chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash x 1 day, papules on skin, itchy, no fever, acts fine.
No other symptoms or other AE reported; dose of VARIVAX was given following temperature excursion; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  A temperature excursion of varicella virus vaccine live (oka/merck) (VARIVAX) was registered as 7.4 degrees Fahrenheit for 10 minutes on 01-MAR-2022. On 14-MAR-2022, the patient was vaccinated with the improperly storage dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route were not provided) with lot # U022732 and expiration date of 20-JUL-2023 for prophylaxis. There was no previous temperature excursion. No other symptoms or other adverse event (AE) reported.  This is one of four cases received from the same reporter.; Sender's Comments:  US-009507513-2203USA010197: US-009507513-2203USA010326: US-009507513-2203USA010401:
Significant lightheadedness and mild vertigo, beginning 30 minutes after injection and lasting 5-6 hours.
About 5 minutes after I received my shot I started getting very sharp stabbing pains in my left leg. I reported it to two pharmacists at the table where I received the shot and they said they haven?t ever heard of that being a side effect, so just sit for a while and rub it out and stretch it. I felt lightheaded and the sharp pain (take my breath away) pain kept happening every few minutes. I stayed for observation for an hour, and started to feel a little better so I walked to my car. I drove to my pharmacist close to my house to ask her what she would recommend, and she said to try Tylenol . The stabbing pain kept happening on and off all day yesterday, causing weakness in my leg. Today I woke up and it has been achy, tingling, burning And somewhat numb. After researching online whether these symptoms have happened to anyone else, I found that there were some concerns about these symptoms. I?m concerned that it may be Transverse M
Patient reports redness and swelling that she describes as a "rash" accompanied by pain and tenderness. Patient states that symptoms began the day after receiving vaccinations but have improved as of today, 5/14/18. Patient still has some redness and swelling, but she reports an improvement in symptoms.
PATIENT REPORTED TO PHARMACY TODAY, 11/25/2019, WITH SWELLING AND REDNESS OVER ENTIRE DELTOID AREA AND ABOUT 1/4 INCH PAST THE MUSCLE. PATIENT STATES SWELLING HAS REDUCED A LOT AND JUST HAS ITCHING. SHE WANTED TO SHOW ME BECAUSE SHE HAD CONCERN THE RPH GAVE THE SHOT TOO LOW.  SHE REPORTED NO PAIN OR FEVER AT THIS TIME, JUST SWELLING AND ITCHING. I RECOMMENDED SHE BE SEEN BY A PHYSICIAN BUT SHE REPORTS SHE DOES NOT HAVE MONEY TO GO. ADVISED TO GO TO ER IMMEDIATELY IF SYMPTOMS WORSEN OR REDNESS SPREADS BEYOND CURRENT AREA OR NEW RASH DEVELOPS AWAY FROM INJECTION SITE
Pain around injection site; Redness around injection site; Swelling around injection site/ still swollen; Cellulitis at the injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic (had allergy to neomycin) and allergy to chemicals (had allergy to formaldehyde).   On 21st February 2023, the patient received the 1st dose of Shingrix. In February 2023, less than a week after receiving Shingrix, the patient experienced injection site cellulitis. On 21st February 2023, the patient experienced injection site pain, injection site erythema and injection site swelling. The patient was treated with cefalexin (Keflex). On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site cellulitis were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix. The reporter considered the injection site cellulitis to be unrelated to Shingrix.     Additional Information: GSK Receipt Date- 24-FEB-2023 and 27-Feb-2023 Reporter's Comments- The patient received a dose of Shingrix  in left arm and minutes after injection given she experienced pain, redness and swelling around injection site.  The patient stated that arm was becoming more swollen and her symptoms did not resolve. The patient mentioned that she was allergic to formaldehyde and neomycin and asks if Shingrix contains any of those ingredients.  On 27th February 2023, the health care professional reported that the patient visited her primary care provider and received a diagnosis of cellulitis at the injection site. The patient had completed a round of Keflex for treatment.  The patient was advised by her primary care provider that it was not a reaction to the vaccination and to continue the Shingrix series. Medical disclaimer and medical information phone number and transfer provided.  Spoken as per content, offered package insert and website. The reporter consented to follow-up.
