chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Bivalent given as second dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Bivalent given as second dose) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     It was reported that patient had no relevant medical history or conditions, allergy, concomitant diseases and risk factor.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Batch/lot number - EW0185) on 19-May-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 17-Mar-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Bivalent given as second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Bivalent given as second dose) 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 WRONG PRODUCT ADMINISTERED (Bivalent given as second dose).    No concomitant medication were reported.  Nurse stated that they had a patient last who lied about the vaccination status, patient stated that she was already fully immunized, so they gave patient the Moderna bivalent booster dose. When they checked the vaccination record, they found out that patient had only 1 primary dose which was Pfizer. No adverse event was reported by the patient after the administration. No treatment information was provided by the reporter.
Arm sore/muscle ache. After few days, pt states feels better without muscle ache/soreness.
lump at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site lump in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, less than 6 months after receiving Bexsero, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was not recovered/not resolved.   It was unknown if the reporter considered the injection site lump to be related to Bexsero.  Additional details were reported as follows The age at vaccination was not reported. The reporter indicated that her daughter received the first dose of Bexerso six weeks ago and still had a lump at the injection site.
This spontaneous report as received from a physician refers to a several female patients of unknown age who on an unknown dates, were vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (dose and lot number not reported). It was reported that over the past two weeks in approximately May 2013, the patients complained of headaches after receiving GARDASIL. No lab diagnostics studies were performed. At the time of the report the patient outcome was unknown. The patients did not seek medical attention. The relatedness for headache and GARDASIL was unknown. Additional information has been requested.
Breakthrough COVID 19 hospitalization in fully vaccinated patient with primary 2 dose series.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 2:26 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Nov-2021 at 2:26 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 68.16.  Concomitant products were not provided.  On 03-Nov-2021, Excursion time was 10 AM, temp was 35; total doses given for the day was 117, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Oct-2021. 6 vial was moved to clinic. Vaccine BUD date was 15-Nov-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Fever 102.9 have been taken Tylenol 500mg 2 doses every 5 hours. Legs feel very heavy had to use the furniture to walk around.  Very tired.
Patient had injection site reaction. MD states size of an orange and raised. Patient told nurse it was hot and itchy.
Tinnitus?NON STOP,  this started shortly (<2weeks) after I tested positive (PCR) for COVID (pharmacy) on 1/27/22.
7/14-7/16 chills, SEVERE migraine, vomiting 7/17 heart pounding My son has NEVER been so sick!   As of 7/21, he is still not back to normal.
Initial report received on 07 August 2009 from a consumers parent. A female patient (date of birth not reported) had received a first dose of IMOVAX Rabies vaccine; a first dose of JE-VAX vaccine; and a first dose of  TYPHIM VI vaccine on 31 July 2009. The lot numbers, routes and sites of administration for all vaccines were not reported. Three days after receiving the vaccinations, the patient had a fever of 102.2 degrees Fahrenheit, nausea, vomiting, diarrhea and headache. Per the parent, the patient had dinner with three other people on 03 August 2009 that experienced the same symptoms, but they had not received any vaccinations. The patient did not seek medical attention. It was unknown if the patient had nay illnesses, pre-existing medical conditions, or use of other medications at the time of vaccination on 03 August 2009. Recovery status is unknown. No contact information was provided for follow-up. No further information is expected. Follow-up information received from another manufacturer (BIKEN) whose case identification number for this case is F0854. No other relevant medically significant information was added to the case.
About 12 hours, post vax, client has nickle-sized swollen welt at injection site which progressed to half-dollar sized. Now, today, 4/7/00, it is a 6" band around arm 3" in diameter, swollen, hot and painful. Client's symptoms resolved after 4 days.
DPH (after the Lot number); I started with a very severe pounding tension headache - 6:00 am; very severe fatigue; very severe arm pain at injection site. And then unable to complete daily functions: do to headache; suffered from headache - took one gram tylenol to address a low grade fever that day and the headache, too. fever subsided with tylenol. Headache was relentless; I tried 600 mg of ibuprofen as well to treat headache with no success; Started to suffer severe pain; couldn't open eyes from pressure of headache. Went to ER due to never having such a severe headache before. Tests did not show pathology that would cause headache. Was given one liter of IV fluids. Was given 25 mg of Benadryl ; 10 mg of Compazine. Along with toradol. And 20 meq of potassium. Also tested for covid and was negative. And discharged home. FOllowing day: mild headache and with resolution of left arm pain.  By the 27th it felt like headache was resolved.
Pt spiked a 103 degree fever 7 days after he was given MMR. Parents are worried about side effects of vaccines.
