chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse Event; HCP called to state that the patient was given 2 doses of GARDASIL 9 in one day. HCP refuses to be contacted about this and wishes to not discuss this case any further.; This spontaneous report was received from a nurse refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-MAY-2023, the patient was vaccinated with two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot# w026977, expiration date: 04-JAN-2025, 0.5 dosage form/series (exact dose, route of administration and anatomical location were not reported) for prophylaxis (vaccine overdose). No additional adverse event reported (no adverse event).
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium
pt recvd vax & one arm shook, pt was unresponsive; to er having sz, addl sz lasting 55 min; admit to hosp; in ICU;
Fever, extreme irritability, poor feeding, Septic work up including CBC, UA, LP.
ACT-HIB vaccination that contained the appropriate Hib lyophilized powder portion but was reconstituted with sterile water from a Merck varicella vaccine instead of the diluent provided in the ACT-HIB box,with no Adverse Event; Initial information received on 30-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient who was vaccinated with HIB (PRP/T) VACCINE [ACT-HIB] vaccination that contained the appropriate hib lyophilized powder portion but was reconstituted with sterile water from a merck varicella vaccine instead of the diluent provided in the act-hib box with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; rotavirus vaccine for Prophylactic vaccination; iodinated glycerol (IPOL [IODINATED GLYCEROL]); diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DAPTACEL) for Prophylactic vaccination; and varicella zoster vaccine (VARICELLA VACCINE).  On 29-Mar-2022, the patient received 0.5ml dose of suspect HIB (PRP/T) VACCINE, once, (strength and formulation: unknown) (lot UJ589AAA, Expiration Date: 25-Oct-2025) via intramuscular route in the right thigh for prophylactic vaccination.  On 29-Mar-2022 the patient received act-hib vaccination that contained the appropriate hib lyophilized powder portion but was reconstituted with sterile water from a merck varicella vaccine instead of the diluent provided in the act-hib box with no adverse event (product preparation error). The caller asked that "if this would count as a valid dose and how soon the patient could be re-vaccinated".  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event act-hib vaccination that contained the appropriate hib lyophilized powder portion but was reconstituted with sterile water from a merck varicella vaccine instead of the diluent provided in the act-hib box,with no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Developed rash and fever, negative strep test on 7/28/15, fever better but rash worsened on 7/29/15.  Rash consistent with erythema multiforme.
No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 13-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621929, expiration date: 06-DEC-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. 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; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Patient stated she felt tingly and weak in her legs off and on and it moved up to her stomach area.
pt sates she had horrible full bottle musclular contractions all night long, fever and aches.  She took an aleve arounfd 5am and seems tohelp with the muscles, however do to continuous contractions all night all muscles in body sore today and extremely tired
Multiple pulmonary embolism in both lungs; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 25Feb2021 10:00 (Batch/Lot Number: Ew6202) as single dose, for covid-19 immunisation at a pharmacy/drug store. Medical history included diabetes. The patient has no known allergies and no COVID prior to vaccination. The patient has other medications in two weeks but no other vaccine in four weeks. The patient experienced multiple pulmonary embolism in both lungs on 28Feb2021 08:00. The patient was hospitalized for multiple pulmonary embolism in both lungs for 3 days. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care visit, and considered life threatening illness (immediate risk of death from the event). The patient was treated with blood thinners. The patient had the second dose of BNT162B2 on 18Mar2021 at 11:00 am in the left arm. The patient was tested for Covid post vaccination via nasal swab (rapid) on 10Apr2021 which was negative. The outcome of the event was not recovered.
Following MMR inject pt devel hives on chest, shoulders & upper arms; BP 134/72, P74, R20 w/ no distress; pt c/o numbness & tingling of extremities; BP 190/82, P96; taken to ER via ambulance;
Body aches, fever, chills, cough, runny nose, headache, dyspnea onset within 5 hours of injection.
The patient (pt) had pain, redness and swelling over injection site. Pt developed fever over the following 24 hrs. She was admitted to the hospital for cellulitis. She was place on IV antibiotics. The pain and swelling increased with persistent fever. She had a surgical consult due to a MRI of her arm showing a fluid collection in the muscle with substantial edema. The patient had an incision and drainage in the operating room which showed purulent fluid (suspicious for infection)without abscess. There was no sign of necrotizing fasciitis or necrosis of the muscle. Pt is recovering in the hospital on IV antibiotics.
