chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a consumer regarding a 7-year-old female patient who experienced fever 102 deg. F., headache and GI symptoms. At 7 years of age, the patient received the second dose on 18-Feb-2003. Medical History: The child had no relevant medical history. The child was reported as "fine" following receipt of her first dose of Flumist on 16-Dec-2003. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 18-Feb-2004. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: The patient developed a fever of 102 deg. F. (pyrexia) on 20-Feb-2004. She was treated with Tylenol (acetaminophen) and recovered after 3 days. In March 2004, she again developed a fever of 102 deg. F. with headache (headache) and GI symptoms (gastrointestinal disorder). She was treated with Tylenol (acetaminophen) and recovered by 16-Mar-2004. The reporter indicated that the physician was not notified of these events. No additional information was available at the time of this report.  Follow up: information received from the physician provided sibling immunization history and medically confirmed the event.
rash/quarter size rash; very painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (very painful) and VACCINATION SITE RASH (rash/quarter size rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), MULTIVITAMIN [VITAMINS NOS] and PROBIOTICS NOS for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (very painful). On 01-Feb-2021, the patient experienced VACCINATION SITE RASH (rash/quarter size rash). On 27-Jan-2021, VACCINATION SITE PAIN (very painful) had resolved. At the time of the report, VACCINATION SITE RASH (rash/quarter size rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Patient date of birth was mentioned This case was linked to MOD-2021-228430 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow up received on 18-June-2021  contains information on first dose event outcome, second dose and events after that, separate case created for second dose. On 18-Jun-2021: Follow up received on 18-June-2021 does not contain any significant information.
c/o pain immdeiately after injection, pain continues to get worse, contacted physician, instructed to call medical office, difficulty moving, ROM decreased, pain with movement, pain level 4, not taking any medications for pain at this time,
Information has been received from a physician concerning a pt who was vaccinated with a first and second dose of Pneumococcal 23v polysaccharide vaccine, the first in 1995 and the second on 10/24/05 (lot 650302/1039P, 0.5ml, IM). On 10/25/05 the pt was diagnosed with cellulitis of the arm. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Patient developed Shingles on 1st branch right trigeminal. Patient has pain, swelling, itching, redness to right side of face and forehead. Temp 99.0. Symptoms started 3 days after receiving Zostavax injection (06/14/09). Treatment given Acyclovir 800 mg 5 times a day for 7 days. Treatment will be started today June 19, 2009.
mom called to say the last time after 4 month vaccines and again after 6 month vaccines, patient developed a hoarse voice for a few dasy no difficulty in breathing or swallowing, resolved on its own.  patient was not seen, resolved.
(3/16/2021) Around 4pm felt weak and could barely talk and by the time paramedics arrived could not move arms or legs. When I was put in the ambulance, recovered motor function and could talk. ER test given (CAT scan, Blood, EKG) No treatment given for ongoing. Mild case of COVID 19 but similar event happened about a month from today. Fainting from low blood pressure. Advised for eating habits and exercise.
approx 45min p/vax pt devel an inj site rxn characterized by swelling, warmth & a rash;tx w/DPH;
Pt developed very large local reaction 14x 14 cm large erythematous, painfull, pruritic, whole left arm involved. No joint involvement & no systemic findings except for headache.
Paralysis of hands and arms(stiffening and curling into body), pain in hands and arms, tingling in hands and arms, face tightening  all lasting 20 mins as soon as vaccine was given then it ended
THROMBOSIS IN THE LUNGS; This spontaneous potential legal report received from a consumer concerned multiple female patients (8 women) of unspecified race and ethnicity. No past medical history or concurrent conditions were reported. The patient's received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Reporter stated that, she read on vaccine that on an unspecified date, the patients (8 women) had experienced thrombosis in the lungs also (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thrombosis in the lungs was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220100267.; Sender's Comments: V0: 20220102356 -covid-19 vaccine ad26.cov2.s-  Thrombosis in the lung . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Excessive crying-unconsolable for 24 hrs after imm. Decreased appetite, no fever, no redness.
