chrisvoncsefalvay/vaers-outcomes huggingface dataset:
started on the 15th at 7pm had a red itchy burning rash on my breast and then it spread to my other breast it is very painful . Went to the express care on the 16th  and was told i had shingles and the rash got worse so went to the ER. Dr said I was misdiagnosed it was not shingles.  But that the vaccine  had flared up my auto immune disease, have me IV dexamethasone and 40 mg prednisone and it did not help. Went to the ER yesterday with the same rash but  Had terrible chest pains and pain in my back and lightheaded and felt jittery. Was told i have inflammation in my chest and skin.
"trigger finger" in her left middle finger; This is a spontaneous report from. A contactable nurse (patient) reported that an adult female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: EM9810 (also reported as 'EL3427'), intramuscular, administered in the left arm on 15Jan2021 at 14:30 as a single dose for COVID-19 immunization.  Medical history included diabetes mellitus from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included metformin (manufacturer unknown) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent a nasal swab covid test on 25Jan2021 with a result of negative.  On 17Jan2021, two days after the first dose of the vaccine, the patient started to experience "trigger finger" in her left middle finger. The event resulted in a doctor/health care professional office/clinic visit. The patient received steroid injection in the left hand. The patient recovered from the event.   Information on lot and batch number has been obtained.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Cellulitis, redness, swelling, warmth and induration noted by patient the following day after vaccination. Treated with KEFLEX and Hydroxyzine.
delayed hypersensitivityreaction (itchy, burning and swollen arm from shoulder down to elbo); This spontaneous case was reported by a physician and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivityreaction (itchy, burning and swollen arm from shoulder down to elbo)) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivityreaction (itchy, burning and swollen arm from shoulder down to elbo)). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivityreaction (itchy, burning and swollen arm from shoulder down to elbo)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
1 of 3 pts who exp an inject site reaction described as local erythema, tenderness & warmth from shoulder to elbow lasting approx 4-5 days; no tx initiated; pt recovered w/no residual sequelae;
08/18/2021 Routine Covid19 Testing  = Positive/Asymptomatic
Pt. inadvertently received a 0.1 ml intradermal injection of Tetanus and Diphtheria Toxoids Adsorbed, Ultrafined on 08/26/1999 and subsequently developed an injection site reaction characterized by redness, itching and hardness. Pt was seen by the physician on 08/30/1999.
initial (4:30 am 11/14/19) chills, severe whole body shakes. lasted 2 hours. 4:30-19:00: diarrhea, nausea. by 19:00 muscle pain and weakness lasting a further 12 hours. arm was red and raised at injection site, size about that of a grapefruit.  Treated with ibuprofen.
Shingles rash left wrist dermatome C6 (prior history of chicken pox, no prior history of shingles.) Child is 8 and otherwise healthy with no illness prior to flu vaccine.)
After having the vaccination, felt woozy, headache. Went to bed, up Sunday morning, about 1:30, 1:45 had sever headache, feverish, no energy, sick to her stomach. Monday morning, excessive heart rate. Did not go to work. Was pale looking. By Monday evening, felt better. Today, wasn't feeling 100% but did go back to work.
