chrisvoncsefalvay/vaers-outcomes huggingface dataset:
meningitis; pneumonia; cardiovascular event; congestive heart failure; postherpetic neuralgia; multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or about 27-JUL-2016, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date after the vaccination, the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, meningitis, pneumonia, cardiovascular event and congestive heart failure. As a result of these symptoms, patient was seen and treated by medical providers and was still under their care. As a result of vaccine live(ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient also had incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of above events was considered as not recovered. The reporter considered the events to be disable and related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, meningitis, pneumonia and congestive heart failure were determined to be medically significant.
Massive swelling, from the shoulder to just above elbow. Extreme heat and hardness in the area.
Patient reported left arm sore and achy, some tingling to fingers. Patient monitored for 30 minutes. Tingling resolved at end of 30 mins, arms remains with achiness.
This spontaneous report as received from a registered nurse refers to a 67 year old female patient. In 2009, the patient was vaccinated with ZOSTAVAX dose 1 (dose, route, anatomical location, lot #, expiration date were not reported). On 31-DEC-2014, the patient was subcutaneously vaccinated with ZOSTAVAX lot # K015308 dose 2, 0.65 ml, in the right deltoid. No adverse effects reported. Additional information has been requested.
1O:35AM CHILD GIVEN VACCINES; IPOL,HEPA,DTAP. 10:40AM COUGH AND SOB,10:45 GIVEN CLARITEN 10mg, SX PROGRESSED TO WHEEZING 10:50 NEB TREATMENT WITH XOPONEX 0.63AND PULMICORT 0.5mg. IMPROVED WITH TREATMENT. OBSERVED UNTIL 11:30 WHEN CLEARED TO LEAVE FOR HOME WITH RX P=ORAPRED 30mg DAILY FOR THREE DAYS AND NEB TREATMENTS PRN.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 19-MAY-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, 0.5 ml lot # L026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt had no obvious reaction to the vaccine. 10/23/09 Death certificate received. DOD 9/20/09. Cardiogenic shock, Hypoxic encephalopathy. Ventricular fibrillation.   11/17/09:  Discharge Summary and Medical Records received for date of service 9/20/09:  Final Dx:  Out of hospital cardiac arrest, ventricular fibrillation, cardiogenic shock, severe hypoxic encephalopathy, respiratory failure.  Assessment:  Experienced sudden onset severe chest pain at home.  Ambulance arrived and found pt. in ventricular fibrillation.  Received 2 shocks en route to hospital and upon arrival was intubated with additional CPR and defibrillations.  Major vasopressors were administered for support of blood pressure.  CPK was 3000.  Admitted to ICU and maintained on maximal support for 12 hours including ventilation, temporary pacemaker and major vasorpressors at high doses.  No urinary output.  Pupils fixed and unresponsive.  Pt. eventually experienced cardiac arrest and died after DNR was signed.
Redness noted on bilateral legs next AM (about 12-16 hrs after vaccines). Flared worse 1 PM later left much greater than right. Continued to expand on left side despite Keflex; improving after 24 hours on Bactrim (area red/hot/sl. tender but not indurated)
Covid19 breakthrough. 1st vaccine received on 01/22/2021. 75 y/o PMH of DM, MI, COPD presents to ED via EMS with c/o cough, SOB, CP, Sore throat, and burning with urination x3 days. CT Chest-Covid PNA, Rm air sat 97%, afebrile.  Treated with steroids.
Patient felt greater than usual pain at injection site immediately after injection.  Pain continued for 2 days, but upon waking and taking a shower on the morning of the 2nd day she noticed a swelling along her clavicle, not at the injection site.  She went to urgent care and they told her it was probably a swollen lymph node.  They gave her a shot of a pain killer and told her to take otc anti-inflammatories when the pain killer wore off.  They told her this may have been the result of a vaccine administered too high.  She did not mention if they said it may also simply have been a side effect of the vaccine.   She  said the shot had decreased the pain, but the swelling has not completely subsided.
Sore throat 3am after injection in prior mid-afternoon; and Swollen lymph nodes noticed 9am after injection in prior mid-afternoon
This spontaneous report was received from a pharmacist referring to patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX, 0.65ml subcutaneously, (lot # L015417, expiry date 16-AUG-2016 (also reported as 21-SEP-2016). No adverse effects were reported. The outcome of expired product administered and no adverse event was unknown. Additional information is expected.
