chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Sep2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Sep2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 05Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Known allergies: Sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 18Aug2023 to 23Aug2023 for COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288121 same patient, different drug/event;
Two weeks after receiving the vaccine I started having pain both hands and feet almost like joint pain. This has been ongoing even today. November 1, I saw a doctor and she said she does think it may be related to the vaccine. I was given a prescription for Meloxicam. This medication wasn't helpful I was still in great pain and discomfort.
Case number PHHY2013US117506 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 498788) on 15 Oct 2013: This report refers to a 53-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal Influenza vaccine (manufacturer and batch number unknown) on an unknown date. On an unknown date, after vaccination, she experienced a large painful bump at the injection site. She stated that no treatment was given for the event. The patient did not seek medical attention. Outcome of the events was reported as not recovered as of 10 Apr 2013. Seriousness and causality was not reported for the events.
This spontaneous report as received from a consumer. The patient is a 26 year old female patient with drug allergies to VICODIN, morphine, codeine, and COMPAZINE. Concomitant therapies included PULMICORT. On 02-OCT-2014, the patient was vaccinated with a second dose of GARDASIL. The patient reported that she experienced feeling weak for 20 to 30 minutes after GARDASIL injection. The patient reported that one week after receiving GARDASIL she found out she was pregnant. The patient reported that she has been vomiting and sick to her stomach since her pregnancy diagnosis. No further information provided. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient was vaccinated with ZOSTAVAX 4 years ago. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced incorrect storage of drug. No treatment information was reported. The outcome of incorrect storage of drug is unknown. Incorrect storage of drug is not related to ZOSTAVAX. No adverse effect reported. No other information provided. Additional information is not expected.
Chills; Backache; This case was reported by a consumer via call center representative and described the occurrence of chills in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 21st October 2020, less than a day after receiving Shingrix, the patient experienced chills and back pain. On an unknown date, the outcome of the chills and back pain were recovered/resolved.   It was unknown if the reporter considered the chills and back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 23rd January 2020, the patient received the 1st dose. The patient reported after receiving the vaccine within 5 hours she had chills and a backache and these lasted a couple of days and then resolved.  For tolerance to 2nd dose refer linked case US2020AMR222005 and US2020AMR221923, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221342:same reporter US-GLAXOSMITHKLINE-US2020AMR221923:same reporter
Pt left upper lateral arm has mild redness. Moderate warmth and mild swelling measuring 10cm x 6cm. Area is tender to touch. Parent noted reaction 26 hrs after injection. TYLENOL and cold compresses applied. Pt advised to continue TYLENOL, cold compresses and one dose BENEDRYL pharmacist to dose. Report to Pediatrician or ER if symptoms worsen.
Flu like symptoms; Injection Site Pain; Injection Site Swelling; Red Circle at the Injection Site; Area was hot as fire and swollen; Hurt muscles; shivering; headache; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax.   On 27th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th August 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, injection site pain, injection site swelling, injection site erythema, injection site warmth, muscle pain, shivering and headache. On an unknown date, the outcome of the influenza-like symptoms, injection site pain, injection site swelling, injection site erythema, injection site warmth, muscle pain, shivering and headache were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, injection site pain, injection site swelling, injection site erythema, injection site warmth, muscle pain, shivering and headache to be related to Shingrix.  Additional details were provided as follows: The patient had the Zostavax vaccine many years ago and he got shingles later. The patient received Shingrix in his left arm at physician's office. The patient immediately experienced pain, swelling and a red circle at the injection site. The area was hot as fire and swollen. He also reported about hurt muscles, flu like symptoms, shivering and headache. The patient stated, these side effects were worse than when he had shingles previously. The experience was so painful that he would not be getting the 2nd dose of Shingrix. All of his reactions continued and were unchanged. The patient consented to follow up and provided his physician's address. This case has been linked to US2019158373, reported by the same reporter.
Deep arm pain that radiates through shoulder. Tenderness to palpation. No erythema or swelling.  Pt complaining of worsening pain on day 13 after event.
Vaccine diluted with incorrect diluent. Nurse used lidocaine instead of the specific sterile diluent.
PT HAD FEVER, CHILLS AFTER RECEIVING THESE VACCINATIONS. PT CALLED US AND TOLD US ABOUT IT.
swelling of upper left arm with redness & warmth noted.  measurement not obtained until Friday, 10/27/23, noting area is 21.5cm x 18cm and arm circumference 42cm.  Area outlined with black marker with noted improvement over the weekend.
