chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After several weeks the patient developed recurring urticaria and angioedema which was striking in that it occurred in different places on the body including swelling in the limbs, face, throat,  at different times
Patient had been administered FLUZONE QUAD first and TWINRIX second. After the TWINRIX patient said she was about to throw up and after few seconds patient lost consciousness. Hands were cold and the head had cold sweats, after that the patient started to produce a growling sound, pharmacist administered EPI PEN right away, after the administration, pharmacist requested cashier/ technician to call  911. Patient regained consciousness before the EMS arrived. EMS checked the patients vitals and it was normal. Patient left premises with the EMS.
fever, chills, and extensive join swelling and pain including knees, ankles, wrists, elbows, fingers, and toes. Joint swelling in the knees, especially, led to visible edema with restriction in range of motion. Swelling lasted for four days before beginning to diminish. Joint swelling took about 1 week to resolve.
That night I had a sore arm and it went away in 20 hours. Then three months later I tested positive for COVID.
Patient received Moderna COVID-19 vaccine, as per patient request, where patient should had received Pfizer COVID-19 vaccine for age restriction, but age was overlooked by administrator/reviewing pharmacist. Patient has no adverse reactions, no complaints. Patient waited the required observation time after administration, patient was fine and left the site with No complaints.
EE RECEIVED COVID VACCINE AND TESTED POSITIVE TO COVID ON 8/8/21
(R) thigh swelling and then development of painless rash, started at or near injection site of MMR and Varicella shots roughly 9 days after injection.
receiving an expired dose of pentacel yesterday with no reported adverse event; Initial information received on 02-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 1-year-old male patient and it reported that he received an expired dose of Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] yesterday with no reported adverse event.  The patient's past vaccination(s) included Pediarix on 30-Jun-2021, Pentacel on 22-Sep-2021, HIB on 30-Jun-2021, HIB on 22-Sep-2021 and HIB on 30-Nov-2021.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine, measles vaccine, mumps vaccine, rubella vaccine (MMR) and varicella zoster vaccine (varicella vaccine) all for Prophylactic vaccination.  On 01-Feb-2023, the patient received 0.5 ml (milliliter) (dose 4), 1x (once) of suspect Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot number: UJ634AA, expiry date: 28-Jan-2023) (with unknown strength and route) in the right thigh for prophylactic vaccination (immunization).  On 01-Feb-2023, the reporter reported that patient received an expired dose of pentacel yesterday with no reported adverse event (expired product administered) (latency; same day).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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.
PATIENT WAS GIVEN TDAP AND TD GIVEN ON THE SAME DAY. NO MANIFESTIONS OF AN ADVERSE REACTION PRESENT. PT DENIED PAIN OR DISCOMFORT TO INJECTION SITE.
102.1 fever, strong shoulder pain which has eased somewhat. fever is down to 100.0
Information has been received from a medical assistant concerning a 65 year old female with no pertinent medical history and no drug allergies, who in 2000 was vaccinated with her first dose of PNEUMOVAX 23, and received her second dose on 08-SEP-2009 (lot # 662842/1296X). There was no concomitant medication. A few hours after the second vaccination, the patient developed redness, swelling, warm at injection site, extending from shoulder to elbow. It was unknown which arm was involved. The patient contacted the office by phone on 10-SEP-2009. No treatment was prescribed. There were no labs and diagnostic tests performed. Follow up information has been received from a pharmacy intern reporting the patient was recovering. She was experienced fever and extreme tiredness along with the injection site reaction. The patient was "getting better" but not yet recovered. This is an amended report. The trade name had been changed from PNEUMOVAX to PNEUMOVAX 23. Additional information has been requested.
Product Storage Error; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number T543J, expiry date 25-JAN-2025) for prophylaxis.   On 05-MAY-2023, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-Mar-2023 Pharmacist reports clinic experienced a temperature excursion with Kinrix vaccines on 4th May 2023 that lasted 45 minutes and reached a low temperature of -0.8 degree C.  On 5th May 2023 a dose of Kinrix was administered to 4 year old female patient.   At the time of reporting, the dose had not been repeated. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The follow-up would not possible as no contact details were available.
