chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00552062).  This case involves a 20-month-old male patient who received an expired 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5611BA and expiry date: 03-Apr-2021) via an unknown route in the right thigh (vastus lateralis) for prophylactic vaccination on 07-Apr-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE and HIB VACCINE CONJ (OMPC) (PEDVAXHIB) for prophylactic vaccination.  This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements. 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.
This spontaneous report as received from a registered nurse, via company representative, refers to a patient of unknown age and gender. Pertinent medical history, drug reaction or allergies were not reported. On an unknown date the patient was vaccinated with several series of unspecified hepatitis A vaccine, inactivated (manufacturer unknown) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. No adverse effects were supported. The outcome of the events was unknown. Additional information has been requested.
Patient describes rash of small red dots all over body starting the morning after having received the vaccine. This rash was extremely itchy, especially in the arm of the injection site, which was also very red. She also became very fatigued beginning the day after receiving the vaccine, and she experienced pain in the skin of her abdomen.  These symptoms lasted until yesterday, 1/19/2020. Patient saw her medical doctor today, who drew blood labs to determine if she experienced an allergic reaction to the vaccine. Doctor also recommended that she notify the health department so that we could file a report with VAERS.
Swollen right leg in AM four days after vaccine. Diagnosis of DVT next day, five days after vaccine. Have been on eliquis for about 4 months. Leg is still swollen. Not surprising since the covid spike protein causes blood clots.
extremely ill; rash; fever; fatigue; This case was reported by a other health professional via interactive digital media and described the occurrence of unwell in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 31st July 2019, the patient received Bexsero. On an unknown date, less than a week after receiving Bexsero, the patient experienced unwell, rash, fever and fatigue. The patient was treated with antihistamine (Antihistamines), esomeprazole magnesium (Nexium), ondansetron (Zofran), topical steroid nos (Steroid Cream), nsaid's and prednisone. On an unknown date, the outcome of the unwell was not recovered/not resolved and the outcome of the rash, fever and fatigue were unknown.   It was unknown if the reporter considered the unwell, rash, fever and fatigue to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was pro vaccination but his daughter got a shot and had been extremely ill since. The reporter did the normal treatment antihistamines, Nexium, Zofran, rubbed the arm with alcohol, put a steroid cream on the rash, gave Non Steroidal Anti Inflammatory Drug for the fever, and marked the rash to determine the growth. The reporter found it very disturbing that this shot has caused her so many side effects and that she's completely fatigue 3 days later. The reporter talked to the nurse and then to the doctor and they said they have done everything aside from giving her prednisone to help her so try to ride it out and she should feel better in a week. The reporter was sure when she gets better it would just be a bad memory but she needed the booster shot.
Cellulitis; Inflammation; interrupting his ability to work; Headache as pretty painful / interrupting his ability to work; This case was reported by a physician via call center representative and described the occurrence of cellulitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), inflammation, headache and inability to work. On an unknown date, the outcome of the cellulitis, inflammation and inability to work were unknown and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the cellulitis, inflammation, headache and inability to work to be related to Shingrix.  Additional details were p[rovided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced cellulitis, inflammation, headache and inability to work following dose 1 of Shingrix administration. The reporter stated that, the patient received another vaccine at the same time (name was not provided). The patient had headache as pretty painful, which lasted for 4 days. No additional details were provided. The reporter did not consent to follow up.
Generalized hives developed 72 hrs. after vaccination. Intense itching, large areas of red rash over entire body. Hives have not resolved and are present every day.
Following immunizations immediately had hives on abdomen resolved, woke up in morning with rash on cheeks resolving.
Joint Pain began 1 day post immunization. Pt still has intermittent joint pain to date.
Pt appeared light headed immediately after immunizations, which care was rendered, mom in attendance on 3/3/16. Next day mom called to report diarrhea, rash on bilat arms, fatigued, headache, poor appetite and not taking in fluids. Also with lower back pain. Sent to ER 3/4/16.
