chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This subject is a 76 year old male who died while enrolled in the RSV11 study. The subject received RSV vaccine or Placebo and influenza vaccine on 11/13/02. The investigator was informed by one of the family members that the subject had died in July, 2003. Specific dates not reported. Causality was not reported. Further info from the investigator has been requested. The death certificate received on 11/20/03 states myocardial infarction and CAD. Follow up on 11/26/03: "Efforts are being made to contact next of kin and to obtain a death certificate through the State.  No details are known at this time. Additional info received 11/18/03.  The subject died on 07/08/03, 237 days post immunization.  Death Cert: Cause of Death: Acute MI due to CAD.  The acute MI was reported by the investigator as not related to the study vaccine." Follow up on 12/16/2003: "Additional information received 12/01/2003: Complementary Information Form: Diagnoses at Enrollment: COPD, Bronchiectasis, Ischemic heart disease.  Medication: Psyllium oral power, Ranitidine, Furosemide, Nitroglycerin, Albuterol, Beclomethasone NS, Hydrocodone/Acetaminophen, Tamazepam, Ipratropium bromide inhaler, Lisinopril, Salmeterol inhaler, Prednisone, Theophyline."
Sxs began 1/8/2021 (immunized 1/5/2020). light headed and nausea. 1/9/21. migraine, chills nausea B/P 180/100. 1/10/20 headache 170/106. 1/11/2020 161/100 153/80. Saw neurologist 1/10 and started on 20 mg propranalol for migraine h/a 1/12 /10, 159/89 L arm became warm, tender and pruritic. 1/13/21 161/101  L arm warm, tender, redness extending. Pruritic when touched.Has MD appt today 1/13/21 at 5:45 pm to evaluate arm and discuss 2nd covid dose advisability.
Extreme migraine, pressure in the head. Blindingly painful. All other symptoms have pretty much cleared up but this migraine and pressure in the head is none stop. No treatment has been effective at relieving it. OTC medicine. Allergy medicine. Steam bath. Netti pot. Nothing.
Burning sensation, then tenderness, then moderate swelling (3-23-10)above and then below elbow (3-26-10) and then hot to the touch (3-25-10). Nurse strongly recommended that client visit clinic physician today or tomorrow and she stated that she would. Client stated that she did start to take Benadryl on 3/23/10.
Pounding heart rate, body aches, chest tightness, cold sweats and fever.
This spontaneous report has been received from a 69 year old female patient consumer referring to herself. The patient's concurrent conditions included diabetes mellitus. She did not have medical history, drug reactions/allergies or concomitant medications. On 03-AUG-2014, the patient received 1 dose of ZOSTAVAX (strength, dose, route, lot #, expiration date or anatomical location were not reported) for prevention of shingles. Approximately in March 2015, the patient experienced shingles and the outbreak lasted for about 3-4 weeks until she recovered in an unspecified date in 2015. The second outbreak of shingles was around April 2016 and lasted for an unspecified amount of time until she recovered from it in an unspecified date in 2016. The third outbreak of shingles was around 04-AUG-2016; the patient developed shingles in her eye and then she had cataracts develop. Though the patient recovered from the shingles on an unspecified date in 2016, the patient still had cataracts to the time of reporting. She also had not been able to drive since then. The patient then developed shingles for a fourth time on an unknown date in December 2016 (reported as "around Christmas of 2016") and lasted for 3 months before she recovered from the shingles on approximately in March 2017. The last time the patient developed shingles was about in March 2017 (reported as a month ago) and she was still recovering. She talked with the physician and although no diagnostic laboratories were performed, the patient received treatment for the adverse events. No further adverse event information was provided. The causal relationship between all the events and the suspect therapy was not provided. Upon internal review the herpes zoster ophthalmic was considered a medically significant and a disability event. The cataracts were considered as a disability event. Additional information has been requested.
Vaccine 1: Side effects started 20 hours after vaccine, listed by length and severity - Lethargic:  4 days Nausea:  4 days Diarrhea: 4 days Headache:  3 days Chills: 3 days  Side effects started 20 hours after vaccine, listed by length and severity - Lethargic:  4 days Nausea:  4 days Diarrhea: 3 days Headache:  2 days Chills: 2 days
Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose; Sometimes it itches on the body; Like red spots; swollen; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose), PRURITUS (Sometimes it itches on the body), ERYTHEMA (Like red spots) and SWELLING (swollen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose), PRURITUS (Sometimes it itches on the body), ERYTHEMA (Like red spots) and SWELLING (swollen). At the time of the report, MENSTRUAL DISORDER (Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose) outcome was unknown and PRURITUS (Sometimes it itches on the body), ERYTHEMA (Like red spots) and SWELLING (swollen) had not resolved.            No concomitant medication information was provided. No treatment medication were provided. The  itches on the body, like red spots and was swollen and that sometimes it goes and come. The menstruation problems appeared after 15 days from the second dose.   This case was linked to MOD-2021-413408 (Patient Link).
Began to have increasing pain swelling and pain (R) deltoid - measured at 10 cm at urgent care. Was placed on antibiotics.
