chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included Peripheral vascular disease, Knee pain (Right.), Thrombocytopenia, Leukopenia, Sinus bradycardia, Rotator cuff tear, Cough, Bronchitis, Hypoxemia, Acute pharyngitis, Neck pain, Foreign body in ear, Secondary thrombocytopenia, Diverticulosis, Impaired fasting glucose, Cataract, UTI, Lumbar radiculopathy, Lumbar strain, Grover's disease, Vertigo, Renal insufficiency, Urinary retention, Change in bowel habits, Abdominal bloating, Abdominal pain, Diarrhea, Hearing loss, Adenoma and Laceration of leg. Previously administered products included for Product used for unknown indication: Influenza vaccine (Series 1) on 03-Oct-2018, Influenza vaccine (Series 2) on 15-Sep-2021 and Influenza vaccine (Series1) on 28-Sep-2021. Past adverse reactions to the above products included No adverse event with Influenza vaccine, Influenza vaccine and Influenza vaccine. Concurrent medical conditions included Hyperlipidemia (Hyperlipidemia with low HDL), Iron deficiency, BPH, GERD, Obstructive sleep apnea syndrome, Osteoarthritis, Meniere's disease and Allergic rhinitis. Concomitant products included OXYGEN for Hypoxemia and Obstructive sleep apnoea hypopnoea syndrome, SILDENAFIL CITRATE (SILDENAFIL [SILDENAFIL CITRATE]) for Sexual problem, VITAMIN D3, SELENIUM, SAW PALMETTO [SERENOA REPENS], FOLIC ACID, TOCOPHEROL (VITAMIN E [TOCOPHEROL]), SULFAMETHOXAZOLE, TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM), PANTOPRAZOLE, COENZYME Q10 [UBIDECARENONE], FLUOCINONIDE (FLUCINONIDE), ROSUVASTATIN, CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]), MELATONIN, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]) for an unknown indication.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: elevated (High) High and elevated (High) High. On an unknown date, C-reactive protein: elevated (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lung cancer screen, Skin cancer screen, Screening for Prostate cancer and colon cancer screen. Other concomitant medications included Centrum Silver oral tablet (Multiple vitamins Minerals) one by mouth once a day, Triple flex (glucosamine-chondroitin-MSM, 500-400-125 mg) oral tablet, one by mouth twice a day and SARS COV2 semi quantitative antibody 164090
Initial report received from a non-health care professional on 06 DECEMBER 2013. A 50-year-old female patient had received a dose of TENIVAC lot number U4591AA, intramuscularly in the left deltoid, on 5 DECEMBER 2013. It was reported that, 30 minutes after vaccination the patient experienced delirium, chills and fever to 103 F, bilateral knee pain and could not walk these events was started at 1 AM. The patient had received Ibuprofen 200 mg as corrective treatment. Laboratory details were not reported. At the time of this report the patient was not recovered. Documents held by sender: none
"1 cm area of ecchymosis with induration tenderness from upper shoulder to forearm. Area bruised". (Patient went to Urgent Care).
Pt described pain ranging from (L) neck down to (L) arm. States also numbness and tingling did not report earlier due to expected pain from injection. Now after one month, still painful - believe from neuritis.
Fever, chills with temperature range between 101.8 - 102.5 F while on acetaminophen to max 24 hour dose; unilateral left axillary and subpectoral adenopathy - easily palpable nodal conglomerate; fever resolved the next day; adenopathy resolved in 5-6 days
Presented 10/12/07 complaining of itchy, generalized vesicular rash which started about 2 weeks prior.
Arm pain, jaw pain, "feels like lymph nodes are swollen", no improvement after 2 weeks
Client felt dizzy after receiving vaccines and sat on the floor in the main lobby of the facility. Complained of nausea, dizziness, noted diaphoresis. EMS assessed client, client's parents declined transfer to hospital. EMT assessed client and declared vital signs stable. Client admitted to eating not eating since breakfast and was very nervous before receiving the vaccines.
booster shot office gave them .5 dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (booster shot office gave them .5 dose.) 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.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (booster shot office gave them .5 dose.). At the time of the report, ACCIDENTAL OVERDOSE (booster shot office gave them .5 dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported  Patient got his booster shot instead of getting .25 dose
On December 25th developed a rash that started on the stomach, spread down legs then up the back on December 26th, all over body by the December 28th.  Started off as a blistery area then turned to dry flakey skin,  on the 28th started itching.  by December 29th the itching had started to subside.  Rash did not occur on the face but was in the scalp area.  Patient took diphenhydramine but it die not help.  As of the time this report is being filed has not contacted any healthcare provider.
Headache, Myalgia, Fever, fatigue, chills, Temp 100.9 Narrative:
6/22/06 Mother reported at Immun clinic today that pt had reaction from injection which was given 4/20/06. He had a large knot on left leg which was red for 2 1/2 wks and visible for 1 month. And can still feel a bump 2 months later. Had taken him to MD and told injection was given wrong.
