chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a 59-year-old male patient who received SHINGRIX. Concurrent medical conditions included blood pressure high. Concomitant products included LIPITOR. On 9th May 2018, the patient received the 1st dose of SHINGRIX. On 10th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site discoloration, injection site swelling, injection site erythema and injection site warmth. In May 2018, the patient experienced pain in arm and shoulder pain. On an unknown date, the outcome of the injection site discoloration, injection site swelling, injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the pain in arm and shoulder pain were unknown. The reporter considered the injection site discoloration, injection site swelling, injection site erythema, injection site warmth, pain in arm and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. The patient reported events to his pharmacist prior to contacting GlaxoSmithKline. On the 9th May 2018, at 9:45, the patient received SHINGRIX in the right arm. The patient did not have lot number or expiration date of the suspect. The patient received Blood pressure medicine and strength of LIPITOR was 40mg. The patient noted that the pain noted approximately 18 hours after SHINGRIX injection. The patient described pain as soreness and pain in his right shoulder and right arm. The patient noted area around injection was discolored and it was described as discolored as redness with some black and blue. The patient noted area around injection was hot and swollen and it was described swollen as swelling of at least 3 inches. The patient noted that the skin puncture from SHINGRIX injection appears as black dot. The pain, discoloration, heat, swelling and black dot had not improved or worsened since it began. The patient denied hospitalization for treatment of any of the events described. The patient could not recall the name of pharmacist that administered the vaccine. No additional information was provided.
complaints of cold; sore throat; coughing up dark brown phlegm; extreme headache; nausea; feels weak; feels really sick; tired; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 15Aug2021 as dose 1, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  It was reported that after vaccine, she was fine for two to three days. But, after 2-3 days of vaccination, on an unspecified date in Aug2021, patient started having complaints of cold, sore throat, coughing up dark brown phlegm, extreme headache, nausea, feels weak, and feels really sick and was very tired. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
A report was received from a healthcare professional on 10/02/2003 concerning a group of 40 vaccinees who inadvertently received 1.5ml Fluvirin instead of the recommended 0.5ml from 10/01/2003 onwards. From 10/01/2003 onwards 40 vaccinees inadvertently received 1.5ml Fluvirin. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 10/10/2003: A follow up report received from a healthcare professional indicated that the vaccinees were aged between 61 and 95 years of age.  There were 31 females and 9 males.  No adverse events were reported in association with the incident.
Report A0369098A describes a positive test for Hep surface B antigen in a 77 y.o. female who received Hep B vaccine recombinant (Engerix-B). The vaccinee was a hemodialysis PT. Concurrent medications were not specified. On 5/7/02, an unspecified "titer test" was positive for Hep B surface antigen. The reporting nurse had been told that "the false positive may have been due to a reaction with heparin when using the red tube for the collection of blood." A repeat titer was scheduled for one month post-vaccination. The reporter stated that the positive test for Hep B surface antigen may possibly be related to Engerix-B administration.
So the first time I had the problem was 12/30/2021 but the day before I had discomfort in my lower back I woke the morning with a burning and blood in my Urine my doctor thought I had perhaps passed kidney stone and sent to me to a Urologist and that doctor ran several tests. On 05/15/2022 I had another episode, I was then prescribed cefdinir. On 06/11/2022 I had the same episode again, another prescription of cefdinir was given me on 06/22/2022 an abdominal ultrasound showed numerous gall stones. On 07/10/2022 I also tested positive for COVID-19 as well and was prescribed PAXLOVID and fully recovered. On 07/21/2022 I had a surgery to remove my gallbladder. On 12/15/2022, 12/29/2022 and 01/02/2023 I had additional episodes of burning and blood in my urine. Doctors are unsure if I am passing kidney stones and cause unknown and more tests are forthcoming.
Mom called to report that child had developed Chicken Pox and injection site infection. She stated that child developed fever up to 102.3 at 3-4 days after vaccines given and site was swollen, raised, purple-red and hot to touch. He was taken to an urgent care clinic and dx with infection and chicken pox. He was started on an antibiotic for the infection. Mother claims that site of infection was "oozing clear fluid". Also states that lesions were tested "and it is chicken pox".
