chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt lethargic; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt lethargic), PYREXIA (Fever) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No COVID-19 diagnosis was reported.  Concurrent medical conditions included Blood pressure high. Concomitant products included METOPROLOL, SIMVASTATIN, APIXABAN (ELIQUIS) and AMLODIPINE for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LETHARGY (felt lethargic), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, LETHARGY (felt lethargic), PYREXIA (Fever) and HEADACHE (Headache) had resolved.            Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that fever, headache and she felt lethargic, with 1st dose this lasted 3 or 4 days.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728878 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728878:(Bivalent Case)
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 08-DEC-2009 the patient received an expired dose of PNEUMOVAX23 25/0.5 (lot # 661527/0112Y, exp date 29-NOV-2009), 0.5 ml, intramuscular. Concomitant medications were not reported. No adverse effect reported. This case is linked to cases 1307USA015839, 1307USA015842, 1307USA015841, and 1307USA015840, via same reporter link. Additional information has been requested.
Hives around heat starting the following day,  lasted about 6 days  Back and muscle pain starting about day 4 that's still ongoing.   Same as stomach and gastrointestinal issues
Patient reportedly fell and hit his head as he and his mother were checking out. Our front desk staff called for a doctor. He was on the ground and conscious when we got to him. BP was checked in 15 minute intervals, pulse ox and pulse for an hour. He had a knot on the (R) side of head from falling.
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Sep2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient took any other medications/products within two weeks of starting COVID-19 treatment was mentioned as yes. Tylenol was received as treatment for the adverse event. The patient was previously received a COVID-19 vaccine. Product COVID-19 Treatment, brand paxlovid, treatment start date on 24Dec2022 and  treatment stop date on 29Dec2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Hives appeared by 7PM that evening, by 12/20/2009 wheezing and coughing controlled by albuterol, 12/24/2009 still on steroids, antihistamines, not responding to albuterol breathing treatments, taken to ER for shot of epinephren.  As of 1/4/2010 still has hives and continues to be on antihistamines.
Peripheral neuropathy beginning gradually two to three weeks after second shot, affecting feet, lower legs, hands and face. Current treatment: Gabapentn 600 mg per day.
PATIENT SAID THE SURROUNDING AREA AND NOT THE ACTUAL INJECTION SITE WAS BLISTERING. HE CAME TO THE PHARMACIST WHO ADMINISTERED THE VACCINE THE FOLLOWING DAY AND WAS GIVEN ADVIL AND SOME ANTIBIOTIC CREAM. TODAY 8/26/16 PATIENT COMES BACK WITH IS SKIN BEING PEELED LEAST A QUARTER INCH AWAY FROM THE VACCINATION AREA. SUGGESTED TO SEE THE DOCTOR WAS NOT SURE IF ITS IS DUE TO THE VACCINATION ITSELF.
Information has been received from a certified medical assistant concerning two patients who were vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently, the patients experienced cellulitis-like reactions. The patients were treated with an antibiotic. At the time of the report it was unknown if the patients recovered. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. In follow-up it was reported by the physician that a patient with no pre-existing allergies, birth defects, or medical conditions was vaccinated intramuscularly in the a.m., on approximately 08-FEB-2007, with pneumococcal 23v polysaccharide vaccine, (Lot # 651406/0620F). It was reported that the patient had a localized cellulitic-like reaction. The patient had a clinical exam only. It was reported that the patient recovered. The reporter stated that there were three other patients that had localised cellulitic-like reactions after receiving the pneumococcal 23v polysaccharide vaccine, (WAES # 0702USA03808, #0711USA03296, 0711USA03298). Additional information has been requested.
Moderna vaccine was administered outside of source- reported by patient ? NO LOT NUMBER WERE SUPPLIED  I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 6/23/2021 DM 2 W HYPERLIPIDEMIA I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 6/23/2021 ANEMIA OF CHRONIC DISEASE
4-month-old male accompanied by mother presenting with fever and vomiting that began yesterday.  Mother states that the patient had received his scheduled vaccinations yesterday and had recently developed a fever.  Mother states the fever was as high as 100.1 °F.  The mother states that the patient had one episode of vomiting earlier today.
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of Pneumovax 23. Within a few hours after the administration, the patient experienced severe arm pain extending from the injection site to the elbow. The patient also experienced difficulty moving the affected arm which has caused significant disability. Unspecified medical attention was sought. It is unknown if laboratory diagnostic studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of 4 reports from the same source. Additional information has been requested.
Monday evening around 5-6 pm started w/ slight fever at 99 F with a headache. Then temp increased 101 and pt. felt dizzy about 2 hours after vaccines given. No respiratory symptoms, or anaphylaxis. Overall sense of "Not feeling well". She felt anxious got hives. The hives went away in a few hours. Per pt. anxious felt not right x 24 hours. By Wednesday was OK.
