chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; diarrhea; Felt like 1000 needles under her skin; Woke up screaming during the night; Pain; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th May 2019, the patient received the 1st dose of Shingrix. On 10th May 2019, less than a day after receiving Shingrix, the patient experienced fever, diarrhea, pain of skin, screaming and pain. On 12th May 2019, the outcome of the screaming was recovered/resolved. On 14th May 2019, the outcome of the fever and diarrhea were recovered/resolved. On an unknown date, the outcome of the pain of skin and pain were recovered/resolved.   It was unknown if the reporter considered the fever, diarrhea, pain of skin, screaming and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated that the patient was administered Shingrix and for 3 to 4 days, the patient experienced diarrhoea, 102 degree F fever, felt like 1000 needles under her skin, woke up screaming 2 nights in a row with horrific pain.
Varicella: Secondary transmission: information has been received from a health care professional concerning her 4 year old daughter with codex allergy who on 08 Apr 2000 developed a fever.  On 12 Apr 2000 and 13 Apr 2000 the patient's two brothers were vaccinated with one dose each of varicella virus vaccine live.  serveral days after the start of her fever.  the patient broke out in a rash.  she sought medical attention and was diagnosed with chickenpox.  Neither of the patient's vaccinated brothers experienced a rash or any other adverse experience.  Follow up information received from a nurse at the physician's office reported that their office believes the patient was incubating wild type chickenpox at the time her brothers were vaccinated and that the fever was part of the prodomal phase of chickenpox.  They did not believe that the patient's chickenpox had anything to do with her brothers vaccinations.  No further information is available.
severe hives; Headache; fatigue; Aches all over body; Was bedridden for 6 days; off label use; Product use for unapproved combination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Nov2021 13:00 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 12Nov2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OFF LABEL USE (non-serious) with onset 12Nov2021, outcome "unknown", described as "off label use"; PRODUCT USE ISSUE (non-serious) with onset 12Nov2021, outcome "unknown", described as "Product use for unapproved combination"; URTICARIA (non-serious) with onset 14Nov2021 12:00, outcome "recovered" (2021), described as "severe hives"; HEADACHE (non-serious) with onset 14Nov2021 12:00, outcome "recovered" (2021), described as "Headache"; FATIGUE (non-serious) with onset 14Nov2021 12:00, outcome "recovered" (2021), described as "fatigue"; PAIN (non-serious) with onset 14Nov2021 12:00, outcome "recovered" (2021), described as "Aches all over body"; BEDRIDDEN (non-serious) with onset 14Nov2021 12:00, outcome "recovered" (2021), described as "Was bedridden for 6 days". The events "severe hives", "headache", "fatigue", "aches all over body" and "was bedridden for 6 days" were evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria, headache, fatigue, pain, bedridden. Additional information: The events were not serious.They did not meet any seriousness criteria. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The reported event took place 2 days after injection withheld the patient developed severe hives. Headache and fatigue. Aches all over body. Dr prescribed prednisone and an antihistimine which she took for one week. The patient was bedridden for 6 days. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. There were no known allergies.   The lot number for bnt162b2 was not provided and will be requested during follow up.
headache, sinus congestion, body aches, sore throat from drainage, cough (until she threw up x 2), night sweats. starting 12/27/21
Information has been received from a health professional concerning a male patient who on 19-APR-2001 was vaccinated with a dose of Varivax (lot # 635453/0756K). On an unspecified date, the patient developed a mild case of breakthrough chickenpox. Unspecified medical attention was sought. The patient subsequently recovered. A product quality complaint was not involved. Additional information has been requested.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient reported blisters formed at injection site
A physician reported that an infant rec'd Prevnar, Hib-Titer, and Acel-Imune vaccines on 4/6/01. That day, she developed urticaria. Additional information rec'd from the physician on 10/30/01 indicated that the infant recovered.
