chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left facial tingling, left sided headache, no vision changes, denies CP, denies SOB
Patient presented to the hospital on 11/5/21 for  elevated blood pressure. Patient presented to the hospital on 11/28/21 for severe preeclampsia and laparotomy cesarean section. These visits are within 6 weeks of receiving COVID vaccination.
On 1/11/21 (6 days after dose), patient describes arm as itchy and feels "very itchy under the skin" which lasted for about 4 days until 1/15/21.
Patient's father stated that when his wife picked patient up from daycare she did not look good, kept on opening and closing her eyes as though she was falling asleep. Mom tried to arouse her in the backseat of car. She was very hard to wake.   11/25/09:  ED Records received for date of service 11/12/09:  Dx: Syncope  Presented to ED after child went limp and unresponsive in the car, unresponisve to stimuli x 5 min.  Admitted to the peds. unit for monitoring. 11/12/09:  Hospital progress note received for date of service 11/13/09.  Dx: RSV. Plan to discharge later in day if remains clinically well.
Patient's mom falsified the patient's information (date of birth) to 2009 to ensure that she would get vaccinated.
Lymph node swellings under her arm pit; Night sweats; This spontaneous case was received on 25-Nov-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-05432) and concerned a 61-year-old female patient.  The patient's medical history and concomitant medications were not reported.   On 06-Nov-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; route of administration: intramuscular, indication, dose, anatomical location: not reported). The batch number was not reported.  On 07-Nov-2020, one day after receiving Flucelvax QIV, the patient experienced night sweats and lymph node swellings under her arm pit.  At the time of initial reporting, the patient had not recovered from the events and was monitoring the events.  The reporter did not provide a causality assessment.  Company comment: A 61-year-old female patient developed lymphadenopathy and night sweats one day after vaccination with the suspect product, Flucelvax QIV. Information regarding the patients underlying medical history and concomitant medications have not been provided. More information regarding the anatomical location of the vaccination as well as the location of lymphadenopathy is needed. With information presented, causality cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes).; Sender's Comments: A 61-year-old female patient developed lymphadenopathy and night sweats one day after vaccination with the suspect product, Flucelvax QIV. Information regarding the patients underlying medical history and concomitant medications have not been provided. More information regarding the anatomical location of the vaccination as well as the location of lymphadenopathy is needed. With information presented, causality cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes).
the liquid sprayed all over her hands upon adding the liquid conjugate to the lyophlized conjugate; liquid sprayed all over her hands; Exposure via skin contact; vial stopper damage; This non-serious case was reported by a other health professional via call center representative and described the occurrence of occupational exposure while preparing product for administration in a 70-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA932A, expiry date 30-JUN-2024) for prophylaxis. This case was associated with a product complaint.   On 10-JUL-2023, the patient received Menveo. On 10-JUL-2023, an unknown time after receiving Menveo, the patient experienced occupational exposure while preparing product for administration (Verbatim: liquid sprayed all over her hands), exposure via skin contact (Verbatim: Exposure via skin contact) and vial stopper damage (Verbatim: vial stopper damage). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: the liquid sprayed all over her hands upon adding the liquid conjugate to the lyophlized conjugate). The outcome of the occupational exposure while preparing product for administration, exposure via skin contact, vial stopper damage and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 10-JUL-2023. The healthcare professional calling to report a leaking vial of Menveo.   The reporter stated that the liquid conjugate vial was drawn into the syringe and inserted into the lyophilized conjugate component, the liquid sprayed all over reporter hands upon adding the liquid conjugate to the lyophlized conjugate, coming in contact with her skin. During drug preparation the defect was discovered. The reporter did not get far with mixing or shaking performed after reconstitution.  The vial held upside-down when the vaccine was being withdrawn. The product was not administered. The healthcare professional preparing the product is an experienced user. The lyophilized conjugate was affected. Air was injected into the liquid conjugate vial, "the same amount as the liquid in the vial." The leak was coming from the needle puncture in the stopper of the lyophilized conjugate vial. The vial stopper and metallic skirt did not detach or become loose.  The customer removed only the plastic flip-off cover. There was no evidence of leakage in the box. The reporter did not consent to follow-up. Liquid sprayed all over reporter hands upon adding the liquid conjugate to the lyophlized conjugate, coming in contact with her skin which led to occupational exposure while administering product and exposure via skin contact.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment  medications were reported.