Information has been received from a registered nurse concerning an adult patient with unknown medical history and unknown drug reactions or allergies, who "over the last ten days" in October 2005, was vaccinated intramuscularly with a 0.5 ml dose pneumococcal 23v polysaccharide vaccine (Lot# unknown).  Subsequently, in October 2005 the patient developed a local reaction at the injection site including soreness, warmth, erythema and swelling.  Unspecified medical attention was sought.  The patient was reported to be recovering.  No product quality complaint was involved.  Additional information has been requested.
BODY ACHES; CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and body aches. This report was non-serious. This case, from the same reporter is linked to 20210333265.
I had  a positive COVID-19 test and called my doctor regarding Paxlovid which I picked up later that day and began taking it the next day or third day and took it for five days. My symptoms we dry cough and fatigue but I was able to due my daily activities. I stayed home and my Husband picked up my prescription and did the shopping . 15FEB2023 I was still testing positive on 18FEB2023 I tested negative.
Disoriented feeling; Pretty hot at injection site; Red rash at injection site; Red rash at injection site; Very itchy at injection site; Arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen), INJECTION SITE ERYTHEMA (Red rash at injection site), INJECTION SITE RASH (Red rash at injection site), INJECTION SITE PRURITUS (Very itchy at injection site) and INJECTION SITE WARMTH (Pretty hot at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical reported history). Concomitant products included METOPROLOL TARTRATE for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen). On 28-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Red rash at injection site), INJECTION SITE RASH (Red rash at injection site), INJECTION SITE PRURITUS (Very itchy at injection site), INJECTION SITE WARMTH (Pretty hot at injection site) and DISORIENTATION (Disoriented feeling). The patient was treated with LORATADINE (CLARITINE) ongoing since an unknown date at a dose of 1 dosage form; IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form and BACITRACIN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Arm was swollen) had resolved and INJECTION SITE ERYTHEMA (Red rash at injection site), INJECTION SITE RASH (Red rash at injection site), INJECTION SITE PRURITUS (Very itchy at injection site), INJECTION SITE WARMTH (Pretty hot at injection site) and DISORIENTATION (Disoriented feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This case concerns a female of unknown age with NS unexpected injection site warmth, peripheral swelling, disorientation, and NS expected injection site rash, injection site pruritus, injection site erythema.  Event onset the same day as first dose mRNA-1273, with rash on Day 14. Treated with Claritin, ibuprofen, bacitracin. Based on the current available information and temporal association between use of the product and the start date of the events, a causal relationship cannot be excluded.
I am experiencing shoulder pain; 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), administration date 05Apr2022 (Lot number: FK9893) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "I am experiencing shoulder pain".  Additional information: Primary Immunization series complete. Concern: Consumer stated, patient called because patient was experiencing shoulder pain after patient got shot this morning and was wondering if it will be safe to take either ibuprofen or Tylenol. Consumer stated, that the COVID-19 shot, the booster shot (Pfizer COVID-19 Vaccine). Consumer was informed about the Pfizer Medical Information department and telephone was shared as, option 3, 8 AM to 9 PM, Monday to Friday, as per EST. Consumer was informed about the role of Pfizer drug safety. Consumer hung up abruptly. Product details, Pharmacy details and other details could not be probed as consumer hung up abruptly. Hence further probing could not be done. Limited information available over the call.  No follow-up attempts are possible. No further information is expected.
