chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 35-yr-old female diagnosed with ITP in May 2018. Patient was initially treated with a pulse of Dexamethasone in May 2018 and Prednisone taper in July 2018. Platelets responded to treatment and have remained around the 200,000 range since that time. Patient received COVID-19 booster (Moderna) on 11/23/2021 and was subsequently noted to have decrease in platelets to 119,000 at routine physical exam on 12/14/2021. Repeat evaluation of platelets on 12/19/2021 were 88,0000 and 101,000 on 12/28/2021. Patient has not had any intercurrent bleeding or bruising and denies recent febrile illnesses. She has not started any new medications. As patient has not had ITP exacerbation in 3.5yr and only known change has been recent COVID booster (Moderna), COVID booster (Moderna) is thought to be likely precipitant of patient's recent drop in platelets.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 08-NOV-2012 04:36, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Information was received from a 63 year old female patient with allergy to codeine, arthritis (since 2000), and history of "blood condition for six years" (unspecified), knee replacement and shoulder replacement.  In late December 2016, the patient was vaccinated by an unspecified pharmacist with ZOSTAVAX 19400 PFU injection (lot number, exact dosage, and route of administration not provided) to prevent shingles.     Concomitant therapies included lisinopril (manufacturer unknown), oxycodone, and "Zanas" (spelling confirmed). In approximately January 2017 (reported as within 4-5 days after being vaccinated), the patient reported that a "red, bumpy, itchy rash developed on the left side of her head onto the scalp area. Within the last 2 months the rash spread to her left shoulder, upper legs, right hip and lower back areas." The patient was currently being treated by a physician and had an office visit with a dermatologist who performed a biopsy. Treatment was reported as prednisone 20 mgs and unspecified ointments. She underwent unspecified blood work (results not provided). The outcome of the events was reported as not recovered. No further details available. Follow-up information was received on 22-MAR-2017 from medical records provided by the patient. Biopsy of left anterior distal upper arm was performed on 09-MAR-2017 with clinical information of erythematous papules, rash unspecified versus contact dermatitis other versus hypersensitivity reaction versus drug eruption. Dermatopathology report diagnosis: Spongiotic dermal hypersensitivity reaction. Differential could include an arthropod assault reaction or other hypersensitivity reaction, such as to a drug, contactant or allergen. Clinical correlation suggested. Periodic acidSchiff (PAS) stain was negative for fungal organisms. All available medical records will be provided upon request. Additional information has been requested.
Besides the usual and expected soreness at the site of the injection, the lymph nodes in my armpit have swelled up considerably, adding to the pain in my shoulder.
Pain, weakness, numbness in (L) arm. Pt states vaccine solution burned while administered.
really tired; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (exhausted) and FATIGUE (really tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced FATIGUE (exhausted). On 02-Mar-2021, the patient experienced FATIGUE (really tired). At the time of the report, FATIGUE (exhausted) and FATIGUE (really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Patient is recent immigrant. Catch-up vaccine schedule instituted. DTaP was given mistakenly despite patient's age.
(R) leg was swollen, warm to touch not red per parent. Pt unable to walk on leg.
Patient received  vaccine on 3/6/21  in the afternoon and his symptom started  in the early morning of 3/7/21  continuing today with subjective fever, chills, facial pain, and mouth blisters. Has used APAP for fever control, last dosage yesterday night.  Patient complains of difficulty eating due to lip swelling and blisters. On physical examination, patient is afebrile, has lip angioedema and multiple blisters on perioral region. Patient has difficulty opening his mouth due to lip swelling and pain.   Patient was prescribed prednisone  40mg po qd for 5 days, acyclovir-hydrocortisone 5-1% topical,  Lidocaine oral viscous solution for oral pain control as needed,  OTC ibuprofen recommended as needed
The afternoon of the shot (maybe around 4 or 5pm) I felt like I had a tickle in my throat and some minor coughing. On about the 11th through the present day  (15th) I have felt minor chills, headaches, and muscle aches, and overall feeling unwell.
