chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain; swollen lymph node under arm on the left side (injection on left arm).; pain in diaphragm/ rib; pain in diaphragm/ rib; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left  arm on 31Mar2021 at 09:00 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history included high triglycerides and the patient had a history of seasonal and environmental allergies. The patient received unspecified medication within two weeks prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021, the patient experienced injection site pain, swollen lymph node under arm on the left side and 5-6 days later occasional pain in diaphragm/rib when taking in normal deep breath. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the adverse events. The clinical outcome of the events injection site pain, swollen lymph node and occasional pain in diaphragm/rib was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
The patient presented to clinic on today after signing up and booking an appt. the day prior, to receive her COVID vaccination. The student was vaccinated with the Moderna vaccine and observed for 15 min after vaccination. After student was vaccinated, it was discovered that she had already received a COVID vaccine - Johnson & Johnson 1 dose on March 6th. I called student to inquire and discovered that she did in fact already receive a 1 dose vaccine and had now received the 2 dose Moderna vaccine. She received her first dose of the Moderna vaccine on today after receiving the Johnson & Johnson vaccine 13 days prior.  She did not have an immediate reactions, but I raised concern over this and if she might after receiving 2 different COVID vaccines in less than 2 weeks apart.
PATIENT INITITALLY STATED FEELING NAUSEOUS. SHE ASKED FOR A BARRELL IN CASE SHE GOT SICK. WHEN ASKING, SHE SAID SHE WAS STARTING TO FEEL LIGHT HEADED. RPH CAME OUTSIDE TO ASSIST HER TO HER CHAIR. DURING TRANSPORT PATIENT SAID HER VISION WAS GONIG BLACK AND SHE COLLAPSED. I, THE RPH, CAUGHT HER BEFORE SHE WENT DOWN. 911 WAS CALLED AND I REMAINED WITH THE PATIENT UNTIL HELP ARRIVED. WE PROVIDED HER WITH WATER AND A SNACK AS SHE STATED SHE HAD NOT EATEN OR DRANK ANYHTHING THAT MORNING. BY THE TIME HELP ARRIVED SHE WAS FEELING BETTER, BUT WAS STILL CHECKED OUT. DECLINED TRANSPORT.
Incidental positive COVID infection found during routine testing.  Patient admitted to rehabilitation unit after stroke and found to be COVID detected.  Asymptomatic throughout stay.
Presented at 9:00AM for Flu vaccine, known allergy to Flu vaccine, so was given FLUBLOCK. Pt consented to this vaccine. Called back at 11:50AM stating she was starting to itch and breaking out in a red, burning rash. Returned to Employee Health for progression of symptoms. She was sent to ER for generalized whole body rash and itching.
Headache, high fever, sleepy, tired, didn't want to eat all the day of. The following day he started breaking out in a rash on his face and hands. Within a few weeks he was starting to complain of being tired and weak, showing signs of weakness, and complaining of the sun being too hot on his skin. After a few months he couldn't climb up a few stairs in the the house up to his room. January 2012 he was diagnosed with Dermatomyositis, after being misdiagnosed for months with hand foot mouth disease. Diagnosed at medical center.
Information has been received from a physician concerning a female with an allergy to clindamycin and no medical history, who had received three doses of RECOMBIVAX HB in the past, but when a titer was drawn, it was negative. On 08-FEB-2007, 13-APR-2007, and 23-JUN-2007, the patient was vaccinated with additional "booster" doses of RECOMBIVAX HB (Lot# 6533636/1064 and 653268/0223F). There was no concomitant medication. The patient's titer was drawn again, but it was negative. It was reported that the patient saw the physician. The physician reported that the patient had a vaccine failure. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Pt called on 9/11/15 to report some side effects that onset 9/8/15. Feeling pronounced flu-like symptoms (fatigued, achy), but also tingling in hands and fingers. This comes and goes, sometimes just in the thumbs, sometimes all over the hands, but only there. He reports being strangely weak, his grip is difficult to maintain sometimes.
Developed fever of 100.4, chills, muscle aches on Wednesday, 31MAR21.  No treatment sought for any symptoms.  Fever and chills resolved on 01APR21.  Muscle aches resolved on 02APR21.
