chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm pain; chills; This is a spontaneous report from contactable consumer. An adult female patient (No Pregnant at the time of vaccination) received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm pain and chills on 24Mar2021. No treatment received for the adverse event. The outcome of the events was recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a 64 year old male consumer with hiatal hernia cancer of the leg, lower back problems, allergies to sulfa and CIPRO, with a history of prostatitis who on 28-SEP-2007 was vaccinated with 0.5 ml subcutaneous in the left arm of Zostavax (Oka/Merck) (lot# "108484").  Concomitant vaccination included influenza in the opposite arm (right).  Concomitant medications included CLARITIN, FLONASE, NEXIUM, ADVAIR, baby aspirin, and FLOMAX.  There was no reported history of chicken pox, and no reported recent exposure to chicken pox or herpes zoster.  He reported that later that evening (28-SEP-2007), he developed a blister-like rash on the middle of his back.  He also experienced a burning and itching sensation all over his body.  The next day (29-SEP-2007), he developed red, itchy, non-fluid bumps on his chest area.  Since then the red itchy bumps developed in any area that was exposed to heat or became warm.  He has had the rash on the back of his neck, crotch area, legs, palms of his hands, and feet.  The rash usually cleared if he self administered BENADRYL and applied cool compresses.  On an unspecified date, he was examined by his physician and was prescribed a tapered dose of prednisone for 6 days.  He developed hives and redness over his entire body after the first day of starting the prednisone (date not reported).  By the end of the sixth day of prednisone, the hives had resolved and he was back to the state he was prior to starting the prednisone.  The blisters on his back have scabbed and healed.  The patient's physician reported that on day # 4 post vaccination (02-OCT-2007), he developed a red itchy rash at the injection site.  Medical attention sought for the site events was not reported.  There was no reported collection of a specimen for "PCR" or a direct fluorescent antibody.  The physician reported that on an unspecified date, the patient had recovered.  It was noted that the patient started radiation therapy three weeks after the administration of Zostavax (Oka/Merck).  A product quality complaint was not reported.  This is one of two reports from the same source.  Additional information has been requested.
Information has been received from a 26 year old female patient who on 09-DEC-2009 was vaccinated with her first dose of GARDASIL (lot # not reported). There was no concomitant medication. At the time of this report, the patient should have started her menstrual cycle between December 11th and 15th, however she still had not gotten it. No diagnostic laboratory test was performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Deceased (10.4.21);  Hospitalized (9.30.21);  COVID-19 positive (9.30.21);  fully vaccinated  Discharge Provider: MD Primary Care Physician at Discharge: None Physician, MD None Admission Date: 9/30/2021 Date of Death: 10/4/21 Time of Death: 12:50 PM Preliminary Cause of Death: Acute respiratory failure due to COVID-19 PRESENTING PROBLEM: Hyponatremia [E87.1] Type 2 diabetes mellitus with hyperglycemia, without long-term current use of insulin [E11.65] COVID-19 [U07.1] Acute respiratory failure due to COVID-19 [U07.1, J96.00] Acute hypoxemic respiratory failure [J96.01]   HOSPITAL COURSE: Patient admitted for acute hypoxic respiratory failure due to COVID-19 pneumonia. Patient was fully vaccinated, however she did not respond well to maximum medical therapy including iV decadron, IV remdesivir, and broad spectrum antibiotics to cover superimposed bacterial pneumonia. She was transferred to the ICU on maximum HFNC. She continued to have low oxygen levels. Patient decompensated and after long discussion with the family, resulted in transition to comfort care. She expired comfortably surrounded by family at 1250 on 10/4/21.
Cough, congestion, aches, low grade fever, headache, chills.  Was off work a week.
