chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; Information has been received from a lawyer regarding a case in litigation, concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided.   In or about January 2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) at a clinic, for routine health maintenance and for its intended purpose: the prevention of shingles (dose, route of administration, anatomical location, lot number and expiration date were not reported).   In or around August 2013, the pt presented to the physician, with complaints of a painful rash around his left hip, which was diagnosed as shingles. The shingles rash lasted several weeks, causing severe pain and suffering. Symptoms resulted in physical limitations not present prior to vaccination and the pt experienced mental and emotional distress due to resulting physical limitations and seriousness of the condition. The pt suffered severe, 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. Moreover, the pt had incurred and would continue to incur medical expenses and other economic harm.   The outcome of the event was considered to be not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event of shingles was considered to be disabling.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer vaccine on 18-Dec-2020. Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.   This case was linked to MOD-2021-395985 (Patient Link).
Sudden onset of extreme nausea, vomiting, dizziness, imbalance while in shower.  After two days went to my primary care physician, who referred me to Audiology for testing.  Diagnosis after extensive testing was Right Peripheral Vestibulopathy and Otolith Dysfunction.  Started therapy at Audiology two times per week, plus exercises on home computer two times per day.  Symptoms are improved but I still have dizziness, mild nausea and imbalance that comes and goes.
I developed facial shingles on 5/22/2021. I experienced severe pain in my teeth, face, and ear on the right side only. This happened despite my having been inoculated against shingles in 2018. I am still experiencing pain in the same areas, only it is now much milder. I was given Valtrex and prednisone to treat it, and they do help.
Patient went to the doctor with complaints of headache, nausea, abdominal pain, and swollen lymph nodes.  Doctor stated it was a rare side effect to vaccine.
lympatoniditis on the left auxilla, was tender to the touch, regressed in size, soft, painful but resolving over days without an issues besides APAP.
Received shot in morning. Woke up at night 3:00 with a fever 100 degrees and aching all over. Foot and neck completely stiff. Foot felt like it was broken. In a lot of pain and thought they gave me wrong shot. Could barely move neck. After about hour made it to bathroom and layed in hot water in bath tub. Eventually neck muscles relaxed and kept stretching foot with hands and it took awhile for foot to be normal. I was feeling very ill for two days. I never got a reaction from the first shingles shot. This one was Completely different and never had a reaction from a shot like this before.
No additional adverse event; a 19-year-old patient was inadvertently administered a pediatric dose of VAQTA; This spontaneous report as received from a nurse and refers to a 19-year-old patient of unknown gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 18-JUN-2020, the patient was inadvertently administered a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (route of administration was not reported), lot # T001419 and expiration date 06-JAN-2021, for prophylaxis (incorrect dose administered). No additional adverse event reported.
Immunized on 2/26/02. Developed hemolytic, uremic syndrome on 3/1/02. (Atypical presentation/course ) requiring emergency dialysis.
itching; redness 2 inches around like a square shape around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness 2 inches around like a square shape around the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness 2 inches around like a square shape around the injection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness 2 inches around like a square shape around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure medication.
HOUR AFTER RECIEVING INJECTION, EMPLOYEE EXPERIENCED FEVER LIKE SYMPTOMS, BLURRY VISION, TINGLING SENSATION TO TONGUE, TINGLING TO FINGER, TINGLING FEELING TO THE BACK OF HER HEAD, STIFFNESS TO JAW, NECK, ACHE AND PAIN TO SHOULDER AND UPPER BACK AREA.
Information has been received from a physician concerning a female patient who on a unspecified date was vaccinated with a dose of GARDASIL (lot not reported) (the reporter was unsure of which dose this was in the series) and then the patient fainted. Additional information has been requested.
