chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the Moderna COVID-19 Vaccine Bivalent booster after a temperature excursion; Facility had a temperature excursion in the freezer; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent booster after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer) and NO ADVERSE EVENT (No Adverse Event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent booster after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent booster after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent booster after a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer).    No concomitant medications were reported.   The facility had a temperature excursion in the freezer. They had an inspection and saw that their DDL was not recording the temperatures.  At the time of the excursion, the vaccine was in frozen storage. The vaccines were in broken cartons with vial size of 2.5 ml and 5.5 ml.  Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.  The excursion duration was unknown. The vaccine was returned to the freezer.   The visual inspection showed the vaccine state as still frozen.  The vial underwent temperature excursion for the first time.  No treatment information was provided by the reporter.
Arm red, swollen to elbow by evening same day. In morning, very red, swollen to wrist. Painful. Given steroid injection and oral CLARINEX 5mg x10 days.
Information has been received from a published literature article. Nephrotic syndrome (NS) comprises of several signs and symptoms that denote kidney damage, which include proteinuria, hypoalbuminemia, hyperlipidemia, and edema. In addition, immune abnormalities have been reported to be associated with NS. We present 3 patients with congenital NS who demonstrate unique patterns of immune deficiency and illustrate the importance of immune evaluation in this condition. Case Report: Three 4-year old patients (two males and one female) presented with chronic nasal congestion, recurrent otitis and a history of frequent relapsing idiopathic minimal change NS. Immune evaluation revealed normal lymphocyte subsets, IgA and IgM, as well as protective antibody titers for tetanus and diphtheria. However, they were found to have IgG 300-400 and non-protective pneumococcal antibodies despite vaccination. Variability was present in lymphocyte mitogen stimulation test with low pokeweed mitogen simulation response. This case report refers to one of the 4 year old male patient. Conclusion: Children with NS may have a high prevalence of impaired antibody response to pneumococci and pneumococcal polysaccharide vaccine, which may lead to susceptibility to bacterial infections, particularly pneumococci. Thus, immune evaluation is warranted in this condition regardless of remission state. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous prospective pregnancy report as received from a registered nurse for GARDASIL, a pregnancy registry product, refers to a 17 years old female patient with asthma, PERCOCET allergy and seasonal allergy. The patient was vaccinated with dose 1 of GARDASIL (dose, route and lot # not reported) on 18-APR-2012. Concomitant medications included albuterol. The patient was vaccinated with dose 2 of GARDASIL (dose, route and lot # not reported) on 21-AUG-2012. The patient became pregnant with a last menstrual period on 02-AUG-2012, and an estimated delivery date: 09-MAY-2013. The patient went to an office visit, and on an unspecified date blood pregnancy test was positive. Initial exposure to GARDASIL was at 0 week(s). The patient was exposed to GARDASIL during trimester 1. No adverse effects were reported. Additional information has been requested.
No additional adverse effect reported.; The nurse reports that patient received improperly stored PEDVAXHIB; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not the reported.  On 19-JUN-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) injection, as prophylaxis (lot number S023646 which has been verified to be valid, expiration date reported and validated as 31-MAR-2022) (dose, route of administration, vaccination scheme and anatomical site of injection were not reported). The administered dose of the vaccine experienced a temperature total time and highest temperature above 47 degrees Fahrenheit (F)/9 degrees Celsius (C) 9.15 C, during a time frame of 15 minutes, as recorded by a data logger. There was a previous temperature excursion with total time and highest temperature above 47 F/9 C 8.62 C, during a time frame of 11 minutes. No additional adverse effect reported.
