chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered just the liquid portion of Shingrix without prior reconstitution; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-OCT-2023, the patient received Shingrix. On 04-OCT-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered just the liquid portion of Shingrix without prior reconstitution) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-OCT-2023 The nurse reported that heath care provider from the clinic administered just the liquid portion of Shingrix without prior reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up. No patient information available. No lot number or expiration date for the vaccine.
Pt had seizure like activity-- head back, eyes rolled back, face red Lasted about 1 minute PT was lowered to the ground by staff out of chair No other injuries Pt then had nausea and vomiting -- was observed for about 1 hour-- more nausea and vomiting as he was taken to the car Pt agreed to be seen in the ED-- was given zofran and released   Later wife stated he has similar reactions to other immunizations
Information has been received from a licensed practical nurse concerning a 19 year old female patient with sulfonamide allergy who on 11-MAY-2010 was vaccinated SQ in the left upper armarea with a 0.5 ml dose of VARIVAX (Merck) (lot number 661984/1429Y, expiration date 16-OCT-2011). Secondary suspect therapy included a dose of ADACEL given in the left deltoid muscle. Concomitant therapy included unspecified oral contraceptive. The patient was also administered a tuberculin skin test on 11-MAY-2010. On 13-MAY-2010, the patient came to the office to read the tuberculin skin test; which was negative, and was found to have a "50 cent piece size" area of redness, swelling, induration and warmth at the site of the ADACEL injection. The patient had a similar injection site reaction at the site of administration of VARIVAX (Merck), but the reaction was "25 cent piece size". The patient was prescribed oral BENADRYL and warm compresses. At the time of the report the patient was recovering. The patient sought medical attention by an office visit. Additional information has been requested.
Red rash in a two inch circular area at injection site.   The rash is slightly raised and has an intense itch.  Warm to the touch  and slightly sore.
Developed papules on face and trunk, and continued to get more bumps for 5 days.  No other signs of illness.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a  patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information was reported.   This case was linked to MOD-2021-340870 (Patient Link).
24 hours after the second vaccine, I felt so out of breath and my heart rate had gone up to 115 that I had to go outside and have my daughter drive me home.  I did not go to the hospital because I did not believe what was happening and I did not want to worried my daughter on her special day. This was on Saturday May 1 at about 5:00 pm. I went home and went straight to bed. My wife was in disbelief and thought I was faking it. I have been having shortness of breath ever since. I am a teacher and on Monday I spoke to the school nurse and she had told me she had the same reaction and that it would be over in a month or two. I have had the same issues, but over the weekend of the 22 and 23rd of May, I have not been able to sleep as much. On  Monday, May 24, I went back to the nurse and she had took my blood pressure. It was 176/99 and that same day I went to the ER . I had all the blood work done and the only thing I had according to the doctor was high blood pressure. I had never had my blood pressure so high before.
01/05/22 presents to Surgery for "robotic right colectomy vs transverse colectomy". PMHx of "Colon Cancer" " Avascular necrosis"
About 4 hours after receiving this vaccine I experienced burning down my left arm and up into my chest. I had chest tightness and over the course of the day it became worse. I developed a fever of 100.9 and  I woke in the night to SEVERE body aches and a migraine headache. Fever and chills I also had a runny nose earlier that day.  It is now the second night after the vaccine and I am still experiencing severe pain in my joints back and kidneys. Also muscle pain If I have a fever in the am, should I wait to go back to work?
Patient developed a rash on her neck 2 days after receiving her vaccine that spread to her face later that evening. Rash remains 3 days later without improvement after taking multiple doses of Benadryl and using hydrocortisone cream. Patient reported the rash to her primary care doctor.
