chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT COMPLAINED OF A SORE ARM THAT SHE HAD FOR 2 DAYS AFTER IMMUNIZATION.
VACCINE ADMINISTERED 10/31/2005. PT RETURNED TO CLINIC 11/1/2005 COMPLAINING OF REDNESS AND SWELLING IN ARM WHERE VACCINE WAS ADMINISTERED. SOLUMEDROL 125 MG GIVEN IM. ON 11/8/2005 PT RETURNED TO CLINIC FOR FOLLOW-UP AT WHICH TIME SHE FELT BETTER. PT STATED FEELING "CREEPY, CRAWLY" HAD DIMINISHED. PT WAS TAKING BENADRYL AND AYRTEC AT THAT TIME, BUT HAD STOPPED TAKING PREDNISONE DUE TO HYPERACTIVITY. 3/28/06 Received autopsy report which revealed COD as coronary artery atherosclerosis (years)/ss
After second Moderna vaccine I could not walk; the pain is excruciating on my ankles and heels. I have not walked since March 5, 2021.
Patient was accidentally given pediatric dose instead of adult dose. Patient mom decided to not have us redose in 21 days.
Foggy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced FEELING ABNORMAL (Foggy). On 19-Feb-2021, FEELING ABNORMAL (Foggy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No laboratory details were  provided.  No treatment medications were reported.
This spontaneous report was received from a pharmacist and refers to multiple unspecified patients of unknown age and gender. There were no medical history and concurrent conditions reported for the patients. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of MMR II (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of two cases from the same reporter. Additional information has been requested.
Mild arm soreness,  fatigue, and joint/muscle pain on first day. Woke up on 1/30 the day after with severe headache, fatigue, swollen lymph nodes, very pronounced joint and muscle pain
Pt had high pitched scream immediately p/vax given which continued for four hrs; pt slept 3 hrs but resumed screaming on awakening;
shingles and other zoster-related conditions.; shingles and other zoster-related conditions.; This spontaneous report was received from a lawyer and a patient (Pt) of unknown age and gender, regarding a case in litigation on 18-APR-2022, via legal memo. The Pt's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On or about 2017, the Pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (lot #, expiration date, strength, route of administration, anatomical location not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the Pt was treated at the hospital for the following injuries resulting from zoster vaccine live (ZOSTAVAX) vaccination: shingles and other zoster-related conditions. At the reporting time, the outcome of the events was unknown. The reporters considered herpes zoster and other zoster-related conditions to be related to Zoster Vaccine Live (ZOSTAVAX).
10 days after her vaccines she developed fussiness and petechia and very small purpura all over her body the following day it all went away and then more purpura developed on her L hand and remained for several days. No other symptoms.
This spontaneous report was received from the patient's mother refers to her son a male patient of unknown age. In approximately August 2013 (about a year ago) the patient was vaccinated with GARDASIL (route, lot number and expiration date not reported) recommended by physician. There was no concomitant medication reported. The patient's mother reported that her son had missed his third dose of GARDASIL. She stated that her son received dose one and dose two within the prescribed period. No adverse event symptoms have been reported. Additional information has been requested.
the patient was administered an improperly stored dose of VAQTA on 5/19/2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.          On 19-MAY-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) (lot # S032055, expiration date 09-NOV-2020, dosage detail, route and strength were not provided) for prophylaxis (product storage error). Administered doses of vaccine experienced temperature excursion of 12.1 degrees Celsius (C) for 16 hours and 11 minutes. There was no previous temperature excursion. Digital data logger was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032055; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Left arm swelling, under arm swelling, armpit swelling and excruciating tenderness, left breast swelling and tenderness, left neck stiffness.
First Shingrix / May of 2020 / received / 2nd vaccination today / One year between the two doses; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 2020).   On 30th June 2021, the patient received the 2nd dose of Shingrix. On 30th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional information was provided as follows: This case was reported by patient herself. The patient received her 1st dose a year before reporting and got her 2nd dose a year later, received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. The patient wanted to know would that be effective or need to get a 3rd dose in 2 to 6 months. The patient did not know the lot number or expiration date. The reporter consented to follow up.
Patient is describing feeling as if he took Niacin, he is flushed, red in the face but cool to the touch and itchy skin
Receive flu shot 10/17/06. 10/28 and 10/29 soreness at injection site Right deltoid. 10/30 noted burning sensation Left arm, left shoulder, left forearm onto L chest-continued thru today. Some days intermittent some days worse then others. To Employee Health-Emergency department to rule out cardiac, PCP
Got a red rash at arm site 2 days after injection. Possible urticaria and pt would like to know if she should get the second dose.
