chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lungs problems; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LUNG DISORDER (lungs problems) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LUNG DISORDER (lungs problems). At the time of the report, LUNG DISORDER (lungs problems) outcome was unknown.            no treatment information was provided no concomitant medication were reported   Reporter did not allow further contact
tactile Fever; Fatigue; received 0.5ml Moderna instead of a 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (tactile Fever), FATIGUE (Fatigue) and ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of a 0.25ml booster dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Nov-2021, the patient experienced PYREXIA (tactile Fever), FATIGUE (Fatigue) and ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of a 0.25ml booster dose). On 19-Nov-2021, ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of a 0.25ml booster dose) had resolved. At the time of the report, PYREXIA (tactile Fever) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reports tactile fever and fatigue for the first 12-24 hours following vaccine. No relevant concomitant medications were provided. No treatment information was provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 12:30 as dose 4 (booster), single (Lot number: GJ2524) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "class 1 obesity" (unspecified if ongoing); "right thyroidectomy" (unspecified if ongoing), notes: hx of right thyroidectomy; "high platelet count" (unspecified if ongoing), notes: high platelet count. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information:There is none known allergies.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Hives began on 03/06/2002 in the morning. Parent gave Benadryl at home.
Erythema and induration of 45mm X 55mm at the injection site, 7 days, post vax. Pt complained of tiredness.
pt recv vax 17MAR98 & was reported that 18MAR pt began to c/o muscle aches in rt arm then on 18MAR Pm arm began to swell;pt was seen on 19MAR w/redness, swelling-most of deltoid was swollen, hard & warm;it also itched;
I had blurry vision on 12/27/2020. When I looked at grid the lines were a little wavy. I contacted my ophthalmologist macular hole in the left eye. I had surgery to repair a week ago Tuesday. I am home recovering.  I have a follow up appointment on next week.
Narrative:  Admission 09/23/2021, Discharge 09/28/2021. Diagnosis: COVID pneumonia On 9/16/2021, 59 yo male with history of CAD (post PCI 6 months prior to admission), HTN, and Diabetes presented to the Emergency Department with complaints of chills and body aches for 3 days. He tested COVID positive despite being fully vaccinated at the local medical hospital with Pfizer COVID vaccine on 1/13/2021 and 1/26/2021. Since the patient had temp 99.7@ the Emergency Room, HR 101, Vital signs otherwise stable, Patient non-toxic appearing. Good breath sounds, no shortness of breath, the decision was made to administer "mab" as outpatient therapy on 9/18/2021. This was completed as planned. On 9/18/21, he had some mild worsening in his breathing from previously. no chest pain. Vital signs were stable and he was in no distress. On 9/23/21, he returned to the Emergency Department with shortness of breath which seemed to get much worse around 9/21/21. He was unable to walk around his house due to the the SOB and had decreased appetite. He had worsening creatinine from 1.1 on 9/12 to 1.5 today. He was also anemic with hemoglobin of 10, unknown if this was an acute change. WBC was elevated at 11.1. His chest CT showed moderate to severe covid pneumonitis without any signs of PE. Pt is tachypnic at rest but is saturating at 94% on room air. With any movement he becomes more tachypneic and desaturates to 88%, because of this he is now on 2L NC and was admitted to the hospital. He was treated with remdesivir and dexamethasone (described in more detail above) and was discharged on 9/28/21. At the time of discharge, he was on room air at rest, but 2L O2 needed with exertion. Pulmonology providing home oxygen on discharge.
a patient missed a dose in her GARDASIL 9; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route of administration, indication, lot #, and expiration date were not reported) for prophylaxis. On an unknown date, she missed a dose in her HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccination schedule (inappropriate schedule of vaccine administered). No adverse event was reported.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave dose of Moderna Covid-19 vaccine after the expiration date.) and NO ADVERSE EVENT (No adverse event) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis. No Medical History information was reported. On 22-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave dose of Moderna Covid-19 vaccine after the expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave dose of Moderna Covid-19 vaccine after the expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter. On unknown date, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Treatment information was not provided.
