chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated a couple hours after receiving immunization, his upper arm around the immunization area started to swell and hurt. He said it progressively got worse over the next couple days and lasted for 5 days. He described the swollen area to be the size of a tennis ball, was red, tender, throbbing at times. He described the muscle pain/soreness to be similar to getting hit in the arm with a baseball. He said he did not lose feeling in the arm and retained normal motor function although was sore to lift arm. He does not remember if it was warm to touch. He did not seek medical attention or advice and remedied the issue by wrapping an ice pack around his arm. He only reported this when we reminded him it was time for his 2nd dose. He has opted not to get the 2nd dose.
Patient received the PNEUMOVAX Vaccine on Monday 10/30/17 and reports having an itchy throat and feeling bad overall on Wednesday, 11/01/2017. He stated he progressively started feeling worse and had a fever accompanied by a cough that prompted him to see a physician at an urgent clinic on Saturday, 11/04/2017. He stated he was diagnosed with pneumonia by an exam and chest X-ray at the urgent clinic. The prescriber gave him an antibiotic, steroids, and breathing treatment solution.
Initial follow up information has been received from a certified nurse midwife for the Pregnancy Registry for GARDASIL concerning an 18 year old obese, female who on 18-OCT-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot# and site not reported). Subsequently, the patient found out she was pregnant (LMP approximately 07-OCT-2007). On and unspecified date in December 2007, the patient was prescribed  ranitidine (unspecified) for heartburn. On 31-DEC-2007, 06-FEB-2008, and 03-MAR-2008, the patient had ultrasounds for "routine dating and follow up" which were reported to be within normal limits. On an unspecified date, the patient developed mild pregnancy induced hypertension (not further specified). The patient was induced at 37 weeks gestation. On 21-JUN-2008, the patient gave birth to a normal male infant (7 lb, 4 oz; 48.3 cm). There were no congenital anomalies. The infant had Apgar scores of 7 and 9. No additional information was provided. Additional information is not expected.
Patient administered 0.3 ml and not 0.2ml of Pfzier Covid vaccine 5-11years.
Initially, pain and swelling in the upper arm, and extreme fatigue the following day.  Reporting because as of day 3, the injection site is a hard lump, and is very itchy.
vial was initially stored in the refrigerator on 8MAR2021; After beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 8MAR2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (After beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 8MAR2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (After beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 8MAR2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. The vial was initially stored in the refrigerator on 8-Mar-2021. It was unknown whether the vials underwent any temperature excursions. No treatment information was provided.   Reporter did not allow further contact
8 days following vaccine, injection site became painful again. Day 10 it became itchy, red, and hot. Feels bruised.  (Initially on days 1-3 only had arm soreness)
Swollen arm at injection site came back; Chills; Normal dizziness; Swollen at injection site; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Normal dizziness), VACCINATION SITE SWELLING (Swollen arm at injection site came back), VACCINATION SITE SWELLING (Swollen at injection site), FATIGUE (Tired) and CHILLS (Chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and BUSPIRONE for Anxiety.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (Normal dizziness), VACCINATION SITE SWELLING (Swollen at injection site) and FATIGUE (Tired). On 12-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swollen arm at injection site came back) and CHILLS (Chills). At the time of the report, DIZZINESS (Normal dizziness), VACCINATION SITE SWELLING (Swollen arm at injection site came back), VACCINATION SITE SWELLING (Swollen at injection site), FATIGUE (Tired) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pfizer bivalent 6m-5yrs 10 dose vial after dilution, Pfizer vial was not diluted prior to giving patient their dose of 0.2ml. called the facility nurse and our lead immunizations coordinator. Nurse stated patient got a bit more than what patient should have received, but that patient should be fine other than maybe having a fever. mother of child was informed of incident and advised to keep a close eye on patient for any severe reactions.
I was having a headache on Monday long with fatigue. On Tuesday I was starting to get congestion and runny nose the next day the congestion was worse so that Wednesday I did a COVID-19 home test and it was positive. I called my doctor and they had me get zinc and vitamin D3 and C along with putting me on PAXLOVID. I am very fatigued right now.
This spontaneous report as received from a licensed practical nurse refers to multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 26-OCT-2015, the multiple, unspecified patients received improperly stored doses of GARDASIL 9 lot # L016429 (route of administration, dose and expiration date were not reported). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, Arthralgia, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE, Narrative:  Other Relevant History:
Received 2nd dose in 8 week after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose in 8 week after 1st dose) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose in 8 week after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose in 8 week after 1st dose) had resolved.            Concomitant product information was not provided.  Treatment information was not provided.
I have had a constant daily headache every day since the day after the first dose of my vaccine.
2 hours post vax, the  pt broke out in whelpy rash on thighs, back, and feet. Physician described rash as faint maculopapular rash. Mother states rash covered her whole body by next day and was raised.