Extremely tired and leg pain . went to doctor on 7/29 and blood clot was found.
Moderate Anaphylaxis. Treated with Epinephrine, Diphenhydramine and Solumedrol. Symptoms mostly resolved within 30 minutes and stable for 4 hours.
Redness and swelling of (R) arm around the area of injection of Varicella and Meningococcal vaccines.
Altered State of Consciousness.; This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on 16Feb2021 16:30 at single dose on left arm for Covid-19 immunisation. Medical history included breast cancer with chemo in 2004. No known allergies. The patient did not have Covid prior vaccination. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN). The patient did not have other vaccine in four weeks.The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:  EL1283) via an unspecified route of administration on Jan2021 07:00 AM on left arm for Covid-19 immunisation. The patient experienced altered state of consciousness on 17Feb2021 at 07:00. The patient felt like she was standing beside herself, removed from herself. Lightheaded and remote from her thinking or what she was saying. As if on a psychedelic drug. No flu like symptoms at all. No treatment was received for the event. The outcome of the event altered state of consciousness was recovered in Feb2021. The patient did not have covid tested post vaccination.
I began to experience some challenges in my skin integrity after the Covid injections which subsequently lead me to bring this to the attention of my PCP Dr. Upon explaining to him the most compromising symptoms which I could not effectively treat at home, I brought that to Dr.'s attention during a routine office visit by which he examined the area and prescribed a topical medication to use an antifungal cream which resolved the most challenging issue.
Egg-sized lump developed at site of Pediarix, warm and mildly tender to touch.
Day one: pain in arm, extreme fatigue, nausea, fever, blurred vision, heavy chest, headache, eye burning pain, pain in side of neck and intonarmoit, pain in right calf, runny nose, burning in nose and throat, oversensitive to touch like clothes Day 2: runny nose, fatigue. congestion, headache, injection site pain Day 3: scratchy throat, watery eyes, arm sore at infection site, naseua, low energy Over the next four days symptoms lessened. At day seven finally felt back to normal. Day 18 &19- spotting blood, period is 9 days early which is not normal. I'm never this early or irregular
sore arm, nausea, temp, fatigue, elevated pulse 108, BP High 147/99, headache
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 3/02/21 and 6/21/21. Prior admission 2/11-24/22 for Covid. Presented to ED 3/17/22, admitted w/heart failure exacerbation and hypoxia, tested Covid+. Mental status deteriorated c/b severe cardiomyopathy deemed unable to respond to rescue treatment. Course c/b superimpose PNA, kidney and liver failure. Made DNR and transitioned to comfort care. Expired on 4/1/22. Treated with steroids, Zosyn, cefepime.
Information has been received from a health professional concerning a 12 month old patient who in approximately January 2010, "early 2010", was vaccinated with a dose of VARIVAX (Merck). Suspect secondary vaccination administered on the same day included a dose of MMR II. Two weeks later the patient presented with rash all over the body. The patient called the physician's office. On an unknown date the patient recovered from rash all over the body. Follow-up information was received which reported that there was no patient involved. Additional information is not expected.
Suspected vaccination failure/First vaccine yrs ago / 2 part vaccine / Shingles now; My body is a mess with shingles now. Buttocs and back; First vaccine yrs ago / Turned 65 / 2 part; This case was reported by a consumer and described the occurrence of Suspected vaccination failure in a 65-year-old 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. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and drug dose administration interval too long. On an unknown date, the outcome of the vaccination failure, shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose. The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient had f1st vaccine years ago and when turned to 65 years the physician  pushed  into getting the 2 part vaccine. The patient's body was a mess with shingles, buttocs and back. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation test were unknown at the time of reporting.