Fevers started on Wednesday evening, April 14th. Over the next three to four days, the fevers and chills continuously got worse. Patient experienced fatigue, congestion, headaches, sore throat, body aches, neck pain. Conducted a televisit on Sunday, April 18th, and then went into the doctor on Monday, April 19th. The day of the doctor appointment, the patient could not get out of bed and could not stand for longer than 15 minutes at a time before extreme fatigue set in. Blood tests were taken at the doctor, a Z-pack was prescribed. The evening of the 19th, the doctor called after hour to send patient to emergency room to be admitted to hospital. Patient went immediately to Medical Center at which point, the patient was admitted for the next 19 days. The patient was released from the hospital on Saturday, May 8th. While in the hospital, the patient saw almost every "category" of doctor possible. Patient experienced fevers every night for 15 days straight, and after release from the hospital and "fever free for 4-5 days, experienced fevers again for the next week. Doctors were unable for the first two and a half weeks of hospitalization to draw a conclusion about what was the cause of the sepsis (systemic). Patient received daily blood tests, MRIs, CAT scans, spinal tap, bone marrow biopsy, echocardiogram, etc. Patient spent the first two and a half weeks on an antibiotic, antifungal, and antiviral.  The "final" diagnosis, which is still not confirmed, as histoplasmosis, which per the doctor would not have placed the patient in the hospital. Determined the fevers were officially "fevers of unknown origin" with a diagnosis of MIS-A and a vaccine contributing factor. Medication put patient in kidney failure and did not address the fevers (patient had fevers of 103+ for 25+ days in a row).  On May 27th, doctors are conducing new fungal tests and patient is discontinuing antifungal medication because of severe liver damage.  Patient was not and is not in a situation where histoplasmosis is a logical conclusion based on the patient's daily activities.
No adverse event.  Monovalent COVID vaccine given at 4/19/2023 date,
Dose 1:  extreme arm pain, swelling, bruising, loss of movement.  started within hours, swelling lasted 4 days, pain 6 days, bruising almost 14 days.    General malaise, low grade fever 38C 2 days Dose 2:  Fever, weakness, lethargy, trouble concentrating, 4 days.    Shortness of breath after 1 week, persistent (current through today, 21 Sept 21)
This spontaneous report was received from a certified medical assistant and refers to a 12 weeks old, female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 21-APR-2016 at 12:09, the patient was vaccinated with improperly stored first dose of ROTATEQ lot# L033543, expiry date 30-MAY-2017, orally (dose was not reported). No adverse symptoms were reported. Administered vaccine experienced temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source. Additional information is not expected, as all scheduled correspondence was received.
Fully vaccinated patient admitted to hospital with detected COVID PCR test.  Patient with positive COVID swab in ED on 05/31/21.  Came to ED with leg swelling, weakness.  Discharged home on 1 L/NC of O2 due to lower O2 sats 92-94%.  Patient seen again in ED on 06/06/21 this time for increasing shortness of breath, increasing oxygen demand, and icnreased work breathing.  O2 needs since last ED visit increased to 2-3 L.  Admitted to hospital for COVID infection and CHF exacerbation.  Treated with aggressive diuretics, remdesivir, and dexamethasone.  Blood cultures tested positive and was started on IV ATB's.  Patient discharged back to AFC with Hospice services.
pain is excruciating, it has been terrible, the pain in left arm; she can hardly move her arm, she cannot dress, states she cannot do anything; she can hardly move her arm, she cannot dress, states she cannot do anything; This is a spontaneous report from a contactable consumer reporting for herself.  An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via intramuscular on 19Jan2021 at 13:30 (at the age of 86 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history was not reported. Concomitant medication included tramadol 50mg tablet by mouth every 8 hours as needed for pain from 19Jan2021, and she stated it does not do any good. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date, the patient experienced excruciating pain in left arm, it has been terrible, the pain in left arm. The pain is between her elbow and shoulder, she can hardly move her arm, she cannot dress, states she cannot do anything. woke her up in the middle night hurting. The patient received treatment of excruciating pain in the left arm. The clinical outcome of excruciating pain in left arm was not recovered, and for she can hardly move her arm, she cannot dress, states she cannot do anything was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Left deltoid area, pain, swelling, warmth, indiration, itchiness, and tenderness
had COVID 30 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (had COVID 30 days ago) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (had COVID 30 days ago). At the time of the report, COVID-19 (had COVID 30 days ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: This case concerns a male patient with no relevant medical history, who experienced the unexpected non - serious AESI event of COVID-19. The date of onset of the event was not reported, neither vaccination date. The event occurred after the second dose of mRNA-1273 Moderna vaccine. The rechallenge for COVID-19 is not applicable. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
When patient woke up day after vaccine administartion, one side of his face/cheek was swollen. Patient is concerned it may have something to do with the flu shot.
