chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was tender; maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) and TENDERNESS (arm was tender) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 09-May-2021. On 19-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On an unknown date, the patient experienced TENDERNESS (arm was tender). On 19-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. At the time of the report, TENDERNESS (arm was tender) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medicines include blood thinner medications called Lenovax, prenatal vitamins  treatment medicines were not reported
Within 10 minutes of immunization, the child developed a facial rash, diffuse redness began on right side of face, then spread to the left side. Lung sounds clear bilaterally. The child was alert and responsive throughout. EMS was called and the child was taken to an urgent care facility.
This spontaneous report as received from a healthcare worker refers to a 6 months old patient of unknown gender. The patient's medical history and current conditions were not provided. On 13-MAY-2016, the patient was inadvertently vaccinated with a dose of VAQTA (lot #, expiration date, dose and route were not reported) instead of RECOMBIVAX HB. No adverse experience has been reported. The healthcare workers reports that there was no product confusion between VAQTQ and RECOMBIVAX HB, the unspecified nurse who administered the vaccines "just grabbed the wrong product". This is one two reports received from the same reporter. Additional information has been requested.
Pt called health system call ceneter c/o covid vaccine side effects. . Pt stated pt got 1st covid vaccine Moderna 4/21/2021 at EVC and pt got vertigo after vaccination.  Pt said pt was not able to get up, walk on next day of covid vaccination. Noted no emergency s/sx at this time.Pt stated no treatment took for vertigo.Pt said pt missed covid 2nd vaccine schedule yesterday d/t pt concerned that pt experienced vertigo after 1st covid vaccination. Noted pt has asthma, chronic hepatitis C. Pt intended to speak with MD before 2nd covid vaccine. Pt scheduled UC 5/20/2021 for consultations. Pt made aware. Pt is educated covid vaccine side effects.
Around 13 hours later 7AM didn't sleep well.  Woke up with dull headache and back of neck muscle aches.  This lasted all day and evening.  Today 3/26/21 I woke up feeling much better, dull headache pretty much gone.  That was all that I had for side affects.
Pt. had ADACEL vaccine on 5/5/08.  On 5/7/08 went to school nurse with large, hard knot on left arm, red, swollen, feverish.  No trouble with breathing.
low grade temperature; Coughing; Reaction Left Full Arm; fever 99.7F; Headache; Nausea; Fatigue,tired; Hot; Chills; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue,tired), FEELING HOT (Hot), CHILLS (Chills), MYALGIA (Body Aches) and PYREXIA (low grade temperature) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced FATIGUE (Fatigue,tired), FEELING HOT (Hot), CHILLS (Chills), MYALGIA (Body Aches), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION COMPLICATION (Reaction Left Full Arm) and PYREXIA (fever 99.7F). On 05-Apr-2021, the patient experienced PYREXIA (low grade temperature) and COUGH (Coughing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency. On 04-Apr-2021, FATIGUE (Fatigue,tired), FEELING HOT (Hot), CHILLS (Chills), MYALGIA (Body Aches), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION COMPLICATION (Reaction Left Full Arm) and PYREXIA (fever 99.7F) had resolved. At the time of the report, PYREXIA (low grade temperature) and COUGH (Coughing) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test: positive (Positive) positive. On 01-Apr-2021, Body temperature: 99.7 (High) Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided.
( + ) REDNESS, ERYTHEMA, TENDER RIGHT ARM IN ARE MMR.
Red spotty skin rash on left side of body (LF abdomen and LR back).