Red macules/vesicles crust on limbs, anterior to right ear and back; a few spot total.
Low grade fever, from elbow to the shoulder arm was swollen, very tender at injection site, pain from elbow up to ear lasted approximately 4 days.
lips began swelling; the swelling began moving to different parts of face; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9262), via an unspecified route of administration in left arm on 08Mar2021 at 15:30 hours (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included estrogen (MANUFACTURER UNKNOWN), progesterone (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN) and fluticasone propionate/ salmeterol xinafoate (ADVAIR) received within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 10Mar2021, 36 hours after the injection, the patient lips began swelling and the swelling began moving to different parts of the face. Two and half weeks later, the patient still had swelling, although it was not as pronounced. No therapeutic measures were taken for the reported events. The adverse 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 lip swelling and parts of face swelling was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
A physician reported that a 3 month old male recived his second dose of Prevnar (pneumococcal 7-valent conjugate vaccine on 07/06/02. On 07/21/02, at 4 months of age, he was examined in an emergency department. A blood culture was performed;Streptococcal pneumoniae serotype 23F was isolated.A diagnosis of pneumococcal bactermia (without focus) was made. The child survived. Streptococcal septicemia was considered medically important. As of the date this was reported, no further information was available. Additional information received on 11-Sep-2002 from the reporting physician provided pt's birth weight, concomitant vaccine therapy and additional adverse event information.
Abdominal pain, cramps, diarrhea, headache, cough, nausea with 1 episode of vomiting.
Onset 2-18-161 severe HA, left neck pain and left upper outer arm 4x5 cm area of pink, warm skin center of this pinkened area 1x2 cm area of firm induration, c/o pain with palpation. T 36.4. Left neck not swollen, pink or warm, no swollen glands noted.
Clinical depression (exhaustion, lack of ability to find pleasure or joy in anything, lack of interest in typical daily things, thoughts of suicide), fatigue, lack of focus, extreme emotional distress; Clinical depression (exhaustion, lack of ability to find pleasure or joy in anything, lack of interest in typical daily things, thoughts of suicide), fatigue, lack of focus, extreme emotional distress; Clinical depression (exhaustion, lack of ability to find pleasure or joy in anything, lack of interest in typical daily things, thoughts of suicide), fatigue, lack of focus, extreme emotional distress; emotional distress to include involuntary tears that would not stop; Clinical depression (exhaustion, lack of ability to find pleasure or joy in anything, lack of interest in typical daily things, thoughts of suicide), fatigue, lack of focus, extreme emotional distress; This is a spontaneous report from a non-contactable consumer (the patient). A non pregnant 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 27Jan2021  at 17:45 PM, (at the age of 33-year-old)  as a single dose for COVID-19 immunization. Medical history included anxiety and depression (well under control at time of vaccination), COVID-19. The patient had known allergies to soy, almonds, green beans, peas, celery, cherries, strawberries, and eggs. Concomitant medication taken within two weeks of vaccination included cetirizine hydrochloride (ZYRTEC), diphenhydramine hydrochloride (BENADRYL), fluticasone propionate (FLONASE), and unspecified birth control. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin and cefdinir and experienced drug hypersensitivity. On 01Feb2021, the patient experienced clinical depression (described as exhaustion, lack of ability to find pleasure or joy in anything, lack of interest in typical daily things, thoughts of suicide). She also experienced fatigue, lack of focus, extreme emotional distress, to include involuntary tears that would not stop. The patient did not receive treatment for the events. The clinical outcome of the events clinical depression (described as exhaustion, lack of ability to find pleasure or joy in anything, lack of interest in typical daily things, thoughts of suicide), fatigue, lack of focus, extreme emotional distress to include involuntary tears that would not stop, was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. Information about lot number cannot be obtained.
