chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; Information has been received regarding a case in litigation from a lawyer and consumer, referring to a patient of unknown age and gender. Information about concurrent condition, historical condition and concomitant medication was unknown.   On or about 25-NOV-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency and route unknown) for the long-term prevention of shingles and/or zoster-related conditions, by a healthcare provider.   On an unknown date, the patient was treated for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of event was considered as not recovered/not resolved. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Started with runny nose and a cough initially. I started to get a headache and sensitivity to light. Photophobia. Just overall weakness. I took an at home COVID-19 test after the second day of symptoms and that was positive. I then called the doctor's office and talked with a nurse. They prescribed Paxlovid over the phone. They phoned the prescription over to the pharmacy and my wife picked that up. I started the 5 day regimen and my symptoms improved significantly over 24 hours. I finished the course of Paxlovid and I basically just had a cough after that. That has persisted on and off to this day.
pt with dizziness and painful left arm, redness to nose and face. Benadryl 50 mg given
12h - 17h after injection: arm pain, headache,nausea, chill, back pain. fever to 101.8F. Take 2 tablets of Tylenol. Body temperature decreases to normal. 24h after injection: back pain. Headache.chill. nausea, fever again. 100.7 F. Take 2 tablets of Tylenol. Body temperature decreases to normal during sleep. 34h after injection: back pain. nausea, headache. Fever again. 100.5F. Take 1 tablet of Tylenol.  48h - 72 h. Normal temperature (below 100 F). Strong headache with vomiting. Vomited for several times. Fatigue.
No additional AEs or PQC reported.; Caller reported VARIVAX administered after temperature excursion.; This spontaneous information has been received from an administrator, concerning a male patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.    On 16-MAY-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection at dose of 0.5 milliliter (ml) subcutaneously (SQ), with lot number U022321 and expiration date 15-JUL-2023, for prophylaxis (vaccination scheme frequency and anatomical location was not provided). This administration was performed after a temperature excursion (product storage error), with a temperature of 6 degrees Fahrenheit (F), time frame 30 minutes; it was reported that there was no previous temperature excursion. No adverse events were reported.
Rotavirus is not to be started after 12 wks of age this pt. is 6 mons old.
Dizziness, Mild Hypertension (167/94), mild chest tightness, and flushing. Persisted for almost 3 hours, monitored BP levels and administered 12.5mg liquid diphenhydramine for allergic prophylaxis pre-BP monitoring. Had patient rest for duration, released after problem abated.
Patient told pharmacist he has habit of passing out when giving blood or getting shots.  He was nervous.  He did well getting shot, set in room for 5 min., then moved him to waiting room where I asked him to stay 15-20 more min. Over a few min he looked very pale, we offered him water. (he barely sipped any). after 5 min he started sweating. He did not call for help, but technician on duty saw him put his head in his lap. We both went out to tend to him. While we were talking to him, he passed out. We called 911. While giving vitals and info to 911, he came to before they got on scene.  While paramedics were assessing him, after about 5-10 more min...he passed out again. This time when he came to, seconds later...he projectile vomited on the paramedics.  They tended to him until about 1:15-1:30. PT refused their suggestion and urging to go with them to hospital. Paramedics left him in pharmacy to leave facility on his own will. Pt refused our suggestion to call someone to come pick him up and not drive.  After sitting outside to get some fresh air, PT came through our drive thru to tell us he was much better and leaving Store. We told him we would call and check on him 5/17/2021. We have called now 2 days (5/17/ and 5/18) and can not get him to return our call.
Red, swollen arm. Hot to the touch. Knot under the skin of the injection site.
arm soreness Narrative:  Moderna COVID-19 Vaccine EUA This patient experienced  an administration error in which the second dose of the vaccine was given one week earlier than due
Within 48 hours felt like I had COVID again, headache, body aches, fever, cough, congestion, chills, loss smell and taste for 12 hours, nausea, sore throat. By day 11 I was in the ED with diverticulitis
When I had the vaccine I was starting my cycle and pretty abruptly just stopped so in the month of January I did not run my cycle it just petered out and in February my cycle was shorter or came earlier and the duration was actually longer and I was bleeding so heavily I considered going to the ER.  I had clots during this mensuration that I had never had before and the volume and clots were very distressing,  in the subsequent months through October they continued to come early and a lot more bleeding than I ever had before in my past thirty years of mensuration. I also had periodic leg pain not like thrombosis but pain. In 11/01/2022 my doctor said we could continue to monitor and/or test for uterine cancer. On my two month follow up my cycle has adjusted to slowly getting more normal but still weird.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "htn" (unspecified if ongoing); "kidney dz" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: LISINOPRIL; HCTZ; SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and covid 19 cannot be ruled out.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan2022) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022 at 12:13 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022 at 12:13 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   This case was linked to MOD-2022-542869 (Patient Link).