This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Concomitant products included Stem Cell Infusion. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and several months after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had no reaction after her first dose of SHINGRIX. Several months before the date of reporting, the patient received her second dose of SHINGRIX in her left arm. An unspecified period later, the patient received a stem cell injection in her right arm. The patient called the nurse office and reported that she had developed shingles. This was all the information nurse had and she agreed to be contacted for follow up. The reporter was unaware of the patient's initials and date of birth. This case was considered as suspected vaccination failure cases as the vaccination schedule, time to event onset and laboratory results were unknown at the time of reporting.
decided not to go ahead with 2nd Vaccine; hives over entire body; 1 was a cyst; a lump on left breast; lump on left breast, was tender; lump on left breast, was sore and had pain; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (a lump on left breast), BREAST TENDERNESS (lump on left breast, was tender), BREAST PAIN (lump on left breast, was sore and had pain), CYST (1 was a cyst) and URTICARIA (hives over entire body) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma since 03-Mar-1996, Allergy to animals (Cats) and Allergy to animals (Horses). Concomitant products included FLUTICASONE FUROATE (ARNUITY ELLIPTA) from 05-Jan-2018 to an unknown date and MONTELUKAST from 05-Jan-2018 to an unknown date for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced BREAST MASS (a lump on left breast), BREAST TENDERNESS (lump on left breast, was tender) and BREAST PAIN (lump on left breast, was sore and had pain). On 30-Mar-2021, the patient experienced CYST (1 was a cyst). On 12-Apr-2021, the patient experienced URTICARIA (hives over entire body). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (decided not to go ahead with 2nd Vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. On 15-Apr-2021, URTICARIA (hives over entire body) had resolved. At the time of the report, BREAST MASS (a lump on left breast), BREAST TENDERNESS (lump on left breast, was tender), BREAST PAIN (lump on left breast, was sore and had pain) and CYST (1 was a cyst) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (decided not to go ahead with 2nd Vaccine) had resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Mammogram: inconclusive (Inconclusive) Found 2 lumps and 1 was a cyst. On 30-Mar-2021, Ultrasound breast: inconclusive (Inconclusive) Found 2 lumps and 1 was a cyst. On 06-Apr-2021, Biopsy: inconclusive (Inconclusive) The doctor could not identify one of the lumps and felt the other was a cyst, that was aspirated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Updated allergies. Updated diagnostic data - biopsy. Updated Event onset date of Lump on breast, Tenderness Breast, Pain Breast. Updated event outcome of Hives to recovered. Updated concomitant medications.
dizziness; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 DIZZINESS (dizziness). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at a dose of 1 dosage form. At the time of the report, DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Joint pain in the elbow was reported as worsened.; have been experiencing joint pains to our elbows for 5 weeks; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 48-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8736; Expiration Date: 31Jul2021) via an unspecified route of administration in Arm Left on 06May2021 15:30 as 2nd dose, single dose for COVID-19 immunisation. The patient previously received first dose of Pfizer vaccine on 15Apr2021; Lot number: EW0150 and the expiration date on 31Jul2021 via an unspecified route of administration in left arm. Medical history included ongoing diabetes mellitus diagnosed a little over a month ago. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No other vaccines within four weeks prior to first administration. On 08May2021, two days after receiving vaccination, the patient experienced joint pains to elbows for 5 weeks and on an unspecified date, experienced joint pain in the elbow was worsened. The caller reports her joint pain was in one elbow. This began probably two days after the caller received the second dose Pfizer Covid Vaccine. The caller reports the pain was not constant, it was just like if the caller moves. The caller states the joint pain in the elbow has worsened. The patient did not visit emergency Room or physician office, but the caller thinks she is going to go within the next week if her pain doesn't get better. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021594113 Same reporter/drug/AE, different patient
Very stiff neck (never B4 with any vax) Bad headache on & off 4 1 week ( I do not get headaches, & never B4 with any vax) Bloody nasal mucus (never before with any vax) Baseball size swelling, deep red skin with itch like bee sting 4 3 days Nausea for three days no appetite for one week Extreme lower abdominal pain Friday morning contemplating visit to urgent care Bloody mucus and diarrhea Sunday through Wednesday with abdominal pain
