chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/10/12: Received phone call from mother: Child woke on 10/9/12 with nosebleed and abdominal pain. Nosebleed intermittent, abdominal pain intermittent. Denies: fever, "cold", cough, rhinorrhea, nausea, vomiting, diarrhea, other symptoms. Unable to return to this clinic so mother took child to a nearby clinic.
This spontaneous report was received from an unspecified reporter (working in a physician's office) via a company representative concerning a female patient of unknown age. There was no known medical history. It was unknown whether the patient had any drug reactions or allergies. The reporter stated that in 2013 and 2014, the patient was vaccinated with GARDASIL (dose, route of administration and lot number not reported). It was reported that on an unknown date, the patient started to experience seizures. The patient "was doing fine" before GARDASIL administration. It was reported that the patient sought medical attention (unspecified). The outcome of seizures was unknown. The relationship between vaccination with GARDASIL and the event was not provided. Upon internal review, the seizures were considered medically significant. Additional information has been requested.
LARGE SCATTERED BLISTER LIKE RASH TO BOTH LEGS\ARMS FACE MOUTH AND EAR, COUGH DROOLING PAIN.
This spontaneous report as received from a registered nurse refers to an 11 month female patient. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 21-JAN-2016 at 11:39, the patient was vaccinated with the first dose of PEDVAXHIB lot # L030869, intramuscularly, in the right thigh (strength, dose and expiration date were not reported), which was improperly stored. This is one of several reports received from the same reporter. Additional information has been requested.
A magnet will stick to her injection site.; This is a spontaneous report from a contactable other health professional (nurse). This report is 2nd out of 9 reports. A female patient of unspecified age received bbnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on unspecified date as unknown, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a magnet will stick to her injection site. The nurse stated that if Pfizer had any information regarding the magnetic effects at the injection site after receiving vaccination with the Pfizer-BioNTech COVID-19 vaccine. The nurse called to report on one of her patient who knew 7 women within her friend group and within her family who were able to have a magnet stick to their injection site after receiving the Pfizer COVID vaccine. The nurse assessed the event as non-serious. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Swelling on her lips; Difficulty swallowing; Fever 101 F after booster; Felt very tired immediately after booster; This spontaneous case was reported by a nurse and describes the occurrence of LIP SWELLING (Swelling on her lips), DYSPHAGIA (Difficulty swallowing), PYREXIA (Fever 101 F after booster) and FATIGUE (Felt very tired immediately after booster) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease and Blood pressure high. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VALSARTAN for an unknown indication.    On 14-Nov-2021 at 1:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Nov-2021, the patient experienced FATIGUE (Felt very tired immediately after booster). On 15-Nov-2021, the patient experienced LIP SWELLING (Swelling on her lips) and DYSPHAGIA (Difficulty swallowing). 15-Nov-2021, the patient experienced PYREXIA (Fever 101 F after booster). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in November 2021 at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swelling on her lips), DYSPHAGIA (Difficulty swallowing), PYREXIA (Fever 101 F after booster) and FATIGUE (Felt very tired immediately after booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received the first dose of Moderna COVID-19 vaccine on 27-Dec-2020 (Lot# 039L20A & Exp. Date: Unknown). She received the 2nd dose of Moderna COVID-19 vaccine  on 25-Jan-2021  Lot#  013L20A & Exp. Date: Unknown). Year of birth is provided 1965. Patient spoke to one of the ER doctor's from her job and he told her to go to the ER if the lip swelling gets worst.   This case was linked to MOD-2021-019819 (Patient Link).
tenderness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (tenderness in her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Urinary tract infection. Concomitant products included NITROFURANTOIN (NITROFURABTOIN) for Urinary tract infection.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (tenderness in her arm). At the time of the report, PAIN IN EXTREMITY (tenderness in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.
Little discomfort on patient's arm at injection site after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Little discomfort on patient's arm at injection site after first dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 004621A) 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) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE DISCOMFORT (Little discomfort on patient's arm at injection site after first dose). On 01-Apr-2021, VACCINATION SITE DISCOMFORT (Little discomfort on patient's arm at injection site after first dose) had resolved.            Patient reported that for first dose the sticker from the vial was peeled off and put on the card by the vaccination provider for documentation of the first dose of vaccine administration. Patient also reported that after the first dose the vaccination provider gave record card with time stamp for the time he had to sit for 15 minutes before he can leave. No concomitant medications were reported. No treatment medications were reported.
C/O fever - 99.7, itchy bumps on body and sore itchy throat. Rates pain in throat at 3.
Information has been received from a nurse practitioner concerning a 16 year old female with a fever at the time of vaccination who a few months ago was vaccinated with a 0.5 ml first dose of Gardasil.  There was no concomitant medication.  Subsequently the patient fainted.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  Additional information has been requested.