Information has been received from a consumer concerning her 17 year old daughter with no medical history or drugs allergies, who on 01-MAY-2009 was vaccinated with a first dose of GARDASIL. There was no concomitant medication. Subsequently the patient was determined to be pregnant. Her LMP was in April 2009. The pregnancy was confirmed with a home pregnancy test. The patient will be contacting her primary physician for referral to obstetrical practice. The patient did not seek medical attention. Follow up information has been received from a physician concerning a female with asthma and no previous pregnancies, who on 01-MAY-2009 was vaccinated with the first dose of GARDASIL (Lot: 661953/1130X). The physician reported that the pregnancy was not diagnosed in her office; the mother of the patient called to the office on 02-JUL-2009 and reported that the patient was 2-3 months pregnant (LMP: 02-APR-2009, EDD: 07-JAN-2010). The physician also reported that the patient was being followed by an OB/GYN. Follow up information has been received from the physician who indicated that the patient had just been seen in the office (no further details provided). Follow up information received from the physician indicated that on 03-FEB-2010 at 41 2/7 weeks from her last menstrual period, the patient gave birth to a normal female with no congenital anomalies. The baby's weight was 6 pounds and 15 ounces, her length was 20 inches; apgar score was 9/9. The patient did no have complications during pregnancy or labor. It was also reported that on an unspecified date the patient experience increase gestational blood sugar. The outcome of the patient's increase gestational blood sugar was unknown. No further information is available.
On 11/27/99, the pt developed a rash on her stomach, back, hand, feet and neck area. The rash was diagnosed as erythema multiforme.  Physical exam revealed a hyperemic and bulging right tympanic membrane with signs of effusion.  A diagnosis of otitis media with effusion was made.  A skin exam showed red papules on the chest abdomen and both hands and feet. Follow up information reported that on 11/30/1999, the pt recovered. No further information is expected.
Patient had a bullseye rash at site of VARIVAX injection two days later, which progressed to a baseball sized rash that was throbbing, itching, and painful.
Patient experienced discomfort and lower range of motion following the injection on 10-10 but states continued loss of motion over time reported 13 days post injection.
Patient had pancreatic tail erosion on CT and elevated Amylase & Lipase enzymes.
PT developed rash and fever of 100.0. Seen at a facility where hives were diagnosed. Pt was given Benadryl. Pt contacted PCP office d/t rash spreading and becoming worse. Pt rash spread to face, chest, buttocks, and LE's. Pt also has hard nodules beneath immunization site the size of silver dollars. Pt's mom using ice packs, heat, and Benadryl.
Next morning patient reported noting a 2.5X2.5 area with soreness, swelling, erythema and "roughness" of the skin at the injection site.
The patient showed pre-syncope symptoms, including dizziness, drowsiness, black spots in vision, and skin that felt heated and clammy. The symptoms disappeared within 20 minutes without syncope occurring. When we spoke to their mother 3 hours later, she reported that the patient had no further problems.
2 bumps under right arm, same arm where vaccines were given. Pain under arm where vaccines were given.
pt recv vax & exp abd cramping & fatigue;exp n & projectile v; felt very weak & achy;to clinic given med;still weak & tired & exp gen body aching & abd cramping;lethargy, mental status pt felt not nl;walking w/limp;staph food poisoning;
fever; thought his lungs were inflamed; headache; felt unwell; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (Solution for injection), dose 1 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from Jul2020. He had Covid-19 on July last year, allergic to NSAIDs. The patient's concomitant medications was not reported. The patient previously took montelukast for allergies and experienced pneumonia. He has already been taking Montelukast to treat his allergies. The patient after receiving the 1st dose of the vaccine, he had fever, felt unsettled, and thought his lungs were inflamed so he took Montelukast. He said he only took it one time and wants to know if this has affected the vaccine. Low grade fevers ranging from 99.7 to 99.8. He said his fever ranged from a low temperature of 96.2, and the highest it reached was 99.8. He said the fever comes and goes for a week now. He also said he had headache and felt unwell. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
felt like could not move or walk; her right hand feels numb and tip of the finger and it could be also the chemotherapy and radiation therapy; hip pain, ankle pain, the ankle pain radiated up and down; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (felt like could not move or walk), HYPOAESTHESIA (her right hand feels numb and tip of the finger and it could be also the chemotherapy and radiation therapy) and ARTHRALGIA (hip pain, ankle pain, the ankle pain radiated up and down) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer in 2016 and Rheumatoid arthritis.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-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 experienced GAIT DISTURBANCE (felt like could not move or walk), HYPOAESTHESIA (her right hand feels numb and tip of the finger and it could be also the chemotherapy and radiation therapy) and ARTHRALGIA (hip pain, ankle pain, the ankle pain radiated up and down). The patient was treated with DIETHYLAMINE SALICYLATE, METHYL NICOTINATE (ASPERCREME [DIETHYLAMINE SALICYLATE;METHYL NICOTINATE]) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (felt like could not move or walk), HYPOAESTHESIA (her right hand feels numb and tip of the finger and it could be also the chemotherapy and radiation therapy) and ARTHRALGIA (hip pain, ankle pain, the ankle pain radiated up and down) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.