felt colder than usual; left injection site arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (felt colder than usual) and VACCINATION SITE PAIN (left injection site arm was sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced FEELING COLD (felt colder than usual) and VACCINATION SITE PAIN (left injection site arm was sore). On 28-Jan-2021, FEELING COLD (felt colder than usual) and VACCINATION SITE PAIN (left injection site arm was sore) outcome was unknown.      No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.   This case was linked to MOD-2021-288144 (Patient Link).
Information has been received from a consumer concerning to his 74 years old wife with osteopenia and cholesterol who on 10-JUL-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included generic alendronate sodium (manufacturer unknown) and lovastatin (manufacturer unknown). On 21-JUL-2008, the patient experienced excruciating, terrible head pain and sores from the nape of her heck to the crown of her head, on 1 side. The sores were "small, pink and rounded." The consumer and patient suspected it was shingles. Physician prescribed VALTREX. The patient went to the ER on Wednesday 30-JUL-2008. The patient sought medical attention at the emergency room. Additional information is not expected.
arm pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 4th September 2019, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The patient received 1st dose of Shingrix on an unknwon arm. The patient had arm pain at injection site. This case has been linked with case US2020033088, reported by the same reporter.
No additional AE details provided. No additional AE; Nurse calling for evaluation on frozen products mentions 2 doses of PROQUAD were administered to 2 patients. See additional AE case 02230619 for additional patient.    ?    Names of vaccines involved (including lot/exp) PROQUAD  U039261  6/9/202; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On 19-AUG-2022, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) reconstituted with a sterile diluent for prophylaxis, lot # U039261 and expiration date on 09-JUN-2023 (strength, dose number, anatomical location and route of administration were not reported).   It was reported that the vaccine underwent a temperature excursion of 14°F up to 46°F (21F) during a time frame of 1 hour 28 minutes 0 seconds. Previous temperature excursion was not occurred. No adverse event was reported.  This is one of 2 reports from the same reporter.; Sender's Comments:  US-009507513-2208USA008611:
Patient received HPV & MCV4 vaccines on 27 July 2011. States he developed a rash on nose and forehead the next day. By 29 July 2011, rash had spread to many areas of face.
Minor soreness at injection site. Tingling from injection site to fingertips difficulty in grasping objects. Numbness along arm. Suggested use of APAP for pain, see Dr if needed. (Dr notified 12/21/12).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 16Sep2023 to 20Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Reported 01/09/04 about 30 days after influenza #1.  Mother claims child had complained of sore throat and cough 102 days after injection.  5 days after, red, multiple raised, scattered vesicular-blister like rash developed beginning on abdomen then moving to left arm.  3.5 weeks later, rash remains worse on left arm.  Mother claims she went to MD whom was unsure of rash or origin.  No complaints of itching, scratching, fever or pain, no swollen glands.
After first shot I got intermittent deep tissue numbing (not tingling) over the span of 5 days beginning about 12 hours after the injection on left side of body (injection on left arm. After the second shot (in right arm) I got tingling in right side of face about 30 min after injection. Effects weren?t bad until Sunday night when I began feeling ?odd?, deep tissue numbing in left arm, could feel my heart but didn?t feel like it was racing or pounding TOO hard, chest pains, loose stools, and when I took my BP it was high and rose to 188/??. It is usually 111/55ish. We called EMS and they gave aspirin, ekg showed PVCs (which is normal for me) and still high BP. At hospital still high. It seemed to have set off my orthostatic which usually drops but this time it was up and down. On Monday it was high 130s/80s to low 101/50s. And on Tuesday my HR kept dropping into 40s even when walking around. Wednesday I felt okay but started getting numbing late at night and just not feeling right.  It is Thursday morning and I still don?t feel right.
I had it for 2 months but I did get the 2 shots/suspected vaccination failure; the side affect was worst pain; had it for 2 months; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 18-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient get the 2 shots and had them for 2 months also but the side affect was worst pain. The patient ever had to deal with. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 27-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 06-FEB-2017, the patient was inadvertently vaccinated with a partial dose of ZOSTAVAX vial, subcutaneously, lot # M033336, expiration date 01-OCT-2017 (dose was not provided) which was diluted by sterile diluent (STERILE DILUENT) injection, once, subcutaneously (strength, dose, indication, lot# and expiration date were not reported), due to leakage from the needle connection to the syringe. No adverse effects were reported. Product quality complaint was not involved. Additional information is not expected, as there was no consent to contact the reporter.
