chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in her arm). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided.
16 year old patient presented to clinic with parent for first Covid vaccine, patient was administered Moderna instead of Phizer. Parent was notified and no additional adverse signs and symptoms reported by parent.
This case was reported by a consumer and described the occurrence of high-pitched crying in a 2 month old male patient who received DTAP, Hep B recombinant and IPV combined Pediarix for prophylaxis.  A physician or other health care professional has not verified this report.  The patient reportedly had no relevant medical history, concurrent conditions or concurrent medications.  Family history was significant for an unspecified "reaction to pertussis" in an older sibling; the sibling did not complete the pertussis immunization serious.  In 2003, when the patient was 2 months of age, he received the 1st dose of Pediarix.  Two hours post-immunization, the patient experienced "screeching".  The "screeching" resolved after four or five hours.
Upon using left arm, left hand starts shaking; Constant numbness in the left arm & 2 fingers/ Degree of numbness goes up and down in the left arm & 2 fingers; Hands and feet get hot and cold; Headaches that will not stop; Swollen lymph node under the left arm; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Upon using left arm, left hand starts shaking), VACCINATION SITE ANAESTHESIA (Constant numbness in the left arm & 2 fingers/ Degree of numbness goes up and down in the left arm & 2 fingers), FEELING OF BODY TEMPERATURE CHANGE (Hands and feet get hot and cold), HEADACHE (Headaches that will not stop) and VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node under the left arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0US1B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced TREMOR (Upon using left arm, left hand starts shaking), VACCINATION SITE ANAESTHESIA (Constant numbness in the left arm & 2 fingers/ Degree of numbness goes up and down in the left arm & 2 fingers), FEELING OF BODY TEMPERATURE CHANGE (Hands and feet get hot and cold), HEADACHE (Headaches that will not stop) and VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node under the left arm). At the time of the report, TREMOR (Upon using left arm, left hand starts shaking), VACCINATION SITE ANAESTHESIA (Constant numbness in the left arm & 2 fingers/ Degree of numbness goes up and down in the left arm & 2 fingers), FEELING OF BODY TEMPERATURE CHANGE (Hands and feet get hot and cold), HEADACHE (Headaches that will not stop) and VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node under the left arm) outcome was unknown.        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.   No concomitant information was provided. No treatment information was provided.
I tested positive for Covid-19 on 8/10/20.  Symptoms were moderate (No hospitalizations/oxygen/interventions.  Just flu like symptoms with significant chest pain.  MI & PE ruled out in two ED visits, symptoms last about a month).  Moderna Covid-19 Vaccine on 1/2/21 at 7:45 am.  Developed significant chills at about 8:00 pm that evening.  By 10:30 pm, chills, rigors, bodyaches, & fatigue (no fever).  1/3/21:  Significant fatigue, chills, bodyaches, and now headache.  Essentially stayed in bed the whole day; completely useless.  Symptoms improved throughout the day.  Was about 45% better by bed time.  Severe diaphoresis in the middle of the night.  1/4/21:  75% better.  Went to work and completed my shift.  95% better by the end of my shift.
Day after vaccine 11/11 - Postmenopausal spotting started and lasted 5-6 days.
Per mother, 10-27-18 child  had redness, warmth to touch and hardness to left thigh at injection site. Hardness started at 2 inches and progressively got worse, up to 4 inches. Went to ER on 10-29-18.  Given one dose of Rocephin 1 gram and Augmentin 750 mg bid x 7 days for left leg cellulitis. Noticed improvement on 10-30-18. Seen in clinic 10-31-18 for follow up. Markedly improved.
2-3 minutes after getting vaccine, symptoms- Shortness of breath, Wheezing, Fatigue. Patient had asthma pump, Inhaled it, felt better after few minutes. called 911, they checked all vital, everything normal. no admission to ER or hospital.
Itching, redness and inflammation at the injection site that started approximately 16 hours after injection. Improvement noted after 48 hours
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 17-FEB-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Within 24 hours experienced heavy fatigue, body aches, dark bruising at injection shot lasting more than a week, fever of 100.5, with chills, lasting 6-8 hours. Recovery within 24 hour of symptom onset.
came to the hospital due to acute hypoxemic respiratory failure in the setting of COVID-19 pneumonia.  Patient underwent several tests including CT abdomen and pelvis showing multiple liver masses secondary to metastases and omental carcinomatosis.  Patient underwent evaluation by Hematology-Oncology, in which patient underwent biopsy in which showed urothelial carcinoma.  Discussion was held with Hematology-Oncology and recommendation was for hospice services since patient is unable to tolerate any chemotherapy.  Family in agreement.  Patient will be discharged today under hospice services.
Horrific migraine attack that has not let up after 2 weeks. Started late night of 9/1. Missed 40 hours of work, need imaging, unable to function at full compasity for days at a time. Temporary confusion, temporary loss of short term memory.