Missed window for second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed window for second dose) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed window for second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed window for second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter
pt recvd vax;baby fell asleep; mom instructed by rn to wake pt & feed;RN called back p/ pt fell asleep p/ 3min feed; T 103.8;
pt recv vax 30OCT96 & 31OCT96 rt arm swollen, red, warm to touch;1NOV96 rt shoulder, arm to elbow swollen, warm to touch, red, hard;cellulitis severe rt arm secondary allerg react;
Boostrix administered intravenously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 22-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) for prophylaxis.   On 21st April 2022, the patient received Boostrix (intravenous). On 21st April 2022, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 21-APR-2022  Reporter's Comments: Pharmacist reporting Boostrix administered intravenously. Reported information was all that health care professional (HCP) provided at this time. HCP gave permission for safety team to follow up. The reporter consented to follow up. Additional Supportive Information: the patient got Boostrix dose via IV route, which led to intramuscular formulation administered by other route.
My eye sight kind of sort of dead; Seizures; tearing my left tendon; Nausea; Pain in ankle; This is a spontaneous report from a contactable consumer (patient). A 55-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: FE3592), via an unspecified route of administration, administered in Left arm on an unspecified date as dose 3, single for COVID-19 immunization. Medical history included asthma, where patient don't use the inhaler every day, and migraine from an unknown date and is Immunocompromised. Concomitant medications included oxcarbazepine; cefaclor; fluticasone; quetiapine fumarate (SEROQUEL) and amitriptyline hydrochloride (TRIPTA) all for an unspecified indication. Historical vaccine included first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, as single dose for COVID-19 immunization and the patient experienced seizures and had a bad reaction/wicked reaction on an unspecified date after the second dose. On an unspecified date, after the third dose, patient had reaction, patient experienced nausea and had pain in the ankle, also was ended up in tearing of left tendon, which lead to calling of ambulance. Patient had taken all of ondansetron and Oxycodone 5 mg was used in the emergency room and was sent out with prescription too. Patient was given Geodon (off label use). Also reported, that patient had seizures. Patient had bunch of lab tests, where results were unknown. The events nausea, pain in the ankle, tearing of left tendon resulted in emergency room visit. The outcome of the event arthralgia was recovering, while of other events was unknown.
Pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 35-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 24-Dec-2020 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 30-Jul-2020 and the estimated date of delivery was 30-May-2021. On 24-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 24-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) 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.   No Concomitant medications were provided. No treatment information provided.  This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
This spontaneous report as received from a Registered Nurse refers to a currently 51 year old patient of unknown gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 injection, lot # L003188, expiration date 06-JUL-2016 in the arm (dose and route of administration were not reported). On the same day, the patient received FLUZONE (formulation, dose, lot #, expiration date and route of administration were not reported). On an unknown date, the patient experienced nausea, a headache, "terribly achy body" and fever. It was also reported that the patient's arm was red and she/he had a knot the size of a baseball at the injection site after being vaccinated with PNEUMOVAX23. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX23 was not reported. The patient sought unspecified medical attention. This is one of the several reports received from the same reporter. Additional information has been requested.
p/vax pt felt like fainting & went pale then was stiff (tonic) w/hands for about 5 seconds; came to & was crying & shaking; c/o numbness of hands & feet; hyperventilating; given o2 by mask
Intense inflammation including turgescence, heat, and edema spreading to entire thigh, surrounding administration site, over 48 hour period. Low grade fever.
Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient complained about nausea/feeling sick within 10 minutes of vaccine. Had come back into a quieter area in the pharmacy to rest with  head down. Patient vomited around minute 15 post-vaccination. Patient said she felt relief/ok after vomitting. Her pulse felt regular rhythm and she didnt feel dizzy/look pale or clammy. Had her rest again, after another 15 minutes she vomitted 2nd time. She mentioned this has happened with other vaccines. Let her go when she felt fine made sure ok to drive
Sudden onset shortness of breath, wheezing started several minutes after leaving office. Pt still with same symptoms today.