This literature marketed report has been received from the authors of a published literature article and refers to a healthy 10-year-old boy presented with verrucae on both hands and his right elbow. Several rounds of debulking followed by cryotherapy were initially attempted. Because of unsatisfactory improvement after 13 months, topical salicylic acid and imiquimod were trialed for three months but failed. On an unknown date, the patient and his parents elected for a single intralesional injection of the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, lot # and expiration date were not reported) into the two largest warts on his hand. The patient was previously vaccinated against measles, mumps, and rubella (MMR) but not Human Papilloma Virus (HPV). Four weeks after the single treatment, the injected warts demonstrated involution. Four months later, all treated warts as well as untreated warts demonstrated complete involution without recurrence.
c/o itchiness and papular rash around the body, primarily on her stomach and back that started on Sunday (03/13/2022) s/p covid vaccine 2nd dose (03/11). Pt also noticed of wheals (2x1cm) on her both feet and right elbow. States feeling soreness on the injection site. This morning (3/16) she also noticed that her eyes alittle bit puffy. Patient also states that she applied  lotrimine cream for her stomach and notice of mild improvement on her itchiness. Denies tongue swelling, fever, or SOB at the moment she was at the clinic.  Prescribed kenalog 0.1% bid for affected skin, and benadryl p.o 25 mg q4h PRN for 2 days for the allergy reaction. Request to be off work today for possible adverse effect of covid 19 vaccine. Request to follow up with  herPCP by the end of today or tomorrow, or visit ER if the symptoms worsen. F/U call is scheduled today as well.
Pain in injection site and hand, with little difficulty to breathe.  that night start feel chili, wake up with fatigue, body ache, headache and fever at 102 degree.
Attacked - disc - sciatica - foot neuropathy and legs. Within 4 hours of shot problems intensified. Body got very cold inside but outside was warm. Something was very wrong. Outside of usual problems.
Breakthrough COVID-19 case with unknown symptom status. Hospitalization, unknown date and duration.  Death 8/11/2021. COD from vital records: hypoxemic respiratory failure,  COVID-19 pneumonia. Place of death: HOSPITAL INPATIENT, PRONOUNCING AND CERTIFYING PHYSICIAN, occ/ind: UPHOLSTERER, UPHOLSTERY
few hrs p/inject pt became fatigued-"exhausted"; arm became swollen-upper arm; redness > 1/2 of upper arm warm, no fevers, sl painful couldn't lay on it;
Swollen lump at injection site; Headache/ feels a light headache coming on; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache/ feels a light headache coming on) and VACCINATION SITE SWELLING (Swollen lump at injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced HEADACHE (Headache/ feels a light headache coming on). On 04-Aug-2021, the patient experienced VACCINATION SITE SWELLING (Swollen lump at injection site). The patient was treated with PARACETAMOL (TYLENOL) on 03-Aug-2021 for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache/ feels a light headache coming on) and VACCINATION SITE SWELLING (Swollen lump at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.
temp to 100.0, chills, wheezing on inspiration (mild) jittery feeling, fatigue, dry eyes, swelling, myalgias lasted for 1-2 days;
Caused disruption to my menstrual cycle. My flow should have started on April 30 but did not come until May 8 leading to a cycle length of 32 days. That started a cycle of 22 days in length and my current cycle length is unknown (at least 24 days). Prior to vaccination my cycle was 25 days +/- 1 day.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 07Jul2023 to 12Jul2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250507 same patient/reporter, different drug/AE;
pt recvd vax; hosp p/ 24oct95; high T, inc WBC;
suspected signs and symptoms of COVID-19 as follows: mild shortness of breath with moderate walking, dizziness, mild headache, mild GI upset; suspected signs and symptoms of COVID-19 as follows: mild shortness of breath with moderate walking, dizziness, mild headache, mild GI upset; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 at 12:00 as dose 1, single (Lot number: HF9275) at the age of 54 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUAD), on 26Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Dermatitis atopic" (unspecified if ongoing); "Exposed to Covid-19 via domestic partner" (ongoing). There were no concomitant medications. Vaccination history included: pfizer covid 19 vaccine (DOSE 4 (BOOSTER), SINGLE, bivalent), administration date: 06Dec2022, when the patient was 53-year-old, for COVID-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 05Apr2022, when the patient was 53-year-old, for COVID-19 immunization; bnt162b2 (DOSE 1, SINGLE), administration date: 27Mar2022 (as reported), for COVID-19 immunization; bnt162b2 (DOSE 2, SINGLE), administration date: 17Apr2021, when the patient was 52-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Nov2023, outcome "not recovered" and all described as "suspected signs and symptoms of COVID-19 as follows: mild shortness of breath with moderate walking, dizziness, mild headache, mild GI upset". Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: Exposed to Covid-19 via domestic partner (no recent Covid vaccinations, only 2 primary series received 2021), who tested Covid positive in nasal swab test on 04Nov2023. My symptoms started the same day. Highly suspected signs and symptoms of COVID-19 as follows: mild shortness of breath with moderate walking, dizziness, mild headache, mild GI upset, eye light sensitivity, mild dry cough, mild rhinorrhea, joint/muscle aches, fatigue, somnolence, hypersomnia (slept 18 hours during a 24 hr period), mild temperature and occasional shivers. Still ongoing symptoms. Have had COVID-19 three times before over past 3 years. Did not do COVID test at this time.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine bnt162b2 omi xbb.1.5 in this patient cannot be completely excluded.
