chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse refers to 6-month-old patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On 06-APR-2018, the patient was vaccinated with first dose of ROTATEQ, oral (dose, units, frequency, lot# unknown) expiration date 19-FEB-2019, at about 24 weeks (inappropriate schedule of drug administration). Other suspect therapies included pneumococcal 13v conj vaccine (crm197) (PNEUMOCOCCAL 13V CONJ VACCINE (CRM197)) (Lot# C5368AA) (dose, units, frequency and expiration date unknown) via intramuscular route at quadriceps, influenza virus vaccine (unspecified) (INFLUENZA VIRUS VACCINE (UNSPECIFIED)) (lot# UT5897MA) (dose, units, frequency and expiration date unknown) via intramuscular route at quadriceps and hib conj vaccine (unspecified carrier), diphtheria toxoid, pertussis acellular vaccine (unspecified), poliovirus vaccine inactivated (unspecified), tetanus toxoid (DIPHTHERIA TOXOID (+) HIB CONJ VACCINE (UNSPECIFIED CARRIER) (+) PERTU) (lot# T52790) (dose, units, frequency and expiration date unknown) via intramuscular route at quadriceps. Data logger was not involved. No product quality complaint was reported.
Patient received a booster 0.25ml Modera vaccine on Friday 10/29/21 at 4:52pm. She states that evening she felt pain and her left knee that became swollen and warm. Not any redness. Her main concern was that she also received a total knee replacement in the same knee on Aug 11, 2021. She took tramadol she had and alternated between ice and heat in the evening. By the morning the swelling was worse and affected both knees. She took ibuprofen 800mg with minimal relief. She wants to wait to inform orthopedic MD after 48 hours. I will followup tomorrow. Informed patient to not hesitate to seek medical attention if needed.
Very "hot" injection. I felt like I had been shot (as with a bullet). Typical pain and fever that follows a anthrax shot. Continued pain in the Left Upper/Mid shoulder, elbow, and hand. Pain still continues to this day. Pain is more prominent with exertion.
Information has been received from a physician concerning a 2 month old male with a history of being 27 week premature baby on 17-AUG-2007 was vaccinated with a dose of Rotateq. Concomitant therapy included Prevnar, PedvaxHib and Pediarix. In August 2007, the patient experienced apnea and respiratory syncytial virus and was hospitalized. The reporter felt that apnea was related to therapy with Rotateq. The physician considered Apnea and respiratory syncytial virus serious due to hospitalization and were considered to be immediately life-threatening. Additional information has been requested.
Extremely itchy palms, red/swollen eyelids, hives all over chin, some on chest, hairline, inner elbow; paleness.
Stroke after third dose; On 06Sep2021, patient started to feel poorly; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke after third dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced FEELING ABNORMAL (On 06Sep2021, patient started to feel poorly). On 08-Sep-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke after third dose) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 08-Sep-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke after third dose) had not resolved and FEELING ABNORMAL (On 06Sep2021, patient started to feel poorly) outcome was unknown.            The patient reported to be suffering from a stroke after receiving the third dose of the Moderna COVID-19 vaccine on 04-SEP-2021. On 06-SEP-2021, the patient reportedly started to feel poorly. On 07-SEP-2021, the patient said she went into work and had to leave early. On 08-SEP-2021, the patient was admitted to the hospital for stroke.   Company Comment:  This case concerns a 73-year-old, female patient with no relevant medical history, who experienced the unexpected event of Cerebrovascular Accident. The event occurred approximately 4 days after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine) and patient was hospitalized at the same day. The rechallenge was not applicable, as the event happened after the third dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of  mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 73-year-old, female patient with no relevant medical history, who experienced the unexpected event of Cerebrovascular Accident. The event occurred approximately 4 days after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine) and patient was hospitalized at the same day. The rechallenge was not applicable, as the event happened after the third dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of  mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Within approximately an hour of administration, patient developed raised, red hives on trunk, extremities, back, neck.
