chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID-19; She was sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She was sick) and COVID-19 (Tested positive for COVID-19) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced VACCINATION COMPLICATION (She was sick). On 10-Aug-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, VACCINATION COMPLICATION (She was sick) and COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided.   This case was linked to MOD-2021-300317 (Patient Link).
pt recv vax 19NOV96 & same day pt devel rash on back;rash became generalized & spread to face, trunk, genitalia & legs;it consisted of about 50 or a little more;
Information was obtained on a request by the Company from the agency via a Public Case Detail form (local reference # AUS/12/1356, OPR#300172) concerning a 56 days male patient who on 02-MAY-2012 was vaccinated in the morning with a dose of ROTATEQ oral, 1 dose unspecified, 1 time (batch and lot number not reported). Secondary suspect vaccine given on the same day (in the morning) included a dose of PREVNAR 13, 1 dose unspecified, 1 time (route, batch and lot number not reported) and a dose of INFANRIX HEXA, intramuscular, dose unspecified, 1 time (batch and lot number not reported). On 02-MAY-2012, the patient presented to the emergency department with fever and tachycardia and was irritable at home. Temperature measurement was of 38.1C. The child was admitted. Overnight he was afebrile and was discharged. The patient was seen by a general practitioner. Subsequently, on an unknown date the patient recovered from the events. The agency felt that fever, tachycardia and irritable were possibly related to therapy with ROTATEQ, PREVNAR 13 and INFANRIX HEXA. The original reporting source was not provided. Additional information is not expected.
Patient report haveing joint pain in her Knees and hips that developed 2 days after receiving her FLUZONE HD and PREVNAR 13 vaccination on 9/14/16. She is still having joint pain that has only slightly improved.
Body aches, headaches, fevers, chills,  lethargy and brain fog; Sick for a month, not just a day or a few days.
One day after vaccination the patient reported swelling to his tongue and was given Benadryl 25mg IM at 0930 and later that day he reported body aches and received Tylenol 650mg PO at 1450. The patients symptoms resolved on follow-up 1 hour after administration.
Physical Exam: General appearance - alert, well appearing, and in no distress Abdomen - soft, nontender, nondistended, no masses or organomegaly     Selected Results: Last CBC    Recent Labs   07/07/23 0621 WBC 5.2 HGB 9.9* HCT 29.9* PLT 656*   Last Chem 7    Recent Labs   07/07/23 0621 NA 142 K 3.8 CL 108 CO2 23* BUN 16 CR 1.56* RBS 91   Last LFT    Recent Labs   07/07/23 0621 ALT 59* AST 65* ALKP 802* TBILI 3.9* BILIDIRECT 2.4* LIPASE 32   Last Coags    Recent Labs   07/07/23 0621 PT 12.9 INR 1.0       Assessment and Plan: 57/M with PMH of CVA with residual deficits, CKD, HTN, CAD with stents on Brilinta, CKD, diabetes, s/p cholecystectomy for biliary colic (2/28/2023), cholangiocarcinoma s/p EUS / ERCP with Spyglass and confirmatory biopsy at on 3/7/23, s/p repeat ERCP with switch plastic stent to 10 X 60 mm uncovered metal stent 4/2023 as intraductal RFA ablation felt to be of low additive benefit, who was admitted 7/3 with fever, increased LFTs, proximal  proximal biliary ductal dilation, though stent has pneumobilia.  Discovered to incidentally have COVID 19 though CXR normal and remains on room air.  Pt placed on IV zosyn.  GI consulted for further management.  Pt's ASA and Brilinta has been held since 7/3.    Impression Cholangiocarcinoma s/p uncovered metal biliary stent placement 4/2023.    ERCP on 7/5 showed tissue ingrowth at the proximal margin of the stent.  A second 10 x 60 mm uncovered metal stent was deployed overlapping with the first stent.  Some pus encountered on balloon sweep in addition to blood clots and debris, so would favor at least 7 days of antibiotics   TBili downtrended today to 3.9 (from 6.4)   No abdominal pain.  Tolerating regular diet.     Recommend: Continue to monitor liver tests, H&H Continue IV Zosyn?at least 7 days of antibiotics in total given some pus swept out of the bile duct . Switch to PO Cipro/Flagyl on discharge Follow up blood cultures from 7/3, no growth to date. Okay to try resuming Brilinta in addition to baby aspirin plan for d/c today. OK to d/c from a GI perspective. GI will sign off. Please call back if with questions.                 Note Details  Author File Time 7/7/2023  4:17 PM Author Type Physician Status Signed Last Editor  Specialty Gastroenterology Hospital Admit Date 7/3/2023  ED to Hosp-Admission (Discharged) on 7/3/2023  ED to Hosp-Admission (Discharged) on 7/3/2023   Detailed Report  Note shared with patient Care Timeline  07/04   Admitted from ED 0144 07/05   RETROGRADE CHOLANGIOPANCREATOGRAPHY ENDOSCOPIC 07/07   Discharged 1300  pt not vaccinated
the syringe was leaking during administration of vaccine; the syringe was leaking during administration of vaccine / nurse requests information on revaccination; This spontaneous report was received from a nurse referring to a 13-year-old patient (gender not reported). The patient's concurrent conditions, pertinent medical history, drug reactions/allergies or concomitant therapies were not reported.  On 08-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1637651, expiration date 09-JUN-2022, 0.5 milliliter as prophylaxis (dose number, route of administration, anatomical vaccination site, and frequency were not reported). On that same day, while administrating the vaccine, the syringe was leaking (incorrect dose administered); it appeared to be leaking from the tip of the syringe, where the needle was attached, but the needle was securely fastened to the syringe (syringe issue). The nurse requested information on revaccination due to this situation. It was reported that needle was securely attached to the syringe, and the leakage was noticed while the plunger was being pushed forward during the administration. The syringe was discarded after its use.  The outcome of syringe issue and incorrect dose administered was unknown. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry: ; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
