chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness/ red strip; tenderness/ tender to touch; This case was reported by a nurse via sales rep and described the occurrence of red rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date, 6 months prior).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced red rash and tenderness. On an unknown date, the outcome of the red rash and tenderness were recovered/resolved.   It was unknown if the reporter considered the red rash and tenderness to be related to Shingrix.  Additional details were provided as follows: The patient was healthy. The age at vaccination was not reported. The patient experienced a 6 inch red strip and tender to touch for 3-5 days after 2nd dose of Shingrix. All the events were resolved. The reporter did not agree to follow up from GSK.
pneumonia; pleural effusion; fever; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 01-SEP-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered pneumonia, pleural effusion and fever. As a result of these symptoms, the patient was seen and treated by medical providers and was under their care. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior the using of Zoster Vaccine Live (ZOSTAVAX). The patient also experiences mental and emotional distress due to resulting in physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of patient's conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and no economic damages.  At the reporting time, the outcome of pneumonia, pleural effusion, and pyrexia was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of pneumonia was considered to be medically significant.
11/15/2002 c/o pain, redness, and itching at injection site. injection site red around 4.5 x 2, hot, tight. temp 95.8
Tinnitus starting on the left side after the second Moderna shot and continuing still. The ringing in my ear is distracting and quite loud at times.  In addition to the persistent tinnitis, I experienced intense headaches to the point where I was seeing flashes of light as well as cold sweats, body chills.
No other AE; The caller said she administered an adult dose of VAQTA to an 18 month old patient today; This spontaneous report was received from a medical assisstant, referring to a 18-month-old patient. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 09-DEC-2021, the reporter said that she administered an adult dose of hepatitis a vaccine, inactivated (VAQTA) to the 18-month-old patient as prophylaxis (product administered to patient of inappropriate age) (exact dose, route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number t040581 has been verified to be a valid lot number for hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, expiration date reported and upon internal validation established as 28-MAR-2022). No adverse event was reported.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 01-OCT-2015, the patient was inadvertently vaccinated with a dose of RECOMBIVAX HB, (lot # H015537, dose, dose number and route were not reported), which expired on 09-JUL-2015. No adverse effects were reported. Additional information has been requested.
Narrative: per report from Monitor Room RN, pt had elevated blood pressure 196/96 (systolic blood pressure 130s prior to vaccination witnessed by Monitor Room RN), L side of face swollen, and light headedness. Patient escorted to the ER immediately.
Contracted Covid, positive PCR test 3/14/22.  Sore throat, cough, low-grade fever, body aches, nausea, headache.  Lasted approximately 6 days
extremely red; would scratch and they would bleed; noticed a little petechiae; very itchy on his lower legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (extremely red), SKIN HAEMORRHAGE (would scratch and they would bleed), PETECHIAE (noticed a little petechiae) and PRURITUS (very itchy on his lower legs) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), CLONAZEPAM, CLONAZEPAM and CLONAZEPAM for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced ERYTHEMA (extremely red), SKIN HAEMORRHAGE (would scratch and they would bleed), PETECHIAE (noticed a little petechiae) and PRURITUS (very itchy on his lower legs). At the time of the report, ERYTHEMA (extremely red) outcome was unknown and SKIN HAEMORRHAGE (would scratch and they would bleed), PETECHIAE (noticed a little petechiae) and PRURITUS (very itchy on his lower legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Paxlovid: Treatment of COVID-19; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 at 19:00 as dose 1, single (Lot number: EP7534) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Mar2015. Past drug history included: Percocet, reaction(s): "Known allergies:Percocet". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" and all described as "Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (10May2022) Negative, notes: Resurgence and worsening of Covid symptoms and a positive covid home test after a negative covid home test on day 14; (May2022) Positive, notes: Resurgence and worsening of Covid symptoms and a positive covid home test after a negative covid home test on day 14. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up attempts completed. No further information expected.