Constant dull pain at injection site, swelling, rash. Limitations of left arm movement.
patient tested positive for COVID 19; patient tested positive for COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), on 18Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 25May2022, outcome "unknown" and all described as "patient tested positive for COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive.  Clinical course: Description of Event: This 59-year-old male patient received the Pfizer COVID 19 vaccine on 28Jan2021, 18Feb2021 and a booster dose on 29Oct2021. On 24May2022 the patient developed a headache and fever. On 25May2022 the patient tested positive for COVID 19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PT BEGAN WITH TEMP 104.7 ON 11/25/06. ON 11/26/06 PT HAD TEMP 102.7 AND RED WARM RASH ON BOTH THIGHS. ON 11/27/06 WOKE WITH BOTH CHEEKS BRIGHT RED AND WARM TO THE TOUCH. ON 11/28/06 NO FEVER, APPROX 35 RED LESIONS ON BELLY AND BACK. SEEN IN OFFICE 11/28/06 BLANCHING RASH, SLIGHTLY RAISED HEAD TO TOE SMALL SLIGHTLY PINK SKIN PATCH RIGHT POSTERIOR UPPER THIGH. NO TREATMENT PRESCRIBED.
vaccine was administered outside of facility - reported by patient ? NO LOT NUMBER WERE SUPPLIED ----------------------------------------------------------------------------------------------------------------------- G47.33 OBSTRUCTIVE SLEEP APNEA 7/8/2021 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/13/2021 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 12/24/2021 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE G47.33 OBSTRUCTIVE SLEEP APNEA 7/8/2021 COR PULMONALE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/13/2021 COR PULMONALE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 12/24/2021 COR PULMONALE
Initial unsolicited report received from a healthcare professional on 08 April 2015. A 11-year-old male patient, whose medical history was reported as none and concomitant medications were not reported received a second dose of ADACEL (batch number C4713AA) (expiry date, dose, route and site of administration were not reported), a second dose of PNEUMOCOCCAL VACCINE (batch number, expiry date, dose, route and site of adminsitration were not reported), a dose of HEPATITIS A vaccine (batch number, expiry date, dose, route and site of administration were not reported) and a dose of HEPATITIS B VACCINE whose batch number, expiry date, dose, route and site of adminsitratiton were not reported on 03 April 2015. On 06 March 2015, the patient received a second dose of IPOL and also a second dose of MMR II whose batch number, expiry date, dose, route and site of administration were not reported. It was reported that after the vaccination the patient experienced fever of 103 degrees F and swollen lymph nodes of axilla of arm in which had received ADACEL vaccination. It was reported that previously the patient had received first dose of ADACEL (batch number U4963AA) (expiry date, dose, route and site of administration were not reported), IPOL, MMR II and Pneumococcal vaccine (whose expiry date, batch number, dose, route and site of administration were not reported for all the vaccines) on 05 Februray 2015. It was reported that several days after vaccination, patient experienced fever of 103 degrees F and swollen lymph nodes at axillary area of arm in which ADACEL was given. Corrective treatments and other lab test reports were not reported. At the time of this report the patient outcome was unknown. It was reported that patient required Emergency Room/doctor visit. Documents held by sender: none. Follow up information received from a physician on 08 May 2015. It was reported that, patient had received 0.5 ml dsoe of Pneumococcal Vaccine (Batch number: LI3063, Mfr: - Pfizer) and 0.5 ml dose of IPOL (Batch number: K007827)), 0.5 ml dose of HEPATITIS A VACCINE (Batch number: K007827, Mfr: - Merck) and HEPATITIS B VACCINE (Batch number: K02144, Mfr: - Merck). All the vaccines were administered intramuscularly. No new additional information reported. Documents held by sender: none. Follow-up information received from a physician on 06 July 2015. Patient had previously experienced fever and lymphadenopathy when he received first dose of ADACEL, IPOL, MMR II and pneumococcal vaccine. Patient had received antibiotics previously as corrective treatments. A CXR (chest X-ray) and blood tests were conducted which were found to be negative. Patient has visited the office twice. It was reported that the patient was doing well with no further symptoms and recovered from the events on unspecified date. List of Documents held by Sender: none.
pt recv vax & 2hr p;vax pt exp 15sec period of shaking legs, cheeks, arms & legs;pale looking;30min later 5sec period dazed looking, sleepy, still pale;t99.9R then up to 101.4R the following day;
cough, mild periorbital swelling and erythema, moderate air entry with biphasic wheeze 30 minutes after vaccine with Hepatitis A and Varicella. Pt given Prednisolone PO, BENADRYL PO & XOPENEX neb.