Rash started 1 week after injection.  Went away in 4 days and came back today.
~18 hours of intermittent chills, fever as high as 102.5 degrees, very low energy, aches, difficulty sleeping. I took ~6 tylenol throughout the day which seemed to help for short bursts. My energy started coming back after ~18 hours but I didn't feel back to 100% for at least a few days.
On Friday 9/15/2017 Patient reported being unable to lift her arm more than ten degrees and "no range of motion." She planned to see a physician on Monday 9/18/2017. On Monday 9/18/2017 Patient reported almost complete recovery as of Saturday 9/16/2017, with symptoms 95% resolved. She decided against seeing a physician.
Pt with subjective fevers, body aches, chills, fatigue, anorexia x 2 days.
8-7-14 - Itching at inj. site per pt. local soreness (L) deltoid. 8-8-14 - per mo. 4" area of redness, pallor at site of inj (L) deltoid) itching. 8-9-14 - 16 cm circumferential area around inj. site (L) deltoid. Red, blotchy warm, no swelling or tenderness noted at office visit today. Rx: DESONATE gel to AA 2x QD.
This spontaneous report as received from a nurse practitioner refers to a 87 year old female patient with hypertension, COPD and arthritis. The patient's medical history included drug reactions or allergies to ZYBAN and Sulfa. On 20-SEP-2008, the patient was vaccinated with ZOSTAVAX injection, 1 shot, subcutaneously (exact dose, dose number, anatomical location, lot # and expiration date were not provided). Concomitant therapies included benzonatate, carvedilol, DETROL, gabapentin, lorazepam, losartan potassium (manufacturer unknown), metaxalone, simvastatin (manufacturer unknown), NAMENDA and carbidopa (reported as "carbodopa"). On 01-JUN-2015, the patient was diagnosed with an outbreak of shingles and later in the same month she was also diagnosed with postherpetic neuralgia. She was given LIDODERM patches to use for 12 hours a day, as a treatment. The outcome of the events was reported as recovered/resolved, on unknown dates. Causality assessment was not provided. Additional information has been requested.
Unable to walk from excruciating joint swelling and inflammation in knees, ankles,  and hips lasting for 2-3 days with reoccurring ?flare ups? of excruciating knee, ankle, hip pain ever since.
Fever of 102 Fahrenheit and chills. Started about 18 hours after receiving vaccine and lasted about 8 hours
Patient positive for COVID-19 on 4/5/21 after completing vaccination. She states that she completely lost her sense of smell and sense of taste.  She has had some mild rhinorrhea, otherwise, no symptoms.
Pt had very terrible pain in the back of her hips and lower back beginning at 3am the night she got her vaccine, similar pain to menstrual pain/cramping.  Pain was severe enough to cause her to cry; it lasted for 1-2 hrs and then she took tylenol and was able to fall back to sleep. riday morning when she woke up, pain was barely there, some achiness.  Then symptom completely gone over 1-2 days.  She also noticed left face/hip with raised red areas that looked like she had been bitten by ants on 4/2 (day after receiving vaccine).  This rash was gone in one hour and no symptoms since.
Left hand in the spot of the vaccine is hard, is red and it feel itch. Strong  headache since 4/8/2021
1 hour after vaccine -itchy injection site and small rash starting on top of left arm, took 50mg of Benadryl 1 hour after Benadryl- rash was spreading to the whole arm , neck and intermittent labored breathing started  patient was taken to hospital and received 2 doses of epinephrine and nebulizer treatment
This spontaneous report as received from a pharmacist via Market Research refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of PNEUMOVAX 23 (lot#, expiration date, dose, route and site of administration were not reported). The reporter stated, that data was lacking for efficacy in preventing infections. It was reported that PNEUMOVAX 23 was removed from hospital core measures. The patients were getting multiple vaccinations (dates unspecified) due to poor medication histories. The outcome of adverse events was unknown. The relatedness between adverse events and PNEUMOVAX 23 was not reported. Additional information is not expected as the reporter was not willing for the Pharmaceutical company's safety team to contact them to discuss further.
Patient reported light headedness, feeling faint immediately after vaccination , BP 100/60, given Gatorade and water, symptoms resolved shortly after, monitored for 30 minutes.