had the vaccine over three years ago and the injection site has never healed; This case was reported by a consumer via interactive digital media and described the occurrence of injection site reaction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was not recovered/not resolved.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-AUG-2022 Reporter's Comment: This case was reported by the consumer via interactive digital media.  The patient received the vaccine over three years ago and the injection site has never healed. It was not the potential product quality complaint. Additional Supportive Information: The follow-up could not be possible as no contact detail were available.
Received her first GARDASIL 9 shot "last week" and after 10 minutes stood up, told the NP that she was feeling dizzy and then fainted; This spontaneous report was received from a physician concerning an adolescent female patient. The patient's concurrent conditions, medical history, drug reactions/allergies, historical drug and concomitant therapies were not provided.  On approximately 08-SEP-2020 (reported as "last week"), the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Route of administration, lot number and expiration date were not provided) for prophylaxis. On the same date, 10 minutes after, the patient stood up, and told the reporter that she was feeling dizzy and then fainted (syncope).  At the time of the report it was unknown if the patient had recovered from the syncope. The causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the syncope was unknown.  Upon internal review it was considered the syncope to be medically significant.; Sender's Comments:  US-009507513-2009USA007009:
Nurse administering vaccine used incorrect diluent when mixing vaccine. Nurse used diluent for varicella vaccine and not normal saline.
Pt recvd Td vax & 2 days later devel a local reaction w/redness, pain & swelling;
Information has been received from a physician concerning a 4 year old male pt who in about 1997 at the age of 18 months, was vaccinated with varicella virus vaccine live. On 3/7/00, the pt developed shingles. The pt was referred by his physician to see a dermatologist. It was noted that the lesions began on the pt's back and came around to the front at the waist line area. The rash is located on the right side and extends to the upper thigh. Additionally, it was noted that the shingles had a "classic appearance". The mother noted that the pt "felt febrile" on 3/9/00. Additional information has been requested.
she has tested positive for COVID with a home test kit; she has tested positive for COVID with a home test kit; she says she did get sick on the second dose; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in upper left arm as single dose for COVID-19 immunization, dose 1 on 08Apr2021 18:00 (Lot Number: EW0153), dose 2 on 29Apr2021 18:00 (Lot Number: EW0153). Her children had COVID before she tested positive. Her children both tested positive on 06Jul2021 and then her children tested negative on 11Jul2021. She used to do dental hygiene and she was right handed so she always got her flu vaccine and everything in her left arm so her right arm would not be sore. There were no other medical history or family history. There were no concomitant medications. There were no vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient had tested positive for COVID with a home test kit. One of her positive results was today 13Jul2021 and the first positive results she had was on 08Jul2021. Both of her children had it last week, neither of them are vaccinated and they both tested negative yesterday with the home kit. After second one the patient got sick but never ran fever, no medications were administered. No Emergency Room or Physician Office was required. The outcome of events was unknown.  Investigation results received on 15Jul2021 included Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0153 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0153, fill lot EP8692 and the bulk formulated drug product EW8071. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up attempts completed. No further information expected
muscle soreness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of MYALGIA (muscle soreness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Essential hypertension.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced MYALGIA (muscle soreness). At the time of the report, MYALGIA (muscle soreness) had not resolved.        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.   Concomitant medications were not reported. Treatment for the event included acetaminophen.  Company Comment: Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported event and the product use cannot be excluded.  Myalgia is consistent with the known safety profile of the vaccine.; Reporter's Comments: Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported event and the product use cannot be excluded.  Myalgia is consistent with the known safety profile of the vaccine.
