chrisvoncsefalvay/vaers-outcomes huggingface dataset:
partner with COVID sx since 02May2022 and then tested positive on 07May; partner with COVID sx since 02May2022 and then tested positive on 07May; feels seriously ill; hard to breathe; fever; HA; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 28-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 01Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 09May2022, outcome "unknown", described as "HA"; MALAISE (non-serious) with onset 09May2022, outcome "unknown", described as "feels seriously ill"; PYREXIA (non-serious) with onset 09May2022, outcome "unknown", described as "fever"; DYSPNOEA (non-serious) with onset 09May2022, outcome "unknown", described as "hard to breathe"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "unknown" and all described as "partner with COVID sx since 02May2022 and then tested positive on 07May". The events "partner with covid sx since 02may2022 and then tested positive on 07may", "feels seriously ill", "hard to breathe", "fever" and "ha" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive; (09May2022) Positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162b2.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old male patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms. The patient was treated with TYLENOL. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received his first shot in the left deltoid and although he experienced flu like symptoms the following day, they dissipated after a couple of days and were not as intense as the second shot. He was treating the symptoms currently with extra strength TYLENOL. The patient indicated that he was in good shape physically. This case has been linked with US2018137496, reported by the same reporter.
Redness on neck and chest; Hives/Welts; Soreness in injection arm; Itchiness; Missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on neck and chest), URTICARIA (Hives/Welts), VACCINATION SITE PAIN (Soreness in injection arm), PRURITUS (Itchiness) and PRODUCT DOSE OMISSION ISSUE (Missed second dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). On an unknown date, the patient experienced ERYTHEMA (Redness on neck and chest), URTICARIA (Hives/Welts), VACCINATION SITE PAIN (Soreness in injection arm) and PRURITUS (Itchiness). On 15-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved. At the time of the report, ERYTHEMA (Redness on neck and chest), URTICARIA (Hives/Welts), VACCINATION SITE PAIN (Soreness in injection arm) and PRURITUS (Itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.
Should pain immediately after injection.   Pain worse one day after vacination.  Very sick for three days after vacination (fever, extreme muscle pain, weakness, chills)  Shoulder pain did not show any signs of improvement for 2 months.  Diagnosed with Covid in August 2021, 2 months after vacination.   Slowly getting more range of motion in arm but still painful to lift left arm above shoulder height.
10 minutes after receiving DTaP, developed cough, wheezing, SOB followed by red flush and hives. Resolved with DECADRON, epinephrine IM, oral BENADRYL.
SORENESS AT INJECTION SITE, FATIGUE, CHILLS Narrative:  EMPLOYEE STATES RECEIVED FROM NON-AGENCY SOURCE (PSYCHIATRIC HOSPITAL)  Other Relevant History:
On 11/30/2020 at 1:30 I brought my son into Pediatrics for what should have been his flu shot. I signed the paperwork for just his flu shot. The nurse came into the room and gave my son three vaccinations. Later that day my son began developing a rash. I contacted them and found out that they gave my son the wrong vaccinations. The problem is that they will not tell either myself or his pediatrician Dr . what they gave him. He still has this rash. His doctor doesn't know how to treat him without knowing what they gave him.  I have tried requesting this information. His primary care doctor has tried getting this information and we still don't know.
Injection site swelling; injection site redness; injection site pain; injection site warm to touch; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva759a, expiry date 30-NOV-2023) for prophylaxis.   On 25-APR-2023, the patient received Menveo (right deltoid). On 25-APR-2023, less than a day after receiving Menveo, the patient experienced injection site swelling (Verbatim: Injection site swelling), injection site erythema (Verbatim: injection site redness), injection site pain (Verbatim: injection site pain) and injection site warmth (Verbatim: injection site warm to touch). The outcome of the injection site swelling, injection site erythema, injection site pain and injection site warmth were resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain and injection site warmth to be related to Menveo.     It was unknown if the company considered the injection site swelling, injection site erythema, injection site pain and injection site warmth to be related to Menveo.   Additional Information: GSK Receipt Date: 04-MAY-2023 The nurse reported that the patient received Menveo and on the same day evening experienced localized swelling, redness, pain and warm to touch at the injection site. The adverse event started the evening of the day the patient was vaccinated.  The adverse event had resolved. The reporter consented to follow up. The case is linked with US2023064923 case, by same reporter. Note: Clarification was requested regarding event onset date however, it was captured conservatively as per narrative start date of vaccination.; Sender's Comments:  US-GSK-US2023064923:Same reporter - Male case
She had no reaction to the vaccine. She tested positive for COVID-19 on with a home test 01/14/2023. In 12/2022 she tested positive for RSV.
patient presented via ambulance with complaints of generalized weakness and shakiness. decreased appetite, fatigue and lightheadedness.  tremors bilateral upper extremities. mild electrolyte imbalance, however Dr. documented that this does not explain the etiology of these symptoms and that this may be vaccination related. patient now is unable to return home and needs nursing home placement related to the change in functional status
Swollen, palpable lymph nodes in right axilla starting a few days after 2nd COVID Pfizer vaccine.