I feel a lot less energy after the 2 series of Phizer\BioNTech vaccines. The first one was on 6/1/2021, the second dose on 6/22/2021. Immediately after the vaccine I felt super tired. Little by little the effects became less horrible, however by june 21, 2021 I still didn't have enough energy to drive to the same place (about 1 hour away) for the second vaccine. So I went to a nearby store - only 15 min away. The second dose made me have headaches and feel dizzy. 2 weeks and 1 day later I still didn't have enough energy to drive 2 hours away for an interview. I didn't have enough energy, nor optimism to go to gym classes. Overall I still feel worse than before the vaccine. I just don't have enough energy and feel very sad. I never feel like running anymore (and I did before the vaccine). Now I stay in an even worse place, because I still don't have a job. Sometimes I fall asleep during the day, which rarely happened before the vaccine. It scares me. I have not read anywhere that the vaccine can have such an effect. Also, I thought the pandemic will end once there are widely available vaccinations, which happened some time in June. There is still a pandemic. People are still wearing masks. When will the pandemic end?  How can I get the same energy and optimism I had before, i.e. reverse the negative effects of the vaccine? Will the effect of the vaccine wear out and if so in how much time?
Narrative: COVID infection following COVID vaccine series 07/01, Pfizer, dose #1 07/22, Pfizer, dose #2 12/28 COVID swab, result: detected 12/27 pt cc: chills, cough, diarrhea, fatigue, fever, dyspnea exposure: unknown 12/29 ESR: 11 12/29 LACTIC ACID: 1.59 12/29 CXR impression: No pleural effusion or pneumothorax. No pulmonary edema or focal consolidation. Normal cardiomediastinal silhouette.
2hr post vax pt devel swollen eyes & swelling checked w/administration of children's DPH given by parent;no further problems;
I tested positive for COVID-19 in October 2022. I had congestion, body aches, fatigue, cough, fever, tingling in my throat and drainage. I contacted my doctor but was not prescribed medications. I did take TYLENOL, and TYLENOL PM. I was sick for about four days after that I still had fatigue, but no other symptoms.
Rash from site of injection to elbow, fever of 101'f, chills, diarrhea, nausea, vomiting and shakey hands.
Vomiting; Fever; Arm pain; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration on 19Apr2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On an unknown date in Apr2021, the patient experienced vomiting, fever, arm pain, and tiredness. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events which was unspecified. The clinical outcomes of events vomiting, fever, arm pain and tiredness were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:28 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:28 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 63.32   Concomitant products were not provided.  On 03-Apr-2021 Excursion time was reported at 09.00 am with  temperature as 34 degrees Fahrenheit, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021 , vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  Vial was stored on cooler 1, on 03-Apr-2021, Excursion duration At 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM : 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
HBP reports the patient had a negative titer for MMR II and VARIVAX despite being fullly vaccinated; HBP calling to report an inadvertent administration of PROQUAD to a 20 year old.; Office inadvertently administered PROQUAD with the intention of administering MMR II AND VARIVAX as 2 seprate vaccines.; This spontaneous report was received from an office manager and refers to a 20-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.      On 18-JUL-2023 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (exact dose, dose number, route and ste of administration, lot number and expiration date were not provided) instead of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (product administered to patient of inappropriate age and wrong product administered).    On an unknown date the patient experienced antibody test negative. The outcome of antibody test negative was unknown. Action taken with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) regarding the event was not applicable.   The causality between measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and the event was not provided.
On 02/18/2002, pt received DTap in the right leg. Had high fever which began on 02/19/2002. Had low fluid intake; seemed "off balance" to mom. Had a runny nose. Exam consistent with otitis media. Also had a fine 1mm papular exanthem on back (100.7 deg F. at the time). Mom was concerned it was related to the vaccine.