chrisvoncsefalvay/vaers-outcomes huggingface dataset:
77 year old female presented with altered mental status. Pt is normally alert  X4 as baseline but has been having a decline in her mental status. Daughter reports that pt was recently hospitalized from 11/8/2021-11/12/2021 with right femur fracture and traumatic subdural hemorrhage. Pt underwent right hip hemiarthroplasty on  11/9/2021. Pt was diagnosed with COVID19 11/17/2021 POA. At arrival, CT brain with no acute finding. CTA chest with early pneumonia but no PE. Pt initially on oxygen. She was started on dexamethasone and remdesivir. Pt symptoms improved quickly and she has been on room air for the past couple day . Pt is now being discharge back to the HCF to complete the course of dexamethasone. remdesivir has been completed
02/20/2003- Right red, swollen- cool washcloth. Rev on 02/21/2003- Area with same symptoms- V'ed by doctor. Pt started on Augmentin OS. No reaction on LT. To rev on 02/24/2003
flu like symptoms; This case was reported by a consumer and described the occurrence of flu like symptoms in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of shingrix on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced flu like symptoms. On an unknown date, the outcome of the flu like symptoms was recovered/resolved.   It was unknown if the reporter considered the flu like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's wife reported that the patient received dose of Shingrix in 2019. After the vaccination the patient had flu like symptoms for few days. The reporter stated that she had a lot of friends who had gotten some side effects with the second dose. No additional details were provided. The reporter did not consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR093183:Friends' case
Fatigue; achy body; dose may have been given Subcutaneously; received an incomplete 1st dose of Shingrix; During administration leaked on the patient's arm; exposure via skin contact; experienced tingling throughout his body; experienced episodes of hot flashes, multiple, runs through his entire body; This case was reported by a physician via call center representative and described the occurrence of fatigue in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 6th March 2020, the patient received Shingrix (subcutaneous) and the 1st dose of Shingrix. On 6th March 2020, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fatigue, general body pain, intramuscular formulation administered by other route, accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. In March 2020, the patient experienced tingling and hot flashes. On an unknown date, the outcome of the fatigue, general body pain, tingling, hot flashes, intramuscular formulation administered by other route, accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the fatigue, general body pain, tingling and hot flashes to be related to Shingrix.  Additional details were provided as follows: The reporter was the daughter of the patient. A physician reported that a patient received an incomplete 1st dose of Shingrix. During administration leaked on the patient's arm, then they were given a full dose immediately, which led to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. The provider reported the dose may have been given subcutaneously, which led to incorrect route of vaccination. The provider also reported that the patient experienced episodes of hot flashes, multiple, runs through his entire body and tingling throughout his body. Initially fatigue, achy body reported immediately after the dose and 1 week later the other symptoms developed. Consented to follow up.
This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a adult female patient who received SHINGRIX for prophylaxis. On 19th March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced muscle weakness and general body pain. On an unknown date, the outcome of the muscle weakness and general body pain were not recovered/not resolved. It was unknown if the reporter considered the muscle weakness and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine and was experiencing muscle weakness and aching all over. The reporter declined to provide any contact information. The reporter did not give consent to follow up.
periorbital swelling and forehead, large swelling around injection site , 1/09/22 already improved
About a day after the 1st vaccine, I got a rash on my face that felt like sandpaper.  My face was became more swollen after four days and finally started decreasing in swelling after the 5th day.  My eyelids were the most noticeable.
Got sick from the flu; Initial information received on 08-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via Regulatory Authority.  This case involves a female patient of unknown age who got sick (Illness), after receiving INFLUENZA VACCINE.  The patient's past vaccination(s) included INFLUENZA VACCINE for prophylactic vaccination. The patient's medical history, concomitant therapy, medical treatment(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Burning sensation immediately after shot, feeling of being electrocuted, Severe twitching and jerking of left arm beginning at 5pm...went to ER...identified as a severe motor tic...next 24 hours had vomiting. Nausea, migraines, stomach pain, lethargic, no appetite-48 hours after and as of the time I am filling this out still twitching and having migraines.
total distortion of smell/smells putrid and horrible; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old nonpregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 15Apr2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 in Jan2021. Concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, the patient waited 3 months to get vaccinated and after the second vaccine had total distortion of smell. Everything smelled putrid and horrible. Coffee, onions, bread and much more smells horrible which made hard for to eat. This had really been a horrible experience and didn't happen until had the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event total distortion of smell, everything smells putrid and horrible was unknown.   No follow-up attempts are needed. No further information is expected.
