chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 69 years old female patient with environmental allergies and drug hypersensitivity. The patient's medical history included hypothyroidism, hypercholesterolemia and neuropathy. The patient was vaccinated with ZOSTAVAX in the 1990's. No other co-suspects were reported. Concomitant medications included NASONEX and other unspecified medications. In DEC-2012 the patient experienced ocular herpes zoster and shingles lesions on the right side of her face. Patient was treated with unspecified antiviral medication. The outcome of ocular herpes zoster and shingles lesions on the right side of her face was reported as recovered on an unknown date. The relatedness for ocular herpes zoster and shingles lesions on the right side of her face was not reported for ZOSTAVAX.
Swollen tongue; Swollen lip; Blotchy red; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swollen tongue), LIP SWELLING (Swollen lip) and RASH MACULAR (Blotchy red) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (Swollen tongue), LIP SWELLING (Swollen lip) and RASH MACULAR (Blotchy red). At the time of the report, SWOLLEN TONGUE (Swollen tongue), LIP SWELLING (Swollen lip) and RASH MACULAR (Blotchy red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Developed a myositis in my quadricep muscle 24 hrs after the injection. I also developed tenderness and spasm on my Masseter muscles which resolved quickly. However I also developed edema of my supra-glottis requiring treatment with Prednisone.
pt recv vax 2APR96 & 22NOV96 pt to MD w/50 lesions over lower legs & buttocks & pt had approx 120 lesions total, & mild fever & pruritus;
Patient with history of asthma, diabetes. Patient brought to the ED by EMS on 12/9/22 after sustaining a head injury - she rolled out of bed and hit her head. Additionally, she reported shortness of breath, noting that for the past week she has been feeling generalized weakness, body aches, subjective fever, and congestion. A COVID PCR test was done which resulted positive. Ultimately patient admitted 12/9/22 - 12/18/22. Discharge diagnoses include acute hypoxic and hypercarbic respiratory failure, COVID-19, among other diagnoses. During admission, patient used BiPAP as needed for excessive work of breathing and overnight. Patient has received the COVID primary vaccine series.
This medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a female adult patient. On an unspecified date in 2013, the patient received AFLURIA injection (batch number not provided). On an unspecified date following the vaccination, the patient experienced swelling of lymph nodes and pain in collar bone area. The outcome was not reported. Linked to case 2015048070.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 12 month old patient. On 05-OCT-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N017698, expiration date: 09-JUN-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
Pt. is walking but her left leg wont bend. She looks, acts, and now walks like she is handicapped.
Three months post vax, the pt developed chickenpox, following exposure to varicella from her son who was infected with chickenpox, post vax with varicella. Physician stated pt had high IgG level. The reporter believed that there was no association between the patients symptoms and vax.
Dose Number: 3; Eczema-like lesions as well as red raised bumps on torso; entire body rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 13:00 (Lot number: FD0809) at the age of 59 years as dose 3 (booster), single, administered in arm left, administration date 09Apr2021 13:30 (Lot number: EW0162) as dose 2, single and administered in arm left, administration date 19Mar2021 12:00 (Lot number: ER8727) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021, outcome "unknown", described as "Dose Number: 3"; ECZEMA (non-serious) with onset 25Apr2021, outcome "not recovered", described as "Eczema-like lesions as well as red raised bumps on torso"; RASH (non-serious) with onset 25Apr2021, outcome "not recovered", described as "entire body rash". The events "eczema-like lesions as well as red raised bumps on torso" and "entire body rash" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eczema, rash.  Additional information: Patient was administered most recent Covid-19 vaccine in facility: Pharmacy or Drug store. Patient did not received any other vaccines within 4 weeks prior to the Covid-19 vaccine. Patient did not received any other medications within 2 weeks of vaccination. Patient was started experiencing events with the 1st dose, and escalating BADLY after the 2nd dose, it was Began to subside (though faintly with getting better and worse intermittently) and now EXTREMELY bad again after the booster. Patient have had treatments continuously including Prednisone, Cyclosporin, UV light treatments and multiple antihistamines. All to very little effect. Patient was not diagnosed with Covid-19 prior to vaccination. Patient was not tested for Covid-19 since vaccination.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-year-old patient of unknown gender. On 09-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N034554, expiration date 05-DEC-2019 (exact dose and route of administration were not reported) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
fatigue; soreness in the arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (soreness in the arm) and HEADACHE (headache) in a 64-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue), MYALGIA (soreness in the arm) and HEADACHE (headache). At the time of the report, FATIGUE (fatigue) and MYALGIA (soreness in the arm) outcome was unknown and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information were not provided by the reporter. Concomitant medications were not reported by reporter.   This case was linked to MOD-2021-293377, MOD-2021-293631 (Patient Link).
