chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; Information has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.  In 2014, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for  long-term prevention of shingles and zoster-related conditions (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unspecified date (subsequent to inoculation), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had and would continue to 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.   By the time of this report, the patient had not recovered from shingles. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
This case was reported by a healthcare professional and described the occurrence of inappropriate route of vaccination in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 25 September 2009 at 14:00 the subject received a dose of FLUARIX (15 mcg, subcutaneous, unknown) and experienced inappropriate route of vaccination. No additional information was known at the time of reporting. The subject received FLUARIX by subcutaneous injection. The subject also reported in "previous years" on unspecified dates, she received doses of Influenza vaccine (unspecified) (unknown). Several hours after the vaccinations she experienced flu like symptoms that would resolved with "intervention"; no other details were provided.
It started with dizziness and progressed to fever and chills, severe body aches, restless sleep with disturbing dreams, extreme fatigue and persistent low grade fever and chills too severe to do anything but stay in bed.  At 2:30 pm, I took some tylenol based cold medicine, which started some improvement, and I was able to eat something.  I'll take more before going to bed.
Information has been received from a consumer concerning his approximately 39 year old wife with no pertinent medical history and no known drug reactions/allergies who in approximately January 2008, "in the early part of 2008", was vaccinated with an IM dose of GARDASIL (Lot# not reported). Concomitant therapy included ROBAXIN. In April and June of 2008 the patient went for a pap smear test which was positive. The patient took both a regular and a high-risk screening pap smear and they were positive. The reporter stated that up to that point his wife always had negative readings. The patient sought medical attention by an office visit. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
This spontaneous report as received from a nurse refers to multiple unknown patients. The patients received improperly stored doses of VARIVAX (lot # M005971 and lot # M045205 with expiration date 11-NOV-2018, dose and route unknown) for prophylaxis on multiple unknown dates. Lot and expiration for properly stored sterile diluent (manufacturer unknown) was unknown by reporter. The vaccine was stored at -14 degrees Celsius to -10 degrees Celsius for 63 hours. There was no temperature excursion previously. No adverse effects were reported.
Within 15 min. I had an allergic reaction in my lungs and abdominal discomfort. Six hours later fever and whole-body inflammation started. The inflammation and fever (up to 102.0 with ear thermometer) lasted for four days. Whole-body aches and tiredness lasted two weeks.
Onset of increased tinnitus with second Moderna shot-- 4 days following vaccine.  I also reported the same incident after 1st shot.  It has become very loud hindering sleep and overall quality of life.
sick; arm is quite inflamed; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (sick) and INFLAMMATION (arm is quite inflamed) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) at an unspecified dose. In December 2021, the patient experienced INFLAMMATION (arm is quite inflamed). On 29-Dec-2021, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick) was resolving and INFLAMMATION (arm is quite inflamed) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Patient got Flu shot on the evening as well on 29DEC2021
One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eight grade adolescent female. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.
Pt received vaccination. Pt was talking and appear to be fine. Pt was in hallway talking with others and stated I need to sit down. Pt fainted and hit trash can. Pt placed on back with feet elevated. Pt pale, sweating and dizzy. Ice pack and ice water given.
Cellulitis reaction to immunizations of 4/30/05, starting Keflex.
had all 3 doses he was 95 years old and died of covid; had all 3 doses he was 95 years old and died of covid; had all 3 doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 95 year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, medically significant), COVID-19 (death, medically significant), outcome "fatal" and all described as "had all 3 doses he was 95 years old and died of covid"; IMMUNISATION (death, medically significant), outcome "fatal", described as "had all 3 doses". The patient date of death was unknown. The reported cause of death was drug ineffective, covid-19. The reporters best friend he was vaccinated with the covid vaccine, The reporter was unsure who made the patient's covid vaccine.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.; Reported Cause(s) of Death: had all 3 doses he was 95 years old and died of covid; had all 3 doses he was 95 years old and died of covid
11 out of 120 pts recvd Hep B vax & did not respond p/ 3rd dose. 1 pt recvd total of 5 doses & was non-responder.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 23-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
I walk 3 miles everyday. I went out for my walk around 4 pm  and after walking about 10 minutes I realized I was short of breath this increased the longer I continued to walk. I have never had it happen before and I believe it is a side effect of the vaccine. I walked the next day and though I was still short of breath it was not as severe.
