chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4488613-00.   A 64-year-old male patient received BNT162b2 (BNT162B2), on 04Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 20Apr2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown), subcutaneous for psoriasis, psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19". The action taken for risankizumab was unknown.  The reporter considered "covid-19" related to BNT162b2.  Clinical course: In Jul2022, the patient experienced COVID-19. MODERNA COVID-19 VACCINE (ELASOMERAN) and PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) were also considered suspect. In Jul2022, the patient had covid-19 and was unable to contact dermatologist so on 27Jul2022, he made his own decision to take Skyrizi shot. The reporter's causality for the event(s) of COVID-19 with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events suspected Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of suspected covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Previous pnuemonia vaccination reported by client on consent. Client stated that at onset of adverse event, 2/6/2103 4:00 pm, she noticed at 3-4 inch diameter of redness below the injection site. Client stated that she took one Benadryl when she got home. When she woke up the next morning, 2/7/2013, she noticed redness and swelling half way down to elbow. At 3:00 pm, 2/7/13, her arm remained red and swollen. At this time she saw MD, who assessed the client and drew a line around the redness and swelling. Client was told that if the redness and swelling exceeded beyond the drawn line to see her doctor. At 3:20 pm, 2/7/2013, she left home and arrived at urgent care. At this point the redness and swelling had exceeded beyond the elbow. Client had lab tests drawn (unknown lab test per client. She received a prescription for Prednisone to take 2 times a day for three days (unknown dosage per client), and Cefadroxil 500 mg to take over ten days. As of today, 2/11/2013 the client stated that she has "blotching" to the area and that there has been improvement related to the adverse reaction. She had been advised to go to a follow-up appointment on 2/11/2013 as a result of the reaction and she did not go the appointment by personal choice.
temperature excursion range from 31.7F to 52.4F for 300 hours due to a refrigerator malfunction; vaccine administration  post excusrion; medication error due to administration post excursion vaccine with no adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old female patient who experienced medication error due to administration post excursion vaccine with no adverse event, temperature excursion range from 31.7f to 52.4f for 300 hours due to a refrigerator malfunction and vaccine administration  post excusrion while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL).  On 19-Jul-2022, the patient received a  0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE once  (lot U7268AA; expiry date: 22-Apr-2023)  via intramuscular route in the right deltoid for immunization.  On 19-JUL-2022 the patient developed a non-serious medication error due to administration post excursion vaccine with no adverse event (medication error),   vaccine administration  post excusrion (poor quality product administered) and On an unknown date the patient developed a non-serious temperature excursion range from 31.7f to 52.4f for 300 hours due to a refrigerator malfunction (product storage error) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.   Action taken: not applicable.    At time of reporting, the outcome was Unknown for the event medication error,poor quality product administered, product storage error    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Intense fatigue, intense muscle and joint pain.   No treatment given except for bed rest.  Symptoms mostly gone by the next day (they lasted around 12-20) hours).
Pregnancy history: 8 weeks pregnant. Estimated due date: 10/31/2021  Side Effects: chills, soreness around injection site, headache, dizziness.
This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age. It was reported that doses of VAQTA, that were exposed to temperatures out of range on 02-JUN-204 were administered to an unspecified number of unspecified patients on unspecified dates (approximately in June 2014). No other concomitant therapies reported. The temperature excursion was supported. No adverse effects has been observed or reported. The outcome of the events was unknown. No PQC reported. The case has been linked with the cases (same reported link) # 1406USA012405, 1406USA011663, and 1406USA012415. Additional information has been requested.
dizziness at various points in day.... not spinning but feeling like head is very heavy and dizziness occurs with ordinary events when head is tilted a little to eat a meal or write something or even just sitting.
Minutes after the administration of the vaccine, the patient was sitting down and started losing consciousness. Seconds later, she came back. She was a little disoriented and incoherent. We immediately laid her down on a flat surface and observed her. She fully regained consciousness, was coherent and vocal. She explained that this happened to her before once when she was visiting someone at a hospital. She said sometimes it gets triggered with the smell of alcohol (i.e the alcohol swab). She stated that she was fine and felt like normal. I explained adverse events, what to expect and what to do in case of an emergency.
sore throat, fever, malaise; later, violent unproductive and constant cough. Support medications given by doctor (Albuterol, Symbicort, Robitussin AC). Patient is has been ill the entire time since then, but fever has receded since 10/01/2009
Patient tested positive for COVID-19. Patient was fully vaccinated.  He started feeling "different" about the middle of July. He was more fatigued, disoriented, and unstable. The following week, he developed cold symptoms which everyone assumed was just the common cold. Pt. daughter was sick the previous week with a common cold (took her 3yo to the doctor to confirm, but wasn't tested for Covid). After 7/26, his condition started to deteriorate more with fever and vomiting. By the evening of 07/30, he was having great difficulty breathing and so he was taken to the hospital. He was admitted for very low blood oxygen levels as well as Covid pneumonia. He has several underlying health conditions to include heart disease and obesity.  Patient died due to COVID.