This consumer report (initial receipt 26-Feb-2014) concerns a 15 month old male patient. On an unspecified date, the patient received the flu vaccine (manufacturer and batch number not reported), the MMRII vaccine (batch number not reported) and VARIVAX (batch number not reported). On an unspecified date after immunisation, the patient had seizures, a fever for two months and was later diagnosed with autism. Outcome was reported as not recovered.
Injection site pain; Injection site redness; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old, male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0150) via an unspecified route of administration in the left arm on 02Apr2021 at 00:45 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient had history of allergies to sulfa-based antibiotics. Concomitant medication included tamsulosin (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Apr2021 at 13:00, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site redness, feeling unwell. The patient reported that the events lasted for 72 hours or so. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site redness, feeling unwell were resolved with lasting effects on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Painful injection site; High fever of 101.8 degree; Nauseous; Vomit (1x); Achy; Jaw hurt; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 7-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16May2022 at 15:45 as dose 1, single (Batch/Lot number: unknown) at the age of 7 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: if covid prior vaccination Yes. There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 17May2022 at 01:00, outcome "recovering", described as "Achy"; PYREXIA (non-serious) with onset 17May2022 at 01:00, outcome "recovering", described as "High fever of 101.8 degree"; PAIN IN JAW (non-serious) with onset 17May2022 at 01:00, outcome "recovering", described as "Jaw hurt"; NAUSEA (non-serious) with onset 17May2022 at 01:00, outcome "recovering", described as "Nauseous"; VACCINATION SITE PAIN (non-serious) with onset 17May2022 at 01:00, outcome "recovering", described as "Painful injection site"; VOMITING (non-serious) with onset 17May2022 at 01:00, outcome "recovering", described as "Vomit (1x)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, pyrexia, nausea, vomiting, pain, pain in jaw.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
allergic dermatitis on weaning course of Prednisone and cleared, I was seen by my allergist on January 18, 2021 for an allergic reaction that would not go away.. Now on a longer course of steroids Benadryl antibiotics creamsTriamcinilone for itching
Soreness on her arm; A little tiny rash (6 little dots that felt itchy.); Feel an itchy sensation on her leg, and arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced those 2 days after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine soreness on her arm, A week later a little tiny rash (6 little dots that felt itchy), feel an itchy sensation on her leg, and arm. Reporter wants to know how effective the Pfizer-BioNTech Covid-19 Vaccine would be with just one dose and if she could still receive the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine later than the recommended 3-week-interval if in case she decides to postpone her original schedule. The outcome of event soreness on her arm, feel an itchy sensation on her leg, and arm was unknown, a little tiny rash (6 little dots that felt itchy) was recovered. No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of erythema; 'knot' noted on left deltoid Itchy, but painful; pulse 77 to 94 from lying to standing; 'knot' noted on left deltoid Itchy, but painful/left lateral deltoid with 3.75 x 5 cm mildly tender; indurated area of erythema, with central erythematous punctum (presumed site of injection); indurated area of erythema, with central erythematous punctum (presumed site of injection); This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, 30mcg/0.3ml), intramuscular on 31Dec2020 15:38 (also reported as 08:30 am) at 0.3 mL, single at left deltoid for covid-19 immunization. Medical history included significant for Covid 19 infection (positive test 28Oct2020), shortness of breath, dizzy, hospitalized for decreased O2 saturation from 04Nov2020. Patient was treated with remdesivir for Covid 19 infection. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, it was unknown if patient had been tested for COVID-19. Patient felt dizzy after receiving injection on 01Jan2021, left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 01Jan2021; knot grew to 5x5 cm max size over 48 hours, itchy, but painful if tried to scratch. Some dizziness with position change. Examination: no fever, no orthostatism to BP, pulse 77 to 94 from lying to standing, left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Patient took diphenhydramine hydrochloride (BENADRYL) 03Jan2021, and cetirizine hydrochloride (ZYRTEC) 04Jan2021 for events (Instructed to take OTC antihistamine (cetirizine hydrochloride) daily until 7 days after symptoms resolve). Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment diphenhydramine, certitizine for events. The report is considered as non-serious. Outcome of events was unknown.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood pressure" (unspecified if ongoing); "emphysema" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical Course: Anti viral details product COVID 19 Treatment brand Pfizer treatment start date on 28Apr2022 and treatment stop date on 02May2022 indication treatment of COVID-19, adverse event return of symptoms cough, runny nose, sore throat, congestion. Fatigue  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd vax;became very pale w/ dec responsiveness at approx 1-1:30pm;V x 1 then went on to cry for about 1 hr;T 100.8 p/ apap given;slept from 3:30 till 7pm & was back to nl;
About 2 minutes after vaccine (Gardasil, 2nd dose), patient noticed pain, swelling/tightness of upper arm near vaccine, and streaks of slightly swollen reddened skin out to about 4 cm surrounding injection site.  Subsided within 8 minutes.  Treatment was MD assessment and Claritin 10mg reditab.