Painless thyroiditis; Paresthesia; Join pains; This literature-non-study case was reported in a literature article and describes the occurrence of THYROIDITIS (Painless thyroiditis) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.       Concurrent medical conditions included Autoimmune thyroid disorder. Concomitant products included LEVOTHYROXINE for Autoimmune thyroid disorder.    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 THYROIDITIS (Painless thyroiditis) (seriousness criterion medically significant), PARAESTHESIA (Paresthesia) and ARTHRALGIA (Join pains). At the time of the report, THYROIDITIS (Painless thyroiditis), PARAESTHESIA (Paresthesia) and ARTHRALGIA (Join pains) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood thyroid stimulating hormone: 0.1 liu/ml 0.1 lIU/mL and normal TSH rose to 21 which returned to normal limits after progressive increase in dose of levothyroxine.. On an unknown date, Thyroxine free: 1.6 ng/dl 1.6 ng/dL.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered THYROIDITIS (Painless thyroiditis), PARAESTHESIA (Paresthesia) and ARTHRALGIA (Join pains) to be possibly related.    Treatment information was not provided.  Patient presented with left thyroid lobe painless swelling, paresthesia and join pains 2 weeks after her first dose of moderna vaccine.  This is a literature-non-study case concerning a 47-year-old female patient with history of Autoimmune thyroid disorder, previously euthyroid on levothyroxine, who experienced the serious  unexpected event Thyroiditis. The events occurred approximately two weeks after  the first  dose of mRNA-1273 Moderna vaccine, on an unknown date.  The medical history of autoimmune thyroid disorder remains a confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-372388 (Patient Link).; Sender's Comments: This is a literature-non-study case concerning a 47-year-old female patient with history of Autoimmune thyroid disorder, previously euthyroid on levothyroxine, who experienced the serious  unexpected event Thyroiditis. The events occurred approximately two weeks after  the first  dose of mRNA-1273 Moderna vaccine, on an unknown date.  The medical history of autoimmune thyroid disorder remains a confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
On 1/9/2021,  my son noticed I had symptoms of bells palsy.  I had droopy lips and left eye lid was also droopy.  He rushed me to the ER.  At the ER, they did CT scan and found I had a stroke.  They took me to the OR and tried to do a thrombectomy.  They were unsucessful to do a full thrombectomy . They were able to do a partial thrombectomy.   I was kept in ICU for 1 week. My left side was paralyzed at that time.  After a week, I was discharged to a rehab hospital Sheltering Arms and I was there for 2 months.  I received physical therapy and occupational therapy.   I was prescribed a holster monitor and started a new medication called Plavix.  I am also to continue taking my previous medications prior to the vaccine.  Currently, my left hand is fully paralyzed and my left leg is partially paralyzed.
Info has been received from a physician concerning a 68 year old female pt with a drug hypersensitivity to sulfa and sodium pentathol and concurrent conditions of hypertension and arthritis who on 12/10/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #644217/1026M). Concurrent medications were amiloride hydrochloride (+) hydrochlorothiazide (MSD), valdecoxib (Bextra), and omeprazole (Prilosec). On 12/12/2002 the pt developed a 7 by 10 cm erythematous patch at the site of reaction. The physician reported it looked somewhat like a dermatitis. Unspecified medical attention was sought. The pt was given "palliative treatment". Additional info has been requested.
pt recv vax & devel a sore throat, pleuritic chest pain, fever, hyperbilirubinemia, & elevated liver function tests;pt hosp;
COVID vaccine breakthrough case. Pfizer 4/30/21 EW0164, 5/21/21 EW0172 and boosted 10/27/21 FF2590
Woke up the next day with fatigue, headache, cough, weakness, body ache and chills. Dizzy if move head quickly. Symptoms continue 3 days after vaccine.
From Oct 21-24 intense itching all over body except for face.  From Oct 25-31 intense itching all over with redness of skin and bumpy areas  Met with doctor on Friday Oct 29 and was prescribed Hydroxyzine, started taking 20mg at night to help with sleep From Nov 1-2, itching is moderate but skin is bright red with any type of scratching or any rougher touch to the skin (for example taking a shower causes redness all over from light washing with a wash towel. The redness also includes my face but it is less noticeably red than my body.
