chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness underneath her opposite (non-injection arm) armpit and on both sides of her opposite elbow; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route in arm on 06Feb2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. Historical vaccine included 1st dose of BNT162B2 VACCINE for Covid-19 immunization and didn't have any reaction. Patient reported a redness underneath her opposite (non-injection arm) armpit and on both sides of her opposite elbow, but nothing at the vaccination site.  She stated that it was "not itchy or anything". She stated redness under armpit and fleshy side of the elbow, but nothing at the vaccine, opposite from injection site. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2016, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date, the patient experienced shingles (herpes zoster) and other zoster-related injuries despite being inoculated with the ZOSTAVAX vaccine (vaccination failure). On 25-JAN-2017, the patient was treated by a health care provider for shingles. It was also reported that, on unknown dates, the patient suffered serious physical, emotional and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of laten conditions, lost wages, loss of earning capacity and other losses and damages. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered the adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
no further AE information provided; administration of improperly stored vaccines; This spontaneous report as received from a certified medical assistant refers to a 4-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapy was not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose and route of administration were not reported, lot # T002848, expiration date 23-JAN-2022), for prophylaxis. The vaccine was reconstituted with a sterile diluent (STERILE DILUENT). Previously, the vaccine had experienced temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (8.47 Fahrenheit degrees) for 30 minutes.  The current temperature excursion was from 4 Fahrenheit degrees to 14 Fahrenheit degrees (10.56 Fahrenheit degrees) for 50 minutes. Digital data logger was used. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000777: US-009507513-2009USA000747: US-009507513-2009USA000676: US-009507513-2009USA000699: US-009507513-2009USA000749:
11/7 PC from client - reports fever of 101 deg F, chills, aches during night. Plans to see Dr. today - Reports just finished antibiotic; 11/6 - Back incision no Redness or drainage. P/C on 11/8 PC Reports has 6" Red area left arm at injection site. States Dr. -refilled antibiotics as questioning fever from post - back laser surgery; 11/3 - P/C - Redness Edema left arm gone - no further Fever, chills.
Patient presented for 2nd dose of Pfizer covid vaccine. While waiting after vaccination, patient felt unusual and walked to front counter for assistance. Patient then lost consciousness and fell backward onto the floor, hitting the back of her head. RN arrived to patient, who regained consciousness within ~15 seconds. Shortly after transferring patient to wheelchair patient lost consciousness a second time. Patient was transferred to clinic exam bed where she regained consciousness again within ~15 seconds. She was provided apple juice at this time and EMS was contacted. Vitals via automatic cuff measured with BP range: 100/65 to 120/76, HR 58-74, SpO2 98-100%. EMS arrived to evaluate patient and transported to hospital.
A patient came in yesterday and verbally requested a flu shot and a booster for Moderna as well as checking flu shot and COVID booster on immunization intake form; the patient attested multiple times both verbally and on intake form which shots he needed/requested. Patient's wife called and told us the patient "forgot" he got his flu shot at another pharmacy on 10/15/21. Patient's wife said she is not placing blame on the pharmacy because her husband requested the shot and it was his mistake. I called patient this morning to check on him and he said he is completely fine and no adverse side effects.
This spontaneous report was received from a registered nurse referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and past drug reactions/allergies were not reported. The patient's concomitant therapies included sterile diluent. On 13-JUN-2018, the patient was vaccinated with an expired dose of VARIVAX lot # M028546 with expiration date: 07-JUN-2018 (strength, dose, route and anatomical location) for prophylaxis. No adverse effects were reported.
Abnormal breathing; Frequent urination; Mobility affected; Couldn't come out of bed for 1.5 days; Rib cage from down side sore; Fever 100.2; Headache; Weak/  Still feeling weak; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATION ABNORMAL (Abnormal breathing), POLLAKIURIA (Frequent urination), MOBILITY DECREASED (Mobility affected), ILLNESS (Couldn't come out of bed for 1.5 days) and MUSCULOSKELETAL CHEST PAIN (Rib cage from down side sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included ATENOLOL and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced RESPIRATION ABNORMAL (Abnormal breathing), POLLAKIURIA (Frequent urination), MOBILITY DECREASED (Mobility affected), ILLNESS (Couldn't come out of bed for 1.5 days), MUSCULOSKELETAL CHEST PAIN (Rib cage from down side sore), PYREXIA (Fever 100.2), HEADACHE (Headache) and ASTHENIA (Weak/  Still feeling weak). At the time of the report, RESPIRATION ABNORMAL (Abnormal breathing), POLLAKIURIA (Frequent urination), MOBILITY DECREASED (Mobility affected), ILLNESS (Couldn't come out of bed for 1.5 days), MUSCULOSKELETAL CHEST PAIN (Rib cage from down side sore), PYREXIA (Fever 100.2), HEADACHE (Headache) and ASTHENIA (Weak/  Still feeling weak) outcome was unknown.            Acetaminophen was given as treatment medication in response to events.   This case was linked to MOD-2021-061000 (Patient Link).