Upper arm turned light pink / pink area on the arm came back after it went away; Two small pink blotches developed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Upper arm turned light pink / pink area on the arm came back after it went away) and RASH MACULAR (Two small pink blotches developed) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer and Cancer surgery (done 22 years ago). Concurrent medical conditions included Lymphedema (Lymphedema in right arm from a breast cancer surgery from 22 years ago), Rosacea (takes a facial ointment for Rosacea), Oral herpes (last time  outbreak was 8 years ago and then got an outbreak one week before the first vaccine) and Sensitive skin (skin is so sensitive. Can't wear a bandage). Concomitant products included VALACYCLOVIR [VALACICLOVIR] for Oral herpes, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Upper arm turned light pink / pink area on the arm came back after it went away) and RASH MACULAR (Two small pink blotches developed). At the time of the report, VACCINATION SITE DISCOLOURATION (Upper arm turned light pink / pink area on the arm came back after it went away) outcome was unknown and RASH MACULAR (Two small pink blotches developed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She went grocery shopping right after vaccine and had no other reaction. The next day, she called the dermatologist and by the time they called her back she was able to get to a public computer and saw there was something called Covid arm, so she was not very concerned. About 5 days later, the pink came back again, no blotchy, no other reaction at all. She went back to the library to use the public computer, and it seems like the second time the pinkish area came back is the most normal. Concomitant medication also included a facial treatment for Rosacea. The patient did not receive any treatment medications.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (regular arm pain/arm felt super achy/felt like she was punched in the arm), RASH MACULAR (Rash on both arms/8 spots on left arm/16 spots on right arm), RASH PRURITIC (noticed red bumps that were itchy on right forearm), SKIN LESION INFLAMMATION (Rash inflamed) and SKIN BURNING SENSATION (skin felt like it was on fire/"it felt hot") in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dust allergy and House dust mite allergy. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 10-Feb-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (regular arm pain/arm felt super achy/felt like she was punched in the arm). On 12-Feb-2021, the patient experienced AXILLARY PAIN (pain on left armpit), NAUSEA (nausea) and PYREXIA (fever of 101.6F). On 18-Feb-2021, the patient experienced RASH PRURITIC (noticed red bumps that were itchy on right forearm) and SKIN LESION INFLAMMATION (Rash inflamed). On 19-Feb-2021, the patient experienced RASH MACULAR (Rash on both arms/8 spots on left arm/16 spots on right arm). On 21-Feb-2021, the patient experienced SKIN BURNING SENSATION (skin felt like it was on fire/"it felt hot") and SKIN REACTION (skin around the bumps looked angry). The patient was treated with Bed rest for Pyrexia. On 17-Feb-2021, AXILLARY PAIN (pain on left armpit) had resolved. At the time of the report, PAIN IN EXTREMITY (regular arm pain/arm felt super achy/felt like she was punched in the arm), RASH MACULAR (Rash on both arms/8 spots on left arm/16 spots on right arm), RASH PRURITIC (noticed red bumps that were itchy on right forearm), SKIN LESION INFLAMMATION (Rash inflamed), SKIN BURNING SENSATION (skin felt like it was on fire/"it felt hot"), SKIN REACTION (skin around the bumps looked angry), NAUSEA (nausea) and PYREXIA (fever of 101.6F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medication use included birth control (type not specified)  Treatment medications included ibuprofen, Benadryl and hydrocortisone cream.  The consumer gave consent for Safety follow up.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Contact Info updated
Information has been received from a registered pharmacist concerning a 42 year old female patient with no drug allergies or pertinent medical history who on 06-NOV-2009 was vaccinated IM in the left arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot number 665270/1398Y). There was no concomitant medication. On 07-NOV-2009 the patient experienced irritation, pain and difficulty moving her left arm. The patient reported to the pharmacist that she felt that her left shoulder "pop" after a night of using ice on her arm as directed by her physician. At the time of the report the patient had not recovered. No laboratory tests were performed. The patient sought unspecified medical attention. Follow up information has been received from a physician concerning a 42 year old female patient with penicillin (PCN) allergy who on 06-NOV-2009 was vaccinated IM in the left arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot number 665270/1398Y). On 06-NOV-2009 the patient complained of left arm pain during injection and for several weeks after. Physician reported that on her last visit, on 24-FEB-2010, the patient still had minimal soreness but almost improved in an 85-90 percent.  No further information is available.
01/15/23 presents to ED for "lightheadedness". PMHx "HLD, overactive bladder"
patient was found to have fainted in the waiting area. Reports hitting his head, but was conscious by the time we examined him. A+Ox3, vision intact, speaking normally, complaining of slight pain where he hit his head
Tinnitus. It lasted 3 days, only at night. Woke me up it was so loud, but I was able to go back to sleep.
Got both his shot year ago, shingles now/ suspected vaccination failure; Has them right now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In December 2022, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 4-Dec-2022 Reporter's comment: The case was received from the patient's wife via interactive digital media. The patient got both his shot a year ago and he had them right now. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
The client reported she developed itching and "red and white blotches" on her arms and legs bilaterally about 24 hours later. The client states the "blotches" were palpable on her skin. The client denied any symptoms on her torso. The client denied using any new skin products prior to noticing the symptoms. The client stated her symptoms lasted about 5 days. The client denied any dizziness or shortness of breath. The client did not seek treatment for the her symptoms at the time, did not follow up with a PCP. The client did not take any medications or use any topical cream for her symptoms. The client denies any chronic conditions. No current medications. No known allergies.