soreness at the injection site; slight fever; tiredness; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced soreness at the injection site, slight fever and tiredness on 22Dec2020. The outcome of events was recovered in Dec2020.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
5min p/vax severe indigestion like pains-cont 2hr;5 times for next 2 days-very severe;nothing like that a/shot-nothing last 2wk;pt took med to stop pain-never needed before;
Information has been received from a registered nurse concerning a female nursing student who was vaccinated with 0.5 ml subcutaneously with a booster does of measles virus vaccine live (Moraten) (lot number not available). Subsequently, the patient had a negative titer. There was no treatment required. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Case number PHEH2015US004134, is an initial spontaneous report from a medical assistant received on 27 Feb 2015. This report refers to a 13 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch numbers: U5036CA, U5018AA, UI173AB, UI1207AB and 14511P) intramuscularly at a dose of 0.5 ml on 26 Feb 2015, which reached 31 degree F for two hours. No adverse event was reported following this administration error.
Expired Kinrix admiistered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 29th August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment: The lead medical assistant stated that an expired dose of Kinrix was administered to a patient on Monday. The reporter consented to follow up via postal. Additional Supportive Information: The patient received an expired dose of Kinrix, which led to expired vaccine used.
pt recvd vax; pt devel hypotension w blood pressure of 80/30, tachycardia w/ pulse of 130, severe diarrhea, vomiting, abdominal cramping, & dehydration w/ poor skin tugor; pt seen in ER & tx IV fluids; phenergan & suppositories;
I could not move my arms/shoulders, to the extent that I could get out of bed and then could not get up from a couch.  I was taken to the ER and stayed for 5 days.  Prednisone allowed me to regain function.  I stayed on the steroid for about 1.5 years and then tapered off.  I still have symptoms, but less in my shoulders and hips, but more pain in knees.  I have been seen at 3 locations.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 14-JUL-2015 the patient was vaccinated with one dose of improperly stored LIQUID PEDVAXHIB, lot# L002867 with expiration date of 11-NOV-2015 (strength, dosage, frequency and route unspecified). No adverse effects were reported. This is one of 4 reports received from the same reporter. Following AEQIR review, it was determined that the report did not meet criteria for a quality investigations. Incorrect product storage was not considered a true Adverse event and there were no reported adverse effects. Additional information has been requested.
Headache, Myalgia, Fever, Rash, UrticariaPruritus & NauseaVomiting Narrative:
Patient had original redness at injection site for 1-2 days following injection that went away. Patient now has same redness at injection site that is warm to touch and itches.  Area is approx. 2 inches across in diameter.  Patient states is getting larger in size. Area does not have well defined boarder.
I couldn't breathe and I felt horrible. I went to the ER. I was hospitalized for 3 days. I had a massive migraine. When I went home, I couldn't walk. I saw my doctor. They said I had a horrible reaction to the vaccine. I was still sick a week later. I called my doctor again. I went back to the hospital for another X-Ray. They told me had I had deflated air pockets in my lungs.   My doctor thought I had pneumonia. I was prescribed two inhalers. The combination of both inhalers provided some relief. I take a lot of supplements to try to give myself relief as well. I still get really winded most days - its sometimes difficult to walk up the stairs, walk to the parking lot, or move around at work & most places. I'm going back to the doctor in July.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date, the patients were vaccinated PNEUMOVAX23 (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On unknown date, PNEUMOVAX23 was improperly stored for an unspecified amount of time and administered to an unspecified number of patients. No adverse effects reported. The outcome was unknown. Product quality was not reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Fingers felt tingly and  then hand felt numb. Started after shot.  Seen by EMT, reported site looks good.  No difficulty breathing.
Patient states that about 2 weeks after she was given the flu shot she started to experiences muscle aches in her arms and cannot reach around to her back or lift her arms high. Patient is not sure if it is the flu shot or not, but says that is the only thing that she had before the pain started. Patient has an appointment to see the doctor 1st week of the new year.