Information has been received from a consumer concerning her 15 year old daughter, with an allergy to pollen and a history of tonsillectomy, who on 04-OCT-2007 and 04-Dec-2007 was vaccinated with her first and second doses, respectively of Gardasil (lot #s not reported). "Sometime later in December 2007", the patient began to have breathing problems (NOS), sometimes accompanied by a rapid heart beat. Also, it was reported that she has been much more fatigued than usual. It was reported that periodically, some of these episodes have been very severe and temporarily incapacitate her. Usually, the breathing problems last for one or two minutes and then they dissipate. The patient's breathing problems and fatigue persisted. Unspecified medical attention was sought. A CAT scan endoscopy and echocardiogram are schedule to be done in March, 2008. Additional information has been requested. Follow-up information was received from the physician and nurse who reported that the patient was an active dancer who developed shortness of breath after dancing. She was referred for an allergy and asthma evaluation as well as a cardiac evaluation. Her allergy and asthma tests as well as echocariogram were negative, and she was ruled out as having cardiac, asthma or allergy problems. On an unspecified date she was diagnosed with excercise induce reactive airways disease and bronchospasm. The doctor stated that the rapid heart beat and breathing problems (shortness of breath) were symptoms of this. These events (as well as the fatigue) were considered non-serious. At the time of this report the patient still continued to occasionally have this breathing related reaction after she danced but was reported as stable. The physician also reported that on 18-FEB-2008, the patient was evaluated for joint pain and achey muscles (also considered non-serious). The patient was diagnosed with arthralgia and bronchospasm. All lab work including CBC, ANA, ESR and others were within normal limits (labs not provided). On 26-FEB-2008, the patient was seen in the office and she reported that her joint pain and achey muscles were better at that time. During the visit she presented with a complaint of back pain and lump on the left side of her throat (onset date 25-FEB-2008). The patient was diagnosed with sinusitis and treated with AMOXICILLIN 500 mg TID x 10 days. At the time of this report it was unknown if the patient had recovered from these events.
72 hrs p/receiving inject of vax pt devel fever, pain redness & edema of rt arm which required ER treatment & ATB therapy for 3 days p/;
Information has been received from a registered nurse (R.N.) concerning her 15-year-old daughter who on an unspecified date was vaccinated with a second dose of Varivax. Subsequently, the patient experienced cellulitis after vaccination. It was unspecified if medical attention was sought. No outcome was reported. The patient's sibling also had adverse experiences following vaccination (WAES# 0609USA04120 and 0609USA02450). Additional information has been requested.
No additional adverse events; the dose of GARDASIL 9 expired on 04/29/2021 and was administered today on 05/05/2021; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  The reporter was calling to verify if the potency of a dose of expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was still supported that expired on 29-APR-2021. The reporter stated the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) expired on 29-APR-2021 and was administered on 05-MAY-2021 (0.5 ml, lot # R017134, expiration date 29-APR-2021; route was not reported) for prophylaxis (expired product administered).    The reporter stated there was no previous temperature excursions reported on this dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). This expired dose was found supported by memo. No additional adverse events were reported. Device was not available for evaluation (obtain was false). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R017134; expirationdate: 29-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Severe muscle pain, I jumped off the needle. She reinserted same needle and added a tetanus/pertussis shot. I had had an allergy shot at 11am, 2 hours prior. I turned down shingles shot as I never had chicken pox and was vaccinated for it in 2012? I believe. In 24 hours extremely painful, now more so at 48 hours post injection. Site is hot, swollen, stiff, shoulder joint and neck are quite stiff and painful. Hydrocodone alleviates a lot.
Left thigh redness, increased warmth and firmness, cellulitis cephalexin oral antibiotic.
pt started to feel nausea and vomited about 10 min after recieving his first hep a vaccine.  we took pt back to an exam room layed him down end elevated his legs w/ cool compresses to the head.  he stayed like ths for about 40 min befor e feeling better.
Screamed for 7 hours.  Had fever of 102.5. No wet diapers.  Went to ER 10/6/16.
