chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 9 year old male with no past medical history and no known drug allergies who on 11/18/96 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (lot # 617695/0776D). There was no illness at the time of vaccination. On 6/12/03 the patient presented to the physician's office with a varicella breakthrough, described as approximately 20 varicella lesions on his face, back, arms, head, and genital area. The area was pruritic. The outcome was reported as recovered. No other details were provided. Unspecified medical attention was sought. There was no product quality complaint. There were lab data or diagnostic tests reported. The reporter also indicated that 2 other patients experienced breakthrough varicella. No additional information is expected.
Information has been received on 27-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 26-SEP-2013, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 2015, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
No adverse events, patient was administered a covid booster dose that was good at the time of administration, then a recall was issued after the administration for that lot number
Telephone encounter 1/26/16 - Patient states she has a very sore arm the next day after receiving injection - no redness nor swelling; States has body ache (chest and back), chills x 24 hours.
Information has been received from a male patient who on 30-MAR-2011 ("12 days ago") was vaccinated with ZOSTAVAX (Merck) (lot # not reported). Subsequently the patient experienced a rash, but not at the injection site. At the time of reporting, the patient's rash persisted. It was unspecified if the patient had sought medical attention. No further information is available.
extreme body aches, fever of 101 degrees F, pain at injection site, severe headache
pt recvd vax;approx 20 mins later c/o n,faintness,pounding heart rate,pale;sxs subsided p/10 mins;cont to exp shaking chills;hot flashes;BP=140/60;MR=112 RR20;c/o fatigue,drowsiness,neck pain;sxs subsided p/ 3 hrs;to notify MD;hx of NKA;
Vaccine EUZ.  Nausea, Headache, Aches and Pains, Chills, Felt Faint
Patient received Fluvirin vaccine on 12/13/2014 in the left deltoid muscle. Patient was feeling well at time of vaccination and seemed healthy. On May 19th, patient approached the consulation window and asked to speak with myself, the vaccine administrator. She stated that there is as lump on her arm as a result of the vaccine she received in December. Lump is not visible when arm is relaxed, but when patient flexes muscle, a palpable lump about 2mm can be seen on her left deltoid region. She stated she spoke with her doctor about it and the doctor told her it would go away in time. She stated that the lump is sometimes painful and that it interferes with her range of motion. When I touched the lump she did not show any signs of pain at that time. I told her I had not seen that reaction before and that I would report it to VAERS for her.
Pharmacist mixed a pediatric vial of Pfizer COVID instead of the adult version. Patient received a pediatric vaccine. Pharmacist on duty called Pfizer and pharmacy was informed to call patient and have them return for a full dose of the adult version as soon as possible. The patient returned on 12/07/2021 and received the correct dose.
Kidney cancer; Thyroid cancer; This spontaneous case was reported by a consumer and describes the occurrence of RENAL CANCER (Kidney cancer) and THYROID CANCER (Thyroid cancer) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012A21A) for COVID-19 vaccination.   No Medical History information was reported.  On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced THYROID CANCER (Thyroid cancer) (seriousness criterion medically significant). In August 2021, the patient experienced RENAL CANCER (Kidney cancer) (seriousness criterion medically significant). At the time of the report, RENAL CANCER (Kidney cancer) and THYROID CANCER (Thyroid cancer) outcome was unknown.  The patient was diagnosed with kidney cancer a month ago. Patient also recently had stents placed in heart . Patient was currently not receiving cancer treatment because of the stents.  No concomitant medication information provided.  company comment: This case concerns a 71-year-old, female patient with no relevant medical history, who experienced the unexpected events of Thyroid and kidney cancer.. The event Thyroid cancer occurred same month (unspecified date) after the first dose of Moderna Covid-19 vaccine, and the event kidney cancer occurred around 5 months after second dose. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 71-year-old, female patient with no relevant medical history, who experienced the unexpected events of Thyroid and kidney cancer.. The event Thyroid cancer occurred same month (unspecified date) after the first dose of Moderna Covid-19 vaccine, and the event kidney cancer occurred around 5 months after second dose. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.
Felt achy several hours after vaccine.  In a.m., 102 temperature, took motrin 2x, H/A during daytime.  Friday a.m., felt fine.  States similar episode when she received injection last time (2 years ago).
Pt reported redness, swelling, pain 5/10 and heat stating 4 days after injection. Erythematous and edematous area 9 cm X 7.5 cm at injection site. Started on ABx BACTRIM. Improved within 24 hours.
Pt left arm (upper) has hard band at injection site band width is 80mm x 35mm vertical. Tissue in measured site is extremely hard. Pt description is "hard as a rock". PHN agrees.