12 hrs at 66.92 °F and  42 hrs 24 minutes at 65.6 °F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th November 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 30-NOV-2022 Reporters comment: The office manager reported that the bexsero vaccines had a temperature excursion lasting 12 hours with a maximum temperature of 66.92 Fahrenheit, and then a second excursion lasting 42 hours 24 minutes, with a maximum temperature of 65.6 Fahrenheit.  She reported that the 1st dose of the vaccine were administered to patients after the second excursion occurred. At the time of reporting, the Office Manager did not have patient specific identifiers. Vaccine administration facility was the same as primary reporter. The reporter consent to follow-up. Additional Supportive information: The bexsero vaccines had a temperature excursion lasting 12 hours with a maximum temperature of 66.92 Fahrenheit, which led to incorrect storage of drug. This case is linked to the case US2022AMR179995 and US2022AMR179996, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR179995:Same reporter US-GSK-US2022AMR179996:Same reporter
Rash on aqueduct of both eyes/Both eyes have a rough rash under them/rash lower down to where aqueduct and passing eye entering cheek area; allergic reaction that is not going away; lowered her immune system; she might be shrinking; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP6955, Expiration date was not reported), via intramuscular route of administration, administered in left arm on 26Mar2021 as 2ND DOSE, SINGLE DOSE (at the age of 64-years-old) for COVID-19 immunization. Medical history included compromised immune status, obesity, respiratory illness and allergies to pollen (from an unknown date and unknown if ongoing). Patient had ongoing genetic/chromosomal abnormalities, ongoing endocrine abnormalities (including diabetes) and ongoing asthma (born with it). Patient did not have any asthma attack. Concomitant medications included ibuprofen (occasionally) and vitamins not otherwise specified (NOS) taken for an unspecified indication (start and stop date were not reported). Patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6204, NDC number and Expiration date: unknown), via intramuscular route of administration in left arm on 05Mar2021 at 15:00 hours, as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had an allergic reaction that was not going away. Patient reported that this started after the vaccine. Patient thought Pfizer COVID vaccine had lowered her immune system. When patient got up in the morning, she had a rash in aqueduct of both eyes (lower down to where aqueduct passing eye entering cheek area) which could be felt on touching. It started a month ago on 28Apr2021 after second dose. Both eyes had a rough rash under them. Patient noticed it when she washed her face in the morning (did not have an exact time). Patient was not using any harsh products and face wash was same as before and the moisturizer was just extra virgin olive oil because she did not want to use any chemicals. She waited patiently for it to subside but it was not going away. Patient stated she might be shrinking and said it occurred after she received the vaccine. She was going to have a checkup on 08Jun2021, and blood work done. Outcome of the event rash in aqueduct of both eyes was not recovered while of other events was unknown.
Headache, nausea, and fatigue that prevented me from working for the following 16 days (after day 4 post vaccine) including today.
Pt w/multiple comorbidities p/w 2-day duration of SOB, coughs and fevers. COVID test was positive despite receiving Janssen vaccine on 3/31/21. Was admitted given his risks for treatment of acute hypoxemic respiratory failure secondary to COVID PNA per CXR. Received dexamethasone with improved O2 sats. Pt did not meet criteria for remdesivir or tocilizumab and was eventually discharged home following home O2 evaluation.
HPV vaccine for right foot warts (plantar warts); This literature marketed report has been received from the authors of the published article, concerning a 63 year old male patient. The patient's pertinent medical history include therapy with liquid nitrogen, salicylic acid, candida albicans, duct tape and zinc (unspecified). The patient's current conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for right foot warts (plantar warts) (product use in unappoved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  This is one of several reports received from the same literature.  Sender's Comments:  US-009507513-1912USA001729:
Syncopal episode this am, pt feel, hitting head on wall. She had mild twitching, vomited x 2 with in 30 minutes. Was her normal self in 3 hours.
RECEIVED HALF DOSE FOR BOOSTER; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 25 year old male of unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (suspension for injection, route of admin not reported, batch number: unknown expiry: UNKNOWN) dose was not reported, 1 in total, (dose number in series: 1) for prophylactic vaccination and it was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, 1 in total, (dose number in series: 2), administered on 27-NOV-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 27-NOV-2021, the patient experienced received half dose for the booster (vaccine underdose) and off label use (dose number in series: 2). HCP (from public health department) stated that there were 33 patients who received half doses (0.25ml) for their booster or 3rd dose. Most of them were patients from Texas. HCP stated that something was printed and disseminated that said to administer .25ml. HCP was not sure where that information came from. Stated it was over the holidays so people could have thought that info changed, and staff was just not made aware. HCP stated that they figured it out after the event because they could not figure out how so many doses were given. They were looking for a discrepancy in the number of vials perhaps, but then realized that half doses were given. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for booster and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211202193, 20211201082, 20211200717, 20211200723, 20211200752, 20211200769, 20211200994, 20211201168, 20211201179, 20211201286, 20211201304, 20211201351, 20211201362, 20211201392, 20211201443, 20211201450, 20211201963, 20211202161, 20211202199, 20211202207, 20211202246, 20211202371 and 20211202379.