First symptom was pain between the right temple and the eye on 4/22 at 10pm.  Pain was deep behind the eye and persisted for weeks. Few days after I got little bit of rash on my forehead only on the right side.  Next day I got even more rash and decided to see a doctor (Item 14) which diagnosed me with Shingles on 4/ 26 at 9am and prescribed Valacyclovir 1000mg.  I was also seen by optomologist DO the same day at 1:15pm and my eye was fine. Two days after doctor (item 14) prescribed antibacterial cream to put in my eye as I complained about  eye pain, this was over the phone.  On morning of 4/29 my eye was swollen and it was hard to open because I got a bacterial infection as a complication and went to the Urgent Care. Urgent care doctor prescribed oral antibiotic and eye drops instead of eye cream I used before. Oral antibiotic worked but cream caused my eye to get bloody in the white part so I stopped putting drops in my eye.  ]On 5/2 I went to the ER and was seen by MD as I got very foggy vision in my right eye and they found the virus in my eye using a visual acuity screening. They refilled my Valacyclovir and told me to put same cream antibiotic in my eye as before, not to take eye drops that caused blood in my eyes and prescribed antiviral eye drops.  On 5/8 I went to see the optomologist MD and complained about not being able to sleep for 3 days because of itching and numbness on my forehead and eyebrow so he prescribed 600mg gabapentin.  He also found virus scaring on my cornea on the side and center and told me that this is a lifelong disease and that the virus is only dormant and can start causing damage again at any time.  On 5/10 I went to see neurologist Dr and she confirmed postherpetic neuralgia and told me to take Gabapentin.  I still have numbness and itching and can't sleep without a lot of medication to put me to sleep. It is very hard for me to work as I have sensitivity to light and can't look at the screen without taking pain medication. All my daily activities are heavily impaired and I can hardly do anything because of light sensitivity and pain. On the day when I got the Tdap vaccine I was fine and my blood tests were normal. Tdap vaccine was given to me on a yearly physical exam while visiting Drs by a nurse. My uneducated guess would be that Tdap vaccine caused my immune system to drop and that caused Shingles to appear earlier than my age would suggest.  Impaired immune system also caused all these side issues like bacterial infection, virus to infect my eye, forehead and eyebrow numbness and itching which normally happens with people with weak immune system.  My blood test before the vaccine was normal so there is no reason to believe my immune system was impaired before and I was not sick for very long time.
This information has been received from a Licensed Practical Nurse and administrator concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 lot # M038359 and expiration date on 13-MAY-2018 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis. On an unknown date, the patient experienced muscle spasm at the injection site (on an unspecified arm) and also had complaint of chest pain. The patient was taken to the emergency room at an unspecified hospital and received treatment for the events. The outcome of muscle spasm at the injection site and chest pain and the causal relationship between the events and therapy with PNEUMOVAX23 were not reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA003937.
Chlamydia; Vaccine exposure during pregnancy; This is spontaneous case, initially received from other health professional on 01-Apr-2020, concerning a pregnant female patient of unknown age of body weight 97 lbs, height 63 inches and body mass index (BMI) 17.2. It was reported that the patient's age at conception was 17.  The patient's current medical history included teenage pregnancy and low BMI.  The patient's concomitant medication included Prenatal vitamin (unspecified vitamins and minerals) for pregnancy.  The patient's obstetrical history included that the patient had no previous pregnancies. The patient had no maternal or paternal history with major congenital malformation (MCM). The patient did not consume tobacco, alcohol or illicit drugs during pregnancy.   The patient's last menstrual period (LMP) date was 01-Sep-2019. The type of pregnancy was singleton. The patient's estimated delivery date (EDD) was 08-Jun-2020 and corrected estimated date of delivery (CEDD) was 11-Jun-2020.  On 07-Nov-2019, the patient underwent ultrasound and no MCM was noted.  On 04-Dec-2019, the patient underwent non-invasive prenatal testing (NIPT) and no MCM was noted.  On 03-Jan-2020, the patient underwent maternal serum alpha-fetoprotein (MSAFP/serum markers) test and no MCM was noted.  On 27-Jan-2020, at gestational age of 21 weeks (calculated per LMP), the patient was administered Afluria QIV [influenza vaccine, batch number: P100112488, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an unknown indication. On the same day, the patient underwent anatomy ultrasound and no MCM was noted.  On 09-Mar-2020, 1 month and 11 days after vaccination, the patient developed chlamydia and started treatment for it with tablets of azithromycin at a dose of 2 g,administered  once a day via oral route of administration.  At the time of initial reporting, the outcome of chlamydial infection' was not resolved.  The event of chlamydial infection' was considered serious due to the criterion of medical significance.  The reporter did not provide a causality assessment to Afluria QIV.  Company comment: A pregnant subject experienced Chlamydial infection, 1 month and 11 days after receiving Afluria QIV. Chronology is compatible. The subject's current condition included teenage pregnancy and low BMI. Causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related to the event (defaults to "related" in the safety database for reporting purposes). Vaccine exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A pregnant subject experienced Chlamydial infection, 1 month and 11 days after receiving Afluria QIV. Chronology is compatible. The subject's current condition included teenage pregnancy and low BMI. Causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related to the event (defaults to "related" in the safety database for reporting purposes). Vaccine exposure during pregnancy assessed as not related per company's conventions.