This spontaneous report as received from a 68 years old male consumer with high blood pressure and no drug reactions/allergies. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot # not reported) on approximately 26-SEP-2012, "about 30 days ago" in the left arm. Other suspect therapies given on the same date, included a dose of Influenza Virus Vaccine (manufacturer unknown) (dose and lot # not reported) given subcutaneously in the left arm. Concomitant medications included lisinopril (manufacturer unspecified). On an unspecified date, the patient experienced an injection site reaction consisting of swelling and redness, which went away after a few days. About one week ago, on approximately 19-OCT-2012, the patient started to experience nerve pain on his left side, which traveled from his thigh down to his calf. He was seen by his doctor for the nerve pain. His doctor administered an unspecified steroid shot (unspecified manufacturer) and prescribed hydrocodone/acetaminophen 10 mg/650 mg for the pain. There were no labs/diagnostic studies performed. The patient continued to take the hydrocodone/acetaminophen and stated that the steroid shot did alleviate the pain greatly. However, he described his present status as still recovering because the steroid shot seems to have "worn off," and the nerve pain had returned. The patient stated "Even with the pain medication, I still have some pain." The relatedness for nerve pain on his left side, injection site redness and injection site swelling was unknown for ZOSTAVAX  and Influenza Virus Vaccine (manufacturer unspecified). Additional information has been requested.
Prior to taking vaccine, my personal health was really good w/no major heart issues AT ALL. Within a few days of receiving J&J vaccine, began having trouble breathing & my chest felt tight. Developed dull pain initially, which developed forward into deep chest tightness/pain. This was non-stop from end of April, 2021 to early July when it finally let up a bit. My blood pressure was all over the chart (hi/low). My primary care physician added Losartan to meds (early July 2021), resulting in almost immediate BP  bottom readings in high 50s-low 60s. Physician changed to lower dose of Losartan after only 3 days on higher dose.  Between April 2021-July 2021, I was miserable with chest pain so I took Benadryl, 2-325 mg doses of aspirin, + 1 Aleve which helped with inflammation, even though it took several months to get any relief. Since early July 2021, I am still experiencing  intermittent chest pains. I go back on Aleve & aspirin which seems to help. I firmly believe vaccine damaged what was a perfectly healthy heart. I also believe those first few months I experienced myocarditis or some type of inflammation around my heart.
1/6/09 left upper arm became red, warm & swollen.  Injection site induration to size of 50 cent piece and was fury red.  Cold compress applied.  On 1/7/09, prescribed Z-PAK.  Also took 60 mg ALLEGRA X one day and 180 mg X 2 days.
The patient reported that he had a rash on his stomach and back that started about 4 days after his first moderna vaccine.  He said it was itchy for a few days and is still resolving a month later at his second dose.  He also mentioned that he works in a chemical lab, and is not sure if the rash is related to his occupation.
Pain and swelling in joints fingers, knees and feet status post Anthrax vaccine #2 worsened and exacerbated after Anthrax vaccine #3. Swelling start: 07/22/03; pain and edema of both hands and knees.  Joint pain, multiple joints start: 07/07/03.
At first just the arm was sore and tender and by the end of the day that he received the injection he wasn?t able to lift it very high. The next morning when he woke up at 7am, he complained about his stomach hurting badly, having a terrible headache, and then he vomited around 8 AM.  There is also a large red rash surrounding the injection site that has not subsided.
This spontaneous report as received from a physician refers to a female patient of unknown age with multiple (unspecified) allergies. On an unknown date the patient was vaccinated with an unspecified hepatitis B vaccine (manufacturer unknown). On an unknown date the patient experienced hives. The outcome of hives is unknown. No causality statement was provided. Additional information has been requested.
approx 3-5 days p/inject devel severe joint & bone pain lasting approx 1 wk;
(L) arm pain/swelling red some weakness joint pain fever-101. Supportive care -ice, NSAIDS. Decrease ROM. F/U 1 week.
Patient received 1st dose of Pfizer primary series on 9/8/22.  She returned to have her second dose of primary series on 11/2/22.  She received the bivalent booster instead of the second dose of her primary series.  They were advised to be revaccinated to complete the primary series.  They were also asked to get the
Pt recvd 1 dose of Engerix-B 6SEP91 & exp an elevated white count & liver enzymes & was sick x 3 wks; the vax series was discontinued & the sx abated;
Pt recv vax in early 1997; in 9/98 pt exp lack of response
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's concomitant medications included MERCK STERILE DILUENT lot# M039200 expiration date 03-MAY-2019. The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 07-FEB-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck) PROQUAD injection, lot # N022972, expiration date 19-FEB-2019, for prophylaxis (frequency, route and anatomical location were not provided). The administered dose of vaccine experienced a temperature excursion in the range between 6°F to 14°F during 6 hours as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA003986: US-009507513-1803USA007255: US-009507513-1803USA007256: US-009507513-1803USA007257: US-009507513-1803USA007259.
