chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Based on additional information received on 24 August 2015, this case became medically confirmed. Initial unsolicited report received from consumer (patient's mother) on 15 May 2015. A 10-year-old female patient, whose medical history was none and concomitant medication was not reported, had received a first dose of ADACEL (batch number, expiration date, dose and site of administration were not reported) intramuscularly on 20 February 2015. The patient did not have illness at time of vaccination and any pre-existing physician diagnosed allergies, birth defects, medical conditions were denied by the reporter. She did not previously receive ADACEL vaccine. Two weeks later on an unspecified date after vaccination, the patient had experienced growths on feet which was diagnosed as granuloma annulare. It was reported that, as per physician granuloma annulare could be triggered by tetanus vaccine. The patient was evaluated by a pediatrician, podiatrist and patient would be seeing an infectious disease specialist. Laboratory investigation and corrective treatment were not reported. At the time of this report, outcome of the event was unknown. Follow-up information received from a healthcare professional on 24 August 2015. The batch number of ADACEL was updated as U4875AA and expiry date was 25 October 2016. Site of vaccine administration was left arm. The patient did not experience any other delayed reactions after the vaccination. List of documents held by sender: none.
Pt received flu and pneumonia at same time at same arm on 10/8/15. Pt is suffering still from pain and cannot move freely with that arm been more than 10 days.
Shortly after the vaccine, he started feeling tired, out of sorts, disconnected. In January 2010, he started having headaches, seeing double, difficulty swallowing, eventually lost continence. Would fall and be unable to get up. MRI on 1-29-10 dx 2cm tumor in ponds. Admitted to hospital. Died 2-14-10.
itching and swelling at the injection site; weak; 100.7 F very low; literally couldn't get warm; like a flu; Her body is trying to keep that out of her body; itching and swelling at the injection site; cold; absolutely frozen; shaking; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (absolutely frozen), TREMOR (shaking), FATIGUE (fatigue), ASTHENIA (weak) and PYREXIA (100.7 F very low) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced FATIGUE (fatigue). On 21-Feb-2021, the patient experienced FEELING COLD (absolutely frozen), TREMOR (shaking) and NASOPHARYNGITIS (cold). On 23-Feb-2021, the patient experienced ASTHENIA (weak), PYREXIA (100.7 F very low), FEELING COLD (literally couldn't get warm), INFLUENZA (like a flu), FEELING ABNORMAL (Her body is trying to keep that out of her body) and PRURITUS (itching and swelling at the injection site). On an unknown date, the patient experienced VACCINATION SITE SWELLING (itching and swelling at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING COLD (absolutely frozen), TREMOR (shaking), FATIGUE (fatigue), ASTHENIA (weak), PYREXIA (100.7 F very low), NASOPHARYNGITIS (cold), FEELING COLD (literally couldn't get warm), INFLUENZA (like a flu), FEELING ABNORMAL (Her body is trying to keep that out of her body), PRURITUS (itching and swelling at the injection site) and VACCINATION SITE SWELLING (itching and swelling at the injection site) outcome was unknown.            This case was linked to MOD-2021-033813 (Patient Link).
I was having sweats and my body was hurting and I lost my taste. My nerve damage went crazy in my legs. Covid-19 home test, positive. I am having breathing issues and hard to catch my breath.
slight nausea that comes and goes, next day- soreness in arm at  and around injection site, tired dopy feeling that lasted for 24 hrs. Day 2 - soreness is still apparent in arm and nausea is less apparent but still comes and goes.