I experienced heel pain and then a swollen bruise on the side of my left leg, which radiated heat. I had internal thigh pain and left side groin pain. I made a doctor's appointment. There was a concern that it may be a blood clot. I had an ultrasound and took blood tests. I was diagnosed with having an inflamed vein called phlebitis. Since the diagnosis, I've been experiencing severe uneasy bruising. Pain in the leg has subsided, but I am still dealing with some bruising.
Extreme muscle aches, sore throat, extreme fatigue, mild fever, starting about 30 hours after the shot and continuing still
tinnitus; Exactly 2 weeks after my second shot, I lost hearing in my left ear; A few days later when I went to the ENT, he diagnosed me with sudden sensorineutral hearing loss (SSHL); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 2, single (Lot number: 30155BA) at the age of 26 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FH8020), administration date: 11Nov2021, for COVID-19 immunization. The following information was reported: DEAFNESS NEUROSENSORY (disability, medically significant) with onset 25Nov2021, outcome "recovering", described as "A few days later when I went to the ENT, he diagnosed me with sudden sensorineutral hearing loss (SSHL)"; DEAFNESS (disability, medically significant) with onset 25Nov2021, outcome "recovering", described as "Exactly 2 weeks after my second shot, I lost hearing in my left ear"; TINNITUS (non-serious), outcome "unknown". The events "exactly 2 weeks after my second shot, i lost hearing in my left ear" and "a few days later when i went to the ent, he diagnosed me with sudden sensorineutral hearing loss (sshl)" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: If covid tested post vaccination- Yes. Therapeutic measures were taken as a result of deafness, deafness neurosensory. Clinical source:Thankfully, steroids helped me regain some of my hearing. However, it is not perfect and now I have tinnitus.Doctor or other healthcare professional officeclinic visit, Emergency roomdepartment or urgent care, Disability or permanent damage.Patient oose not had covid prior vaccination and covid tested post vaccination.  Follow-Up (24Jun2022): Follow-up attempts are completed. No further information is expected.
Legs are stiff; Health dropped; After second dose patient was 2 days sick; Around 2 weeks later, patient's legs started getting real hard, stiff and hurting; Hard to walk and going up the stairs was impossible; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (After second dose patient was 2 days sick), PAIN IN EXTREMITY (Around 2 weeks later, patient's legs started getting real hard, stiff and hurting), GAIT DISTURBANCE (Hard to walk and going up the stairs was impossible), MUSCULOSKELETAL STIFFNESS (Legs are stiff) and GENERAL PHYSICAL HEALTH DETERIORATION (Health dropped) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (naturally recovered).    On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ILLNESS (After second dose patient was 2 days sick), PAIN IN EXTREMITY (Around 2 weeks later, patient's legs started getting real hard, stiff and hurting), GAIT DISTURBANCE (Hard to walk and going up the stairs was impossible) and GENERAL PHYSICAL HEALTH DETERIORATION (Health dropped). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Legs are stiff). At the time of the report, ILLNESS (After second dose patient was 2 days sick), PAIN IN EXTREMITY (Around 2 weeks later, patient's legs started getting real hard, stiff and hurting), GAIT DISTURBANCE (Hard to walk and going up the stairs was impossible), MUSCULOSKELETAL STIFFNESS (Legs are stiff) and GENERAL PHYSICAL HEALTH DETERIORATION (Health dropped) outcome was unknown.            After second dose patient was 2 days sick. Around 2 weeks later, patient's legs started getting real hard, stiff and hurting. It was hard to walk and going up the stairs was impossible. The patient cannot walk. It was difficult and painful legs was stiff. Patient said it was not like that before Moderna vaccine. No concomitant and treatment medication were reported.   This case was linked to MOD-2021-407200 (Patient Link).
8/12 3:40 PM- vomited - (crying since receiving vaccines). 3:45 PM- redness around mouth. 3:50 PM- breathing S.O.B. 4:40 PM- lips swollen. 7:15 PM- vomited11:30 PM- Vomited. 2:30 AM- Vomited. Mother gave BENADRYL. 8/13/09 morning - Swelling gone; lips hot red. No S.O.B. -No appetite. 2:30 PM -still refuses bottle/food taking a nap.