The pharmacist told the patient that her 20-something year old niece also got pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (The pharmacist told the patient that her 20-something year old niece also got pericarditis) in a 3-decade-old female patient 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 PERICARDITIS (The pharmacist told the patient that her 20-something year old niece also got pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (The pharmacist told the patient that her 20-something year old niece also got pericarditis) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 20-something year. Concomitant medications were not reported. It was unknown if the patient had any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reporter stated that the pharmacist told reporter that her 20-something year old niece also got pericarditis. The pharmacist also told to the reporter that their family will not be getting the booster because of all the issues. No treatment medication information was provided by the reporter.  Company Comment: This is a spontaneous case concerning a 3er decade, female patient with no reported medical history, who experienced the serious (due to medically significant) expected, AESI of pericarditis, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The outcome was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-592491.   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-592491:Reporters case
pulmonary embolism that presented with chest pain and inability to take a deep breath, admitted and started on Heparin drip.  Patient transitioned to Apixiban.
No additional adverse effect reported.; an expired dose of VARIVAX was administered on 5/5/2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 05-MAY-2020, the patient was administered an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N022983 with expiration date: 23-AUG-2019, strength, dose and route were unknown) for prophylaxis. Merck sterile diluent (lot # and expiration date were unknown) used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX). No additional adverse effect reported.
injection site reaction; Inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 76-year-old female patient who received HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, unknown after receiving Twinrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated the patient was ten days late receiving dose 2nd of Twinrix, which led to incomplete course of vaccination . The pharmacist declined to answer additional questions at this follow up, stated the pharmacy was about to open.   Follow up information received from pharmacist on 12th August 2019: The patient's demographic details were updated. The patient received the 2nd dose of Twinrix via intramuscularly late by 10 days , which led to lengthening of vaccination schedule. The reporter considered the injection site reaction to be related to Twinrix. Possibly unknown if this was suspected transmission of an infectious agent via a medical product.
PENTACEL was given to a patient but the patient was not able to get the HIB component of the vaccine with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves pentacel was given to a patient but the patient was not able to get the hib component of the vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the suspect diphtheria/tetanus/5 hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine via unknown route in unknown administration site for Immunization (strength, dose, batch number and expiry date: unknown) was given to a patient but the patient was not able to get the hib component of the vaccine with no reported adverse event (single component of a two-component product administered) (latency same day). Information on the batch number was requested  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event single component of a two-component product administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Dematographia/skin writing. Bumps and hives unassociated with scratched spots. Inflammation and itching extended even to throat upon couching or sneezing.
Customer says since she received her flu shot she developed a lump under her arm and a sore neck.
Joint pain started in late October - left elbow, left wrist, neck, hips, hands & shoulders. Pain became progressively worse into December. Blood work 12/7/22 after apointment w/ healthcare provider. Hematologist consultation  recommended based on abnormal lab  results 12/28/22 saw Hematologist, labs repeated & additional lab work ordered for 2/7/23. 1/6/23 Appointment w/ health care provider due to increased join & muscle pain & insomnia. Multiple medications ordered including steroids, Nambutone, Gabapentin, Tylenol Arthritis.  (I have tried to fax this form numerous times but it would not go through 1/13/23, 1/18/23 2/13/23) I have had additional medical appointments and blood work and continue on medications.
Patient hasn't received her 2nd dose yet; Patient was positive for covid 5 days after receiving 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Patient was positive for covid 5 days after receiving 1st dose) and INTENTIONAL DOSE OMISSION (Patient hasn't received her 2nd dose yet) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced COVID-19 (Patient was positive for covid 5 days after receiving 1st dose). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Patient hasn't received her 2nd dose yet). At the time of the report, COVID-19 (Patient was positive for covid 5 days after receiving 1st dose) outcome was unknown and INTENTIONAL DOSE OMISSION (Patient hasn't received her 2nd dose yet) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, SARS-CoV-2 test: Positive.     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.