Pt developed cellulitis @ site of injection. Developed later that night. hot & swollen
Within seconds, post vax, the pt had apnea and was arousable with stimulation but continued to have 4 other episodes and was admitted.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 01-OCT-2012 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot # not reported) that had been improperly stored. No adverse effects reported. It was unknown if the patient sought medical attention. Additional information is not expected.
After receiving the vaccine, pt claims he can't see or hear well. Offered to call 911 or monitored until pt felt better. After 20 min pts vision was coming back and hearing was normal. 30-35 min later, vision and hearing came back to normal. Monitored pt for 1 hour and was okay to leave. verified if pt was okay and he was okay with no other symptoms. Temporarily experienced side effect.  Pt will follow up with pcp doctor tomorrow just in case.
pulse is low, around 45-50; feels like they are going to have a heart attack; strong dizziness; feels like their going to stop breathing; cannot explain what is happening to them.; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE DECREASED (pulse is low, around 45-50) and CARDIAC DISCOMFORT (feels like they are going to have a heart attack) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. notprovided) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Aug-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 01-Sep-2021, the patient experienced HEART RATE DECREASED (pulse is low, around 45-50), CARDIAC DISCOMFORT (feels like they are going to have a heart attack), DIZZINESS (strong dizziness), DYSPNOEA (feels like their going to stop breathing) and FEELING ABNORMAL (cannot explain what is happening to them.). At the time of the report, HEART RATE DECREASED (pulse is low, around 45-50), CARDIAC DISCOMFORT (feels like they are going to have a heart attack), DIZZINESS (strong dizziness), DYSPNOEA (feels like their going to stop breathing) and FEELING ABNORMAL (cannot explain what is happening to them.) outcome was unknown.            No concomitant product was provided by the reporter. No treatment medication was provided.
LPN's at the pfizer table accidentally gave a 7th dose from the vile to the above patient. Normally they keep track of 6 doses by keeping 6 syringes on the table until all doses are given. New staff was instructed to call nurse manager before mixing next vial so she could observe, new nurse. Nurse manager identified error when she realized they did not count their does correctly. First vial, had to waste one because dose was < than .3 mL. Second vile, they got to 12th dose and forgot to subtract one for the wasted dose in count. Patient had already left the clinic before identifying the error.
This spontaneous report was received from a female consumer of unknown age reporting on herself. The consumer was vaccinated with ZOSTAVAX on 20-JUL-2012, in her arm (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the consumer's arm swelled to tennis ball size at injection site. No treatment information was reported. At the time of report, the swelling was starting to subside. It is unknown if the patient sought medical attention. The relatedness for arm swelled to tennis ball size at injection site is unknown for ZOSTAVAX. Additional information is not expected.
injection site swells up about 2 inches.  Patient feels hot and tingling at the injection site.  Her hand is also swollen and the swelling runs down to her finger.  She has pain started from her shoulder and runs down to the arm.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients. Pertinent medical history, allergies and drug reactions were no reported. On 27-JUL-2016, the patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ orally lots # M004890, M014544 and M007125, expiry date 10-NOV-2017, 27-NOV-2017 and 06-OCT-2017 respectively. The doses and routes of administration were not reported. At the same date no adverse effects were reported. Additional information has been requested.
Body aches and headache around 10:00 PM when I tried to go to sleep. Restless the entire night while feeling hot like I had a fever. Tool temperature but no fever. In the morning, felt dehydrated. After washing my hair and face, had a fainting spell but never fully fainted, which left me recovering on the bathroom floor for about 20 minutes. Still very sore and had chills with no fever still. Took Tylenol and Advil at different times to help. Not really any symptoms come 9:00 PM on 01/20/22.
Myalgia, Fever, nights sweats, fever 101F, body aches Narrative:  Symptoms still present, but improving
Approximately five minutes after injection, patient began feeling faint, nauseated and weak.  Her parents had her sit down.  She began vomiting and sweating.  We called 911.  Her Dad starting taking vital signs.  He is an ER Dr at local hospital.
weakness, cough, fevers, body aches, increase shortness of breath, pulse Ox 80% on room air
Racing Heartbeat, cough not related to any type of chest congestion etc.,  unable to tolerate exercise, chest pain which was much worse when laying down, occasional shortness of breath and swelling of ankles.  Current treatment: 650mg aspirin TID for 7 days, then 650mg daily for 7 days  colchicine 0.6 mg tablet 1 by mouth 2 (two) times a day. (180 tablets) omeprazole (PRILOSEC) 40 MG capsule 1 capsule (40 mg total) by mouth daily.
