chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; Information has been received from a lawyer and th epatient regarding a case in litigation, concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On or about 07-OCT-2014, the patient (pt) was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions.  Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (date unspecified) and was treated by a health care provider at a health care department, and was hospitalized due to the event (date unspecified). As a direct and proximate result of pt use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt 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 will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Mother called stated child had MMR 1 week ago. Now has T 101 mild rash.
Individual stated he was anxious about needles and the vaccine. Within 10 minutes of receiving the vaccine, he stated he was lightheaded, fatigued and slightly nauseated. He did not faint. He was given cold water and we had him lay down. We observed him for 30 minutes after onset of symptoms. He was too fatigued to go back to work. He was escorted home. We checked on him 5 hours after the vaccine. He stated he was still very fatigued but was not lightheaded or nauseated. He was able to eat and drink.
small bumps on arm near injection site; muscle pain; Rash on arm; A spontaneous report was received from a consumer concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced myalgia (muscle pain), vaccination site mass, and vaccination site rash (rash on arm).   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 03421A) Intramuscularly for prophylaxis of COVID-19 infection.  On 9 Mar 2021, the patient experienced rash on arm, small bumps on arm near injection site and muscle pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Itchy, raised rash (oval in shape) on the left arm near the injection site - warm to the touch.  (exactly 1-week after the injection)
Terrible pain in chest that took breath away that went away quickly; that took breath away; diarrhoea; mild headache; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Terrible pain in chest that took breath away that went away quickly), DYSPNOEA (that took breath away), DIARRHOEA (diarrhoea), HEADACHE (mild headache) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatic fever (rheumatic fever as a child).   On 02-Apr-2021, the patient received second 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) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced CHEST PAIN (Terrible pain in chest that took breath away that went away quickly), DYSPNOEA (that took breath away), DIARRHOEA (diarrhoea), HEADACHE (mild headache), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, CHEST PAIN (Terrible pain in chest that took breath away that went away quickly), DYSPNOEA (that took breath away), DIARRHOEA (diarrhoea), HEADACHE (mild headache), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.            Treatment medications not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: TCR included- NNI, does not want to share email address, no consent to further follow up.
Additional information provided patient demographics medical history and updated laboratory results. Information regarding PREVNAR was received from a healthcare professional regarding a 13-month-old male patient who experienced received PREVNAR that had been improperly stored (refrigerator temperature went from 41 to 69.8 degrees Fahrenheit), asthma exacerbation, asthma exacerbation and fever. The patient received a dose on 02-Apr-2010. The patient received PREVNAR that had been improperly stored (refrigerator temperature went from 41 to 69.8 degrees Fahrenheit) and experienced asthma exacerbation and fever on 02-Apr-2010. The patient recovered. No additional information was available at the time of this report.
In Oct-2011 the patient received one dose of AFLURIA (batch number: '1057307' - non CSL batch number) intramuscularly for routine immunisation. About 5 hours after receiving the immunisation, the patient experienced a burning sensation all over her body. The burning continued for over 1 month. The reporter could not provide any details about the burning, if it was constant or intermittent, if there was a rash or redness involved or if any area of the body was more involved than any other. The patient had seen several physicians but no one had been able determine the cause. It was unknown if any treatment was attempted. The event outcome was not reported.
Information has been received from a nurse practitioner referring to a 12 month old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an adult dose of VAQTA 50/1.0 U/ml (1 unspecified dose, route, lot# and expiration date unknown) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported.
Pt was given an MMR as per protocol on 6/3/08 (not immune to rubella or mumps). She contacted this writer on 6/20 to report joint pain, swelling and rash. Advised to contact PCP doctor for further evaluation and treatment. Spoke with pt today (6/24). She saw doctor and started Rx anti-inflammatory. She continues to have significant joint pain.
Within 45 min of receiving the shot I felt nauseous & like I was going to faint. I also developed a migraine and shortness of breath shortly after. Later, while at a business, I passed out. I also was unable to sleep the entire night due to my nausea & shortness of breath. I am feeling the same way today (except I have not actually passed out-yet anyway).
Low grade fever of 99.9 sustained over 10 hours. Congestion, runny nose, and yellow mucus began around 6pm. On Sunday got progressively worse through Monday. Vomited at 12:05am on 2/21 and then at 4:05am 2/21 coughed up yellow phlegm and mucus from chest. Slept 2/21 all morning until noon, no appetite.