Information has been received from a healthcare professional referring to a female patient of unknown age. On an unknown date, the patient in reaching into the box to remove the vial of ZOSTAVAX (lot# L031271, expiration date: November 2016, route and dose were unknown) without looking another healthcare worker, so she was pricked in finger. This was how the broken vial was discovered. Product quality complains (PQC) was filed. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
test positive on 17Jan2022; test positive on 17Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old patient received BNT162b2 (BNT162B2), on 13Mar2021 at 14:00 as dose 1, single (Lot number: EN6205) intramuscular, in left arm, on 03Apr2021 at 14:00 as dose 2, single (Lot number: EP7534), in left arm and on 13Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FF2J90) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Osteoporasis" (unspecified if ongoing). Concomitant medication(s) included: ALENDRONATE, start date: 01Nov2020; VITAFUSION WOMEN'S; LEVOTHYROXINE; ACETAMINOPHEN; HYALURONIC ACID; ZAFIRLUKAST; PANTOPRAZOLE; FLAXSEED; FISH OIL; SUPER B COMPLEX [VITAMIN B COMPLEX]; ZINC; ARNUITY ELLIPTA; GABAPENTIN; VIACTIV CALCIUM PLUS VITAMIN D & K; OXYBUTYNIN; IRON. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Jan2022, outcome "unknown" and all described as "test positive on 17Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jan2022) Positive, notes: Home test.  Clinical information: The patient received  Dose 4 on 02May2022 at 08:00AM Route of administration Left arm, Intramuscular . The patient received Covid-19 treatment brand name or manufacturer Pfizer from 22Jul2022 to 25Jul2022. Batch/Lot Number: 1910754A. The patient received other medications/products within 2 weeks of starting COVID-19 Treatment, Include prescribed medicines, store bought medicines, dietary supplements and herbal remedies. The patient experienced adverse events Mild itching all over, unable to sleep at night from 24Jul2022 at 10:00PM and the outcome of the events was reported as not recovered and the patient did not receive any treatment for events. Patient was not an allergic to any medications, food or other products. Other diagnosed illness/medical history/chronic health conditions: Asthma, Arthritis, Osteoporosis. The patient received  Product Diltiazem. Brand name or Manufacturer: Name. Start date :23Jul2022. Batch/Lot Number: 21365059, Glucosamine chondroitin msm turmeric. Brand name or Manufacturer: Name. Start date :17Jul2022.Batch/Lot Number 116409.
she's still having ringing in her ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (she's still having ringing in her ears) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 22-Mar-2021, the patient experienced TINNITUS (she's still having ringing in her ears). At the time of the report, TINNITUS (she's still having ringing in her ears) had not resolved. Not Provided          no concomitant medications reported, no treatment details reported.   This case was linked to MODERNATX, INC.-MOD-2021-089263 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-089263:
Patient reported a rash that started on 4/12/2021. Rash is pinpoint, flat, red dots. Rash started on inner thighs and has now spread to navel and chest area. Rash is burning and itching. Patient has reported that he was mowing the lawn on 4/12 and thinks he saw poison ivy. Patient has not tried any treatment for his rash.
Hives and itchy from head to toe.  Gave a oatmeal bath and a dose of Benadryl.
Client stated 6 am client woke up and was dizzy & nauseated. Later in the afternoon client was weak and pale. Client started itching. Client stated itching will come and go. Client's arm was red and itching for two weeks.
Soreness in my arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness in my arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Soreness in my arm). At the time of the report, INJECTION SITE PAIN (Soreness in my arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. Ginger ale was reported to be used for treatment.   This case was linked to MOD-2021-083249 (Patient Link).
REPORTING A REACTION: One week following the Moderna COVID-19  vaccination there is swelling (hardness), redness, and heat, about 2.5 inches in diameter at the vaccination site.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt fainted...I went across the register where she was... she was fully responsive the entire time. She mentioned that she did have very low blood pressure and anticipated that she might faint. She was responsive to all my questions and was fully cognitive. She laid down little bit with legs raised.. drank some water... Sat in the chair and was Ok the entire time. Spoke with her and she said she was ok.
