chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 58 year old female with PMH of hypothyroidism, HTN, lyme disease and rectal bleeding s/p polyps and hemorrhoids who presents with c/o chest pressure. Patient states that she had chest tightness and intermittent sharp substernal pain. Patient is unable to score the pain on a scale of 1-10 but describes it as "annoying". As per patient, she ate some cheese on Christmas eve and thought that may be he cause. The patient did an at home test for Covid Christmas eve and it was negative. Yesterday the patient developed dizziness associated with the chest tightness and took another at home Covid test but this one was positive. Patient is fully vaccinated with Pfizer including the booster. Patient denies nausea, vomiting and shortness of breath.
48hr p/vax T103-104 relieved by APAP q 3hr;anorexia, lethargy, gastric distress;72-96hr p/vax T decreased to 100-101 w/o APAP;red rash over trunk front & back no itching;appetite inc still not feeling well;
facial swelling; unspecified allergy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (facial swelling) and HYPERSENSITIVITY (unspecified allergy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced SWELLING FACE (facial swelling) and HYPERSENSITIVITY (unspecified allergy). The patient was treated with PREDNISONE at a dose of used for 5 days and DEXAMETHASONE on 26-Mar-2021 at a dose of 1 dosage form. At the time of the report, SWELLING FACE (facial swelling) and HYPERSENSITIVITY (unspecified allergy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication information not provided.
Faint pin point reddish spots on shoulder and legs, (petechiae on arms and legs).
pt recvd vax 13DEC95 & evening 19DEC95 states noticed redness in area of inj, w/some muscle tenderness & itching;20DEC95 @ clinic below area of inj an area of redness 1 1/2" x 3 1/2" & an area of hardness 1 1/2" x 2 1/2";heat;cellulitis
Legs swollen where injection administered, raised red lump about an inch long and half a centimeter high.  Madison was acting fussy and cranky, like she wasn't feeling well and in slight discomfort.  We gave her baby Tylenol a couple times.
7/15/22 Noticed she started needing her allergy medicine more frequently than normal. About another month later, I began giving her Flonase to help with her symptoms and as needed cough and cold medicine. Her symptoms were a lot worse than they used to be. About a month ago, we had an appointment with an Allergy Specialist. He went over her symptoms, did allergy tests and changed her medicines. He put her on hydroxyzine and increased her Flonase to the maximum dose. A few weeks later he gave her a prescription for a steroid for a few days.  She is a little bit better now, but still not back at base line.
Arm has a dull, aching, annoying pain that I can't describe. This eventually resulted in my arm cracking and in excruciating pain during the day and especially at night when sleeping.
Information has been received from a Certificate Medical Assistant (CMA) and registered nurse (RN) regarding a patient of an unknown age and gender. The RN stated that on 12-AUG-2013, the patient received a dose of PROQUAD (lot number: J001052, expiration date 28-JUL-2014)(dose and route were not reported) that had been improperly stored. The R.N. stated that the patient had not experienced adverse effects. No additional details had been provided at that time. This is one of several reports form the same soruce (other MARRS #s 1308USA013854, 1309USA013043 and 1309USA013044). Additional information is not expected.
Itching that has lasted for 2 1/2 and months with bruising.  The vaccine has left a long white scar.
swollen, red and itchy at vaccine site a week after vaccine about an inch and a half in diameter.
This spontaneous report was received from the patient´s mother regarding her son, an approximately 1-year-old male patient. It was reported that the patient had no concomitant medication, pertinent medical history or drug reactions/allergies. On an unspecified date in 2014, the patient received the first dose of M-M-R II in his thigh for prophylaxis (dose, route, therapy type, lot number and expiration were unknown by the reporter). Regarding the indication for the vaccine, it was reported that it was because: "she didn't know the truth about vaccinations". On an unspecified date in 2014, one day after the vaccination, the patient developed encephalitis. It was reported that the patient sought medical attention and receive treatment for the event, however, no laboratory diagnostics or studies were performed. At the time of reporting the patient had not recovered from the encephalitis. There was no causality assessment provided between M-M-R II and the encephalitis. This is one of two reports from the same reporter (Information captured in MARRS case # 1904USA006023). Upon internal review, the encephalitis was considered to be a medically significant event. Sender's Comments: US-009507513-1904USA006023.
