chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Missed 2nd dose of Moderna vaccine on recommended interval; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed 2nd dose of Moderna vaccine on recommended interval) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed 2nd dose of Moderna vaccine on recommended interval). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed 2nd dose of Moderna vaccine on recommended interval) 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.   Patient had no symptom after first dose vaccine.  No treatment medication were reported.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 042L20A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021 at 9:32 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021 at 9:16 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
9PM 11AUG h/a started; 830AM 12AUG nausea & vomiting & low grade fever; lt arm is sore but no swelling @ inject site;
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 2nd August 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 2nd August 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, intramuscular formulation administered by other route and vaccine administered at inappropriate site. On 3rd August 2018, the patient experienced injection site swelling, fever, injection site erythema and injection site warmth. On 7th August 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site swelling, injection site erythema, pain in arm and injection site warmth were recovered/resolved and the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site swelling, fever, injection site erythema, pain in arm and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient was given the vaccination in the tricep area of her arm intramuscularly, which led to incorrect route of vaccination. The patient noticed the swelling and other side effects took longer to heal than her husband who was given the vaccination intramuscularly. She had pain a couple of hours after the vaccine but the 2nd day (1 day after receiving vaccination), the area was very swollen, red and hot to touch.  The patient also had a systemic fever for 4 days. The patient's arm looked bad for a couple of weeks and the had  a stripe going down her arm from the injections site which took weeks to go away. All symptoms slowly resolved. The reporter consented to follow up. This case was linked to the case US2018201340, reported by the same reporter for her husband.
Narrative:  Patient is a PC patient that received COVID vaccine #1 on 3/12/21 and #2 on 4/9/21. Per notes, she lived alone and was seen by home health on 4/12/21 and did not have any concerns and had stable vital signs. On 4/13/21, notes indicate that she was found deceased on the floor of her home. Date of death is recorded as 4/12/21. No other details are available, no autopsy report is available. Time from vaccine #2 to date of death is 3 days.
Pt's left arm became warm to the touch and from his deltoid down to his elbow, on the left side,  became pink/red in color and was painful to the touch.  Pt had a very small discolored area, bruising,  at the injection site.  Area was swollen and painful for about 2 days.  today it has started to become less pink in appearance, with some swelling still noted, and no complaint of pain in the area today.
1 hour after: local site pain, ache throughout same extremity 24 hours after: chills and overall skin sensitivity 48 hours: respiratory symptoms- cough, sore throat, runny nose, congestion
Pt c/o flush and sweaty approx 30 min post-vaccination. Symptoms resolved with rest. Denies chest pain, palpitations, SOB. Discharged home in stable condition.  SpO2 98% RA  Respirations unlabored.  BP 116/68 HR 66
Severe headache for over 24hrs so far. I?m only about 36hours post vaccination.
Headache at migraine level; Pain from elbow into neck; Pain from elbow into neck and behind shoulder blade; Headache; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 03May2021 at 18:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and migraines and allergy to some chemical sensitivity. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN) and tizanidine hydrochloride (ZANAFLEX); from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021 at 00:00, the patient experienced pain from elbow into neck and behind shoulder blade for 2 full days before subsiding and fully stopped after 5 days. Also experienced headache for a full week. First 2 days were at migraine level. Extreme fatigue has reduced, but still experiencing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of pain from elbow into neck and behind shoulder blade was resolved on 09May2021 after the duration of 5 days. The clinical outcome of the was resolved with sequelae on 11May2021 after a full week. The clinical outcome of the event headache at migraine level was resolved with sequelae on 06May2021. The clinical outcome of the event extreme fatigue was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
