chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case involves an unknown age and gender patient who experienced flu (influenza), after receiving INFLUENZA VACCINE. The patient's past medical treatments, vaccinations, concomitant medications and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient experienced a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Funny, when I stopped taking flu shots, I stopped getting the flu. Officially it's not supposed to work that way, but there it is." It is unknown if the patient experienced any additional symptoms/ events. It is unknown if there were laboratory data/ results available. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome of the event was reported as unknown. There will be no information on the lot number for this case.
Initial unsolicited report received from a non-healthcare professional on 15 October 2015. This case involves a (44-year-old) female patient who was vaccinated with a intramuscular [dose series not reported] dose of FLUZONE QIV NP (batch number UI444AA, expiry date 30 June 2016) in left deltoid on 24 September 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Concomitant medications was not reported. On 25 September 2015, one day following the vaccination patient experienced pain, limited range of motion (ROM) and problems moving left arm day. On an unspecified date the patient had left shoulder pain. It was reported that, patient was evaluated by her child's pediatrician. Patient was re-evaluated by her own physician who ordered a left (L) shoulder x-ray which was negative and may possibly had an magnetic resonance imaging (MRI). It was reported that, patient required emergency room (ER)/doctor visit. Corrective treatment was Ibuprofen three times a day and a medrol pack. Patient reported left shoulder pain came back post medrol pack. The outcome of event was unknown. List of documents held by sender: none.
COVID Arm.  Swollen, red, hot, itchy upper arm.  Swelling and redness started on day 3 and hot and itchy sensation started on day 4.  Worse on current day 5.  No other adverse symptoms.  Have been icing periodically and taking acetomyicin.
DAY6 AFTER FIRST COVID 19 VACCINATION, I HAD LUMPS ON RIGHT FOREARM AT INJECTION SITE WHICH ON DAY 7 LUMPS TURNED INTO RED, ITCHY, IRRITATION, THEN DAY 9 I HAD A  RED AND ITCHY LUMP UNDER MY LEFT JAWLINE; SLIGHT UPSET STOMACH, TIREDNESS
On 12/27/2022, I tested myself for COVID-19 because I felt funny. When it was positive, I didn't feel too bad. Over the course of the next few days, the left side of my face felt slight tingling and numbness and I felt like I was favoring my left side when walking. I called 911 on 12/30/2023, after thinking it was sinus issues for a few days. They took me to a nearby hospital. They confirmed my positive COVID-19 results. That night, the doctor told me I had a mild stroke. They recommended that I see a neurologist. It was a holiday weekend, so I was unable to be seen. They ultimately air lifted me on 01/01/2023, to another hospital. They didn't think it was too severe, but I had very high blood pressure as well. I saw two neurologists as well as the head neurologist. They all concurred that I had a mild stroke and my blood pressure was just getting worse. I don't remember what all kind of medications they gave me. I also developed a really bad COVID-19 headache. As soon as I was diagnosed, I called my primary doctor, who recommended I take PAXLOVID. I was only able to take 9 of the 10 doses, which my doctor said was alright. I was only in that hospital for 2 days. They always considered it a mild case. Eventually the head neurologist came in and informed me that I actually did not have a stroke. His conclusion was that I had Bell's Palsy. He believed that the COVID-19 cause inflammation that affected the nerves in my brain which gave me stroke like symptoms. The morning of 01/02/2023 or 01/03/2023, they discharged me, and I've been ok since. Even today, I feel lucky because the only remaining symptom has been occasional fatigue. About every 2 weeks or so, I get extremely fatigued. Sunday, I took multiple 2-hour naps and then went to bed at 09:00PM.
She said her arm hurt very bad, almost unbearable, had taken an Advil with no relief. Then said at 4am it woke her up it hurt so bad, was in tears.
Day 8 after vaccination, shot site became itchy.   Day 9, red rash appeared, itching continued, and area was warm to the touch.   Day 10 red rash continued and expanded, with continued warm to touch.    Itching ceased.   Day 11 red rash seems to be dissipating, but still warm to touch and not expanding.
Severe muscle pain, fatigue, redness swelling at site of injection for greater than 1 week.
