chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning an adult male with an allergy to digoxin (LANOXIN) who on 11/22/02 was vaccinated IM in the left arm with his first dose of pneumococcal vaccine 23 polyvalent (lot # 643782/0675M). There were no concomitant medications. It was reported that the patient was well at the time of the visit. On the evening of 11/22/02, the patient's whole arm from his deltoid down to his fingers developed redness, tenderness, stiffness, and swelling. The patient was directed by the doctor to go to an emergency room where he was given IV and oral antibiotics, Indocin and Augmentin, and released. By 11/24/02, the patient's symptoms worsened and the patient was hospitalized and treated with IV antibiotics and warm compresses. He was discharged from the hospital on 11/27/02. The doctor reported that the patient is afebrile and WBC are normal. The reporter expressed concern regarding the lot number 643782-0675M. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested. The follow up received on 12/19/02 states on the evening of 11/22/02, the pt's whole left arm from his deltoid down to his fingers developed redness, tenderness, stiffness, warmth, and swelling. The pt was directed by the doctor to go to an ER where he was treated with warm compresses and given IV indomethacin. He was then sent home on Augmentin. By 11/24/02, the pt's symptoms worsened with marked warmth and redness from the deltoid to the ower forearm area. Upon physical examination, the report indicated that the male was in mild distress when seen. It was reported that his vital signs were stable and he was afebrile, head, eyes, ears, nose and throat were normal, lungs were clear, cardiac was regular, and his abdomen was soft and nontender. The examination also noted his left arm to be warm, red and tender fromt eh deltoid area down to the lower forearm with normal strength and reflex sensation. It was reported that he had no loss of strength or numbness, no fever, no chills, no chest pain, and no SOB. The pt was hospitalized and treated with Unasyn. It was reported that he had slow progressive improvement. Swelling,warmth, and redness improved dramatically. He had no further complication during the hospital stay. Lab data indicated that electrolytes, BUN, creatinine, calcium, CBC with differential, and glucose were all normal. He was discharged from the hospital to home on 11/27/02 on seven additional days of Augmentin 875mg bid, and to follow up in 7-10 days in the office. It was reported that the pt did recover. At the time of discharge, final diagnoses were "cellulitis, left arm atherosclerotic heart disease, chronic atrial fibrillation." Artherosclerotic heart disease and chronic atrial fibrillation were considered to be incidental findings. No further info is expected.
Shot received 0900 on 11/18/08 during NOC of 11/18/08 had chills, severe convulsions and arm so sore couldn't use - really nauseous, also all NOC long. 11/19/08 felt flulike all day and 11/20/08.
Since first vaccine, sore glands on and off, still here.  Second vaccine site is swollen, hot, slightly pink/rashy.  In front of bicep, also pink/rashy and swollen.  (Site is high on arm.)
So I started having symptoms on 7/4/22 with a scratchy throat, dry cough, and fatigued.  I tested by home test for COVID-19 on 7/5/22 and was positive.  I did a virtual health consultation and was prescribed Paxlovid for treatment and instructed to stop taking my cholesterol medication while on the anti-viral.  I would say I was sick about 5 days.  I did not take the prescription of Paxlovid due to the physician telling me I might lose my sense of taste but I did get the prescription filled.
asthma/hard time breathing; Fever; aches; chills; headache; asthma/hard time breathing; This is a spontaneous report from a contactable consumer (Patient) or other non hcp.   A 12-years-old non pregnant female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EP6955), dose 2 via an unspecified route of administration, administered in Arm Left on 16Jun2021 16:00 as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included asthma. Concomitant medications included fluticasone propionate (FLOVENT); albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) as needed and Multivitamin. No relevant past drug history. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not tested for COVID-19. On 17Jun2021 morning the patient had Fever, aches, chills, headache, and asthma/hard time breathing. The outcome for all events was recovered on 19Jun2021.  Follow-up attempts are possible. Further information is expected.
On February 8th I started feeling feverish and started having a sore throat and the next day it got worse. The next day I went to urgent care and was tested for RSV, COVID-19 and the flu. I was negative for all three then I lost my voice, and I had a nasal infection and I had discharge. That lasted for about 10 days, then the symptoms aviated, and I had postnasal drip that lasted for about 2 + weeks. I took over the counter MUCINEX, FLONASE and ibuprofen. This all helped me sleep at night and all my nasal passages were blocked at night without this medication.