Client had a syncope episode after receiving the vaccine.  Client states he has a history of syncope after vaccination.  97.9 degrees, HR 68, BP 127/72.  1:30 pm asst. to BR, gait steady, no c/o dizziness, continued to wait in observation area.  Allowed to leave at 2pm.
The morning after the vaccine, I began experiencing chills, injection site pain, and pain in both calves.  The chills and injection site pain went away within a couple of days, but the pain in both calves did not go away and continues to the present. It has not affected by ability to walk, but I continue to experience pain, as well as some throbbing and tingling in both calves.  There has also been occasionally tingling I my feet.  After extensive consultation with several doctors, and a variety of tests, it is suspected that this is a small fiber neuropathy that was caused by the vaccine.
orange urine; digestive; stomach pain with nausea; swollen lymph nodes of neck; stomach pain with nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (orange urine), DIGESTIVE ENZYME NORMAL (digestive), ABDOMINAL PAIN UPPER (stomach pain with nausea), LYMPHADENOPATHY (swollen lymph nodes of neck) and NAUSEA (stomach pain with nausea) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 025b21a and 036a21a) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoma, Drug allergy (allergic to amoxicillin.), Drug allergy (allergy to tetracycline.) and  macroglobulinaemia since 11-Jan-2018.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced CHROMATURIA (orange urine), DIGESTIVE ENZYME NORMAL (digestive) and LYMPHADENOPATHY (swollen lymph nodes of neck). 28-Oct-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain with nausea) and NAUSEA (stomach pain with nausea). At the time of the report, CHROMATURIA (orange urine), DIGESTIVE ENZYME NORMAL (digestive), ABDOMINAL PAIN UPPER (stomach pain with nausea), LYMPHADENOPATHY (swollen lymph nodes of neck) and NAUSEA (stomach pain with nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient weight reported  as 150 unknown units. The patient reported that he is about to do the blood test, CAT scans for the issues. No treatment details were reported. No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2021: Follow-up received on 06-Nov-2021 contains demographic details, patient history  and product information, new events added.
I went to see my primary doctor due to experiencing swollenness to my left arm. I also has swollen lymph nodes in my throat were swollen.  I still have some swollen, more than a little swollen today.  I had a severe headaches greater than 15 days. I was very tired constantly. I had a lot of aches and pains. I had joint pain all on the left side, hip, knee and ankle.  The lymph nodes throat just going down now a little bit. My doctor said to take Tylenol for the pain and disregarded me.  I also ran a fever after my vaccine.
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 08-JUL-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown, which was stored at -6.66 Celsius Degrees for 2352 hours. The type of excursion was refrigerator and the vaccine status in excursion. The concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Pt came in 2 day before 2/5/15 which would have been 2/3/15. Left bicep with mild erythema color and edema.
Redness at the injection site; Hot to the touch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE WARMTH (Hot to the touch at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE WARMTH (Hot to the touch at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE WARMTH (Hot to the touch at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Developed symptoms of covid 19 infection confirmed positive by PCR test. On 10/31/2021, despite receiving 2 doses of Pfizer?s MRNA vaccine. First dose lot number EN5318 received on 1/30/2021, 2nd dose lot number EN6201 received on 2/22/2021.
Information has been received from a company representative, reporting on a literature article (article name and author not specified) concerning patients who were vaccinated with a dose or doses of GARDASIL (date unspecified). According to the article, there were 4 cases of fainting after receiving GARDASIL. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/14/2007.  Follow up information confirmed that only one patient was identified with the events (WAES #0610USA04009).  Therefore, WAES # 0704USA000572 is being deleted from our files.  No further information is expected.  This report was previously sent in a monthly submission to PLA V501 on 14-MAR-2007.
Pain on injection site. It was swollen to a quarter size red lump. She can hardly move her arm.
