chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021; No adverse event; Patient got 1 dose of Moderna COVID-19 vaccine last yr on 12-Nov-2021 with expiry date 08-Nov-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got 1 dose of Moderna COVID-19 vaccine last yr on 12-Nov-2021 with expiry date 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got 1 dose of Moderna COVID-19 vaccine last yr on 12-Nov-2021 with expiry date 08-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got 1 dose of Moderna COVID-19 vaccine last yr on 12-Nov-2021 with expiry date 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient got 1 dose of Moderna COVID-19 vaccine last yr on 12-Nov-2021 with expiry date 08-Nov-2021) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021).    Concomitant drugs were not reported.  It was reported that the monovalent vial of size 5.5 ml was initially stored in refrigerator on 12-Nov-2021.  The vial did not underwent any temperature excursion.  Treatment medications were not reported.
pt recv vax 24OCT96 & 27OCT96 pt devel a varicella-like rash all over body;pt recovered from sx;
I had a rash under my right breast and on my forehead and I started getting hives on the left side of my face and neck. I thought it was poison ivy. That's the first time I went to the doctor. It cleared up. The second time I went to the doctor it was on my left breast, left eye and left side of my face. He looked me over and he diagnosed me with shingles. He put me on Aciclovir 400 mg 3 times a day for 2 weeks. It has cleared up.
After receiving vaccination pt became light headed woozy, and ash color started to fall to floor caught by volunteer. P. 88 BP 130/78 no S.O.B.
Severe pain, lost all mobility in arm. Felt nauseous, developed a cough. Lasted for 2 weeks.
Patient received Pfizer monovalent instead of Pfizer bivalent as Covis-19 booster.
Patient was a perfectly healthy baby up until his set of shots at 2 months old... He began to have infantile spasms which started out small and progressed into harder seizures. The infantile spasms started within 5 days after the shots. We told pediatrician of our concerns and she continued to administer shots. On June 20, 1999 he was officially diagnosed with infantile spasms. He has received pet scans, mri, blood test, eegs, ltm eegs all of which came back perfect hypsarrhythmia was the only thing showing with no explaination of why. Since diagnoses and tests he has received treatments of all available drugs which all proved to be unsuccesful in controlling the seizures. He has also been on the keto diet which did not control the seizures, from Jan 2000 to Sept he had no seizures and no hyparrhythmia. Dr. assured us it was safe to give him immunizations again which on  Sept 12, 2000 he received another DTP shot within 2 days his seizures were back and worse than ever.... He has had many hospital stays and has been treated for serious side effects such as itp to certain drugs given him. He is now 5 years old and his infantile spasms has progressed into lgs he is develpomentally delayed and has recently been diagnosed with autism. His seizures are still uncontrolled but since we refuse to give him any more shots they have gone down to no more than 2 a day. We as parents truly believe the shots caused or aggravated an underlying seizure disorder and his autism which he started showing signs of in May 2000 when his mmr was given to him. Signs of autism were he lost his speech he no longer speeks the few words he knew and seemed to regress into his own world where he no longer knows how to smile or laugh or interact with people. Records are received from Medical Ctr. for admissions from 10/16/00 through 2/28/03. These records confirm a diagnosis of infantile spasms in 6/99 w/ evolution to intractable generalized seizures by 2/03 per follow-up exam w/ neurologist on 2/19/03. Prolonged EEG one week later noted high voltage chaotic and multi focal spikes. Records note that child had a hx for AEs w/ Klonopin and Tegretol in the form of a rash and also w/ Depakote in form of ITP. Records for long term EEG monitoring at Hospital indicate a finding of modified hypsarrhythmia. Also observed were clinical events associated w/ beta seizures.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Large, red itchy rash  around injection site with heat still two days after appearing (10 days after vaccination)
Patient was given 2nd GARDASIL injection. Patient was fine while getting the injection. Patient went to get off of the table and felt dizzy then nauseated. Patients grandfather helped her sit down in the chair and patient slumped over. I left the room to get the doctor. Doctor came in the room and got patient to lay down on the bed. Patient felt, dizzy, faint and nauseated. Patient was given time to feel better before leaving. Time span of 20 min.
No other issues or concerns noted; administered expired dose of VARlVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 18-FEB-2022, the patient was administered expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T003706, expiration date 30-JAN-2022; strength, dose, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No other issues or concerns were noted. No product quality complaint (PQC) was reported.