Information has been received from a consumer concerning her granddaughter who in February 2009 was vaccinated with the 0.5ml first dose intramuscularly of GARDASIL (Lot # unknown). In April 2009, she was vaccinated with the second dose of GARDASIL (Lot # and route no reported). The consumer reported that the third dose should had been administrated in September 2009, however she stated that when her granddaughter went to get her medical records from school, it stated that she had not gotten the third dose of GARDASIL. It had been listed that she received the influenza virus vaccine (unspecified) (name and manufactured no reported), which the office nurse confirmed. No further information is available.
Fever; Sickness; can't breathe; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 21Feb2021 (at the age of 68-year old) as dose 1, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On 21Feb2021, since the vaccination, he had fever and was sick. It was reported that, he thought that the last couple days had been killing him. He stated that, he also can't breathe, and his next shot is scheduled on 15th. At the time of report, it has been 9-11 days already since he was sick. Patient reported that he has not spoken to his doctor yet, and the patient was referred by call handler to ER or an urgent care if he feels like his life is at risk. He stated that this was the worst he has felt in his life. He mentioned that he would try to get a hold of his doctor and see if they care, as he is so sick. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
local angioedema on right arm treated by PAC with Xyzol (escitinzene (antihistamine) 5 qd
PATIENT FAINTED IMMEDIATLEY AFTER RECEIVING THE VACCCINE.  WAS MONITORED AND BLOOD SUGAR CHECKED BECUASE SHE REPORTED NOT EATING THAT DAY
Live Zoster vaccine administered on 7-13-2011. Starting in December 2013 I have had shingles repeatedly. Episodes have been very severe. I have experienced ongoing weight loss and nausea and severe pain.
Subsequent to receiving a fourth dose of Engerix B the pts hepatitis status was drawn and determined to be negative. Labs were drawn on the pt after both the first and second doses of Engerix B, with negative HBsAg and ALT/AST within normal limits Subsequent to third dose of Engerix B labs were drawn and a positive HBsAg was received. Pts blood was redrawn and sent to an independent lab where a second positive HBsAG was reported. The most recent information received, reports the condition of the pt as ongoing.
Initial unsolicited report received from a Medical Assistant on 12-Jan-2015. A 57 years old female patient had received a dose of ADACEL (batch number: U4886AA, via intramuscular route in the left arm) on 05-Dec-2014. The patient had no illness at the time of vaccination. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergies and patient had no medical history and concomitant medications were not reported. On 05-Dec-2014, the patient experienced muscle soreness of arm and "impingement upon raising her arm". The symptoms continued till 12-Jan-2015. She stated that the symptoms may have improved somewhat but continues to have the symptoms. Laboratory investigations and corrective treatments were not reported. The patient required ER/doctor visit. At the time of this report, the outcome of the patient was reported as not recovered. Documents held by sender: none. Follow-up information received from a healthcare professional (physician Assistant- certified) on 07 April 2015. The patient did not have any illness at the time of vaccination and patient had medical history of anxiety, post-menopausal symptoms and no known allergies. The patient had received LEXAPRO 10 mg, Premarin tablet, Xanax 0.5 tablet. It was reported that, patient had not received any vaccine within 4 weeks prior to vaccination. The patient was vaccinated at private doctor's office/hospital and vaccine purchased with private fund. The patient did not experienced adverse event following prior vaccination. Documents held by sender: none. Follow-up information received from a health care professional on 11 May 2015. As of 13 February 2015, it was reported that the patient was still continuing to have pain in left upper arm and some discomfort as the patient lies on the arm during night. List of Documents held by Sender: None. Follow-up information received from a health care professional on 06 Jul 2015. It was reported that, as of 02 April 2015, the patient continued to have mild muscle tenderness in left arm but definitely continuing to improve. The patient was recovering from the muscle soreness of arm and mild muscle tenderness. List of Documents held by sender: None.