Local reaction to left upper arm, 6x4cm erythema with 4x2cm target wheal.  Ice applied and advised to apply ice x24 hour. If s/s persist or worsen to return to HC.
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 2 years old. The patient demographics were updated. On 02-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
approximately 12 hours after injection developed flu like symptoms- rigors, chills, myalgia, malaise, nausea, excessive thirst, but what concerned her more was she had a presyncopal episode. did no lose consciousness but describes acute onset "tunnel vision, ringing in ears" so laid on the ground on her side and the symptoms subsided after 20 minutes or so
patient was having hot sore area around the injection site  that enlarged over 2 days. came into the pharmacy and I looked at it. I recommended she go to urgent care to have it checked.
Lymphadenopathy of axilla, neck progressing to painful lymphadenopathy requiring steroid treatment to improve symptoms
Juvenile rheumatoid arthritis as diagnosed by a doctor. Extreme joint pain, restricted movement in joints, permanent joint damage.
The usual upper respiratory flu-like issues. The doctor, after consultation over the phone, wanted to see him. Did multiple PCR COVID tests over the course of 3mo. All were negative. Just a physical and no treatment given. Over the counter medication suggested for the duration. No treatment otherwise.
Child brought to clinic by day care provider approx 45 hr following administration of #4 DTaP. Left leg/thigh with swelling and inuration approx 10 x 12cm. Red and warm to touch. No analysis given on sn presiding 24hr. Activity level normal. Adv Tylenol and cold packs to area. F/U at 24 hrs. Swelling resolved.
Feel like a little bit of tightness on my chest when I eat, when I swallow and when I move around a little; I don't know why I can hear an echo, I don't know why; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious), outcome "unknown", described as "Feel like a little bit of tightness on my chest when I eat, when I swallow and when I move around a little"; DYSACUSIS (non-serious), outcome "unknown", described as "I don't know why I can hear an echo, I don't know why".  Additional information: Consumer stated, I have a concern, I am not sure if I should actually go and get checked out or if its just a reaction of the vaccine, so I feel like a little bit of tightness on my chest when I eat, when I swallow and when I move around a little.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient has a round red rash the size of a grapefruit, stated it was hot. She is having chills. Advised her to take some ibuprofen and some BENADRYL. Explained this is a side effect and it could last up to a week.
WAS TERRIBLE FEELING / feel messed up; This case was reported by a consumer via patient support programs and described the occurrence of feeling abnormal in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   The reporter considered the feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced terrible feeling and felt messed up. The patient reported that she felt messed up and  did not knew what to do. The information regarding consent to follow up was not reported. No further information was available.
Dose was in freezer 5 days too long and given accidentally; Dose was in freezer 5 days too long and given accidentally; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 65 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 16Nov2021 (Lot number: 30155BA) at the age of 65 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Manufacture: Jansen/ Vaccine Name: COVID 19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Vaccine Name: COVID 19, Manufacture: Jansen, Batch/Lot: 1805022, Route: IM, Anatomical location: R deltoid, No. of previous dose: 0, Date: 08Mar2021), administration date: 08Mar2021, for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown" and all described as "Dose was in freezer 5 days too long and given accidentally".  Additional information: The patient did not provide information to you regarding the reported adverse event(s) with the use of the product. Did the reporter considered Pfizer product had a casual effect to the adverse event(s) was not applicable. Vaccine administered at Military facility was no. Specific Relevant Test for thromboembolic events with thrombocytopenia was none.  No follow-up attempts are possible. No further information is expected.
Developed general body aching and chills approx. 36 hours, post vax, symptoms lasting approx. 48 hours.
1. Incontrollable Shaking of body and limbs-- for 2 days,  2. Migraine, Body aches, Stomach Cramps, Cough, Shortness of breath, Chills, Heavy chest, Hives, Soreness at injection site --all for 9 days
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: skin looks pale
After second shot chest tightness, pressure feeling & anxious. Felt like I took an energy drinking, even though I can't take those. made my heart feel very hypersensitive Tachycardia. Effects went way within 24-48 hrs. In the month of May no menstrual cycle came , no signs of pregnancy. Last cycle was in April 2021. Become somewhat worried. Checked with my OBGYN, was advised to wait a couple more weeks. Next Cycle arrived  June 17, 2021. Since then cycles have been light and shorter in days.