This spontaneous report as received from a nurse refers to a 15 year old patient of an unknown gender. On 17-FEB-2015, the patient was vaccinated with improperly schedule GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a 52-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 02-DEC-2016, the patient was inadvertently vaccinated with PROQUAD (lot # M012986, expiration date was not provided) (dose and route of administration were not provided). The patient was scheduled to receive VARIVAX. No adverse effects were reported. Product quality complaint was not involved. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA001689.
Pt recv vax on 10/27/98; post vax pt exp pain at vax site
Headaches for the past several weeks, possible Bells Palsy. Getting CT scan to rule out brain bleeds
COVID symptoms and tested positive for COVID today; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID symptoms and tested positive for COVID today) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 16-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (COVID symptoms and tested positive for COVID today). At the time of the report, COVID-19 (COVID symptoms and tested positive for COVID today) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Oct-2023, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  HCP states that he had a patient who received the Spikevax 2023-2024 vaccine on 9OCT2023.  HCP wanted to know if the Spikevax vaccine can cause a false positive COVID test result a week after receiving it.   Treatment information was not reported.
12/7/2007 given zoster vaccine.  Seen 12/10/07 for sinusitis, taking Cipro 500 mg one BID & pen 8 mg/Celestone 6 mg IM.  Urticaria rash on 12/15/07.
Patient described numbness in lower arm of the arm we used to inject flu vaccine. BP was recored as 184/126 pulse 100 patient sent to hospital via ambulance. Patient diagnosed with stroke. Patient claims doctor told her flu vaccine caused stroke.
Rotateq vaccine given to infant (1 yr 2 mo) which was above manufacturer recommended age limit.  No other complications.
About 11 hours following injection experienced body aches, chills, and overall run down feeling. I took 400mg of Ibuprofen every 4 hours starting 4 hours after symptoms on set and was fine 6 hours after first dose.
Patient received 2nd dose of Pfizer vaccine on 01/12/2021. Then developed symptoms of  cough, headache, and nasal congestion related to Covid-19 on 07/26/2021. Symptoms of loss of taste and smell then developed on 07/30/2021. Patient was tested for Covid-19 on 07/30/2021 and positive results received on 07/30/2021.
Myalgia discomfort/redness at injection site, chills, fatigue Narrative:
A physician reported that a 72 year old female rec'd an injection of Flu Shield (2001-2002 formula) in 10/01. Immediately following immunization, the pt felt tired, run down, feeling bad all over and achy. On 11/8/01, she was hospitalized with acute renal failure. The pt was also diagnosed with rhabdomylysis and placed on dialysis. On 11/19/01 the pt was discharged to a nsg home where she remains on dialysis.
On 16-MAY-2013, the patient was vaccinated with the first dose of GARDASIL Lot # H020910, 0.5 ml, intramuscular (IM), (indication reported as recommendation). Concomitant medication was reported as none. On 17-MAY-2013, the patient broke out in a red rash that was itching on both arms and legs for 2 days. No treatment was given for the event. Laboratories were not performed. The event did not represent a significant disability or incapacity. On an unspecified date, the patient sought medical attention. On 19-MAY-2013, the patient recovered of the red rash that was itching on both arms and legs for 2 days. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MOTRIN [IBUPROFEN]. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
pt recv vax 26FEB98 & NOV98 pt exp a documented case of haemophilus & was hosp for 1 day only;it was reported that throat cult was performed & beta-lactamase test was positive for streptococcal pharyngitis & haemophilus;
Pfizer-BioNTech COVID-19 Vaccine EUA: patient hospitalized for COVID-19 pneumonia, venous thromboembolism, and sub-massive pulmonary embolism (PE).  Administered dexamethasone, remdesivir, oxygen, and anticoagulation. Discharged to home medically stable on oxygen and anticoagulation. On outpatient follow-up patient continues to improve.