3 pts recvd a seeries of 3 Engerix-B vax on various dates followed by 2 booster doses of Engerix-B on various dates & were non-responders;
Initial report received from Nurse on 08-Oct-2013. The patient had received ADACEL (lot number, route and site of vaccination were not reported). (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 at 17:30 as dose 4 (booster), single (Lot number: FK9893) at the age of 68 years, in left arm for covid-19 immunisation; Covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: ace inhibitors, reaction(s): "Known allergies: ACE inhibitors". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- The patient received vaccine. Anti-viral details Product-COVID 19 treatment, Brand-Paxlovid, Treatment start date-30Jun2022, Treatment stop date-05Jul2022, Lot Number-Unknown, Indication-Treatment of COVID-19, Administrator route- Oral. Adverse event: Recurrent cough and nasal discharge. Adverse events start date: 09Jul2022. Adverse events start time: 07:00 PM. Ae resulted in none of the above. If patient recovered it was recovering. If treatment ae was no.  Conclusion-This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the One and Done' business process according to in PQS Q1215 and/or Q1252. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for Pfizer-Biontech Covid-19 Vaccine was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FK9893. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Manufacturing facility concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
slight soreness in both the doses; Little annoying but nothing else; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight soreness in both the doses) and IRRITABILITY (Little annoying but nothing else) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced VACCINATION SITE PAIN (slight soreness in both the doses) and IRRITABILITY (Little annoying but nothing else). At the time of the report, VACCINATION SITE PAIN (slight soreness in both the doses) and IRRITABILITY (Little annoying but nothing else) outcome was unknown.            No treatment information was provided. No relevant concomitant medications reported.   This case was linked to MOD-2021-029670 (Patient Link).
This case was reported by a pharmacist and described the occurrence of nodule injection in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medical conditions included pulmonary disease, endocarditis, intestinal perforation, prematurity at 25 weeks gestation and retinopathy. Concurrent vaccination included pneumococcal vaccines (non-GSK); Wyeth Labs; unknown; unknown given on 29 June 2013. Concurrent medications included Ampicillin, Caffeine, LASIX, GENTAMYCIN, PRED FORTE and Parenteral fat emulsion (TPN lipids). On 29 June 2013 at 12:54 the subject received 1st dose of PEDIARIX (.5 ml, unknown route, left thigh). On 30 June 2013, 1 day after vaccination with PEDIARIX, the subject experienced nodule injection site. The nodule was described as large. The subject was in the neonatal intensive care unit at the time of vaccination. The pharmacist reported that the immunization series not discontinued or delayed. On 11 July 2013, 12 days after onset, the event was resolved. The pharmacist reported 4 other cases. See cases A1033993A, A1033994A, a1033995A, and A1033997A for details on the other cases. Follow up received on 6 August 2013. The lot number was reported as AC218406CA from the reporter; however, based on safety lot number review, the lot number was updated to AC21B406CA.
At around 10:00 P.M shakes & shivering and sore all over body. Spent next day in bed. Drank fluid all day. Took 2 days till he felt better. Felt like he had a fever.
Initially, Mild hives on stomach and chest. Two days later hives on back on bottom.   4 days to clear with antihistamines and topical steroids.
Pt reported lightheadedness, flushing face 435 PM. Given ammonia pearl 455 PM, reported urticaria. Given .5 ml Epi (L) deltoid SQ. Squad called and transported to hospital 515 PM.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient had no pertinent medical history, drug reactions or allergies. On 13-SEP-2016, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 intramuscularly (lot # L014876, expiration date 13-SEP-2016) (it was recommended). Concomitant therapies included lovastatin (manufacturer unknown), metformin, losartan potassium (manufacturer unknown) and omeprazole. On 14-SEP-2016, the patient did not feel well, had general malaise, could not sleep and then developed a red rash at the injection site which was itchy and covered the top half of her arm. The reporter stated, that the patient was self medicated by applying an unspecified antihistamine cream on the rash as treatment (date was unspecified). No lab diagnostic studies were performed. The patient sought medical attention and was seen by pharmacist. The outcome of the events was reported as not recovered. The relationship between the adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
This spontaneous report as received from a physician refers to a 2 years and 5 months old female patient. On 19-NOV-2013 the patient was vaccinated with the first dose of MMR II (lot # 1579AA, expiry date 12-OCT-2013, 0.5 ml, intramuscular) and it was expired. No adverse effects reported. Additional information has been requested.
Patient developed painful genital ulcers. Looked most consistent with Lipschütz ulcers.
