chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a Pharmacist via other company, Merck (Reference number-00308614) on 03 January 2017. This case involves a 06-month-old female patient who was vaccinated with a dose of Ipol (lot number, expiration date, route of administration, site of administration, dose and dose in series were not reported) on an unknown day. The medical history and concomitant medications were not reported. On an unknown day, unspecified day following the vaccination, the patients suffered paralysis. The laboratory test and the corrective treatment were not reported. The outcome of the event was not reported. Upon internal review the company decided to consider the event serious because of important medical event as paralysis. List of the documents held by sender: none.; Sender's Comments: This case concerns 57 year old female patient who received IPV (VERO) VACCINE at age of 6 month and developed paralysis . Time to onset was not provided. Further information regarding etiological work up, concurrent condition at the time of vaccination, reaction to previous vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case. Based upon available information role of vaccine cannot be ruled out
Rash around shot site began to develop, child also reported feeling tired and irritable.  Rash got progressively worse over about 4 days.  It spread from the top of her shoulder down to her elbow and was densely broken out with rough small red bumps. It took a full three weeks to subside.  Child has has a number of Dr. visit's since the shot due to coughing, has had STAPH, and had a severe gastrointestinal illness for 5 days about one week after the rash went away.  She has also had an increase in defiant behavior and consistently reports being tired and irritable.
After leaving office, mother noticed patient stiffening and turning grey. She returned to office. Patient examined by dr. Observed for 1 hour. Dx - post vaccine seizure with post ictal phase. Sent home/fluids and rest. Dr called at 20:40, no further episodes doing fine, per mom.
3rd dose of 2023-2024 Covid vaccine administered too soon from previous dose.  Administration of 2nd dose covid vaccine was given on 11/2/2023. Patient received covid vaccine 3rd dose on 11/21/2023 5 weeks too soon.
Sunday (8 days after vaccine) noticed a red 1 inch round rash near injection site. No pain, no itch. Monday (9 days after vaccine)  it had grown to approximately  4 inch rash on left arm. It continued to grow the next few days  and seemed to slip (move) down my arm the next few days. My doctor had prescribed antibiotics and on day 12 the rash seems to be going away.
Red, hot, raised, circular rash on upper right forearm. Perfect circular red raised rash.
THE DAY AFTER VACCINES ADMINISTRATION PT STARTED HAVING A  BAD  TASTE IN THE MOUTH  AND A BAD  SMELL IN HER NOSE WHICH ACCORDING TO HER IS SO DISTINCT. ALL THESE LASTED FOR 2 WEEKS. SHE STILL SMELLS IT UNTIL NOW BUT IT IS NOT AS STRONG
10 min after injection, started to feel very light headed with chest pressure/discomfort . Was monitored/observed for about two hours instead of the 15/30 min.
vaccines stored outside of recommended range were administered to patients; No additional AE details; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drugs reactions or allergies and concomitant medications was provided.  On an unknown date, the patient received a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, lot # U039258 for prophylaxis, expiration date 09-JUN-2023 (strength, dose, frequency, route of administration were not reported) for prophylaxis. Other suspect therapies included sterile diluent, solution for injection/infusion (strength, dose, frequency, route of administration, indication, lot # and expiration date were not reported). Administered dose of vaccine was exposed to a temperature excursion of 7.9 degrees Fahrenheit (reported as "6 F up to 14 F (7.9F)") for 4 hours 8 minutes. There were no previous excursions reported. No additional adverse event details (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA001043:02158519 US-009507513-2205USA001061:02158514 US-009507513-2205USA001205:02158509 US-009507513-2205USA001272:02158506 US-009507513-2205USA001202:02158490 US-009507513-2205USA001271:02158523
This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's relevant medical history, drug history and concomitant medication information was unknown. On an unknown date, the patient was vaccinated with GARDASIL 9 lot/batch# 36301 with expiry date December 2017(dose, frequency and route were unknown). The administered vaccine underwent a temperature excursion and had been exposed to a temperature of 32.1 degree Fahrenheit for 7 hours. The patient did not experience any adverse events. It was unknown if any relevant tests were done. Lot number 36301 is an invalid lot number for HPV vaccine. This is one of several reports received from the same reporter. Additional information has been requested.
patient had joint aches for 4 days.  also rash on legs and inside the elbow that started 4 days after vaccination.
