chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2015US020298, is an initial spontaneous report received from a nurse on 08 Oct 2015. This report refers to a 63 year old male patient. Historical condition and concomitant medication were not provided. The patient was vaccinated with FLUVIRIN (batch number: 1515701) intramuscularly at a dose of 0.5 ml on 07 Oct 2015. It was reported that the patient was administered with FLUVIRIN vaccine which was stored out of 47 degree Fahrenheit temperature. No adverse event was reported following this maladministration.
2nd dose 1 week early; A spontaneous report  was received from a health care professional concerning a 38 year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and received a second dose 1 week early (inappropriate scheduling of vaccine administered).      The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    The patient received their first of two planned doses of mRNA-1273 (Batch number: 025J20-2A) on 13-JAN-2021.  On 03-FEB-2021, approximately the patient received their second of two planned doses of mRNA-1273 (Batch number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.    The patient received the second dose 1 week early from 28 day recommendation.  Treatment information was not provided/unknown.    The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The event, second dose 1 week early, was considered resolved/recovered.; Reporter's Comments: This report refers to a case of inappropriate scheduling of vaccine administered for mRNA-1273 (Batch number: 025J20-2A) with no associated AEs.
Fatigue, chest pain, pam post exertional malaise, PBC's, shortness of breath and abnormal baseline heart rate, hypotension
A non-serious spontaneous report of "administration of expired product" and "vaccine given to a patient" was received from a non healthcare professional concerning a 51-year-old male out of 18 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 20-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
On 4-21-11 ZOSTAVAX lot # 1457Z exp 29 Jan 2012 was administered instead of VARIVAX to a 4-year-old female. The mother was notified 4-25-11 and reported no adverse reactions.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 26Mar2021 as dose 2, single (Lot number: ER2613), in left arm and on 30Nov2021 as dose 3 (booster), single (Lot number: 30145B4) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Stroke" (unspecified if ongoing); "Known allergies: Pcn" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; LEVOTHYROXINE.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Unknown results; (14Jul2022) got a rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient took paxlovid.
hurts; she could not even lift the arm; This case was reported by a consumer via other manufacturer and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis (diagnosed years ago, taking treatment with celebrex for years). Concomitant products included celecoxib (Celebrex).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and mobility decreased. On an unknown date, the outcome of the pain and mobility decreased were unknown.   It was unknown if the reporter considered the pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient works at a hospital as a director and she was not a healthcare professional. The patient had Shingrix 1st dose in December 2018 and 2nd in March 2019. The patient stated regarding shingles shot that it hurts to where she could not even lift the arm. The reporter did not consent to contact primary healthcare professional. The reporter consented to follow-up. Note: It was not clear after which dose the events occurred.
R leg, per mom, swollen on 6/6/08 in evening + increased to size of softball 6/7 with redness + then improved.  No fever at that time.
Eyes swollen; Lips swollen; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eyes swollen) and LIP SWELLING (Lips swollen) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (Eyes swollen) and LIP SWELLING (Lips swollen). At the time of the report, EYE SWELLING (Eyes swollen) and LIP SWELLING (Lips swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: significant follow up received on 20 JUL 2021, Outcome of events updated.
Patient was given the children comirnaty (5-11 year old) vaccine instead of the adult vaccine
Patient experienced sweating and light headed about 11 minutes later. Onsite EMS was called vitals  HR 60 BP 91/54. He was advised to drink water, felt better and went home.
1st doze: 3/17/21 - at 11:20am - 4 hours later I felt a strong headache, body aches, chills, hot flashes or blushing, stomach cramps, neck and shoulder pain. This continued until the entire day of 3/18/21. 3/19/21 only the strong headache remained and hot flashes. On 4/14/21 at 11:20a I received the 2nd doze. On 4/15/21 at 1:50am I woke up to a severe headache, body aches, stomach cramps, and hot flashes. All day today 4/15/21 I have body aches from head to toe. My right arm twitches, hurts every step, hurts to even swallow. Random head and neck pain all day.  I have only taken Tylenol once at 2am 4/15/21 2 tabs. I have been resting, drinking tea, eating.
She has swelling, inflammation, redness, pain, and itching.  Patient is being treated with prednisone 20mg and cephalexin 500mg.  Patient states that the drugs are helping and is feeling better.
