chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderate costochondritis starting 4th day after vaccine. Currently 6th day and is worst so far. I have undifferentiated connective tissue and have experienced costochondritis before but only before I was on hydroxycholoquine.
High fevers within 2 days of MMR, Varicella, lasted 3 days.
This spontaneous report as received from an unspecified type of reporter refers to a female patient of unknown age. On 17-MAR-2013 in the evening the patient was vaccinated with PNEUMOVAX23. The dose number, route of administration, anatomical location, lot number and expiry date were not reported. Concomitant therapies included SYNTHROID for thyroid treatment and estrogens, PREMARIN as hormone medication. On 18-MAR-2013, 2 days after onset of therapy the patient became very weak and developed a low grade fever. The patient was instructed to visit an ER facility where received Cephalexin and was diagnosed with cellulitis. The patient was discharged the same day. The outcome of cellulitis was reported as recovered/resolved, the date of recovery was not reported. Additional information is not expected.
Arm pain; Chills; 102.2°F temperature/100°F temperature/fever; Body aches/muscle aches; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm pain), CHILLS (Chills), PYREXIA (102.2°F temperature/100°F temperature/fever) and MYALGIA (Body aches/muscle aches) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), CHILLS (Chills), PYREXIA (102.2°F temperature/100°F temperature/fever) and MYALGIA (Body aches/muscle aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), CHILLS (Chills), PYREXIA (102.2°F temperature/100°F temperature/fever) and MYALGIA (Body aches/muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 102.2 f (High) 100 F middle of the night - 102.2 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-020331 (Patient Link).
FLU LIKE SYMPTOMS, SEVERE ABDOMINAL PAIN, NO FEVER LASTING 3-4 DAYS.
Sore arm at injection site for 5 days.  Headache for approximately 5 days.  Brain fog (could not think clearly) for approximately 5 days.   12 days later I?m now having a small headache again and I just feel weird, like I?m more susceptible to illness - slight headache cold coming on.
Intense severe flushing and swelling of face; face turned a deep purple hue and white rings around eyes and nose and mouth. Searing stinging pain in face with flushing. Lasted 6 hours.  Severe tinnitus within 24 hrs, has continued and not abated. Disruption of menstrual cycle, delayed period by 10 days, spotting and stop in period cycle and starting again .
SEIZURES; This spontaneous report received from a consumer concerned a male of unspecified age, 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, batch number and expiry were not reported) dose and start therapy date were not reported for prophylactic vaccination. 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 seizures. The reporter stated patient had seizures daily. Later, on a n unspecified date, the patient got hospitalized for seizures. The patient was hospitalized for 4 months (number of days was not specified).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizures was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220140223-Covid-19 vaccine ad26.cov2.s-Seizures. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt tested positive for Haemophilus Influenzae via throat culture obtained on 1/29/2021, which indicates a vaccine failure.
8-23-12 After shot had a welt - that lasted a couple of hours. Went to bed (welt gone). Woke up about 2 hours after bed with vomiting, then cold sweats for rest of night. 8-24-12 - Woke about 6am, no N/V, but arm sore between shoulder & elbow. 8-25-12 - Fine.
Delayed onset reaction of a raised, red, itchy, rash covering an area of approximately 6 inches x 4 inches in size which is located on the left bicep.
Burning and redness both ears, burning and itching posterior head, hive behind right ear, chest and back, mild rash chest and right forearm.
On 6-25-2022, I started having body aches, headache, temp up to 102.0, shortness of breath, chest pain and a sore throat. On 6-26 I felt as all my symptoms had increased in severity so I called my lung doctor and he told me to go to the ER. They ordered a CT scan of my chest, X-ray of my chest, and blood work. I was also tested for COVID-19 with positive results. I was given an infusion of bebtelovimab antibodies. My fever went away after 48 hours but I am deaf in my left ear now. My primary care doctor sent me to an audiologist on 7-29 who said the ear deafness is likely not permanent. I also had an MRI of my head on 8-23 and they told me I had mastoiditis of left ear that was possibly due to a virus. I am feeling a lot better although with my hearing loss but I do have occasional headaches and vertigo. I am reporting a breakthrough case of COVID-19.
lethargy, fever, chills, shaking, thirst.  Began approximately 8:30pm and ran through the night.  Somewhat improved following day - next night same symptoms recurred but were milder.  Took Ibuprofen and liquids.