At day 6, developed a hive (about 7-8cm in diameter) at the vaccine site with some itching, redness, warmth. No systemic symptoms.
hot, itchy, swollen arm.  She received prednisone taper and Benadryl
40 yo F with a history of SAH presents with allergic reaction after receiving Moderna vaccine. Received vaccine ~8:30 AM and subsequently felt her "throat closing." She denies change in voice, diaphoresis, nausea, vomiting, dizziness, or difficulty breathing. She drank some water and had no issue swallowing. She stated her throat felt similar to how it feels when she has a viral infection. Given epinephrine and benadryl at 8:50 AM for symptoms.
Patient received two doses of the Pfizer COVID-19 Vaccine. Pt was offered the vaccine during his daughter's visit and was administered the vaccine. The paperwork was placed in the box for the covid vaccine clinic and the RN running the clinic was paged. After two patient identifiers were done and the patient was administered the   COVID vaccine, the patient stated he already got a vaccine today.
This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 23rd February 2019, the patient received the 1st dose of SHINGRIX. On 23rd February 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injection site rash. On an unknown date, the outcome of the injection site pain and injection site rash were unknown. It was unknown if the reporter considered the injection site pain and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The reporter was made aware of injection site pain from the patient previous night before the day of reporting. The patient had been experiencing pain and rash in the injected arm since receiving the vaccine. The reporter said they knew that this need to report and take all adverse events very seriously. The reporter would like to know if there was need of any additional information and she would be happy to share what they have.
I got covid. I only lost sense of smell and taste and my arm was weak for a day after. Other than that, I was okay
pt presented 6 days post immunization witk localized inflammation (red, round wheal approx 5 to 6 inches in diameter)at or near injection site - pt describes as "itchy and tingling" - pt saw their physician who prescribed antibiotic (unknown) and antihistime
Extreme pain in left arm, unable to lift arm for 1 week following injection. Visible bruise. Pain in shoulder still persists. Extreme fatigue/lethargy, unable to carry out daily responsibilities for 4 days following injection. Fatigue/lethargy persisted up to 11 days following injection. Loss of taste and smell for 1 week following injection and still has not fully returned. Debilitating headache for 3 days following injection.  Diarrhea for 4 days following injection. Overall sense of feeling poorly for 1 week following injection.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about October 2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about an unknown date later in 2013, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Approx 4-5 hrs after vaccination, developed dry cough, wheezing, nasal congestion, left arm soreness, overall fatigue
The patient was noted to have "red circular spots" on the left arm, darkened scab area on the left upper arm, and "circle-like red spots" in the abdominal area. No pain or itching was reported. No respiratory distress was noted or reported." Maculopapular rash concentrated on the trunk (abd/chest/back) with a few scattered similar lesions on Bilat UE. LUE with 1 solitary lesion that appears larger excoriated with central dark scab & Minimal surrounding erythema.
2/16/12 received PCV13, PENTACEL (DTaP, Hib, IPV), ROTATEQ and vomited right away-large amounts. 4/9/12 received PCV13, PENTACEL, ROTATEQ and vomited within 24 hours of immunes.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 4:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 37.08.  Concomitant products were not provided.  On 11-Jan-2021, Excursion time was 10 AM temperature was 33 total doses given for the day was 201, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 29-Apr-2021. 5 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 36, 10 AM: 33, 11 AM: 44, 12 AM: 45, 1PM: 45, 2 PM: 44, 3 PM: 45, 4 PM: 44.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
headache; tired; fever; arm hurts; nauseous; diarrhea; This is a spontaneous report from a Pfizer-sponsored program  Support. A contactable Female consumer (patient) reported  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced headache, tired, fever, arm hurts, nauseous, diarrhea. Patient stated that after 1st dose, she experienced 5 days symptoms and after 2nd dose she experienced headache, feeling very tired, felt like having a fever, arm hurts, nauseous, severe diarrhea. It was reported first dose, she experienced 5 days symptoms and after 2nd dose she experienced headache, feeling very tired, felt like having a fever, arm hurts, nauseous, severe diarrhea and she also mentioned that she took Advil. Therapeutic measures taken for events with Advil. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is from the ER on 9/20/2021: This is a new problem. The current episode started more than 2 days ago. The problem occurs daily. The problem has been gradually worsening. Associated symptoms include shortness of breath. Pertinent negatives include no abdominal pain. Associated symptoms comments: Generalized body aches ,  Chest congestion , cough after a recent second Covid shot a week ago . . The symptoms are aggravated by walking and exertion. Nothing relieves the symptoms. He has tried rest for the symptoms. The treatment provided no relief  He was treated with: ZPak, Medro Dose Pack, Albuterol HFA  Chest x ray done, along with negative Covid swab  9/23/2021 Patient was seen in clinic for no change in symptoms, he was treated with Zithromax 500 mg and put on Symbicort inhaler.  9/28/21 patient was again seen in clinic, symptoms slowly improving. chest x-ray redone along with EKG. no medication changes at that time, he was kept off of work for 2 more weeks
Received expired dose of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP gave 6 shots of vaccine on 05-OCT-2021 morning that expired on 01-OCT-2021. Initially that vial was stored in the refrigerator on 27Sep2021. Concomitant medications were not provided. Treatment information was not provided.