Black/blue bruise at injection site. Raised skin about 2 inch perimeter. About 4 inch red warm skin.
This spontaneous report was received from a pharmacist refers to a 67 year old female patient with actinic keratosis, diabetes, allergy to paraben's, milk and wheat. On 23-JUN-2014, the patient was vaccinated with ZOSTAVAX (lot # K0052621; expiration date 20-MAR-2015 , 0.65 ml, subcutaneous. Secondary and concomitant therapies were reported. Pharmacist reported that the patient came into the pharmacy on 25-JUN-2014 (reported as today) and showed her that she developed a large 3" x 3" oval shaped red patch below the injection site after receiving ZOSTAVAX. Pharmacist stated that the injection site was swollen, hot to touch, itchy, and she noted that a "knot" in the middle. Pharmacist sent her to her physician right away. Pharmacist stated that the patient was seen by the physician on 25-JUN-2014 (reported as today). The physician informed the patient to apply a cold compress to the injection site and to took BENDARYL. At the time of the report, the outcome of the adverse events was reported as not recovered. No labs diagnostics were performed.  Additional information has been requested.
Bilateral foot pain in ball of foot and toes, stiffness in the plantar fascia.
Patient's arm was reported to be very sore for days and not getting much better. The arm was still bright pink about the size of a softball around the area.
Recommended 2 mos vaccines received afternoon of 11/16/17. Evening of 11/16/17, child vomited large amounts 3 times at home. Contacted nurse hotline. Never heard from doctor or saw doctor until 4 mo checkup. Once again informed doctor of reaction to vaccine and symptoms were dismissed as coincidental.
Body aches, fatigue, swollen lymph node in armpit on the side the shot was given in
bakers cyst behind my right Knee; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, lot number EH9899, via an unspecified route of administration in left arm on 06Jan2021 at 09:00 at single dose for COVID-19 immunization. The patient received vaccination in Doctor's office/urgent care. Medical history included bladder cancer from an unknown date, cancer treatment with tumor vaccine therapy BCG (Bacillus Calmette Guerin) on 23Dec2020, bone spur in right thumb from an unknown date, COVID-19 from an unknown date and drug allergy to amoxicillin/clavulanate potassium (AUGMENTIN). The patient has not been tested for COVID-19 since the vaccination. Concomitant medication included doxycycline. On 08Jan2021 (also reported 3 days after the vaccine) at 05:45 the patient experienced pain and swelling in his right knee/calf and ankle. Pain and swelling in the right knee, calf and ankle continued until 14Jan2021 when the patient went to the urgent care. He was sent to the emergency room with a suspected blood clot and ultrasound proved no clot was in the leg. On 15Jan2021 the patient went to a hematologist and had an additional ultrasound which found a bakers cyst behind his right knee. He continued to have pain and swelling in the right leg and left hand which had already arthritis and he suspected it was an immune response to the vaccine. Rest, ice, compression and elevation were suggested as therapeutic measures to treat the events. The reported events had not resolved yet at the time of the report.
Had shot at 11am, around 6pm I got chills and body achey. Took tylenol, helped a little, went to bed, woke up still a bit body achey, but a bit better. Did not contact a doctor.
Within 8 hours of receiving the vaccine, she became very weak and disoriented. She knew her name but not the date or where she was. She also seems to be describing hallucinations. She was unable to stand or walk. She was taken to Urgent Care and then the emergency room by a family friend.
Tingling and numbness L arm L neck L face and ear to top of head L side since day after in am
I am a migraine sufferer. After getting the first Pfizer Vaccine my migraine headaches escalated I had three headaches between the first and second vaccine shot. I have also continued to have more headaches than normal since receiving the vaccine. I have had a total of six headaches to date since receiving the first vaccine.. Normally I have less than six migraine headaches in a whole year. I have also developed a constant ringing in my ears which started the day of or the day after I got the first shot.