Patient is s/p whipple procedure 12/2020. He has been complication free for many months. On 12/6/21 he developed acute pancreatitis. He was hospitalized from 12/6-12/10. He had another episode of pancreatitis on 12/18. He noticed recurrent injection site soreness on 1/3/22 and 1/10/22. He developed another episode of pancreatitis on 1/13/22 requiring hospitalization.  No other medication or diet changes to prompt the pancreatitis.
Patient states after receiving second dose of vaccine in October 2021, her arm developed knot within next day and arm soreness. Knot was hot to touch and skin was red. Knot went away within 1-2 weeks, but arm soreness has persisted and is still present to this day.
Patient called complaining of itching, redness, and swelling at the injection site. She said it was painful if you it on the sport and there's a big red circle about 2 inches wide. Instructed the pt to take some benadryl, use ice packs to help reduce swelling, and use some hydrocortise cream to help with the itching. I also instructed her to take some tylenol.
Pfizer vaccine given by outside source - Patient reported  I95.9 HYPOTENSION 12/17/2021 HYPOKALEMIA I95.9 HYPOTENSION 12/17/2021 LEUKOCYTOSIS I95.9 HYPOTENSION 12/17/2021 HYPONATREMIA
I had a sore throat and white patches on tonsils lasting 2-3 days.
This spontaneous report as received from a Register Nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 01-JUN-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (route, dose and anatomical location were not reported), (lot # J014228 expiration date 13-MAY-2016). There was no concomitant therapy reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Two hours after Flu shot fast heartbeat dizzy weakness hoarseness cough headache Temp 104.7 chills shaking ok after 72 hours I m a CRHA- have had flu shot with uce yr. - NCUCE
pain; swelling/puffiness; hardness; feeling ill; nauseous without vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), SWELLING (swelling/puffiness), INDURATION (hardness), MALAISE (feeling ill) and NAUSEA (nauseous without vomiting) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN (pain), SWELLING (swelling/puffiness), INDURATION (hardness), MALAISE (feeling ill) and NAUSEA (nauseous without vomiting). On 10-Apr-2021, PAIN (pain), SWELLING (swelling/puffiness), INDURATION (hardness), MALAISE (feeling ill) and NAUSEA (nauseous without vomiting) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
patient was stabilized on warfarin 6mg daily for a year. after vaccination her INR increased and I had to reduce her dosage to 5.5mg daily which she seems to be stabilizing on now.
had a vaccine, now has shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 10-May-2022 Reporter's comment: The case was received from the patient's wife via interactive digital media. The patient had a vaccine a few years ago and now had shingles but had not broken out on the outside. The reporter thought he had broken out on the inside. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.  The case was linked with case US2022AMR077472 and US2022AMR077476, reported by same reporter for herself.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR077472:Same reporter US-GLAXOSMITHKLINE-US2022AMR077476:Same reporter
At 1;30 Am the following morning patient reported shortness of breath, bad headaches, hives, and arm pain. Patient reported to ER and was prescribed an inhaler to help with breathing.  On November 29th at 2:30AM the patient reported hives on feet, neck, and throat. Patient claims to have not changed her diet or start any new medications.
Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age ten months old patient who was vaccinated with a 0.25 ml second dose of FLUZONE QUADRIVALENT (Batch number: UT6259LA, expiration date: 30-Jun-2019, site of administration: left thigh and route was not reported) on 06-Nov-2018 and on 15 Oct 2018 patient had also received same vaccine (Batch number, expiration date, dose, route and site of administration was not reported). The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate schedule of vaccine administered (a ten month old received second FLUZONE QUAD 0.25 ml vaccination a week early). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose: not reported, administered on Apr 29, 2021, immunization. Unable to perform follow-up to request batch/lot numbers. May 2021, patient experienced flu symptoms and sickness. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered from flu symptoms and sickness.
Information has been received from a physician concerning a 29 year old female with no medical history who in her teens, was vaccinated with two doses of VARIVAX (Merck) (lot # not reported).  Subsequently the patient had a negative varicella titer.  At the time of the report, on 24-FEB-2009, the patient has not recovered.  The patient was seen in the office.  Additional information has been requested.