Awoke feeling achy, tired, warm, chills, headache on  3/2/21  Bright red rash down right arm , warm to the touch, swelling of arm and hand on 3/4/21  Arm Itchy and swollen, slowly dissipating since 3/4.  Minor symptoms of arm  and neck still today 3/8/21
body aches (pain); Initial information received on 29-May-2021 regarding an unsolicited valid non-serious case from a consumer from a patient support program via Regulatory Authority, (Manufacturer Report Number- UNT-2021-009583).  This case involves a 44 years old female patient (68 kg) who experienced body aches (pain), after receiving INFLUENZA VACCINE and while treated with TREPROSTINIL SODIUM [REMODULIN].  It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included SILDENAFIL CITRATE.  On 26-Apr-2021, the patient started taking REMODULIN (TREPROSTINIL SODIUM, 2.5 mg/ml, batch number and expiration date not reported) via subcutaneous for Pulmonary arterial hypertension. The current dose was reported as 0.00125 Î¼g/kg, continuous via subcutaneous (SQ) route.  On 22-May-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  In May-2021, the patient developed a non-serious body aches (pain), within few days following the dose intake of TREPROSTINIL SODIUM and in the same month following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  No laboratory data reported.  Action taken with SQ (subcutaneous) Remodulin was not reported for the event of pain.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the event pain.  The reporter did not provide causality for the event of pain.  There will no information on the batch number for this case.
Pt exp fever of 102 approx 24 hrs p/immun; Seen in office the next day w/dx of OM; tx Augmentin;
Severe redness, swelling, pain at site of injection radiating to axilla.  body wide muscle aches/pains.  Started within 12 hours of vaccine.  Treated with naproxen/loratadine as patient declined prednisone burst.
1st dose: had chills as soon as I got home, headache, fatigue, and body aches 2nd dose: had a headache several hours later, fatigue, abdominal pain, body aches, and dizziness
About two weeks after receiving my second dose, I was walking my dog and I felt like my body became heavy. I was short of breath also. The next day, I was at work. I took my patient to the mall and I couldn't continue walking so we had to leave. The following day, I felt like I was choking if I tried to drink something. My oxygen dropped to 85. The chest pain was constant. By 04/11, I couldn't get down the hallway without stopping three times. My husband took me to the ER and I was given a prescription for my asthma. I went to get the prescription filled and noticed that my breathing was even worse. My husband took me back to the local HCF and two minutes after being taken back, there was a cardiac alert for me. They performed the EKG and I had congestive heart failure and a heart attack. I had pericarditis, possible pneumonia, myocarditis and pleural effusion. I was so short of breath, they had me on 10-20 liters of oxygen and it was not helping. They tried to rush me to have a triple bypass surgery, but I declined. I later found out that I have small arteries that wouldn't last during a bypass. I decided to get another opinion, so I went to another HCF and I ended up having to get 5 stents in my heart. My heart is now at 24-26%. I no longer have any faith in myself, I lost my self esteem, I lost my job, my voice, my vision, my house and my mother because of this vaccine. I am crying all of the time and currently living at a hotel. This has turned my world into a whirlwind.
Source of Information: Available medical record   History of Present Illness:  This is a 88y.o. female with hx of dementia (AAOx1 per records), CHF, VTE on eliquis, Factor V Leiden, HTN, GERD who presents to Hospital via EMS from Facility with a chief complaint of failure to thrive per EMS report. Pt is currently nonverbal, lethargic therefore unable to obtain history from the patient.    Called family member listed in chart, to obtain further history. At baseline, pt is perky, sits outside of her room and talks to the residents. She does not ambulate and uses a wheelchair at the facility. She reports the patient was diagnosed with COVID approximately two weeks ago and is supposed to be out of isolation now. She continued to be weak and was informed that the patient had pneumonia due to aspiration and the Facility wanted to start antibiotics. She states the Facility originally informed her that she was getting better and eating, however on 1/29, she was informed that she was pocketing food which progressed significantly to complete cessation of eating/drinking. She states the facility discussed initiation of a feeding tube and the guardian declined, stating it is too risky with her being on anticoagulation. She continued to decline in regards to PO status and informed today that she will go to the ED.
p/vax pt devel an inj site rxn characterized by pain, swelling, warmth, & redness;pt recovered;
Red ?rash? around injection site about 2? in diameter. Sore to the touch and  slightly swollen/firm. Began about 6 days after injection was received and still present several days after that. No treatment given.
Headache; runny nose; cough; sore throat; This is a spontaneous report from a contactable consumer. This consumer reported that a 20-year-old non-pregnant female patient received bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot Number: EP6955), dose 2 intramuscular, administered in Arm Left on 16Apr2021 (Age 20-year-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical Vaccine included bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot Number: EP6955), dose 1 intramuscular, administered in Arm Left on 26Mar2021 (Age 20-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not diagnosed with COVID-19, prior to vaccination. The patient not been tested for COVID-19 Since the vaccination. There were no known allergies. Facility included a clinic the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications were not received within 2 weeks of vaccination. The patient experienced headache, runny nose, cough, and sore throat on 16Aug2021. No treatment was received for the events headache, runny nose, cough, and sore throat. The outcome of the events was reported as recovering.