I want to report that I had a serious adverse event produced by the Shingrix vaccine. I have never had an allergic response to a vaccine. After the injection on Monday August 26th, I felt little discompfort at the site of injection but dry cough appeared after 3-days. The symptoms continued with rhinitis, sinusitis, headacke, blocked ear drums, chills, cold sweat that made me go to the Emergency room.  X rays were clean but CRP level  was 105 mg/L. Monocytes were 10.5% with 1.08*10^9. All other cell types and levels were within normal range. They treated me with paracetamol IV and polaramine im. I stayed for over 3hrs and they let me go with bilastine 20 mg qd. When returned home visited the Drs. office and was treated with amoxicillin and Flonase .  I also visited an ENT due to the ear blockade.  She told me it will take sometime to clear up (ears were ok but my hearing was decreased).Today, October 2nd, I am still with ear drum blockade but no headache or pain. FYI I had chicken pox when I was a child and was vaccinated with Zostavax approximately 3 years ago.
I received my flu shots about 2 weeks ago. Ever since then my shoulder has been bothering me, but today (10/18/18), the pain is really intense.
8 x 8" area of erythema no induration NSAID/BENADRYL.
Extreme sinus congestion; Cough; Got sick; Fatigue; Slept half the day away; Night sweats where she was sweating through everything she was wearing and the sheets; Slight sore arm; low grade temp around 100 but never went higher than that; So fatigued could not even drive/got so fatigued had to lay down; This spontaneous case was reported by a nurse and describes the occurrence of SOMNOLENCE (Slept half the day away), HYPERHIDROSIS (Night sweats where she was sweating through everything she was wearing and the sheets), PAIN IN EXTREMITY (Slight sore arm), SINUS CONGESTION (Extreme sinus congestion) and COUGH (Cough) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced SOMNOLENCE (Slept half the day away), HYPERHIDROSIS (Night sweats where she was sweating through everything she was wearing and the sheets), PAIN IN EXTREMITY (Slight sore arm) and PYREXIA (low grade temp around 100 but never went higher than that). 28-Apr-2021, the patient experienced FATIGUE (So fatigued could not even drive/got so fatigued had to lay down). On 02-Jun-2021, the patient experienced SINUS CONGESTION (Extreme sinus congestion), COUGH (Cough), ILLNESS (Got sick) and FATIGUE (Fatigue). On 29-Apr-2021, SOMNOLENCE (Slept half the day away), HYPERHIDROSIS (Night sweats where she was sweating through everything she was wearing and the sheets), PYREXIA (low grade temp around 100 but never went higher than that) and FATIGUE (So fatigued could not even drive/got so fatigued had to lay down) had resolved. At the time of the report, PAIN IN EXTREMITY (Slight sore arm) had resolved and SINUS CONGESTION (Extreme sinus congestion), COUGH (Cough), ILLNESS (Got sick) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Follow up information received included additional events and lab data.
Staff at adult family home brought out wrong resident for vaccine and I gave a Covid booster and Flu shot to someone who had already had both this year. No adverse events have been reported yet but shots were administered only two hours ago
Patient's 2nd dose was given too early. Patient received first COVID dose on 3/8 and 2nd on 3/25. Patient did not have any side effects
About 4 hours later my lungs started to feel like I had a band around them and they itched. Then I started to lose my voice. Continued and was getting worse with me getting short of breath. Severe malaise after 1 day. Went to doc and she gave me prednisone to take for 5 days - and felt it was an allergic reaction. It is now day 6 (six) since the shot and still feel week/sick and still feel short of breath and still have malaise.
had a variant of Guillan-Barre called Amsan; This is a spontaneous report from a contactable nurse. A 78-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, unknown lot number and expiration date) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that her mom, the patient, had a variant of "Gulliame Barre" called AMSAN following the vaccine. Outcome of the event was unknown.  Information on the batch number has been requested.; Sender's Comments: Based on the information currently available, the event variant of "Gulliame Barre" called AMSAN more likely represents an intercurrent medical condition associated with the patient's underlying contributory factors unlikely related to vaccination with PREVNAR 13.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
PROVIDER WENT BACK IN WITH FAMILY TO INFORM INCIDENT, FAMILY WAS FINE NO SYMTOMS OR SIGNS, PATIENT WAITED 15 MINUTES AFTER.
