chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No PQC or additional AEs reported; Caller states she has a 17 yo that received 1st dose of GARDASIL 9 about one year ago, received the second dose on 6/28/2021.; This spontaneous report as received from a pharmacist refers to a 17-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  Approximately in July 2020 (reported as about one year ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 28-JUN-2021, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, intramuscularly, lot # T028582, expiration date 04-MAR-2023 (anatomical location was not reported) for prophylaxis. There was no adverse event reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T028582; expirationdate: 04-MAR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
tired; feeling dizzy/she woke up dizzy; legs felt weak; weakness/she felt weak; This is a spontaneous report received from a contactable reporte from medical information team. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 07May2021 (Batch/Lot number: unknown) at the age of 47 years 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: FATIGUE (non-serious), outcome "unknown", described as "tired"; DIZZINESS (non-serious) with onset 12May2021, outcome "recovered", described as "feeling dizzy/she woke up dizzy"; MUSCULAR WEAKNESS (non-serious) with onset 12May2021, outcome "not recovered", described as "legs felt weak"; ASTHENIA (non-serious) with onset 12May2021, outcome "unknown", described as "weakness/she felt weak".  Additional information: Patient had her first dose of the Covid 19 vaccine on Friday, 07May2021. That day she was fine, her arm was fine, she didn't get tired, none of that. Reporter (patient) stated her head didn't hurt, she didn't have a fever, she was tired but that was it. However, today (12May2021) she woke up feeling dizzy and her legs felt weak and she felt weak. Patient described it as weakness like when you have a fever, but she does not have a fever. She went back to sleep for 2 hours and is not dizzy anymore but her legs are still weak. Patient stated she is not sure if going to work on Monday and Tuesday tired her up. She asked if these symptoms are normal and is it normal for them to start this late. Reason for no lot number: of Pfizer Covid 19 vaccine: Caller unwilling to complete the report Expiry Date of Pfizer Covid 19 vaccine: Not Provided   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, chills, fever, aches, very  tired.  Sleep, anacin, execedrine migraine, drink lots of water
A physician reported that several immunodeficient children up to 9 years old received Prevnar. One month, post vax, the physician checked the children's antibody levels and found either no response or an inconsistent response. The reporter indicated that 15 children experienced this event; however, they are not presently identifiable. Additional reports will be generalized when identifying information is provided.
On 08/26/2022 I was exposed to COVID-19 infection. On 08/28/2022 I had dry cough, fatigue, loss of taste and smell. I was wiped out for a day. On 08/29/2022 I did a COVID-19 home test which was positive then I went to my doctor's office they did COVID-19 test which was positive. He prescribed me PAXLOVID and advised me to take over the counter cough medication.
On 2/1/2021 began to have severe itching at the vaccine site. Within a few hours there was a softball size hive. The area was very itchy, red, and warm to the touch.  On 2/2/2021 the area was mildly itchy and by evening the swelling had decreased. The area now has a distinct red circle around the edge with lighter pink in the middle. The area is still warm to the touch and is mildly sore.
A report has been received from a Health Professional concerning a child, subject of unknown gender, who had been receiving nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced nasal congestion. The outcome of the event of nasal congestion is unknown. The report was considered to be non-serious.
My husband has been experiencing flu like symptoms since the day after his vaccine.  These include body aches, chills, no taste or smell, low grade fever up until 48 hrs. ago and extreme fatigue and tiredness.
On Thursday morning, 2/11/21, about 8 hours short of a full week after the vaccination, I experienced a sudden onset of chills/severe shaking, general achiness, headache, severe fatigue and loss of appetite.   I spent the following 72 hours mostly prone in bed, taking only minimal nourishment, and drifting in and out of sleep.  Now, three days after that onset, I am feeling significantly better but am still weak, perhaps because of lack of food.
