chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given 1 dose of FLUZONE QUAD PF 2018-19 Pre-filled syringe at approximately 10:56AM and told to stay around store for 20 mins. At approximately 11:15, patient came back to pharmacy stating that she had an "itchy spot" at the back of her throat and felt "lethargic". I verified that patient did not have any pain or residual reaction at site of injection, itchiness moving throughout body/extremities, swelling, or trouble breathing/constriction of airway. Patient has not had flu shot since age 14 and did not remember any reaction. After confirming with patient she felt in normal state of mind and was not having current severe issues breathing. I gave her 50MG dose (2 x 25MG tabs) diphenhydramine per standing order. I sat with patient and made sure she maintained consciousness, awareness, and normal ability to function and kept her in conversation. I discussed with patient that emergency medical help can be coordinated if patient feels severe reaction or symptoms that may lead to anaphylaxis. Patient denied need for EMT or EMS and wanted to sit and continue to recoup. I re-evaluated patient status every 2 to 3 mins to ensure she was feeling ok and to determine next treatment step per standing order. After 10 mins after initial dose, patient stated "itchiness" felt slightly better and was not getting worse, but feeling still bothersome. She described it as if something were "stuck on back of throat". I verified breathing felt normal and no swelling, tingling, or itchiness was spreading throughout body or extremities to which she denied. I gave her another dose of 50MG diphenhydramine (2 x 25MG tablets) as it seemed to slightly alleviate described "itchiness" and may do more to ensure potentially severe reaction does not escalate. Patient requested to go to bathroom at approximately 11:40AM to which I confirmed that she felt better and could ambulate on her own. I offered a female associate to accompany her to the restroom, but she thought she was feeling better and could go on her own. She returned at approximately 11:44AM and confirmed that she felt better overall with itch, but still slightly lethargic. I sat with patient until approximately 11:52AM when patient's mom arrived as patient had contacted her. At this point, I continued to reevaluate patient status (every 2 to 3 mins) and confirmed that patient felt better overall and was comfortable leaving with mom to go home and rest. I gave patient my contact inform and told her and mom to call me that day to update me on status. I also tried calling patient's phone number at 2:45PM and left a voicemail to contact me as soon as possible to check status. As of this writing, I had not heard back from patient to current status. No epinephrine was administered. Amendment: 10/21/18 4:17PM I spoke with patient's mom and she is doing ok - sleepy from BENADRYL but no systemic reaction or further issues breathing.
This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. On 18-JUL-2017, the patient was vaccinated with an improperly storage dose of PNEUMOVAX 23 lot number m042324 with expiration date on 10-JUN-2018; lot number reported as "m044564" with expiration date on 22-OCT-2018 or lot number n001007 with expiration date on 09-SEP-2018 for prophylaxis. No adverse effects were reported. The doses of PNEUMOVAX 23 were exposed to a temperature of 47 Fahrenheit degrees (F) to 77 F for time frame of 1 hour 20 minutes. There were no previous temperature excursions. Digital data logger was involved. No symptoms reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1708USA002800.
RED ITCHY RASH SPREAD FROM INJECTION SITE, DOWN TO ELBOW AND UP THE SIDE OF THE NECK AND ONTO THE BACK SHOULDER. PATIENT HAD BEEN USING HYDROCORTISONE CREAM 1% TO RELIEVE ITCHING. PATIENT WAS INFORMED TO TRY BENADRYL CREAM ON THE RASH AND TAKE AN ANTI-HISTAMINE.
headache, nausea, vomiting, body aches, abdominal pain, sinus pressure, congestion, and insomnia
Developed severe muscular pain in right shoulder on 11/20/2021, that rapidly developed into severe nerve pain of varying qualities starting in right shoulder, and radiating down arm and into 4th and 5th fingers, and across right side of chest/collarbone.  Seen by PCP on 11/21/21. Referred to orthopedic.  Seen by orthopedic on 11/30/21. Diagnosed with brachial plexitis of the medial cord and thoracic outlet syndrome.   On 12/2/21 nerve pain progressed to muscle weakness. Unable to do any weight bearing with right arm or hand, or perform basic tasks without extreme pain and effort.  Seen by neurologist on 12/13/21. Referred to neuromuscular specialist.  Follow up with orthopedic on 12/30/21.