Approximately 10 seconds after I gave the HPV #2 vaccine to this patient in her right deltoid, she passed out and fell off the exam table landing on the floor. she fell on the opposite side of the table of where I was landing face down on the floor.  this broke a part of one of her front teeth off which also puntured her lower lip.In about 4 secconds she was totally alert, asking what happened and started crying because her mouth was sore. We had her spit out the blood that was in her mouth, removed the piece of tooth that was in her lower lip and applied a cold cloth then an ice pak. Parents were called. Dad took her to their dentist. Will receive further dental treatment in a week when the gum has firmed up.
No adverse effects; the patient was inadvertently administered one dose of MMR II by intramuscular route.; This spontaneous report was received from a pharmacy technician, referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions, allergies, concurrent conditions, and concomitant medications were not provided.      On 26-MAR-2019, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), 1 dose, intramuscular (incorrect route of product administration) (strength, lot# and expiration date were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date were not provided). No adverse effects were reported.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. On 03-DEC-2003, the patient was vaccinated with first dose of RECOMBIVAX HB and on 05-JAN-2004, with second dose of RECOMBIVAX HB (dose, product lot#, expiry date not reported). On 05-MAR-2004, the patient was vaccinated with third dose of RECOMBIVAX HB that was on a schedule that was outside of the prescribing information. No adverse events were reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information is not expected as there was no consent to contact the reporter for follow up information.
Sore arm; Fever 100F; Tired; A day in bed; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (A day in bed), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever 100F) and FATIGUE (Tired) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced BEDRIDDEN (A day in bed). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever 100F) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 17-Aug-2021, BEDRIDDEN (A day in bed) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever 100F) and FATIGUE (Tired) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100f (High) 100F.         Concomitant product use was not provided by the reporter.  On 18 Aug 2021, the patient was feeling fine but not 100 percent.   This case was linked to MOD-2021-290368, MOD-2021-290627 (Patient Link).
I received my third booster of Moderna Bivalent COVID-19 vaccine and a flu vaccination on the morning of 12/5/2022. About a week to ten days later, I had an outbreak of cold sores on the top left corner of my mouth. I took my valaciclovir, as I always do during an outbreak or whenever I feel an outbreak approaching. This outbreak lasted for twelve days. It then cleared up, and about a week later, I had another outbreak in the same spot. This lasted about ten days or so. Whenever the cold sores went away, I always ceased taking the valaciclovir, because it's a very strong medication. I then drank copious amounts of water, because I wanted to clean out my system. I ended up having two outbreaks on the top left corner of the mouth in January 2023. In February 2023, I had an outbreak on the bottom lip in the middle of the left side. I always get cold sores on the exact same spots whenever I have breakouts. The cold sores on the bottom lip are usually bigger than the ones on the top lip, and they usually last a week to ten days. I always feel a tingling or a twitching beneath the skin on these areas when a breakout is approaching, but just before my breakout on the bottom lip in February, it was much stronger than usual. It felt like a live wire beneath the skin of my lip. I remembered then that about a month after getting my first round of the Moderna COVID-19 vaccines, I had a bad breakout about a month later. Normally, my breakouts occur very seldom. They usually come every couple of years or so. However, since I have gotten the third Moderna booster, they have come much more frequently. I was planning to get the shingles shot, but now I'm afraid to do so, because I don't know what effect it may have. I went to the doctor in March 2023. I had undergone some bloodwork in January or February 2023, and everything was perfect. When I told my doctor about the increasing cold sore breakouts, he advised me to take the valaciclovir twice a day (every 12 hours) for a month. Normally, I take it only once a day, and that's only when I'm either having an outbreak or feel one coming on. Since taking the valaciclovir twice a day, there has been an improvement. I have not had any outbreaks in the last 30 days. I feel a twitching sensation under the skin of the area where I normally get the breakouts, but they are much weaker and less pronounced now.