Information has been received from a physician concerning a 12 month old male with an allergy to amoxicillin who on 28-MAR-2007 was vaccinated intramuscularly in the left thigh with a 0.5 mL third dose of PedvaxHib (lot 653523/0063U). The patient was concomitantly vaccinated subcutaneously in the right thigh with a 0.5 mL first dose of MMR II (lot 654820/1027F) and intramuscularly in the left thigh with a fourth dose of Prevnar (lot B08684K). An unrelated pinpoint rash over trunk and diaper area was present prior to vaccination on 28-MAR-2007. On 28-MAR-2007, the patient experienced increased irritability, fever, redness around the injection site of MMR II, and redness below the site on the left thigh. The patient developed injection site swelling shortly after vaccination with PedvaxHib and went to the emergency room. The patient was not admitted to the hospital. The patient was examined in the office on 29-MAR-2007, and the reaction was described as a red, warm, swollen, painful knot the size of a quarter. The patient was treated with cephalexin 125mg/5mL 4cc three times a day for 7 days. On 30-MAR-2007, the patient's mother reported that the patient was recovering as of that date. On 05-APR-2007, the patient recovered that the patient was recovering as of that date. On 05-APR-2007, the patient recovered from erythema, injection site erythema, irritability, and fever. The patient's increased irritability, fever, redness around the injection site of  MMR II, and redness below injection site on left thigh were considered to be other important medical events by the physician. The office requested a lot check be performed on  lot 653523/0063U. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. This is one of several reports from the same source. No additional information is expected.
Mild pain/soreness at injection site starting later the day of injection and next day. Approximately 2 pm the day after injection, began feeling overly hot and nauseated. That was followed by pressure type headache, muscle/bodyaches, and overall feeling of no energy progressing as the afternoon and evening continued. Spent that evening sleeping on/off. The following day spent in bed with continued headache, body/muscle aches, feeling overall drained/ no energy.  Nausea improved some; was able to stomach some soup later in the day.  So far today, feeling  some improvement with bodyaches, but overall drained of energy. Headache has lightened some as well.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Possible "COVID arm"-Mild
Initial report received from a healthcare professional on 31 July 2013. A 61-year-old female patient, had received an intramuscular first dose of ADACEL vaccine (lot number: C4365AA) in left deltoid on 25 July 2013. The patient had a medical history of diabetes. The patient had no known allergies and no illness at time of vaccination. Concomitant medications were not reported. On 26 July 2013, one day after vaccination, the patient developed 6 x 8 cm red and warm area at the injection site. Laboratory investigations and corrective medications were not reported. On 31 July 2013, there was no improvement in the patient and the patient visited a physician who verified the measurements. Documents held by sender: None.
After receiving  the vaccine, the patient stated that he felt light-headed, and was sweating profusely. He vomited.  His blood pressure was 118/82 mmHg, pulse 81 bpm, and respirations 16 bpm.  He said he felt like his throat was closing, so we gave him liquid diphenhydramine. At this point, we called 911. The patient was alert and talking the whole time.  The patient went with EMS. The patient came back later after being released from the hospital and said that he didn't have an allergic reaction, but he had vasovagal syndrome.
VET CALLED BACK REPORTING PAIN AND SWELLING IN ARM WHERE SHE GOT INJECTION. SHE  SAID PAIN WAS 10/10 YESTERDAY AND WAS ACCOMPANIED BY NAUSEA. SHE REPORTS PAIN IS  AN 8/10 TODAY BUT REDNESS IN AFFECTED ARM IS WORSE ABOUT THREE INCHES. SHE  REPORTS THE LYMPH NODES UNDER HER ARM APPEAR TO BE INVOLVED. SHE REPORTS SHE  USED ADVIL YESTERDAY AND PUT ICE ON ARM BUT GOT LITTLE RELIEF.                                PLAN: Cool compress, rest, Ibuprofen 600mg one TID #24 given note for work off next 2 days. F/U with PCP
4 days following vax had 1 minute convuls-afebrile, apnea