Patient states her arm had been sore since the evening she got the injection (10/3). When she looked at her right upper arm on Saturday (10/6) she said that it was dark purple like an eggplant and that since it had still been hurting her, she decided to go to the ER on Saturday morning. The doctor there told her that they suspect an artery or vein had been hit when patient was immunized. She showed me her arm today (10/13) and said that the color is much lighter, but it has traveled down her arm.
12 y/o male who received second dose of Pfizer mRNA COVID-19 vaccine (lot number EW0187) on 06/07/2021. Developed chest pain the morning of 6/10 /21 at 0430 and was admitted on 6/10 to Intensive Care Unit for monitoring.  Lab and imaging studies were consistent with acute myocarditis. Troponin peaked at 3.32 on admission and was down to 1.33 by the time of discharge on the following day on 6/11/21. No interventions except NSAIDs (ibuprofen) were administered during the admission and he did well. He will follow up with Cardiology as an outpatient.
received a third dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose of Shingrix 4 months before 3rd dose).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at the vaccination was not reported. The pharmacist reported that the patient between 60 and 70 years old received by mistake a third dose of Shingrix, which led to extra dose administered. The pharmacist also reported that it had been 4 months between second and third dose of Shingrix. No data about patient´s details or lot number from Shingrix third dose at the moment of the call. The reporter consented to follow up via email.
Began 16 days after my injection. Hives began on my forearms, moved to my abdomen, chest, upper legs within 12 hours. By day 2 (Wednesday after initial Monday evening presentation) hives were on my face, chest, full abdomen and back swaths, full legs, hands and feet. Tuesday afternoon, I spoke with a Teladoc doctor who prescribed prednisone (40mg daily for 3 days). By Thursday, not much had changed so I went to my local dermatologist. He immediately said I should not get the second dose of the vaccine due to the hives being on my eyelids as well as having an itchy throat. I'm currently waiting for a call back from my primary care physician to balance the tie - even though I am giving the dermatologist's advice a little more weight due to being somewhat more risk averse and his suggestion to have an epipen on hand.
pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; Date the vial was initially stored in the refrigerator was 23-Dec-2022.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 23-Dec-2022.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 23-Dec-2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 23-Dec-2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 23-Dec-2022.).    No concomitant medications were reported.  It was Unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 42 doses of 6M-5Y vaccine were administered after 30 day use by date to patients. Vial size was reported as 0.4 ml per vial. The vial was initially stored in the refrigerator on 23-Dec-2022. The vaccine was administered on 26-Jan-2023, 27-Jan-2023, 30-Jan-2023, 31-Jan-2023, 02-Feb-2023,06-Feb-2023, 08-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. The vial did not undergo any temperature excursions.  No treatment details were reported. This case was reported for patient 11 out of 42 Patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:
After both injections my seizures and migraines were more frequent and I am currently having a new type of seizures out of the blue that we are trying to treat I am also experiencing a visual loss. After both of my vaccines  my blood sugar and blood pressure have been high  which prompted  a visit to the Emergency Department (when it has always been very low.) I also experience an elevated heart rate. I am now having to be treated for Hypertension.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (lot#, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
additional dose of Boostrix on 01Nov2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 15-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number NR5DX, expiry date 02-FEB-2026) for prophylaxis.   Previously administered products included Menactra (On 27th July 2020, received a dose) and Boostrix (On 5th May 2023, received a dose, batch number: 34FR4, expiry date: 23-SEP-2024). Concomitant products included MENVEO.   On 01-NOV-2023, the patient received Boostrix. On 01-NOV-2023, an unknown time after receiving Boostrix and an unknown time after receiving MENVEO, the patient experienced drug dose administration interval too short (Verbatim: additional dose of Boostrix on 01Nov2023). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 1-NOV-2023  A nurse reported a patient received a dose of Menactra on 27th July 2020 and a dose of Menveo 01st November 2023.  The patient also received a dose of Boostrix on 05th May 2023 and an additional dose of Boostrix on 01st November 2023. The reporter consented to follow up. The patient received another dose of Boostrix earlier than recommended schedule, which led to shortening of vaccine schedule.