Initial unsolicited report received from other non-health care professional on 13 April 2016. This case is linked with case 2016SA074914 (same reporter, same lot number) and case 2016SA074966 (same reporter). This case involves a 48-year-old female patient who was vaccinated with a dose of ADACEL (Batch number: U5288BA, expiration date: 30 March 2018, dose number, route and site of administration were not reported) on 30 March 2016. Patient's medical history and concomitant medication were not reported. On an unspecified date, post vaccination (reported as one week later), the patient had experienced sore arm that she could not lift it and was swollen and red. Laboratory investigations and corrective treatment were not reported. The outcome of the events were not reported. List of documents held by sender: none.
Patient was crying and feverish all night.  In the morning after injections Mom notice a rash on right anterior thigh.  Erythematous and papular, some confluence, rest of exam normal.  Treated with Tylenol and Zyrtec syrup.
This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 16:00 (Lot number: 331268D) at the age of 54 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]. Past drug history included: Codeine, reaction(s): "Allergy". Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 010m21a, Location of injection: Arm Left, Vaccine Administration Time: 02:15 PM), administration date: 18Mar2021, when the patient was 54 years old, for COVID-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 031L20A, Location of injection: Arm Left, Vaccine Administration Time: 02:15 PM), administration date: 11Feb2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), OFF LABEL USE (non-serious) all with onset 24Nov2021 16:00, outcome "not recovered" and all described as "Moderna 1st&2nd dose, Pfizer booster dose"; IMMUNISATION (non-serious) with onset 24Nov2021 16:00, outcome "not recovered", described as "booster"; HERPES ZOSTER (non-serious) with onset 25Nov2021 08:00, outcome "not recovered", described as "Shingles"; SKIN LESION (non-serious) with onset 25Nov2021 08:00, outcome "not recovered", described as "lesions appeared on abdomen"; HEADACHE (non-serious) with onset 25Nov2021 08:00, outcome "not recovered", described as "headache"; INFLUENZA LIKE ILLNESS (non-serious) with onset 25Nov2021 08:00, outcome "not recovered", described as "flu like achiness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of interchange of vaccine products, immunization, off label use, herpes zoster, skin lesion, headache, influenza like illness. Follow-up attempts are completed. No further information is expected.
On past well baby clinic appointment the infant had #2 DTaP, # 2 IPV, and #1 Hib. The mother states that despite the Tylenol, the baby had a seizure which began at 2 PM and got so bad by 6 PM amserv was called. The baby was hospitalized in NICU. Doc 197661 states that mentioned child is being followed by a neurologist and has been placed on anticonvulsants. This physician recommends that the patient receive any immunizations until she is at least 12 months of age.
A report was received from a health care professional on 11/02/03 concerning a 30 year old male vaccinee who inadvertently received expired Fluvirin on 11/1/03. The vaccinee had experienced no adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/02/04: A follow up report was received from a health care professional indicating that the vaccinee inadvertently received 1ml of expired Fluvirin on 11/01/03. No adverse events were reported at the time of the follow up report. No follow up pending, all information received. See ref.: PJP200300968 and PJP200300969.
A patient received 2 dose of FLUZONE HIGH-DOSE QUADRIVALENT no AE; A patient received 2 dose of flu vaccine instead of one flu vaccine and one pneumovax shot no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via consumer/non-health care professional via Medical Information (Reference number- 00814628) and transmitted to Sanofi on 15-Oct-2021.  This case involves an 88-year-old male patient who was received 2 dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Extra dose administered) instead of PNEUMOCOCCAL VACCINE (Wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 15-Oct-2021, the patient received two doses of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ766AA, expiry: 30-Jun-2022) first one via intramuscular route in the left deltoid and second one via intramuscular route in the right deltoid for prophylactic vaccination instead of PNEUMOCOCCAL VACCINE.  It was a case of an actual medication error due to Extra dose administered and Wrong vaccine administered (latency same day).  It was reported "Pharmacist states that an 88 year-old man came in for a flu vaccine and a pneumovax shot. He accidentally gave 2 FLUZONE HIGH-DOSE QUADRIVALENT immunizations."  No other adverse event was reported.   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.
Patient reported to pharmacy today 08/24/17 that she has been feeling tingling and numbness and swelling in the last 3 fingers of her arm that she received the vaccine in. The symptoms started same day after vaccination and last until 08/23/17.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 73 years, in left arm 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date: 07Jul2023 and stop date: 11Jul2023).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300257760 Same patient, different drug and event;