1/18/22  50 y/o female with PMH significant for IDA, asthma who complains of CP, SOA.    Pt reports her symptoms began yesterday. Her CP is pleuritic, left sided, radiates into her back. For several days before this developed she had been having chills, myalgias, HA, nausea, left ear pain. Admits chronic cough unchanged from baseline, nonsmoker. Denies fever, vomiting, bloody stools. She is vaccinated against COVID but not boostered. ER work up was significant for hemoglobin of 6.1. She had required blood transfusion a few years ago and was at one point prescribed iron pills but she never had these refilled. Admits irregular menses and post coital bleeding. LMP 12/9 - 12/12/21. Active Problems:   Severe symptomatic
Pfizer Dose 1 3/20/21 (ER2613) Pfizer Dose 2 4/17/21 (EW0164) Pfizer Dose 3 9/21/21 (FF2588) COVID Positive 1/7/2022  1/7/22: The patient presents with worsening shortness of breath.  Onset: gradual .  Location: generalized. Context: The patient is a 60 year old male presents to the ED with worsening shortness of breath. He has associated fever, chills and body aches. The patient denies chest pain. He does not endorse any other pains and symptoms such as abdominal pain, nausea, and vomiting. The patient has a Hx hypertension, hyperlipidemia, diabetes, stage III renal disease and hepatic cancer with liver transplant. His transplant was done at hospital in 2009. The patient tested positive for COVID 19 recently. He was evaluated. Patient was hospitalized, while he was admitted he did require supplemental O2. He was recently discharged earlier in the week without any oxygen requirements. Today, he is requiring 3L via nasal canula which is new requirement for him. .  Timing: gradual. Character: moderate.  Associated Symptoms: moderate and fever, chills and body aches.  1/21/22: Severe septic shock with multi organ failure on Levophed, phenylephrine, Ang II, vasopressin, Adrenaline ;Family decided on comfort measures and patient expired  Acute hypoxemic respiratory failure due to  COVID-19 pneumonia  Possible superimposed hospital associated pneumonia   Alcoholic cirrhosis status post liver transplant in 2009, markedly elevated LFTs  and lactic acid, possibly shock liver  Chronic immunosuppression for liver transplant  Acute kidney injury on CKD stage IIIA   Diabetes mellitus with hyperglycemia  Hypertension, now hypotensive on pressors   Hyperlipidemia   Obesity  Chronic low back pain  Insomnia  Leucocytosis  The patient expired from progressive multiorgan failure due to Acute covid-19 infection while immunosuppressed and in the background of extensive comorbiditeis
within an hour,patient said arm was sore to touch,from injection site on left arm tricep to elbow.the pain/numbness continued to 9am the next day. i gave her an ice pack,she will take benadryl caps for reaction when she gets home,along with alternating tylenol and ibuprofen.she will let me know if it gets worse,and i will follow up with her via phone later and tomorrow
given expired Daptacel, No Ae; Initial information received on 18-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA046254, 2020SA046245 and 2020SA046248.  This case involves 15 month old male patient (patient 3) who was vaccinated with fourth 0.5 ml expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5366AA and expiry date: 07-Feb-2020) via intramuscular route in the right thigh on 14-Feb-2020 for prophylactic vaccination. (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) for Immunisation on 14-Feb-2020.  It was actual medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  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.
I work nights, had the Covid-19 Booster shot at that morning 10/05/2021, immediately after work, then went home to sleep. When I awoke in the afternoon, my left arm site was swollen with a large bump, quite red, sore, and very itchy. So I used an anti itch cream, and ice, Went to work that night, and used a hot pack, and then ice again. Plus Tylenol  Today, 10/08/2021, a coworker said it looked larger and redder than it had Tuesday night
pt was not eligible to receive Booster dose at the age of 17 years and 8 months. Pt could have got it after 4 months due to recent guideline change.