This 41 year old patient reported having bilateral 20/20 vision prior to receipt of his smallpox vaccination and oral typhoid on 2/18/2013. He advised that evening he couldn't read large highway signs driving home having to close his left eye 1/2 way to get clear vision. A few days later he noted same problem had extended to his right eye. He advised he was very careful not to touch SPV site; and that he did not touch his eyes after dressing changes. His SPV site progressed normally with a normal site reaction. His medical records document on 3/1/2013 (day 10 after vaccinations) he reported to optometry complaining of "major changes in left eye vision". Provider noted left eye had 20/25 vision with right 20/20 uncorrected. Cornea had "diffuse superficial keratitis (SPK) with RTBUT and left eye showing oblique scar thru pupil from 2-8 superior mid pupil" otherwise a normal exam (surrounding eyelid and eye had no pustules, lesions, abrasions, abnormalities, etc). An optical tomography showed left eye with "temp thickening of macular zone and right eye was fine". He was given a diagnosis of astigmatism, presbyopia, and superficial keratitis left eye and treated with prednisolone 1% ophth susp drops. Follow up complaints of painful redness in left eye 3/8/2013 (day 17) was treated with lubricant eye drops which did not help his pain (3/10). On 3/11/2013 his eyes felt better but still hurt. A slit lamp exam again showed diagonal scar thru left eye line of sight (denied injury or surgery) with right eye 20/20 and left eye 20/20+1.00 added. He was instructed to taper ophth steroids over next 10 days then stop. On 6/5/2013 he was seen by flight surgeon for SFFP. Prior aviation examinations were held due to March eye issues and he was given a medication refill for herpes simplex (Acyclovir prescribed since 2/2009 for recurrent cold sore outbreaks-no documentation of frequency of outbreaks). On 6/25/2013 he completed his aviation SFFP physical. Another medical exam on 7/10/2013 listed patient "wants a second opinion as he may resume flying and is required to have vision corrected to 20/20/OU. He currently denies any issues with distance vision." Visual exam: 20/25 OS, 20/20 OD and 20/20 OU. He was diagnosed with presbyopia and referred to ophthalmology.
STARTED WITH PAIN AND SWELLING AT INJ SITE PROGRESSING TO TINGLING FINGERS OF SAME ARE TO NUMBNESS IN ARMPIT AREA. NEXT DAY EXPERIENCED ABOVE SX PLUS FATIGUE AND WEAKNESS
A report has been received from a Health Professional concerning a 1 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on an unknown date. It was reported that reporter inadvertently administered FLUMIST quadrivalent to 7 children under 2 years of age which started on 17-Nov-2014. The outcome of the event of inadvertently administered FLUMIST quadrivalent to 7 children under 2 years of age was unknown. The report was considered to be non-serious.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: after immunization patient was sat down for observation. shortly after, patient felt weak in her chair. pharmacist was called to clinic. upon arrival patient continued to feel weak. while speaking with her mother next to her, patient fainted in her chair and was promptly brought tot he floor and legs raised. patient awoke shortly after and was given water. after a few minutes patient fully recoverd. patient stated for another 15 minutes for further observation. patient had no further issues
hearing loss; vision issues; On or about 2009, Patient was administered the ZOSTAVAX vaccine; Information has been received regarding a case in litigation from a lawyer referring to a 55 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) in a Family Practice for the long-term prevention of shingles and zoster-related conditions (Inappropriate schedule of product administration). Subsequently, the patient was treated by providers for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: hearing loss and vision issues. The outcome of the events hearing loss and vision issues was unknown.  Upon internal review, hearing loss was determined to be medically significant.
SkinRash, Rash, rash at the injection site, itchy eyes, nasal congestion, rhinnorrhea Narrative:
ADVERSE EVENT BEGIN WITH PAIN AND STIFFNESS IN NECK, THEN PAIN AND STIFFNESS PLUS ERYTHEMA AND EDEMA IN ARMS, FOREARMS, THORAX ANT AND POST, THIGHS, LEGS, ANKLES AND FEET.  THIS WAS FOLLOWED BY THE DEVELOPMENT OF BULLOUS LESIONS ON PINNAE, ARMS, HANDS, LEGS AND FEET. HIS FACE WAS SPARED. HE HAD NO FEVER.  HE DEVELOPED MARKED EDEMA IN ALL AREAS, SO SEVERE SHOES COULD NOT BE DONNED.  HE SOUGHT TREATMENT FROM PCP AND DERMATOLOGIST, HAD 4 (FOUR) SKIN BIOPSIES, LAST FROM RIGHT LATERAL KNEE SKIN WAS POSITIVE FOR BULLOUS PEMPHIGOID.  HE WAS TREATED WITH TRIAMCINOLONE TOPICALLY, PREDNISONE ORALLY, CLOBETASOL TOPICALLY, DOXYCYCLINE PO, NIACINAMIDE PO.  AS HE IMPROVED HE DESQUAMATED DIFFUSELY AND BULLOUS LESIONS ARE HEALING.  HE HAD NO EYE, MUCOSAL, GI OR GENITAL INVOLVEMENT.  HE WAS ABLE TO RETURN TO WORK SEVEN WEEKS AFTER THIS ILLNESS BEGAN.