Received shots 3/9/12 and 1 1/2 hours later, pt developed 104 fever, achy joints & was sleepy x2 days but still tired. Had slight cough before shots & still has it. Fever gone. On 3/14/12 broke out with rash on hands - Dx Hand Foot Mouth.
Narrative: Patient developed headache following  administration of second dose of Pfizer covid vaccine. No treatment initiated.
Burning sensation in chest within 5 ministers of receiving immunization. Continued for 4 hours. 3 hours into symptoms, treated with Zyrtec and proposed. Symptoms resolved 1 hour after treatment.
The patient received the FLUZONE HD vaccine on 9/23/17. On 11/7/17 she came to the pharmacy and reported that she has had continuous muscle soreness in her left deltoid since the vaccine was given and that she has difficulty raising her arm.
On Thursday, December 22, 2022, I had a sore throat, cough, and congestion. I consulted on online doctor who gave some advice but did not provide medication. The symptoms worsened through December 25th and 26th to included headache and fatigue. I went to urgent care on December 26, 2022. The provider administered a COVID-19 test. The result was negative. I was diagnosed with an ear infection, a sinus infection, and conjunctivitis. The cough and congestion continued until about January 5 or 6, 2023. Minor sinus symptoms continued through January 12, 2023.
He got his tetanus vaccine, all of his muscle in his whole body hurt.  At nighttime his legs are really bad, he has to put a pillow under his knees, but it's all of his muscles including his jaw.  It hurts to close his mouth.  He called his doctor and he told him to take Excedrin, which does not do anything.  The symptoms have not improved any, it just stays the same.  If it was not his whole body he would not be concerned, but it is and he's concerned about it.  It's none of the symptoms that are typical of the vaccine.
redness & swelling noted @ inj site on 21FEB96;painful to touch;no fever;Ibuprofen & DPH cream;
Arm and back muscle spasm/pain; Arm and back muscle spasm/pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Arm and back muscle spasm/pain) and PAIN IN EXTREMITY (Arm and back muscle spasm/pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Arm and back muscle spasm/pain) and PAIN IN EXTREMITY (Arm and back muscle spasm/pain). At the time of the report, MUSCLE SPASMS (Arm and back muscle spasm/pain) and PAIN IN EXTREMITY (Arm and back muscle spasm/pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
pt recvd vax 6DEC93 & noted pimple @ site; 10DEC93 progressed to painful induration; eval by MD 22DEC93 dx localized cellulitis;
Within 30" of vaccines had itching, by 1 hour after vaccines developed hives over chest abd. & extremities. right vesicle x 1 clear & mucousy ->911 called & Benadryl given by mouth after v'd by Medics -> to ER -> hives subsiding. No subsequent v.
Developed a heated very warm sensation in my chest. This sensation came back a few times within the hour that I was being monitored. Was given 5 mg Benadryl .
5days p/vax pt c/o lt arm soreness, swelling & redness @ inject site, sz of golfball. by 6/21 there was pus at site, 6/23, elevated temp. 6/25 site of inject oozing blood in addition to pus. 6/30 bleeding/discharge stopped,  still swollen.
Little reaction to the first 2 shots of Moderna vaccine; Lethargy; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Little reaction to the first 2 shots of Moderna vaccine), LETHARGY (Lethargy) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 VACCINATION COMPLICATION (Little reaction to the first 2 shots of Moderna vaccine), LETHARGY (Lethargy) and FATIGUE (Tiredness). At the time of the report, VACCINATION COMPLICATION (Little reaction to the first 2 shots of Moderna vaccine), LETHARGY (Lethargy) and FATIGUE (Tiredness) outcome was unknown.            No Concomitant medication reported. No Treatment medication reported.   This case was linked to MOD-2021-320916.