Sensitivity started within four hours of dose. Autistic sensitivities to maximum. Scrambling of all senses including proprioception to the point of not being able to move from standing  or sitting. By hour seven, all sensory inputs were too overwhelming to do anything but shut down and sleep. 911 was not an option because they don't let you sleep, and ERs are overwhelming already, before maximizing all inputs. 7.5 mg hydrocodone for overwhelming pain and sensitivity, allowed sleep. On waking, sensitivity was lessened, but the pain started, 18 hours after the vaccination. Emotional lability for three days. Average aching of arm and injection site were not above expected levels. "Brain fog" and lack of ability to articulate (another autism symptom) started within that first seven hours, and diminished over next ten days. Not yet gone as of today  Dry mouth; overproduction of thick 'chunky' mucus that wouldn't cough out, treated with guaifenesin, lasted three days. Shortness of breath and cough associated with that mucus also diminished after three days. Not completely gone ten days later.   Excessive thirst, onset two hours after vaccine, lasted two days.   Hyperalert (can't sleep without drugs), hyperactive despite weakness, and hypervigilant (extreme startle reflexes) lasted three days as well. Sleep was achieved with hydrocodone and THC.  All over body pain, feelings of immune mobilization (coming down with) for two days were not above expected levels.   No fainting or other collapse at time of injection, or later.  Knowing that severe over-stimulation is exacerbated in a medical setting, it was decided not to seek medical support for three days of systemic symptoms that would have easily merited hospitalization.
Right side of her face was swollen; Swollen lips; Swollen lymph nodes at her occiput (the back of her head); Hives, Raised Hives, Hives leaves a pink area on her skin for few day; Itchy Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives, Raised Hives, Hives leaves a pink area on her skin for few day), PRURITUS (Itchy Hives), SWELLING FACE (Right side of her face was swollen), LIP SWELLING (Swollen lips) and LYMPHADENOPATHY (Swollen lymph nodes at her occiput (the back of her head)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced URTICARIA (Hives, Raised Hives, Hives leaves a pink area on her skin for few day), PRURITUS (Itchy Hives) and LYMPHADENOPATHY (Swollen lymph nodes at her occiput (the back of her head)). On an unknown date, the patient experienced SWELLING FACE (Right side of her face was swollen) and LIP SWELLING (Swollen lips). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives, Raised Hives, Hives leaves a pink area on her skin for few day), PRURITUS (Itchy Hives), SWELLING FACE (Right side of her face was swollen), LIP SWELLING (Swollen lips) and LYMPHADENOPATHY (Swollen lymph nodes at her occiput (the back of her head)) outcome was unknown.            Concomitant medications were not provided by reporter.  The hives start in the same place every single time, it starts on the right side of patient's stomach about the size of a quarter then draws a line across patient's stomach to the left side of stomach and it is about the size of her palm. Patient thought that patient was having a stroke. At the ER, patient was treated with IV Steroid. Patient took over the counter Benadryl after the episode in 07-Aug-2021. Patient's healthcare provider was not sure what was going on with patient and referred patient to a Dermatologist, Hematologist and an Allergist.
Nausea, fatigue, malaise, low grade temperature for one day. Discomfort, redness, heat at injection site for 3 days (continuing today).
low grade fever; fatigued; out of sorts; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 on an unspecified date for covid-19 immunization and experienced sore arm for a day and a half. On an unknown date in Feb2021, 12 hours or so after the shot the patient experienced low grade fever, fatigued and was out of sorts and that lasted about 1.5-2 days. At the time of this report, the outcome of events was recovered on an unknown date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a physician and described the occurrence of muscle soreness in a 49-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On 13 May 2011 the subject received unspecified dose of BOOSTRIX in the left arm. On 13 May 2011, less than one day after vaccination with BOOSTRIX, the subject experienced muscle soreness, swelling and erythema. At the time of reporting, muscle soreness was unresolved and swelling and redness were resolved. The physician considered the events were probably related to vaccination with BOOSTRIX.
Facial dermal fillers (Allergan Voluma and Volbella) in cheeks and under eye area performed  in August 2020 (Voluma in cheeks) and December 2018 (Volbella in under eyes) became swollen and tender to touch the morning of 3/27/21 36-48 hours after receiving 2nd Pfizer Covid vaccine. I took Prednisone 20 mg, one dose of Xyzal, and Benadryl 50 mg and swelling stayed stable (did not worsen but did not improve much) and tenderness persistent over the day. There was no redness or sign of infection to the area and no other symptoms associated. The next morning, 3/28/21, tenderness resolved completely and very minimal swelling was present which resolved over the day. By 3/29/21 there was no sign of any swelling.