Pt came into office with mother. Mother noted increasing bruising over past 2-3 days. Pinpointed red spots on torso today. Admitted to Pediatrics for IVIG.  12/04/09 H&P for DOS 10/01/09  10/02/09 DX: Immune Thrombocytopenic Purpura  Pt c/o easy bruising, rash, petechiae, fever.  On examination: mucous membranes bleeding, R distal lingual area, R lower lip, no focal deficits, patechiae scattered on BUE/BLE, echymosis, purpurae.  TX: IVIG, IVF, Tylenol.
Patient is experiencing moderate muscle pain resulting in "pain when raising her arm" after over a month from vaccination. She states she has tried icing it and applying lidocaine.
Caused my period to last longer. Currently on day #11 and I still have a light flow. My periods generally last 5 days. My lymph node was sore in my left arm pit as well as on left side of my neck which made swallowing uncomfortable which both started on day 2, lasting until day 4 after the shot.
Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2022 at 4:59 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Mar-2022 at 4:59 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported  No Treatment medication reported
This spontaneous report was received from a 48-year-old patient of unknown gender reporting on themselves. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (exact dose, frequency, site of administration, lot# and expiration date were not reported) for prophylaxis. No adverse effects were reported.
I am reporting the reaction I got from my Pfizer booster shot.  (I got the Moderna vaccine for shots #1 and #2, but decided to get Pfizer for the booster).  I got the Pfizer booster in my right arm at 2:30 pm on December 6.  On the morning of Dec 7 I thought my right bicep area looked slightly pink, as did my upper stomach, but was not sure.  Around 3:30 pm, I noticed that the areas were redder so I took an Allegra antihistamine (the 12 hour non-drowsy ones).  When I woke up on the morning of Dec  8 (today), the arm and stomach rash had evolved and were larger and redder.  The arm rash also itched a bit.  I took an Allegra tablet at 7:30am.  By this afternoon, the arm rash was had grown and was much redder, and the stomach rash was also ?filled in? more (less mottled).  By this evening,  I also had a rash area at top of right breast, towards collarbone. At 7:30 pm this evening, I took another Allegra tablet.  Just want to mention that when I took Moderna vaccine #1 shot (right arm), after 7 days I got an arm rash and dr advised to treat with Allegra, which I successfully did.  The rash cleared within a week.  When I took Moderna vaccine shot #2 (left arm), after only one or two days I got rash on both my left and right arms, and on stomach.  Treated with Allegra again.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ME/CFS/PEM" (unspecified if ongoing), notes: ME/CFS/PEM; "ME/CFS/PEM" (unspecified if ongoing), notes: ME/CFS/PEM; "ME/CFS/PEM" (unspecified if ongoing), notes: ME/CFS/PEM. The patient had no known allergies. The patient's concomitant medications were not reported. The patient had not received any other vaccine within 2 weeks of vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Aug2022) Positive;(unspecified date) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: After 2 days of testing negative, the patient felt a sore throat and tired. The patient was tested positive again on 16Aug2022 at 12:00 PM. The patient had received Paxlovid from 09Aug2022 to 13Aug2022 for the treatment of COVID-19. The device date was mentioned as 19Aug2022. The lot number for [BNT162b2], was not provided and will be requested during follow up.
Itching in left arm and red flat rash 8? X 4? approximately.  Started 8 days from 2nd injection. 1st injection stung like bee sting with sore arm about a week.  2nd injection I didn?t feel and soreness was minimal.
This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A patient of an unspecified age, gender, race and ethnicity received PREVNAR 13 single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced arm muscle pain. The patient asked if there were any actions in order to reduce the discomfort. The patient did not recover from injection site muscle pain, while clinical outcome of the other adverse event was unknown.
Blood clots; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EN1283), via an unspecified route of administration on 08May2021 (at the age of 58-Years-old) as Dose number Unknown, Single for COVID-19 immunization. Given facility where the most recent COVD-19 vaccine was administered.  The patient was not pregnant at the time of vaccination. The patient medical history was reported as many and concomitant medications were not reported. Allergies were reported as Yes. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (prior vaccination was none). The patient received other unknown medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced blood clots on 08Jul2021. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care as the event was life threatening illness having immediate risk of death from the event. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included SARS-COV-2 test with result negative on 10May2021. The patient was treated with blood thinners for the reported event. The patient have known allergies and many other medical history. Device date reported as 20Jul2021. The outcome of the event was reported as not recovered.
(+) erythema with slight firmness at injection site to (Rt) upper arm began day after imm. Seen 7/11/13 at PCP - 6cm x 9cm area redness; small induration no warmth afebrile - mod. localized imm. reaction. Tx -I.P. children's BENADRYL and ibuprofen.
Patient was administered 6 month immunizations (PENTACEL, PCV, and Rota) instead of 12 month (Hep A, MMR, Varicella, and PCV). Age of patient at time of event: 12 months.
Narrative: A 45yo female patient who present to the establish care reported to the nurse Moderna Covid-19 vaccine induced throat swelling which occurred immediately after she received the vaccine. Nursing note indicated the patient received the first Moderna covid-19 vaccine on April 15, 2021 and reported she was advised not to take the second dose or the boosters. No other detailed information regarding the vaccine were reported. The report did not include whether the patient received any treatments for the swelling.
