chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 24-AUG-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date later in 2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, 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. Additional information has been requested.
Local swelling, induration and erythema of RLE at vaccine site. Limited use of same extremity.
This is not an adverse event, the pt has parotitis/probable mumps. Mumps reported to the health dept.
The pt developed a generalized erythema multiforme 1 day post vax. Treated with Benadryl and Pediapred, and Atarax.
Respiratory symptoms - Burning pain when inhaling in lower trachea and upper chest.  Feeling of weight on upper chest.  Breathing was not obstructed.  Chills but not fever, hypothermia (97.1 F), body aches,  dizziness, spots and floaters in vision, tiredness, slight nausea.  Note this related find from internet research: A team of researchers have found that exposure to the SARS-CoV-2 spike protein alone was enough to induce COVID-19-like symptoms, including severe inflammation of the lungs. https://medicalxpress.com/news/2021-04-sars-cov-spike-protein-lung.html Messenger RNA vaccines work by instructing cells to create "spike proteins." These proteins simulate part of the SARS-CoV-2 cell structure and trick the body into believing it's infected with the virus.
Received vaccine at approximately 0930 during school vaccination clinic. Stated headache, nausea, dizziness started after eating lunch. Teacher assistant notified mom. Student's temp was 98.5. No vomiting. Denied SOB, scratchy throat, itching, feeling of edema to tongue or throat, no difficulty breathing. Mom took student home. At 1400, spoke with mom. Student resting in bed, no rash, no changes in above symptoms.
Information has been received from a physician, via a company representative, concerning a 15 year old female patient, who on 28-JUN-2007 was vaccinated IM, with the first dose of Gardasil (Lot #657737/0522U). Concomitant therapy included DTaP and Menactra. On 28-JUN-2007, after the vaccination with Gardasil, the patient "experienced syncope." The physician indicated she "recovered after approximately 1 minute. The patient sought unspecified medical attention. Additional information has been requested.
Client presented for first dose of Moderna Vaccine.  He was given a "booster" dose amount (0.25 ml).  Client was still present when error was discovered and he was immediately given a second 0.25 ml dose.
Patient presented to the pharmacy on4/6/2021 showing older rash/hives on forearms and stated they began to appear the day after his first Covid Vaccine on his arms, trunk, inner thighs and the worst is on his back. He stated the inner thigh hives were starting to become irritated from rubbing.   He administered Cortisone -10 over the counter and it had provided no relief.  He had contacted Urgent Care and was told it was normal, but the pharmacist after seeing the patient urged him to go into the Urgent Care and present as he said it is not getting better but becoming worse.  He stated he has had no trouble breathing.
Headache, Myalgia, injection site pain, chills, lymphadenopathy Narrative:
On 2/28/2019 administering RN received call from employee. Reported client was seen by FNP for vaccination reaction. Administering RN and second immunization RN travelled to facility to inspect  reported vaccine reaction. Day 1 client received 1 dose of Tdap in right deltoid on 2/21/2019 . Reports soreness at injection site on day 1  of vaccination. Client reports soreness and redness at injection site day 2. Client states at day 3 site was normal, no signs or symptoms of reaction. Client states at day 7,  2/27/2019 had symptoms of redness, swelling and hardness at injection site which extended from injection site approximately 4 inches down arm. Client was taken to FNP for evaluation. FNP reported that the signs and symptoms at injection site appeared to be cellulitis. Client was prescribed antibiotics for presumed cellulitis. Reporting RN viewed injection site, signs as described. redness, swelling starting at injection site and extending down arm approximately 4 inches. Client reports currently taking antibiotics for symptoms.
pulled 19 dose out of the Moderna vial and administered to different patients; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (pulled 19 dose out of the Moderna vial and administered to different patients) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced UNDERDOSE (pulled 19 dose out of the Moderna vial and administered to different patients). On 24-Nov-2021, UNDERDOSE (pulled 19 dose out of the Moderna vial and administered to different patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Event verbatim was updated On 30-Nov-2021: The recent follow up contains significant information due to adverse event(s) did not occurred after the vaccine was administered.