Fever, weakness, muscle pain, joint pain, lymph node swelling, arm pain, hot flashes, night sweats, cold shivers
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 9:31 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:31 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 28.99.  Concomitant products were not provided.  On 3-Apr-2021, Excursion time was 9 AM, the temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  Vial was stored on cooler 1, on 3-Apr-2021, Excursion duration at 8 AM: 38, 9 AM:34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
dispensed 28 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Patient had no known allergy. It was reported that patient had never been diagnosed/ tested positive for COVID-19. Patient had no chronic or long-standing health conditions. Patient had no acute illness at the time of vaccination and up to one month before.  On 06-Apr-2022 at 9:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022 at 9:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. It was reported that patient had no adverse event from the vaccine on 6 Apr 2022.  The vial did not undergo any temperature excursions. On unknown date the vial was initially stored in the refrigerator.  No treatment medication information was provided.
Fever, Tmax 104, URI SXS with measles-like rash s/p MMR on 10/22/19. SXS began 10/28/19
1) Soreness in injection site and arm where the shot was administered 2) Tiredeness and very light fever 3) Teeth sensitivity to cold
Patient states he has continuous arm pain at injection site uses heating pad to relieve pain. Pt followed up with physician, who, according to the patient did not address issue. Patient has history of back pain from previous unrelated injury. Person spoke with nurse at physician's office 2/25/14. Nurse said patient has been complaining of back pain with no mention of arm pain.
Vaccine given on Jan 19.  Normal reaction following days with some redness and swelling. Then it started going away on Jan 24 On Jan. 25 7days  after vaccine it started to itch. And get a little redder, hotter and more swollen so Itook a Tylenol.  Jan. 26. Spot where vaccinated became redder, more swollen, hotter. Later that day it started with chills followed by fever. (100 degree) Took Tylenol Jan. 27 woke up no fever but arm was the same. I was very tired with muscle aches, headache and loss of appetite. Later that day fever arrived again. 100degrees. Took Tylenol    Jan. 28 called Drs. Office to see if this was normal.  Feeling much better today.  Jan 29. Arm is much better and feeling better.
This spontaneous report was received from a physician referring to a 61 year old male patient. The patient's concurrent conditions included intervertebral disc disease and iodine allergy. The patient did not have taken any known concomitant medication. On 08-FEB-2017, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. The physician reported that the patient was seen at an unspecified primary care physician's office for knee pain and shoulder pain, "approximately 1 month after receiving the ZOSTAVAX. Then he saw an unspecified orthopedic surgeon on an unspecified date and was given a cortisone injection into his knee. Subsequently on 16-MAR-2017, the patient was seen at her office with hip pain and blood work for inflammation was ordered which results showed that the patient had elevated erythrocyte sedimentation rate (ESR) and a diagnosis of "polymyalgia" was given. Additionally a magnetic resonance imaging (MRI) was performed, the physician started the patient on therapy with prednisone 20 mg daily. It was reported that the patient now had complaint of severe numbness and tingling in his left arm. No further information was provided. There was no product quality complaint (PQC) involved. At the reporting time the outcome of the events was unknown. The reporter did not assess the causality between the events and ZOSTAVAX. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jun2022 at 16:00 as dose 4 (booster), single (Lot number: FP7135) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hereditary elevated cholesterol" (unspecified if ongoing), notes: Hereditary elevated cholesterol; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: SIMVASTATIN, start date: 01Jun2015, stop date: 14Sep2022. Past drug history included: Macrobid, reaction(s): "Known allergies: Macrobid".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Negative, notes: After Paxlovid treatment, felt fine and tested negative for two days; (Sep2022) Positive, notes: Then on the third day had mild sore throat and runny nose, tested and was positive again; (Sep2022) Negative, notes: After Paxlovid treatment, felt fine and tested negative for two days. Therapeutic measures were taken as a result of drug ineffective, covid-19.