Child fainted approx 5 minutes after receiving immunizations. Had 10-15 second episode of jerking of extremities; was then alert. Complained of headache ("whole head"). Observed 30 min. Phone call to home in 1/2 hour. Napped for 20 min and was okay then with no headache or any other signs/symptoms.
Experiencing muscle weakness in my proximal muscles severe enough to be in a wheelchair.  The symptoms began three days after my vaccination.  I had COVID-19 (diagnosed Feb. 1st, 2021) and 3 days after my COVID symptoms went away, I had severe weakness in my proximal muscles which put me in a wheel chair for 4 weeks. I was diagnosed as a "long hauler" with Post-Covid syndrome.  I had just started walking again on Monday, March 15, 2021 and my vaccine was Friday,  March 19, 2021.  I asked my neurologist prior to the vaccine if he thought it was safe for me.  He assured me that it was.  I started experiencing muscle weakness again 3 days after vaccination, which coincidentally, was the same time frame that I experienced these same symptoms post COVID.  It appears the vaccine caused a relapse of post-COVID syndrome.
Patient c/o dry cough, left sided headache, since returing  in may. was seen in ER on 5/17. COVID test neg. symptoms improved and patient received  I dose of COVID vaccine on 6/4 21. since then c/o constant left sided headache, left eye pain, on/off blurring of vision, severe dry cough. c/o  loss of vision in left eye, headaches and feeling "a lot of pressure" for about 3 weeks since receiving the vaccine, sees 2 spots in the left eye that got larger than before. Had 4 episodes of vision in left eye only going black for several seconds, then when vision comes back it is "no good" for 20-30 minutes, last occurrence was 10 days ago. Pt also felt dizzy. patient has a history of stroke.  After multiple provider and specialist visits patient was diagnosed with iritis and transient vision loss. Patient received second dose of vaccine on 06/27/21  (both at pharmacy) and reported return of symptoms which resolved as reported on their 06/30/21 follow up with PCP and vision specialist.
Poisoned booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (165141). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) 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 completed., MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: TOXICITY TO VARIOUS AGENTS (non-serious), outcome "unknown", described as "Poisoned booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4 days of progressive rt supraclavicular tenderness. LAH about 2 X 3 cm firm tender LN (positive mobile) smallpox vaccine given in rt deltoid region. Negative axillary or other evidence of systemic diagnosis or neoplasia by history of exam. Observation at this time with HSAID.
Vaccine administered on 8/4/03. On the evening of 8/5/ he experienced "clamminess" and lightheadedness. On 8/6/ he experienced lightheadedness and a headache and he stayed home from work. He felt fully recovered on 8/7/03.
pt recv vax & had an unspecified adverse exp;no further info was abailable @ the dat eof this report;
hurts a little bit; it's hard to lift her arm; "Feels like she was exercising and did too much"; Inject site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (hurts a little bit), VACCINATION SITE PAIN (Inject site pain), VACCINATION SITE INDURATION (it's hard to lift her arm) and MYALGIA ("Feels like she was exercising and did too much") in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018821A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (Inject site pain). On 25-Mar-2021, the patient experienced PAIN (hurts a little bit), VACCINATION SITE INDURATION (it's hard to lift her arm) and MYALGIA ("Feels like she was exercising and did too much"). At the time of the report, PAIN (hurts a little bit), VACCINATION SITE PAIN (Inject site pain), VACCINATION SITE INDURATION (it's hard to lift her arm) and MYALGIA ("Feels like she was exercising and did too much") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported  No treatment information was provided
I experienced vertigo while taking an out door walk.  This caused me to fall down and subsequently spraining my right wrist.  The vertigo lasted only a few seconds,  but long enough for me to lose my balance completely.  I had treatment for the sprain, but none for the vertigo.
pt recv vax OCT97 & pt was reportedly febrile;pt was 1 of 2 people vaccinated from the same household both of whom were dx w/Duchenne type muscular dystrophy;both pt suffered from chronic fevers of unk origin;pt hosp & expired;
Patient received dose 1 (4/3/21) and 2 (5/1/21), patient admitted to Hospital, positive COVID on 9/12/21
Health Department informed up we had an excursion with our refrigerator and that our vaccine was nonviable at the time.