This is a spontaneous report from a Pfizer sponsored Program. A contactable consumer (also the patient) reported that a 67-year-old male patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization, VIAGRA, via an unspecified route of administration from an unspecified date to an unspecified date at unspecified dosage for an unspecified indication. The patient medical history was not reported. Concomitant medication included influenza vaccine, MUCINEX, ALKA-SELTZER PLUS. The patient got a cold on an unspecified date. The patient was 195 and was little bit weight, might be about 200 pounds now. The patient received that shot at doctor's office. The consumer didn't remember the date of experiencing of cold. The consumer confirmed that cold was improved. The action taken in response to the events for sildenafil citrate was unknown. The outcome of the event cold was recovering, for the other event was unknown.
Feeling of swelling in lips, hands and feet and numbness of tongue with itching. Urticarial, pruritic, generalized rash. Responded to Benadryl and had resolved 36 hrs later.
welts in the arm and in the leg; This is a spontaneous report from a contactable consumer (Patient). A 77-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN0151), via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:00 as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications were not reported. After 2 days he got small scratches on my hands, arms, neck, chest and face at 11:30 those of the hand disappeared those of the arm lasted two days together with those of the neck those on the chest, a very large slot was made from the size of the hand to the height of the heart and he still have it tomorrow it is already a week of the second dose of the vaccine those on the face on the right side disappeared after 2 days, those on the left side swelled up or grows a lot have gone decreasing but are still present and he started to leave today welts on my arm and leg on 05Apr2021. Treatment received with Benadryl. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
After one week, localized site reaction. Generalized hives, skin eruptions with pain over most of the body and back.
Apprx. 125mm height x 150mm length are and swelling, redness, increased warmth, itching and intermittant tingling, just distal to mid tricep injection site. Started day 1 post injection, resolved day 7 w/o treatment. No other systemic or local reaction.
This spontaneous report was received from a physician via company representatives from a support services director concerning a patient (encounter key # 165622) of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Concomitant therapies were not provided. On 24-NOV-2015, the patient was vaccinated with an improperly stored do se of PNEUMOVAX 23 (10Pk-0.5mL SD-PFS LLokwTip) lot number K010466, expiration date of 23-MAR-2016 (route of administration was not reported). The vaccine had two temperature excursions: one for 24 hours and another one for 32 hours. The lowest recorded temperature for the first excursion was 34 degrees Fahrenheit (1.111111111 Celsius) and the highest recorded temperature for the second excursion was 48 degrees Fahrenheit (8.888888889 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Mom states rec'd immun 16APR91 asymptomatic until eve of 18APR91 constant crying, screaming as if in pain; 0 temp, 0 redness @ inject site; MD notified in Feb when same rxn occured;
Felt like "2 major acne pimples" in nape of neck, then progressed to a "tight band" across the back of his head from ear to ear.  "Pimples" resolved, then pain went into right ear.  It was a throbbing pain, getting faster and more painful as time went on. 1 week later, he went to his physician assistant.  He ws given Tylenol #3 and Valium.  The tightness and ear pain resolved.  He soon (not a very good recollection of time frames) started a dry cough.  His lungs were clear. No nasal drainage or swelling in his lymph nodes. No fever reported.  He went on an eight day trip to family.  His granddaughter had an ear infection.  He came home yesterday.  Today his productive cough worsened, glands swollen, sinus drainage. Felt like he had a slight temperature yesterday.  He took a dose of Tylenol and went to see his PA.  He had a chest x-ray done with normal results.
Information has been received from a registered nurse concerning a 9-year-old female with drug hypersensitivity to diphenhydramine (Benadryl) and a history of chicken pox in June 1994 and cleft palate repair who on 03-MAY-1999 was vaccinated subsequently with a 0.5 mL first dose of Varivax (Lot # 630037/0290J). There was no concomitant medication. There was no illness at the time of vaccination. There were no adverse events following prior vaccinations. On 28-JUL-2003, the patient experienced shingles and was seen in the emergency room. She was told to rest. No diagnostic studies were performed. Subsequently, the patient recovered from shingles. No additional information to report. There was no product quality complaint. No additional information is expected.
Numbness and tingling sensation in my face and eyes 25 minutes after shot lasting about 20 minutes in duration
Laid-up on Saturday and Sunday after booster; he received twice the dose of the booster vaccine instead of a half dose; Loss of appetite; Body aches; Fatigue; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), MALAISE (Laid-up on Saturday and Sunday after booster), MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Headache) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 023M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced MALAISE (Laid-up on Saturday and Sunday after booster) and ACCIDENTAL OVERDOSE (he received twice the dose of the booster vaccine instead of a half dose). In November 2021, the patient experienced DECREASED APPETITE (Loss of appetite), MYALGIA (Body aches), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills). On 06-Nov-2021, ACCIDENTAL OVERDOSE (he received twice the dose of the booster vaccine instead of a half dose) had resolved. At the time of the report, DECREASED APPETITE (Loss of appetite), MALAISE (Laid-up on Saturday and Sunday after booster), MYALGIA (Body aches), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported. Patient reported that he called his manager at vaccine facility job and they set up a meeting for next week. They have not told him as to what happened.