First began with sharp pain in my back on the right side.  When the pain did not subside, but worsened and began to radiate to my chest, I made an appointment with my PCP.  During the visit, I was told that my heart rate was very low (40) and that they were going to try to see they could get me in to see a cardiologist on that day - if not, I was advised to go to the ER (after an EKG test was run in office).  When a cardiologist was not found to be available, I was told to go directly to the ER, and was given the EKG printout to take with me.  I went to hospital on July 8, 2021 and after several  hours and tests there, I was admitted into the cardiac unit.  I was released the next day, with instructions to follow-up with my PCP and a cardiologist (still in pain). I followed all of the instructions given to me - and was told that I had "had low heart rate since 2014" but there were now some abnormalities that were showing up on the EKGs that were done.  I have been going to the same practice for several years, and never has anyone ever indicated that my heart rate was low, mentioned bradycardia or anything of that nature.  Although the physician that I saw on my doctors visit wasn't my regular PCP,, I had seen her in that practice before, and I also have access to My (medical records online) and there is nothing that points to any heart issue at all until two weeks [exactly] after my second shot.  I am currently still being seen by a cardiologist, and just days ago had to have an echocardiogram done.  This is all new for me and very daunting.
Nausea, stomach pain, (not gastric irritation), fatigue, enteritis, nausea continues with difficulty eating food, weight loss, 5#.Stomach pain and abdominal bloating, now less.
multiple patients were vaccinated with improperly stored VARIVAX; No adverse effect; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 19-NOV-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R017642 and expiry date 20-JUN-2019) for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
general reaction; This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. Medical assistant reported that the patient experienced a general reaction after Shingrix rather than a local one. Additional information was not known, including the nature of the general reaction. The reporter did not give consent to follow up. No additional information was available.
This spontaneous report was received from a 61 year old female patient via Novartis (manufacturer control # PHEH2016US009713). No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (dose, route of administration, administration site, lot # and expiry date were not specified). The patient reported, that she was extremely allergic to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). She was at an healthcare provider's office and was stuck with the vaccine, despite not wanting it and was forced to sign a paper. On an unknown date, after vaccination with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), the patient was covered top to bottom in sores. The outcome of the event was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). This is one of several reports concerning the same patient. Additional information has been requested.
Information has been received from a female consumer who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). The patient stated she experienced redness and swelling at the injection site. At the time of the report the patient was recovering. It was unknown if the patient sought medical attention. No further information is available.
Student rec'd Tdap on 3/31/08. The next evening developed: HA, felt feverish, 2 lymph nodes swollen and painful at the base of the left posterior supraclavicular region. Also, nauseated. Student refused recommend MD evaluation. Instructed to cont. Tylenol for HAs and injection site pain.
She started with a dry, persistent cough within 1-2 minutes after the vaccine.  She stated "I can't breathe."  Her skin was flushed red.   I administered 0.15 mg of epinephrine.  She was given oxygen.  Her initial oxygen saturation was 82% but quickly went to 97% with oxygen.  She was transported by EMS and discharged home the same day.
Hives/rash developed on chest and side of neck, as well as facial flushing, about 15/20 minutes after the injection. Blood pressure was taken repeatedly and high 150/100.
1st vaccine made me a little sick.  2 days after 2nd vaccine given on 4/22/2021 I started getting sick and kept getting sicker & sicker.  I ended up with double pneumonia and 105.1 degree fever.  I was so sick I ?lost days? and don?t remember them.  After 3 dr. Visits, 2 puffers and two rounds of antibiotics I?m very, very weak and still coughing but better.  I was told by the pharmacist to report this because they had numerous people came down with double pneumonia and a high fever just like I did and NOT TO TAKE THE VACCINE AGAIN!
Very sore Large itchy lump size of egg on day 3 LRge itch lump size of baseball day 4  Hot to the touch