Pt developed increased redness, swelling and warmth of her left upper arm. Extreme discomfort noted for 36 hrs after injection pt's 2nd Pneumovax.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. On 28-AUG-2017, the patient was vaccinated with PROQUAD lot # N014759 for prophylaxis. Other suspect therapies included VARIVAX, M049126, 15-DEC-2018 and  sterile diluent for prophylaxis. On 28-AUG-2017, the patient experienced overdose and no adverse event. The outcome of overdose and no adverse event was unknown. The reporter considered overdose to be not related to PROQUAD and VARIVAX. The reporter considered no adverse event to be not related to VARIVAX and PROQUAD.
I was having a lot of coughing and shortness of breath. I couldn't clear the mucus from my chest and had a slight fever. I went to the doctor on May 30 and was given medication. I went back in June or July and the dosage of medication was upped. I got better, but once the medicine was gone, I got worse again. I went back to the doctor and was given another round of medications that helped. I always feel better on the medication but feel worse when I'm not taking it. I have a pain in my back, under my shoulder blade. I was told it was a muscle spasm. I saw a doctor a week ago and was given more medicine. I still have a problem with coughing and getting the mucus out of my chest.
Was in the hospital for his heart condition; he had something around his chest area, some kind of pressure on his chest area; Chills; He ran a temperature of 100.4/running a temperature of 100.8; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9261), via an unspecified route of administration on the left arm on 27Jan2021, at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter (patient's wife) stated that both (patient and patient's wife) had the Vaccine shot on Wednesday, 27Jan2021. After that she was okay but he was not, he had something around his chest area, some kind of pressure on his chest area on Thursday (28Jan2021), he was in the hospital for his heart condition. Patient was done with stress test was good, had another test (unspecified) and he was okay. He had some temperature on Thursday while he was in hospital, next day on Friday (29Jan2021) he was relieved, then he was doing fine. He came home on 29Jan2021, and he started getting aspirin (given in hospital) and took cardiac medicine (unspecified). Everything was okay until few hours later, around 7 o'clock he started getting chills with running a temperature of 100.8 and then by 8 o'clock he ran a temperature of 100.4 (on 29Jan2021). Then call to nurse and the doctor, nurse said to give him the Extra Tylenol which was given at 9 o'clock and then patient's wife took his temperature again last at 11 o'clock, it was 99.55. Then this morning (30Jan2021) at 8 am it was 99.5 and patient had Tylenol and then also at 11 o'clock this morning it was 98.2, this afternoon at 2:45 it was back up to 99. At then at 3:53 it went up to 100.2, so at that point at 4 o'clock, given him Tylenol. He had some chills with it (Clarification unknown), chills were going back and forth. Seriousness of the events heart condition and chest pressure was reported as hospitalization. Outcome of the events was unknown.
pt felt itchiness in a large surface area of their body ( left arm ) and then after few days the itchiness start to form red blisters .  pt went to MD and took Medrol dose pack and Keflex .
pt recv vax 13SEP95 & 23JUN97 pt devel chickenpox;pt recovered;
covid pos after vaccination, started to have cough, runny nose, n/v, chills. called in sick 8/7. was aware he was covid positive.  fully vaccinated for covid since 3/2021.  advised to quarantine x10 days since symptoms first appeared and at least 24hrs passed since last use of medications. will need to be cleared with DOH and asymptomatic prior to seeking RTW clearance at clinic.  instructed to update manager. Antibodies testing ordered.
Twelve-year-old patient was given pediatric Pfizer BioNTech which is indicated for ages 5-11.  The administrating nurse noted at the top of the consent form that the parent wanted the pediatric dose even though her child was out of the indicated age range.
This spontaneous report was received from a pharmacist referring to a 17 year old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL for prophylaxis, when she was 12 years old, then on 21-JUN-2017, the patient was vaccinated with a dose of GARDASIL 9. No adverse events were reported.
Admitted 13JUL91 to Hosp w/inc swelling over inject site, w/inc warmth, redness rt arm; Spread from deltoid to ant cubital fossa-over 2 days; Pt seen in ER given ATB sx worsened t103; dx cellulitis;
COVID Arm           Hot, swollen, red, extremely itchy rash R arm injection sight.  10 days after second shot.
About an hours after injection, felt tingling in lower jaw. About an hour later tongue was about double size. Took an antihystamine