"23mins post vaccination, pt c/o dizziness with 1 episode of vomiting. C/o mild right sided chest pain.  Pt denies other pain, tearful. Vitals: @14:15 BP 160/112, HR 83, O2Sat 100% -- > @14:20 137/89, 76, 98% -- > @14:25 118/85, 72, 99% -- > @14:30 117/82, 70, 99% Pt symptoms improved.  Pt stable and released from the vaccination site 55mins post vaccination.  Pt verbalied understanding to call 911 or seek immediate assistance if symptoms persist or worsen.  Pt has no known allergies PMH significant for long standing urinary incontinence w/ urgency, anemia, and TRANSUMBILICAL AUGMENTATION MAMMAPLASTY in 2013. Known medications include a multivitamin PO Daily."
fever; This spontaneous report was received from a pharmacist concerning an over 65-years-old male patient.   The patient's medical history, concurrent conditions, drug reactions or allergies were unknown by the reporter.   On an unspecified date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, lot #, expiration date, anatomical location or route of administration were unknown by the reporter), administered for prophylaxis. The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was concomitantly administered with zoster rgE vaccine (mammalian) (SHINGRIX), and then the patient developed a fever. It was unknown if the patient sought medical attention, received treatment, if he had any diagnostic labs or studies performed. No further information was provided.  At the time of the report it was unknown if the patient had recovered from the event.   The causal relationship between the event and the vaccines was not provided.
Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days", There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
More than half of the dose leaked out around the luer lock while I was injecting the vaccine.  Syringe and needle were stuck but not completely tightened, which I saw when I looked later.  After discussing with manager and doctor on call, re-administered 0.5ml dose.
ABOUT 5 -6 HOURS AFTER RECEIVING THE INJECTION PATIENT HAD SWELLING WITH WEEPING WELTS ON HER RIGHT UPPER ARM AND SHOULDER (INJECTIONS WERE BOTH IN THE LEFT DELTOID). ABOUT 8-10 HOURS AFTER THE INJECTIONS, PATIENT EXPERIENCED BONE PAIN ON HER LEFT SIDE FROM HER NECK TO HER ELBOW. HER ARM IS STILL NUMB AND SHE CANNOT LIFT HER LEFT ARM UP WITHOUT EXTREME PAIN. HER FACE BROKE OUT WITH WELTS WHICH TURN TO ECZEMA. HER FACE IS HEALING AFTER ONE WEEK AFTER USING HER OWN PREVIOUSLY PRESCRIBED TOPICAL STEROIDS.  SHE STILL HAS TROUBLE SLEEPING WITH PAIN ON HER LEFT NECK AND SHOULDER AND NUMBNESS IN HER LEFT ARM.
Patient presented to clinic for Covid-19 vaccine. Patient started complaining of chest pain 5 minutes after vaccination. Patient denied shortness of breath, but states the pain worsened with deep breathing. Patient denies other complaints or symptoms. Vital signs stable and work of breathing normal. RN auscultated lung sounds, upper lobes clear bilaterally. Blood sugar 227. Patient states she has diabetes and hypertension. Patient kept closing her eyes, RN encouraged patient to keep her eyes open, but patient kept stating, "I'm tired." RN notified provider, provider in to assess patient. Per provider, patient to go to ED via EMS. Patient's husband notified and arrived to clinic to be with patient. RN contacted EMS and report given.
Patient returned to clinic one day following four month vaccinations. Parents state fever to 103.1, little cough, not fussy and that baby did not sleep as long as usual.  Fever 102 rectally upon exam., with Right thigh slightly swollen (4 cm erythema proximal thigh).  Cried & guarded Rt. thigh with palpation.  Left thigh slightly swollen at injection site without erythema.  Acetaminophen ordered by provider.
punctured IPOL was administered post excursion with no reported adverse event; highest temperature reached 52.5 F and the total excursion lasted 1 hour 30 minutes with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 10 years old male patient and it was reported highest temperature reached 52.5 F and the total excursion lasted 1 hour 30 minutes and punctured IPV (VERO) [IPOL] was administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) for Immunisation.  On 21-MAR-2023, IPV (VERO) [IPOL] underwent temperature excursion and it was reported that highest temperature reached 52.5 f and the total excursion lasted 1 hour 30 minutes with no reported adverse event (product storage error) (latency: unknown).  On 03-May-2023, the patient received 0.5 mL of punctured IPV (VERO) Suspension for injection (batch/lot number: V1B902M; expiry date: 02-Jun-2024; strength: standard; frequency: once) via intramuscular route in the deltoid NOS for immunization post excursion with no reported adverse event (poor quality product administered) (latency: same day).  It was reported that, the vaccines were moved to a back up fridge while the fridge was being cleaned. The caller stated that the excursion occurred in the fridge that the products are normally stored in. The punctured IPOL was administered to four patients post excursion.   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the events.  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.