This spontaneous case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns a 59-year-old male patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular, Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
Initial report received from nurse on 16 Dec 2009: One dose of FLUVIRIN (batch no. 1008142P) was administered to a 3-year-old child on 14 Dec 2009. No adverse effect was reported.
Developed red hives during night. 0300 eyes itchy, itching, no throat tight, difficult to swallow, lips swollen. Prednisone 20mg PO, Benadryl 50mg, cool packs. No MD.
Headaches; Nausea; Diarrhea; Lightheadedness; Fatigue; Muscle aches; This is a spontaneous report from a contactable other healthcare professional, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 04May2021 at 16:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS) and hypothyroidism. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID); taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route of administration in the left arm on 08Apr2021 at 15:45 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. On 08May2021 at 08:00, the patient had headaches, nausea, diarrhea, lightheadedness, fatigue and muscle aches for over four days, starting several days after injection of second dose and symptoms ongoing. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headaches, nausea, diarrhea, lightheadedness, fatigue and muscle aches 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.
Arm hurt all night; Patient received 3rd dose of Moderna vaccine but is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt all night) and EXTRA DOSE ADMINISTERED (Patient received 3rd dose of Moderna vaccine but is not immunocompromised) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A, 032M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt all night). 07-Oct-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient received 3rd dose of Moderna vaccine but is not immunocompromised). On 07-Oct-2021, EXTRA DOSE ADMINISTERED (Patient received 3rd dose of Moderna vaccine but is not immunocompromised) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm hurt all night) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications were reported.
Sweating; Feeling nauseous; Vomited; Slight headache; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03Sep2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, allergy to penicillin and plums. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paroxetine hydrochloride (PAXIL) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received meningococcal vaccine (reported as meningitis) (MANUFACTURER UNKNOWN) on 20Jul2021 for meningitis. On 04Sep2021 at 11:00 in the morning, the patient started sweating, feeling nauseous, then vomited and currently had a slight headache. The events did not result in doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sweating, feeling nauseous, vomited and slight headache were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mother states pt. had developed a rash at 6-14 days post-vaccination that resolved. Mother stated pt. developed another 'red, splotchy hive-like rash,' on 05/13/17. Mother denies respiratory issues for pt. or fever, only other complaint is increased, 'fussiness.' RN encouraged mother to receive emergency medical treatment if mother feels pt. is currently having an allergic reaction, which she denies. RN also encouraged mother to follow-up with PCP today for pt.'s rash, mother agreed to this.
Severe pain in right leg, limping on leg, weakness in leg, off balance, having to hold on to wall/table/chair to hold herself up, falling down because she cannot hold herself up.
First dose I had swelling, painful, hot to touch, itching left arm. Happened exactly a week after first dose. Lasted for 3 days.  Second dose I had fever, chills, aches and pain starting 18 hours after second dose. Lasted a day.  7/12/2021 I had a reaction to what is assumed to be peanuts. Testing cannot be completed until 3 months after a steroid injection. I?ve never had an allergic reaction to anything except seasonal allergies prior to this. I had hives, swollen lips, ears, cheeks, uncontrollable itching, change in voice, high heart rate and low oxygen levels.
First few days like reaction to my first 2 (Pfizer) vaccines -- fatigue, aches, out of sorts. Then my left arm got red from shot location down to elbow and developed an itchy rash which lasted 2 or 3 weeks. Worse reaction was I noticed my lymph gland swelling on both sides of my neck and gradually getting larger for a few days when they peaked. They were very swollen. Also felt a gland under my left arm. Left side of neck most swollen. Also some pre-existing lumps on my scalp swelled up. I was very fatigued at first and significantly fatigued until about a week ago when my energy started to feel more normal. The swollen glands have very gradually gone down but are still enlarged.
Lightheadedness, diaphoresis, nausea, post vaccine. Elevated BP to 190/100 though has hx of HTN.
RN gave Varicella only when the order was for MMR and Varicella combination vaccine. The patient had to get an additional vaccine for MMR.
