chrisvoncsefalvay/vaers-outcomes huggingface dataset:
couldn't raise his arm; stung then that feeling moved from his upper arm down to his elbow; got a bad rash on it looked puffy and had a pain sensation; Initial information regarding an unsolicited valid non-serious case was received from a Non-Healthcare Professional (consumer) via Medical Information (Reference number- 00515208) and transmitted on 11-Mar-2021.  This case involves a male patient of unknown age who couldn't raise his arm (mobility decreased), stung then that feeling moved from his upper arm down to his elbow (pain in extremity), got a bad rash on it looked puffy and had a pain sensation (rash), while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (batch number and expiration date were not reported via unknown route in unknown administration site via prophylactic vaccination.  On an unknown date, the patient couldn't raise his arm (mobility decreased, non-serious), stung then that feeling moved from his upper arm down to his elbow (pain in extremity, non-serious) and got a bad rash on it looked puffy and had a pain sensation (rash) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Also reported that Caller wanted to know if he should be careful of getting the Covid-19 (coronavirus disease)  shot? Caller stated that last month a physician told him that the flu vaccines aren't made the same so probably won't have the same effect. Caller wanted to know how flu vaccines are made differently? Also he wanted to know if patient's can get a flu shot if they have a history of mono or chronic fatigue syndrome.   No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was unknown for all the reported events.  There will be no information on the batch number for this case.
muscle ache at the injection site; total body ache and soreness; headache; This is a spontaneous report from a contactable consumer (patient). This 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL1283) via an unspecified route of administration in the left arm on 19Jan2021 at 08:00 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included a pacemaker, chronic obstructive pulmonary disease (COPD), asthma, and high blood pressure (HBP). Prior to the vaccination the patient was not diagnosed with COVID-19. The patient did not have any allergies. Concomitant medications included aspirin; lisinopril; fluticasone furoate, umeclidinium bromide, vilanterol (TRELEGY); and montelukast. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 19Jan2021 at 11:00 the patient experienced muscle ache at the injection site, total body ache and soreness, and headache. The patient did not receive treatment for the events. The outcomes of injection site, total body ache and soreness, and headache were not recovered. It was also reported that since the vaccination the patient was not tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
slight soreness in my right arm; This is a spontaneous report from a contactable consumer report for self. A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) via an unspecified route of administration at right arm on 25Jan2021 15:30 at single dose for covid-19 immunization. The patient's medical history included allergies to Amoxil, but not severely. Patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medication within 4 weeks prior to the COVID vaccine included influenza vaccine, ethinylestradiol, levonorgestrel (KURVELO), fluoxetine hydrochloride (PROZAC). On 25Jan2021 05:00 PM, patient developed just slight soreness in right arm, but that usually happens to her when got any vaccine. No treatment received for the adverse event. Event outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19.
This spontaneous report as received from a registered nurse refers to a 1 year old patient of unspecified gender. On 01-OCT-2013, the patient was vaccinated with a first 0.5 ml dose of VARIVAX (Merck), subcutaneous (lot # and expiration date were not provided). On 01-OCT-2013, the patient received an expired dose of VARIVAX (Merck) for his/her first dose. No adverse effects were reported. Additional information has been requested.
MUSCLE SORENESS AND MUSCLE WEAKNESS LASTING GREATER THAN 12 DAYS.
10/1 received seasonal inactivated flu shot at school, 22 days later developed Acute Demyelinating Encephalitis (ADEM).  12/10/09, 1/4/2010 ED, hospital records, discharge summaries received. Service dates 11/6/09 to 11/23/09. Assessment: Acute disseminated encephalomyelitis (ADEM), Seizure.  Patient presented with 2 weeks of intermittent fevers, headaches, and 24 hours of diplopia with distant gaze. Vomiting. Headache, speaking nonsense. slurred speech, feels weak. Several prior ER visits for presumed viral illness. Admitted to neurology. Poor attention and 'moderately-bad' recall. Meningismus, neck pain on flexion. Transaminitis. Seizure. Apneic. intubated. ICU. Acute renal failure with rhabdomyolysis. Decompensated Esophoria.