Trouble breathing starting within 10-days. Saw a Pulmonologist and determined GERD related and prescribed Prilosec. Seizures/loss of motor control started around August 6th and were occurring around 1-2 times per days. ER and transfer to Hospital admission on 8/12/2021. Starting around August 21st, loss of feeling in the lower extremities, loss of motor control below the waist, increased Knee/Joint pain, currently confined to wheelchair with no firm diagnosis to cause.
Chills; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), 24 hrs after the suspect product(s) administration, outcome "unknown"; FATIGUE (non-serious), 24 hrs after the suspect product(s) administration, outcome "unknown".  Additional information: Reported as, AE 24 hours after the bivalent booster. Symptoms of chills and fatigue. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient was diagnosed with Crohn's disease; This spontaneous report was received from a medical assistant via a company representative, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown by reporter.      In 2017, the patient received 3 doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis, an later, at unspecified date, she was diagnosed with Crohn's disease. The patient's mother, who was a registered nurse, believed that quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused the patient's Crohn's disease but the prescriber did not feel it was related. It was unknown if patient received treatment for the adverse experience, if any laboratory study was performed or if medical attention was sought. At reporting time, patient was not recovered from Crohn's disease. The causality assessment was not reported.  Upon internal review, Crohn's disease was considered a medically significant event.
Erythematous, hot rash at injection site; Erythematous, hot rash at injection site; This is a spontaneous report from a contactable physician based on the information reported to Pfizer on behalf of Moderna, (Manufacturer Control No: MOD-2021-068713).   A 121-year-old female patient (secretary) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown; Expiration date: Not reported), via intramuscular route on 02Apr2021 as dose 1, single ( at the age of 121-years-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. On 05Apr2021, the patient experienced Erythematous, hot rash at injection site. It measures 3.5 x 2.5 inches, north to south. It was reported that, patient received the injection last Friday (02Apr2021), but the rash did not develop until Monday (05Apr2021). It is better today (unspecified date) and seems to be decreasing in size. Further information and Consent for Safety to contact was not obtained as caller was in a hurry to get off the phone. There is no product complaint associated with this case. The outcome of both event was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
101 fever for 36 hours after injection.; Tired; achy; chills; Injection site reaction with swollen and tender arm.; Injection site reaction with swollen and tender arm./Swollen area tender to touch. Significant swollen lymph node on left side between shoulder and neck.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Dec2021 (Batch/Lot number: unknown) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer ,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not, available/provided to reporter at the, time of report completion,, prev dose dose number=1), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01Jan2022, outcome "not recovered", described as "significant swollen lymph node on left side between shoulder and neck."; PYREXIA (non-serious) with onset 02Jan2022, outcome "not recovered", described as "101 fever for 36 hours after injection."; FATIGUE (non-serious) with onset 02Jan2022, outcome "not recovered", described as "Tired"; PAIN (non-serious) with onset 02Jan2022, outcome "not recovered", described as "achy"; CHILLS (non-serious) with onset 02Jan2022, outcome "not recovered", described as "chills"; PERIPHERAL SWELLING (non-serious) with onset 02Jan2022, outcome "not recovered", described as "Injection site reaction with swollen and tender arm."; TENDERNESS (non-serious) with onset 01Jan2022, outcome "not recovered", described as "Injection site reaction with swollen and tender arm./Swollen area tender to touch.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, pyrexia, fatigue, pain, chills, peripheral swelling, tenderness.  Additional information: Patient did not receive other vaccine in four weeks. AE treatment: Ibuprofen. If Covid prior vaccination: Yes. If Covid tested post vaccination: No. known allergies: NA. other medical history: NA  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12/19/21 Pt had a positive COVID test; given Vitamin C, D and zinc; 12/27/21 brought to ED with persistent more SOB, altered mental status; BP dropped, apneic; code initiated; intubated; oropharynx full or purulence; purulence continued through ET tube; pt didn't respond, no pulse; pt passed away in the ED
Right arm was sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included PNEUMOCOCCAL VACCINE (PNEUMONIA SHOT).   On 25th August 2021, the patient received the 1st dose of Shingles vaccine. In August 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for himself or herself. The age at vaccination was not reported. The patient reported that the got Pneumonia shot in left arm. The patient also reported that the got shingles vaccine in right arm right and stated that the right arm was sore for 2 days.  No reddish and no fever. The patient's 2nd shot was due in October 2021. The patient's contacts details was not provided so follow up was not possible.
Information has been received from a registered nurse concerning a 12 month old male twin with a history of premature delivery who on 12-FEB-2007 at 14:30 was vaccinated with a PO first dose of Rotateq (lot # 656105/1232F). Concomitant vaccination administered that day at 14:30 included an IM first dose in the left thigh of Pediarix (lot # AC21B092AA), an IM first dose in the left thigh of ActHib (lot # UE704AA), and a first IM dose in the right thigh of Prevnar (lot # B08672K). On 12-FEB-2007 at 16:30 the patient developed diarrhea. A doctors visit was sought. There were no laboratory tests performed. Subsequently, the patient recovered from diarrhea on an unspecified date. There was no product quality complaint involved. It was reported that the patient's twin sister (WAES# 0703USA00869) experienced a similar event after vaccination with Rotateq (lot # 656105/1232F). Additional information is not expected.