Classic symptoms of polymyalgia rheumatic; neck, shoulder hip pain, elevated ESR and qCRP; responded to prednisone,
Physical therapist reported that she received one or more doses of VARIVAX, but titers drawn indicated insufficient antibodies; She received one or more doses of VARIVAX/The patient received an additional dose of Varivax on an unknown date to boost her immunity/Treatment Provided: additional dose of Varivax administered; She receoved one or more doses of VARIVAX/The patient received an additional dose of Varivax on an unknown date to boost her immunity/Treatment Provided: additional dose of Varivax administered; This spontaneous report was received from a female physical therapist of unknown age, referring to herself.  Her current condition included a history of not producing an adequate response to a vaccine. Her past drug and medical history, as well as concomitant medications, were not provided.   On an unknown date, the patient was vaccinated with one or more doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (reported as vaccination) via subcutaneous (concentration and anatomical location of vaccination were not reported; dose, frequency of vaccination scheme, lot number and expiry date were unknown to the reporter).   On an unknown date, the patient sought medical attention and varicella titers were drawn which indicated that the patient had insufficient antibodies (varicella virus test negative).  On an unknown date, the patient received an additional dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) to boost her immunity (incorrect dose administered, circumstance or information capable of leading to medication error). The patient did not know her current antibody levels.   The outcome of varicella virus test negative was unknown. The causality assessment between varicella virus vaccine live (Oka/Merck) (VARIVAX) administration and the occurrence of the event, was not reported.
C/O intermittent shortness of breath after receiving flu vaccine. Mild erythema seen in Ed. Treated with steroids, BENADRYL. Last year had mild itching at site NKA. Also reported chest pain had (-) EKG transferred to ED for eval.
the third dose/shot being being very painful/a lot of stinging at the injection site; She thought she was going to pass out; This spontaneous report was received from a consumer via company representative and refers to an approximately 22-year-old female patient. Her medical history and concomitant therapies details were not reported. Concurrent condition included a mental disorder.  On an unknown date, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient had a lot of stinging at the injection site and she also experienced dizziness, she thought she was going to pass out, but she also got worked up over shots. The third shot of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was very painful. No additional information was provided. No additional adverse event or product quality complaint was reported. No further information was provided. The outcome of the events was reported as recovered.  The causal relationship between the events and suspected therapies was not reported.
After sitting calmly for a few minutes post vaccine, there was a sudden hot flush that rose up through my chest and into my face. My heart then started pounding very hard a quickly and my body started trembling. I became short of breath and lightheaded, but never felt I was wheezing. The pharmacist did not seem to know what was going on and told me to just stay seated and let him know if there were any changes. I took my mask off to get enough air and after a few minutes my heart rate slowed down and then the issue seemed to come in waves for about 10 minutes. After 15-20 minutes I felt shaky and lightheaded, but my heart rate seemed normal. At that point I asked the pharmacist to take my BP,  which was normal. Over the next week I had an increase in heart palpitations and difficulty sleeping. It felt like I had increased amount of adrenaline in my system. 3 weeks out I still have increased palpitations, but they are less frequent than they were initially.
Persistent itching at site, 5mm firm, raised red bum (post-scab lesion).
Pt was sitting in observation chair after receiving vaccine and became pale, and then loss consciousness. Pulses were very weak, but thready. Respirations rates were also decreased.  when patient  awoken, ems was approaching patient. EMS found patient to be bradycardiac. Pulses remained weak, pt remained pale and diaphoretic, very shallow slow respirations but alert and orientated just weak at this time. Pt admitted this happens frequently with injections and blood draws. Pt was asked to see if he could sit up where patient became dizzy, nauseas and then vomited. Pt admitted to not eating today and then refused to go to the hospital. Pt was observed in waiting area for almost 45 minutes, where patient made a full recovery.
Patient received potentially affected vials that was stored in freezer with no DDL monitoring; Patient received potentially affected vials that was stored in freezer with no DDL monitoring; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) and PRODUCT STORAGE ERROR (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) and PRODUCT STORAGE ERROR (Patient received potentially affected vials that was stored in freezer with no DDL monitoring). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) and PRODUCT STORAGE ERROR (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) 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.  There was no change in the state of the vaccines, no temperature excursion history (the temperatures of the freezer remained consistently within range and was recorded in a log) and received them from shipment in frozen and remained frozen when in the freezer. Vial was thawed when patient came for vaccination. Storage condition was frozen. The lot numbers supposedly affected were 022J21A, 083J21A and 059M21A. Maximum/minimum temperatures were not recorded; only morning and evening temperatures were recorded. The excursion in question was from 8-Feb-2022 to 20-May-2022 and affected only 6 patients within that time frame. The vials were moved to the refrigerator to be thawed for vaccinations on 8-Feb-2022, 21-Feb-2022, 31-Mar-2022, 2-May-2022 and 20-May-2022. The vials were stored in a fridge/freezer combo unit which are completely separate compartments with completely different temperature.  No treatment medication was reported by reporter.
Permanent scar at the site of the intradermal injection that has not gone away over the course of a month. The FDA EUA does not mention this possibility and it did not occur with dose 1 when administered subcutaneously.
Swelling of tongue, difficulty swallowing, odd feeling in chest. Given epinephrine, decadron, benadryl and pepcid. Monitored for 4 hours. Symptoms resolved and was discharged.