Approx. 48 hrs after receiving vaccines, client awoke with drooling L side of mouth, could not close L eye, tearing L eye, headache, eye sensitive to light.  Went to ER and was diagnosed with Bells Palsy. Was prescribed Prednisone 20 mg. one every day x 5 days. HX of having Bells Palsy at age 11
Extreme tiredness, lack of energy, muscle joint pain, headache, nausea, blurry vision, slept 17 hours straight, pain in arm. Herpes sores appeared, hadn't had a break out in two years. Felt like I got a flu shot instead of shingles. I had VOSTRIX in 2011, side effects were not like this. Took 50 mg of sumatriptan. I feel the problem is, dosage for vaccine is the same whether you weigh 200 or 110, my husband (200) didn't have any side effects, I weigh 110.
feeling tired; swelling has gone down; red; hot to the touch; itchy; Covid Arm; swollen; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Covid Arm), SWELLING (swollen), ERYTHEMA (red), HOT FLUSH (hot to the touch) and PRURITUS (itchy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Covid Arm), SWELLING (swollen), HOT FLUSH (hot to the touch) and PRURITUS (itchy). On 10-Apr-2021, the patient experienced ERYTHEMA (red). On 12-Apr-2021, the patient experienced SWELLING (swelling has gone down). On an unknown date, the patient experienced FATIGUE (feeling tired). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Covid Arm), SWELLING (swollen), ERYTHEMA (red), HOT FLUSH (hot to the touch), PRURITUS (itchy), FATIGUE (feeling tired) and SWELLING (swelling has gone down) outcome was unknown. Not Provided          No relevant concomitant medication was reported.  Treatment details include, ice packs and oral antihistamine.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. It was reported that on an unspecified dates in 2015, since 05-FEB-2015, an unspecified number of patients were vaccinated with an unspecified number of doses of M-M-R II, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were incorrect stored. No adverse effects were reported and no product quality complaint (PQC) was filled. Additional information has been requested.
Initial report received from a health care professional on 15 August 2008. A 39 year old, female patient, with a medical history of no known allergies and gestational diabetes, received a 0.5 ml intramuscular, left deltoid injection of ADACEL, lot number C2936AA, on 31 July 2008. The patient was pregnant at the time of vaccination. Her last menstrual period was 05 July 2008 and her estimated date of delivery is 10 August 2009. She denied having any current medications. She has a history of 5 previous pregnancies, with a 5 full term deliveries and normal/viable pregnancy outcomes. It was reported a pregnancy test done on 14 August 2008 was positive. Per the reporter, there was no known adverse event. Follow-up received from a health care professional on 22 September 2008. The reporter amended the patient's estimated date of delivery from 10 August 2009 to 10 April 2009. No additional information was provided. Follow-up information was received from a health care professional on 04 May 2009; it was determined, based upon this new information, that the case should be upgraded to serious. On 23 January 2009 the patient, who had a history of gestational diabetes in previous pregnancies, underwent a three-hour glucose tolerance test which was positive for gestational diabetes. She was referred to "Sweet Success". The following prenatal testing was normal: Genetic screening (CG screen) on 03 September 2008, alpha fetoprotein on 30 October 2008, ultrasound on 24 November 2008, and fetal stress test on 24 March 2009. Serology on 27 October 2008 revealed low ferritin, and the patient was diagnosed with iron deficiency anemia. On 26 March 2009, at 37 weeks gestation, the patient gave birth via C-section to a female infant weighing 6 pounds 14 ounces. Apgar scores were 9/10 at one minute, and 9/10 at five minutes. No congenital anomalies were noted, and there were no complications of labor or delivery.
A consumer report has been received. The report concerns a 4 year old, male consumer, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient experienced congestion. The outcome of the event of congestion is unknown. The report was considered to be  non-serious. Corrected report on 26-Sep-2014: Az date was updated.