Fever over 103 for over 48h Joint redness, tenderness, swelling at 72h (hands and knees with difficulty walking stairs, and I am active) Balance distortion Severe redness with swelling of entire upper L arm, dark reddened area, extremely tender, has appeared adjacent to inj site Axillary lymphadenopathy
Fast heart beat; Palpitations; it make me feel real bad and it is going; Stress; Tired; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 22Mar2021 (Batch/Lot Number: ER8727) as 1st dose, single for COVID-19 immunisation. Medical history included blood pressure high, asthma, thyroid, cholesterol, allergy. Patient stated "I take medications. I have high blood pressure. I am asthmatic, I have asthma and allergy. I take lot of medications. I take thyroid medicines, I take inhaler for my asthma (Captured as per verbatim), I have eye drop latanoprost (not spelled, further clarification unknown) and I take cholesterol medicine." Patient stated "I had rapid, fast heart beat the same day. They gave me a paper and I took it that if I have any of these features then I should not have the second vaccine. I had one of those, I had palpitations and it made me feel real bad and it is going, I don't know what is going on so when I had after an hour I had the shot, I still had the palpitations. I drive back home I live by myself so I feel really bad I didn't know what happened so finally the next day I went to the emergency care because I figured out that I might be having palpitations they say yeah you have and there is nothing we could do about so finally after 3 days they stopped they used to come off and on right after the shot like three 3 days in a row and then it finally stopped, then I went to the Cardiology, they telling me I guess I have age but now I have the real stress and tired. So the shot, I guess, it started it for this started to happen to me when I had the shot. So, I would not take the shot but I have my doctors, and when I called them to talk, they would tell me just take the second shot. When I read the CDC guidelines, I should not take it, and then there are my doctors. I am trying to say that I wouldn't take it and my doctors, some of my family members, so what do I do? I don't want to go through that again and it was really bad, I thought like I was going die. I didn't take my second shot and my doctor, they were little upset with me and my children that if you have that bad reaction and you feel that bad then you should try to take it anyway I guess the second one would kill me so it's okay, I don't have to worry about the virus because I won't be there. I had a EKG right after because of my heart palpitation. No, I had no treatment. They are trying to find out if I have a heart problem. So I had EKG which shows that I had the palpitations and then I am scheduled to have echocardiogram, another heart test next week." Outcome of events fast heart beat, palpitations, and 'it make me feel real bad and it is going' was recovered, of remaining events was unknown.
A company representative reported that a 9 month old child received the 1st injection of Prevnar and developed a fever of 104F, which lasted 3 days, staying "around the 102F range."
Blanching maculopapular rash torso and arms and upper legs 9 days after IZ antihistamines prn.
nausea/dizziness, eye redness, extreme fatigue (inability to stand) hypertension, sob
Started ~4 hours after vaccination - severe headache, vomiting, slight fever. Symptoms lasted 24 hours. No hospitalization.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On 01-FEB-2015, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 01-JUN-2016, the patient was treated at a health center for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
Noticed swollen lymph nodes. Contacted healthcare provider a couple weeks later. Provider also noticed cysts in breasts then ran imaging.
11:41 am, patient states that she is nauseas and lightheaded. Patient is A/OX3. Vitals : BP 178/119, HR 66, Spo2 98%, RR 20.  Patient states that she has a headache. Patient given ice pack and water. BP retaken manually 162/74. Patient states she has no double vision , radial pulses are strong, no tingling or numbness in arms.  11: 50 patient is given orange. 11:55 patient nauseas is relieved.  12:04 vitals retaken : BP 176/78, HR 56, Spo2 96%, RR 18. 12;08 pm patient is advised to go to Hospital or Emergency Room because of her high  Blood pressure. Patient states that she is ok and does not need medical attention. RN educates on the importance of going to the ER  if high blood pressure persists, if patient experiences chest pain, SOB, visual disturbance. Patient understands and verbalized to seek medical assistance at nearest ER  if symptoms worsen at home .
Prolonged crying and screaming (1 1/2 hrs) approx. 4-5 hours, post vax. Resolved in car en route to ED: not seen.
Patient was given expired Ipol, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from a physician via Agency (Reference number- 00567209) and transmitted to Sanofi on 19-Apr-2021.  This case involves a 04-year old male patient who was given expired IPV (VERO) [IPOL] on 09-Apr-2021 (lot number: R1B25 and expiration date: 13-Mar-2021] at 0.5 ml total dose via intramuscular route in the right thigh for prophylactic vaccination.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE).  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  It was not reported if the patient received a corrective treatment.  Disclaimer: 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.
Received Tdap, Varicella and MENVEO on 4/8/14. On 4-10-14 Right arm was swollen, red hard and warm to touch. Took ADVIL and BENADRYL. 4-11-14 AM symptoms had improved.
Cellulitis of upper right arm which developed 4 days after vaccination. Arm was red, hot and sore with a spreading edge. Went to urgent care clinic and received 7 day course of BactrimDS. Now dealing with a drug rash from the antibiotic, but it seems that original infection has resolved.
Reconstituted with Sterile Diluent; Reconstituted with Sterile Diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 28-MAR-2023, the patient received Menveo. On 28-MAR-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted with Sterile Diluent) and inappropriate dose of vaccine administered (Verbatim: Reconstituted with Sterile Diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 28-MAR-2023 The health care professional (HCP) reported that a patient received the 2-vial Presentation of Menveo reconstituted with sterile diluent instead of the supplied Liquid conjugate. No reactions reported. The reporter did not consent to follow-up. The patient 2-vial Presentation of Menveo reconstituted with sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Site: Pain at Injection Site-Mild, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Unable to Sleep-Mild, Additional Details: mom  called to report adverse reaction to 2nd dose of pfizer vaccine. pt had chills on monday, fever on tuesday, wed morning child passed out in the kitchen mom heard her fall, she did call 911. child was transported via ambulance to strong ER. pt was diagnosied with syncope. pt is now home with mild headache/lethargy and recovering. mom has called pcp waiting to talk to her.