Fever; arm around injection site red and indurated, painful.  Erythema to face, back, and arms. Symptoms were much better by time of discharge 72hr later.
12/07/21 presents to ED for "fatigue and shortness of breath x9 days. She was diagnosed w/ Covid 1 week ago". PMHX of "hypertension, hyperlipidemia, hypothyroidism, asthma, and obesity".
(Prevention) Gave 25mg/0.5ml Benadryl to prevent allergic reaction. History of reaction to injections/ testing solutions.
Extremely high heart rate for about two days following each does. I am an endurance athlete and have not felt that I can achieve the same level of performance as before the shot.
Very swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Very swollen lymph nodes) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0471321A or 047B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included THEOPHYLLINE, AMLODIPINE, HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) and Flexeril for an unknown indication.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Very swollen lymph nodes). At the time of the report, LYMPHADENOPATHY (Very swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sore Throat; Chills; Headache; Fever of 101.7; Arm Hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Hurting), OROPHARYNGEAL PAIN (Sore Throat), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever of 101.7) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm Hurting). On 09-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever of 101.7). At the time of the report, PAIN IN EXTREMITY (Arm Hurting), OROPHARYNGEAL PAIN (Sore Throat), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever of 101.7) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.7 (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
On April 22, 2023, about 10am, I, RPH, administered a Pfizer monovalent Covid Vaccine (NDC: 59267102504) to the patient. I had not worked since April 18th, 2023. I did not realize that the guidelines had changed on April 19th, 2023. The patient had never received a Covid vaccine so I administered based on the old guidelines, believing they were the most current.
Received vaccine at 0900.  By  1900 employee was having body aches and headache.  Symptoms improving this afternoon (1/20/21).
After first COVID vacc: Shingles outbreak, left side of abdomen and back. Pain/ache/slight itch started 3/19. Rash started 3/20. Rash and pain accelerated 3/22. Doctor confirmation 3/23 and started on acyclovir & gabapentin. 90% cleared up by mid-June. As of 7/1 still not totally resolved (tingling, numbness, sensitivity, rash).  After second COVID vacc: Right eye uveitis. tart of symptoms approximately 4/13. Exact date unknown because symptoms were masked by Posterior Vitreous Detachment in right eye, which had started 3/3/21.  Symptoms of uveitis: severe inflammation in back of eye, with overall grayish haze, reduction of light contrast, increased light sensitivity, pixilation, overall vision deterioration.
Approximately 10 minutes after receiving the vaccine, I developed nausea, funny sensation in throat. I then vomited, became lightheaded, dizzy and felt that my throat was closing.  I also developed hives and erythema. I was then rushed to the ER where I was found to be tachycardic and hypotensive. I developed a headache while in the ER I was sent back to the ER the next day for the headaches. Seen by my PCP again for the headaches, seen in urgent care for headaches and then again in the ER for headaches at which point I was diagnosed with status migrainosus. Unfortunately, I have now been placed on daily medications for headaches
This spontaneous case reported by an other healthcare professional, describes the occurrence of asthenia (feeling weak), balance disorder (unsteady) and thirst (felt thirsty) in a  patient, of an unknown age and gender, 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 asthenia (feeling weak), balance disorder (unsteady) and thirst (felt thirsty). At the time of the report, asthenia (feeling weak), balance disorder (unsteady) and thirst (felt thirsty outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
1-3 days after his booster Covid shot (1/31/2022), he developed fevers (>101 F), loose stools, malaise. This continued for a few days. He developed dyspnea and was seen in the ER 2/8 and found to have large left lower extremity DVT and bilateral PEs.