bruise; This is a spontaneous report from a contactable consumer. This consumer reported for the female patient. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 09Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She said that she got a bruise after it and the bruise had just gone away. She had said that she wanted to get someone else this time. The patient experienced bruise on an unspecified date in 2021. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recvd vax 26JUN92 1125AM & @ 1140 c/o feeling faint while watching sister have blood drawn; VS stable, had pt lie down shortly p/began to c/o pain in legs between thigh & ankle, said could not move legs; denied numbness or tingling;
This case was considered medical important. Information regarding PREVENAR was received from a physician regarding an 11-month-old male patient who experienced seizure and infantile spasms. The patient received the second dose on 13-May-2010. The patient experienced seizure in May-2010, about 5 days after vaccination and infantile spasms on 19-May-2010. The mother described the seizures as the child was bearing down as if to have a bowel movement and would fling his arms around, then he was unresponsive for a few minutes. On an unknown date in May, the patient was taken to the Emergency Department and was admitted to the hospital. An EEG was performed on 19-May-2010, and the child was diagnosed with infantile spasms. He was treated with an unknown medication that did not seem to work. He was then started on a ketogenic diet, which seemed to help. The patient had no more seizures. The outcome of seizures and infantile spasms was resolved. No additional information was available at the time of this report.
Swelling, redness, pain, in left arm and spreading from deltoid to forearm and pectoral areas.  Fatigue.  Fever 102 F.
Headache, Tachypnea, headaches/tachypnea (intermittant) lasting >2weeks post vaccine Narrative:
Pt c/o severe pain, swelling and redness at injection site c/o fevers (102), sweats and racing heart. Sent to ER for evaluation.
5 min after vaccine admin pt had 5/10 Chest pain, Hypertensive 166/100,  Tachycardia 135. Pt received 25 mg benadryl IM once at onset of symptoms. Resolved at arrival to ED.
Information has been received from a physician concerning a 13 year old female who on 30-JUL-2007 was vaccinated with a first dose of Gardasil.  On 02-AUG-2007 the patient experienced swollen eye and welts developed all over her body.  Medical attention was sought.  The patient recovered from swollen eye and welts developed all over her body.  Additional information has requested.
Hoarseness, achy, coughing 5 hrs after the vaccination, is getting better today.
The morning following my COVID 19 vaccination shot, I awoke with swelling of my fingers and hands to the point where I could not remove the rings from my fingers. Over the next few days, the swelling continued and I started feeling pain and stiffness in all of my joints including my shoulders, fingers, wrists, hip joints and knees. I have never had or been diagnosed with any kind of arthritis, but I felt like all of a sudden I was arthritic. I have also experienced swelling of my eye, only on the left side of my body.  It has been 18 days since my injection and my symptoms have not improved.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with GARDASIL.  The physician reported that the patient experienced an adverse event.  The physician is not sure whether or not the adverse event is related to the vaccine.  No further information was provided.  Additional information has been requested.
My mouth is being very dry; Cold sores; Right side of my face and like under my ear of being very swollen, a lump is there and it hurts even to touch it; Right side of my face and like under my ear of being very swollen, a lump is there and it hurts even to touch it; Right side of my face and like under my ear of being very swollen, a lump is there and it hurts even to touch it; Chills; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 79-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6207), via an unspecified route of administration on 12Mar2021 (at the age of 79-years-old) as dose number unknown, single for COVID-19 immunisation. The medical history of the patient included Blood pressure high. The concomitant medications of the patient included carvedilol (CARVEDILOL) taken for hypertension, start and stop date were not reported. On 12Mar2021, the patient experienced chills, on 14Mar2021 experienced right side of my face and like under my ear of being very swollen, a lump is there and it hurts even to touch it and also my mouth is being very dry, cold sores on an unspecified date. The patient reported that she had the vaccination shot Friday around 4'o clock and experienced the chills all night and all day Saturday and Sunday but Sunday afternoon she started with her right side of her face and like under her ear of being very swollen, a lump was there and it hurts even to touch it and her mouth was being very dry and then she got a cold sore on top of that so she do not know if this is related to the vaccine or something else is going on. She stated chills she had right after she came home all through the weekend but the swelling came in previous day Sunday about may be 7 o'clock at night started happening and the lump got really big and hurted. They do general blood work and checked for her AC Lung and Cluster lung (Not clarified. Hence, not captured in the tab). The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date. The patient recovered from chills on 14Mar2021 and the outcome of the events right side of my face and like under my ear of being very swollen, a lump is there and it hurts even to touch it, my mouth is being very dry and cold sores was reported as unknown.  No follow up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant referring to 4 year old patient of unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 08-JUN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (rHa) lot number: N021727 (expiration date: 06-FEB-2019) for prophylaxis (strength, route and dosage schedule were not provided). The sterile diluent used to reconstitute the vaccine, was properly stored. There was digital data logger involved. The storage characteristics were the following: - Temperature: 15°F to 46°F for 36 minutes. Previous temperature excursion: 15°F to 46°F for 1 hour and 15 minutes. No adverse effects were reported.