Myocarditis; High blood pressure/ blood pressure remained high for several days.; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09May2021 09:30 (Batch/Lot Number: ER8732) (at the age of 26 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included anxiety disorder, asthma, food allergy (almonds) from an unknown date and unknown if ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 15Apr2021 08:00 in the Left arm (Batch/Lot Number: EW0158) (at the age of 26 years) for covid-19 immunisation. Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. There were no other vaccines in four weeks. Concomitant medications included escitalopram (ESCITALOPRAM) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, etonogestrel (NUVARING) taken for an unspecified indication, start and stop date were not reported. On 10May2021, patient experienced severe chest pain and pressure, and difficulty breathing. Myocarditis and high blood pressure. Patient's blood pressure remained high for several days. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient recovered with lasting effects/sequel on 2021. Patient did not receive treatment.   No follow-up attempts are possible. No further information is expected.
GARDASIL-9 was administered to a 46 year old female patient; No additional AE/PQC; This spontaneous report has been received from an unspecified reporter and refers to a 46-year-old female patient.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the 46-year-old patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (Product administered to patient of inappropriate age), administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided). No additional adverse events were reported.
Red and raised area. Warm and tender to touch. Complained of discomfort to area. Advised patient to follow up at ED for further evaluation.
Day of vaccine, developed elevated temperature, chills, nausea, spastic BM's, body ache, severe swelling of left arm; splotchy red rash on left arm spreading to neck, other arm and partially down chest; 3 very sore lumps on left arm.  Rx'd on 11/19/06 with Keflex qid and Zyrtec. 11/21/2006 A little better, 2 lumps on arm still present (2" and 1 1/2" diameter) - a little better.  Private provider (staff) stated client did not need to be seen if she were improving.
Hard lump, redness, itching, swelling, and pain at injection sight. Symptoms seemed normal for first few days as they are common. But it is now 5 days since the vaccination and the redness, itching, and lump are not resolving.
Day of vaccine- Within hours, site soreness, raised red, approx size of a quarter, mildly painful, with a "lump (that is still palpable) under the surface of the skin". Within 5-6 hours following vaccine administration, she reports she developed fever, chills for approx 2 days with fatigue and hot flashes on and off.  ** On 4/7/2021, patient states that in the morning she developed pain in her right calf. She saw her PCP.
Woke up Saturday morning with hives all over her body, took some benadryl later went to the doctor and was given steroids.
8AUG94 tingling feet & hand; 10AUG94 swollen glands & sore throat;
Severe stomach and intestinal pain on day two after the shot; Severe stomach and intestinal pain on day two after the shot; This is a spontaneous report from a contactable consumer, the patient (reported for self).  A 57-years-old (non-pregnant) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318; Expiration date: UNKNOWN), via an unspecified route of administration, administered in right arm on 28Feb2021 at 11:15 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history included known allergies, Allergic to several antibiotics. The patient's concomitant medications were not reported. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN318; Expiration date: UNKNOWN), via an unspecified route of administration, administered in right arm on  07Feb2021 at 14:30 as a single dose for COVID-19 immunization. The patient had not received other vaccine within four weeks. Prior to the vaccination the patient was not diagnosed with COVID-19.   On 02Mar2021 at 03:00, the patient experienced severe stomach and intestinal pain on day two after the shot. It was unknown, whether the patient received any treatment for the events. Patient was not tested for COVID post vaccination. Events severe stomach and intestinal pain were non-serious. Outcome of the events severe stomach and intestinal pain was reported as unknown.  No follow-up attempts are needed. No further information is expected.
some fatigue; Injection site pain; Minor body aches; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Nov2022, outcome "unknown", described as "Injection site pain"; PAIN (non-serious) with onset Nov2022, outcome "unknown", described as "Minor body aches"; FATIGUE (non-serious) with onset Nov2022, outcome "unknown", described as "some fatigue". Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient passed out after receiving the Pfizer covid vaccine from a sitting chair position.