My vaccines were all trouble free. I caught Covid January 13. I missed three weeks of work due to extreme fatigue and weakness. I could not walk more than 20 feet without resting. I had a mild fever one day and a mild sore throat a couple of days. Otherwise, my only symptom was the weakness/fatigue. It begain with my daughter being sick the day before my symptoms began. I woke up with a mild sore throat and decided to stay home from work and schedule a Covid test. By noon, I felt too weak to drive myself to the test. After 3 weeks, I returned to work, but was still very weak. Over the next two months I have regained my strength, but still do not feel as well as I was before getting Covid. When I wake in the morning, I tend to be weaker. I can walk very slowly. By noon, I feel stronger, but by dinner I feel weaker again.
had 2nd covid vaccine Tuesday, then at 2:30 am woke from sleep with severe arm pain where she got the shot, then progressed to her left back, hip , shoulder, neck, headache, chills, took hot shower and got severely nauseated and dry heaving, and diarrhea and dizzy, then from the back of her neck to her arms she went numb and both hands started spasming, had trouble speaking
With the first shot, I had a sore spot on my arm and I was tired and fatigued for about a week.  With the 2nd shot (11am) I was fine for the first 5 (4pm) hours, then a horrible headache started.  About 6 hours after (6pm), my whole body felt extremely stiff and sore and I had to go to bed.  I took advil and tylenol, alternating these two every two hours.  I woke up at about 10 hours (9pm) after the shot and had body pains and a headache like I have never before had.  I took several hot baths, trying to get comfortable.  From 9pm that night and for the next 36 hours, I felt the most horrible flu symptoms I have ever had.  I felt hot and cold, and the body pains were very severe.  I started hallucinating that someone was stacking boxes on my eyeballs inside of my head and causing the excruciating pain in my head and about my eyes.  After 48 hours after the shot, the symptoms were better, but I was extremely fatigued for another 4 days.  Since then, I have had a horrible taste in my mouth that never goes away and started drooling from this side of my face about 3 months ago.
fever of 100-101 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100-101 degrees Fahrenheit) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (fever of 100-101 degrees Fahrenheit). At the time of the report, PYREXIA (fever of 100-101 degrees Fahrenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of the event included, paracetamol. No concomitant medications were reported.
Patient developed fever on Friday, September 9th, not known how high fever was.  Clinic was called at 14:45PM 09/12 by child's aunt stating he had a rash resembling hives on face and red blotchy rash on neck and arms.  He had no fever or swelling or trouble breathing.  Caretaker had given Benadryl 1 teaspoon and hives rash had resolved.  Other rash resolved over 24 hours.  Child playing normally.
Vaccination given at 8:00 a.m. on 7/6/07;symptoms started at 10:30 p.m. 7/6/07.Vomiting, diarrhea, fever, headache and eyes were sore and dry
This case was reported by a physician and described the occurrence of pain in a 39-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included cephalosporin allergy. Previous and/or concurrent vaccination included influenza virus vaccine; GlaxoSmithKline; unknown given on 19 October 2010. The influenza vaccine was reported as FLULAVAL, however, the lot number that was reported corresponded to FLUARIX. There were no concurrent medications. The subject had not experienced any adverse events following previous vaccinations, with the exception of having pain after the 2nd dose of TWINRIX. On an unspecified date, the subject received 2nd dose of TWINRIX (details unknown) and experienced pain. No other information was provided. The outcome of this event was unspecified. On 19 October 2010, at approximately 10:50 AM, the subject received 3rd dose of TWINRIX (1 ml, unknown, left arm). On 19 October 2010, at time of vaccination (10:50 AM) with TWINRIX, the subject experienced pain and injection site reaction. On 20 October 2010, less than one day after vaccination with TWINRIX, she experienced swelling injection site, injection site pruritus and injection site redness. The subject was treated with BENADRYL, antihistamine, ice pack and heat application. At the time of reporting, the events that occurred after the 3rd dose of TWINRIX were improved. The physician considered the events that occurred after the 3rd dose of TWINRIX were probably related to vaccination with TWINRIX. At the time of TWINRIX injection (3rd dose), the subject experienced pain and achiness. The subject was given an ice pack at the time of the vaccination. The reporter notes that the next morning, she experienced a golf ball sized swelling at the site of the injection. There was itching as well. The subject took BENADRYL and an antihistamine and applied heat. The events did not require medical attention. At the time of the report, the symptoms improved. Follow-up information was received on 22 November 2010 via healthcare professional who reported the events experienced by the subject resolved on 22 October 2010. At the time of the report, no other information was provided.
people who got shingles got the shingles shot-suspected vaccination failure; Shingles; This case was reported by a consumer and described the occurrence of Suspected vaccination failure in unspecified number of a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient only know the people  that who got the shingle shot got the shingles. The contact details were not reported hence follow up was not possible. This case considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not reported.