Headache, tylenol, no results, only took 4- 500mg tablets because the pain didn't ease I stopped and started using Ice pack, no result, head still hurts on Thursday February 18. So I just rested. Pain at injection site, Tylenol, after the 4 tablets and no relief and used ice pack, arm feels better. Fatigue, rested
After waiting 15 minutes patient said did not feel well after vaccination. Patient complained of burning throat and was coughing. Advised patient we should wait another 15 minutes to monitor for allergic reaction. Patient said burning feeling progressed to ears and head. Kept saying he felt like he could breathe but would mention having trouble making a breath. Patient then said his eyesight was hazy and having trouble feeling. We decided to call 911 at this point. Patient was able to speak and breathe during the wait for EMS. EMS arrived and took patient out to ambulance to further treat. Not sure what happened after ambulance left.
Reports "f eels like heart racing" post vaccination (2nd dose); assessed HR 102 Monitored x 30 minutes, rest w/ no additional complaints  symptoms resolve, released from facility home
p/vax pt devel pruritic welts (hives) at waistline; disseminating to lower abd/chest;neck over 60-90 min; lips & tongue began to tingle & numb; went to ER; Rx: Celestone; benadryl; home instruction;
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 89-year-old female patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient received SHINGRIX and later reported developed Shingles. She reported that the shingles was resolved at the time of report. The pharmacist read what could be interpreted from a scanned document. No additional details were provided.
Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA323313, 2018SA323314 and 2018SA323312 (same reporter). This case involves a 11 years old male patient who was vaccinated with 0.25ml dose of FLUZONE QUADRIVALENT (batch number: UT6315PA, expiry date: 30-Jun-2019) intramuscularly in left deltoid instead of 0.5 ml , on 21-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due vaccine underdose. They accidentally gave 4 older children ages 11-18 an injection of 0.25mL of FLUZONE QUADRIVAENT instead of the 0.50mL dose. The patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This spontaneous report was received from a nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with PROQUAD and VARIVAX during the same office visit. No adverse effects reported. Additional information has been requested.
pt vax 3 doses of hepta B. pt responded w/ high anti-HBs titer.  1990 pt sustained needle stick and anti-HBs titer was neg. 21aug90 pt vax addit. hepta B. pt devel diarrhea, nausea, and dizziness.
Soon after the shot, while waiting the 15 minutes, my face from my chin to my eyebrows felt very warm. Like it was getting red and numb.  I sat very still and did not panic. I took a Claritin while waiting. The pharmacist who gave the shot had gone back to work. At the end of 15 minutes I received my paperwork and left the pharmacy. I was not checked on or asked if everything was OK.  I went home and sat quietly for the evening. The sensation wore off about 5 1/2 hours later. I took another Claritin before bed.  When I had received the previous 2 shots I did not have any concerning reactions. They had been given by pharmacy - EN5318 & EN6199 in right arm.
This spontaneous report as received from a physician via field employee refers to an unspecified number of patients of unknown demographics. Medical history and current conditions for the patients were unknown. On an unknown date the patient was vaccinated with ZOSTAVAX (refrigerated vial 19400 PFU) (dose, lot and expiry date unknown). On an unknown date the patients developed shingles after receiving a dose of ZOSTAVAX (refrigerated vial 19400 PFU). The physician treated the patients with acyclovir (manufacturer unknown). The outcome of shingles is unknown. No patient contact details were available. Varicella Zoster Virus Identification Program (VZVIP) packet was faxed. Additional information has been requested.
shortness of breath and heart palpitations usually happens around midday and when  patient is in the heat  Chest pains
Dizzy, the lost consciousness & about 2 sec of tonic-clonic movements of upper & lower extremities. Pale, conscious within 10 sec. No cyanosis.
PATIENT DID NOT HAVE AN ADVERSE EVENT, BUT DID RECEIVE BOTH TYPES OF VACCINE MODERNA AND PFIZER.  PATIENT WENT TO AN OUTSIDE CLINIC AND RECEIVED PFIZER 01/26/2020 AND THEN THEY DID NOT HAVE A SECOND DOSE FOR HIM.  HE THEN CAME IN AND RECEIVED A FIRST DOSE MODERNA 02/12/2021 AND SECOND DOSE 03/12/2021.  PATIENT DID NOT INFORM STAFF THAT HE HAD ALREADY HAD PFIZER PRIOR TO MODERNA VACCINE.  PATIENT TOLERATED WITH NO ISSUE.