Information has been received from a certified medical assistant concerning a 17 year old female who on 20-AUG-2007 was vaccinated intramuscularly with a first dose of GARDASIL (Lot# not reported).  On 17-DEC-2007, the patient was vaccinated intramuscularly with a second dose of GARDASIL (Lot# not reported).  On 25-FEB-2008, the patient was vaccinated intramuscularly with a third dose of GARDASIL (Lot# not reported).  Concomitant therapy included multivitamins (unspecified).  The patient is now experiencing thyroid problems and on 25-APR-2008 was started on Synthroid 25 mcg po once daily.  It was reported that the patient had no thyroid problems in the past.  The patient reported that her hair was falling out. Many factors considered such as chemical coloring, stress, now BCP initiation. Patient's mother was convinced it was due to GARDASIL. Physician's records show hari loss back to March 2007. Thyroid tests were ordered. The patient's status was reported as not recovered.  Additional information has been requested.
2 weeks post vaccine, pt developed facial swelling, lip swelling, edema of genitals, red patches and plaques on legs.
Mental status changes starting 7 days after immunization with fever, headache, lethargy, inability to walk, discoordination, signs of autonomic instability (BP/pulse).  Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 month following onset of symptoms.  Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months.  She has diffuse, symmetric hyperreflexia in all extremities with 1-beat clonus of the right ankle. Diagnosis of ADEM was made.  No treatment given.  12/23/2009 Clinic note received for DOS 11/18/2009. DX: Post Vaccine ADEEM Patient presented complaint of tachycardia lasting 3 to 4 days, pain in leg, episode of right hand shaking for a few minutes, episode of rapid trembling, shortness of breath and increased headache and fatigue. Assessment: No evidence of recurrence of demyelinating lesion, re-current symptoms are residual from first attack.   12/23/2009 Neurology consult, clinic note and MRI report received for DOS 07/14/2009-11/18/2009. DX: ADEM One week after receiving Gardasil vaccine, patient developed high fever, tachycardia and unsteady gait. Patient was hospitalized (2 days) for headache and tachycardia and was treated with antibiotics. Due to persistent fatigue, patient was re-admitted and diagnostic tests were performed. All symptoms improved. Patient still has fatigue and notes twitching on arms, legs and face. Gait has returned to normal. 01/06/2010 Hospital H&P, consults and diagnostic tests received for DOS 07/13/09- 07/14/09 and laboratory tests received for DOS 06/05/09. DX: Lethargy, Headache, Weakness. Poss. Acute Demyelinating Encephalomyelitis. Patient c/o increasing weakness, pressure in the head when moving, passed out two days earlier, headach. Neurologic examinaton noted hyperreflexia with sustained clonus.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 3:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 3:36 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 65.28 for dose administered on 14-Feb-2021   No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 14-Feb-2021 with temperature 32 degrees Fahrenheit from 09:00 AM to 11:00 AM and 35 degrees Fahrenheit from 02:00PM to 03:00PM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Product was initially placed in refrigerator on 4Jun2022 and administered on 6Jul2022; No adverse event reported; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Product was initially placed in refrigerator on 4Jun2022 and administered on 6Jul2022) and NO ADVERSE EVENT (No adverse event reported) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 06-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product was initially placed in refrigerator on 4Jun2022 and administered on 6Jul2022) and NO ADVERSE EVENT (No adverse event reported). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Product was initially placed in refrigerator on 4Jun2022 and administered on 6Jul2022) and NO ADVERSE EVENT (No adverse event reported) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event reported) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Product was initially placed in refrigerator on 4Jun2022 and administered on 6Jul2022). No concomitant drug information was provided. Patient had received half dose of the vaccine. Vial was initially stored in refrigerator on 04-Jun-2022. The product hadn't undergone any temperature excursion issue. No treatment drug information was provided.