Patient experienced muscle and joint ache, weakness, and extreme fatigue approximately 12 hours after receiving both doses of the vaccine.  Her symptoms improved within 24 hours after the first dose and 48 hours after the second dose.  Patient took Tylenol and had to miss work due to the severity of her symptoms.
blood clots; Stroke; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots) and CEREBROVASCULAR ACCIDENT (Stroke) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced THROMBOSIS (blood clots) (seriousness criteria death and medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria death and medically significant). The patient died in 2021. The reported cause of death was blood clots and Stroke. It is unknown if an autopsy was performed.            No concomitant medication was reported.  Reporter stated that his/her brother died suddenly in 2021 after the Moderna vaccine from blood clots. His/her brother had a stroke.  No treatment information was provided.  Company comment: This spontaneous case concerns a male patient of unknown age with no medical history reported, who experienced serious (death and medically significant) unexpected AESIs of thrombosis and cerebrovascular accident, that occurred  after the dose of the mRNA-1273.  The exact dose number and onset latency were not provided. Patient's sibling reported that the patient passed away due to blood clots and had a stroke. No further details were provided. It was not reported whether an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-695227.; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no medical history reported, who experienced serious (death and medically significant) unexpected AESIs of thrombosis and cerebrovascular accident, that occurred  after the dose of the mRNA-1273.  The exact dose number and onset latency were not provided. Patient's sibling reported that the patient passed away due to blood clots and had a stroke. No further details were provided. It was not reported whether an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2023-695227:1st brother's case; Reported Cause(s) of Death: blood clots; stroke
extreme tiredness, sweats Narrative: Employee referred to PCP if sx worsen or persist. Empl. agreed with plan
While I was in bed I had to pee so I tried to get up but I could'nt! I kept trying to get up until I ended up on the floor.  I laid on the floor for a while until I had help to get me up. This lasted a few days where I could not get up by myself.
Awoke at 0500 with lower back ache assuming it was associated with flu like symptoms.  Had my usual two ups of coffee and small orange juice.  Took my meds at approx 0730 with small glass of water.   From 0800 until 1030 I had frequent visits to the bathroom to urinate. My backpain was more associated with my Kidneys as the frequent urinating was causing mild pain.  After 1030 I had one at aprox 1230 and did not pass any urine until aprox 1830 that evening.  I did hydrate with water during that time.  After 1830 I had no issues.
Stroke-like symptoms experienced, numbness on side of body vaccine was administrated (right side) within 30 minutes of vaccine. Drooping of eye and mouth. Dizziness. Migraine-like headache. Could only speak out of left side of mouth. Uncontrollable lip licking. Some tearing and drooling. Confusion and difficulty speaking.
pt recv vax; T of 103 x 2 days; glands swollen ; red throat;
An expired dose of Fluzone quadrivalent was administered to the patient, no AE; Initial information was received on 28-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a patient (gender unspecified) who was given an expired dose of QUADRIVALENT INFLUENZA VACCINE (INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED) (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. The patient received no other vaccines.   On 28-Aug-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number not reported, expiry date: 30-06- 2020) once via intramuscular route in the arm NOS for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  At the time of report, the patient had no adverse event.  Lab data, corrective treatment and outcome: not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on lot number.
This spontaneous report was received from a medical assistant refers to a currently 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. The patient's concomitant medications included DILUENT MRK INJ lot# L040453 expiration date 17-MAY-2018. On an unspecified date, the patient was vaccinated with improperly stored dose of Oka-Merck PROQUAD injection, subcutaneously, lot # N014758, and expiration date 08-NOV-2018, route not specified, for prophylaxis (dose number and anatomical location were not provided). The vaccine experienced a temperature excursion in the range between 6°F to 14°F during 36 hours as recorded by a data logger. Also, the vaccines had a previous temperature excursions in the range between 6°F to 14°F during 24 hours. There was no adverse effect reported. No further information was available. This is one of the three reports received from the same reporter. Sender's Comments: US-009507513-1804USA006354: US-009507513-1804USA002530.