This spontaneous report as received from a registered nurse refers to a 18 year old patient of unknown gender. On 27-JUN-2013 the patient was vaccinated with the first dose of GARDASIL injection (strength, route, lot number and expiration date not provided). On 29-OCT-2013 the patient was vaccinated with the second dose of GARDASIL injection (strength, route, lot number and expiration date not provided). On 27-DEC-2013 the patient was vaccinated with the third dose of GARDASIL injection (strength, route, lot number and expiration date not provided). No adverse event was reported. Additional information has been requested.
run a fever of 107F; He also had aches all over; He just feels horrible; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02Jun2021 17:30 (at the age of 13 years old) (Lot Number: EW0217) as single dose for covid-19 immunisation. Medical history included had gotten Covid twice this year; He had allergies to food, dog dander, and fish; Asthma. He had them for years. He had an asthma medication, Qvar. He was an allergy kid and had an epi pen. Concomitant medications included epinephrine (EPIPEN 2-PAK); beclometasone dipropionate (QVAR) ongoing for asthma (They just changed his medication about a year ago. She (mother) didn't know where it was to give a dosage). No vaccines administered on same date with the Pfizer vaccine considered as suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No Family Medical History Relevant to AE(s). The patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine yesterday, 02Jun2021. Today (03Jun2021) he started to run a fever of 107F and was given Tylenol and went down to 100.3F. He also had aches all over. Caller was asking how high was the normal fever, what can she give to her son and how long would the AE last. He was running a fever and had aches all over. This was his first dose of the Covid vaccine. She asked if that was normal and how high his temperature should go. Aches all over was reported as worsened. The mother called and said he was running a fever. Her daughter just gave him Tylenol and he still had a fever of 100.3. It was a little bit higher. It was like 100.7 and came down to 100.3 (03Jun2021). He just feels horrible. It was Extra Strength Tylenol, lot: SMC200, expiration date: Jun2022. The aches started this morning. The events did not require a visit to Emergency Room and Physician Office. The outcome of the events was not recovered.
I suspect that I caught COVID-19 at my office. We had a meeting in the conference room on Monday April 4th and 7 of my colleges got sick as well with confirmed COVID-19. On Friday the 8th I started feeling bad, I woke up with 102.5 fever in the morning, took a rapid test which was positive, scheduled an appointment with my doctor he ordered PCR test that came back positive. I had fever for 10 days, headache, mild coughing, extreme fatigue and easily winded. I only started to feel better yesterday April 20th, still feeling fatigued. Tested negative on Tuesday. My GP checked my oxygen and he said it was fine and he prescribed medicine for me to take which was Flovent inhaler, Aspirin daily, Zinc Sulfate, Vitamin C & D and also Fluvoxamine.
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. On an unknown date in 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, 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 condition of herpes zoster. On an unknown date later in 2014, the patient was treated by the physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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.
Experienced fever (99.6 degrees F); malaise; skin sensitivity; Dose number=5; Dose number=5; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 59 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 30Sep2022 as dose 1, single (Batch/Lot number: unknown), in right arm. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing), notes: Other medical history: Hypothyroid and hypercholesterolemia, both controlled on medication; "hypercholesterolemia" (unspecified if ongoing), notes: Other medical history: Hypothyroid and hypercholesterolemia, both controlled on medication; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medication(s) included: ATORVASTATIN; LEVOTHYROXINE; CALCIUM; VITAMIN D [COLECALCIFEROL]; COSAMIN. Past drug history included: Known allergies: aspirin, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Dose number: 4 (Booster), unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose number: 3 (Booster), unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose number: 2, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose number: 1, unknown manufacturer), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 30Sep2022, outcome "unknown" and all described as "Dose number=5"; PYREXIA (non-serious) with onset 01Oct2022, outcome "recovered" (Oct2022), described as "Experienced fever (99.6 degrees F)"; MALAISE (non-serious) with onset 01Oct2022, outcome "recovered" (Oct2022); HYPERAESTHESIA (non-serious) with onset 01Oct2022, outcome "recovered" (Oct2022), described as "skin sensitivity". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, malaise, hyperaesthesia.  Additional information: The reporter was reported case as non-serious. No other vaccine in four weeks. No treatment received for AE. Covid tested prior vaccination. No Covid tested post vaccination. Device stamp date was 01Oct2022.
Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 9:23 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 9:02 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    administered on 02-Mar-2021 and 54.02 for dose administered on 30-Mar-2021.  No concomitant medications were reported.   Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature at 9 AM: 27 Fahrenheit. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021.  Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit from 09:00 AM . This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a  traceable temperature monitor at every hour.  No treatment medications were reported.
pt had a fever & a high pitched scream while was screaming, back stiffened out really hard; then would catch breath while relaxing & then scream & stiffen; lasted 6-8 hrs;
I had first had symptoms on January 25th of 2023. I had a headache at first, the next day I felt body ache, nasal congestion and cough. I was away, I went to a clinic for testing COVID-19 on January 27th I tested positive.  Tylenol and keeping down liquids helped me I needed no other medications.