15 min post vax, patient stood up and became light headed, warm, and c/o visual disturbance. LOC approx 30 sec. After comfort care and food/drink, she recovered.
pt recv vax in JUN96 & JUL96 pt devel chickenpox w/less than 50 lesions on back, arms & face;pt treated w/med;pt sibling recv vax & devel chickenpox also;
Info has been received from a physician concerning a 24 month old Hispanic female who was vaccinated IM, with a dose of varicella virus vaccine live. The reporter indicated that the pt was vaccinated in a clinic and then "last week", on approximately 3/24/05, the pt traveled to another country and was exposed to a wild type of chickenpox. The pt experienced break through chickenpox with greater than 50 lesions. The reporter indicated that it did not last as long as wild type varicella. Unspecified medical attention was sought. At the time of the report, the pt was noted to be recovering. A product quality complaint was not involved. The reporter noted that the case was reported to the state health department. Additional info has been requested.
pt recv vax 14AUG97 & w/in 24hr pt exp localized redness (described as the size of the palm of hand), induration, heat & pain;
Patient presented to pharmacy on 7/7/22 with a warm, red swollen area on right arm. Stated that it was extremely sore the day before and she had been sick the day before as well. Her doctor told her it may be an allergic reaction. She had not taken any medication to alleviate the swelling. Pharmacist instructed patient to take benadryl.
About 3.5 hours after immunizations, patient was crying inconsolably for 1 hour and had redness, warmth, and swelling on the left leg. Afebrile. Patient interactive. Treatment with Tylenol and ice packs on legs. Diagnosis: local immunization reaction.
My skin developed a blotchy red itchy rash all over my neck, chest and parts of my face. It has stayed about 5 - 6 days but seems to be going away now.
Within 24 hours of receiving the Pfizer Bivalent vaccine, we noticed that he started having a tick in his face. The pediatrician said it's a facial tick/flinch. It's like he is having Tourette's. The doctor told us that it may be from the vaccine or it may just be something that is happening to him.
Facial rash, pain to lymph glands of neck, appeared 5/27/08. Afebrile. Resolving as of 6/2/08. Took (OTC) Tylenol only with good effect, declined to see physician.
Left thigh has lump, redness-pt running high fever 102. Fussy-not sleepiing.
pt adm to hosp w/severe myalgia of both calves, fever, noc sweats, malaise & fatigue; devel weakness of hip flexors; hemoglobin was 12 G/L, leukocytosis was 13,000 MM E 3, ESR was 90 MM/H, AST sl elevated; erythrocyturia & proteinuria 0.42;
Nausea started about  8 hours after getting vaccine and progressively got worse over 12 hours
Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Body Aches Generalized-Medium, Systemic: complaing about redness and pain at injectio site left arm\.pain raidiate toward neck on 2nd day towords right ear with trobbing pain in right ear which then subside with throbbing pain in left ear.complain about severe sensitivity on skin of legs when ws-Medium
Pt received first dose pfizer lot #EW0167 on 5/13/2021. Pt returned 6/7/2021 for 2nd pfizer dose and patients parent provided incorrect birthday at first appointment to get child vaccinated. On call provider was called and he recommended two options - ask parent to reschedule for after 12th birthday or to give today as off label use if parent wanted to accept risk of off label use. Parent opted for vaccination today and accepted all risks stating "he is a strong boy - stronger than me!" Patient was vaccinated without incident.
Pt vaccinated with DTP developed fever 103, swelling, redness, knot, bruising & tenderness at injection site following immunization, large knot & discoloration still present 2 wks later
Pt.'s states that after receiving the 1st dose of Phizer 08/18/2021, started experiencing symptoms 08/25/2021 of shortness of breath, fatigue, dry cough, difficulty breathing while sleeping, and heaviness in the chest. 09/02/2021 Primary visit, Prescribed Inhalers for Follow-Up. Emergency Room transported (passed out), Pt. passed 09/08/2021. Cause of Death : Acute Hypoxia Respiratory Failure and Covid Pneumonia.
7 DAYS POST-ADMINISTRATION, HALF OF PT'S FACE WAS SWOLLEN WITH NO SENSATION. EXPERIENCED SUDDEN SHARP HEADACHES, CHEST PAIN
Leg blotching redness, severe stomach cramps, vomiting 24 hours more than 10 times, arm swelling redness and soreness, nausea, fatigue, shortness of breath, body aches, left side numbness, throat soreness, trouble walking, fever (hot to the touch), dizzy, loss of motor skills, irritable, mood swings, felt like I was dying.