anthrax1:red, raised itchy pimple like lesions on both arms from elbows up to shoulders similar to heat rash. anthrax2: soreness. anthrax3: red pimple like, fluid filled blisters that itched, were sore, had a burning sensation a numbness. It was more wide spread affecting areas on her trunk including her breast as well as her arms and legs.Says rash was constant from December98 until after Feb2000. She was treated with different medications (calamine and benadryl lotion, atarax, hydrocortisone, triamcinolone and nizoral creams, Betamethsone ointment and keflex) to name a few. The lesions were biopsied and diagnosed as Nummular eczema. Also began experiencing recurrent UTI (NOV98, DEC98, FEB99); amenorrhea: no pds from December 98 until Jan2000; episodes of "thrush and tender gums"; headaches with photosensitivity, "loose stools on and off" from Oct 99 thru Dec 99 and extreme fatigue. Anthrax4: soreness that resolved in 2-3 days. Had an exacerbation of rash on her forearms as well as new eruption of erythematous, pruritic, "blister-like lesions on her chest and neck 5 days after immunization. See in Sep for patch test postive for formaldehyde and nickel. Treated with steroid creams and advised against receiving further anthrax vaccinations. Received a Medical Board that found her "fit for duty" and recommended resumption of anthrax. Anthrax5: in less than 24 hours again reports having an eruption of "blister like, itchy rash on my arms and legs" and again advised to receive "no further anthrax vaccinations". Current problems: nummular eczema, poly-cystic ovarian disease, fatigue, problems with short term memory, insomnia.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 01-FEB-2016, the patient was inoculated (by an unspecified healthcare professional person) with ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-APR-2016, she was treated (by an unspecified healthcare professional) at a hospital emergency department (ED) for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles.   As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Expired Moderna Covid-19 vaccine ere administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine ere administered) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Patient was never diagnosed or tested positive with COVID -19. Patient does not have any acute illness at the time of vaccination and up to one month before.  Concurrent medical conditions included COPD, Hypoxic respiratory failure (Respiratory failure with hypoxia) and Pulmonary contusion.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine ere administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine ere administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided by reporter. It was reported that there were no other vaccine given on the same day as Moderna COVID-19 vaccine and other vaccine received within one month prior to any dose of Moderna COVID-19 vaccine. The date at which the vial was initially stored in the refrigerator was unknown. It was transferred from another source. The vial did not undergo any temperature excursions.
Rapid onset of fever of 103.5.  Ibuprofen given, fever returned in 6 hours - 102.1.  No rash, bumps, lumps yet (he received the MMR vaccine).  Still monitoring.  Irritability and sleeping more than usual.  Slept through high fever. I realized he had a high fever when I heard him breathing fast.
Patient received the 1st COVID vaccine (Pfizer, Lot #: EW0161 and expiration date: 08/2021) on 04/13/2021 at 10:57 AM. Client presented to the vaccine site today, 05/04/2021, for her second dose appointment. As the vaccinator conducted a health screening, some medical concerns came up. As a result, nurse was called over to consult. Client expressed that while she was waiting in the observation area after her first dose, she developed lower jaw discomfort within 15 minutes of receiving the vaccine and it lasted for a total of 30 minutes. Client reported that the discomfort was rated as a 3 out of 10 on a pain scale and since it resolved, it has not come back. Client also reported that the following day, she developed a rash around the injection site. The rash lasted about a week and the client described it as being itchy and that it would exacerbate about 2- 3 times a day. The rash has since resolved, but there is still a slight, bruise- like area at the injection site. Client denied any past medical history and denied any current medical diagnoses. Client is not currently taking any medications and has anaphylactic reactions to Penicillin, IV contrast, Prednisone, and anesthesia. The client reports having a primary care provider, but stated that she did not consult with the provider regarding the symptoms experienced after receiving the first dose. Nurse requested a medical consult and the medical doctors recommended that a set of vital signs be taken. If the vital signs came back within normal ranges, we could proceed. The client would receive the second dose and then wait in the observation area for 30 minutes. Vital signs were taken by medic, at 1224, while the client was sitting: blood pressure: 128/80, heart rate: 76, respiratory rate: 14, and skin was warm, dry, intact, and normal. Vital signs were stable, so patient received the 2nd COVID vaccine (Pfizer, Lot #: EW0167 and expiration date: 08/2021) on 05/04/2021 at 12:21 PM. Client was educated to follow up with her primary care if the lower jaw discomfort and rash developed after the second dose. Client then checked in with the EMT and was educated on the use of V- safe. Client sat in the observation area and waited a total of 30 minutes. Client then left the vaccine site with a steady gate.