This spontaneous report as received from a pharmacy technician concerning a currently 41 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 01-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J005416; expiration date: 02-MAY-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Pt recvd vax in JUN92 & 1 wk following vax devel a severe h/a; devel pain in the shoulder & cervical area; wk p/onset arthralgia; devel inject site pain & redness;
A 50 year old female, with history of environmental allergy, upset stomach to eggs and asthma, had received an injection on left deltoid of influenza vaccine on 24-Oct-2005 AM. In the afternoon of the same day, she complained of shoulder pain. There was no history of injury. Then, she complained of whole arm pain, unable to raise arm laterally without pain. There was no numbness or tingling. She received corrective treatment with Tylenol, sling and ice. Patient's recovery status: not recovered. The patient has been rechecked 3 days later. Follow up information received on 03/Apr/2006. Per the reporter, the patient recovered from these events. No further information is expected.
Developed a "golf" ball sized lump at injection site the day of the vaccine The area has gotten bigger to the size of "soft ball" Has an appointment with family provider.
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 04-APR-2016, the patient was vaccinated with a dose of improperly stored VAQTA  "10Pk 50U/1ml SD Llok w Cap Adult" with lot number L031196 and expiration date of 15-FEB-2017 (dose, route of administration and anatomical location were unknown), which was stored at the lowest recorded temperature of 33 (0.555555556 Celsius degrees) for 104 hours, at the lowest recorded temperature of 32 (0 Celsius degrees) for 184 hours, at the lowest recorded temperature of 31 (-0.555555556 Celsius degrees) for 224 hours, at the lowest recorded temperature of 30 (-1.111111111 Celsius degrees) for 136 hours, at the lowest recorded temperature of 29 (-1.666666667 Celsius degrees) for 72 hours and at the lowest recorded temperature of 34 (1.111111111 Celsius degrees) for 72 hours. The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
when she was given the injection her cyst "bubbled up"; she believes that it was inadvertently given subcutaneously; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch and expiration date unspecified), subcutaneous on 07Jan2021 at single dose at left arm for COVID-19 immunization. Medical history included history of cyst on her upper left arm. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date for COVID-19 immunization. The patient reported that when she was given the injection, her cyst "bubbled up" on an unspecified date. She believed that it was inadvertently given subcutaneously. She wanted more information on the effectiveness of the vaccine if given subcutaneously. Outcome of event when she was given the injection her cyst "bubbled up" was unknown.  Information on the Lot/Batch number has been requested.
Chills; leg cramps; This is a spontaneous report from a contactable consumer. A patient of unknown age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported) via an unknown route of administration on an unknown date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced chills and leg cramps after use of the vaccine. The outcome of the events was unknown.  No follow-up attempts were possible; information about lot/batch number cannot been obtained.
RN administered 1st dose of pfizer vaccine to left arm. During observation with RN to complained of dizziness and tightness to throat. Benadryl 25mg  given by mouth by RN. Reassessed after 15 minutes, pt stated feeling better and decreased throat tightness. Pt retained for another 10 minutes in sitting position. Pt continued to feel well and discharged home.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 43-year-old female patient 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) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients. No treatment medication was provided.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 56 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), second lasting for 24 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius), third lasting for 24 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.89 degrees Celsius), fourth lasting for 8 hours, with the lowest recorded temperature of 29 degrees Fahrenheit (-1.67 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient states ongoing pain in shoulder upon raising arm. Pain is worse at night. Went to family dr who told her to use heat and repetitive but pt still has no relief.
Rapid onset of injection site pain, chills, myalgia, diffuse arthralgia, mild episodic headache, fatigue beginning 6 hours after injection.  Symptoms worsened progressively over next 18 hours, then gradually dissipated.  Moderate improvement with acetaminophen 1000 mg q6 h.  Largely resolved after 36 hours with residual fatigue which resolved after 48 hours.
Rash, fever. Bilateral legs erythematous rash, early vesicular rash.
I started to put my son in the car in the parking lot of the drs. office approximately 10 minutes after his 11/21/06 ~10A.M. 4 year wellness visit and receiving the DTap5 vaccination and the IPV4 vaccination. I realized he started to suddenly be congested. When he tried to speak he would cough and I heard a wheeze. I brought him back into the dr.'s office, told her I suspected an allergic reaction and wanted to watch him there. I watched him there for approximately another 10 minutes. The coughing and wheezing continued. The doctor then examined him and said that indeed she heard a wheeze that she had not noticed during his earlier examination. We gave him benadryl and she then gave him a breathing treatment of albuteral and then pulmicort with a nebulizer. We watched him for at least another half an hour. The wheezing seemed to subside. The doctor recommended I continue with treatments of pulmicort once daily for the next two days and albuteral every four for the next three days. On the last day of treatment, he did have a recurrence of the wheezing after running around.