HYPERtension diaphoresis, fuzzy thinking Narrative:  2/1 ED visit for high blood pressure (190/90's - no history); Went to PCP in following days; placed on bp med Losarten 40mg daily. 2/13 donated blood and had syncopal episode and hypotension - diagnosed in ED  Other Relevant History:
Headache, Chills, Extreme Pain in right arm, Swollen, Red Spot approximately the size of 2 quarters,  Fever 99.8
Left sided numbness and incoordination, resolved in a few hours, admitted in hospital  Right anterior cerebral artery small stroke, embolic appearing,
4 canker sores at the side of tongue; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 12Mar2021 at 14:00, as a single dose for COVID-19 immunisation. Medical history included CV disease, high blood pressure and cancer. The patient had known allergies to sulfa, tetanus, pneumovac and strawberries. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccine, patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received medications (unspecified) within 2 weeks of vaccination. On 14Mar2021 at 13:00, the patient experienced four canker sores at the side of the tongue, not large. Uncomfortable but not out of control. It disappeared in about a week; had appeared day and half after vaccination. The patient did not receive any treatment for the adverse event. The clinical outcome of the event was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
3 immunizations on 11-12-15. Resulted in high fever and an emergency room visit on 11-14-15. Blood test results showed white cells in blood. PA and hospital report indicates it could be from the injections. Three (3) different vaccines administered, Thursday, November 12, 2015 about Noon-12:15 pm, by pharmacist. I reported this reaction by phone to my doctor (Monday, Nov. 16?), and also a pharmacist (19th) where the injections were given. All 3 injections were given in my left arm/shoulder because I have a torn rotator cuff on my right shoulder. The shingles vaccine was injected under the skin under my upper left arm and the other 2 injections were given in the top of my shoulder. As I expected, my left shoulder was tender to the touch, and very uncomfortable when leaning on it, similar to past immunizations. I report this because I had to go to the emergency room where white cells/bacteria were found in my blood. I was told there by the PA that it was probably introduced with the vaccine injections. On 11-12-15 I had a 10:00 a.m. appointment with Dr. at the local clinic, not for an illness, but for a routine, 6-month appointment, including a routine blood test. Everything was fine. I talked with Dr. about having the 3 immunizations that another clinic had recommended when I was there Sept. 22. Both Dr. and a pharmacist said it shouldn't be a problem to have all three vaccines at one time. She contacted the local pharmacy. I had no problems until about 10:50 p.m. that night. I felt intermittent chills, and after I was in bed, my body started sharking uncontrollably for what seemed like a long time, until I went to sleep. The next morning, Friday the 13th, my temperature was about 100 degrees, and it kept rising all day. I had a terrible headache, couldn't think clearly and was unable to get out of bed except to go to the bathroom. I did not eat all day, and when I drank a glass of skim milk, it curdled and came up. After I woke up Saturday, all morning my temperature varied from 102 degrees to over 103 degrees (103.7 degrees at one point). In mid-morning when my daughter phoned, she told me that I wasn't making any sense. When I didn't recognize my husband, he took me over to our local hospital to the emergency room. They did a variety of tests (blood test, urine, chest x-ray), and the PA said there were white cells in my blood, saying it was bacteria most likely.
Information has been received from a medical assistant concerning an 86 year old female patient with hyperlipidaemia, hypertension, coronary artery disease, hypothyroidism, non-Hodgkin's lymphoma and not drug reactions or allergies who on 28-SEPT-2007 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 658211/0884U, Exp date 02-DEC-2008) (route not reported). Concomitant therapy included vitamin D (unspecified), simvastatin (manufactured unknown), hydrochlorothiazide, SYNTHROID, aspirin, allopurinol and NORVASC. The medical assistant reported that on 22-OCT-2010 the patient developed shingles. The patient developed rash underneath arm. At the time of the report, the outcome of the patient was not reported. There were not laboratories performed. The patient sought unspecified medical attention. Follow up information has been received from the physician concerning the retired female patient who on 28-SEP-2007 was vaccinated with the second dose of ZOSTAVAX (Merck). On 25-OCT-2010 the patient was diagnosed with herpes zoster (previously reported as 22-OCT-2010). At the time of this report, the patient recovered. No further information is available.
CCIR 10.V.3.  (U) Administration of Moderna past expiration/beyond use date and vaccine error. (U), roughly 46 patients received Moderna 0.25mL dose #3, from expired/beyond use date. The Beyond use date was 24 Mar 2022. Use of expired vaccination was not discovered until 08 April 2022 during inventory. The expired vaccinations were located in freezer unmarked and not separated from unexpired vaccines and then were removed, thawed, and used on 5 Apr. PSR has been submitted and the manufacturer contacted to determine final disposition along w/recommended course of action.  Once final disposition is determined, a follow-up CCIR will be submitted to detail any further actions taken.
increased tooth pain; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (increased tooth pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TOOTHACHE (increased tooth pain). At the time of the report, TOOTHACHE (increased tooth pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided. The event was reported to be subsiding
Red, hot area on upper arm.  Very sore.   Took a benedryl today... Tylenol yesterday
Covid-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) 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 03-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 COVID-19 (Covid-19) (seriousness criterion hospitalization). The patient was hospitalized on 28-Mar-2021 due to COVID-19. At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided by the reporter. Treatment information was not provided.  Patient doctor suggested to wait for 3 months for the second shot.  Although a temporal association exists, based on the current available information, due to biological implausibility the event of COVID-19  is assessed as not applicable to mRNA-1273.   Reporter did not allow further contact; Sender's Comments: Although a temporal association exists, based on the current available information, due to biological implausibility the event of COVID-19  is assessed as not applicable to mRNA-1273.