The patient reports a severe allergy to Corn/corn syrup.   S: I feel itchy and nauseous. I feel like my chest is heavy. Denies CP or SOB. Denies dizziness or lightheadedness.    O: A&O x3. Skin is pink, warm, and dry. No rash. Resp: normal resp rate- no cough no stridor. Cards: RRR in the 80s. Radial pulse palp.    A/P: 67 y/o female who reports severe Corn allergy and is having symptoms of s/p Pfizer vaccine that are similar to when she ingests corn or corn derivative. She takes Cetirizine when this happens but does not have any with her. Cetrizine 10 mg po x1 given Patient monitored for 30 min with a resolution of reported symptoms
Patient received vaccines on 8/12/10. Developed diffuse hives 8/17/10. Treated with oral BENADRYL until 8/18/10 was seen by physician, given KENALOG 80 mg and XYZAL 5 mg. Pt. also had Lt. otitis externa 8/18/10 - treated with FLOXIN OTIC.
Shaking chills, body aches, lump at injection followed by continued swelling at site until it reached 5 by 12cm red painful welt.  Chills and malaise lasted until the morning of the 28th.  On the second day stabbing head pain started and last intermittently for 36 hours.  Treated by round the clock ibuprofen and Tylenol.  Called clinic on Friday but couldn't get through.  They called back on Monday.  This is day 6.  Site pain and some joint pain persist.  Chills gone.
8 days after vaccine developed itching left upper arm between shoulder and elbow.  10 days after vaccine developed erythema of arm from shoulder down arm to above elbow
Got a strain of flu not being vaccinated against; Initial information was received on 07-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves a patient with unknown demography who got a strain of flu (not being vaccinated against) (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, past vaccinations, concomitant medication 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 expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got a strain of (influenza), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test results included: On an unknown date laboratory test showed strain of flu.  It was not reported if the patient received any corrective treatment or not.  It was reported that the patient tried various doses three years and got a strain of flue each year within a week of shot.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
Guillain-Barre syndrome after getting the shot; could not walk properly; body stiffness; muscular dystrophy; painful neck; headaches; feeling unwell; 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 64-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre syndrome after getting the shot"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "could not walk properly"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "body stiffness"; MUSCULAR DYSTROPHY (non-serious), outcome "unknown"; NECK PAIN (non-serious), outcome "unknown", described as "painful neck"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; MALAISE (non-serious), outcome "unknown", described as "feeling unwell". Clinical course: Patient mentioned about side effects she had when she got the Pfizer Covid vaccine. (Body stiffness, muscular dystrophy, painful neck, headaches, feeling unwell, could not walk properly). She wants to know if it is possible to get Guillain-Barre syndrome after getting the shot. Patient confirmed she had received it on 22Oct2022 and it was the new vaccine that would fight the omicron. After referring caller back to her HCP, she answered: "well she sent me for therapy, you know, I went for 9 weeks of therapy, and I went religiously. And other things are turning up, like it started on the left side of my body which is the side that I always got the injection in and now it's starting to creep up on my right side".   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300218569 Same patient/vaccine/event, different dose;US-PFIZER INC-202300218534 Same patient/vaccine, different dose and event;
the day after the injection, I experienced heaviness in the arm. after few days, i have been experiencing needle like pricks in the same area where I received the injection.  I am still experiencing heaviness, shooting pain at the area where I received the vaccine and tingling sensation on the left hand.  Till today as I am writing this report, the pain is still present.  It is a shooting pain that comes and goes.
Mom described area on (R) leg is approximately 1 inch from injection site. 3 inches wide and 2 inches tall and red and hot to touch. Per mom spoke with RN on call Sunday 6-7-09 - Spoke with another RN on Monday 6-8-09 and area more red but child had just come in from outside playing
03/27/2015 Skin infection on bilateral arms and inflammation got treated with KEFLEX antibiotic and BACTROBAN oint.
Patient tested positive for Covid after receiving booster dose; Patient tested positive for Covid after receiving booster dose; Patient tested positive for Covid after receiving booster dose; This is a spontaneous report received from a contactable reporter (Consumer).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown, ), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown, ), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "Patient tested positive for Covid after receiving booster dose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive.  The lot number for the vaccine, [bnt162b2 ], was not provided and will be requested during follow up.