4/10/21 11:30 a.m.  Vaccine administered 6 p.m. Dizziness 6:30 p.m. Chills, leading to low-grade fever 10 p.m. 100.5 degree temperature; took 400 mg Motrin 11 p.m. felt very hot 4/11/21 9:30 a.m. Chills, 99 degree temperature 11:15 a.m. 99.5 degree temperature, slight headache, took 400 mg Motrin 12:40 p.m. Felt very hot again, subsided after a while --  In the middle of the night hands were very sweaty, soaked through my shirt 4/12/21 Occasional feelings of dizziness 7 p.m. Red spots on both hands  Note: I am breastfeeding. Baby has been sleeping through the night for weeks, but on the second night after my vaccination (4/11/21) she woke up multiple times in the middle of the night and has seemed fussier than usual.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Batch/Lot number: unknown), in right arm, on 12Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 20Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Aortic stenosis" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was treated with Paxlovid from 29Aug2022 to 02Sep2022. Patient did not have any Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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 Vaccination failure and covid 19 cannot be ruled out.
This case was reported by a nurse and described the occurrence of pallor in a 15 year old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The pt's medical history, concurrent conditions and concurrent medications were not reported.  On 04/21/03 the pt received the 1st dose of Engerix-B.  Approximately 3 hours post-immunization, on 04/21/03, the pt experienced pallor, clamminess and dizziness.  A health professional was consulted regarding the events, but no medical treatment was provided.  The events resolved after approximately 30 minutes.  The Engerix-B immunization series was discontinued.  The reporting nurse considered the events were probably related to vaccination with Engerix-B.
Titers were tested / showed she was not immune; This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a 23-year-old female patient who received HBV (Engerix B) (batch number 53P39, expiry date 12th February 2020) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   On 15th May 2019, the patient received Engerix B (intramuscular). On an unknown date, the patient received Hepatitis B vaccine. In December 2020, between 1 and 2 years after receiving Engerix B and unknown after receiving Hepatitis B vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.  Additional information was provided as follows: The patient received Hepatitis B series as a child. A year before reporting, the patient received a dose of Engerix-B, titers were tested and showed immunity. In December 2020, a week before reporting, patient's titers were tested and showed she was not immune. The patient was getting a job in a hospital as a nurse. The reporter consented to follow up.
Information has been received from a RN concerning a 3 year old female with pervasive developmental disorder PDD and a Hx of Tympanostomy tube insertion who on 10/07/2002 was vaccinated in the RL with the first dose of varicella virus vaccine live. Concomitant vaccination on that same day included the first dose in the LL of MMR virus vaccine live. The RN reported that on 02/07/2005 the pt was seen in the office with a rash appearing to be varicella. A DX of chicken pox was made and the pt's mother was advised to give the pt Benadryl Q 4H PRN. At the time of this report the outcome was unknown. Additional information has been requested.
Headache Lightheadedness, sinus pressure body ache, fatigue Narrative:
on 4/19/21: Dizzy, headache, nausea , arm was hot- swelling,  fatigue on 4/21/21 : 2 nosebleeds ,  arm still warm, no headache
Broke out all over body in hives. From top of head to bottom of feet.  Lips were swollen as well as throat was very hoarse. Itching was unbearable. The intense rash, hives and swelling lasteduntill the 18th of Sept. It is now the 20th of Sept and I still have occurrences of hives in various parts of body.
Expired vaccine administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 040B21A and 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to animal (cats), Hay fever, ADD and Irritable bowel syndrome.   On 20-Apr-2021 at 9:04 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-May-2021 at 9:11 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Jan-2022 at 10:38 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Jan-2022 at 10:38 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration). On 24-Jan-2022 at 10:38 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration) to be not related.    No concomitant medications were provided.  No treatment medications were provided.  The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date.  No Adverse event reported.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 1st March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 1st March 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain and feeling unwell. On an unknown date, the patient experienced incomplete course of vaccination. On 3rd March 2018, the outcome of the injection site pain and feeling unwell were recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the injection site pain and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the reporter for her accountant. The age at vaccination was not reported. Only limited information was provided by the reporter. The patient experienced pain at the injection site, and did not feel well (unknown symptoms). Also, the caller reported that till the time of reporting, the patient had not received his second dose of SHINGRIX, which led to incomplete course of vaccination.
This spontaneous report as received from an office administer (also reported as an office manager) refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 11-JUL-2016, the patient was vaccinated with an improperly stored (the call was because of a data logger, lowest reached temperature: 32 Fahrenheit degrees, time frame: 57 hours) dose of ROTATEQ (lot # L039638, expiration date 23-AUG-2017, orally, dose was not reported). There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt was given expired vaccine in error. Moderna 044A21A expired on 8/31/2021 and wrong expiration date was written on box. Pt was notified of vaccine error and offered to repeat dose. Moderna notified as well. Pt reports her only reaction was a headache, bodyaches and injection site soreness for about 28-30 hours. Moderna is conducting lot assessment to see effectiveness of dose that could take 8-10 days. Pt reports she desires to wait on results before repeating dose.