Inositol vaccine 01/21/2021. Injection site was fine within a week. Began taking doxycycline on Fri 01/29/2021 prescribed by Dr for dermatological issue. Woke up Sun 01/31/2021 6am with blotchy red, painful injection site, swollen, and hot to touch.  Redness & swelling is about 6 inch diameter.  Stopped taking doxycycline until can speak to doc. By 8pm, redness almost gone but still a little hot to the touch.
DEATH; This spontaneous report received from a consumer concerned multiple patients of unspecified age, sex, race and ethnic origin. The weight, height, and medical history of patients were not reported.  The patients received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients died from unknown cause of death. The autopsy details were not provided. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210747770-Covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patients mother called and reported that patient was in hospital, that the Dtap/polio vaccination had given her child a Staph infection. Where injection was given it was a softball size.
early third dose; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 58-year-old female patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B) and HEPATITIS B VACCINE (ENGERIX B).   On 24th July 2021, the patient received the 3rd dose of Engerix B. On 24th July 2021, unknown after receiving Engerix B, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received an early third dose of Engerix-B, which led to shortening of vaccine schedule. No reaction reported. The reporter consented to follow up. This case has been linked with case US2021AMR202719, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202719:same reporter
Influenza - like disease - Information has been received from a registered nurse concerning a 30 year old female, who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 635921/1181k.  subsequently, the patient experienced flu - like symptoms.  Unspecified medical attention was sought.  The patient recovered from the flu-like symptoms.  Additional information has been requested.
A non-serious spontaneous report of pt received H1N1 in third trimester was received from a physician concerning a 32-year-old pregnant female. The patient did not have any medical history. The patient's obstetrical history included gravida two and para one at the time of vaccination. The patient was 29 weeks pregnant or in third trimester of pregnancy at the time of vaccination. The expected delivery date of the patient was 12-Jan-2010. Patient was not taking any concomitant medications. On 31-Oct-2009, the patient received H1N1, Intranasal. On 05-Jan-2010, the patient delivered a normal, healthy baby boy vaginally without complications and the neonate's weight was 8 lbs at birth. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments were not applicable. The outcome of the vaccine exposure during pregnancy was resolved. Additional information was received on 15-Feb-2010 and incorporated into the narrative: about pregnancy outcome, date of delivery, type of delivery and condition of the baby.
6 PM exam by MD. Bumpy papular rash over right deltoid. Swelling. No redness left deltoid.
Presented with hypotension; diagnosed with COVID-19 in January and still tested positive. Patient was placed on oxygen, restarted back on steroids but he was able to be quickly weaned off to room air. Meds: Decadron, Singulair,  zinc
Headache,  enlarged and sore lymph nodes under jaw on right side, sore throat, body aches, and chills
Pt experienced syncope immed after vaccine on 1/18.  On 2/4, pt developed dizziness, vertigo, vomiting.  Dizziness, vertigo, headaches continue to persist.  She has had - MRI.  Normal visual exam.  - ENT eval.  Continues to be symptomatic.  8/13/2008 Office records received. Pt fainted following HPV4 vax on 1/18/2008. Returned 2/7/2008 with several day hx of vomiting and diarrhea with syncopal episode that am. Assessment: vomiting and fainting probably due to viral infection. To increase fluids. Seen again 2/12/08 with dizziness reported since 2/4/08 (worse on change of position and/or on feet) and 2 syncopal episodes. PE (+) for ataxia and (+) Romberg and mild horizontal nystagmus. DX:  Labyrithitis. Seen again 2/28/08 with same sx slightly improved with Antivert. DX Labyrithitis. Vertigo. 3/13/08 seen for vertigo. 3/26/08 HPV #2. Seen 6/25/08 with dx diplopia, 7/21 with vertigo and 7/25 with plantar warts and cystic breast mass.
