle pains, and abnormal bodily functions, and now has constipation and it is still not right.     He is having chest pains, muscle soreness and bowel movement issues (constipation).  He has frequency of urination now.  He saw his PCP and is going to see a cardiologist next week.  Had a calcium score done after this and it was 2842 was his level.
Lightheaded, nausea and vomiting x2, Severe headache behind eyes.
This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE DISCOLOURATION (spot has some discoloration), VACCINATION SITE INDURATION (the area is still a bit hard), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) 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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (spot has some discoloration), VACCINATION SITE INDURATION (the area is still a bit hard), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). The patient was treated with CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) for Adverse event following immunisation, at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. In January 2021, VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (spot has some discoloration) and VACCINATION SITE INDURATION (the area is still a bit hard) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
That evening started with chills, and mild headache. Upon waking headache was worse and had bodyaches along with continuing chills; That evening started with chills, and mild headache. Upon waking headache was worse and had bodyaches along with continuing chills; That evening started with chills, and mild headache. Upon waking headache was worse and had bodyaches along with continuing chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 11Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for influenza immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious), HEADACHE (non-serious), PAIN (non-serious) all with onset 25Sep2023 at 23:00, outcome "not recovered" and all described as "That evening started with chills, and mild headache. Upon waking headache was worse and had bodyaches along with continuing chills". Therapeutic measures were not taken as a result of chills, headache, pain.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021307812 Same patient/drug and different doses;
Mom phoned 3PM 6DE90 stated pt's temp was 103.6 (ax) gave tylenol Q4H ever since DTP was given 5PM 5DEC90. Denied any other sx except decreased appetite. Seen by MD put on Pediaporphyin which lowered temp according to mom.
awoke on 2-17-2021 at approximately 11:55pm with SOB and chest pain-prior to these symptoms had body aches, sore throat, fever (100.3-101), chills approximately 5 hours vaccination
pt recvd vax 18SEP95 3PM & next day arm felt weak, t103 815AM (by friend) chills; went to clinc PM, got dosed) fine by 10AM; denies rash, n/v; had flu shot Thursday prior to HBV
The following information was received from a physician via distributor on 12 May 2011. A patient (no further information reported, however, as the distribution channel was specific, a military associate may be possible) received IXIARO (batch number not reported) on an unknown date. After vaccination patient experienced a seizure. No further information available at time of report.
36 hours of fever, chills, headache, diarrhea, and body aches. Treatment was IBU 400mg Q6H until fever stopped.
Extremely sore arm first day and night (couldn't lift it), then sore arm for a week.   Vomiting first night, fever. Several illnesses over next few weeks-one like pneumonia (which patient had once)--aches, fever, backache
Pt developed a fever to over 104F without localizing signs. Fever lasted x 4 days.
Patient became woozy when she returned to her second floor work area.  Her colleagues came to get me in the auditorium. When RN and I reached patient she was very weak, she was sitting in a chair. I instructed her colleauges to call 911 immediately. Patient was having a little trouble breathing. I think she was scared. I gave her 10 mlL of benedryl and RN administered a 0.5 mL dose of epinephine in her left arm. Patient was helped to the  floor and her feet were elevated.  RN put on a blood pressure cuff. Before she could get a reading, the paramedics were there and took over. Patient was transported to Hospital.
Pt developed palpitations, tachycardia and lightheadedness appx. 10 minutes after injection. HR was noted to be elevated initially at appx. 120.  Symptoms improved after several minutes. BP was noted to be158/94.  HR improved to 70s. Pt noted a metallic taste in mouth as well. EMS services and hospital evaluation were offered but pt declined. She elected to go home and mentioned that she will call her doctor.
Her daughter has redness at injection site after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Her daughter has redness at injection site after first dose) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Her daughter has redness at injection site after first dose). At the time of the report, VACCINATION SITE ERYTHEMA (Her daughter has redness at injection site after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Patient tested positive for COVID-19 after first vaccine dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Patient tested positive for COVID-19 after first vaccine dose) in a 57-year-old female patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient tested positive for COVID-19 after first vaccine dose). At the time of the report, COVID-19 (Patient tested positive for COVID-19 after first vaccine dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Anti-body test was done and it was negative, and doctor told the patient to start over the vaccine process..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment provided include IV medicine for COVID-19.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11May2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 25Sep2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 23Mar2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis for 37 yrs" (unspecified if ongoing), notes: Rheumatoid arthritis for 37 yrs; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: SIMPONI, start date: 14Apr2022, stop date: 14Apr2022; VITAMIN C; VITAMIN D. Past drug history included: Avelox reaction(s): "Known allergies: Avelox", notes: Known allergies: Avelox. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Negative; (11May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The patient received other medication in 2weeks. The patient received treatment with Paxlovid on 30Apr2022 and stop date: 05May2022, it is used for Indication as treatment of COVID-19. she took the Paxlovid as prescribed. Felt better after 2 full doses. Completed the medication after 5 days and was well. Tested negative on day 8. Not feeling well on day 10. Tested and was positive today (day 11) and not well. before taking Paxlovid the COVID was like a bad flu. Now with the rebound it is mostly like a bad head cold so far. Adverse event start date: 10May2022. The outcome of event recovered. she was not received treatment with medication.  The information on the batch/lot number for (BNT162B2) has been requested and will be submitted if and when received
Week after receiving vaccine: Extreme bout of dizziness Aggravated existing tinnitus (left ear only) Appeared to be further hearing loss in left ear  Sensations in face
Patient reported rash around injection site on upper arm.  I instructed her to take BENADRYL every 6 hours and to call her doctor if worsens or not clears completely.