Information has been received regarding a case in litigation concerning a child who, as an infant, was vaccinated with a dose of hepatitis B virus vaccine rHBsAg yeast manufacturer unknown. the alleged result of receiving the mercury contained in the thimerosal containing vaccinations is that he suffers, and will continue to suffer, neurological and immunological damage with symptoms including, but no limited to, developmental delay, loss of language, and failure to meet social and motor milestones. Upon internal review, neurological and immunological damage, developmental delay, loss of language, and failure to meet social and motor milestones were determined to be other important medical events (OMIC). No further information is available.
Hard lump site of a quarter near injection site. Symptoms self resolved after 1 week.
She was drowsy for hours after. She cried during the evening more than during her two month visit, in which we split up the vaccines into two appointments a week apart. This time we did them all as recommended. 12 hours after vaccines were administered she spiked a fever of 102 degrees. It was treated with a cold compress. Sleepless all night; baby usually sleeps well and is rarely fussy. All night she refused breast and refused bottle. She didn't eat well for two days. Fever persisted for two day around 100-102 degrees and was managed with cold compresses. Her extremities were clammy. No symptoms of cold/flu/strep were present. She had swelling and highest fever around her temples and brain stem.
discomfort from the shot; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site discomfort in a adult 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 injection site discomfort. On an unknown date, the outcome of the injection site discomfort was unknown.   It was unknown if the reporter considered the injection site discomfort to be related to Shingrix.  Additional details were reported as follows: The age vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient received Shingrix vaccine and experianced discomfort. The patient ask for advil as a treatment for discomfort.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted on the floor gave him crackers and gatorade fell better called 911 but he refused to go to the hospital. patinet was ok and responsive when he left. He fainted for a few seconds and care was given immediately. patient had no pain or swelling
Trouble breathing and pale. Patient has history of asthma is on XOPENEX and had URI(upper respiratory infection) and slight change prior to the VARIVAX.
No additional AE; an excursion of 4 Celsius degrees for 20 minutes during transport and 4 Celsius degrees for 20 minutes during transport/ administered on 09-SEP-2021; This spontaneous report was received from a registered nurse (also reported as medical assistant) and refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 07-SEP-2021 during transport, the varicella virus vaccine live (oka/merck) (VARIVAX) lot# U015682, expiration date: 18-MAY-2023, lot# U002394, expiration date: 22-JAN-2023 and lot # U010400, expiration date: 01-APR-2023 , experienced an excursion of (4 Celsius degree) for 20 minutes. On 09-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot# U015682, expiration date reported as 18-MAY-2023 (formulation, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). Administered dose of vaccine experienced the temperature excursion of -10 Celsius degree (C) to 8C ( 4C) for 20 minutes and -10C to 8C ( 4C) for 20 minutes. Previous temperature excursion: -10C to 8C ( 4C) for 7 hours and 30 minutes. No additional adverse event was reported (no adverse event).  This is one of the several reports from the same reporter concerning this vaccine.; Sender's Comments:  US-009507513-2109USA005628: US-009507513-2109USA005618: US-009507513-2109USA005632: US-009507513-2109USA005744: US-009507513-2109USA005742: US-009507513-2109USA005776: US-009507513-2109USA005881: US-009507513-2109USA005945: US-009507513-2109USA005964:
Extreme pain/discomfort x 2 weeks reported by patient. Left arm swelling x 2 weeks
Pt describes pain in arm (left) so severe. Can't lift child. Went to see physician about 1 week after 1/7/14 shot who ruled out infection. Pain still persists.
MY EARS ARE RINGING, THROAT SWEALING,SHORTNESS OF BREATH,  COUGHING, RUNNING  NOSE, SEVERE HEADACHE,NAUSEA, FEELS HOT AND  COLD. TEARY EYES. THIS  TIME  I HAD FLU 4TIMES SINCE I RECEIVED FLU SHOT 10/2022,WENT  TO URGENT CARE. AND REPOETED TO MY  DOCTOR ALSO.  HAD  MY TONGUE  SWOLLEN HALF IN THE  PAST BUT  DIDN'T  WHAT WAS  THE  COURSE THEN.