Patient presented on 10/4 at 9:00 AM with a large, softball sized red, itchy rash around injection site on R arm. Patient dosed with BENADRYL and given ice pack to use PRN and advised to seek medical attention if it worsened. Patient went to school, per my request, the nurse assessed him at 2:00 PM. The size of the reaction had decreased drastically, but was still red and slightly feverish;  the itching and other symptoms had subsided for the most part. He was given an ice pack and refused benadryl and stayed at school per his usual. Patient reported being fine other than slight soreness the say after.
Client is a 27  year old female who received a Moderna Vaccine  a dose of  0.25ML in the right arm , client experienced no adverse reactions or events.
I just moved to town about 2 months ago and my daughter was due for her 12 month check up and immunizations. My husband (who is still residing in town) went to my daughters pediatricians office and signed a release of information form to have her medical records sent to her new pediatrician. I arrived to my daughters appointment and per the receptionist and MA they did not receive any medical records for my daughter. I called the pediatricians office, so they can fax the records again. I waited about 20 minutes and the receptionist motioned to me that she received them. We went in to see the doctor, she gave her a checkup and explained to me what vaccinations were going to be given. After she received her shots, I walked to the front to check her out. The MA handed me a copy of records, I noticed that my other daughters name was on the top. The shots were administered to my daughter based on the shot record from my older daughter who is 8 years old. I voiced my concerns to the receptionist in the front. She proceeded to say that its no big deal, that all shot records are the same. I am not sure where to go from here and what I need to do so this does not happen again to someone else.
PATIENT STATES HAS HEART PALPITATIONS. PATIENT HAS NO SHORTNESS OF BREATHE, SWELLING OR RASH. PATIENT IS SLIGHTLY DIAPHRETIC. PATIENT STATES I JUST ANXIOUS AND REFUSED AND INTERVENTIONS. PATIENT STATES FEELS BETTER AND WENT HOME WITH FAMILY.
Information has been received from a pharmacist concerning a 67 year old female who on unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) in her shoulder. On unspecified dates, the patient's shoulder was very bruised and inflamed and it was possibly infected. The patient asked about the shoulder where her physician had administered ZOSTAVAX (Merck). The pharmacist believed the adverse experience might be due to how ZOSTAVAX (Merck) was administered to the patient. At the time of the report, the outcome was unknown. Additional information is not expected.
c/o  of itchy throat and tingling in the throat, no sob, 110/70, 95,98% given H2O , rechecked 9:59pm still itchy throat still itchy but not progressing, no sob or other symptoms.108/72, 66, 100% more H2O, final check 10:09 pm no further itching or tingling, feeling better no other symptoms 110/72, 66,100%. Husband driving and sent home. called back next day 01/08 at 9:22pm feeling much better, sore arm and fatigued. Told to check in with their provider or use 911.
Mom reports:  noted basesball size area at shot site, left arm, on 8/21/03 A.M.-area was red and hot.  Ice applied and Advil given throughout the day.  By night time, area was the size of my whole hand.  On 8/22/03 A.M., swelling had spread under her arm; I took her to her doctor(8/22/03)-he said she had cellulitis and started her on Keflex."
GOT LARGE RED KNOT, HOT, SWOLLEN ABOUT SIZE OF GRAPEFRUIT TO LEFT THIGH WITH DTAP
On 03/08/2002 left upper arm developed swelling from shoulder to mid arm, and shortness of breath. Given Benadryl
1h after injection, (L) deltoid swelled up and continued to the size of a tennis ball about 3-4" diameter - warm, tender, red, & flu like s/s. Treated with KEFLEX over the phone; then DEPO-MEDROL IM.
Pt came back to pharmacy the day after getting vaccine and has pain, redness, and swelling at injection site. Pt states she is going to MD 11/15/13 to get evaluated. Also advised pt to put ice pack on site and to take ibuprofen for pain.
her sister had the same "severe respiratory reaction" to the vaccine that she experienced; This spontaneous report was received from a consumer concerning her sister, a female patient of unknown age. Prior, the patient's sister experienced a severe respiratory reaction after vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) ( case 1308USA014995). No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported), as vaccination. According to the reporter, the patient had the same "severe respiratory reaction" (hypersensitivity) to the vaccine that she experienced.  At the time of the report, the outcome of hypersensitivity was unknown. The causal relationship between the aforementioned event and the suspect vaccine was related.  This is one of the two cases from the same source.
