chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received HIB on 06/29/05.  States on Friday 07/01/05, started getting red blisters all over and then developed fever.  7/05/05- Grandmother called and reported this.  Child still sick and has blisters.  Instructed her to take child to family Dr. for eval. took to Dr. Diagnosed with a virus.
Given 2 vac-> HPV #1 Tdap on 5/9/07 on 5/13/07 at ER-diffuse rash-itchy "hive like" rash. Breathing difficulty Dx "urticarial rash". 2 hr vac. -> Rx'd Decadron, Benadryl, Pepcid-  Prednisone x 50 mg
chest pain Follow-up: Called facility - patient rec'd tdap. They do not do SPV at their facility.
No adverse out come. Patient only aged 60 and received fluad (only approved for 65+)
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient, their physician  and their pharmacists used the ZOSTAVAX vaccine in the manner in which it was intended. The patient was inoculated with a dose of ZOSTAVAX vaccine in October 2014 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about December 26, 2014, the patient was treated by his physician at a hospital, for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about February 5, 2015, the patient received subsequent treatment from his physician for ongoing and worsening symptoms, diagnosed as post-herpetic neuralgia, a chronic condition of irreversible nerve pain and damage secondary to shingles. The patient has been prescribed gabapentin (manufacturer unknown), lidocaine (manufacturer unknown), and VALTREX for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
The staff from another of our own company facility had come for getting vaccinated at this Clinic. After around 15 minutes or so after vaccination, she was feeling little light headed, and nauseating and tried throwing up during the observation period as per protocol after vaccination. We advised her to stay longer and  as precaution, we reached out to our facility, who advised to observe her for some more time and if she does not feel better, she can go to Urgent care accompanied by someone. We gave her Gatorade and after around 40-45 minutes she was feeling better and someone from her family came to pick her up. She did not wanted to go to Urgent Care at that time but we advised her if she does not feel good, she should go to Urgent Care.
108 doses given instead of 120; Dose administered after 30-day Use By Date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (108 doses given instead of 120) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ACCIDENTAL OVERDOSE (108 doses given instead of 120) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). In 2021, ACCIDENTAL OVERDOSE (108 doses given instead of 120) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided. The vial was initially stored in the refrigerator on 16-Sep-2021. Vaccines was administered from 18-Oct-2021 to 02-Nov-2021.
Information has been received from a pharmacy student concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with a dose of Pneumovax 23.  Subsequently the patient experienced an allergic reaction.  The patient sought unspecified medical attention.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Patient came on May 8 to pickup a prescription to help for the rash on his arm, legs and torso. He had the rash 1 week after the SHINGRIX shot. The rash gets better and he's on CLARITIN daily for itchy 5/20/18.
TIA Stroke, SVT tachycardia, loss of vision, paralyzed (loss all feeling in arms and legs), developed epileptic seizures, developed ANA autoinflammatory disorder, myocarditis, pericarditis, peripheral neuropathy in arms and legs, developed anaphylaxis and new allergies. All disorders still ongoing. I am still receiving treatments to control pain and symptoms of disorders.
This spontaneous report was received from a nurse, referring a patient of unknown age and gender. Information regarding pertinent medical history, concurrent therapies and drug reactions or allergies was not provided. On 19-JAN-2018, the patient was vaccinated with a dose of VARIVAX which had a lot # N021581, with expiration date on 09-AUG-2019, subcutaneously (dose, strength and anatomical location were not provided) for prophylaxis, also the patient received a dose of PROQUAD which had a lot number reported as N009171 and sterile diluent (STERILE DILUENT) all administered together (overdose), however no adverse effects were reported. Lot # N009171 was not valid for PROQUAD.
Administered the vaccine in the left deltoid of the patient. When entering in the information in the computer system to have record of the administration of immunization, the vaccination was noticed to be expired.
Hard to turn neck from one side to other; Muscle ache; Knee Muscle Pain; This spontaneous case was reported by an other health care professional and describes the occurrence of NECK PAIN (Hard to turn neck from one side to other), MYALGIA (Muscle ache) and ARTHRALGIA (Knee Muscle Pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced NECK PAIN (Hard to turn neck from one side to other), MYALGIA (Muscle ache) and ARTHRALGIA (Knee Muscle Pain). At the time of the report, NECK PAIN (Hard to turn neck from one side to other), MYALGIA (Muscle ache) and ARTHRALGIA (Knee Muscle Pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-037537 (E2B Linked Report).; Sender's Comments:  MOD-2021-037537:
Severe edema, swelling, red in color, hard and hot to touch. Swelling and pain from the neck down to the right elbow. Sinus pressure and headache.
administered dose that was not reconstituted; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 7-week-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 9th September 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 9th September 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication 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:09-SEP-2022 Reporter's Comment: The reporter declined to provide patient information aside from age and gender. The reporter reported that, a patient was administered a dose of Rotarix that was not reconstituted, so the patient only received the liquid diluent portion.  The reporter did not have the lot number / expiration date information at the time of call.  The patient had not been redosed at the time of reporting. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  Additional Supportive Information: The reporter reported that, a patient was administered a dose of Rotarix that was not reconstituted, so the patient only received the liquid diluent portion, which led to inappropriate preparation of medication.