Information has been received from an office manager concerning an 18 year old male patient with a birth twin who on 14-JUN-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number unspecified). The office manager reported that after the three doses of RECOMBIVAX HB were given to the patient, all blood work (hepatitis B surface antibody) came back negative, not immune (lab was less than 5); requiring a fourth dose of the vaccine. The patient received lot# 603895/0748V but it was unknown which dose. At the time of the report, no follow up laboratories had been performed yet. The patient did not develop hepatitis B. No other adverse experience was reported. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. The office wanted to know if lot# 603895/0748V was associated with failed immunity. Follow up information has been received from the office manager who reported that on 02-DEC-1992 (at the age of 7 months) the patient was vaccinated with a dose of RECOMBIVAX HB (lot number lot# 603895/0748V) (adult dose) as an infant. The office manager could not confirm if the vaccine was stored correctly back in 1992. A lot check has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of RECOMBIVAX HB. Additional information will be provided upon finalization of this manufacturing investigation. Follow-up information was received from the office manager who reported that  the non smoker male patient on 11-MAY-1992, was vaccinated with the first dose of RECOMBIVAX HB (lot number not available). On 11-JUN-1992, the patient received the second dose of RECOMBIVAX HB (lot number 603481/0584V) and on 02-DEC-1992; the patient received the third dose of RECOMBIVAX HB (lot number 603895/0748V) into the left leg. Concomitant vaccine given on 20-NOV-1992 included the third dose of ACEL-IMUNE (lot # 330910) into the left leg and the third dose of HIBTITER (lot # MOZQJE) into the right leg. On 25-JAN-2010 an anti-HBs titer was performed which was less than 5. The patient did not have immunity to hepatitis B virus at that moment. On the same day, a varicella zoster virus AB (IGG) was done which was 2.56 (positive). On 14-JUN-2010, the patient received a fourth dose of RECOMBIVAX HB (lot # AHBVB789AA) -manufacturer unknown). On 04-AUG-2010, a hepatitis B surface antibody test was performed which was less than 5. The patient did not have immunity to hepatitis B virus at that moment. On 23-AUG-2010, the patient received a fifth dose of RECOMBIVAX HB (lot # AHBVB789BA). At the time of the report, the outcome of the patient was unknown. This is one of several reports received from the same source. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of RECOMBIVAX HB. Additional information will be provided upon finalization of this manufacturing investigation.
Tuesday 4.20.2021: muscle soreness - began around 7pm Wednesday 4.21.2021: runny nose, feeling tired - began around 10pm Thursday 4.22.2021: runny nose continued, sore throat, feeling exhausted - began 7:30am. upset stomach - began around 11am.  Friday 4.23.2021 - Monday 4.26.2021: runny nose, head congestion, pounding headache, feeling exhausted, no appetite, low fever, chills (off and on), sore throat - began around 7am and continued through Monday morning (7am) 4.26.2021.
My aunt very sick from it; She had a diarrhea all day; She throw up the Pepto-Bismol that I gave her earlier/ She throw up everything.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FJ6369) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "doesn't stand up" (unspecified if ongoing); "multiple sclerosis" (unspecified if ongoing), notes: she has multiple sclerosis(intent: history); "paralyzed from waist down" (unspecified if ongoing), notes: She is paralyzed from waist down(intent: history); "bedridden" (unspecified if ongoing), notes: she bedridden(intent: history); "colostomy bag" (unspecified if ongoing), notes: she has a colostomy bag; "catheter" (unspecified if ongoing). Concomitant medication(s) included: HYDROCORTISONE. Vaccination history included: johnson and johnson (he got it 25Jun2021, the lot number. I guess it's the number underneath is 1808978, First Dose), administration date: 25Jun2021, when the patient was 60-year-old, for COVID-19 immunization; Covid-19 vaccine (Third Dose (first booster)), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "My aunt very sick from it"; DIARRHOEA (non-serious), outcome "recovering", described as "She had a diarrhea all day"; VOMITING (non-serious), outcome "unknown", described as "She throw up the Pepto-Bismol that I gave her earlier/ She throw up everything.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea.  Additional information: Reporter stated, "Me and my aunt both have Pfizer the booster (Pfizer covid vaccine) second booster vaccine my aunt very sick from it she has multiple sclerosis (intent: history), and she bedridden (intent: history) she has a colostomy bag, a catheter, she had a diarrhea all day I change her 4 times today, she throw up everything and I suppose to report it that is what the paper says. she doesn't stand up, she has multiple sclerosis. She is paralyzed from waist down (intent: history) and she probably weigh probably 180 to 190 pound may be, you know they are heavy when they are paralyses so, but normally she weigh around 160 something like that if she was normal (Reporter was not sure about the height and weight of the patient hence not captured in tab). she takes medication for her she take hydrocortisone (not confirmed over the call hence not captured in tab). Reporter stated she gave her Imodium A-D for diarrhea and it stop, it slow down now, and she throw up the Pepto-Bismol that the reporter gave her earlier. Reporter stated that its been longer than 4 weeks the last vaccine was given, like 15Dec2021, Dec2021 somewhere around there the booster, no she got Johnson and Johnson the first time. No, that's the one she got in Jun2021.   No follow-up attempts are possible. No further information is expected.