Recurring rash / where he received / vaccines / rash has appeared 4 times; In the same area where the shots were given / gets red; In the same area where the shots were / It is itchy; This case was reported by a contact via sales rep and described the occurrence of injection site rash in a male patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis, GARDASIL for prophylaxis and INFLUENZA VACCINE for prophylaxis.   On 26th October 2020, the patient received Tdap Vaccine (intramuscular) and Menveo (intramuscular). In October 2020, the patient received GARDASIL (intramuscular). On 16th November 2020, the patient received INFLUENZA VACCINE (intramuscular). On an unknown date, less than 3 months after receiving Tdap Vaccine, Menveo and INFLUENZA VACCINE, the patient experienced injection site rash, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site rash, injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the injection site rash, injection site erythema and injection site itching to be related to Tdap Vaccine and Menveo.  Additional details provided as follow: This case was reported by patient's mother. The patient received the Tdap and Menveo in left arm and Gardasil in his right arm and about 3 weeks later received the flu vaccine in the same left arm. The patient's mother reported recurring rash every few weeks in patinet's left arm where he received some vaccines. The rash would be itchy but usually with self resolve but always would occur in his left arm. The patient had getting a rash in the same area where the shots were given. It was itchy and gets red. It came and then goes away after a few hours. The first time it happened was somewhere between the vaccines and the second time it happened (January 8th). Therefore, the rash had appeared 4 times since the vaccines were given. The reporter was concerned and was wondering if the vaccines administered to that arm was causing this recurrent rash usually several weeks apart.  The patient did not have any problems or reactions to any vaccines in his life. The reporter stated that patient never had a rash in this location until after the vaccines were given and was wondering if any of these vaccines could have caused this record rash. He has had no other symptoms. The reporter consent to follow up.
Nausea; vomiting/cannot keep anything down; got sick; sleepy; headache; muscle pain; joint pain; chills; fever; fatigue/ tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick), SOMNOLENCE (sleepy), NAUSEA (Nausea), VOMITING (vomiting/cannot keep anything down) and HEADACHE (headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced SOMNOLENCE (sleepy), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue/ tired). On 17-Nov-2021, the patient experienced ILLNESS (got sick), NAUSEA (Nausea) and VOMITING (vomiting/cannot keep anything down). The patient was treated with SALINE [SODIUM CHLORIDE] on 20-Nov-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (got sick) had not resolved and SOMNOLENCE (sleepy), NAUSEA (Nausea), VOMITING (vomiting/cannot keep anything down), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue/ tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient went to the emergency room on 20-Nov-2021 and there she received intravenous (IV) fluid, 3 bags of saline and unspecified anti emetic medication which helped her until the next day.   This case was linked to MOD-2021-401280, MOD-2021-401370 (Patient Link).
RED BUMPS ON ARMS, LEGS AND CHEST; ITCHY ARMS, LEGS AND CHEST; ACID REFLUX; SKIN TINGLING; CONFIRMED COVID-19 INFECTION; ELEVATED HEART RATE, INTERMITTENT; LIGHT HEADED; FOGGY; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (1 per week, infrequent), and non smoker, and other pre-existing medical conditions included: The patient did not have known drug allergies. The patient did not have any history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191 and expiry: UNKNOWN) dose was not reported, administered on 05-JAN-2022 for prophylactic vaccination. Age at time of vaccination 56 years old. No concomitant medications were reported. On 06-JAN-2022, the patient experienced confirmed covid-19 infection, elevated heart rate, intermittent, light headed, and foggy. Laboratory data included: Heart rate (NR: not provided) Elevated (Elevated heart rate, intermittent). On 08-JAN-2022, the patient experienced skin tingling. On 10-JAN-2022, the patient experienced acid reflux, and itchy arms, legs and chest. On 24-JAN-2022, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On an unspecified date, the patient experienced red bumps on arms, legs and chest. Treatment medications (dates unspecified) included: omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, was recovering from foggy, light headed, and elevated heart rate, intermittent, and had not recovered from red bumps on arms, legs and chest, itchy arms, legs and chest, acid reflux, and skin tingling. This report was non-serious.
Injection Site Hurts; Hard Injection Site; Big Knot Injection Site; Hot Injection Site; Red (Baseball size) Injection Site; Itchy Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection Site Hurts), INJECTION SITE INDURATION (Hard Injection Site), INJECTION SITE MASS (Big Knot Injection Site), VACCINATION SITE WARMTH (Hot Injection Site) and VACCINATION SITE ERYTHEMA (Red (Baseball size) Injection Site) in a 46-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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE PAIN (Injection Site Hurts), INJECTION SITE INDURATION (Hard Injection Site), INJECTION SITE MASS (Big Knot Injection Site), VACCINATION SITE WARMTH (Hot Injection Site), VACCINATION SITE ERYTHEMA (Red (Baseball size) Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site). On 12-Apr-2021, VACCINATION SITE PAIN (Injection Site Hurts), INJECTION SITE INDURATION (Hard Injection Site) and VACCINATION SITE WARMTH (Hot Injection Site) had resolved. At the time of the report, INJECTION SITE MASS (Big Knot Injection Site), VACCINATION SITE ERYTHEMA (Red (Baseball size) Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.