My first dose I got a reaction - bad joint and body pain. I wasn?t  able to move for a couple hours but then it subsided less than 24 hours. It hurt but not so much where I didn?t want to move forward with 2nd dose. About 9 hours after my 2nd dose my joints in my body starting hurting and it was so painful I couldn?t move my body. It was a lot worse than my first dose. I started feeling high fever but I couldn?t get up to check temperature. It felt like someone threw me off a building and I couldn?t get up. That reaction lasted until morning and then that went away and then I got headaches. Headaches eventually went away the next day but it was a very painful experience I was scared. I don?t feel any of the symptoms anymore but wanted to report.
fatigue; Headache; Intermittent facial flushing; Nausea; Lightheadedness; Malaise; This is a spontaneous report from a contactable nurse. A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 19:00 in right arm at single dose for COVID-19 immunization. Medical history included HTN (hypertension), ADD (attention deficit hyperactivity disorder) and latex allergy from an unknown date and unknown if ongoing. Concomitant medication included losartan, bisoprolol, duloxetine hydrochloride (CYMBALTA), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and paracetamol (TYLENOL). The patient experienced moderate fatigue, headache, intermittent facial flushing, nausea, lightheadedness and malaise on 24Dec2020. The facility where the most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Headache; chills; fever of 101.8 for about 24 hours then fever of 99.8 for 2 days; lethargy; This is a spontaneous case from a contactable consumer (patient). This 66-years-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6200) on 17Feb2021 at 14:30, at single dose, for COVID-19 immunisation. No other vaccine was given in 4 weeks. Medical history included asthma, COVID and allergy to amoxicillin. Concomitant medications were not reported. On 18Feb2021 at 14:30 the patient experienced headache, chills, fever of 101.8 for about 24 hours, then fever of 99.8 for 2 days and lethargy. The events did not require any treatment and were resolving. COVID was not tested post vaccination.
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: Patient reposrt left shoulder pain from elbow to top of shoulder. Intermittent during the day and constant at night. most pain on movement. difficulty raising arm. currently taking motrin and tramadol prn. will see PCP in coming days and will report back with outcome
IMMUNIZATIONS ADMINISTERED APPROXIMATELY 9:30 A.M. 5/11/06 5 P.M. ONSET OF BLOTCHES ON FACE, CHIN, AND STOMACH. NOSE AND THROAT SWELLING ALSO NOTED. EVAL AT ER GIVEN BENADRYL. MOTHER DOES NOT KNOW LENGHT OF SIGNS/SYMPTOMS AS SHE WAS AT WORK BUT REPORTED ALL SIGNS/SYMPTOMS RESOLVED BY SUNDAY 5/14. ER DR. ATTRIBUTED TO MMR AS NO HISTORY OF REACTIONS WITH PREVIOUS VACCINATIONS.
15 mins after getting the 2nd shot, I had a burning in my throat & lips. Also my ears clotted, vision got blurry& my face got numb. A pain on my left arm & my whole right side of face swollen.  After being hospitalized the Dr. said I got Bell's palsy
Exactly 2hr after administration. I became wheezy & was coughing. This progressed to difficulty breathing, only able to speak 1 word sentence. Took 25mg BENADRYL po - total time of event 1 1/2 hr.
