chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weight loss; Inflammation; Nauseous; Tiredness; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Weight loss), INFLAMMATION (Inflammation), NAUSEA (Nauseous), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Rheumatoid arthritis.    No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced WEIGHT DECREASED (Weight loss), INFLAMMATION (Inflammation), NAUSEA (Nauseous), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, WEIGHT DECREASED (Weight loss) had not resolved and INFLAMMATION (Inflammation), NAUSEA (Nauseous), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Stool analysis: Unknown.  Concomitant product use was not provided by the reporter.  The patient lost 40 pounds in three months, sore arm with 1st vaccine, inflammation, nauseous when eats and tiredness with Humira. On unknown dates, the patient experienced lost 40 pounds in three months, inflammation and nauseous when eats. In 2021, the patient experienced sore arm with 1st vaccine and tiredness. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of lost 40 pounds in three months with Humira was no reasonable possibility. The reporter's causality for the event(s) of sore arm with 1st vaccine, inflammation, nauseous when eats and tiredness was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Treatment information was not provided.
patient stated she received booster Pfizer vaccine at a pharmacy Location on 3/10/22.  Patient presented to Clinic symptoms of confusion, disorientation and temporomandibular joint disorder.
I received the shot around 10:00am and took the bandaid off around 1:00pm that same day on 3/31/21, and had a red mark. Initially I believed that to be a reaction to the bandaid, as I had previously had irritation from bandaids in another area of my body. The next morning the red mark was worse, swollen, warm, and tender to the touch. I put some ice on it, but was not overly concerned. Over the next few days the mark/swelling/redness subsided and was gone by around April 4. I woke up the morning of April 8 to find a red mark back - larger than the first, warm to touch, not tender, but a little itchier. No other symptoms present.
vomiting/Can't keep any food or liquid down; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13May2021 15:30 (Batch/Lot number: unknown) at the age of 19 years 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: VOMITING (non-serious) with onset 13May2021, outcome "unknown", described as "vomiting/Can't keep any food or liquid down"; NAUSEA (non-serious) with onset 13May2021, outcome "unknown", described as "nausea".  Additional information: Caller reported that usually when she gets her period, the same thing happens where she gets a lot of nausea and throws up a lot. Caller reported that she doesn't know if the nausea and vomiting she is experiencing are a symptom of the Covid-19 vaccine or her period that is coming up Thursday, 20May2021. Caller reported that she didn't have her physician's information. Caller reported that she hasn't been able to keep anything down. Caller reported that she can only keep down ginger ale, not even water. Caller reported that she thinks that the nausea and not being able to keep any food or liquid down have gradually gotten worse. Caller reported that she is not sure if that is from the Covid-19 vaccine or from her period. Caller reported that she gets nausea and throws up from her period symptoms. Patient does not take any other vaccine within 4 weeks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Large raised, reddened area around sight of injection. 2 inches in diameter; Large raised, reddened area around sight of injection; Large raised, reddened area around sight of injection. 2 inches in diameter. Painful.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 02Apr2021 at 15:45 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 on unknown dates. The patient did not receive any concomitant medications. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Apr2021 at 07:00, the patient experienced large raised, reddened area around site of injection that is 2 inches in diameter, painful and not itchy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events large raised, reddened area around site of injection that is 2 inches in diameter, painful and not itchy was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Cold sores on his lips; This is a spontaneous report received a contactable consumer, the patient. A male of unspecified age received the first dose BNT162b2 (solution for injection; batch/lot and expiry information not reported) as a single dose via unspecified route on 13Mar2021, for COVID-19 immunisation. Relevant medical history included cold sores on his lips (not ongoing; quite a few years ago now; occasionally gets one or two at a time). There were no concomitant medications or past drug history reported. The patient reported that he received the first dose of the Pfizer vaccine on 13Mar2021, reported as last Saturday, and on 15Mar2021, reported as yesterday, he broke out with quite a few cold sores on his lips. The patient explained that the cold sores are almost 2/3rds around his lip. The patient explained that he has not had cold sores in quite a few years now and would occasionally only get one or two at a time. The patient inquired if this could be possibly related to the vaccine. The outcome of the event cold sores on his lip was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient was extremely exciteable when his cousin that he hadn't seen in over a year came to visit us, his grandparents.  The boys love each other, but they are extremely competitive - they are both 8 years old.  Patient's mother arrived for our Easter Egg hunt and later the boys all went to fish on the lake (we live on the lake).  Within a few minutes, patient was arguing with his brother about who gets which fishing rod - and his mother was taking him up to the shed to find another one.  Patient drew back and hit his mother on the hand.  It was not broken, but they went to the Emergency Room anyway for xrays.  Patient received a whipping from his Dad for this action.  I don't feel it was right, he was competing with his cousin and had been all day.  His cousin was also fishing.  Patient was really upset, more than usual and took it out on his Mom.  He is the sweetest and most thoughtful boy I know of (course I'm Nana) but I think the medicine played a part.  He started it 2 weeks ago.  Please help me.  I've got to try to explain this to my son and his wife.  Patient is taking pills for the ADD - not vaccinations. Thank you.