Pain; Hives; Extreme itching; Redness turned purple and to this day goes its goes completely around my arm; My arm was bright red, hot, swollen at injection site/its goes completely around my arm; My arm was bright red, hot, swollen at injection site; Arm  swollen at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site swelling. In September 2019, the patient experienced pain, hives, pruritus and skin discoloration. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site swelling, pain, hives, pruritus and skin discoloration were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site swelling, pain, hives, pruritus and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On the night of vaccination, the patient's arm was bright red, hot, swollen at injection site.  Several days later, the patient got hives and extreme itching along with the pain.  The patient called the doctor who advised to take OTC (over the counter) benedryl.  The patient stated, the redness turned purple and to this day it spread completely around arm, still painful and occasionally itches.  The patient stated, she would not receive 2nd dose of shingles shot and wished to never get the 1st dose.
weakness on the arms; mild pain; Increase sensitivity to heat and cold on hands; Tingling sensation on hands; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0168) via an unspecified route of administration in the left arm on an unknown date in May2021 (at the age of 64-year-old) as dose 2, single for COVID-19 immunization. Other suspect medications included rosuvastatin calcium (CRESTOR) for unknown indication from an unknown date. The patient medical history included atherosclerosis from an unknown date and unknown if ongoing. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EV0721) via an unspecified route of administration, administered in left arm on an unknown date in Apr2021 (at the age of 64-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date in Jun2021, the patient experienced tingling sensation on hands, weakness on the arms, mild pain and increase sensitivity to heat and cold on the hands when holding a cup. The patient attributed these to CRESTOR but with CRESTOR the patient never had a tingling sensation, usually more pronounce when the patient woke up in the morning. The patient had no idea if this has anything to do with the vaccine, but thought it will be a good idea to let us know. The patient had been getting better but stopped CRESTOR. The patient will resume taking it. The patient had not visited emergency room or physician office or other healthcare professional office/clinic due to the event. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome tingling sensation on hands, weakness on the arms, mild pain and increase sensitivity to heat and cold on the hands when holding a cup was recovering. Follow-up attempts completed. No further information expected.
Now the temples and eyelids and eyebrows are swollen; Now the temples and eyelids and eyebrows are swollen; the hoods of the brow are handing down and was not like that this weekend; temples are wider and puffier; breaking out in hives in random parts of the body on 29Mar2021; ankles and armpits were itchy; Significant body rashes; Rash all over the body; Face is swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face is swollen), SWELLING OF EYELID (Now the temples and eyelids and eyebrows are swollen), SWELLING FACE (Now the temples and eyelids and eyebrows are swollen), SWELLING FACE (the hoods of the brow are handing down and was not like that this weekend) and SWELLING FACE (temples are wider and puffier) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced SWELLING FACE (Face is swollen), URTICARIA (breaking out in hives in random parts of the body on 29Mar2021), PRURITUS (ankles and armpits were itchy), RASH (Significant body rashes) and RASH (Rash all over the body). On 29-Mar-2021, the patient experienced SWELLING OF EYELID (Now the temples and eyelids and eyebrows are swollen), SWELLING FACE (Now the temples and eyelids and eyebrows are swollen), SWELLING FACE (the hoods of the brow are handing down and was not like that this weekend) and SWELLING FACE (temples are wider and puffier). At the time of the report, SWELLING FACE (Face is swollen), SWELLING OF EYELID (Now the temples and eyelids and eyebrows are swollen), SWELLING FACE (Now the temples and eyelids and eyebrows are swollen), SWELLING FACE (the hoods of the brow are handing down and was not like that this weekend), SWELLING FACE (temples are wider and puffier), URTICARIA (breaking out in hives in random parts of the body on 29Mar2021), PRURITUS (ankles and armpits were itchy), RASH (Significant body rashes) and RASH (Rash all over the body) outcome was unknown.        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.   No concomitant medication were provided  Treatment medication included Benadryl
At 1255 patient reported lips itching, tightness in chest and throat, dizziness. Epi adminsitered. Patient transported to the ED
got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got COVID) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced COVID-19 (got COVID). At the time of the report, COVID-19 (got COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   No concomitant medication details was reported. No treatment medication details was reported.
It was reported that an 8 year old male received a Fluzone SV '99-'00 vaccination on 11/5/99. Reportedly, on 11/7/99, the pt developed axillary lymphadenitis. From additional information received on 11/11/99, it was reported that treatment of "PO Keflex" was given. The pt reportedly recovered from this experience.
Since the vaccine I have been having migraines and severe fatigue. I am napping between 2-4 hours each day to feel better. Consistent fever of ~99 degrees F.
Vaccine administered (H1N1) @ approximately 9:15am. 10am - facial flushing and headache "confusion" stated by student but remained alert and oriented x 3. Vital signs WNL T99.5. 10:45am flushing headache and self stated confusion resolved.