pt recv vax 11OCT96 & 12OCT96 devel a rash consisting of small bumps on back & below lt eye;reporter also indicated that bumps on back were red;17OCT96 bumps began to dry up;
The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 4 year old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 06-JAN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S006647 is an invalid lot number, expiry date reported as 05-MAR-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; This is a literature report for the following literature source(s): (Privacy).   Authors sampled 130 NH residents and 95 HCWs 6 months after vaccination who had been previously evaluated 2 weeks following vaccination. Patients were studied from December 2020 to July 2021 from 4 NHs. The HCWs were workers at the NH buildings and medical center who all had access to the same vaccine at the same time as the NH residents. All participants received 2 doses of vaccine regardless of prior SARS-CoV-2 infection. Of 225 participants with available 6-month follow-up, 13 (6%) were excluded for presumed or known SARS-CoV-2 infection between the 2-week and 6-month draws. All of these participants were in buildings or workspaces with known outbreaks. Those with presumed infection had an increase in titer greater than 100% at 6 months from the 2 week post-vaccine level in at least 1 of the immune assays. Five participants had known PCR-confirmed diagnoses; the other presumed cases were clinically undetected. Subjects that have been excluded with documented or presumed infection in the 2 week to 6 month interval: 96-year-old male. Reason for exclusion: PCR +ve, Titer rise (Titer rise denotes an increase greater than 100% in either or all of anti-spike, anti-RBD or neutralization titers); Clinical: Symptomatic (Symptomatic denotes subjects with COVID-like symptoms).  A 96 year-old male patient received bnt162b2 (BNT162B2) (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), outcome "unknown" and all described as "known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws". The patient underwent the following laboratory tests and procedures: antibody test: titer rise; blood immunoglobulin g: unknown results; fluorescent in situ hybridisation: unknown results; sars-cov-2 antibody test: titer rise; sars-cov-2 test: positive; unknown results.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202200314527 Same article/ drug/event and different patient
FEELING TERRIBLE; CHILLS; MUSCLE ACHE; HEADACHES; FEVER; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced feeling terrible. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced muscle ache. On 10-APR-2021, the subject experienced headaches. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle ache, headaches, chills, fever and feeling terrible was not reported. This report was non-serious.
Patient complained of red rash across the chest that started approximately 24 hours after receiving the vaccine. She noted no other changes in lifestyle, eating, etc.
01/23/2021 to 1/23/20201, swollen lymph nodes in throat which causes pain. Saw urgent care 1/27, ENT on 1/29 d/t ongoing side effect. No rx provided, resolved on own
The patient indicated by phone that she had fever, headache, tiredness, and "fever sweats". Patient took acetaminophen. She felt relieved and symptoms disappear.
Intense itching around chest, head, and neck. Symptoms subsided after  taking benadryl.
The injection was not supposed to have been given...she had her first dose at birth, her second dose at 2 months old, and they gave her 3rd dose today...it was too soon for the 3rd dose. She became red in the face, began throwing up, and acting lethargic.
A non-serious, spontaneous report of FLUMIST administered to a nursing mother has been received from a consumer concerning a 33-year-old female patient. The patient's medical history and concomitant medications were not provided. The subject received FLUMIST on 12-Oct-2009. The subject came into close contact of her five-month-old infant (MEDI-0009076) by way of breastfeeding. The subject stated "the pharmacist did not read my form to see that I was breastfeeding and I did not know I was not a candidate." There was no adverse event associated with this medication error for the subject; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Large localized reaction to Pfizer booster. Reports warmth, erythema, pain - denies fever Treat with Keflex.
Immediate pain, loss of use of right arm. Tingling of nerves arm drops down sometimes. Hard to sleep. Still having symptoms.
5/15/13 pt given Tdap - felt pain that night to (L) arm. Since then and (R) arm pain, swelling rt knee, fever 100.2, general fatigue, achiness throughout body, abd pain, h/o, nausea.
Chills, headache, achiness, fever after each Rabies vaccine, more pronounced after 2nd injection. Third vaccine not given, titer drawn.
Palpitations; felt tingle all over; did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), PARAESTHESIA (felt tingle all over) and PRODUCT DOSE OMISSION ISSUE (did not get the second dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0700C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-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 PALPITATIONS (Palpitations), PARAESTHESIA (felt tingle all over) and PRODUCT DOSE OMISSION ISSUE (did not get the second dose). At the time of the report, PALPITATIONS (Palpitations) and PARAESTHESIA (felt tingle all over) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not get the second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant medication was not reported. Treatment information was not reported.
Erythema and swelling of right thigh 11 x 5.5 cm.
Red rash 1 hr p inj Pfizer vaccine Immuniazation #1. Improved and recuured 1 hr later Recd IM Benadryl
COVID positive 12/22/2022 Sore throat, headache, cough, nasal congestion, body aches, fatigue  X 10 days Acute bacterial sinusitis on day 10 treated with doxycycline 100mg bid X 10 days
This spontaneous report as received from Certified Medical Assistant (CMA) refers to a 12 month old infant patient. On 18-JUN-2013 the patient received PNEUMOVAX 23, 0.5 ml, intramuscular (lot # was not reported) instead of PREVNAR. No adverse effect reported. Additional information has been requested.
Pt shows about 2 in. in diameter red circle around injection site reports itching and warm temp. in the area. Pt taken BENADRYL for itching.
Swelling, redness of right arm 7 hours after shot. Arm very painful, unable to sleep. Blurry vision. To P.C.P in am of 10/27 - ordered ice pack only. Went to hospital 10 am 10/27/05 was given prednisone taper pack