This spontaneous report was received from a pharmacist referring to a 67 year old female patient with diabetes. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, strength and dose not reported), subcutaneous. On approximately 16-JUN-2016 (reported as about 3 weeks ago) the patient developed chickenpox outbreak on an unknown area of the body. Then, the patient called the physician for seeking medical attention and was treated with acyclovir. No lab diagnostics studies were performed. On approximately 30-JUN-2016 (reported as about 1 week ago), the patient was recovered. The pharmacist did not provide the causality between chickenpox outbreak and ZOSTAVAX. Additional information is not expected since the reporter did not wish to be contacted.
Patient developed active COVID disease after being fully vaccinated with 2 doses of Moderna (january and february 2021). Patient had to receive monoclonal antibodies on 11/23/21 at hospital.
Clinical varicella infection developed 10 days after receiving Varivax. Initial lesions at site of injection. Risk factor recent high dose of short course steroid for asthma.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with GARDASIL (lot number not reported) on 08-OCT-2007, 02-DEC-2007 and 28-DEC-2009. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
temp. excursion occured, product was administered to patient with no reported adverse event; Initial information was received on 29-Aug-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves 20 patients of unknown age and gender to whom IPV (VERO) [IPOL] was administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect IPV (VERO) (Suspension for injection) (lot V1A011M, expiry date, strength: unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and temp. excursion occured, product was administered to patient with no reported adverse event (poor quality product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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.
10/6-Headache, 10/7-Headache, 10/8-Headache more severe, 10/9 AM -Chills, bloody nose, 10/9 PM-Full body aches, sore throat, chils, 10/9 PM-10/10- slept 18 hrs. 10/10-Aches/sore throa, 10/11-Head, chest conjestion
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-JUL-2016, the patient was vaccinated with a dose of improperly stored PROQUAD (lot # M010478, expiration date: 01-SEP-2017; dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
36-48 hours after 2nd vaccine Sever lymphadenopathy unilateral to side of vaccine in armpit and right breast Chills Headache Read superficial ring around vaccine admin site Diarrhea Body aches  Fatigue
Started breaking out 1-23-2008. Has 50-60 lesions - mouth, on face and torso.
3/31/21, 1558. 63 YO F complaining of dizziness, cough, scratchy throat, tingling sensation in throat. EMS Eval, 4-lead. Negative swelling of tongue, throat, or face. Lung sounds clear bilaterally. Persistent cough, increasing hoarseness while speaking. IV established L AC. 50mg Benadryl administered IV @ 1610. Medorol administered IV @ 1612. Epinepherine administered IV @ 1616. PT care transferred to responding EMS unit. During transfer, hives appeared on PT's lower legs. PT transported to Hospital @ 1623.
Information has been received from a pharmacist referring to a 60 year old male patient. Concurrent condition and medical history were not reported. On 13-AUG-2015 (reported as "yesterday"), the patient was administered with expired ZOSTAVAX lot # K000325, expiration date 27-FEB-2015, 0.65 ml) subcutaneously in left arm. The patient's concomitant medication was not reported. No adverse effect reported. There was no product quality complaints (PQC) involved. This is one of two reports received from the same reporter. Additional information has been requested.
Site of inject swelled and got hard/red and burned. For the next week went to sleep easily but woke up nightly between 2:00 and 3:30 AM wide and wake and couldn't get back to sleep.
After administration of menactra, the patient laid back on the exam table; eyes rolled back, arms flexed; and patient was nonresponsive and very pale.  This lasted less than one minute.  When patient came to, he stood up and was very disoriented for a few minutes.  Once I was able to get him to sit back down on the exam table, he was able to hear me and was able to talk to me and make sense.  He said that he just felt as if he were dreaming or something. He said that he hadn't had anything to eat this morning, so I did give him some orange juice.  After about 5 minutes, he started getting some color back in his lips and said he was feeling OK.