Extreme fatigue, generalized pain, feverish without fever and chills that lasted about 24 hours. Has not occurred previously, but pt received co-administered pneumococcal + influenza while on Hep C treatment.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 10-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (lot # L011079, expiration date 01-OCT-2016, dose, dose# and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
DIZZINESS; FATIGUE; SORE ARM; This spontaneous report received from a patient concerned a 64 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 06-APR-2021, and had not recovered from fatigue, and dizziness. This report was non-serious.
swelling at the site; redness at the site; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: EU9899), via an unspecified route of administration in the left arm on 30Dec2020 at 15:00 as a single dose for COVID-19 immunisation. Medical history included anemia, diabetes mellitus, blood cholesterol abnormal, blood pressure abnormal, and low FE. The patient had no additional vaccine/s administered on the same date as BNT162B2, had no prior vaccinations within four weeks, and had no family medical history. Concomitant medications included liraglutide (VICTOZA; taking for 8 years), labetalol (taking for 20 years), diltiazem (CD taking 20 years), valsartan (DIOVAN; taking for 20 years), rosuvastatin (taking for 10 years), metformin (taking for 20 years), aspirin [acetylsalicylic acid] (taking for 10 years), and iron; all are ongoing. On 30Dec2020, the patient experienced swelling at the site and redness at the site. The patient stated that after the first dose, she noticed a little bit of swelling and redness at the site that went away in 48 hours. She had no relevant tests done. The events did not require any visit to a physician or to the ER. Outcome of the events was recovered.
This spontaneous report as received from a doctor pharmacy refers to a 74 years old female patient with iodine allergy and no pertinent medical history who on 28-AUG-2012, was vaccinated IM with 0.5 ml dose of PNEUMOVAX 23 (lot # 672752/1786AA, exp 08-SEP-2012). There was no concomitant medication. The pharmacist stated that 28-AUG-2012 the patient immediately experienced swelling which was described as "a 2 inch lump". There was no treatment given. At the time of the report, the patient had not recovered. The relatedness for swelling which was described as "a 2 inch lump" is unknown for PNEUMOVAX 23. Additional information has been requested.
Patient came in to get second Moderna dose but was given Pfizer covid vaccine by mistake. Patient was told immediately about the error.  Pharmacist contacted Health and Wellness Manager and Moderna for guidance.
her plantar fasciitis flared for several hours; Patient had fallen on her shoulder,The shoulder then "froze"; adhesive capsulitis, brought on by the vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; Manufacturer unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: PLANTAR FASCIITIS (non-serious), outcome "recovered", described as "her plantar fasciitis flared for several hours"; LIMB INJURY (non-serious), outcome "unknown", described as "Patient had fallen on her shoulder,The shoulder then "froze""; PERIARTHRITIS (non-serious), outcome "unknown", described as "adhesive capsulitis, brought on by the vaccination". The events "her plantar fasciitis flared for several hours", "patient had fallen on her shoulder,the shoulder then "froze"" and "adhesive capsulitis, brought on by the vaccination" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of plantar fasciitis, limb injury, periarthritis.  Additional information: It was reported that 6 months post 3rd Pfizer-Biontech COVID-19 vaccine, the patient received a 4th vaccination. Events occurred after the 4th vaccination. 3 hours after receiving the 4th vaccination, her plantar fasciitis flared for several hours then resolved. Patient had fallen on her shoulder 6 weeks prior to receiving the 4th vaccination. The vaccination was given in the shoulder on which she had fallen. The shoulder then froze. Diagnosis from her physician, post MRI, was adhesive capsulitis, brought on by the vaccination. The physician was not concerned and said he had been seeing reactions to the vaccine that are focused on the shoulder and back of patients. This patient was treated with a cortisone shot. The patient did not received any other vaccine in four weeks. No other medication in two weeks. No COVID prior vaccination and not tested for COVID post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This literature marketed report as received from a physician refers to 2 patients of unknown demography. The patient's current condition included STAT3 deficient hyper IgE syndrome. On an unknown date, the 2 patients were vaccinated with PNEUMOVAX 23. On an unknown date, the 2 patients experienced pneumonia and were hospitalized within 24 hours. The outcome of the event was unknown. The reporter assessed the causality of the event to be related to the suspect therapy. The event pneumonia was considered as serious due to hospitalization. This case is linked to case # 1502USA008319 and case # 1502USA008320 (same literature link). Additional information is expected.
Headache, Arthralgia, Fever, FATIGUE, PAIN/SWELLING INJ SITE Narrative:
stroke; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient).  A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported, expiration date not provided) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced stroke on 13Apr2021. The outcome of the event was unknown. Clinical course: the patient received a Pfizer covid vaccine in April a week later l had a stroke, he talked to someone at Pfizer the other day but didn't have all the information on hand, the reference # was withheld. The date of the first shot was 01Apr2021, the information from the card reads Pfizer 01Apr2021 withheld. He had the stroke on 13Apr2021 and was taken to the ER (emergency room) at (withheld) Medical Center. The doctor didn't know if the vaccine caused the stroke or if it was a coincidence. He wanted someone to be ware. He wasn't sure where else to turn to. Doctor recommended not getting the 2nd shot. He was wondering if any others have had the same issue.   Information on the Lot/Batch number has been requested.