sore arm, body aches; sweating, wrenched in sweat; low grade fever; chills, could not get warm, bone chills; headache, hit like a ton of bricks; every joint hurt; difficult to move and walk; difficult to walk; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm, body aches), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), CHILLS (chills, could not get warm, bone chills) and HEADACHE (headache, hit like a ton of bricks) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast lump (breast limpectomy). Concurrent medical conditions included Blood transfusion (Blood transfusion as an infant), Immunocompromised, Overweight, Smoker and Dermatitis.    On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm, body aches), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt), MOBILITY DECREASED (difficult to move and walk) and GAIT DISTURBANCE (difficult to walk). At the time of the report, VACCINATION SITE PAIN (sore arm, body aches), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt), MOBILITY DECREASED (difficult to move and walk) and GAIT DISTURBANCE (difficult to walk) was resolving.            cholesterol pills, fish oil supplement, she gets once or twice a year a shot for osteoporosis, ointments for dermatitis issues are concomitant drugs and no treatment are provided.   This case was linked to MOD-2021-377322 (Patient Link).
Greatly enlarged axillary lymph node.  Fever. Body aches. Headache. Augmentin
pt recv vax & w/in 24-48hr of vax pt devel a small, raised reddened area the size of a dime on the rt inner forearm;pt recovered p/3wk;
gave an over weight patient the Fluzone Quad but 2 drops came out when she pulled the needle out, no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from  pharmacist.  This case involves patient of an unknown demographics who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot number not reported via unknown route in unknown administration site on an unknown date but 2 drops came out when she pulled the needle out.  The patient's medical history included Overweight. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to vaccine underdose.  At the time of report 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 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.  Information on batch number was requested.
On Day 8 following vaccination, pt reports developing a red circle around the injection site.  Denies itching or pain. Lasted approximately 5 hours then went away. Patient denies treatment or medication.
shot on wednesday, on thursday,  i began experiencing pain in right leg? by sunday pain in the calve muscle? went to ER on Monday afternoon? and was Diagnosed with a DVT? (note, I have no history of blood clots/DVT)
Got head cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Got head cold) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Got head cold). At the time of the report, NASOPHARYNGITIS (Got head cold) outcome was unknown.            The Patient got tested and checked in for COVID   No Concomitant drugs were reported.  No Treatment information  were reported   Reporter did not allow further contact
pt recv vax 17SEP96 & seen by MD on 19SEP96 w/following soreness lt side of neck & swelling under lt ear p/3rd shot;no arm pain-no resp sx;fatigue, sl h/a;tenderness to node below lt ear;poss vaccine rxn;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. During 2015, the patient was inoculated with ZOSTAVAX, at a pharmacy (by an unspecified health care professional)  as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2017, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as Herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Information has been received from an office manager concerning a 3-month-old male who on 25-JAN-2008 was vaccinated intramuscularly with a 0.5 ml dose of VAQTA (659187/1259U) instead of a dose of hepatitis B virus vaccine.  The reason for the product confusion was employee error.  No further information why this occurred was available because the employee no longer works there.  No product quality complaint was involved.  Additional information has been requested.
Death Anemia GI bleed Lactate blood increased CKD (chronic kidney disease) Jefferson fracture
9th, in the late afternoon, I started feeling really cold and I started getting headache and a lot of arm pain. It hurt to reach out to grab steering wheel. I felt very tired. I checked my temperature - 100.5. I got really cold and shivering at about 6:00 pm and I could not warm up for about 2 hours. It went to 101.5. Horrible pounding headache and dizziness. I started having stomach issues and diarrhea but didn't vomit. That went through the night - I felt like I had the flu. Back of my  neck was really stiff and achy - from shoulders up to the back of my skull. I didn't sleep much. I woke up completely soaked in the morning. My fever had broken. SUnday, I felt a little better. Dull headache ( it came and went). My temperature would go up and down -96.8 - to 100.1-ish all day. When my temp went up I got a headache and fatigue and down my headache would be better. Rolling every four hours. Monday, I stayed at 99.2 to about 100.2. Stayed at that the whole day. I was really tired. I had trouble thinking and concentrating. My arm was feeling better by Monday. Monday afternoon, about 1:00 my fever went to 100.5 and I called the nurse then. She told me to call my doctor's office. They sent me to a call to a triage nurse and she advised me to get tested for COVID. So Tuesday morning,  the 12th,at 9:00 am - healthcare clinic - the results were negative for COVID. Tuesday, I was feeling a little better - fever stayed around 99.2 to just over 100 and the headache was dull. I wasn't quite as tired. Wednesday, I was feeling better - like I could go to work but I didn't because of my fever the day before. I went to work on Thursday or Friday. The whole next week then I was better and felt fine. I got the second dose February 1.
MODERATE BLEEDING FROM INJECTION SITE THEN A RAISED, HARD, QUARTER-SIZED KNOT PROTRUDED FROM THE SKIN ABOUT A HALF INCH.
Immunization Administered 10:33am (R) Deltoid IM. Warm, Red and Itchy at 11:08am TYLENOL and BENADRYL OTC.