weight loss (lost 7 pounds); not sleeping; not eating; feels that her immune system is low; fatigued; cold sore; stress related weight loss; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (unable to get age) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration Date was not reported), via an unspecified route of administration on 27Jun2021 as dose 1, single for COVID-19 immunization. Family medical history included renal cancer from Jun2021 and ongoing husband diagnosed with malignant kidney tumor two weeks ago diagnosis came post Pfizer Covid 19 vaccination in April. The patient's concomitant medications were not reported. The patient experienced weight loss (lost 7 pounds), not sleeping, not eating, feels that her immune system is low, fatigued, cold sore and stress related weight loss on an unspecified date in Jun2021. It was reported that, patient she had her first dose of the Pfizer Covid 19 vaccine on 27Jun2021 and was scheduled to complete her series on 18Jul2021. She had experienced weight loss (lost 7 pounds), not sleeping, not eating, feels that her immune system is low, fatigued and currently has a cold sore. Consumer reported that what she was experiencing due to stress surrounding her husband's recent cancer diagnosis. Had not seen HCP since 2019 due to COVID pandemic. Also reported that her daughter had been vaccinated (no details or events provided). Caller further shared that husband diagnosed with malignant kidney tumor two weeks ago. Noted that this diagnosis came post Pfizer Covid 19 vaccination in Apr2021 and will be going through immunotherapy starting tomorrow as caller details. Started to ask if husbands immune system with immunotherapy would affect his vaccine status, but then declined information as they were both going to a doctor appointment this week. Caller wanted to know if she should get second dose of vaccine in the setting of weight loss, lowered immune system and presence of a cold sore (current health status related to stress) and states she will keep her appointment for second dose at the end of call. Patient received first dose, due for second 18Jul2021. Had cold sore and stress related weight loss, asked if this was a reason not to get second dose. The outcome of the events was not recovered.  Information related to batch/Lot no. was requested.
TINGLING IN LEFT AND RIGHT ARMS AND FINGERS; FEVER; PAIN AT INJECTION SITE; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included surgery in left arm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered to left arm on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced pain at injection site. On 27-MAR-2021, the subject experienced tingling in arms and fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, chills, and pain at injection site on 26-MAR-2021, and had not recovered from tingling in arms and fingers. This report was non-serious.
Patient reported a delayed injection site reaction. Day 10 after vaccination, a lemon-sized red, swollen area appeared at site of injection along with a itchy, pimply, pustular rash  extending from upper arm to elbow.
pt recvd vax 07DEC94 in AM, that afternoon had episode of looking white, crying if not held;
Information has been received from a healthcare worker, public health consultant, referring to unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (lot # L018501 and lot L027733, route, dose and expiration date were unknown) which were improperly stored (lot L027733 in 29.6 Fahrenheit (F) for 30 hours and 15 minutes, lot # L018501 in 30.6 F 69 hours). There was no previous temperature excursion. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Rash noticed on Friday 10/23/2020. Came to appointment today to have rash examined. Per Dr.'s note who saw them at visit today:  Patient is a 13mo old female here for exanthem on torso. The exanthem does not bother her and reassurance given that this should continue to resolve over the next 1-2 weeks on its own. Reassurance it is not vesicular and not varicella. This could be viral related however it could also be related to the fact that she just received her MMR about 1.5 weeks prior to initial onset of the exanthem. She does not have any other current viral symptoms present which leads me to believe that this is most likely related to her recent MMR vaccine. Again reassurance given that children with measles rash after vaccine are not contagious and she may go back to daycare.
1 hour after vaccine, experienced throat constriction and wheezing at night. Hives on chin, neck, and left arm injection site. Itching on back of head. Regularly has allergies almost every month - facial swelling from top of lip to bottom of chin. Prescribed Benadryl 25 mg PO Q8h prn for itching and Epipen. Cancelled 2nd vaccine appointment, rec'd J+J vaccine.
Member received 0.25 ml vaccine . Patient attested to immunocompromised so should have received 0.50
I have my Pfizer booster; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Dec2021 11:00 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose 1), for COVID-19 Immunization; Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021 11:00, outcome "unknown", described as "I have my Pfizer booster"; DIZZINESS (non-serious) with onset Dec2021, outcome "not recovered", described as "dizziness". The event "dizziness" was evaluated at the physician office visit.  Additional information; Patient reported "I had my Pfizer booster (further clarification unknown, hence suspect captured as unspecified medication) on Monday at 11 o clock and I am having a really bad side effect, The patient went to see my doctor today. But now The patient having this dizziness."   The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient report that after the 15 min wait she felt fine.. after a half hour she felt nauseous and loopy/off balance... she also had fever off and on 102 fever, also felt very weak and had severe headache
On 10/17/21 I woke up with left leg pain, swelling and redness, went to the ER and was diagnosed with deep vein thrombosis. I had also been experiencing intermittent upper back stabbing pain and shortness of breath which was diagnosed as pulmonary embolism. I was prescribed blood thinner to treat it
Side effect; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Side effect) 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 IMMUNISATION REACTION (Side effect). At the time of the report, IMMUNISATION REACTION (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were reported.   Reporter did not allow further contact