Neck pain when I hold my head back, upper arm, shoulder in front, back and top, elbow when leaned upon.   Numbness in arm hand, and swelling on formarm. Pain when lying down and setting for periods of times, reaching up for items.
This spontaneous report was received from a registered nurse and refers to a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
WOKE UP WITH HEADACHE, NAUSEA. IS RESTING. ATTEMPTING TO EAT TOAST. STILL FEELS SICK. SUGGEST PHYSICIAN IF DOES NOT IMPROVE.
CLIENT RECEIVED SECOND PFIZER DOSE TOO EARLY (5/28/2021) FIRST DOSE ADMINISTERED 5/13/2021.
Information has been received from an office manager, via a company representative, concerning a patient (age and gender unknown), with unknown medical history and unknown drug reaction/allergies, who on an unspecified date was vaccinated (route unknown) with a dose of Varivax (Lot # unknown). The office manager reported that on 31-MAY-2006 that the patient experienced "a breakthrough". The patient's status was not reported. No product quality complaint was involved. Additional information is not expected.
Left arm went numb for about 5 hours. The following day left leg hurt really bad.  Been dizzy, heavy feeling in chest, anxiety issues after shot.
ACUTE SORENESS; LETHARGIC; This spontaneous report received from a vaccine facility via a company representative concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included blood cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ibrutinib for blood cancer. On APR-2021, the subject experienced acute soreness. On APR-2021, the subject experienced lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acute soreness, and lethargic on 07-APR-2021. This report was non-serious.
Headaches, swollen face, hives on her neck, thigh, low back and feeling warm.
Area of inject site right deltoid erythemia, slightly raised, warm ? cellulitis unlikely -advised hot packs, Benadryl and APAP.
Swollen/tender lymph node in right armpit developed on Day 6.  On Day 8, swelling, warmth and tenderness developed on right arm, along with myalgia  in legs.
feeling drained and fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling drained and fatigue) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (feeling drained and fatigue). At the time of the report, FATIGUE (feeling drained and fatigue) outcome was unknown.            No treatment medication details was provided.  Patient took booster dose on Friday but had prior infection and was taking antibiotics at the same time before Patient got the booster
I did not have an adverse reaction to the vaccine. In 01/2023, I work up with a swollen left leg. I have seen many doctors, and no one can determine what is going on. The swelling is constant and no relief. I have not injured my leg. I have follow up appointments with all the doctors I have seen.
Area around injection site developed a swollen and painful, red rash that was warm to the touch.
Patient experiencing neck pain and stiffness for past 2 weeks it is not getting better and acetaminophen is not helping.
On 05/09/2022, I tested positive for COVID. I have had mild cold like symptoms. However, last night I had severe body aches. I started taking Paxlovid yesterday morning. I have had some mild digestive discomfort but nothing major.
Excessive  swelling and redness down to the wrist. Lasted about 5 days.
Patient is a 92y.o. female who presented to the emergency department at hospital from senior living. At bedside, history taking from the patient is somewhat limited. I did contact senior living, and spoke with LPN for further information. LPN states that patient began to exhibit slurring of the speech, which began at approximately 7:30 AM on 11/7/21. She further states that her speech appeared somewhat slower than normal. LPN further states that patient administers her own medications, and doubts compliance. As well, it is noted that patient was found to have alcohol in her room. In addition, it appears that patient has oxycodone on her medication list.    The patient was noted to test positive for COVID-19 on 11/3/21, during routine testing. The patient was noted to be asymptomatic at the time. However, it is noted that patient frequently leaves the living facility, without utilization of mask. Patient COVID-19 vaccinated (Moderna - 2/29/21 and 1/22/21). The patient herself reports poor oral intake. She denies chest pain or shortness of breath, no addition to fevers or chills. Further denies diarrhea or abdominal pain. She does report right hip pain, however denies recent falls.    Her past medical history includes osteoarthritis of the right hip, aortic stenosis status post TAVR in 2018, sinus node dysfunction status post dual-chamber permanent pacemaker implantation, history of DVT in 2012, uterine carcinoma status post total abdominal hysterectomy with bilateral salpingo-oophorectomy in 2011 with subsequent completion of chemotherapy and XRT, impaired glucose tolerance, chronic bilateral lower extremity edema, essential hypertension, hypercholesterolemia, and a remote history of TIA. She is her own decision maker, as verified with LPN. The patient is not on home oxygen therapy.
COMPLAINT OF SEVERE HEADACHE, CHILLS STARTED 3/18/2022 MORNING AFTER 2ND DOSE COVID VACCINE
Pt with fever w/swollen area 4" by 4". Upper (L) arm with profuse heat at site. Redness extends beyond the raised swollen area. Fever to 101 degrees w/body aches.
Dizziness. Not lightheaded, but disorientation to vertical. Occurs upon any movement, including movement which would not affect blood pressure.
The patient reported that his arm got sore, red around the area given, and also a hard spot at the injection site. The patient said it went away, but he just wanted to let us know that it occurred.
This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored MMR II. Strength, dose, route and lot number were not provided. MMR II was exposed to a temperature between 46.5F and a highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014: Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. Follow up information has been received from two registered nurse (R.N.) reported that a 1 year old patient (gender not reported) who on an unknown date in 2014 received the MMR II (lot # reported as J004210 expiration 12-APR-2015; lot# J007155 expiration 20-JUN-2015) (the R.N. was unable to break out per Lot number of vaccine) (dose and route not reported) that had a temperature excursion and were found to be unstable. The MMR II was unstable after 12-APR-2014. The registered nurse stated that the patient needed to be contacted for re-vaccination. This is one of several reports received from the same reporter (other case IDs: 1405USA004214, 1405USA004215, 1405USA002823, 1405USA012476,  1405USA012477, from 1405USA012479 to 1405USA012482 and 1405USA004216). Additional information has been requested.
Tunnel vision, hearing sounded like underwater and almost passed out....couldn't verbally respond when my husband asked me a question for a short time. Fever, chills, sick to my stomach, dizzy, headache,  sore arm, and excessive tiredness.
PSA went from 4.5 to 0.1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 5 (booster), single (Lot number: gt3275) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history included: "prostate cancer" (unspecified if ongoing), notes: he takes vitamins and green tea. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Unknown manufacturer), for COVID-19 immunization. The following information was reported: PROSTATIC SPECIFIC ANTIGEN DECREASED (non-serious) with onset 25Oct2022, outcome "unknown", described as "PSA went from 4.5 to 0.1". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of prostatic specific antigen decreased. Additional information: On 25Oct2022 the patient got his 3rd booster of the bivalent Pfizer COVID vaccine and at the same time, within a few hours, he did a blood draw on his PSA and his PSA went from 4.5 to 0.1. He asked did the COVID shot affect his PSA (prostate specific antigen). The pharmacist didn't tell me, and my doctor can't tell me whether it affected it. He stated he had received 2 booster shots before plus the original 2 shots as the primary series. He has prostate cancer and that he was takng vitamins and green tea. Caller stated, he always thought that the vitamins and green tea brought the PSA down, but that shouldn't be that much, which is why he thought the COVID vaccine may have brought it down.
AT 9:30 am, patient was given 2 vaccines, Dtap, Hib. Returned to office around 11:45 am with hives all over. Mom reports that he had gasped for breath at two different times. No wheezing noted by physician. Patient was currently without respiratory distress. Benadryl 3/4 tsp given by mouth and 0.1 mg of Epinephrine was given IM.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 7 month old infant patient of unknown gender. On 03-JUN-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
per patient statement: severe flu-like sx's, severe back muscle spasms, left leg (entire leg) numbness and weakness