Low grade fever; Headache; Stomach ache; body ache; metallic taste in mouth; sore arm at injection site; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EKQ231), via an unspecified route of administration at the left arm on 11Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 11Jan2021, patient experienced metallic taste in mouth, which was reported as worsened and sore arm at injection site. On 12Jan2021within about an hour after vaccination, the patient experienced lowgrade fever that was slowly going up, headache, stomach ache, & body ache. The patient has not recovered from the events.; Sender's Comments: Based on the time association, the reported events are possibly related to suspect BNT162B2 administration in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Headaches, Rash, locallized pain in area of shot, axillary tenderness. Narrative: Employee reports day after shot, developed headache, localized pain in area of shot, mild pain in axilla on side of shot, and small rash, red, about the size of quarter. Headache resolved within a day, localized pain resolved within a few days. Rash and mild axillary pain continues at day 6, rash has increased to 5cmx6cm, red, blotchy, flat, no sloughing.
Loss of libido- erectile dysfunction. It is harder to get an erection- possible, but requires more effort. Loss of blood flow to the penis
Vision temporarily impaired morning after vaccination for about 1 hour saw floater "hole" when looked at objects; Vision temporarily impaired morning after vaccination for about 1 hour saw floater "hole" when looked at objects; This is a spontaneous report from a contactable Consumer or Non-healthcare Professional reporting for a patient. A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 11Feb2021 at the age of 44-years-old as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive other vaccine in four weeks of vaccination. The patient did not receive other medications in two weeks of vaccination. It was unknown if the patient was diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 12Feb2021, the patient experienced Vision temporarily impaired morning after vaccination for about 1 hour and Saw floater "hole" when looked at objects. No treatment was received for adverse events. Adverse events resulted in none of the above. The outcome of events was recovered on 12Feb2021.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
The next day I had a palpitation event that lasted for over 4 hours. That was unusual. Thereafter, about mid-week after having the shot, I started getting headaches that were not like any I have had in the past. It feels like it's coming from behind the nasal cavity to the sides (right side) and top of the head, more like pain than throbbing. They have been on and off from that point forward. I was rolling with it but just made an appointment with my doctor, whom I have not seen in many years, having moved back to the area after two years away. I am otherwise healthy, do not smoke.
I developed a blood clot in my lower left leg. On 06/27/2021 the varicose vein in my left leg started to become firm. I did not think anything of it until 7/17/2021 when it started to become painful. It was suggested by a family member that I consult my doctor. On 7/20/2021 I called my doctor to see what her suggestion for action would be. She ordered an ultrasound that was performed on 07/20/2021.
Moderate to severe sciatic pain; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP1534) via an unspecified route of administration in the left arm on 23Mar2021 at 11:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis, sciatica, knee surgery, neck surgery and back surgery on unknown dates. The patient did not have any allergies to food, medications, or other products. Concomitant medications included ibuprofen (ADVIL) started on an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications or vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 16:00, the patient experienced moderate to severe sciatic pain on the left side from lower back through left leg which started about 30 hours after the shot and lasted 3 days. She applied heat and topical ointment as well as ibuprofen and pain subsided after 3 days. She had history of sciatica but the pain was only on the side that where she got the vaccine. She believed it was a side effect from the vaccine, plus the fact that she did not have that pain prior to getting the vaccine. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were taken as a result of moderate to severe sciatic pain and included treatment with heat, topical ointment and ibuprofen. The clinical outcome of the event moderate to severe sciatic pain was recovered on 27Mar2021.   No follow-up attempts are needed. No further information is expected.
Pt recvd MMR/Td in lt arm 1 min p/administration of 2nd (Td), pt had a grand mal seizure lasting 10 seconds; Pt had no incontinence postictal seq; Had EEG on 6FEB92;
Lightheaded for about 7 hours. extremely itchy and still itching 10 days later. Taking Benadryl for some relief at bedtime.
This spontaneous report was received from a healthcare professional refers to a patient of an unknown age and gender. Medical history and concurrent conditions were not reported. On 05-MAY-2015, the patient was vaccinated with a dose of GARDASIL lot # K006960 (expiration date, dose, route and sites of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several repots from the same reporter. Additional information has been requested.
Developed symptoms of lower lumbar radiculopathy approximately 4 weeks after second dose of Moderna COVID19 vaccine, which was later diagnosed as VZV (shingles in the lower left lumbar area/quadrant). The shingles and lumbar radiculopathy led to a short-term disability lasting several weeks.