Discharge Provider: MD Primary Care Provider: PA Admission Date: 2/24/2023 Discharge Date: 3/8/23+  PRESENTING PROBLEM: Pneumonia due to COVID-19 virus    HOSPITAL COURSE: Patient is a 68 yo female s/p bilateral lung transplant for COPD 4/2022 with Osteoporosis, esophageal dysmotility, CAD who became symptomatic with cough, fatigue and congestion 2/6/23. She did not opt for treatment at that time due to cost. She continued to have symptoms and assessed on 2/16 via telemedicne visit. Prendiosne 40 mg x 5 days, azithromycin 500 mg x 5 days were given and cellcept stopped. CXR indicated some new GGO. Follow up imaging was stable but since still symptomatic CT thorax ordered and indicated " There are multiple new peripheral and peribronchovascular patchy groundglass attenuations and interlobar septal thickening within the lower lungs compared to the prior study". She was admitted for treatment of COVID PNA.   During admission she improved symptomatically with treatment. Bronchoscopy was completed 2/25/23 to rule out additional infections. 2/28 fungal cultures initially positive for fungus with positive pan aspergillus. She was started on voriconzole the night of 2/28. Cultures updated to show both aspergillus Niger and fumigatus. Given she just completed treatment with voriconazole decision with consultation with ID made to switch to Cresemba and add Micafungin. ID has requested sensitivities from lab which will be pending for 2-3 weeks. Given improvement in symptoms, planned to continue Micafungin while inpatient and dc on Cresemba only.    Significant tenderness of maxillary sinus noted and CT ordered. CT sinus with air fluid levels and ENT consulted. Sinus cultures were negative but patient completed 7 day course of abx for sinusitis.    Throughout the stay, patient had mild AKI as well as hyperkalemia which improved by day of dc. She was also found to have low IGG levels, was given a dose of IVIG and will follow-up with immunology as an outpatient    Patient is being discharged home today to follow up in clinic in 2 weeks with repeat labs Monday.
Patient developed Bell's Palsy within 48 hours after administration of DT injection. 1st day with tingling sensation of tongue; progressed over 48 hours = facial symptoms. Still with symptoms 1/21/04. Recovering (very little symptoms on 1/28/04).
Information has been received from a pharmacist concerning a 13 year old patient who was vaccinated with a dose of Zostavax (Oka/Merck) instead of Varivax (Oka/Merck). Pharmacist was not aware of product confusion. No further details about the incident was reported. No further information was available. There was no product quality complaint. Additional information has been requested.
Pain for 2 days.  On second day red rash  and swollen and a bit itchy
mild fever, chills, fatigue, moderate lower back muscle pain for up to 3 days, inflammed lymph nodes in both armpits.; mild fever, chills, fatigue, moderate lower back muscle pain for up to 3 days, inflammed lymph nodes in both armpits.; mild fever, chills, fatigue, moderate lower back muscle pain for up to 3 days, inflammed lymph nodes in both armpits.; mild fever, chills, fatigue, moderate lower back muscle pain for up to 3 days, inflammed lymph nodes in both armpits.; mild fever, chills, fatigue, moderate lower back muscle pain for up to 3 days, inflammed lymph nodes in both armpits.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0172) via an unspecified route of administration in the left arm on 30Apr2021 at 16:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient medical history and past drug history was reported as no. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0151) via an unspecified route of administration in the left arm on 09Apr2021 at 10:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 at 18:00, the patient experienced mild fever, chills, fatigue, moderate lower back muscle pain for up to three days and inflammed lymph nodes in both armpits. The clinical outcome of the events mild fever, chills, fatigue, moderate lower back muscle pain for up to three days was resolved on 03May2021 and of inflammed lymph nodes was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
No adverse event to patient occurred, but the patient did receive vaccine that was expired per the BUD. The BUD date was 11.26 at 9:00am and the patient was given the dose on 11.26 @ 11:10am. Pfizer was contacted and had extended stability data. Per Pfizer, no excursions occurred, so vaccine is good for 32 days once in fridge.
Mother called 3/9/10 8:38 reported daughters received MCV4 3/5/10 (Fri) and broke out with hives, swollen eyes, saw PMD received cortisone shot symptoms appeared today (Tues 3/9).
Irregularity in heart beats, usually for a 30 seconds to 2 minutes, twice a day, every day since vaccination.