She had no taste now, and she lost her sense of taste 2 days ago; She was not able to eat because of her twisted mouth; She said the COVID-19 Vaccine left her partially paralyzed in the left side of her face only/On the night of 24May2021, she couldn't close her left eye/mouth was getting "twisted; She had a terrible pain in the left-side of her head that started on the afternoon of 24May2021; On the night of 24May2021, her left eye began hurting a lot; On the night of 24May2021, her left eye had a lot of tears coming out of it.; She said she was not able to work; This is a spontaneous report from a contactable consumer. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Left on 24May2021 10:00 as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported that on 24May2021, covid-19 vaccine left her partially paralyzed in the left side of her face only, she had a terrible pain in the left-side of her head that started in the afternoon. On the night of 24May2021, her left eye began hurting a lot, her left eye had a lot of tears coming out of it and she couldn't close her left eye. On the morning of 25May2021, when she went to brush her teeth, she saw her mouth was getting "twisted". She was not able to eat because of her twisted mouth. She said she was not able to work. She had no taste now, and she lost her sense of taste 2 days ago. The events She said the COVID-19 Vaccine left her partially paralyzed in the left side of her face only was reported as serious, medically significant. The outcome of the events she said the COVID-19 vaccine left her partially paralyzed in the left side of her face only, on the night of 24May2021, her left eye began hurting a lot, on the night of 24May2021, her left eye had a lot of tears coming out of it, on the night of 24May2021, she couldn't close her left eye, on the morning of 25May2021, when she went to brush her teeth, she saw her mouth was getting "twisted", she had no taste now, and she lost her sense of taste 2 days ago and she said she was not able to work was not recovered while the outcome of the event she had a terrible pain in the left-side of her head that started on the afternoon of 24May2021 was resolved on unspecified date of 2021.
Patient was given the second dose of the COVID vaccine at 14 days after his first dose of vaccine. Patient was observed for 30 minutes after and informed of the mistake. Patient with no symptoms or reactions.
All 3 of them are sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (All 3 of them are sick) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (All 3 of them are sick). At the time of the report, ILLNESS (All 3 of them are sick) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Suspect product dosage text was reported as unknown. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-737839, US-MODERNATX, INC.-MOD-2023-737864, US-MODERNATX, INC.-MOD-2023-737836 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737839:For Brother case (same reporter) US-MODERNATX, INC.-MOD-2023-737864:For 1st sister (same reporter) US-MODERNATX, INC.-MOD-2023-737836:nephew case
No other adverse event; The caller reported the patient received a dose of VARIVAX on 9/9/2022. While the product was being injected, the needle popped off of the syringe hub and the patient only received half of the dose.; While the product was being injected, the needle popped off of the syringe hub and the patient only received half of the dose.; This spontaneous report was received from a medical assistant regarding a 12-month-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included hepatitis a vaccine (+) inactivated (VAQTA) and pneumococcal vaccine conj 7v (crm197) (PREVNAR) (administered on the same day).  On 09-SEP-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #W012167, expiration date: 12-APR-2024, administered subcutaneously on his right thigh (dosage regimen and strength was not provided) as prophylaxis; which was reconstituted with sterile diluent, 1 dose, administered subcutaneously on his right thigh (strength, lot #, expiry date, and indication were not provided). While the product was being injected, the needle popped off of the syringe hub (Device connection issue) and the patient only received half of the dose (Incorrect dose administered). The patient was not treated for adverse events. The reporter stated that she had reconstituted and administered varicella virus vaccine live (oka/merck) (VARIVAX) many times in the past and this had not happened. Also, she thought this might had occurred because the patient flexed his thigh as the product was being administered. No other adverse event was reported.
booster; Red swollen lump at injection site; blurred vision; lethargy; cognitive confusion; loss of appetite; muscle aches; wheezing; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "Known allergies: Molds" (unspecified if ongoing); "Known allergies: Dust" (unspecified if ongoing); "Known allergies: Pollen" (unspecified if ongoing); "Known allergies: some foods" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: Apr2021, for COVID-19 immunization; Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: Apr2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "booster"; VACCINATION SITE MASS (non-serious) with onset Dec2021, outcome "recovering", described as "Red swollen lump at injection site"; VISION BLURRED (non-serious) with onset Dec2021, outcome "recovering", described as "blurred vision"; LETHARGY (non-serious) with onset Dec2021, outcome "recovering", described as "lethargy"; CONFUSIONAL STATE (non-serious) with onset Dec2021, outcome "recovering", described as "cognitive confusion"; DECREASED APPETITE (non-serious) with onset Dec2021, outcome "recovering", described as "loss of appetite"; MYALGIA (non-serious) with onset Dec2021, outcome "recovering", described as "muscle aches"; WHEEZING (non-serious) with onset Dec2021, outcome "recovering", described as "wheezing". Therapeutic measures were not taken as a result of vaccination site mass, vision blurred, lethargy, confusional state, decreased appetite, myalgia, wheezing.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No previous side effects from 1st 2 doses except very mild soreness at infection site. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
5 days post vaccine injection, at the site, a stinging and itching for 4 days ~ to date.  Treatment~ none.
First dose: headache and pain at injection site Second dose: immediate headache, slightly nauseous, pain at injection site.  After 24 hours an itchy rash for a couple of days on entire arm of injection site