Health Commission organized a vaccine clinic for facility. Patient was a new admission to facility the night before, patient's son had contacted facility administrator regarding the clinic stating his mother never received her second dose of Pfizer. Patient's son presented patient's CDC vaccination card with Pfizer vaccination given on 4/7/2021, but second dose was left blank. Patient's son stated she was supposed to get her second shot in dialysis when she was due but they did not give it to her because was feeling ill. Health Commission registered and administered her second shot and completed the CDC vaccination card. After the administration of vaccine, patient's son had called facility administrator and told her that his father just now had given him a second separate card that had documented the completion of the Pfizer vaccine. No adverse events noted at this time. RN advised facility administrator to make aware RN taking care of her in facility, to contact PCP and to closely monitor the patient.
Noticed a small spherical lump near collarbone possibly lymph node, no pain, no treatment. Will monitor over time.
The day after I experienced extreme muscle and joint pain that lasted about a week. And it started to get better but the following Saturday I got a very terrible headache. And over the course of that week I started bruising very easily and all the veins all over my body were very prominent. The headache wouldn't go away and I started to have chest pain by that monday. And at that point all the muscle and joint pain came back and it was very very painful. At that point I called my primary care provider and they scheduled me with someone else in the clinic because i was having the chest pain. And they did a test for covid and urged me to go to the emergency room, which i did. After that I went to the emergency room and sat for 5 hours, they did bloodwork to check clotting factor, basic blood panel and also a CT of my head. According to them, everything was normal and they sent me home with a terrible headache. My biggest complaint was the bruising all over my body but no one ever looked at that.
Left arm has become red and visibly swollen also right side of body exhibiting allergic reaction.
inappropriate schedule of vaccine; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In October 2018, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In June 2018, the patient received 1st dose of Shingrix and develop shingles in October 2018.  The shingles had resolved. At the time of this report, the 2nd dose of Shingrix had not been administered  The Shingrix was administered at another facility with supply issues, but the reporter also mentioned later in the call that his facility might also be having supply issues which impact the timing of the patients' second doses. The reporting pharmacist did not have any other information. The reporter did not consent to follow up.
diarrhea; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and NAUSEA (nausea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced NAUSEA (nausea). On 24-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 24-Feb-2021, NAUSEA (nausea) had resolved. On 25-Feb-2021, DIARRHOEA (diarrhea) had resolved.            The patient's medical history was not provided. Relevant concomitant products usage were not reported by the reporter.  No treatment information was provided.
Shingles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), till Mar2021 at 11 mg for rheumatoid arthritis. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing), notes: Hashimoto's thyroiditis; "Hyperparathyroidism" (unspecified if ongoing), notes: Hyperparathyroidism; "High blood pressure" (unspecified if ongoing); "stroke" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 Manufacturer unknown), for Covid-19 Immunization, reaction(s): "Covid-19". The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for tofacitinib citrate was temporarily withdrawn in Mar2021.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
chest tightness no SOB; left extremity numbness; hR 54; headache; could not lay in one position for long due to the pain; fever 100.7; chills; myalgias; 9-14 received booster at 9am; 9-14 received booster at 9am; heartburn; nausea; This is a spontaneous report from a contactable pharmacist (patient).  A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 14Sep2021 at 09:00 as dose 3 (booster), single for COVID-19 immunization. Medical history included PCOS, menopausal symptoms (Currently taking estradiol patch and progesterone 1 po qd for menopausal symptoms) and PCN allergy. Concomitant medication(s) included ongoing estradiol (ESTRADIOL TRANSDERMAL) and progesterone (PROGESTERONE) taken for menopausal symptoms. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 14Feb2021 as dose 2, single for COVID-19 immunization patient experienced similar but not quite as severe reaction after dose 2. On 14Sep2021 at 09:00, patient experienced fever 100.7, chills, myalgias and 9-14 received booster at 9am, on 15Sep2021 headache, could not lay in one position for long due to the pain, on Sep2021 nausea and heartburn, on 17Sep2021 at 01:00, chest tightness no sob, left extremity numbness, hr 54. On 14Sep2021, patient underwent lab tests and procedures which included body temperature resulted 100.7, on 17Sep2021, heart rate resulted 54. Patient took ibuprofen 800mg for headache. The outcome of event headache, nausea and heartburn was not recovered, myalgias was recovered on 16Sep2021, left extremity numbness recovered on 17Sep2021, 9-14 received booster at 9am and hR 54 was unknown, rest all events was recovered on Sep2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
high pitched crying & inconsolable for 10-12 hrs;temp 102-103 x 4-5hrs; attempted APAP w/no help
Developed shingles 2-3 days later, localized.; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (Developed shingles 2-3 days later, localized.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included MS.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Developed shingles 2-3 days later, localized.). At the time of the report, HERPES ZOSTER (Developed shingles 2-3 days later, localized.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include unspecified immunosuppressive therapy treatment for multiple sclerosis.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Folowup received on 30-June-2021 and contains significant information
Systemic: Fainting / Unresponsive-Severe, Additional Details: PT PASSED OUT ABOUT 1 MINUTE AFTER RECEIVING VACCINE.  HE CAME TO IN ABOUT 10 SECONDS. HE WAS FINE WHEN HE LEFT. HE LAYED DOWN FOR 15 MINUTES THEN SAT UP FOR SEVERAL MINUTES BEFORE HE LEFT.