4/01/16 Hep B vaccine administered (L) upper arm. Developed injection site rash with itching. Symptoms still present as of 5/17/16 office examination. More rheumatoid arthritis joint pain and swelling subsequently.
chest pain in the center of my chest, and tightness in my chest following my second shot. Lasted approximately an hour. Only lessened by laying down. I've never had this kind of pain/discomfort before, so I attribute it to the shot.  I considered going to the ER. Other than the chest pain, the only other reaction I had following the second shot was  sore arm.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient has as of this date not been revaccinated.
Fever, chills, fatigue, body pain, headache, nausea, rash on arm, itching at injection site. Alternated Tylenol and Ibuprofen for symptoms. Symptoms lasted about 48 hours except for the rash and itching which are still ongoing.
Pain in shoulder, neck and wrist.  Swelling of face under eyes and cheeks.   Swelling in hands and feet.
Fainted and fell shopping instead of going to sit after shot.  Fainted in chair.  Gave water.  Felt better after 30 minutes and left.  Followed up next day felt fine.
pt recvd vax & ran fever of 102.5; to MD; dx w/ virus; broke out w/ measles; had cough; still weak; lethargic; poor appetite;
well I had sorness and red rash of small bumps around injection site  Up to today I still feel soreness in my arm  1 week later
This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to an 11 year old patient of unknown gender. On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose and route not reported).         Rubella virus (RuV) has recently been found in association with granulomatous inflammation of the skin and several internal organs in patients with inborn errors of immunity (IEI). Several cases of IEI with granuloma formation have recently been identified in association with RuV vaccine strain RA27/3. Infectious immunodeficiency-related vaccine-derived rubella viruses (iVDRV) were isolated from granuloma biopsies and sequenced. Cutaneous granulomas are the most frequent manifestation diagnosed, but other organs including the liver, spleen, and lungs can also be affected. The aim of this study was to examine Rubella virus (RuV)-associated granulomas from 28 patients with inborn and acquired errors of immunity to determine whether specific inflammatory patterns localize to certain tissue sites or are associated with clinical characteristics.  On an unknown date, the patient experienced necrotizing neutrophilic (N-type) skin granuloma. Skin biopsy was positive for iVDRV. Rubella serology showed persistent RuV IgM antibody. The patient was treated with oral steroids with no improvement. Additionally, the patient underwent hematopoietic cell transplantation but did not survive to the procedure. The patient's outcome regarding necrotizing neutrophilic (N-type) skin granuloma was not recovered.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of six reports received from the same article (MARRS 2201USA004372, 2202USA004885, 2202USA004886, 2202USA004887 and 2202USA004889).; Sender's Comments:  US-0209507513-2201USA004372:
This case was reported by an allergy physician and described the occurrence of rash-pruritic in a 68-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 16 October 2008, the subject received a dose of FLULAVAL (unknown). On 17 October 2008, 1 day after vaccination with FLULAVAL, the subject experienced rash-pruritic. The subject was treated with steroid cream. The subject was received FLULAVAL dose at another office on 16 October 2008. On 17 October 2008, the developed a generalized rash all over. She has been using a steroid cream and the rash is getting better but it is still very pruritic. At the time of reporting the event was improved. Follow-up information was received on 15 December 2008, via healthcare professional, who reported the events resolved on an unknown date. The reporting healthcare professional considered the events possibly related to vaccination with FLULAVAL.
Progressively severe oral stomatitis. Multiple lesions of varying sizes developed over about 5-7 days, up to at least 12 at one time.;  scattered throughout the mouth, throat, & on soft palate. Treated by both my MD & 12 days later by my dentist. RX from each of "Magic Mouthwash" to swish & swallow. Contents of each very similar...visc lidocaine, antibiotic, & steroid combination. Lesions healing &  recurring over 3-4 weeks. Resolved after about 5 weeks.
mild bilateral tinnitus/the tinnitus has significantly been exacerbated; This is a spontaneous report from a contactable Other Health Professional (patient). This 25-year-old male received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1283 and Expiration date unspecified) on 12Jan2021 13:00 (at 25 years of age) intramuscular into right arm as single dose for COVID-19 immunisation.  Medical history was reported as none. There was no reported allergies to medications, food, or other products.  Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to BNT162B2.   Concomitant medications were not reported. On 12Jan2021 13:15, the patient experienced mild bilateral tinnitus/the tinnitus has significantly been exacerbated.  Patient started having very mild bilateral tinnitus 15 minutes after Covid Vaccine and was not concerned, however by 18Jan2021 the tinnitus has significantly been exacerbated.  No treatment was provided.   Lab data included Nasal Swab done 19Jan2021 with pending results which was post vaccination.  Outcome of event mild bilateral tinnitus/the tinnitus has significantly been exacerbated was not recovered.