Pt received ZOSTOVAX vaccine on 2/17/09 and three days later she developed shingles on right breast.
pt recv vax 8APR96 & 10APR96 exp vomiting, diarrhea, & a fever;sx recurred 18APR96, 25APR96, & 2MAY96;a stool gram strain & cult were neg;responsible MD reportedly did not feel the pt sx were related to vax;
Information has been received from a healthcare worker concerning a 51 year old female with arthritis, hypothyroidism, hyperlipidaemia and hypertension who on 25-JAN-2011 was intramuscularly vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # 664535/0060Z). Concomitant therapy included aspirin, calcium (unspecified), FELODIPIN, omega-3 marine triglycerides, ibuprofen, lisinopril, METAMUCIL and pravastatin Na. On 25-JAN-2011 at 5pm, the patient experienced pain in her left deltoid at the injection site. Reporter stated that between 5pm and 6pm on 25-JAN-2011, the patient lost mobility in her left shoulder, and experienced nausea with a fever of 100 F. Reporter mentioned that the vaccine might have been given in the deltoid muscle a little higher up where there is less muscle. On 26-JAN-2011 the patient came into the office to see the physician who confirmed that the injection site was "red", and the patient had decreased mobility in her left shoulder, but the fever was gone. Reporter stated that this patient did not experience any decrease sensation in her left arm, and the patient had full mobility in her left arm in the area of her left elbow and below. No lab diagnostics studies were performed. The patient had seen physician to seek medical attention. Information has been received from a physician and medical record regarding a 51 year old female smoker with pre-existing conditions of hypertension, increased cholesterol, hypothyroidism. The patient had PNEUMOVAX 23 (lot # 664535/0060Z) injection on 25-JAN-11 about 3pm in the upper left arm, more toward shoulder. The patient stated that at 5pm, that same day, it began to get painful. Soon after that she had experienced decreased mobility in her left shoulder, accompanied by nausea and a low grade fever of 100 degrees Fahrenheit. This continued through the evening and the patient took over-the-counter ADVIL 200mg every 4 hours and applied ice. On 26-JAN-11, the patient was seen for evaluation of the complaint. At the visit, a healthcare professional did witness redness at injection site and noticed that the patient experienced soreness and decreased mobility. The patient was diagnosed with pain in shoulder. On 28-JAN-11, the physician spoke to the patient who reported was "getting somewhat better", no fever, soreness still present, and range of motion was slightly better. The patient was doing stretches and using MOTRIN. It was reported that the patient had recovered on 17-FEB-2011. Additional information has been requested. All available medical records will be provided upon request.
Onset 5 days after injection.  Itchy rash, small blisters under chin, on thighs.  Initially used Benadryl susp and topical.  Zovirax cream and Zovirax tablets started 7/1/08, Xyzal tablets.
I'm concerned about COVID vaccine possibly triggering a recurrence of post herpetic neuralgia in my mother, who hadn't had post herpetic neuralgia since 2015  14 hours after dose 2 of COVID vaccine administered on 2/23, patient awoke with sudden onset severe right ear and forehead pain, site of her initial herpes zoster rash in 2004.  No visible rash or changes on eye exam (Pt is taking valtrex for eye sequellae of zoster).  Other symptoms have included fatigue, bilateral axillary and neck lymph node tenderness, and some breathing discomfort.  All symptoms are much improved but persist now (4/12/21).
On Sunday 6SEP client started having fever 103 & h/a; felt better on Monday not to ill then Tues had fever & h/a & vomiting; worse on Wed so mom took client to MD; MD tx Augmentin, Phenergan & APAP;
Large red rash, 4" x 6", on left arm below the injection site developed 7 days after injection.
I received the injection at 3:10 pm on 1/5. In the middle of the night, I didn?t check the time, I had severe rigors that lasted what felt like an hour maybe more. I did not have any other rigors since that episode.