Patient with a subjective complaint after first covid vaccine where patient felt a hot flushed feeling across chest and throat and face of which patient did not self medicate nor seek treatment. Patient was given Benadryl 25mg IM pre vaccination at 12:39pm, vaccine given at 1:00pm and while being observed by vaccination team, patient become diaphoretic, pale, "throat tightness" that was appreciated to be swollen, and difficulty swallowing at 1:11pm at which point Epinephrine 0.3mg was given IM to L anterior thigh. Patient's vitals were the following: BP 148/86, HR 124 bpm. After epinephrine, patient's throat swelling and breathing much improved, and able to swallow. Patient was then transported to ED in wheelchair via wheelchair. Patient was given Dexamethasone 10mg IV, Pepcid 20mg IV, and Benadryl 25mg IV. Only complaint that patient had during ED visit was palpitations of which HR did regulate to 86 bpm, BP 149/70. Patient was discharged on 1/29/2021 at around 4:50pm as patient was fully asymptomatic and able to ambulate on own. Sent home with prednisone 40mg po daily x 7 days, pepcid and benadryl otc. Advised to f/u with PCP in 1-2 days and suggested possible allergy testing.
Administered 2nd booster of Pfizer in afternoon on 4/20/22.  Patient was alert and stated he felt good and no previous issues with the vaccine.  He completed the 15-20 minute observation period without any adverse reactions.  When the observation period concluded, the patient exited the clinic with his wife and returned to his vehicle.  Shortly afterwards, the patient's wife approached some staff members in the parking lot and reported that her husband was having difficulty breathing and was not responding appropriately to her questions while sitting in the driver's seat of their car.  The staff members immediately activated our clinic's emergency response procedure including a 911 notification.  When the vaccine team arrived at the vehicle, they found the patient unresponsive in the driver's seat.  He had a pulse, shallow breath and was diaphoretic.  The team removed the patient from the vehicle, lowering him onto blankets on the ground.  Patient's color was grey.  Vital signs were monitored every few minutes: BP: 165/79, HR 52, O2 sat 97% on RA BP: 165/89, HR 50, O2 sat 96% on RA BP: 152/79, HR 51, O2 sat 97% on RA BP: 163/82, HR 49, O2 sat 98% on RA BP: 171/80, HR 56, O2 sat 95% on RA EMS arrived and took over management of the patient along  with transport to an outside hospital.   On 4/21/22 our staff was in contact with the patient's family who informed us that the patient passed away earlier this morning.
Erythema measuring approximately 5 inches by 3 inches and indurated approximately 2 inches by 2 inches. Running fever at the site and forehead, hard at the site and sore. Guardian took child to Urgent Care and they stated it was an adverse reaction and put the child on Cefadroxil 250/5 Susp twice a day and All Day Allergy Syrup 118mi once a day. Physician requested that it be reported. As of today it is gone and he is returning to school.
Pt had raised rash at site of injection 12cm in diameter c/o itching and limping x 1 day. T 99.5 in evening appears allergic Rxn as opposed to cellulitis examined 10/21 No acute distress No longer limping rash still present.
Date of Admission:  12/29/2021   Date of Discharge:  1/1/2022   Attending Physician:   (M.D.)   Admitting Diagnosis: CORONAVIRUS COVID-19 LOWER RESPIRATORY INFECTION   Principal Diagnosis(Discharge Diagnosis): CORONAVIRUS COVID-19 LOWER RESPIRATORY INFECTION   Secondary Diagnoses:  Active Hospital Problems   Diagnosis   ? (Principal) CORONAVIRUS COVID-19 LOWER RESPIRATORY INFECTION   ? ASTHMA, UNSPECIFIED W ACUTE EXACERBATION     Resolved Hospital Problems No resolved problems to display.   Primary Procedures: None   Secondary Procedures: High Flow Nasal Cannula   Issues to be Addressed at Follow-up: - Patient with severe COVID-19, tested postiive on 12/29/21. Isolation for 20 days from first day of symptoms (untill 1/18/22).  - Second dose of covid vaccine after isolation completed  7yr old boy with PMHx of Moderate Persistent Asthma and OSA with recent hospitalization 3 weeks ago for asthma and walking PNA (discharged on Azithromycin) who presented with difficulty breathing. He was found to have wheezing, s/p Magnesium, Terb, Methylprednisolone, and Albuterol 15mg/h in the ED with improvement in symptoms after these interventions. He later tested positive for COVID-19 on 12/29/2021 and was admitted for hypoxemic respiratory failue secondary to COVID-19 PNA and acute asthma exacerbation. He required HFNC up to 15L/60%. Patient was treated with Albuterol per RT driven protocol and steroids per asthma dosing x 2 days (15 mg Dexamethasone daily x 2 doses). He was transitioned to Dexamethasone 6 mg daily per COVID-19 pneumonia dosing. He was also started on Remdesivir with a loading dose followed by 100 mg daily. Patient improved clinically and was weaned to room air by time of discharge.