23 patients given expired doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (23 patients given expired doses) 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 11-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (23 patients given expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (23 patients given expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Identities of patients were not provided.  Action taken with mRNA-1273 was not applicable.
Information has been received from a certified nurse midwife concerning a 20 year old female with sulfonamide allergy and no pertinent medical history who on 08-MAY-2008 was vaccinated IM with a first 0.5 ml dose of GARDASIL (Lot# 660387/1967U) in the left deltoid. Concomitant therapy included hormonal contraceptives (unspecified).  On 11-MAY-2008, "3 days later" the patient developed about 16 warts in total all over the back of her hands.  The patient's hands started to swell, she was very itchy and had a low grade fever.  The patient sought medical attention in the emergency room but was not admitted to the hospital.  The patient was seen by the dermatologist and had a biopsy (awaiting results).  At the time of the report, the patient's outcome was not recovered.  Additional information has been requested.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. On 27-JUL-2018, the patient was vaccinated with improperly stored VARIVAX, by subcutaneous route, lot # N031002 with expiration date on 03-NOV-2019, or lot # N031004 with expiration date on 13-NOV-2019, for prophylaxis (dose and anatomical location were not reported). The reporter specified that, the sterile diluent (DILUENT MRK) used for reconstitution of VARIVAX, was properly stored. The dose VARIVAX was exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14 °F (5.5 °F) during a time frame of 24 minutes, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported.
Fever started 9 days after administration of MMR vaccine. Fever was 101 F and lasted for 3 days. Vomiting few times with milk only which resolved in two days.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 76-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 16-FEB-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter US-GSK-US2023AMR060527:Original Case : US2023AMR056407 US-GSK-US2023AMR060523:Original Case : US2023AMR056407 US-GSK-US2023AMR060577:Original Case : US2023AMR056407 US-GSK-US2023AMR060588:Original Case : US2023AMR056407 US-GSK-US2023AMR060616:Original Case : US2023AMR056407 US-GSK-US2023AMR060629:Original Case : US2023AMR056407 US-GSK-US2023AMR060624:Original Case : US2023AMR056407
I saw my doctor and I was having blood work done. He told me that my A1C is high and that put me as prediabetic and so I was put on JARDIANCE.
ErythemaMultiform, Angina, chills, lymphadenopathy left axilla to left breast- tender, d dimer elevated, Narrative: ER x2 due to left sided chest pain, d-dimer elevated. cardiology appt scheduled.
No adverse event.  A small amount of the vaccine leaked out of the syringe and dripped down to his elbow.  The majority of the vaccine did go into his arm.
Information has been received from a registered nurse concerning a 12 year old female patient who on 15-SEP-2010 was vaccinated intramuscularly into the left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 665902/1426Y, Exp Date 02-JUL-2011). The nurse reported that on 16-SEP-2010, the patient's mother called stating that her daughter had a fever of 102F and swelling of the left arm. On 17-SEP-2010, the patient was seen at the office with swelling on her left arm from shoulder to left elbow. On 22-SEP-2010, the patient's mother called the doctor office stating that her daughter's swelling had decreased somewhat but the arm was rock hard. The nurse requested an investigation of the specific lot. This is one of several reports from the same source. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. Follow up information has been received from a registered nurse concerning the 12 year old female student with allergy to CECLOR who on 15-SEP-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23. On 16-SEP-2010, the patient experienced febrile, swollen, hard, red and warm. The patient still hard lump at the injection site at the time of reporting. The outcome of other adverse events was reported as recovered. Additional information is not expected.
Moderna vaccines received on 1/2/2021. I took Motrin, Sulfated with minimal relief, then localized symptoms worsening. By date of 1/18/2021, most symptoms subsided except the mild tenderness in L arm.
Patient  who presented with recurrent partial complex seizures and fevers following his second Covid vaccination, Neurology was consulted and overall presentation was thought to be secondary to breakthrough febrile seizures. He had several more episodes during his stay and so he was started on gabapentin, continued on Lamictal Keppra and felbamate and his vagal nerve stimulator was titrated up to the settings below.  He did quite well with this and seem to be back to his baseline.  He will follow up with his primary neurologist after discharge. ED visit to hospital admission the day after COVID vaccine.