Dyspnea/facial swelling/throat swelling and itchy. Has been recieving the flu shot every year without difficulty until this year.
Muscle spasms in upper back/Two weeks later middle neck pain and spasms; One week later, pain moved up toward lower neck. Two weeks later middle neck pain and spasms. Three weeks later the pain has been upper neck and base of skull; Feels like throbbing dull pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for influenza immunisation, on 15Sep2023 as dose 1, single. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/lot number: er8734, Anatomical location: Right arm), administration date: 30Mar2021, for COVID-19 Immunisation; bnt162b2 (DOSE 2, SINGLE, Batch/lot number: ew0162, Anatomical location: Right arm), administration date: 20Apr2021, for COVID-19 immunisation; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/lot number: fe3590, Anatomical location: Left arm), administration date: 07Oct2021, for COVID-19 immunisation; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/lot number: fm9992, Anatomical location: Left arm), administration date: 21Apr2022, for COVID-19 immunisation; bnt162b2 (DOSE 5 (BOOSTER), SINGLE, Batch/lot number: gh9693, Anatomical location: Left arm), administration date: 20Sep2022, for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 2023, outcome "not recovered", described as "Feels like throbbing dull pain"; NECK PAIN (non-serious) with onset 2023, outcome "not recovered", described as "One week later, pain moved up toward lower neck. Two weeks later middle neck pain and spasms. Three weeks later the pain has been upper neck and base of skull"; MUSCLE SPASMS (non-serious) with onset 14Oct2023, outcome "not recovered", described as "Muscle spasms in upper back/Two weeks later middle neck pain and spasms". The events "muscle spasms in upper back/two weeks later middle neck pain and spasms", "one week later, pain moved up toward lower neck. two weeks later middle neck pain and spasms. three weeks later the pain has been upper neck and base of skull" and "feels like throbbing dull pain" required physician office visit. Therapeutic measures were not taken as a result of muscle spasms, neck pain, pain.  Additional information: Patient was administered with Sanofi Pasteur Flu for Influenza immunisation within 4 weeks.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Diffuse Hives, itchy skin, dermatographia  with onset a week after Moderna Booster that has lasted 6 weeks. Steroids, intense antihistamine treatment, pepcid, vitamin D, and low histamine diet needed to manage symptoms. Symptoms still presenting 6 weeks later. Going for first Xolair injection this week.   *note, flu shot received the same day
Abnormal gait, very sleepy, "just not acting right/himself" - symptoms resolved after approximately 48 - 72 hrs.
I have blisters on both hands and both feet. The blisters feel like they are internal. The blisters are inside my skin, and I just feel slight pain when I walk or when I touch something.
Arm pain, fatigue, shivering, fever, chills, nausea all that night and next day until about 2 pm, but still had arm pain until Friday morning.   I took Tylenol a couple times but couldn?t drink or eat much with it.
Heart palpitations, started about 3 weeks after first dose. Lasting upto 2 hrs per episode several times a day. Episodes started decreasing 5 months after. Not resolved
pt was to get the booster / third shot . she rec'd the monochromal pfizer . according to cdc guidelines all boosters are to be bivalent
I had vaccination on 10/07/2022. On 01/05/2023 I started to have a severe headache a little bit of congestion and general awful feeling. I tested COVID-19 positive on 01/05/2023. I contacted my physician and was prescribed PAXLOVID on 01/05/2023. I presently do not feel better on 04/11/2023. I have an upper respiratory infection in 04/2023 and I had the Norovirus in 01/2023. I have a lot of fatigue in 04/2023 as I don't believe my lungs have recovered.
large, local rxn consistent w/SC administration;also indicated may have had a Td shot less than 5 yr ago;
Information has been received from a physician concerning a 24 year old female with a history of eating disorder, no illness at the time of vaccination who on 29-JAN-2007 was vaccinated with a first dose of GARDASIL (lot # 655617/1447F) in the left deltoid at 3:15 PM. On 25-APR-2007 the patient was vaccinated with a second dose of GARDASIL (lot # 657617/0384U) in the right deltoid at 8:30 AM. On 11-AUG-2007 the patient was vaccinated with a third dose of GARDASIL (lot #658282/0929U) in the left deltoid at 11:10 AM. Concomitant therapy included YAZ. In September 2007, the patient experienced migraine headaches, once a month with loss of vision for 30 minutes followed by 2 to 4 days of headaches and dizziness. The patient has seen the neurologist. The patient had sinusitis at the onset of symptoms in September 2007 which cleared up in 2 months with antibiotics (therapy unspecified). Upon internal review loss of vision is considered to be an Other Medical Event. Additional information has been requested.