Chest pains that lasted about two hours and then sporadically after that (lasted about 1 week total), body ache and fatigue
No adverse event; Patient was administered expired VAQTA on 26-JAN-2021; This spontaneous report was received from a nurse regarding a 55-year-old female patient. The patient's pertinent medical, medical history, drug reactions, allergies, and concomitant therapies were not provided.   On 26-JAN-2021, the patient was inadvertent vaccinated with  an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) (dose, route of administration, anatomical location and vaccine scheme were not provided) lot number S037821 has been verified to be a valid lot number, expiration date was on 07-JAN-2021, as prophylaxis (expired product administered).There was no prior temperature excursions reported. No additional adverse event.
Patient started symptoms of fatigue, dizziness on Monday. The following day was weak / fatigued, at approximately 7:30am he fell on the floor. EMT responded. As the day progressed, the weakness increased, and patient went to ER around 2pm on Tuesday. Wednesday while in the hospital, the O2 sats have been dropping. Patient has history of COPD.
Immediately following vaccine, child developed lacy red rash over face, arms, trunk. No SOB. Child had Fifths disease approximately 1 month ago and does break out in rash when overheated. Observed x 30 mins. Rash began to fade. Sent to MD as precaution. MD diagnosed as allergic reaction. Parent stated (L) arm was red & swollen when got to MD office.
Uveitis, inflammation with pain to sternum, left foot right hip, lower back, and irritation of existing injury to right shoulder.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 19-SEP-2016, the patient received improperly stored doses of PROQUAD (lot # M010478 with expiration date 01-SEP-2017, therapy type HSA; dose, route of administration and anatomical location were not reported). It was reported that the  PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. ; Sender's Comments: US-009507513-610USA011245:
Erythematous and swollen right arm - distal to the right deltoid injection site Medrol dose pak.
Pt received Menactra vaccine in left arm.  After receiving the MenB vaccine patient started to experience dizziness and light headiness.  Pt was helped to a lying position and evaluated.  Pt stated that the shot was painful but after receiving is when she felt the symptoms of dizziness/light headiness.  After approximately 10 minutes pt stated that she felt better and was ready to receive her flu vaccine.  After administration in her right arm patient again felt dizzy and light headed.  At this point she also stated that she had ringing in her ears /w her heart beat audible to self as well.  Pt was given some orange juice and observed for another 15 minutes.  After which the patient stated that she felt better and left home.
Headaches; Sinus/tension headache; Sinus/tension headache; Get pain that increases through out the day in my upper and lower sinuses; Pain in all of my upper teeth; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old female patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: Ew0170), via an unspecified route of administration, administered in Arm Right on 30Apr2021 08:45 as 2nddose, single for covid-19 immunisation. Historical vaccination was BNT162b2 (CONMINTARY, Solution for injection, Lot No: Er8737,), via an unspecified route of administration, administered in Right arm on 07Apr2021 at12:45 PM as 1stdose, single for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing, rubber sensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported. The patient experienced headaches on, sinus/tension headache on, sinus/tension headache on 01May2021 12:00, get pain that increases throughout the day in my upper and lower sinuses, pain in all of my upper teeth on May2021 with outcome of not recovered. The patient underwent lab tests and procedures which included computerized tomogram: clear in 2021, sars-cov-2 test: negative   on 29May2021.  Therapeutic measures were taken as a result of headaches, sinus/tension headache, sinus/tension headache, get pain that increases throughout the day in my upper and lower sinuses, pain in all of my upper teeth. The adverse event result in visit to emergency room. Treatment was received. Upon follow-up on 12Jul2021 attempts are completed. No further information is expected. Device date was 04Jun2021.The outcome of the events was recovered.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Fever; Nausea; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Bad headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) 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) (Intramuscular) 1 dosage form.   On 09-Feb-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Bad headache).   At the time of the report, PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Bad headache) outcome was unknown. Not Provided    Concomitant product use was not provided by the reporter. No treatment information was provided.