After I gave her vaccine, she sat for 15 minutes and walk around. She came back to the pharmacy and said she was seeing purples. We asked her if she was taking any other medications. We measure her blood pressure and it was over 160/100.
Flu like symptoms--  night sweats abs chills, low grade fever,   headache, muscle aches.
pt recv vax 1JUL97 & w/in 24048hr exp overall joint pain & muscle aches along w/swelling in hands, malaise & nausea;pt treated for sx w/Ibuprofen & DPH;pt consulted w/MD & recommendation was made that pt discontinued vax series;
"Quarter-sized" lump at injection site starting 8-20-09. Bright red in color, no pain, only slight itch. Pharm recc. ice. Pt icing.
Patient was vaccinated on 09/01 with first dose of Pfizer vaccine. Patient was transferred to hospital on the evening of 09/06.  Patient was found with altered mental status in a camper by friend. Friend said they had been drinking and snorting cocaine. Upon arrival of first hospital, patient was tachycardic, confused, had LLE pain, and left buttock pain (concerning for compartment syndrome). CT angio runoff of bilateral LE showed nonspecific muscular edema involving left gluteus, adductor musculature, and left hamstring musculature. CXR results consistent with pneumonia. Initial procal was 12 at another hospital, was 47 when arrived here. Initial CK was 40,000, but had increased to more than 80,000 one day later. K+ was 8.9 and serum creatinine was 3. BNP was 314 and lactate was 3.3. Patient required pressors at first hospital (dobutamine and levophed) but was off by the time he arrived here. UDS was presumed positive for cocaine. Initial EF was 20-30%, which was concerning for cardiogenic shock. Once transferred to MICU, patient was treated for rhabdomyolysis and hyperkalemia. Treated hyperkalemia with bicarb, dextrose, insulin, and calcium. Rhabdo was treated with IV fluid resuscitation (lactated ringers). It is unclear if events was substance use rhabdomyolysis or vaccine induced. Unable to verify causation.
after 2nd vaccine  his wife experienced headaches; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEADACHE (after 2nd vaccine  his wife experienced headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 HEADACHE (after 2nd vaccine  his wife experienced headaches). At the time of the report, HEADACHE (after 2nd vaccine  his wife experienced headaches) outcome was unknown.            No concomitant medications were provided. Patient got first 2 Moderna vaccines few years ago. The patient was not part of clinical trial for Moderna. No treatment medications were provided.
?Moderna COVID?19 Vaccine EUA?   Within five minutes of injection began to feel some dizziness - it came and went. I was sitting in car the entire timejand I have never felt faint upon receiving shots. On Tuesday evening, approzimately Jan 26, approximately 9PM I began to have chills for several hours, with my teeth actually chattering. Sometime around midnight I was dizzy and had nausea and vomiting - only mucous. Wednesday AM upon arising I had vertigo and dizziness which lessened during the day. This AM Thursday, I have also had vertigo and nausea and will call my internist.
Apparently, at baseball practice, just coming off routine drill he experienced an episode where he felt his vision when dark and immediately was followed by a popping sensation at the top of his head. At the time he was stationary waiting in line, It was a mild day (temp low 80's, no humidity). Sx resolved and he returned to practice, later after practice while sitting, eating lunch with his mom, the "exact same" episode occurred but this episode was more progressive, HA worsened, vision changed (saw red), he began to experience numbness symmetrically down both arms (elbows down) and tingling. No reported change in his visible appearance per mom. Arms became extremely sensitive to even light touch, felt like "fire" R arm improved first but L arm felt as if it was burning. Sx completely resolved while in ED. He was evaluated in Hospital ED CT/CTA (stroke protocol) was normal -transfered to Pedi ED, MRI brain w and w/o contrast was normal, Labs normal except CPK 880