Onset of back discomfort/ache evening of flu vaccination; pain in back and thighs all through evening; Fri am reports back stiff; thighs feel stiff; denies numbness and tingling-"feels a little better; Sat am "felt fine"-Sx resolved never took TYLENOL or ibuprofen.
Parent reports patient had a fever on 9/14/2021 and was sent home from school.  Patient/Parent report that facial swelling began on the morning of 9/16/2021. Patient/Parent deny any anaphylactic difficulty such as trouble breathing, hives or any rashes.
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 30-NOV-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016, (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Fever and chills began about 1 hours after vaccine, about 18 hours  after vaccine I was getting up to take more Tylenol and did not feel well, I had a syncope episode in the bathroom (no issues as I sat on the floor before hand). I was unconscious for about 1-2 minutes. My blood pressure  several minutes later was low (about 90/50 but I took it myself so may not be exactly accurate)
Patient received PNEUMOVAX on 2-6-10. On 2/7/10 patient's arm was red, swollen, and hot.
Pt 2 doses of Hep B vax w/no adverse rxn; On 29MAY91 pt recvd 3rd dose of vax & on approx 2JUN91 pt exp fever, fatigue, cramping, & paresthesias in both arms & hands; Following day fever subsided & pt presented to MD;
Local reaction to (L) arm, red & raised, warm to touch, no tender, educated parent on reaction, instructed to medicate with BENADRYL.
Patient received ZOSTAVAX 4/17/14 and came to pharmacy 4/19/14 with 3" long red rash. Noticed 4/19. Not itchy or scaly. Took BENADRYL 4/19 and by 4/21 rash gone. Was around son w/ shingles 4/20/14.
Patient was administered MENACTRA Vaccine on 08/14/2018 that night patient ran a fever of 103.0. Mother called the office on 08/15/2018 to report fever and was advised to give TYLENOL and MOTRIN. 08/15/2018 fever reached 105.0. Patient also experienced dizziness, weakness and had one episode of vomiting. Physician was called on 08/18/2018 mother was advised  to give TYLENOL and ALEVE to reduce fever. Physician called mother back on 08/19/2018 to check on condition of patient. Patient had not run any more fever on 08/19/2018.
Mom reported the child complained of joint pain and rash after receiving GARDASIL. Lasted a few days then went away.
pt recv vax 24JUN94 & w/in a few hr devel pain @ inj site which radiated to the axilla, the flank & then the neck; MD reported that the pt c/o achiness in the neck, shoulder & arm;
Intramuscular injection given improperly. Injected into shoulder joint space. Immediate pain and inflammation at injection site with subsequent significant pain and reduced joint mobility for 96 hours, gradually improving over 2 weeks. Discussed with colleagues and took nsaids for 96 hours to prevent/ treat SIRVA
Patient received MMR on 08/19/03.  On Friday she started to have some hives in the morning and she complained of leg pains.  Later that day, she got very confused and disoriented and had hallucinations.  She did not even recognize her mother.  She went to the ER.  She was given Benadryl, Motrin and Tylenol.  The confusion stopped right away after the Benadryl.  Saturday she complained of having bad pains in her legs and was not able to walk.  On Sunday, she still had bad pains in her legs and was not walking.  She has had her mental functions clear up very nicely once she went on the Benadryl.  She has been having hypersensitive skin and she did not want to be touched.  She did not even want to have clothes on.  On Sunday morning, I called in some pediapred.  She took one teaspoon and two hours later she had some tremendous improvement in her symptoms.  Her legs did not hurt and she seemed to get back to normal and did not have any more hives and has not complained of any problems whatsoever.  Now she is running around and acting completely normal.  There are no hives.  This is certainly a normal 3 year old.  There is no evidence of any neurologic deficit.  She is very active and appropriate.  We will not give her any more prednisone.  We will give her Benadryl only if she gets hives.  We will give her Tylenol only if she complains of pain.  We will only use prednisone if she gets severe symptoms.  We will see what happens.  We are going to send a report in to the CDC.  I told her mom that I think it would be a good idea if she went to the hospital and talked to them about whether or not she should have immunizations in the future since she has had problems with shots before.