Pt. was not aware that she was pregnant at the time. She had 1st and 2nd trimester bleeding with oligohydramios and abruption with delivery at 28 weeks gestation.
pt recv vax & the following day devel pain on the lt side of the neck radiating to the shoulder & down the arm; pt was treated w/ASA, DPHq 4 hr & an IM inj of Toradol;
Pt had shingle vaccine 7/28 at 1 pm, later that evening, she developed a blister Lt hand. No itchiness or pain; just tender on palpation. NO fever, chills, feeling fine, URI sx's. Pt had h/o chicken pox when she was younger.
"COVID Arm" - i woke up 12 days after vaccination and had a bright red itchy rash around the vaccination location.
Flu; Initial information was received on 08-Dec-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (Patient).  This case involves elderly patient [gender unspecified] who experienced flu (influenza), while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, patient had two shots in 77 years of life and both time got the flu.   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
couldn't lift her left arm for three days; Swollen lymph nodes under her left arm; slept for 5 hours; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes), SOMNOLENCE (slept for 5 hours) and LIMB DISCOMFORT (arm discomfort) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for Immunisation.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes), SOMNOLENCE (slept for 5 hours) and LIMB DISCOMFORT (arm discomfort). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient received 2nd dose of COVID vaccine; was seated in observation area, fell from seated position.  Baseline vitals HR 46, BP 100/50, glucose 111, SPO2 96%.  911 called, patient evaluated, admitted he had drank a Red Bull and "smoked some weed" prior to coming to clinic, patient reports "this happens to me sometimes" and refused transport to ED.
Pregnancy was discovered shortly rafter first vaccine.  Was advised to safely continue, so I did.  My date date was January 16, 2022. Late June I started feeling stabbing pain in my leg occasionally. At 16 weeks pregnant, I suffered a miscarriage and had to deliver the fetus on August 6, 2021.  After delivery the pain in my leg was so bad I couldn?t walk.  There was no swelling, nor color or temperature change- just stabbing and burning pain.  An ultrasound found a DVT, and I have been on blood thinners ever since.  I have had two perfectly healthy pregnancy prior to this.  And have no history of blood clots; and no family history of blood clots.
Patient is a 58 y.o. male patient of, CNP with history of ALS, HTN presented on 3/5/2023 with cc of respiratory failure. HMS consulted by Generic Hms Hospitalists for taking over as primary as patient is transferred out of ICU. HMS called to patient's bedside to pronounce.  ? Patient's time of death was 0117 AM ? Patient's date of death was 3/9/2023 ?     Acute respiratory failure with hypoxia COVID-19 infection Initially on BiPAP on admission, transitioned to nasal cannula Sepsis suspected, likely from COVID Required 6L O2 on exam, pt in distress using accessory muscles of the neck. Refusing to put on BiPAP. Called wife and updated over the phone. Pt acceptable of BiPAP on wifes request. Discussed case with neurology and pulmonary. Wife confirms code status of DNR CCA DNI Very poor prognosis and not much treatment options available. Palliative c/s, dicussed case with NP along with goals of care discussion and rec transition to hospice. Mtg with family with change in code status to DNR CC. Morphine started for SOB.   Recent myocardial injury Essential hypertension Continue metoprolol and atorvastatin, aspirin BP controlled   Hyperglycemic A1c at 4.7, likely hyperglycemia prednisone induced   ALS Nonverbal at baseline, in moderate respiratory distress on exam. Continue Nuedexta and rilusole, atropine drops prn TF bolus four times a day, hold for vomiting at present   Central sleep apnea BiPAP at night as tolerated
it was rpt by RN pt recv 1st dose varivax 2/9/96 & in 6/98 pt devel acute varicella described as ``moderate''