104 degree fever Severe pain and swelling at injection site Muscle pain Severe fatigue  Dizziness  Nausea
Pt was in COVID-19 Observation area pt complained of Headache , shakyness, and Nausea. B/P @ 128/53 P-82. Doctor available in Observation area to evaluate pt and pt taken to Clinic via W/C by  R.N..
Expired vaccine inadvertently administered. Patient was discharged at the clinic stable. No reports of any untoward reaction from mother yet.
Within a minute of administering vaccine both of patient's hands began to swell and turn bright red but no reports of itchiness and otherwise patient was fine and did not report any other symptoms suggesting a systemic allergic reaction. Oral Benadryl  was administered and patient was monitored for 30 minutes with no issues and no worsening symptoms, though the swelling and redness did not go down during that time. Patient mentioned a similar reaction happened after her 1st dose and that the swelling and redness took several hours to return to normal and that a similar reaction happens when she eats strawberries. Patient left on her own after 30 minutes (could not require her to stay) stating she was fine.
No additional AE's and no PQC' s were reported; a GARDASIL 9 vaccine was administered after undergoing a temperature excursion; This spontaneous report was received from licensed practitioner nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant therapies were not reported.  The nurse reported that on 17-JAN-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot  number 1780867 with expiration date 08-AUG-2023 for use as direct for the prevention of human papilloma virus (Dosage, route of administration, and anatomical location were not provided), which underwent a temperature excursion (Temperature excursion and time frame were not reported) (Product storage error). No additional adverse events (AE's) were not reported.
Hives at both upper arms & developing on neck/back approx 2 hrs after immun. No SOB/wheeze/dysphagia was observed in ER b/c new lesions appearing & dc'd.
Rash and swelling on (L) upper arm - inj site. Rash around patients mouth, fever since Friday night (3/3/17).
patient is only 17 years old and should not have received the moderna as it is only approved for 18 years of age and older
This spontaneous report as received from a medical assistant refers to unknown number of patients. On unknown date, patient were vaccinated with a dose of GARDASIL, (dose, route, lot number and expiration date were not provided). The medical assistant reported that in the past there had been an unspecified number of patients who have experienced pain at the injection site when GARDASIL was administered. The reporter had no other information on these patients. The patient's outcome, and the relatedness between the event and suspect therapy was not provided. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a healthcare worker referring to patients at 8 months of age or less than 12 months of age. On unknown dates the patients were vaccinated with MMR II (lot#, expiration date, dose and route unspecified). No adverse effects reported. Additional information has been requested.
LOCALIZED LARGE AREA OF SWELLING, RED, HOT, ITCHY.
About a week after getting my Pfizer booster (I was previously vaccinated with Johnson & Johnson on May 29, 2021), I caught a cold, but had very unusual symptoms.  It started with tinnitus in my left ear, and eventually my ear became so inflamed and filled with fluid, I could not hear out of my left ear for several days.  Since it coincided with the Thanksgiving holiday, I wasn't able to get in to see a doctor until the following Monday (29th of November).  The doctor checked my ears, and prescribed Amoxicilin and steroids, but they did not seem to improve the ear symptoms.  The tissue surrounding my eustachian tubes still feels very inflamed, and I am still getting popping/crackling sounds, even though my cold symptoms have been resolved for weeks now.  I plan to follow up with my doctor, but had not yet been able to do so.
Information has been received from a 60 year old male with depression and allergy to codeine who on 07-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included citalopram. It was reported that the patient realized "yesterday morning", 09-MAR-2011, (previously reported as 09-SEP-2011), the injection site is extremely itchy, swollen, warm, red and it looks like a boil. The consumer mentioned he would call his HCP. He was given unspecified treatment. And no lab diagnostics studies performed. The patient did not seek medical attention. The patient present status was unknown. Additional information has been requested.
bumps; cold sore; felt like flu; tired; sore arm; felt sick; This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 5th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On 6th June 2019, 1 days after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced influenza like illness, tiredness and pain in arm. On 4th November 2019, the patient experienced cold sores. On 10th November 2019, the patient experienced papular rash. On an unknown date, the patient experienced feeling unwell. On an unknown date, the outcome of the influenza like illness, tiredness, pain in arm and feeling unwell were recovered/resolved and the outcome of the cold sores and papular rash were not recovered/not resolved.   It was unknown if the reporter considered the influenza like illness, tiredness, pain in arm, feeling unwell, cold sores and papular rash to be related to Shingrix. It was unknown if the reporter considered the cold sores and papular rash to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received dose of Shingrix and felt like flu and was tired and had a sore arm. The patient felt sick for about 1 week before the symptoms resolved. On 4th November 2019, the patient experienced cold sore and last night before day of reporting, the patient noticed some bumps coming up on body. The reporter consented to follow up.