DTaP#5 given 1/21/04 pt seeen 1/23/04, a large oval, 10cm x 11cm, erythema/central induration and tenderness noted on left upper arm. Dx DTaP #5 rxn vs. cellulitis. Pt put on Benadryl and Cefzil. Rxn: DTaP #5 r/o cellulitis.
bleeding under skin; bleeding under skin; big bruises; 2 bruises on right arm; 1 bruise on left arm; 1 bruise on hand; bruises not at injection site; felt dizzy; feels like she has a temperature; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of INJECTION SITE HAEMORRHAGE (bleeding under skin), CONTUSION (big bruises), CONTUSION (2 bruises on right arm), CONTUSION (1 bruise on left arm) and CONTUSION (1 bruise on hand) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL), CLONAZEPAM, CICLOSPORIN (RESTASIS), ISOSORBIDE, LOSARTAN, FUROSEMIDE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced the first episode of INJECTION SITE HAEMORRHAGE (bleeding under skin), CONTUSION (big bruises), CONTUSION (2 bruises on right arm), CONTUSION (1 bruise on left arm), CONTUSION (1 bruise on hand), CONTUSION (bruises not at injection site), DIZZINESS (felt dizzy) and PYREXIA (feels like she has a temperature). On an unknown date, the patient experienced the second episode of INJECTION SITE HAEMORRHAGE (bleeding under skin). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 26-Mar-2021, DIZZINESS (felt dizzy) had resolved. At the time of the report, CONTUSION (big bruises), CONTUSION (2 bruises on right arm), CONTUSION (1 bruise on left arm), CONTUSION (1 bruise on hand), CONTUSION (bruises not at injection site), PYREXIA (feels like she has a temperature) and the last episode of INJECTION SITE HAEMORRHAGE (bleeding under skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This study case was received from the investigator on 16 August 2012. A male subject with no reported past medical history was found to have on 03 August 2012 mild, asymptomatic, transient elevated Troponin level of 0.11 ng/ml 9 days after the subject had received on 25 July 2012 the following vaccines: ACAM2000 (lot number, route and site of administration not reported) and an injection of Anthrax vaccine (manufacturer name, lot number, route and site of administration not reported). On 07 August 2012, the subject was notified of elevated Troponin level of 0.11 ng/ml, and a repeat Troponin-I level and ECG were performed the same day. Troponin result was reported as less than 0.10 ng/ml, and the ECG was normal. The subject received adequate follow-up from his PCM (Primary Care manager) and no further workup/treatments were necessary. No further information was available at the time of the report. The subject's outcome was recovered/resolved on 07 August 2012 (4 days after onset). The investigator considered the SAE to be possibly related to the vaccinations and was also considered to be an "other important medical event." This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the Adjudication Committee for assessment. Documents held by sender: none.
slight pain in arm, vaccine was administered; a little feverish; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 28Apr2021 13:00 (Lot number: EW0171) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "cholesterol", start date: 2015 (ongoing). Family history included: "HBP", start date: 2003 (ongoing); "Diabetes", start date: 2018 (ongoing), notes: Diet and exercise controlled 17Jun2021 - A1C was 6.8 and Glucose mg/DL was 149. Concomitant medication(s) included: COZAAR taken for hypertension, start date: 2012 (ongoing); HCTZ taken for hypertension, start date: 2012 (ongoing); PRAVASTATIN taken for blood cholesterol, start date: 2015 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Time: 13:00., Anatomical Site of injection: Right arm, Route of administration: Intramuscular, Batch/Lot number:Pfizer EW0151), administration date: 07Apr2021, when the patient was 54 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "slight pain in arm, vaccine was administered"; PYREXIA (non-serious), outcome "unknown", described as "a little feverish". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information:The patient did not receive any other vaccines within four weeks prior to the vaccination. Second dose had slight pain in arm, vaccine was administered, a little feverish that night, took one advil. Patient received treatment for the event fever with advil.  No follow-up attempts are possible. No further information is expected.
headache; fever; This spontaneous case was reported by a non-health professional and describes the occurrence of HEADACHE (headache) and PYREXIA (fever) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and PYREXIA (fever). At the time of the report, HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided by reporter.
About 1 minute after vaccination patient went stiff while seated in bench, dropped to ground, and started to convulse. Pharmacist told technician to call 911 and moved items (privacy screen/bench) away from patient. Patient got up into bench after about 10 seconds. Patient stated she has never had history of seizures. Patient asked to stay in bench and was asked to do so for her own safety. Patient asked for and was given a bottled water. Patient seemed to go stiff for a split second once again but caught herself. Pharmacist asked patient to sit back in bench so as not to fall/hit ground again. Pharmacist asked patient if there was anyone she wanted to call or for us to call so that they could maybe come pick her up, she stated there was no one and said she drove to pharmacy alone. Pharmacist asked if its ok that we called paramedics to come check her and make sure she is ok before she attempted to go, so as not to fall/pass out and hurt herself. Patient said ok. Paramedics arrived and patient told paramedics she did not want to go to hospital and did not want to lie on stretcher, but was ok with walking with paramedics to ambulance so that they could check her and make sure she is ok. Then patient walked with paramedics out to their ambulance.
No reaction after vaccination. However, about 2 days later, developed a bright red blotch on my upper arm just above my elbow crease (left arm). I happened to be visiting a doctor (for another reason) on Oct. 4 and he said it looked as though there was bleeding under the skin. Red blotch eventually faded away.
My whole right arm developed cellulitis it caused my birth control to stop working. I use two types of birth control and still bled for three months straight.