one week post shot joint pain in knees, hips and shoulders lasting at least 6 days so far
Information has been received through the Merck pregnancy registry, from a physician, via a company representative, regarding an 18 year old female patient, who on 05-FEB-2007 was vaccinated with the first dose, 0.5 ml, of GARDASIL (lot #653736/0014U), and on 13-JUN-2007 with the second dose of GARDASIL (lot #655165/0137U). On 16-AUG-2007, the patient had her LMP, and was unknowingly pregnant when on 13-SEP-2007 she was vaccinated with the third dose of GARDASIL (lot #657872/0515U). On approximately 15-SEP-2007 (possibly 16-SEP-2007), she visited the ER with abdominal cramps and pain, and had a positive pregnancy test. On 20-SEP-2007 she visited the physician's office, and the abdominal cramps and pain had resolved; a second pregnancy test was performed and was positive. The estimated date of delivery was 22-MAY-2008. This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow up information has been received through the Merck pregnancy registry for GARDASIL and from a physician and a licensed practical nurse regarding an 18 year old female patient, who on 05-FEB-2007 was vaccinated with the first dose, 0.5 ml, of GARDASIL (lot #653736/0014U), and on 13-JUN-2007 with the second dose of GARDASIL (lot #655165/0137U). On 16-AUG-2007, the patient had her LMP, and was unknowingly pregnant when on 13-SEP-2007 she was vaccinated with the third dose of GARDASIL (lot #657872/0515U). On approximately 15-SEP-2007 (possibly 16-SEP-2007), she visited the ER with abdominal cramps and pain, and had a positive pregnancy test. On 20-SEP-2007 she visited the physician's office, and the abdominal cramps and pain had resolved; a second pregnancy test was performed and was positive. On 16-APR-2008 the patient had an ultrasound for assessment at 35 weeks, 4 days with a normal result. On a unspecified date the patient developed gestational diabetes during her pregnancy. The outcome of the gestational diabetes was unknown. On 01-MAY-2008 the patient had a vaginal delivery of a full-term, healthy, and normal female, weight 6 lbs. 11 oz. with an Apgar score of 8/9. The reporter stated that the patient developed gestation diabetes during the pregnancy which "had nothing to do with the vaccine." Additional information is not expected.
Needle retracted prematurely; Not being covered/so some of the dose was loss; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Needle retracted prematurely), ACCIDENTAL UNDERDOSE (Not being covered/so some of the dose was loss) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised and Metastatic carcinoma (metastatic cancer).    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (Needle retracted prematurely), ACCIDENTAL UNDERDOSE (Not being covered/so some of the dose was loss) and NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE CONNECTION ISSUE (Needle retracted prematurely), ACCIDENTAL UNDERDOSE (Not being covered/so some of the dose was loss) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (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 assessments were provided for DEVICE CONNECTION ISSUE (Needle retracted prematurely) and ACCIDENTAL UNDERDOSE (Not being covered/so some of the dose was loss).    The concomitant medication was not reported by reporter. Patient administered the Moderna Bivalent vaccine and after administered it the needle retracted prematurely so some of the dose was loss. Patient said the patient was immunocompromised with metastatic cancer and the patient was concerned about not being covered. Patient said the doctor suggested to give another half dose, but patient did not know what to do. The treatment medication was not reported by reporter.
Nausea. Fever, chills, body aches. 24 hr duration.
Received flu vaccination in left deltoid, reported that it hurt deeply.  The pain continued and it worsened.The joint and shoulder continues to hurt and has not improved significatnly without Advil. She has pain with movement of shoulder.
About 24 hours after 2nd dose of vaccine received 1/23/21, really intense migraine started. Started about 4pm, lasted through going to sleep at 9pm, and then woke up fine.