1/19/01: 16 days after immunizations she was in ER and diagnosed with gastroenteritis. Also thimerosol in vaccine possibly led to accumulate toxic levels of mercury causing speech and language delays. Possible mild mental retardation. The 60 day follow up received on 5/29/03 states developmental delay at risk of mild mental retardation diagnosed by a psychologist D. We believe it was thimerosal in vaccines. Annual follow up on 04/14/04: "Pt has not recovered from adverse events.  Pt's diagnosis is severe language delay and is highly suggested that a diagnosis of mental retardation at age 5."
Sore throat; Swollen glands in neck; Nausea; Lethargy; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 23Feb2021 at 15:30 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The medical history included mediterranean fever and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included colchicine (MANUFACTURER UNKNOWN) taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 28Jan2021 at 15:30 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. On 24Feb2021, the patient experienced sore throat, swollen glands in neck, nausea and lethargy. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore throat, swollen glands in neck, nausea and lethargy were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Received call from mother stating child had easy bruising and petechia on 7/29/01 and was sent for blood work and platelet count was 55,000.
Case number PHHY2011US68643 is an incomplete spontaneous received from a nurse 27 Jul 2011. This report refers to eight patients of unknown age group and gender. They were given only the the CYW-135 liquid component of MENVEO  (batch number A10030, A10033, A10034, X10034) intramuscularly within the last two months. No other adverse reaction was reported.
Began feeling itchy in the roof of mouth. Began coughing. Felt like her blood pressure was dropping. Received 20 mg IV Famotidine, 10 mg IV Dexamethasone, 0.3 ml sub Q Epinephrine, 25 PO Benadryl and 1 liter Normal Saline. RN documents that blood pressure did drop to 107/64, but did not become hypotensive.  Discharged in stable condition at 1500. Doctor recommended that she not receive second dose.
Eczema; Diaper rash; puffy eyes; Mucous poop; Mucous poop that had vinegar like smell; Irritability; Gas; Daytime sleepiness; Inconsistent sleep; Vomiting; Diarrhea; This spontaneous report was received from the patient's mother and refers to her 9-week-old male son. The patient's concurrent conditions included acid reflux, dairy allergy and allergy to cows milk and protein. No information was reported regarding the patient's historical conditions. Concomitant therapies included famotidine.  On 11-MAR-2020, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally as standard vaccination for rotavirus (lot number and expiration date were not reported).  Then on 12-MAR-2020, the patient began to experience multiple symptoms such as vomiting for a week and a half, diaper rash (normally he did not have diaper rash), puffy eyes, diarrhea, mucous poop that had vinegar like smell, irritability, gas, daytime sleepiness and inconsistent sleep (he would wake up about 5 times a night). Patient then recovered on unspecified date in March 2020 reported as "about a week and a half after receiving first dose". Subsequently, on 07-MAY-2020, the patient received a second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ). Then on 08-MAY-2020, the patient experienced the same symptoms listed above as well as a little bit of eczema on unspecified body part. Patient fully recovered from second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) on 17-MAY-2020. The patient's mother did not seek medical attention for her son and no treatments were administered for the events. No laboratory tests were conducted. Causality assessment was not reported.
Initial information received on 03-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a two months old male patient who received expired product diluent of ACTHIB VACCINE lot UI803AA via intramuscular route on 02-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation. It was actual medication error due to Expired product used. It was unknown if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.