Patient states he was getting up from the bed that he was laying down on and he began to feel numbness in his fingers and a cold sensation. He is complaining of a throbbing pain in his left shoulder and it runs down his arm to his finger tips. He complains of his stomach feeling tight and having some nausea.
Received higher than the recommended dose of vaccine.  0.20 micgrograms in 0.2 mL syringe given of both Pfizer vaccine lot Fl8094 Exp May 31, 2022 and vaccine lot Fk9894 Exp June 4,2022.  Pfizer report reference number LSGY86RU.
body aches and burning, seen by family physician, given methylprednisolone prescription and steroid shot, nausea and diarrhea
Pt c/o slight tightening of the throat that occurred  @1535. No itchiness. Pt advised to take deep breathes and drink water. Pt speaking in clear full sentences. No apparent distress.  Pt notified and shown vital signs stable. Closing of the throat worsened. Pt requested epinephrine due to "closing of the throat."  Epinephrine given at 1554 pt stated throat opening and breathing effortless. Vital signs taken please review.    1613 pt states closing of the throat has not gone away but feels better. Pt speaking in full clear sentences alert      Nurse supervisor,  Chief Doctor,  were notified. Dr.  assessed pt and 911 was called at 1620. Pt transferred @ 1632
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (temperature 101.5) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (temperature 101.5). Patient treated with a dose of two Tylenol (paracetamol) for adverse event. At the time of the report, pyrexia (temperature 101.5) outcome: unknown. Diagnostic results: On an unknown date, body temperature: 101.5 (high). Concomitant product use not provided. This case linked to MOD-2021-375243 (patient link).
After being exposed to people with COVID-19, I started having a sore throat. I took a Home COVID-19 test and was positive. Reached out to doctor and was prescribed Paxlovid. Started feeling better after a week. Took another Home COVID-19 test a week later and was negative.
Cough, sore throat, swollen eyes, seepage from eyes, swollen salivary gland under tongue.  Symptoms were better after 12 hours and much better after 36 hours.  Took no action with symptoms.
Patient received their first dose of Pfizer vaccine on 1.27.2021. Patient reports little red spots that are itchy on their legs, thighs, and chest that started the day after receiving the vaccine. The patient states that they are NOT experiencing any facial swelling, scratchy/itchy throat/ShOB. Patient states the rash has improved with over the counter medications. Encouraged the patient to reach out to provider with any more worrisome or bothersome conditions, including worsening of rash. Reviewed when the patient should seek emergency care.
pt recv vax in 1995 & 10-14 days p/vax devel diffuse, morbilliform rash which devel into a vesicular rash; fever, scattered pustular rash on trunk, thighs, face; pharmacist reported 4 pts;
Started having nose bleeds; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Started having nose bleeds) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A.) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced EPISTAXIS (Started having nose bleeds). At the time of the report, EPISTAXIS (Started having nose bleeds) had not resolved.            On 05-Apr-2021, the patient received their second dose of the Moderna COVID-19 vaccine. On the next day, the patient began to have nose bleeds on the right side of their nose and reported that the patient never had nose bleeds before in their life. The patient also reported that the symptom was still ongoing.   Reportedly, the patient visited a physician who referred the patient to an ENT.   Concomitant medication reported included medication for blood pressure.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Diarrhea, fatigue. arm pain. Swollenl lymph nodes in arm pit area.
Pt came to ER c/o nausea, fever, cough, fever started on 8/18/21.
hurting in her esophagus; really weak; shortness of breath; really bad headaches; tired; This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGITIS (hurting in her esophagus), ASTHENIA (really weak), DYSPNOEA (shortness of breath), HEADACHE (really bad headaches) and FATIGUE (tired) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced OESOPHAGITIS (hurting in her esophagus), ASTHENIA (really weak), DYSPNOEA (shortness of breath), HEADACHE (really bad headaches) and FATIGUE (tired). At the time of the report, OESOPHAGITIS (hurting in her esophagus), ASTHENIA (really weak), DYSPNOEA (shortness of breath), HEADACHE (really bad headaches) and FATIGUE (tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided.
Patient reports an itching bump at site of injection.  She says that she didn't notice it until 3 days after receiving vaccine.  I advised her to use Benadryl + ibuprofen.
After 2 days - site of injection became real red and swollen and sore - stayed this way for about 2 weeks. I put over the counter ointment on site. Also red blotches about size of dime would appear on shoulder and arms they were very itchy, I'm still getting them, I called my doctor he suggested BENADRYL tabs.
Information has been received from a medical assistant referring to multiple unspecified patients. Information on medical history, concomitant medications and drug allergies was not provided.   On known dates, multiple unspecified patients were vaccinated with a dose of improperly stored VARIVAX (lot# M038858, expire date: 14-SEP-2018; dose unknown) for prophylaxis.  The temperature of storage for VARIVAX was above -10 Celsius and below 8 Celsius for 1hour and 2 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA011638: