chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hard red nodule on arm; itchy arm; arm swelling/ bee sting appearance arm; red spot at site of injection; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE NODULE (hard red nodule on arm), VACCINATION SITE PRURITUS (itchy arm), VACCINATION SITE SWELLING (arm swelling/ bee sting appearance arm) and VACCINATION SITE ERYTHEMA (red spot at site of injection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and VACCINATION SITE ERYTHEMA (red spot at site of injection). On 09-Mar-2021, the patient experienced VACCINATION SITE NODULE (hard red nodule on arm), VACCINATION SITE PRURITUS (itchy arm) and VACCINATION SITE SWELLING (arm swelling/ bee sting appearance arm). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE NODULE (hard red nodule on arm), VACCINATION SITE PRURITUS (itchy arm), VACCINATION SITE SWELLING (arm swelling/ bee sting appearance arm) and VACCINATION SITE ERYTHEMA (red spot at site of injection) outcome was unknown.            Concomitant medications include Claritin, Ice pack for an unknown indication. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: follow-up information include:Reported details updated(email).2nd dose details provided.
Injection site swelling and redness which spread continuously until given high dose of benadryl.  Injection site remained unhealed for several weeks and is now scarred over. Since that time, beginning one week after inection, I have exhibited allergic reactions to things that I wasw not prone to react to previously.  I had a bee sting three weeks after injection and reacted, needing attention -- never had reaction before.  Each time I have come into contact with adhesive from a bandaid or medical tape, a reaction occurs.  Again, this never happened previously (and I regularly have contact with medical tape due to blood donations).
The lymph node under my arm has a lump and is swollen; Have a rash, on my elbow; Swelling and pain at the injection site; Swelling and pain at the injection site; Itching on my hand where I did not get the shot; Breasts hurt; Feel awful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "The lymph node under my arm has a lump and is swollen"; RASH (non-serious), outcome "unknown", described as "Have a rash, on my elbow"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "Swelling and pain at the injection site"; PRURITUS (non-serious), outcome "unknown", described as "Itching on my hand where I did not get the shot"; BREAST PAIN (non-serious), outcome "unknown", described as "Breasts hurt"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feel awful".  Additional information: Patient was forced to take the bivalent COVID vaccination in order to get a job and now the lymph node under arm had a lump and was swollen. Patient had a rash, on elbow, swelling and pain at the injection site, itching on hand where patient did not get the shot. Patient breasts hurt patient was feeling fine until patient took the booster. The first series patient was fine got it at (Withheld) this time got the booster at (Withheld) and feel awful. I hope you add this to your data statistics. Patient would never do this again.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Moderna COVID-19 Vaccine EUA Woke up almost 12 hours after receiving the vaccine with a fever of 101.9, nausea, severe headache, chills, and body aches. This lasted for around 24 hours
Muscular discomfort top of left hand; Diarrhea; Sleepiness; Muscle weakness on right arm; Minor headache; Tenderness at the injection site; Swelling at injection site; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISCOMFORT (Muscular discomfort top of left hand), DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepiness), MUSCULAR WEAKNESS (muscle weakness on right arm) and HEADACHE (Minor headache) in an 83-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.     No medical history was provided by the reporter.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 MUSCLE DISCOMFORT (Muscular discomfort top of left hand), DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepiness), MUSCULAR WEAKNESS (muscle weakness on right arm), HEADACHE (Minor headache), VACCINATION SITE PAIN (Tenderness at the injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, MUSCLE DISCOMFORT (Muscular discomfort top of left hand), DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepiness), MUSCULAR WEAKNESS (muscle weakness on right arm), HEADACHE (Minor headache), VACCINATION SITE PAIN (Tenderness at the injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site) had resolved.            No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information included new event details and outcome of the earlier reported events.
74 year old white female pt. received second dose of Moderna-COVID-19 vaccine on 3/4/21. Pt. called to report severe leg rash that started at the end of March 2021 that has been ongoing since and has spread to other parts of her body. Currently rash is located on chest, arms, legs, groin, and breasts. Patient states she was diagnosed with Hashimoto's disease 8 or 9 years ago. She's been taking Levothyroxine 75 mcg daily for nine years, Caltrate 600 + B3 for "many years", vitamin D3,  Vitamin C 1000 mg for 20 years, and Omega 3-6-9 for about a year. She also reports she began taking Atorvastatin 40 mg daily on 4/9/21. Pt. reports an allergy to Wellbutrin that causes pruritis.  Pt. states Monistat cream also causes pruritus. Pt. denies any illness at time of vaccination and prior to. Patient encouraged to seek medical treatment for symptoms by this RN.
No additional adverse effect reported; VARlVAX that underwent a temperature excursion was administered; This spontaneous report as received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided.  On 23-JUN-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T035400, was confirmed to be valid, expiration date 16-OCT-2022 (strength, exact dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine was stored in 42.9 degrees Fahrenheit for 216h. Data logger was involved. There were no previous excursions reported.
Initial report was received from a healthcare professional on 26 November 2012. A 59-year-old male patient with no known allergies and a medical history of diabetes had received FLUZONE INTRADERMAL, lot number UH734AB, in the right deltoid on 09 November 2012. The number of previous doses was reported as "7th flu shots (not ID)." The patient had redness the "size of a silver dollar at site right after injection." This subsided after an unspecified time. "Four days ago," the patient started to complain of "neuritis type of pain from site down to forearm." The patient reported that "using the hand and sleeping on it makes it worse." These events required an ER/doctor visit. No further information was available at the time of the report. The patient outcome was not recovered. Documents held by sender: none.
pt was brought in to ER for altered mental state and sob,  pt was found to be in AFIB,
Information has been received from a lawyer regarding a case in litigation concerning a female of unknown age No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 02-NOV-2013, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
the second shot really really afected her stomach; still having a loose stool; if she eats something more than a cereal or a sandwich she feels terrible; fever; nausea has continued from last wednesday all the way til now; violently throwing up for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (the second shot really really afected her stomach), DIARRHOEA (still having a loose stool), FEELING ABNORMAL (if she eats something more than a cereal or a sandwich she feels terrible), PYREXIA (fever) and NAUSEA (nausea has continued from last wednesday all the way til now) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21 and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SIMVASTATIN (ZOCOR) for Cholesterol.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (the second shot really really afected her stomach), DIARRHOEA (still having a loose stool), FEELING ABNORMAL (if she eats something more than a cereal or a sandwich she feels terrible), PYREXIA (fever), NAUSEA (nausea has continued from last wednesday all the way til now) and VOMITING (violently throwing up for 2 days). The patient was treated with BISMUTH SUBSALICYLATE (PEPTOBISMOL) for Adverse event, at an unspecified dose and frequency. On 20-Aug-2021, VOMITING (violently throwing up for 2 days) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (the second shot really really afected her stomach), DIARRHOEA (still having a loose stool), FEELING ABNORMAL (if she eats something more than a cereal or a sandwich she feels terrible), PYREXIA (fever) and NAUSEA (nausea has continued from last wednesday all the way til now) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took over the counter peptobismol and an antinauseous, and it didn't work.   This case was linked to MOD-2021-299705.
nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced NAUSEA (nausea). At the time of the report, NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
About 2 hours after vaccination started with rash on the right side of cheek and neck. Then started with hot sensation all over the upper body and difficulty breathing.  Worsening of post nasal drainage. She have herself an epi-pen injection. Continued to have difficulty breathing and went to the ER for evaluation.
on 3/4/21- HA, chills, myalgia, sweating, nausea, T max 100.4
Stated positive PCR test/Covid Test with reported symptoms of headache and congestion; Stated positive PCR test/Covid Test with reported symptoms of headache and congestion; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a representative.  A 18 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single, and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome unknown. The patient underwent the following laboratory tests and procedures sars-cov-2 test (Dec2021) positive, Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. It was unknown if the patient received other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a medical assistant concerning a patient who was vaccinated with Gardasil. Subsequently the patient experienced amenorrhea. No further details were provided. The medical assistant also reported the same adverse experience for herself which was captured in WAES #0705USA04044. Additional information has been requested.
Injection site was tender and red initially, and warm to the touch.  Muscle was stiff.  I didn't worry at first since those symptoms were expected.  By Tuesday, the redness, tenderness and stiffness went to my elbow.  By Wednesday it had spread to the right side of my right breast and under my upper arm.  I went to the doctor on Thursday.
Injection site reaction - warmth, redness, pruritis, blisters - about 2" around the injection site. No systemic symptoms per patient.
Received flu shot, 8-9 hours later developed achy joints, generalized fatigue. 3 days post, hips became stiff, sore. Over next 4-5 days, developed diffuse joint pain with stiffness all over body. No fever, no N/V. Advil.
Patient is experiencing an itchy bump on right arm where they received the MMR vaccine.  The itch is not accompanied by any symptoms.  At the time of vaccination, she did not experience any adverse events but started experiencing the itchy bump approximately a month after.
Injection site reaction: Erythema, Pain, Swelling, Warmth, Pruritus. Advised patient to use cool pad and/or take oral OTC analgesic for pain.