fever; Chills; Nausea; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included COVID-19 (Fisrt week of January 2021). Concurrent medical conditions included Kidney stone. Concomitant products included HYDROCODONE from 16-Mar-2021 to an unknown date, CEFDINIR from 16-Mar-2021 to an unknown date, ANTIBIOTICS and ONDANSETRON from 16-Mar-2021 to an unknown date for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Feb-2021, PYREXIA (fever) and CHILLS (Chills) had resolved. On 27-Feb-2021, NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved. At the time of the report, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was taking blood pressure and cholesterol medications on regular basis
no adverse event; VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report as received from a registered nurse refers to a 14 month old patient of unknown gender. On 06-SEP-2022, the patient was vaccinated with an improper stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # W002601 exp date 24-JAN-2024). The temperature of excursion was 1 hour and 45 minutes and there was no previous temperature excursion. No additional adverse event was reported.
Pt recvd vax & exp t105, inject site deltoid rash noted to area-area firm & sore to touch; lt deltoid swollen & warm to touch; small reddish 3cm x 2cm mark over deltoid w/red margin;
The next day after receiving 2nd dose of SHINGRIX, patient reported having significant general malaise, excessive tiredness, sleeping more than usual, and some nausea during 24 hour period after receiving vaccination. Patient also reporting having significant soreness in arm at injection site, not feeling hungry, not eating as usual. Patient did say symptoms improved significantly the next day (48 hours after vaccination). Patient also stated that reaction/symptoms after receiving 2nd dose of SHINGRIX seemed much worse than after receiving 1st dose of SHINGRIX.
Pain in groin, right side. X-ray showed arthritis of right hip joint.  No symptoms prior to this event
within 5 minutes post-vaccination, client lost consciousness.  Was awakened with ammonia salts placed under the nares, within 30 seconds.  911 phoned, child taken to hospital.  Was released in approx 2 hours after observation.  Late entry: client did fall and hit L side of head on floor.
11 days p/vax fever unquantified; 13 days p/vax swelling from lt ear under jaw hard large swelling prob lt parotitis;
REPORT FROM MOTHER STATES CHILD HAD CLONIC TYPE SEIZURES WHICH LASTED A REW SECONDS.  DUE TO OTHER MEDICAL PROBLEMS, MD REFERRED CHILD TO NEUROLOGIST.  MD CALLED DISTRICT OFFICE.
Do not know date and time of event--pt reported symptoms started approximately 4 days prior to admission to hospital on 12/20/2012  symptoms: back and neck pain, generalized weakness, numbness, shortness of breath, difficulty swallowing--> diagnosed with Guillain Barre syndrome with respiratory failure requiring mechanical ventilation/tracheostomy, prolonged rehabilitation.
Pain on back started April 18th followed by a painful rash on back and around right side (upper trunk). Diagnosed by oncology provider on April 22nd with shingles (herpes zoster) and started on valtrex. Immunotherapy (atezolizumab) given on January 11th, February 1st and 22nd, March 22nd and April 12 (maintenance therapy). Completed consolidation radiation end Nov and completed carbo/etoposide/atezolizumab x 6 cycles end of October. Patient is in remission per last PET/CT two weeks ago, continues on maintenance immunotherapy. Patient had shingles vaccine in 2015.
PATIENT DESCRIBES FEVER AND ITCHINESS WITH BLISTERING ON UPPER AND LOWER EXTREMITIES AND NECK FOLLOWING VACCINE
Arm pain begain same night of injection; Next day had fever, body aches, chills, stuffy nose, tiredness; third day a light rash/hives appeared on chest but all other symptoms disappeard  Took tylenol and  generic sudafed on day 2, hydroxyzine on day 3
Localized swelling, redness that wrapped around the arm starting at injection site.  Body aches that started the next day.  Generalized itching that lasted 2 days.
Fever of 103.9 all day Sunday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 26-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 17:30 as dose 4 (booster), single (Lot number: GJ6665) at the age of 26 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LAMICTAL; CLONIDINE. 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; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 09Oct2022 at 00:30, outcome "not recovered", described as "Fever of 103.9 all day Sunday". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia. Additional information: Fever of 103.9 all day Sunday, did respond to Tylenol and Advil but spiked again 4-6 hours later. No covid prior vaccination. Not covid tested post vaccination. No known allergies.  Follow-up attempts are completed. No further information is expected.
grandma noticed 3 days p/vax pt refused to bear weight on lt leg; also cried when lt leg was moved or touched in certain ways;