Case number PHEH2014US001595 is an initial report received from a pharmacist on 15 Jan 2014. This report refers to a 24-year-old female patient. Current condition of this patient includes lactose intolerance. He was vaccinated with FLUVIRIN (batch number: 13472P; expiry date: not reported) intramuscularly on 14 Jan 2014. On the same day after vaccination the patient presented with breathing difficulty and rash. Outcome of the events was reported as recovered completely. Seriousness and causality were not reported.
general malaise; sleep disturbance; hypertensive spikes, 155/99-73; muscle aches; increased nausea; near vomiting; low grade fever 99.2; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (general malaise), SLEEP DISORDER (sleep disturbance), HYPERTENSION (hypertensive spikes, 155/99-73), MYALGIA (muscle aches) and NAUSEA (increased nausea) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 202F234) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 20-Sep-2023, the patient experienced MALAISE (general malaise), SLEEP DISORDER (sleep disturbance), HYPERTENSION (hypertensive spikes, 155/99-73), MYALGIA (muscle aches), NAUSEA (increased nausea), VOMITING (near vomiting) and PYREXIA (low grade fever 99.2). At the time of the report, MALAISE (general malaise), SLEEP DISORDER (sleep disturbance), HYPERTENSION (hypertensive spikes, 155/99-73), MYALGIA (muscle aches), NAUSEA (increased nausea), VOMITING (near vomiting) and PYREXIA (low grade fever 99.2) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 155/99-73. On an unknown date, Body temperature: 99.2.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was unknown if the patient experienced any additional symptoms/events. Treatment medications were not reported.
diarrhea; stomach pains; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of DIARRHOEA (diarrhea) and ABDOMINAL PAIN UPPER (stomach pains) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea) and ABDOMINAL PAIN UPPER (stomach pains). At the time of the report, DIARRHOEA (diarrhea) and ABDOMINAL PAIN UPPER (stomach pains) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not reported.   Reporter did not allow further contact
R anterior shoulder, swelling and erythema R deltoid area, color changes and fever noted morning after injection. Instructed to apply ice for 20 min every hour for 24 to 48 hours.
Information has been received from a physician's office via a wholesaler concerning a male over the age of 55 years who on an unspecified date was vaccinated with a dose of Pneumovax 23 (lot 650302/1039F). Subsequently, the patient developed redness and swelling of the arm, warmth to the touch and arm pain lasting 3 days. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
Elevated blood pressure and headache at immediate injection body aches about 2 hours later follow by nausea low grade temp. On Sunday about 4am I started vomiting with diarrhea, joint pain, Headache, BP of 168/109 and temperature of 100.1.
Itchiness which led to rash; Excruciating headache; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 33-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 19May2021 at 09:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, meniere's disease. The patient had known allergies to strawberries, watermelon, drugs penicillin and valsartan. Concomitant medications included hydralazine (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 09:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19May2021 at 10:30 the patient experienced itchiness which led to rash, excruciating headache and diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events itchiness which led to rash, excruciating headache and diarrhea were not recovered at the time of this report.  No follow-up attempts are needed; information about lot\batch number cannot be obtained.
Hives at injection site noticed at 9pm, Claritin given, 9:30pm hives spread to neck and back, Benadryl given. Symptoms resolved 11pm.
Myalgia, Fever, chills, bodyaches, inability to sleep Narrative: Employee stated around 2am he began to experience fever 100.4, chills, bodyaches, and inability to sleep.