Pt developed a seizure the evening the vaccines (flu, varicella) had been given. His temperature was 104 at the time of the seizure.
blood clot in her left leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot in her left leg) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clot in her left leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clot in her left leg) outcome was unknown.            No concomitant medications were reported. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
PATIENT CALLED PHARMACY AT 1300 ON 2.27.14 TO REPORT THE FOLLOWING ABOUT VACCINE GIVEN ON 9.30.13: She claims that since the injection she can't drive or raise her left arm above the 3 o'clock position without pain or reach behind her or put on deodorant. She has seen Dr. 3 times, had and x-ray, MRI, and is seeing a orthopedic surgeon on March 6th 2014 due to a tear and excess fluid in tendon. Patient says that pain shot down arm and bled when shot administered and her collar bone hurt the next day. Followed protocol per physician.
Itchy red hives all over face, scalp, hands, torso, legs and arms.
Td was mistakenly given intradermally in patient's left forearm. The patient was supposed to have a PPD test. 0.1 ml of Td was injected. The left forearm began to swell 12-17 hours post injection. The site of injection was red and swollen, approximately 6 cm in diameter. Her local reaction is improving. The patient thought the local reaction was a positive to the PPD test, and had a chest x-ray on 8/20/04. The x-ray was negative.
Localized urticaria at injection site and residual hard mass and small vesicle in lt bicep.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
Significant soreness in my right upper arm muscle developed (March 10, 2021), along with a red rash approximately 4 inches below injection site. Muscle soreness level was similar that which I experienced in the first 48 hours after receiving my injection on March 3, 2021.  I did not have any muscle soreness nor a rash during post-injection days 3-7, but in the afternoon of the 8th day muscle soreness and stiffness came on very quickly (within 1 hour), and the rash continued to develop over the next 24 hours. The soreness lasted 3-4 days and the rash (color only, no raised surfaces) lasted 5 days. I has been told to expect soreness in the first couple days following my injection, but did not expect such a significant and sudden reaction a full week after receiving my first Moderna vaccine dose. I'm simply reporting my experience in case it is helpful to you. I experienced no other adverse symptoms or reactions.
No adverse event, but this lot was short dated and accidentally administered to patient. expired on 4/28/21
Paresthesia in the immunized arm. A sensation of a "pricking" as if there was a plastic tab from a clothing sales tag poking into antecubital fossa repeatedly, but no foreign body identified.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ZR8727) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included hypercholesterolemia. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN) and tadalafil (CIALIS); both taken for unknown indications, from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 31Mar2021, the patient reported that for 2-4 days after he received the vaccine, he had a paraesthesia in the immunized arm. He had a "sensation of a pricking as if there was a plastic tab from a clothing sales tag poking into the antecubital fossa repeatedly, but no foreign body identified". It ultimately faded four days out and did not recur with the second dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of the event "paraesthesia in the immunized arm, a sensation of a pricking as if there was a plastic tab from a clothing sales tag poking into the antecubital fossa repeatedly, but no foreign body identified" was resolved on 04Apr2021 after a duration of four days.  No follow-up attempts are needed. No further information is expected.
Extremely tired at 4:30 PM, then fever of 102.6 at 6:30 PM. Then, fever of 101.2 on 7/30, and fever of 100.6 on 7/31. Then, cold symptoms beginning on 8/1.
On 1st day experienced mild flu-like symptoms: Redness, warmth, swelling, joint pain. Now rash seems to be spreading, 5 days after vaccine was administered.
fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The event lasted for 24 hours, incapacitating. The patient gave consent to contact the physician. For tolerance after 2nd dose refer case US2019GSK080332.
pt recvd vax in 1995;16JUN95 pt devel papules on thorax, which turned into vesicles;No further info was provided;
Patient woke up with a moderate fever which lasted all day.  We gave her Tylenol every four hours.   The next day 8/20/10, she cried and was emotional all day.  Even with giving her Tylenol every 4 hours, her fever rose of above 103 and was difficult to keep down.  We sponged her all day, fed her ice cream, and gave her luke warm baths.  The next day 8/21/10 she woke up with a rash all over her body.  We took her back to the Dr. to be checked out.  She still had a fever and was fussy and crying all day.  Throughout the next week, she was extremely emotional and crying off and on (but very out of the ordinary behavior for her). On 8/27/10, she woke up from a nap and told up that she could no longer walk.  She complained that her right foot hurt.   We looked for any type of injury, but there was none.  For the rest of the day she was unable to walk and drug her body around the floor like a baby.  By the end of the day, these issues resolved themselves, but it was a terrifying experience for us.