Got shot but still got shingles / Suspected vaccination failure; Still got shingles; 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 but still got shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 08-APR-2023 This case was reported via interactive digital media. The reporter reported that she knew two people (patients) who got shot but still got shingles. The reporter was wondering why to put this chemical in body, pay for it and then suffer the disease. The reporter also reported that with Polio and measles shot the disease was eradicated. Not so with Shingles or Covid shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination, time to onset and laboratory confirmation of shingles were not provided. The follow up would not be possible as no contact details were provided. This case was linked with US2023AMR037410, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR037410:Same reporter
brain fog; dizziness/light headed; bad flu like feelings; weakness; This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd September 2019, 1 days after receiving Shingrix, the patient experienced influenza like illness and weakness. On 24th September 2019, the patient experienced foggy feeling in head and dizziness. On an unknown date, the outcome of the influenza like illness, weakness and dizziness were resolved with sequelae and the outcome of the foggy feeling in head was recovering/resolving.   It was unknown if the reporter considered the influenza like illness, weakness, foggy feeling in head and dizziness to be related to Shingrix.  Additional details were received as follows: The age vaccination was not reported but could be between 58 or 59 years. The patient had bad flu symptoms, weakness, brain fog, dizziness and light headed. The patient stated that all events resolved except the brain fog. The patient did not consent to follow up.
Employee received Moderna vaccine on 1/22/21 at 1:30 pm and later that day at about 5:00 pm she started having  severe pain to her  left leg and for three days she was dragging  her left foot when walking.  Today (2/23/2021) employee still have moderate pain to her left leg.
Fever, chills, severe inflammation below injection site, tender to touch,  severely swollen arm muscle, fever in muscle below injection site, and dizziness.
Diarrhea; A-afib; A spontaneous report was received from an 83-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea followed by exacerbation of her A-fib (atrial fibrillation).    The patient's medical history included hypertrophic obstructive cardiomyopathy.  Concomitant product use was not provided.  On 25-Jan-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number 011M20A) for prophylaxis of COVID-19 infection.  On 01-Feb-2021 (reported a week later), the patient experienced persistent diarrhea.  She stated, "I believe it's affecting my heart" and that "she went into A-fib since having diarrhea."      Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The events of diarrhea and atrial fibrillation were not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
ED visit for insomnia; treated and released. ED visit to hospital admission for suicidal ideation; also COVID positive. Upon admission she was started on mirtazapine and she did sleep well. She was seen by psychiatry and saw a talk therapist as well, and is engaged in arranging outpatient talk therapy and appointments. Regarding the Covid-19 diagnosis she is well past the onset of her symptoms and no longer requires isolation or quarantine. ED visits and hospital admission within 6 weeks of receiving the COVID vaccine.
Flu like symptoms...joint pains, chills, fever (101.5), nausea. 24 hours later fever 100.3.
1) Began with local reaction to Pneumovax: warmth, redness, swelling. 2) Over next 24 hours progressed to regional reaction with increased arm girth, elbow redness, warmth, swelling, pain and stiffness.  Treatment began today: ice, ibuprofen, Benadryl and hydrocodone.  Anticipate full recovery.
Patient woke up with red, bubbled itchy areas on the skin on her left hand. Later in the day she noticed she had several red itchy patches up her left arm as well as one near her elbow. They are not painful, oozing, or warm to the touch. No pain in the muscle, fever, headache. No change in feeling or appearance since then.
lymphadenopathy, started immediately after booster vaccine. Acute Pancreatitis happened one week after vaccine and immediately caused Appendicitis which I am currently being treated for.  Surgery will most likely be needed.
The school nurse called and stated the child had chicken pox. She stated that pt broke out with chickenpox lesions which spread from the neck to the arms face and trunk. Lesions were too numerous to count. Some itchiness was noted. Treated with Benadryl and calamine lotion.
Atypical varicella; fever then 50 lesions-vesicules, pustules, scabbed lesions-mainly on trunk, fewer on extremes.