got her a little sick/the first one made her sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "sinus problems" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got her a little sick/the first one made her sick".  Additional information: This consumer reported for his daughter (patient). Reporter stated his daughter had the same problems noting the headache is in the same place and that her temperature has backed off. Reporter stated the first dose got her a little sick and the second dose she was in the bed for a couple of days. Reporter wanted to know how long these side effects last. The Reporter was the patient's father. The reporter was reporting about the COVID shot. Stated his daughter had the same reaction but she does not have a temperature anymore. He says she had the same dates as both of his. In his report he said his first dose was on 26Mar2021 and his second dose was on 23Apr2021. He says she had the second one, the first one made her sick, the second one gave her a headache and temperature, but she has no more temperature today. Reporter seriousness for sick was unspecified. He told her about is headache and temperature and she said she had it too. The headache is on the top of her head. He says they both have sinus problems, but this is not a sinus issue. This was a cloned case, report 2 of 2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 06-NOV-2015 00:19, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 9.8 (24 mins) and 2.4 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
on one side of her nose she got a numbness/she was numb under her eyes; She had a funny taste in her mouth; her tongue being number; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN5199, Expiration date: Unknown) via an unspecified route of administration in an unspecified anatomical location on 08Mar2021 (at the age of 64-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. Historical vaccine included TD and P, Flu vaccine which were always be an off flavor in her mouth; both from an unknown date. The patient mentioned that she received the 1st dose of the vaccine today (08Mar2021) and had a funny taste in her mouth, a numbness on her tongue which lasted for about an hour, numbness on one side of her nose up to under her right eye/ under her eyes. It was almost like through her nasal passage through to one side of the eye all went numb and her tongue felt numb. She was just curious if anyone else had reported this with numbness. She mentioned that she was a nurse aid. She confirmed all of this happened today after the dose was given. Her tongue was not numb anymore now but her nose and up by her eye was still a little numb. She confirmed that her tongue being numb and the funny taste in her mouth anymore lasted about a half hour. She indicated that she took vaccine, so that she would not get Covid-19 infection and would not be a carrier as well and because of her comorbidities. She said she knew a lot of people don't want to get it. No investigation assessment was reported. The outcome of the events funny taste in her mouth and tongue being numb was resolved on 08Mar2021 and the outcome of other events was not resolved.  No follow-up attempts are possible. No further information was expected.
Little to no reaction; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (Little to no reaction) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Little to no reaction). At the time of the report, VACCINATION COMPLICATION (Little to no reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.
This is a spontaneous report from a contactable other HCP via Pfizer sales representative. This reporter reported for two patients. This is first of two reports. A 16-year-old female patient of an unspecified ethnicity received TRUMENBA (lot J29203, exp. date 30Jun2016, NDC number: 300050100102), intramuscular in left deltoid on 10Jun2015 at 15:03 at 0.5 ml single dose. The patient medical history was not reported. Concomitant medication included MENVEO (lot A14091, exp. date 30Nov2015, NDC number: 46028020801), intramuscular in right deltoid at 0.5ml single doss on unknown date in 2010. The patient experienced fatigue on 11Jun2015 and flu like symptoms on an unspecified date. The outcome of the event fatigue was not recovered, while the outcome of the event flu like symptom was reported as unknown. This patient had a brother that received the same vaccine on 10Jun2015 and experienced the same adverse events. Follow-up (23Jul2015): New information received from a contactable other-HCP includes: Vaccines Lot # and expiration date updated. Follow-up attempts completed. No further information expected.
Within 30 minutes:  scratchy throat, red face. Began fading within an hour. took a claritin after leaving the clinic. Gone within 15 minutes after that.   Within 4 hours:  sore arm, neck and shoulder, severe diarrhea (watery, large amounts), nausea, chills, lightheaded, fatigue