Hot around injection site; tennis ball size hard area around injection site; Swollen around injection site; Red around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot around injection site), VACCINATION SITE INDURATION (tennis ball size hard area around injection site), VACCINATION SITE SWELLING (Swollen around injection site) and VACCINATION SITE ERYTHEMA (Red around injection site) 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot around injection site), VACCINATION SITE INDURATION (tennis ball size hard area around injection site), VACCINATION SITE SWELLING (Swollen around injection site) and VACCINATION SITE ERYTHEMA (Red around injection site). At the time of the report, VACCINATION SITE WARMTH (Hot around injection site), VACCINATION SITE INDURATION (tennis ball size hard area around injection site), VACCINATION SITE SWELLING (Swollen around injection site) and VACCINATION SITE ERYTHEMA (Red around injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Treatment of events was reported as none.
Post vax, the pt's parents felt a bubble in his right arm, which ruptured and 3 days later he felt a bump which kept on growing.
Erythematous rash on trunk, face and limb. Benadryl p.o. and calamine lotion.
Moderna COVID-19 Vaccine   Exactly one week after the injection of the Moderna COVID-19 Vaccine EUA, the injection site began to itch.  I lightly scratched over the area, which itched similarly to a mosquito bite.  The morning after, the injection site on my arm had become very rosy and the bump had become more swollen.  I have had no other symptoms.
Vaccination failure; Confirmed COVID-19 respiratory Infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 43-year-old male patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown), on 06Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 01Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis", start date: 2009 (ongoing); "CMV colitis", start date: 2021 (unspecified if ongoing); "hypertension", start date: 2014 (unspecified if ongoing); "Diabetes mellitus", start date: 2014 (ongoing); "prior smoker" (unspecified if ongoing); "fatty liver disease", start date: 2014 (unspecified if ongoing); "colonoscopy", start date: 2017 (unspecified if ongoing); "vitamin D deficiency" (unspecified if ongoing). Concomitant medication(s) included: ENTYVIO intravenous, start date: Jun2021, stop date: Dec2021; METHYLPREDNISOLONE oral, start date: 30Jul2021 (ongoing); PHENERGAN [PROMETHAZINE] oral (ongoing); ALBUTEROL [SALBUTAMOL] resp inhalation (ongoing); METFORMIN, start date: 01Jun2021, stop date: 19Jul2022; TYLENOL (ongoing). The following information was reported: COVID-19 (medically significant) with onset 02Apr2022, outcome "recovered" (12Apr2022), described as "Confirmed COVID-19 respiratory Infection"; VACCINATION FAILURE (medically significant) with onset 02Apr2022, outcome "recovered" (12Apr2022). The events "vaccination failure" and "confirmed covid-19 respiratory infection" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Apr2022) Positive, notes: COVID-19 (SARS-CoV-2) infection (confirmed), coronavirus. Clinical course: This patient had an upper respiratory infection then was evaluated in an emergency room on 02Apr2022, and was diagnosed with coronavirus. This did not involve prolonged in patient hospitalized. The infection was confirmed via an unknown COVID-19 test this patient described having flu-like symptoms. Event outcome was indicated as recovered. Recovery date 12Apr2022. The investigator was unable to confirm disease activity prior and at the time of the event. Patient also received BNT162b2 (BNT162B2), as dose 4 (Booster) on 14Apr2022 for covid-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The contributory role of the suspect product to the reported Vaccination failure and COVID-19 cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency. ,Linked Report(s) : US-PFIZER INC-PV202300079420 same patient, different drug/ event;
Patient is having double vision after the 2nd dose; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Patient is having double vision after the 2nd dose) and DIZZINESS (Dizziness) 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 DIPLOPIA (Patient is having double vision after the 2nd dose) and DIZZINESS (Dizziness). At the time of the report, DIPLOPIA (Patient is having double vision after the 2nd dose) and DIZZINESS (Dizziness) outcome was unknown.            No concomitants were reported. No treatment  was reported. The action taken with of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable, reporter didn't provide causality assessment.
Cellulitis of left arm vs allergic reaction. Clarinex 1 po qd x 7. Keflex 500 mg po x 10 TID.