Pt recv vax on 10/12/98; 20 min later pt exp hives on face x 40 min tx=Benadryl
Vaccine happened on November 11 and there were no obvious side effects other than sore arm on left side. On Tuesday November 23 he said he noticed and felt a painful bump on ribs and he didn't tell us until about November 26. We discovered he had a visible lump on his ribs and couldn't feel anything else. It was painful to the touch and we weren't sure what it was. Saturday we looked at it again and it had multiplied to 4 going from his ribs into his armpit and we determined it was swollen lymph nodes. He is 45 pounds and 3 foot and skinny, so you could see them poking out of his skin so it was concerning because he had no other symptoms. We contacted the Doctor and she got us in to see on 12/01 and we saw her and she examined him and palpated him and found another lymph node on his neck on the left side and one in the armpit and we determined it was his lymph nodes. We did a CBC and all his blood work is normal and he has no symptoms of illness other than those lymph nodes. He does currently have a skin irritation called melasma and it's not irritated. No fever other than the lymph nodes being painful there was nothing else that would indicate he is sick, so that's where Doctor suggested we should still get the 2nd shot but we will do it on his right arm just incase and if he swells up we can determine if it's the vaccine. WBC was nice and low and within range and nothing out of range.
Information was received on 19-APR-2017 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 23-DEC-2009, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-JAN-2014, the patient was treated at a physician's office for a painful rash that was diagnosed as shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Passed the 42 day mark to receive the second dose; Second dose given more than 35 days after first dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Passed the 42 day mark to receive the second dose) and OFF LABEL USE (Second dose given more than 35 days after first dose) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no recorder medical history).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Passed the 42 day mark to receive the second dose) and OFF LABEL USE (Second dose given more than 35 days after first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Passed the 42 day mark to receive the second dose) had resolved and OFF LABEL USE (Second dose given more than 35 days after first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was in an adult rehab center and didn't receive his second dose yet. It is passed the 42 day mark to receive the second dose. Treatment medication was not provided.  The patient took second dose more than 35 days after first dose.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Patient details updated, add additional event (off label dosing frequency), updated dosage regimen
Patient came in to report that her left arm is extremely sore, red, swollen and feeling hot. This started 2 days after she had received the DTAP adult vaccine, in her left deltoid. She was advised to take benedryl and ibuprofen. She had no systemic symptoms. She had no known previous reaction to any vaccines.
Initial misuse report received from a health care professional on 10 October 2013.  The patient had received two doses of FLUZONE HD within 6 weeks. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Sore; Fever; This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced pain and fever. On an unknown date, the outcome of the pain and fever were unknown.   It was unknown if the reporter considered the pain and fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The experienced sore and had a fever. The reporter inquired about having a fever after receiving their 2nd dose of Shingrix. The reporter did not consent to follow up.
Pt felt tingling down to her fingers for 3 days after receiving the vaccine.  She observed that the vaccine was injected high into the left arm, possibly near the joint. She did not get seen by a dr to confirm potential vaccine injury. But her nursing director at her school said that the vaccine may have been injected to high and into the joint. She felt better by the 4th day.
Went through menopause in 2022 following the Pfizer COVID vaccine in 2021. Received second dose of vaccine in October of 2021; did not have a menstrual period after that month. Began to have hot flashes, fatigue, joint pain, weight gain, and lack of menstrual period in February of 2022. Kept my house on 64 degrees all winter. Went to first doctor and was told I have PCOS. Went to a second doctor in another location who told me I was fine. Drew labs there; physician called me after labs resulted to tell me my labs were "that of a 50 year old woman". Had already been diagnosed with premature ovarian failure by OBGYN. Officially diagnosed by AMH and ultrasound on 09/14/2022.
COVID 19 Treatment; COVID 19 Treatment; Dose 1, 2, and 3: Moderna/Dose 4: Pfizer / Biontech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 17Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included (within 2 weeks of vaccination): CLARITIN [CLARITHROMYCIN], start date: 20May2019; MAGNESIUM, start date: 01Jan2021; NASACORT, start date: 22May2022; PROBIOTICS, start date: 01Jan2017; VITAMIN D [VITAMIN D NOS], start date: 01Jan2017; Postnatal vitamins, start date: 14Aug2020. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Sep2022 at 12:00, outcome "unknown", described as "Dose 1, 2, and 3: Moderna/Dose 4: Pfizer / Biontech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes using Paxlovid.  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.
Localized injection site allergic reaction,?- raised, erythemus area with 2 inch in diameter rash at injection site, benadryl did not help, going to take the dexamethasone prescibed by PCP.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow up received wherein the patient age group and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:
My COVID-19 symptoms started on 02/12/2023 in the morning. I had a headache, stuffy nose, runny nose and tiredness. I tested with a home  COVID-19 test on 02/13/2023 which was positive. I also did a PCR test on the same day. I did a telehealth with my doctor who then prescribed me with Paxlovid for 5 days. I had to stopped taking Warfarin taking my other medication because it might interact. I felt by 02/16/2023 and I tested negative on the 02/18/2023.
Tinnitus became noticeable one week after receiving the first dose. Pursued recommended treatments, reducing NSAIDS and ear wax removal. No improvement since symptoms began.
No adverse event (No additional AE reported); VARIVAX that experienced a temperautre excursion was administered to the patient after the excursion occured; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drugs reactions or allergies and concomitant medications were not reported.  On 14-JUN-2022, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection 0,5 milliliters (ml) as prophylaxis (lot number: U029496, which was determined to be valid, with an expiration date on 21-SEP-2023) (scheme, route and anatomical location of administration were not reported) (product storage error). Administered dose underwent a temperature excursion of 7.7 degrees Fahrenheit (F) for 30 minutes. It was reported that there was a previous temperature excursion. No additional adverse event was reported.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2206USA007839: US-009507513-2206USA007845:
Headache, nausea,memory loss, delusional,chills,sweating,
diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a female 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 diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose 1 of Shingrix and developed diarrhea that lasted for three months.  The reporter stated that it had resolved at the time of reporting. The reporter did not consent to follow-up. This is 1 of 3 case reported by same reporter.
Toes Itch frequently Hands and fingers swollen, shiny at times,  Finger joints ache frequently Coughing Smell and taste are a hit and miss