pt recvd vax 6NOV89 & following vax the expiration date was noted; vax had expired eight months prev; No further details were provided;
Initial unsolicited case received from a physician on 12 Oct 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (Batch number, expiry date, dose, dose in series route and site of administration were not reported) on an unknown date. Patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination, patient developed abnormal liver function and on an unknown date, she was hospitalized. It was also a case of actual medication error due to extra dose administered as patient received adult dose of twice dosing. Relevant lab tests and corrective treatment was not reported. Outcome of the event was not reported and details about hospital discharge and details were not provided. 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 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. Sender's Comments: The patient experienced abnormal liver function post vaccination with INFLUENZA QUADRIVAL A-B VACCINE. Time to onset was not reported. It was also reported that the patient received adult dose of twice dosing. Therefore this was also a case of medication error. The event might be related to extra dose administered and all possible alternate etiologies including underlying etiologies related to preexisting conditions if any should be investigated. Based upon reported information the role of the vaccine cannot be assessed.
fever 102, screaming episode of 20 hrs, felt pt was jittery-jumpy; recommendation to receive no more DTP;
MBC # 4928142058 Redness and puffiness around the eyes, top and bottom. Spread all over extremities. Breathing; SOB, wheezing.
the patient filled the consent form out on line and did not put in the correct birthday. It was put in making him 18 instead of 17.
Headache, sinus pressure, dyspnea, runny nose, inflamed, red/mucus pockets, cervical lymph nodes swollen, joint pain.
Cry inconsolably for 3 days. Not wanting to eat for 3 days. Fever 101.9 for 3 days on and off with Motrin.
Hand arthritis on side of vax; Started immediately p/vax; localized in small finger PIP; ongoing arthritis 6wks;
I did not have an adverse reaction with the vaccine. I had an appointment with my general doctor and was referred to a therapist. I was diagnosed with anxiety and currently under treatment.
Severe Low back pain and stiffness, cannot sit Severe shoulder pain, burning, pain in armpit, cannot lift arm
Erythema at injection site measuring 9.5 inches by 5 inches one week after injection, pain, itchy, warm to touch.  The patient has been instructed to continue to watch and report any changes.
7/15/2021: Patient presented to the ER due to persistence of COVID symptoms after testing positive on 7/11/2021 with no oxygen requirement & discharged home.  Patient developed nausea, was unable to keep anything down, had bitter taste associated with loss of smell.  7/18/2021: Patient medically cleared for discharge, saturating well on room air and tolerating diet with no episodes of nausea or vomiting.  7.26.21: as of today, discharge cleared, awaiting placement. Note: Patient received J&J COVID-19 vaccine in May 2021.
Administered in subcutaneous tissue instead of intramuscular. Larger round, red, itchy, hot area of skin at injection site.
I began having an adverse reaction soon after my injections.  I had headaches, body aches and extreme abdominal pain, gas, bloating, stomach discomfort.  It usually  occurred in the early  morning then dissipated in the afternoon, only to begin again the next day. I lived with it for about 6 months then finally saw a doctor. I had blood test, ultrasounds, and was scheduled for an colonoscopy and endoscopy. I was treated with Pantoprazle and Gas X with no relief.  My symptoms got progressively worse and I ended up in an urgent care facility twice prior to my endo & colonoscopy THEN I had a "botched" colonoscopy where the Dr. dislodged my spleen causing a nearly fatal hematoma and I ended up in Critical Care for 2 days and bed rest for 8 weeks.
This case is linked to case number 2013SA102257 (same reporter after FLUZONE ID). Initial report received from healthcare professional on 19 September 2013. The 9 patient's whose gender, date of birth, age at the time of event, medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (batch number, route and anatomical site of administration were not reported) on an unspecified date of September 2013. It was reported that on an unspecified date, after receiving FLUZONE ID vaccine, the patient's experienced swelling, large raised bump, redness, pain and itching. The corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.