injection site was slighty sore for 2 days and then i was fine.   9 days later woke up with a very sore, warm at touch, red with a itchy rash and lump.  lasted one day and and continues to get better.    Is this normal and can i get the second shot,
Per mom, patient was fine when seen at well child visit and vaccinations on 10/4. He became irritable that night and more irritable the next day. Pt developed emesis x1 late on 10/05 and again on 10/06. Presented to outside emergency room where patient was distended, hypoglycemic, and severely ill appearing. Fluids and antibiotics given. In transport to us, required start of Dopamine. On arrival  patient was hypotensive to 42/20 and epinephrine started. Pt was obtunded and grey appearing. Intubated emergently without need for sedation. Based on tense abdomen, patient was taken emergently to the operating room. After placement of central lines and a urinary catheter, the abdomen was opened. At this point labs returned with a pH of 6.5. He was felt to have abdominal compartment syndrome. The bowel was generally ischemic, but perfusion began to improve with the abdomen open and transfusion of blood and albumin. Exploration revealed an ileo-ileal intussusception. This was able to be reduced. Additionally, the patient had dilation of the descending and sigmoid colons with thickening consistent with colitis. A portion of the sigmoid colon was resected and sent for frozen section. Ganglion cells were identified and the pathologists noted colitis was more consistent with infectious etiology. An end colostomy was brought up and the abdomen was left open with a wound vac. On initial return to the ICU, the blood pressure was improved to 60-80 systolic. The patient was making good urine. Extremity perfusion was improved. About an hour and a half later, the patient began to deteriorate again. Lactic acid was rising to >20. An echocardiogram revealed an ejection fraction of only 15%. I removed the abdominal dressing and the bowel below had clear necrosis. I re-explored him at the bedside. With evisceration of the bowel, the ejection fraction went up to 35%. On inspection, the ileum that had previously been intussuscepted was necrotic. This was approximately a foot and a half of bowel. This was resected. The remaining left colon and 1/2 of the transverse colon was now necrotic as well and was resected. The terminal ileum and right colon were viable, as was the small bowel proximal to the intussusception. The remaining bowel was placed in a silo bag. The patient continued to deteriorate. Six hours later, all visible bowel was necrotic. The patient was made comfort measures only and expired.
The next day post vax, the pt experienced red spots. The pt was instructed to use warm compresses and Benadryl by the registered nurse.
I went to clinic this morning and gave patient her  Covid  Vaccine. I thought I was giving her the 2nd vaccine.  I called the manager of the facility when I left and she said patient had already received both vaccines. She faxed the copy of her card to me and it showed that she had received her first vaccine on 2/3/2021 her second on 5/13/2021.  I reviewed her prescription records this morning  but I did not go back to February because I thought she was receiving her 2nd shots along with the other residents.   I made a new card and left it with the aid at the home that showed 5/13 as the first dose and 6/10 as the second dose(actually her 3rd ).  ** I should have insisted on having the previous card and I should have check the vaccine registry. This will be done from now on.
Cough  Fatigue  Injection site soreness  Chills  Headache
October of 2020 tumor was found had surgery and chemo, December had second dose. After completing Surgery and chemo . Doctors found an additional tumor 4 days post vaccine.
Patient received a Pfizer booster shot in his left arm then a fluad in his right arm  He then went to stand up and put his sweater back on and he fell over onto the table  then he slowly went down to the ground and he collapse maybe a foot and a half off the ground  Someone shouted please help I ran out and realized he was unconscious then I said call 911 and checked him tried to get him to respond over realized he was out I performed maybe 2 sets of chest compressions  I then saw he was breathing still not responsive  The person on 911 was very helpful then patient started to gag he told me to roll him on his side and keep him there then ems came
Wheezing; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Wheezing) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WHEEZING (Wheezing). At the time of the report, WHEEZING (Wheezing) outcome was unknown.            No concomitant products were reported. No treatments were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14-JUL-2021 contains non significant information. The reporter contact details were updated.