Had the worst case of shingles/Suspected vaccination failure; Had the worst case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 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: 05-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the Shingles vaccine four years ago from reporting. The patient experienced the worst case of shingles last spring form bellybutton to spine on left side. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow up would not possible, as no contact, details were available.
FLUBLOK QUADRIVALENT was given to a 11 years old patient with no AE; Initial information received on 16-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 11 years old female patient who received 0.5 mL dose of an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA2014, expiry date: 30-Jun-2021) via intramuscular route on right deltoid on 08-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination.  It was an actual medication error due to inappropriate age at vaccine administration (latency on same day).  At the time of reporting, patient had no adverse events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
he has cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "he has cold".  Additional Information: Reporter called on behalf of her father who has a scheduled shot of vaccine, for tomorrow Saturday and this week he did develop a cold around Tuesday. He was feeling better today and reporter was wondering if she want to reschedule; how much longer do we reschedule or something and the other question is if he has cold Should he be getting by the second shot tomorrow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case meets criteria for vaccine breakthrough review. SxS include fall.  Otherwise asymptomatic for COVID.
The morning of April 3, staff at the Community Vaccination Clinic discovered a discrepancy in the preparation of Pfizer vaccine doses. It was discovered that several undiluted vaccine doses were administered. Staff accounted for all unused undiluted vaccine doses. Unfortunately, 10 undiluted vaccine doses had been administered to patients and were not able to be retrieved. This patient received one of the undiluted doses.   The medical team contacted the CDC to determine the potential side effects and observation requirements of receiving an undiluted vaccine. The CDC confirmed that the recipients of the undiluted doses may experience stronger side effects and symptoms than someone who received the diluted dose (sore arm, flu-like symptoms, etc.).  The site public health officer spoke with suspected recipients of the undiluted vaccine to explain potential medical side effects. The Health District will follow up to monitor their status.
1. Woke with a painful knot midway between my naval and groin area. Initially the knot was about the size of a nickel, but eventually grew much larger over the next few days.   1. Woke up with right outer calf pain that eventually migrated upward to the outer right hip.
Within 2 days of the second dose I have been having tingling in various areas of my body at random times. The tingling can be in my trunk, head, extremities and not related to rest or movement.
very tired; Slept a lot; arm hurt a little bit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a little bit), FATIGUE (very tired ) and HYPERSOMNIA (Slept a lot) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included TB. Concomitant products included VITAMIN B6 for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurt a little bit). On 28-Feb-2021, the patient experienced FATIGUE (very tired ) and HYPERSOMNIA (Slept a lot). At the time of the report, PAIN IN EXTREMITY (arm hurt a little bit), FATIGUE (very tired ) and HYPERSOMNIA (Slept a lot) outcome was unknown.            No treatment details were provided.    This case was linked.   See case for details regarding the child case.
Pt c/o fever, feeling hot and redness to neck and (R) arm at the injection site
Patient received SHINGRIX vaccine at a local pharmacy. 2 days later he developed burning and itching on his right torso. He was seen at urgent care and diagnosed with shingles. He was given a prescription for Valcyclovir but several days later broke out in a rash.
started to experience reactions; Skin peeling both on hands and legs; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Skin peeling both on hands and legs) and ADVERSE REACTION (started to experience reactions) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DULAGLUTIDE (TRULICITY), LOSARTAN, Aspirin prescribed every morning, PANTOPRAZOLE, Acorvastatin, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), MULTIVITAMIN & MINERAL and EZETIMIBE for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced SKIN EXFOLIATION (Skin peeling both on hands and legs). On an unknown date, the patient experienced ADVERSE REACTION (started to experience reactions). At the time of the report, SKIN EXFOLIATION (Skin peeling both on hands and legs) and ADVERSE REACTION (started to experience reactions) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       she applied lotion at the site of skin peeling . Treatment information was unknown. She was concerned with that peeling of skin and she wanted to know whether any of other patients who received moderna vaccine had the same symptoms.
pain in the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-JUL-2023, the patient received the 1st dose of Shingrix. On 27-JUL-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain in the injection site). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-JUL-2023 The patient had a mild reaction to the first dose with pain in the injection site since administration. The reporter did not consented to follow up. This is 1 of 2 linked report, reported by same reporter for his wife.