Significant discomfort upon injection on dose #1.   Later in the evening and throughout the night: Myalgia, Grade 3, fever, headache, and nausea. The following morning and lasting for 24 hours, headache.
Typical muscle soreness & weakness in upper arm for 2 days following vaccination.  Eight days following vaccination, 4X3" red, itchy patch appeared at injection site. Slight swelling and "lumpiness" under skin. Unchanged 4 days later.
Patient was given expired vaccine, given beyond the 6 hour window after reconstitution. Vaccine was reconstituted at 12:00PM on 7/15/21 and vaccine was given around 5:00PM on 7/16/21.
had chills, non stop shaking for 2 hours, very disturbing. Vomiting, fever, chills with headache.
Ringing in my ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in my ears) 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 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced TINNITUS (Ringing in my ears). At the time of the report, TINNITUS (Ringing in my ears) had not resolved. Not Provided    No relevant concomitant medications was reported. Treatment information was not provided.    This case was linked to MOD-2021-350843 (Patient Link).
This spontaneous report as received from a health care professional via field representative referred to a 4 month old patient. Patient was vaccinated with GARDASIL (Lot#, dose/frequency, route and duration were unspecified) accidentally on an unknown date. No side effects indicated is unknown. The outcome was unknown. Additional information has been requested.
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 31-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml Prefilled Syringe (PFS) (lot # K020795, expiration date 19-MAR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 64 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
A non-serious spontaneous report of FLUMIST administered to a pregnant female was received from a nurse concerning a 20-year-old female. The patient's medical history included bronchitis. No obstetrical history was provided and the patient was not taking any concomitant medications. The patient was exposed to FLUMIST on 01-Oct-2009 at 24 weeks gestation. The patient's last menstrual period was 14-Apr-2009 and the expected date of delivery was 21-Jan-2010. There was no adverse event associated with this pregnancy and after two weeks following administration. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy. Additional information was received on 07-Oct-2009 and incorporated into the narrative: patient and pregnancy information. Additional information was received on 15-Oct-2009 and incorporated into the narrative: no adverse events after two weeks of follow-up.
p/ pt recv vax approx 1mo later pt exp joint pain in his ankles, wrist, elbows & thumb.
Knot at injection site; Injection site itchy and red; Injection site itchy and red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Knot at injection site), INJECTION SITE PRURITUS (Injection site itchy and red) and INJECTION SITE ERYTHEMA (Injection site itchy and red) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE SWELLING (Knot at injection site), INJECTION SITE PRURITUS (Injection site itchy and red) and INJECTION SITE ERYTHEMA (Injection site itchy and red). At the time of the report, INJECTION SITE SWELLING (Knot at injection site), INJECTION SITE PRURITUS (Injection site itchy and red) and INJECTION SITE ERYTHEMA (Injection site itchy and red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Confusion disoriented and Respiratory distress. Admitted to hospital as 24 he obviously
Nausea the next AM after use oral typhoid. Symptoms progressed with chilling and low grade fever, skin tone pale. Advised to seek medical care. Reaction to Typhoid ill x 1 week.
Facial edema, glossitis, slurred speech (non-asymmetrical) onset 1/12/2021 (time unspecified).  Tingling sensations to lips and tongue onset 1/13/21
2 episodes of Shingles outbreak since 1st injection and currently have another outbreak 08-28-21.  I was seen in a Clinic for treatment of shingles but after seeing provider they determined that the symptoms I was having was neurological.  Tingling and numbness from head to toe on left side and some blurred vison.  They were afraid I had a blood clot or stroke and was sent to ER.  EMS was called but I declined to ride due to clinic is across street from ER so my husband drove me to ER.  My CT scan without contrast was normal and EKG was normal and basic blood panel was normal.  Troponin level was normal.  They advised that an MRI brain was needed and asked to me to stay overnight but refused and advised would follow up with PCP.  I am in the process of following up with my PCP.  The ER physician treated me for Shingles with Acyclovir and prescription for Gabapentin was given for tingling and numbness.
Information has been received from a medical assistant concerning a 16 year old female with no history and no known drug allergies, who on 01-JUL-2008 was vaccinated with the first dose of GARDASIL  intramusclar. There was no concomitant medication. On 13-OCT-2008 the patient was vaccinated with the second dose of GARDASIL. On 13-Oct-2008, after administration of the patient's second dose, the patient experienced severe fatigue and a headache. The patient did not recover from fatigue and headache. The patient sought medical attention via telephone. Additional information has been requested.
pt recvd vax & devel h/a, progressed to aching all over; pt exp rashes, fever, chills, abd pain, nausea; all intermittently w/subsequent doses of vax;
My daughter developed a very high fever 103.3 roughly 36 hours after administration of the vaccine. The high fever lasted over 24 hours. She also had swelling of her face and eyes.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Janssen product on 09/13/2021 and 12/01/2021. They tested positive for COVID-19 on 07/25/2022. They experienced complications of Cerebral vascular accident and A-Fib. They were briefly hospitalized and died on 07/30/2022.