PATIENT REPORTS EXPERIENCING SHOOTING PAIN ALL OVER HER ELBOW. PATIENT VISITED FAMILY PHYSICIAN WHO RECOMMENDED PHYSICAL THERAPY. SHE STATES THAT SHE THINKS SHOT WAS GIVEN TOO HIGH.  (PHARMACIST WHO ADMINISTERED SHOT WAS CAREFUL AND BELIEVES SHOT PLACEMENT WAS CORRECT (2-3 FINGERS  BELOW SHOULDER), HOWEVER,  PATIENT IS STILL  HAVING PAIN.)
I got home and felt fine and a bit fatigued 3 hours after vaccine. It wasn't until the next day I started getting brain fog and a tingling sensation in the back of my neck. It started at the top of my head and to the center of my spine and it was intense and felt like someone was tickling me from the inside and felt like sciatica and it got to a point it was constant for three weeks and I couldn't concentrate during work, and it was so painful. I was dizzy and running into walls and couldn't walk straight and felt like I was drunk when I laid down at night because the room was spinning and when I walked around, I felt dizzy and the only time I didn't feel dizzy was when I was sitting at a desk. I had random vomiting periodically throughout this time but not every day and maybe once a week. The dizziness, brain fog, pins and needles feeling were the most debilitating. It was also accompanied by a headache and bursts of pain in head, but it would go away after two seconds, and it wasn't like a headache or migraine but brain zaps. That lasted three weeks. Those were the main symptoms, but I also had a hard time concentrating and couldn't really breathe and I had total fatigue and couldn't stay awake at all. I did a neuro exam and I had gotten an MRI a year before all of this started and so they double checked that MRI to see if I had MS or brain tumor and they didn't and they're unsure as to what is going on. After a month most of the symptoms went away and after a month and a half everything went away. The pins and needles things and majority of symptoms also happened one year before when I had an infection. Maybe my immune system had a reaction.
11SEP91 mom called & stated pt c/o seeing red & blue dots, nausea, vomited once, feels dizzy, & shaky w/joint achiness; fever 101, rash on legs, can't stand up-feels too sick; mom told to call MD; MD states either flu or rxn to MMR or comb.
pt recv vax 27MAR95 1115AM & reported lt arm pain radiating into neck called MD; backache, neck ache, diff sleeping & feeling hot alternating w/cold;adm to hosp, to ICU;liver, renal & cardiac failure; pt died 13APR95
Presents today for vaccinations. Needs Meningitis and TDAP. No complaints. Received vaccination in the past with no reaction.    After receiving the injection, began feeling light headed and dizzy. Patient appeared pale. Did not appear to have an seizure like activity. Respirations were easy and unlabored. However, blood pressure was normal. Patient was still awake and alert. Room was hot. Patient did  not have food to eat prior to coming to clinic.    After resting and ice pack placed on the back of the neck, patient blood pressure was normal, heart rate was normal. Still awake and alert.    Repeat blood pressure and HR - normal  Advised mom that this is not a normal reaction after receiving vaccine. Gave parent number to report to VARES regarding.  Also advised the he not receive Menactra in the future. Mother verbalized understanding and agreement.    This provider will report this reaction as well.
Does not itch, hurts. Several hours later after vaccines, noted swelling and child was complaining of pain. Denies fevers. Denies other trauma. Lesions (raised lesion, straw colored drainage hot to touch, tender, measuring 3cm X 3cm. No streaking. No inguinal lymph node swelling). Treated as Cellulitis with Cephalexin 250 mg/5 mL oral suspension - Take 3 mL twice a day by oral route with meals for 10 days. Follow up scheduled 3/26/18.
Shingles vaccine also on March 10.  I've been keeping track of my menstrual periods since February 2020 and have been regular until March 2021. My periods were always regular and light to normal flow. The dates of my periods have been: January 6 February 1 March 7 March 30 April 18 May 2 May 17 Also, much heavier flow on the dates beginning March 30. I wanted to report this because I've been reading that changes in menstruation may be a vaccine side effect.
On this date CDC required the Bivalent Booster and this patient was given the COVID-19 MOD 6-12/A Booster.