HEADACHE; LOW GRADE FEVER; ITCHING AT INJECTION SITE; This spontaneous report received from a patient concerned a 55 year old female. 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, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced itching at injection site. On 11-APR-2021, the subject experienced low grade fever. On 16-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching at injection site, and low grade fever on 12-APR-2021, and had not recovered from headache. This report was non-serious.
This pt reports that on the day that the vaccination test were administered she had the following symptoms: headache at approx 5:00PM (3 hrs after vaccination test), shortness of breath at approx 7:00PM (5 hrs after vaccination test). Pt went to the ER.  Pt reports that in the approx 3-4 hrs all symptoms resolved.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: About 10 minutes after receiving the J&J vaccine, patient started to feel lightheaded and clammy. NP at patient's side, helped her to lay on the ground and elevated legs on a chair. After about 5 minutes patient reported feeling much better, drank water and felt normal again. She reports this happened to her in the past with flu vaccine.
after recv vax pt exp a disseminated rash over entire body & diarrhea.
24 Hours after  - completely dibilitating     lasted for 2 days. gradual recover to being able to somewhat function  but still  dizziness - vertigo  -    always a little bit    but massive if moving head rapidly,
Patient developed pruritus and diffuse urticaria within 30 minutes of vaccine administration.  Benadryl / ATAVAX was administered / presented.
Patient got SHINGLES, post vaccine. Patient is young 29 year old female with healthy immune system.
Temperature was 97.7 after patient got her injection; she fell into a seizure and fainted complaining of headache,  and throat swelling; Patient was sent to the ER by the physician.
local pain at the vaccine location; Tiredness/fatigue; This is a spontaneous report from a contactable consumer (patient).  A 66-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, lot/batch number: EL9262) , via an unspecified route of administration on the right arm on 20Jan2021 17:15 at SINGLE DOSE for COVID-19 immunization.  Medical history included blood pressure abnormal (reported as BP).  Concomitant medication included amlodipine (AMLODIPINE) for unknown indication and unspecified BP medication. On 21Jan2021 06:00, the patient experienced local pain at the vaccine location and tiredness/fatigue and recovered in Jan2021.  The patient did not receive treatment for the event.  The patient was not diagnosed with COVID-19 prior and not tested since vaccination.
Started feeling achy with chills around 7:00 pm the same day I received the shot.  The symptoms lasted through the night and into the next day until approximately 3:00 pm. I was extremely fatigued all through the day, and part of the 2nd day after receiving the vaccine. The symptoms became less acute; finally going away by 9:00 pm on December 7th. The next morning  (December 8th)I still felt a bit foggy in my head.
FLUBLOK QIV was administered to patient post excursion with no reported adverse event; Initial information received on 15-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 68 years old female patient to whom administered the Influenza Quadrivalent Recombinant Vaccine [Flublok Qiv] after post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Sep-2023, the patient received a dose of 0.5 ml of suspect Influenza Quadrivalent Recombinant Vaccine after excursion(strength: standard, frequency: once, expiry date: 31-May-2025 and lot U8058BA) via intramuscular route in the deltoid nos as immunization (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.; Sender's Comments:  US-SA-2023SA284375:
patient came to pharmacy on 10/17/19 complaining her arm which she was vaccinated in (left) still hurt (ache, no tingling, no burning, no numbness). She has noticed it hurts so bad she is "babying" it. She is feeling the pain mainly from elbow up and sometimes the entire arm from shoulder to wrist. She has not been seen by MD yet.
This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (on her forehead). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, fever, forehead swelling and red face. On an unknown date, the outcome of the injection site swelling, injection site erythema, fever, forehead swelling and red face were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema, fever, forehead swelling and red face to be related to SHINGRIX. Additional details were provided as follows: The patient's initials and date of birth were unknown. The age at vaccination was not reported. The patient also had swelling and redness on her forehead where she previously had shingles in the past. The symptoms lasted for a couple of days. The reporter agreed for follow up contact.