Left arm localized erythema with induration, warm to touch and itchy on site of injection. Patient was told not itch and to do cold compresses to reduce itching and warmness.
Patient had redness all around injection site, about 3 inches in diameter and skin was hot.  Patient was going to take Benadryl and watch closely.
Pt who has dementia was brought on 3/19/21 by a friend and received Moderna vaccine. Pt was then brought in on 3/26/21 by a different friend on 3/26/21 and received another dose of Moderna vaccine. Per pt's friend he is feeling fine.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 38-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was provided.
Erythema, induration and warmth over deltoid muscle of left arm. Developed about 24-36 hours after vaccines were given. Rx: diphenhydramine PRN.
his right foot swelled up and felt painful; his right foot swelled up and felt painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 77 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Wounded Leg" (unspecified if ongoing), notes: He said he has a wounded leg; "big toe swelled up" (unspecified if ongoing), notes: after the first dose. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1), administration date: 23Feb2021, for Covid-19 immunization. The following information was reported: OEDEMA PERIPHERAL (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2021, outcome "unknown" and all described as "his right foot swelled up and felt painful".  Additional information: He said that he took the second dose on 30th (month not confirmed). He said that after the second dose, his right foot swelled up and felt painful and he said that both of his feet are sensitive. He would like to know if any other people are experiencing these same symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On evening after having received Pneumovax: Patient's arm became very sore. By AM, patient arm had become reddened (grapefruit sized) spreading to elbow. Skin is hot to touch. Patient had received Pneumovax previously 10/13/1999.
Psoriasis flare-up/back starts to get itchy couple days before injection; Taste disorder; Chills; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up/back starts to get itchy couple days before injection), TASTE DISORDER (Taste disorder), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 25-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up/back starts to get itchy couple days before injection), TASTE DISORDER (Taste disorder) and CHILLS (Chills). At the time of the report, PSORIASIS (Psoriasis flare-up/back starts to get itchy couple days before injection) had not resolved and TASTE DISORDER (Taste disorder), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and CHILLS (Chills) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-620439 (Patient Link).
This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for 3 patients. This is second of 3 reports. A patient of unspecified age and gender received TRUMENBA, (lot #: s58879), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness at injection site, fever, body ache, nausea all took place after use of product on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2018352648 Same reporter/product, partial same event, different patient; US-PFIZER INC-2018352982 Same reporter/product, and event, different patient.
Lost appetite; Nauseated when see or think of food; A spontaneous report was received from a consumer, concerning himself, a 23-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and had lost appetite and also nauseated when see or think of food.  The patient's medical history was not provided. Concomitant medications reported included vitamin D NOS.  On 14 Feb 2021, one day prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 15 Feb 2021, after vaccination, the patient lost his appetite which had not improved and felt nauseated when he see or think of food. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event lost appetite was not resolved at the time of this report. The outcome of event nauseated when see or think of food was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Lip swelling - no throat noticed about 1 hr after - woke up from nap - was ever bigger.
Cough and chest tightness, patient reports developed about 2 hrs after vaccine. She took po diphenhydramine and sought medical attention at 1:30 pm. Minimal response to medication/diphenhydramine. Epipen administrator, Transfer to ED.
Information has been received from the manufacture and assigned manufacturer report number HWEYEEE984115DEC04. This report concerns a 20 week old female who on Dec 6 2004 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC). On Dec 9 2004 the patient experienced hives all over her body. The patients outcome was unknown. This was originally reported by a physician. Additional information has been requested.
pt devel neuropathy, fatigue & flu like sx several months; numbness & tingling occurring all over skin;difficulty speaking,  weakness in legs; ongoing attacks of neuro dysfunction; depression;pt feels he has a demyelinating disorder  Annual follow-up received on 11/27/00 provided no additional data.
Immediately after child received immunizations, there was generalized flushing of face and body. The IPV injection site had a red appearance with swelling measuring approximately 20-23cm. No respiratory distress present. Ice pack applied to site for 10 minutes. Mother and child waited in the health department, redness and swelling subsided without further swelling.  HR 120 R/S, RSP 26 even
Fever of 103, blood oxygen level 73, extremely low blood pressure, sévère shaking,, ambulance called to ER. Three days in hospital to control fever and oxygen level.