Pt experienced severe headache for 70 hours, redness and hardness of right arm, soreness in elbow for 5 days.
arm swelled from shoulder to elbow. Worsened greatly on October 2nd. Started getting better on October 3rd.
Sore Arm at injection site; Fatigue - within a few hours of receipt; Headache within 12 hours; Chills and joint pain within 15 hours - all over within 18 hours total
Patient described prolonged soreness and loss of range of motion in the arm used for vaccination. Seen doctor, recommended PT, assumed possible frozen shoulder.
Headache and Chills 4am. By morning, patient noticed significant pain of Axilla with Right axillary swelling, redness and tenderness.
Is currently taking Ampicillian for a urinary tract infaction; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 08Apr2021 for covid-19 immunization.The patient's medical history and concomitant medications were not reported. The patient is currently taking ampicillian for a urinary tract infection on an unspecified date. The patient is scheduled to receive 2nd BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 29Apr2021. Therapeutic measures were taken as a result of is currently taking ampicillian for a urinary tract infection. The outcome of urinary tract infection was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Day 9 after immunization patient noticed a red patch starting to appear. Warm, hot, tender, and pruritic. Measuring 8x4.5 inches on the left arm at site of injection. She was seen day 5 in the office and was advised to utilize topical steroids, antihistamines, and cold compresses.
Large swollen red spot at injection site. Arm very painful. Headache within couple hours of injection. Next morning sore muscles, no energy, felt sick to stomach. Felt bad all day. 2nd day after still feel no energy but better. Arm not as sore but still large red swollen area. Never had a reaction like this at injectiin site. Covid vaccine are bad but never large swollen red area
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19. The patient was fighting with covid and vaccine did not work.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000209315.; Sender's Comments: V0:   20211263429-Covid-19 vaccine ad26.cov2.s-Suspected clinical Vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This is a spontaneous report from a contactable consumer (Pfizer Employee reporting behalf of her daughter) and from a contactable Pharmacist. A 19-year-old female patient received the 1st dose of TRUMENBA Batch/Lot # M95612 and expiration date Jul2017, on 05Jul2016 at 11:39 AM, intramuscular in Left upper arm. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced severe arm pain at the injection site at 1:40 PM and severe nausea after the injection, both on 05Jul2016. Patient went to bed, woke up, and still had nausea and severe arm pain. Patient woke up with same symptoms the following morning. At the time of the report the patient was recovering. The pharmacist considered there is a reasonable possibility that the event was related to suspect product. Follow-up (26Jul2016): New information form a contactable Pharmacist included: Batch/Lot # and expiration date, route of administration outcome, causality assessment. Follow-up attempts completed. No further information expected.
? Just shy of half a day after the shot, I got the chills like the worst of the cold wet camping events. Chills, teeth chattering, the whole smash. Thank goodness for flannel PJs and wool socks.  ? I can hear my pulse.  ? I have a headache, also, it's only about three on the ten-point scale, but it throbs, too.  ? It's like the fitness work that I've done since June last year evaporated. The throbbing is like I did a week of hand drumming. (No, I haven't.) I can't close my hands without pain.  ? Every current and past injury is throbbing worse, but the whole body is throbbing.  ? The pain killers that I am able to take aren't even touching it.
This is an instance of (possible) breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Pfizer product on 01/28/2021, 02/18/2021, 10/25/2021, and 05/05/2022. They were a resident in a nursing home and had a clinic encounter on 08/04/2022 after which they were placed in palliative care. They tested positive for COVID-19 via antigen test on 09/15/21022 but a PCR test on the same day was negative. They also tested positive via antigen test on 09/26/2022. Both of these tests were done by the nursing home. I see no indication the individual was hospitalized around the dates of the tests. The individual was described as being in poor and declining health for several months prior to the positive COVID-19 tests. The individual died on 10/01/2022. COVDI-19 is on the death certificate.
Really bad pain on both sides of my mid section of my back for 3 days; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient reporting for himself.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Sep2021 12:30 (Lot number: FC3182) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic Pain" (unspecified if ongoing). Concomitant medication(s) included: OXYCODONE; GABAPENTIN; CELECOXIB. Past drug history included: Codeine, reaction(s): "allergies", notes: known allergies: Codeine. The following information was reported: BACK PAIN (non-serious) with onset 23Sep2021 13:00, outcome "recovered" (26Sep2021 13:00), described as "Really bad pain on both sides of my mid section of my back for 3 days". Therapeutic measures were not taken as a result of back pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Oxicodone 5mg, Gabapentin 300mg, Celecoxib 100mg. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Device Date: 30Sep2021. The reporter assessed event as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. Adverse event resulted in None of the above.  Follow-up attempts are completed. No further information is expected.