Developed low grade fever of 98.9 approximately at 4:00 PM on 2/16/2021. Developed slight case of chills  at the same time. No prior issues on 2/15/2021 post injection or in the  following morning on 2/16/2021.  I am taking Tylenol and sugar free water and vita water to stay hydrated.
Patient presented to Emergency department on 8/10/2021, four days after vaccination, with increased pain, redness, and swelling over the left deltoid where she reports she received her COVID vaccine.  She also reported nausea, dizziness and body aches.  ED provider assessed the patient and diagnosed her with cellulitis at the vaccination site.  Patient was provided with a prescription for Keflex and Zofran.
A non-serious Spontaneous report of "patients over 49 years of age received a dose of H1N1 LAIV" was received from a Consumer/non-health professional concerning a 59-year-old Female. The relevant medical history has not been reported for this Patient. On 23-Nov-2009, the Patient received 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.
patients received the Moderna vaccine which isn't approved for these patients' ages (<18); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patients received the Moderna vaccine which isn't approved for these patients' ages (<18)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patients received the Moderna vaccine which isn't approved for these patients' ages (<18)). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patients received the Moderna vaccine which isn't approved for these patients' ages (<18)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up received does not contain new information.
Pt called pharmacy and reported swollen axilla, "red line" from site of injection pain in and around injection site. Recommended pt see her physician.
Presented with complaint of nuasea, vomiting and weakness on 1/12. COVID-19 +. No respiratory distress. Treated for UTI with + urine culture . Followed by nephrology and transplant services. Started bicarb drip for acidosis.  By 1/16  was requiring 4L O2 and had coffe-gound emesis and melanotic stool. Concerned for possible COVID versus aspiration pneumonia.  Consult with GI service for GI bleed. Started on dexamethasone. Deteriorated gradually with worsening mental status and increasing oxygen requirements. Develop apical pneumothoarax and pneumomediastinum. Discussed wih family and decided on comfort care.
Got shot, got shingles/suspected vaccination failure; Since October gave me; Burning, still burning; Pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shot, got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Since October gave me), burning sensation (Verbatim: Burning, still burning) and pain (Verbatim: Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the burning sensation and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, burning sensation and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 12-APR-2023 The case  was received from the patient via interactive digital media. The patient stated that this disease was terrible nothing compared to the burning and pain, the vaccine was nothing since October gave me and still had that burning on the skin. No contact details were provided. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown demography. Patients concurrent conditions and relevant medical history was not reported. On an unknown dates, unspecified number of patients were vaccinated with unspecified number of doses of GARDASIL (lot number, dose and frequency unspecified) intramuscularly for prophylaxis at intervals other than the recommended intervals in the prescribing information. Concomitant medications were not reported. No adverse effects were reported for any of the unspecified patients. The outcome of the events were unknown. The causality of the events with GARDASIL was not involved. This case is linked to # 1506USA004662 via same reporter link. Additional information has been requested.
Patient describes a stiffness/soreness (similar to muscle strain) from collar bone area to upper shoulder. Patient describes soreness especially with stretching arm behind his back.
Two week after 2nd dose started feeling light headed an sick to my stomach. Started high blood pressure about April 2021 with hard time breathing, not sleeping loss of appetite, fatigue and weakness, sweating & anxiety, went to hospital 6/13/21 and diagnosed with heart failer
PT FELT FAINT AND SHAKY AND STATED THAT HIS VISION WAS VIBRATING. HAD THE PATIENT RECLINE AND ELEVATE HIS FEET APPLIED COLD PACKS TO THE BACK OF HIS NECK AND WRISTS HAD HIM SIP SOME WATER.
Severe vertigo 4 hours after shot and continuing 72 hours now.  No improvement.  Heart palpitations.  Chills (expected).  Treatment - lots of water and benadryl.  No relief.