Initial and follow up information has been received from a pharmacist and the daughter of a 58 yr old female with asthma. On 25Oct05, the pt was vaccinated with pneumococcal 23v polysaccharide vaccine (lot649988/0692P). In Oct 2005, the pt developed redness and swelling of injection site arm. The pt was prescribed antibiotics. It was further reported that the pt developed significant swelling, redness from the top of shoulder to the middle of forearm and pain. The pt sought unspecified medical attention. At the time of this report, the outcome of the events were unk. In follow up it was reported that the pt developed pneumonia (date unk). Additional information has been requested.
the arm is very red; swollen; the arm is very red, swollen, and tender; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (the arm is very red), SWELLING (swollen) and TENDERNESS (the arm is very red, swollen, and tender) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (the arm is very red), SWELLING (swollen) and TENDERNESS (the arm is very red, swollen, and tender). At the time of the report, ERYTHEMA (the arm is very red), SWELLING (swollen) and TENDERNESS (the arm is very red, swollen, and tender) had not resolved. Not Related   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Breakthrough case admission after 4 vaccines Pfizer 12/29/20 Lot# El0140;  Pfizer 1/15/21 Lot# EK9231;  Pfizer 8/30/21 Lot# FC3183;  MOderna 3/30/22 Lot# 027L21A
Pain at injection site, redness at site, swelling in axillary area, increase in baseline of fibromyalgia pain
patient gave an expired dose of PENTACEL vaccine today with no reported adverse event; Initial information received on 12-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient (unknown demographics) who was vaccinated with an expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 12-Jul-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ339AAA and expiry date: 05-Jul-2021) via an unknown route at an unknown administration site (expired product administered) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported that "one of our Medical Assistants gave an expired vaccine today. Does the vaccine need to be re-administered. Pentacel There is no more information for this report due to being a web case".  At the time of reporting, no adverse event was reported.   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.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 06-JUL-2018 the patient was vaccinated with an improperly stored  dose of VAQTA (lot # R003739 exp date 17-MAR-2019) (dose not reported) intramuscularly. There was a data logger issue reported. The temperature of excursion was 32°F up to 35°F (multiple excursions) for a time frame of 13 hours. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1807USA010173: US-009507513-1807USA010174: US-009507513-1807USA010175: US-009507513-1807USA010176: US-009507513-1807USA010177: US-009507513-1807USA010178: US-009507513-1807USA010214:
Mid morning day after the vaccine, I started feeling fatigue and mild headache and mild body aches. It slowly progressed to severe headache and body aches. I developed a low grade fever in the evening (about 4-5PM) and I alternated Tylenol and Motrin (100.4 to 100.8F) by Thursday morning it got to 101.7F and that is when I started developing a cough. I called on Thursday evening my employee health due to my low grade fever and then the next day they sent me to get tested for COVID and it was negative. The symptoms were still manageable and I kept with the Tylenol and Motrin. I also needed to use my rescue inhaler. By Saturday afternoon all symptoms had resolved.
A consumer report has been received. The report concerns a 49 year old, female consumer, who had been receiving Nasal FLUMIST QUADRIVALENT. The patient's medical history included jittery all over, shortness of breath and headache. The patient's concurrent disease(s) included Sulfa allergy. FLUMIST QUADRIVALENT started on 01-Oct-2013. The patient experienced jittery all over, shortness of breath and headache which started on 01-Oct-2013. At the time of reporting, the event of jittery all over, shortness of breath and headache was ongoing. The report was considered to be non-serious.
Pt was given MMRI on 06/17/04.  2 hours later, fever, 2pm-lethargy, anorexia, around 4pm. Headache, on 06/18/04 vomiting, rash. Stomach pain for 2 days, on Sunday testicular swelling spent day at ER.
3/15/2023 10 pm Felt like allergy symptoms, but it wasn?t feeling quite right, felt like something caught in upper chest.  Tested with an At Home COVID-19 test, positive.  Emailed Doctor that evening.  Started coughing on 3/16, this lasted about 3 days.  Doctor proscribed Lageviro and advised to treat symptomatically.   Chest felt better after the 3 day period.  Symptoms cleared up after 10 days, with a mild on again off again cough.  Fatigue lingered for a while, unknown length of time, after that.