Note from record "4cm x 4cm spread Erythema, tender to touch, hot/swollen/ it is noted at point of injection". - symptom 3 days after injection. Seen at a base. *(At pneumococcal injection site).
had a stroke and passes away; This is a spontaneous report from a contactable consumer. A 37-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller is inquiring about the Pfizer COVID-19 vaccine. He wants to know if the booster shot is required in the US for the general population or only for immunocompromised patients? The 37-year-old had a stroke and passes away." The virus is not messing around". Caller was not able to confirm if reported cases were vaccinated or not. Caller stated "Pfizer is better than Moderna. They have done more research." Caller also pleased about the results on the use of the Pfizer COVID-19 vaccine in a younger population. The patient died on an unspecified date. It was unknown if an autopsy was performed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: had a stroke and passes away
01/27/22 presents to ED for "AMS". PMHx of "DM type 2 on (metformin), anxiety, depression, ADHD."
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 18-JUL-2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-OCT-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster with nervous system complications. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pt presented with symptoms of allergic reaction, joint/muscle aches, nausea, left upper arm (deltoid) at injection site (distal to), raised, slightly bruised.
chills; where I got the injection was sore; nausea; vomited; diarrhea; Case reference number MOD-2021-016040 is a spontaneous case report sent by a Other on 04-FEB-2021 00:00:00 , which refers to a Female aged 71 Years The following drugs are known to have been taken by the patient prior to the event: CYCLOSPORINE[] ,CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE][] ,AMLODIPINE[] ,ENALAPRIL[] ,GLIMEPIRIDE[] ,TAMOXIFEN[] ,CLARITINE[] ,BACTRIM[] ,FAMOTIDINE[] ,POLY-IRON [IRON POLYSACCHARIDE COMPLEX][]  .  On   the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some  1 day later,  the patient developed chills. Over a period of the next <ENTER DURATION OF EVENT> days, the patient also developed where I got the injection was sore,nausea,vomited,diarrhea. Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:. The eventual diagnosis made on was Chills . .  The patient was treated for the event with   . <ENTER ANY PROCEDURES> An autopsy was performed on  . The Other did not declare any relatedness between chills and Moderna COVID-19 Vaccine In their opinion, other possible etiological factors included  <STATE OTHER FACTORS> and the patients age/ history or other factors <LIST OTHER RELEVANT  FACTORS> .  The company believes the following facts are also relevant in this case: <LIST OTHER RELEVANT FACTORS HERE> OR  <THERE IS NO KNOWN PLAUSIBLE MECHANISM BY WHICH THE DRUG WOULD CAUSE THE PRIMARY EVENT>.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .   Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Other,  Age- 71 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome-  .
WEAK; FATIGUED/ TIRED; VERTIGO; DIARRHEA; SWEAT(WATER) WAS DRIPPING FROM HER; VOMITING; LETHARGY; NAUSEA; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and thyroid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNWON) dose was not reported, administered on 02-APR-2021 to Left Deltoid for prophylactic vaccination. Concomitant medications included carvedilol for high blood pressure, and levothyroxine for thyroid. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced lethargy. On 06-APR-2021, the subject experienced nausea. On 07-APR-2021 21:00, the subject experienced vertigo. On 07-APR-2021 21:00, the subject experienced diarrhea. On 07-APR-2021 21:00, the subject experienced sweat (water) was dripping from her. On 07-APR-2021 21:00, the subject experienced vomiting. On 08-APR-2021, the subject experienced weak. On 08-APR-2021, the subject experienced fatigued/ tired. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, vertigo, diarrhea, sweat(water) was dripping from her, vomiting, chills, fever, and nausea, and headache on 03-APR-2021, and had not recovered from weak, and fatigued/ tired. This report was non-serious.
Information has been received from a physician concerning a patient who on 04-DEC-2007 was vaccinated with a dose of ZOSTAVAX and was just diagnosed with a mild case of shingles. Patient's age was not specified, but was indicated age for ZOSTAVAX. At time of reporting, the patient had not recovered. The patient sought unspecified medical attention. Additional information is not expected.
Approximately two days after receiving the second dose of the vaccine. my left arm and shoulder became very sore. I have trouble lifting it and cannot lay on that side without pain.
After 3rd dose, about 4-6 hrs later became extremely nauseated with vomiting and the worst headache. Lasted about 6 hours. Felt feverish the next day took 4th dose per CDC phone call.