Resident received a third dose of vaccine in error.  Facility requested vaccination for this resident on 2/16/2021.  There was an error in the screening prior to vaccination and patient received a third dose of the covid vaccine.  He had received 2 doses previously(21 days apart) in January 2021  and did not need a third dose.   Resident did not experience any adverse events after vaccination and after speaking to his nurse 2/20/2021 he has been feeling well.
This morning my sugar was 550; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (This morning my sugar was 550) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN for Type 1 diabetes mellitus.   On 28-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced BLOOD GLUCOSE INCREASED (This morning my sugar was 550). At the time of the report, BLOOD GLUCOSE INCREASED (This morning my sugar was 550) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Blood glucose: 550 (High) morning and 300 (High) after insulin.         Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28 JUNE 2021, updated the outcome of the event.
Vx exposed to 24.9°F and administered; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.  Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received Boostrix, Boostrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Menveo, Engerix B, Engerix B Pre-Filled Syringe Device and DTaP vaccine. On an unknown date, unknown after receiving Boostrix, Boostrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Menveo, Engerix B, Engerix B Pre-Filled Syringe Device and DTaP vaccine, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-DEC-2022 Reporters comment: The nurse reported that Boostrix, Kinrix, Pediarix, Menveo, Engerix-B were exposed to 24.9 degree F and administered to patients. This excursion was initially called in on 27th June 2022, but the health care professional did not reported/mentioned that the vaccines were administered as no adverse event report could be found.  She also stated that a Dtap vaccine was listed as an administered vaccine but it did not verify as a GSK vaccine by the lot number provided. The health care professional had it under GSK vaccines when she initially called about the temperature excursion. she was not able to verify the lot numbers for the vaccines administered as health care professional stated that this happened before she got there. She did not have patient information or dates of admin and declines follow up. Additional Supportive information:The nurse reported that Boostrix, Kinrix, Pediarix, Menveo, Engerix-B and Dtap vaccine were exposed to 24.Degree F and administered to patients, which led to incorrect storage of drug.
Soreness at injection site (did not have this symptom with the first two Moderna injections), low grade temperature, chills then feeling hot then back to chills.  Body aches similar to the flu.  Slept  more then usual during the day & afternoon.   Symptom lasted 24 hours.
Estimated date of delivery is 06/07/2023. 11/9/2022 I started having low back pain which I assumed was part of being pregnant. It steadily got worse and continued for several weeks. On 11/16/2022 I had a urinalysis and was diagnosed with urinary tract infection with suspected kidney involvement. I was prescribed fosfomycin on 11/30/22. It got better after taking the fosfomycin. I have recovered.
Fever, fatigue,headache,stomach pain, muscle pain and weakness.  Starting to feel better today but not completely recovered.
BP:160/91 (04/05/2004 08:19)T:96 F [35.6 C] (04/05/2004 08:19)  P:89 (04/05/2004 08:19) R:16 (04/05/2004 08:19) Allergies:   nkda Have you ever received a Pneumovax?        Yes__x_ date received: today Comments: P:  Routine check-up.  H/O DM.  C/O swelling in feet.  C/O cough x 4-5 weeks with wheezing.  Wife states he snores and he wants this evaluated. Checks BS every am, usually 120 or less. CLINICAL REMINDER ACTIVITY Pneumovax: Patient received pneumo-vac at this encounter.      Site: left deltoid ................................................ Temp:   96 F [35.6 C] (04/05/2004 08:19)Pulse:  89 (04/05/2004 08:19) B.P.: 157/85 (04/05/2004 08:28)Resp. 16 (04/05/2004 08:19)Chief Complaint: Leg swellings Lt >Rt x 3 months. patient came to the CPC and was given Pneumonia vaccine. Pt made this appt B/O B/L leg swelling x 3 months and improved with some " water pill" he got outside.  Wanted to D/W his PCP and came to the clinic. He also has wheezing and snoring and the wife think that the patient has sleep apnea. No HA,N,V. No SOB,CP. Occ cough. No palpitation. No Abd pain; No urinary symptoms; Normal BM's. No fever. Patient has no symtoms except for chronic leg swelling; No leg pain/ redness. No hemoptysis.  patient was found to have Atrial Fibrilation on  EKG and resolved without any intervension when he arrived to telemetry floor. Remain in sinus.