PATIENT REPORTED FEELING OF IMPENDING DOOM. PATIENT WAS THEN TRANSPORTED PER WHEELCHAIR TO ER. PATIENT WAS FEELING FLUSHED, SHAKY AND ANXIOUS UPON ARRIVAL TO ER.
Headache, Arthralgia, Fever, FATIGUE, CHILLS/SWEATS Narrative:
very sensitive skin starting at her belly button going around; few days later she started having pain; after her second dose she felt a little tired; felt cold; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (very sensitive skin starting at her belly button going around), FEELING COLD (felt cold), PAIN (few days later she started having pain) and FATIGUE (after her second dose she felt a little tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced FEELING COLD (felt cold) and FATIGUE (after her second dose she felt a little tired). On 05-May-2021, the patient experienced SENSITIVE SKIN (very sensitive skin starting at her belly button going around) and PAIN (few days later she started having pain). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 04-May-2021, FEELING COLD (felt cold) and FATIGUE (after her second dose she felt a little tired) had resolved. At the time of the report, SENSITIVE SKIN (very sensitive skin starting at her belly button going around) and PAIN (few days later she started having pain) outcome was unknown.            No concomitant medication was reported.
Mother reported about 15 minutes after injection pt standing, fell to floor, had jerking movement, color pale, sweating. Family called 911, paramedics stated BP low, other VS normal. Medics stated fainted did not appear to be reaction to vaccine. No other problems noted.
Info has been received on 6/6/02 from an MD concerning a 73 y.o. male w/diabetes and a history of cardiac heart failure and arrhythmias who was vax'd w/the first and 2nd doses of Hep B vax recombinant. Concomitant therapy included glipizide (Glucotrol XL), insulin human (Humulin R), enalapril, furosemide, amiodarone hydrochloride (Cordarone), carvedilol, multivitamins, and ferrous SO4 (Feosol). The PT's asparate transamine and alanine transaminase levels have been increasing since the 2nd dose. The PT sought unspec'd medical attention. Add'l info has been requested.
This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case pertains to the 88th patient of the total 190 patients.
This spontaneous report as received from a physician via company representative refers to a 54 year old female patient with for prevention for shingles. On an unspecified date in August 2014 (also reported as sometime in August 2014) the patient was vaccinated with ZOSTAVAX (strength, dosage, route and lot number were not reported) for prevention of shingles. Concomitant therapy was not reported. The physician informed that on unspecified date in August 2014 (also reported as sometime in August 2014) the patient experienced migrating neuropathy and tingling all over her body after receiving ZOSTAVAX. The patient sought medical attention by an office visit. The outcome of the events was not recovered at the time of this report. Additional information has been requested.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # M007287 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Additional information has been requested.; Sender's Comments: US-009507513-1707USA001144:
Began with nausea and fever the night of.  The following morning I had fever, nausea with vommitting, all over body aches, headache and extreme fatigue.  The 2nd day I have body aches remaining as well as headache, but the nausea and fever seem to be gone.
This spontaneous report as received from a nurse refers to an approximately 18 year old female patient with asthma and urinary reflux. The patient did not have any drug allergies or reactions. On 23-JAN-2015, the patient was vaccinated with first dose of GARDASIL (lot# K009811, expiration date: 19-JUN-2016, intramuscular, dose and anatomical location was unknown) which was improperly exposed to 67F for the preceding 13 days. Other suspect therapies included DEPO-PROVERA (dose and frequency was unknown) which was also started on 23-JAN-2015. On 06-MAR-2015, the patient was administered the second dose of GARDASIL (lot number, expiration date, dose and anatomical location was unspecified). There were no concomitant medications reported. On an unspecified date in 2015, after administration of first dose of GARDASIL and medroxyprogesterone acetate, the patient experienced urinary tract infection and vaginal yeast infection. There was no product quality complaint involved. On an unknown date urine specimen was examined and the results were unknown. The patient sought medical attention by visiting an unspecified physician. On an unknown date the patient was given DIFLUCAN and Cefdinir (200 mg, one tablet twice per day for 7 days, which was started on 07-FEB-2015) as a treatment for the infections. The outcome of urinary tract infection and vaginal yeast infection was reported as recovered/resolved. The causal relationship between the events and GARDASIL was not reported. No further information was provided. Additional information has been requested.
On 3/7/21 at 7:00am left arm injection site was swollen, red, and hot to touch. No fever. Site with described symptoms for 2 days then it resolved.
Patient reports an adverse reaction to the HIGH DOSE flu shot he received on 10/09/14 in left deltoid IM. Patient states on 10/10 the injection site developed skin blotches, by 10/11/ his arm was itching, s/sx lasted until 10/14/14. Patient states he is fine now. Patient is advised an Vaccine Adverse Event Report will be filed.
This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of PREVNAR 13 on an unspecified date at single dose for immunisation. Medical history included femoral neck fracture. On an unknown date (when she was recovering from femoral neck fracture), she took first dose of pneumococcal 13-val conj vaccine for immunisation. The patient inadvertently received two doses of pneumococcal 13-val conj vaccine on unknown dates, within days of separation from each other. On an unspecified date, after her second dose of the vaccine, she experienced lack of appetite with outcome of unknown. Information on the batch number has been requested.
Red dots started 2 days ago in the stomach and spread to arms and face. Had fever initially. Rash is itchy.
Slipped under high chair stretched out & was noted to be jerking.  Hit forehead on drawer, cried, turned blue, was jerking 1-1 1/2 min.
ATRIAL FIBRILLATION; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age and sex and unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported and expiry: unknown) dose was not reported, 1 total administered and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient stated that, "The J&J vax gave me afib (atrial fibrillation)" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of atrial fibrillation was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0:20220121347-COVID-19 VACCINE AD26.COV2.S-Atrial fibrillation. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).