Less than 24 hours after my 1st dose of the Pfizer Covid Vaccine, at approximately 2:00 PM on 10/27, I started to have menstral bleeding.  My most recent menstal period had ended 3 days before the vaccine date.  I never have any unscheduled, abnormal bleeding  or spotting between menstral cycles.  The bleeding continued for 48 hours.
Apprx 0.5 mm  L postauricularlymphadenpathy, swolllen L deltoid, pt c/o pain when move head to L, denies; fever, difficulty chewing/swallowing or decreased ROM of arm. Instructed pt to continue ibuprofen 400 mg every 6-8 hours with warm compress, report to PCP if unresolved in 48 hours or ER if drooling, high fever, difficulty chewing/swallowing or neck pain.
constant back pain; suffering; vaccination was given "too high" on her arm; it doesn't look right; left arm was bruised at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (left arm was bruised at the injection site), BACK PAIN (constant back pain), PAIN (suffering), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccination was given "too high" on her arm) and FEELING ABNORMAL (it doesn't look right) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hernia in 2003, Back pain (Patient had ongoing back trouble (long history).), Heart valve replacement (heart valve replacement (pig valve) in 2015) in 2015 and Bladder disorder NOS (Patient had bladder problem (stent placed)). Concomitant products included TRAMADOL for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 18-Feb-2021, the patient experienced INJECTION SITE BRUISING (left arm was bruised at the injection site), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccination was given "too high" on her arm) and FEELING ABNORMAL (it doesn't look right). On 19-Feb-2021, the patient experienced BACK PAIN (constant back pain) and PAIN (suffering). At the time of the report, INJECTION SITE BRUISING (left arm was bruised at the injection site), BACK PAIN (constant back pain), PAIN (suffering), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccination was given "too high" on her arm) and FEELING ABNORMAL (it doesn't look right) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: TCR form appended
Pt received flu shot on 12/01/03.  Called clinic on 01/20/04 with complaints of arm pain upon lifting.  He felt due to flu shot.  Pt seen in clinic on 01/20/04, exam negative, was given Vioxx 25mg per mouth every AM with meals x30.  Instructed to use heat, stretching, no heavy lifting and return to clinic in 1 month.
Chills; Fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diabetic. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; GLIPIZIDE taken for diabetes mellitus. The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pyrexia.  Additional Information: Reporter stated that she is the wife of the patient and stated, "He takes the Comirnaty vaccine. He is presenting chills, fever and the most concern is the chills".It was reported that Tylenol was taken as treatment for the adverse events.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Vaccine given at another site. PNEUMOVAX on 10-17. On 10-20-10 presented with pain, redness, swelling over site of injection.
Fatigue; Chills; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    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 FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Headaches). At the time of the report, FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Allids to treat the headaches.  The patient was tested for IgG antibodies after the first dose of the vaccine and did not have any.
Patient had syncope when rising from sitting position.  Hx of fainting/anxiety, needs to be supine for blood draws.  BP not measured because no large cuff available. HR 108; O2 sat 98%; RR 18.  Patient was stable, AO x3 with no dizziness and discharged stable from vaccination site
Pt presents to the ED for fever and urinary frequency.  Symptoms have been going on for the past couple days.  She has also noticed shortness of breath and has required 4 L of oxygen in the ED.  Initial vital signs showed oxygen saturation of 85% on room air, T-max of a 100.2°.  Labs, WBC 7.05, creatinine of 2.2, CRP 13.7, D-dimer 620.  Virology - positive COVID-19.  UA was positive for urinary tract infection. Pt was diagnosed with acute hypoxic respiratory failure secondary to COVID-19. dexamethasone, vitamin-D, vitamin-C, respiratory care protocol oxygen as needed.  Ciprofloxacin was started for urinary tract infection pending urine cultures.  Rest of home medications reviewed and restarted.  Avoid any nephrotoxic agents.  Metformin held due to acute kidney injury gentle IV hydration.   She initially required high-flow nasal cannula and was able to taper back to nasal cannula.  CPAP continued for OSA. She has completed Remdesivir.  She is on a Decadron wean at time of discharge.
discomfort in left shoulder blade area. pain in taking breath in back.  tiredness, sweats, and discomfort in both kidney areas.