10:00 pm- chills, nausea started 10:30 pm- fever of 104.4 with delirium  Also, experienced involuntary muscle spasms/contractions in my chest, abdominal muscles, and legs.  2:00 pm on 10/2- fever 102, muscle aches, fatigue, general malaise
The 2nd booster made me sicker than a dog.; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (The 2nd booster made me sicker than a dog.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Brain inflammation: 325mg for aspirin (325mg for aspirin). Past adverse reactions to the above products included No adverse event with 325mg for aspirin. Concurrent medical conditions included Immunocompromised and Brain inflammation (on 325mg for aspirin.).   On an unknown date, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (The 2nd booster made me sicker than a dog.). At the time of the report, ILLNESS (The 2nd booster made me sicker than a dog.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was stated that patient was on steroids. Patient was not taking steroids anymore. Patient hadn't taken steroids for 3 weeks. Patient denies side effects from all doses of Moderna vaccines except 2nd booster. No treatment medication was reported.   Reporter did not allow further contact
I am a nursing mother and nursed my 11 month old son on his typical schedule of 3 times per day.  On Friday night, he developed a slight fever.  He was showing no other symptoms so we treated it and went on with the weekend.  Saturday his fever increased to 105.  We took him to the ER.  He showed no other symptoms and the doctor could not come up with reason why he would have such a high fever.  It continued throughout the weekend - highest in the evening.  Sunday night he was back to 105.  We called the nurse line but since he had no other symptoms, we scheduled an appointment for Monday with his doctor.  He still had his fever, no other symptoms.  He was screened and his doctor found no sign of illness.  He was tested for strep and it was negative.  His fever went away Tuesday.
Could not move her arm for 2 weeks,Loss of range of motion; received vaccine in her sub deltoid bursa instead of her upper deltoid; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Could not move her arm for 2 weeks,Loss of range of motion) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received vaccine in her sub deltoid bursa instead of her upper deltoid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOKINESIA (Could not move her arm for 2 weeks,Loss of range of motion) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received vaccine in her sub deltoid bursa instead of her upper deltoid). At the time of the report, HYPOKINESIA (Could not move her arm for 2 weeks,Loss of range of motion) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received vaccine in her sub deltoid bursa instead of her upper deltoid) outcome was unknown. Not Provided          For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It as reported that patient had a MRI scan, nerve study and receiving physical therapy.  No Concomitant medication was reported. No Treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-Up was received on 22-Jun-2021 contain Non-Significant information (Reporter contact conformation was updated)
Narrative: 91 yr pt received second Moderna booster on 4/7/22 (1st booster was 10.29.2021); called telephone triage 4 days later to report widespread body itching, body aches, and loss of taste. Evidence of rash/bumps. Patient started applying lubriderm which helped and able to sleep at night. Telephone triage provided additional care instructions including continuation of lubriderm and may consider taking an anti-histamine such as benadryl if needed and see provider within 3 days.
pt recv vax 11DEC95 & 10FEB98 pt exp a breakthrough varicella approx 25 vesicular lesions;pt was seen by MD on 11FEB98 w/lesions on chest, face, extremities, abd & back;no fever was noted;
Fertility issues, tilted uterus, hemorrhoids, cysts on ovaries, mental health issues, anxiety, depression, suicide attempts, mental health issues for offspring.