Initial report received from a health care professional on 30 April 2014. A 13-years-old male patient, had received a dose of TYPHIM VI (Lot number: K1183-1) intramuscularly in the left deltoid on 25 April 2014. The patient does not have any illness at the time of vaccination and pre-existing physician diagnosed allergie, birth defects, medical conditions was unknown. The patient's mother reported that the patient had nose bleeds on 26 April 2014 and was told that it was unrelated to vaccine. Corrective treatment and laboratory details were not reported. At the time of this report, the event was not recovered. Documents held by sender: None.
injection arm  became sore, still sore, painful to lift it up; Still painful to lift it up over her head; Fatigue; Fever; Headache; 2nd dose administered  beyond 6 months; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 07th May 2022).   On 21st December 2022, the patient received the 2nd dose of Shingrix. On 21st December 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased, fatigue, fever, headache and drug dose administration interval too long. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the fatigue, fever and headache were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, fatigue, fever and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-JAN-2023 Reporter's Comment: The patient was self-reported this case. The patient reported that she received Shingrix vaccine. The patient stated that on 21st December 2022, shortly after received Shingrix vaccine she experienced fatigue, fever, and headache. The patient reported that all these symptoms are resolved within 24 hours. The patient also reported that her injection arm right became sore and was still sore.   The patient stated that it was still painful to lift it up over her head.    The patient did not had any further information about the vaccine itself. The reporter did consent to follow up. The patient was beyond the 6 months of recommended time frame for getting her second vaccine.  Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
C/O cough, chills, fever, sore or scratchy throat, headache, runny nose or congestion, myalgia, malaise, and diarrhea
This spontaneous report as received from an administrator via field employee regarding a female patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. The reporter stated that "he heard that a physician gave GARDASIL (dosing details, lot#, expiry and route of administration were not reported) to her daughter and the daughter experienced neurological problems afterwards (on an unspecified date, lasting for an unspecified duration of time). The outcome of neurological problems was unknown. The reporter did not provide the causality between the neurological problems and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information has been requested.
Redness and itchiness at injection site; Soreness at injection site; Redness and itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Redness and itchiness at injection site), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness and itchiness at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-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 PRURITUS (Redness and itchiness at injection site), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness and itchiness at injection site). At the time of the report, PRURITUS (Redness and itchiness at injection site), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness and itchiness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. After about 2-3 days, the patient experienced soreness, itchiness and redness that was 2-3 inches in diameter and was getting bigger.
Off and on Tinnitus. I have had it before with sinus issues and surgery but it had been several years. It's pretty consistent but not 24/7. It began the next day.
Per paramedic, "Pt's mother told staff "my daughter's not feeling well." Paramedic was notified and pt was unc when he arrived. Pt was taken to the medical tent via w/c. Pt regained consciousness and was placed supine with legs elevated."  RN was present when pt transferred to cot without assist. Pt was talking, accompanied by mother who states this happens every time she gets blood drawn or has a vaccine. B/P at time of incident 119/77 HR 91, 98% O2 Sat, at 5min 114/76 HR 77 100% O2 sat, at 10min. standing B/P 110/73, HR 76, O2 sat 99%.  A/O speaking in full sentences, sitting up drinking water. Skin color pink. Pt monitored for 45 min. Stable at d/c by paramedic. Post vaccination instructions given.
Right arm swollen and red. Diag: cellulitis. Started on Keflex 250mg x 1 day.
lymph nodes swelled up in armpit and above clavicle on day 2. then armpit, breast, chest and clavicle swelled approx i inch thick on chest and 1.5 inches deep in armpit. jiggly like filled with water. Very painful. Seemed like a lymph blockage. this kept worsening to day 4 then slowly decreased over the next few days.
pt had 2 szs, both w/in 48 hrs p/vax; afeb @ time;
Starting within 6-8 hours of the vaccinations, I began some menstrual spotting. This has been ongoing lightly for the two days following the vaccination. Initially it was just a tiny bit of pinkish discharge noticed after using the bathroom, but now its is more of a very light menstrual flow. It should be another two weeks before my cycle returns, so this is way off schedule. I cannot think if anything else that has changed and would cause this.
The morning after vax, pts right eye swollen shut. Both eyes swollen now, groin swollen, no pain, itching. Swelling was noted when pt awakened this morning. Aunt brought him to health department at 4:00 pm. She was advised to take pt to Hospital. Pt is alert and playing but swelling remains.