11/23/21 presents to FBC triage for "scheduled repeat C-section and gestational hypertension". PMHx of "anxiety disorder, depression, GERD"
Aug 27 - Athlete (cross-country) has difficulty moving legs. Sept 1 - Gait changes. 4-5min slower times. Sept 3 - To ER. Some increase in muscle enzymes. Decreased knee reflexes. Athletic/PE restriction per Dr. Sept 9 - Improved. Sept 12 - Fever 101 degrees. Sept 15 - Difficulty walking. Upper thigh discomfort. Today: still muscle wasting/decreased strength: thighs.
Pt has a PMH of HTN, HLD, CKD stage III, chronic heart failure with preserved EF, and chronic respiratory failure secondary to COPD. Pt arrived to ED due to chest pain and dyspnea and was found to be COVID-19 positive.
To top it off my hair started falling out by the handfuls; tire quickly.; trouble breathing; fever; Severe headache like migraine; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble breathing), ALOPECIA (To top it off my hair started falling out by the handfuls), HEADACHE (Severe headache like migraine), NAUSEA (nausea) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021. Concomitant products included LOSARTAN, OMEPRAZOLE, ROSUVASTATIN, GABAPENTIN, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), UBIDECARENONE (COQ) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced CHILLS (chills). On 28-Apr-2021, the patient experienced DYSPNOEA (trouble breathing), HEADACHE (Severe headache like migraine), NAUSEA (nausea) and PYREXIA (fever). On an unknown date, the patient experienced ALOPECIA (To top it off my hair started falling out by the handfuls) and FATIGUE (tire quickly.). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 29-Apr-2021, HEADACHE (Severe headache like migraine), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, DYSPNOEA (trouble breathing) and NAUSEA (nausea) had not resolved and ALOPECIA (To top it off my hair started falling out by the handfuls) and FATIGUE (tire quickly.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Antibody test: other (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Added two additional events fatigue and alopecia.
Patient experienced dizziness, palpitations, weakness, shivers, chest pain/pressure. BP 161/98 -- > 155/99 -- > 138/92, HR 99 -- > 104 -- > 93, RR 28 -- > 24,  O2=100%, T=98.4F. Vaccination given at 14:04, adverse event began at 14:20, 911 was called at 14:55, patient taken to emergency room.
Information has been received from a physician concerning a 6 yr old Caucasian male pt with a history of iron deficiency who on 09Feb00 was vaccinated with a dose of varicella virus vaccine live (lot 631170/0713J). Concomitant vaccination on 09Feb00 included a dose of diphtheria toxoid (+) pertussis acellular 4 component (+) tetanus toxoid (Acel Immune) (lot 466925). Illness at the time of vaccination included cold symptoms and otitis media. On 23Jun04, the pt developed an itchy rash at his waist line. By the following day, the pt had vesicles with crusts there as well as on the groin, shoulders, behind the ears and in his axillae. Subsequently in June 2004, the pt presented to the medical office. It was noted that the pt had a breakthrough case of 100 to 150 chickenpox lesions. On 08Jul04, the pt was seen again and was fine. The reporter indicated the pt had recovered. A product quality complaint was not involved. Additional information is not expected.
had both vaccines, months later shingles/Suspected vaccination failure; looks like shingles; rash on  left breast/left breast itches really bad; left breast burn; awful shooting pain in  breast; This 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, itchy rash, burning sensation and breast pain. On an unknown date, the outcome of the vaccination failure, shingles, itchy rash, burning sensation and breast pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, itchy rash, burning sensation and breast pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 23-NOV-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter stated that had this rash on my left breast itches really bad and burn and the patient sometimes got this awful shooting pain in my breast went. The patient's physician stated that it looks like shingles and had both vaccines a few months prior to the reporting was this possible. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
H1N1 shot administered in left arm - Tingling in various parts of the left arm and hand started about 30 seconds later as I left the facility. I waited to report the tingling to you thinking it would go away. The tingling is intermitent. Comes and goes. I have not reported it to my primary care doctor. No treatment.
This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL lot/batch # L033347, expiry date 23-JUL-2017 (dose, strength, vaccination site and route unspecified). The temperature excursion was reported as 34F for 48 hours. No adverse effect were reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
The  patientsreceived a Moderna dose approved for 6-11 years of age on 10/07. This vial was originally approved as a booster dose for patients 18+. So technically, they received a monovalent booster.
Fever 101.9°F, severe headache, severe body pains, hallucinations, nausea, redness in 3? diameter around injection site, swelling & pain in clavicle area on left side of neck
Chills, aches, sore arm, and redness at injection site. Stayed home from work and took advil.