This literature report has been received from the authors of a published article. In this case series, the authors described seven immunized healthy children without a history of primary varicella who presented with herpes zoster that correlated with the vaccination site of live attenuated varicella-zoster vaccine. These cases highlight the varied clinical presentations and diagnostic and therapeutic considerations for herpes zoster in healthy children. Seven vaccinated healthy children without underlying immunodeficiency presented with herpes zoster in the limb that correlated with the vaccination site. Their clinical histories are summarized. Each patient underwent varicella zoster vaccination at 12 to 14 months of age. The pediatrician's office confirmed the site of vaccination in six patients and the parents in the seventh. Median age at presentation was 3 years (range 1.5-6 years). There were no precipitating factors elicited by history in five patients; one patient developed the rash at the site of recent influenza vaccination and one patient developed the rash after surgery. The morphology of the lesions included erythematous papules, pseudovesicles, pustules, and plaques, with associated pain in two patients and pruritus in three. Systemic symptoms ranged from none to low-grade fevers, upper respiratory symptoms, and joint pain. Clinical and laboratory findings, specifically positive direct fluorescent antibody (DFA) testing, were consistent with herpes zoster in four cases; because of distinct similarities in the clinical examination, DFA testing was not conducted in the other three cases. Acyclovir was prescribed for five patients but deferred in two because of the mild or late presentation. The evaluating physician's differential diagnosis in the seven cases included viral exanthem, eczema herpeticum, atopic dermatitis, contact dermatitis, microcystic lymphatic malformation, herpes simplex infection, and herpes zoster infection. In one patient with knee pain, there was initial concern for septic hip, but inflammatory markers were not elevated, joint effusion was not seen on ultrasound, and the rash and knee pain self-resolved after several days. This report refers to a 1 (reported as 1.75) year old female patient without a history of primary varicella. On an unknown date, the patient was vaccinated with varicella-zoster vaccine (code as "varicella virus vaccine live (Oka/Merck) (manufacturer unknown), Zoster Vaccine Live (manufacturer unknown) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (manufacturer unknown)") (dose and route unknown, right arm) for prophylaxis. On an unknown date (reported as 9 months later), the patient experienced herpes zoster in right arm (in C6 dermatomal distribution) with symptoms of fever. The direct fluorescent antibody (DFA) testing was positive. The patient received acyclovir treatment for 7 days for the event. The outcome of the event was recovered without complications. The reporter considered the event of herpes zoster was related to the suspected therapies. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1802USA003640:
Injection site pain, tiredness, headache slight, joint pain, fever up to 101.6, feeling unwell
Shortness of breath. Can?t get full breath. Tightness in chest (near heart) and into my left armpit/arm
This case meets criteria for vaccine breakthrough review. Presented with fevers since Thursday of week prior, SOB, right flank pain and feeling generally unwell.
No other issues or concerns noted; Customer called to report that a 7 month old patient had been administered VARIVAX a few month early.  No PQC.  No other issues or concerns noted.; This spontaneous report has been received from a health professional and refers to a 7-month-old infant patient.  The patient's medical history, concurrent conditions, drug allergies or reactions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, dose description, route of administration, lot number and expiry date were not provided) a few months earlier (product administered to patient of inappropriate age). No other issues or concerns noted.
Severe headache, excessive facial and scapula swelling. Low grade fever, occasional rash.
shingles after first dose; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L2DA) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE, ROSUVASTATIN and TELMISARTAN for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HERPES ZOSTER. The patient was treated with VALACYCLOVIR for Shingles, at a dose of 1 dosage form; GABAPENTIN at a dose of 1 dosage form and VALACYCLOVIR at a dose of 1 dosage form. On 19-Apr-2021, HERPES ZOSTER had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: follow up received event date and outcome updated.
maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 032L20A) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 17-Jul-2020 and the estimated date of delivery was 22-Apr-2021. On 13-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  On 13-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2020, Pregnancy test: positive (Positive) positive.         No Treatment medications was provided by the reporter. Multiple test and ultrasounds were performed and results were normal. NIPT was performed on sep 2020 resulted in normal test results.
Compromised Immune System - before receiving the vaccination, I had a very strong immune system. I would have a biannual cold and would recover within a week. When I had COVID, I would recover in a matter of days.  Immediately after receiving the vaccine, I had a fever. Now, I have cold symptoms at least 2-3 weeks of every month: cough, runny nose, sore throat, cold sores. When I will get healthy for maybe 1-2 weeks before I catch my second cold.
Pronounced Chest Pain that increased throughout the day.  It was at its most severe between 7pm-11pm.  After sleeping the pain was present but not as severe.  Still present currently but not hurting.  Periodically noticeable.  Rest and thinking of speaking with doctor.
I was extremely dizzy, I could not walk, I was unable to feel anything on my left side. My daughter drove me to the emergency room, I was uncertain of knowing if I was having a stroke or something with my heart. Once I got into the emergency room, they did a complete blood panel to check for a heart attack, they did a CT scan to check for stroke. I was kept overnight for observation and to have an MRI to also check for a stroke. All tests came back negative. I have a follow up MRI coming up on May 13, 2023.