Eleven hours following the vaccination, I began feeling chills, then fever a short time later. I experienced body aches a few hours after this and a significant headache. Neither Advil nor Tylenol seemed to help much. The symptoms subsided after about 20 hours.
My son was experiencing stomach pain before he passed on 1/1 /2022 due to an enlarged heart. He had no other heart conditions prior to his passing
03/01/22 presents to ED for "diplopia". PMHx of "uveitis OU and uveitic glaucoma OU"
22yr old female with history of splenectomy (2012) post MVA presented to PCP for annual visit on 11/6. Patient was uncertain if PNEUMOVAX vaccine had been previously administered. MD ordered for Pneumococcal polysaccharide vaccine 23-valent greater than or equal to 2yo SQ/IM (PNEUMOVAX-23), Tuberculin PPD Test (Order 398485110), and Flu vaccine, age 6 mo, 0.5 mL dose, preservative free, IM (QUADRIVALENT). RMA prepared and administered the following: influenza vaccine (Lot # TM9Z5) IM to patient's right deltoid, tuberculin PPD 0.1mL intradermally to patient's left arm (LOT # C5474BA) and PNEUMOVAX vaccine (LOT # R018731) IM to patient's left deltoid. On 11/8, patient contacted office and complained that arm receiving PNEUMOVAX vaccine was "tender to touch with red raised areas noted/warmth near injection site. Pt has been taking tylenol for pain."  Patient seen MD 11/9 for follow up. MD noted "Erythematous, blotchy 2 x 3 cm area of erythema noted on right upper extremity proximal to injection site. Irregular borders". Patient denied fever, chills, drainage or burning. MD concerned for cellulitis who prescribed cephalexin 500mg PO Q6H. PPD read (negative) as well. Patient instructed to continue to take Tylenol or motrin as needed.
Patient received the Covid-19 vaccine. Pt was given his 2nd Pfizer vaccine on 6/6/2021 @ 0916 pt started to complain of itchy throat to RN at approx. 0923. Pharmacy gave RN dose of IM Benadryl 25mg for pt. RN administered Benadryl into Right  Deltoid @ 0933. Pt's vitals were O2: 97% HR: 78. Pt stated he felt better after IM Benadryl. RN left pt on continuous pulse ox. Pt was able to drink water without any issues and remained able to breathe and talk. No swelling on face or tongue. Pt's mom aware to notify his doctor. Pt is seen regularly by allergist per mom.
sore throat symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Jun2021 15:20 (Lot number: EW0183) at the age of 55 years as dose 2, single for covid-19 immunisation. Family history included: "Sciatic pain" (unspecified if ongoing); "upper lower back issue" (unspecified if ongoing); "lower and upper back issues" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Administration date: 09Jun2021, Administration time: 18:00, Anatomical site of injection: Left arm, Route of administration: intramuscular, Lot no: EW0182), administration date: 09Jun2021, when the patient was 55 years old, for COVID-19 immunisation, reaction(s): "pain". The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 14Jul2021, outcome "unknown", described as "sore throat symptoms". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
History of pain at injection site along with numbness/tingling with first dose. Doctor onsite approved to inject 2nd dose to thigh.
intense generalized itching, redness and heat within 10 minutes of receiving vaccine booster dose.  Started with lip itch and progressed. Unsure if it would have been actual hives as I was given 50mg Benadryl by the nurse
Day after Hep A and flu shot received got erythema at the shot site, day after complained that he couldn't walk and eyes were dilated. Taken to ER, diagnosed with inner ear infection and vertigo. Mom comes back look at child and for her was flu like symptoms.
About one week ago he began to experience progressive shortness of breath, dyspnea and cough.  He tested positive for COVID-19 as an outpatient at that time.  He has been checking his O2 sat at home and noted decreased O2 saturations.  He called EMS and was found to be hypoxic in the field into the mid 80's.  He has improved with O2 via nasal canula and has radiographic findings consistent with COVID-19 pneumonia.
Dizzy; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single, for COVID-19 immunization. The patient's medical history included vertigo (in the past, before her COVID-19 vaccination). The patient's concomitant medications were not reported. On an unspecified date, the patient felt dizzy after her second dose of Pfizer-BioNTech COVID-19 vaccine. The patient asked for treatment recommendations using vertigo medicine and paracetamol (TYLENOL). The event was considered non-serious. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Per patient, she still is experiencing pain from injection site starting at right deltoid down right arm to hand. She has not seen a doctor regarding this.
parents noticed small redened area @ inj site;mom questioned pt allergic to band-aid adhesive(as pt is);pt refused to remove band-aid until 4 days p/inj;mom reports area now size of a lemon (circumference), sl warm to touch & blotchy hives;
Patient received first dose Pfizer at vaccination clinic on 5/11/21.  After dose administered, it was discovered patient had already received 2 doses of Moderna COVID vaccine on 3/2/21 and 3/30/21.  This was an unintentional duplication of therapy.  Patient stable post-vaccination, advised her that she may experience typical post-vaccination side effects after the additional dose.