-pain in left arm  -dizziness starting on 4/10/21 to current date
Seen at this office on 9/9/10 for well child exam. Review of systems neg at that time but history of diarrhea for 1-2 days. Later in the afternoon child had fever. Seizure at home lasting around 5 minutes. Temp 101. Taken to ER where diagnosis of febrile seizure made. Child treated with ibuprofen and discharged. Seen at this office 9/10/10 at 3:30PM for continued fever. Diarrhea continues. ROS negative except diarrhea. DX: viral illness.
had pain in my left arm; The pain feels like a knife in my shoulder joint; arm muscle is painful; arm muscle is painful at night and keeps me awake.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Bladder leakage" (unspecified if ongoing), notes: Bladder leakage; "Known allergies: IVP dye" (unspecified if ongoing), notes: Known allergies: IVP dye. The patient's concomitant medications were not reported. Past drug history included: Known allergies: doxycycline, reaction(s): "Known allergies: doxycycline". Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 27Jun2022 at 11:00, outcome "not recovered", described as "The pain feels like a knife in my shoulder joint"; MYALGIA (non-serious) with onset 27Jun2022 at 11:00, outcome "not recovered", described as "arm muscle is painful"; INSOMNIA (non-serious) with onset 27Jun2022 at 11:00, outcome "not recovered", described as "arm muscle is painful at night and keeps me awake."; PAIN IN EXTREMITY (non-serious) with onset 27Jun2022 at 11:00, outcome "not recovered", described as "had pain in my left arm". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, myalgia, insomnia. Additional information: The patient did not have COVID prior to vaccination and not tested for COVID post vaccination. The patient received her 4th COVID vaccine dose (Pfizer) on 04Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About 10 minutes after receiving vaccine,  pt reports chill/flush feeling in the neck/chest to groin.  Patient able to walk and skin flushed. Pulse at 60 and does have history of Arrhythmia.  Shortly after breathing slows and appears to be hyperventilating. Blood pressure reading of 141/101 with pulse of 96. EMS is called. Few minutes later BP of 135/86 with pulse of 102. Before EMS arrives last BP of 122/93 with pulse of 101 with hands numb, white, and tingling.  At 4;17 EMS arrives and pt walked to stretcher. At 7;45 PM, I called to check on pt. She reported another episode at ER but had been discharged and was currently in our parking lot retrieving car
Redness, swelling and pain 1 day after vaccination. She was treated with cephalexin for possible cellulitis.
fever 39.5, myalgias, arthralgias, wheezing; tx APAP, rest, albuterol treatment (inhalers); all outpatient tx;
My cycle did not come for 3 months it was suppose to come on the 23rd of August 2021 and it finally came back on the November 1, 2021.
Severe nausea and vomiting for several hours, then next day patient had a lot of pain in the arm with the injection.
Vaccine was given on 9/14/18 and 9/15/18 patient felt flu like symptoms mounting a response to the vaccine. Later on 9/15/18 the patient had local injection site reaction about the size of a quarter where injection was given. In addition, a rash started to develop on the patient's arm below the injection site and had undefined edges. On 9/16/18 the rash appeared to get worse. Patient reported to the pharmacy on 9/18/18 to have us look at the rash but said after 9/16/18 the rash did not progressively get worse. The rash on 9/18/18 was about the size of an orange starting an inch below the injection site with undefined edges. Patient reports no warmth on rash or fever. Recommended patient follow up with physician (he states will make an appointment). Patient instructed to visit ER if develops fever or if rash becomes warm.
Systemic: see additional comments-Medium, Additional Details: pt was given expired vial of moderna. vial was punctured may 30 2021 at 11am and was not disposed of before we closed.
Information has been received from a nurse practitioner concerning an approximately 16 year old female who was seen in a clinic for a migraine, and subsequently, was vaccinated IM with the first dose of GARDASIL. It was reported that the patient developed seizures within 15-20 minutes of vaccination. The clinic called 911, and the nurse practitioner "believed" the patient was taken to the emergency room, although, it was unknown if the patient was hospitalized. It was also reported that the patient had no prior history of seizures, and that the patient's outcome was unknown. Upon internal review, the patient's seizure was considered to be an other important medical event. Additional information has been requested.