After about a week of having the Covid vaccine I noticed about a 2 inch red circle around the injection. The next day the redness turned triangular shape and larger than 2 inches, then it stayed triangular shape but got about 4 inches.  It lasted about 5-6 days and then went away.
This case was reported by a pharmacist via call center representative and described the occurrence of laceration of finger in a 56-year-old female patient who was inadvertently exposed to SHINGRIX (batch number B327C, expiry date 4th July 2020). On 20th April 2018, the patient received SHINGRIX. On 20th April 2018, immediately after receiving SHINGRIX, the patient experienced laceration of finger, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date,  the outcome of the laceration of finger, exposure via skin contact, inadvertent exposure to vaccine and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the laceration of finger to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not applicable for this report. The pharmacist reported one adjuvant suspension component vial from a box of ten was defective because its bottom was broken. When starting to prepare the product for administration on the day of reporting, after putting the needle in the adjuvant suspension vial to draw out the suspension, she noticed there was no product inside to be withdrawn because the bottom of the vial was broken. The reporter would send GlaxoSmithKline a photo of the defect. There were shards of glass in the bottom of the box. The product box was not damaged in any way. There was no evidence of leakage of product inside the box. The vial's bottom was mostly intact with about one-fourth of the bottom's being missing. She described that it looks like a single hairline crack where the bottom of the vial was broken. The product was stored in the refrigerator. There was no damage or opening to the package upon receipt at the pharmacy. The product was not administered. Instead she proceeded to start the reconstitution process over again using a different syringe and another new dose from the box of ten which was then administered to a consumer without issue. The reporter later noticed that her own middle right finger was bleeding. She attributed the bleeding to her finger's being cut while she had held the broken product in question.
HYPOTENSION 3/31/2022 CROHNS DISEASE EXACERBATION OF SMALL INTESTINE
Sore throat; flu-like symptoms; This is a spontaneous report from a contactable consumer. An adult female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 14Apr2021 (Lot Number: ER8729) as unknown, single dose for covid-19 immunization. Medical history included fish allergy and diagnosed with COVID-19. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Sore throat and flu-like symptoms on 15Apr2021. No treatment received. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovered in Apr2021. No follow-up attempts are needed. No further information is expected.
arm became red , seen in urgent carevand pt was told to place ice on it and take motrin and the swelling went away in24 hours
Little blisters all over body chest, back and arms within the week of SHINGRIX. Patient also reported hot skin and itching and was feeling feverish.
For the first round of this vaccine my arm swelled, and I had pain radiating up to my head.  This dose I had injection site swelling and my arm has large red lines circling it.
Pt with a history of in vitro fertilization treatments and steroid therapy was exposed to a male friend who received one dose of varicella virus vaccine live on 2/1/99. The vaccinee did not have any lesions at the time of exposure. 5 days, on 3/11/99, post exposure, the pr reported a generalized rash and a low grade fever. The pt also experienced back and leg pain and a dry throat. On 3/15/99, the pt was dx'd with classic varicella with over 100 generalized lesions and a continuing low grade fever. Pt was treated with Augmentin and Famvir.
This spontaneous report as received from a physician refers to a patient of unknown age. On 30-SEP-2013 the patient was vaccinated with VARIVAX (lot# reported as H020587, EXP date 13-NOV-2014, route and dose not reported) which was exposed to 48F for 40.5 hours, which was unsupported. No adverse effects were reported. I was unknown if the patient sought medical attention. At the time of report, the status of patient was unknown. Additional information has been requested.
it hurt my arm where I got the shot; have a low white blood cell count; I have back pain; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer-sponsored program COVAX US support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm on an unspecified date at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced it hurt my arm where i got the shot, have a low white blood cell count, i have back pain. Question: Reporter is a consumer calling to ask about interaction between Celecoxib and the Pfizer Covid vaccine. Is there a test that I can take to see if the vaccine worked on me, I have a low white blood cell count, and because when I took the shot it hurt my arm where I got the shot, but that was it. my sister on the other hand was in bed for 2 days. Question: My doctor prescribed Celecoxib 200mg capsule, because I have back pain, and I want to know if taking it will affect the vaccine, since the medication is an anti-inflammatory. Can i use fever-reducing drugs or pain relievers before or after getting the vaccine. Question: When does the vaccine start to protect me after taking the second dose. The patient underwent lab tests and procedures which included white blood cell count: low on an unspecified date. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
High fever of 105 degrees Fahrenheit with "convulsions". Cold towels and alternating Tylenol and Motrin until morning. Went to see pediatrician in am.