15 hours after 2nd dose I experienced the following symptoms and I thought I was going to die. I couldnt get out of bed: 1) Extreme heart palpitations, my heart rate monitor was reading an extremely high stress activity for 2 days post shot. 2) Very Hot and Very Cold body chill and temp swings 3) Sweating profusely, I soaked through my pajamas on 3 different occasions when I woke up from napping. 4) My pee was orange and hurt to pee. 5) My entire body hurt the worst I've ever felt 6) All my joints were super painful, it hurt to walk and I couldn't sleep due to the pain. 7) I had the worst headache I've ever had.
A few hours after this dose I began to get a metallic taste in my mouth. It was a bit foul, rancid and bitter.  The same thing happend after the first dose, given at the same Walgreens Drugstore, on April 22, 2021.  Pfizer ER8732.  The first event lasted for several days, then gradually abated.  This time (2nd dose) the metallic/bitter taste seems to be a little more prominent, and the taste continues into this, the second day after vaccine was given.  The taste of foods and liquids are only slightly altered, and some not at all. I've read this occurs, but it is very rare.  Just reporting for your statistical records.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 19-OCT-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # K022993, expiration 20-JUL-2016, dose was not reported) orally. No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
While patient was in office he received an additional COVID-19 booster. First/original booster wasn't pushed onto database therefore, there wasn't any way of knowing he had already received this. The following day the patient brought in his immunization card (to be updated), and it appeared, on the card,  he had already received a booster elsewhere. No symptoms were reported from the patient and there was no treatment necessary.
A non-serious report of expired FluMist administered has been received from a nurse concerning a 46-year-old female. No medical history nor concomitant medications were provided. The patient and her three teenage daughters received FluMist on 27-Dec-2007. The expiration date on the FluMist was 25-Dec-2007. No adverse event was reported. As of 21-feb-2008, patient had not experienced any adverse events. The event was resolved on 27-Dec-2007. The reporter was provided information regarding additional dosing of the product when a patient is inadvertently administered product after the expiration date. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is liked to the cases for the patient's three teenage daughters who also received expired FluMist. MEDI-0006352; MEDI-0006353; MEDI-0006354. Additional information received on 21-Feb-2008 and incorporated into the narrative: No adverse event experienced.
This spontaneous report was received from a physician via a company representative refers to a patient of unknown demographics. On an unknown date (also reported as a couple of weeks ago), the patient was vaccinated with ZOSTAVAX injection, 1 shot (dosing regimen unspecified). Patient's concomitant medication was not reported. On an unknown date the physician stated that a patient had a rash along leg after ZOSTAVAX. Patient sought medical attention. There was no product quality complaint (PQC) involved. The outcome of had a rash along leg was unknown. Causality assessment was not provided. Additional information has been requested.
Night sweats; Skin burning and tingling like it is burning from the inside out.; Skin burning and tingling like it is burning from the inside out.; This is a spontaneous report from a contactable healthcare professional, the patient. A 49-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. On 17Mar2021, the patient experienced night sweats, skin burning and tingling like it was burning from the inside out. The patient had severe reaction that would not subside with treatment. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with Acyclovir and Benadryl and Aleve. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events night sweats, skin burning and tingling like it was burning from the inside out was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Fever 103- 48 hrs p/shot; rx APAP; fever 101 72 hrs p/shot rx Ceclor & APPA w/fever, plus cough w/minor chest congestion; 6th day post-rash & inc chest congestion;
Developed pruritis and redness around face/neck/upper chest and around injection site for influenza vaccine on right arm.  mild erythema patches on bilateral cheeks - more intense erythema on neck, supraclavicular area bilaterally, and also on proximal right arm.
1st dose probably 2 yrs ago, 2nd never; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose probably two years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-MAR-2023 Reporter's Comments: A health care professional reported that a patient consulted in the facility where she worked to be administered with the 2nd dose of Shingrix as she received only one dose of Shingrix, according with the health care professional statement, in another facility. The reporter did not consent to follow-up. Additional Supportive Information:  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
a 48 yr old patient received shingrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 48-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th May 2021, the patient received Shingrix. On 24th May 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The director of quality reported the 48 year old patient received Shingrix before recommended age, which led to inappropriate age at vaccine administration. The reporter wanted to know if there was any adverse outcome and if it was recommended to complete the vaccine series. The reporter consented to follow up.
This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # L015460, expiration date: 20-JUL-2017, lot# L023936, expiration date: 15-MAR-2017 (dose and route of administration were not reported). The temperature excursion ranged between 32 and 36 degrees Fahrenheit and lasted 72 hours. There was no previous temperature excursion. Digital data logger was not used. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA005126: US-009507513-1703USA005127: US-009507513-1703USA005128: US-009507513-1703USA005129.