Information has been received from a physician concerning a 6 month old Middle Eastern female who was vaccinated with a first and second dose of Rotavirus on 27-OCT-2006 and 29-DEC-2006, respectively. On 03-MAR-2007 the patient was hospitalized for intussusception, which required surgery, but no bowel resection. Subsequently, the patient recovered. No other information was provided. Additional information has been requested. 04/17/07-records received from facility for DOS 3/2-3/5/07 DC DX: Intussusception. Fever. Leukocytosis. 6 day HX of vomiting, has had no stool no diarrhea. Prior to admission fever 103.5. Weight down 14 ounces. Congestion with clear runny nose. Afebrile upon admission. 2nd day of admission passed mucusy stool with streaks of blood. PE: WNL, abdomen soft and nontender.  Surgery reduction ileocecal intussusception and appendectomy
I experienced shortness of breath, I could not carry anything without losing my breath, my heart rate was very rapid and was jumping very high and coughing.
I even got sick on the Moderna; Fever; couldn't use his arm for 3 days because it hurt; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I even got sick on the Moderna), PYREXIA (Fever) and PAIN IN EXTREMITY (couldn't use his arm for 3 days because it hurt) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EW0168) for COVID-19 prophylaxis.              No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I even got sick on the Moderna), PYREXIA (Fever) and PAIN IN EXTREMITY (couldn't use his arm for 3 days because it hurt). At the time of the report, ILLNESS (I even got sick on the Moderna), PYREXIA (Fever) and PAIN IN EXTREMITY (couldn't use his arm for 3 days because it hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Live significant FU appended(events added)
Information has been received from a clinic nurse concerning a male dialysis patient who was vaccinated IM with a 40 mcg first dose of hepatitis B virus vaccine rHBsAg (yeast). Subsequently, the patient developed blurred vision and malaise which lasted for several hours. Unspecified medical attention was sought. It was not known if he was hospitalized or if any treatment was given. Subsequently, the patient recovered from blurred vision and malaise. A product quality complaint was not involved. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a male patient who received SHINGRIX for prophylaxis. On 20th October 2018, the patient received the 1st dose of SHINGRIX. In November 2018, less than a month after receiving SHINGRIX, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the patient experienced speech disorder and eye movement disorder. The patient was treated with prednisone. On an unknown date, the outcome of the bell's palsy was not recovered/not resolved and the outcome of the speech disorder and eye movement disorder were unknown.  It was unknown if the reporter considered the bell's palsy, speech disorder and eye movement disorder to be related to SHINGRIX. Additional details were reported as follows:  The age at vaccination was not reported. The patient and his spouse received a 1st dose of SHINGRIX. In early November 2018, the patient was diagnosed with bell's palsy. The patient also reported that, had a hard time with speaking and his left eye could not blink. The patient's physician put him on Prednisone but it did not really help at all. The reporter gave permission for safety to contact his healthcare professional for additional information. The reporter consented to follow up.
Red Arm (Injection Site); Itchiness (Injection Site); Swollen (Injection Site); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red Arm (Injection Site)), INJECTION SITE PRURITUS (Itchiness (Injection Site)) and INJECTION SITE SWELLING (Swollen (Injection Site)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Red Arm (Injection Site)), INJECTION SITE PRURITUS (Itchiness (Injection Site)) and INJECTION SITE SWELLING (Swollen (Injection Site)). On 16-Feb-2021, INJECTION SITE ERYTHEMA (Red Arm (Injection Site)), INJECTION SITE PRURITUS (Itchiness (Injection Site)) and INJECTION SITE SWELLING (Swollen (Injection Site)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment provided
Itwo days after the vaccine was administered on 2/13/2021, I woke up with severe upper abdominal pain.  Had to go to work . Pain continued to worsen through the day.  Called my physician and she said to come in Thursday. Pain worsened Thursday.  Had blood draw to test Lipase and Amylase. as pain seemed similar to Pancreatitis I had in 2018 which occured after a wasp sting. Dr. called early Friday to tell me to go to ER that my Lipase number was 1547. Went to ER. Very crowded.  They repeated the Lipase and it was down to 474.  Was admitted at 4 that afternoon and treated with IV Fluids, and pentatonix .  Amylase was 474 on day 2, came down to114 on day 3, and 66 on day 4.  Ultraond was done
mild nausea, malaise; irritation & swelling 2 1/2 x 2" around inject site;