chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist via a company representative referring to two patients in their 60's of unknown gender. The patients' pertinent medical history, concomitant medications, drug reactions and allergies were unknown by the reporter. In approximately January 2019, the patients were vaccinated with PNEUMOVAX 23 (strength, dose, route of administration, anatomical location, lot #, and expiration date were not reported) indicated for prevention of pneumococcal disease. In approximately January 2019, the patients experienced extreme swelling and redness following vaccination with PNEUMOVAX 23. It was unknown if a treatment was given for the events and if laboratory diagnostics and studies were performed. In addition, it was unknown if the patients sought medical attention. The outcome of swelling and erythema was unknown and its causal relationship with PNEUMOVAX 23 was not reported.
Chills, tired, headache,  nausea  RASH (3 slightly raised circles in one area) and a small pimple like area that the skin is coming off, both areas are on the arm I received the injection.
Almost right away my tongue got all tingly and I became very dizzy. It eased up after a few hours. Tired and weak feeling for 2 days. Severe arm pain for 3 days. 1 week later the itchy red rash they call "covid arm" appeared and lasted for around one week. I also got a very itchy hive like rash down the back of my left leg at the same time that lasted the same amount of time.
Information has been received from an RN concerning a 42 year old female who on 5/15/97 and 6/18/97 was vaccinated with the 1st and 2nd dose of varicella virus vaccine live (site unknown). A titer performed in 11/01 did not show seroconversion. The pt sought unspecified medical attention. Additional information has been requested.
Nausea; Malaise; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 62-year-old 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 nausea, malaise and fatigue. On an unknown date, the outcome of the nausea, malaise and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the nausea, malaise and fatigue to be related to Shingrix.  Additional details were provided as follows The reporter reported for himself. After getting the vaccine the patient began having nausea, malaise and fatigue. The patient would speak with health care professional. No health care professional information was given. The reporter did not consent to follow-up
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. Initial solicited case was received from the investigator participating in a trial on 25 November 2014. A 19 year-old male subject with a past medical history of chest pain and numbness or paralysis was found to have acute pericarditis on 02 September 2014, 7 days after the subject had received the following vaccines on 26 August 2014: an injection of ACAM2000 (lot number and site of administration not reported), Typhoid VI vaccine (batch number, route and sites of administration were not reported) and Anthrax vaccine (batch number, route and sites of administration were not reported). Troponin I was not performed. On 02 September 2014 an ECG was abnormal. An echocardiogram, lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
hives  Onset 6 days ago.  Severity is 7.  Location is generalized and more on upper extremities.  The patient describes it as erythematous, itchy and papular.  It occurs continuously.  The problem is worse.  Relieving factors include IM Benadryl..   Pertinent negatives include diarrhea, fatigue, headache, sore throat and vomiting.   Comments: h/o hay fever and Had his 2nd booster shot of Moderna COVID vaccine on 6/15/21 at 2 PM(no problems with previous 3 doses). Started itching at 6 PM and full blown hives at 9 PM with periorbital/lip swelling(R>>L). Angioedema/swelling  The symptoms began 6 days ago. daily. Angioedema/swelling  The symptoms began 6 days ago.  The symptoms are reported as being moderate.  The symptoms occur daily. He states the symptoms .  Had significant periorbital and lip(R>>L) swelling with hives. off & on since 6/15. 3 ER visits for the problem. Parenteral Benadryl provided temporary relief.  Switched from dose pack to higher dose of PO Prednisone(40mg).  History of mild hayfever since childhood, usually doesn't take meds.  Patient Plan 1) Allegra 180 mg 2-4 QAM. 2) Zyrtec 10mg 2-4 QPM. 3) Pepcid 20mg 1-2 B.I.D. 4) Singulair 10mg QD (monitor for stimulant/behavioural side effects as explained). 5) Continue PO Prednisone as before.
Was given the injection and within the first five minutes had severe headache and body pain. Numbness in lips. Was taken back after the 15 minute window and checked for swelling in throat or mouth. Non visible. Waited another 30 minutes and then was released because there was no swelling in the throat.   On the drive home, starting around 7pm the front right side of my tongue started to twitch painfully. Occasionally the back right would also spasm.  Continued nonstop. I called a 24 hour nurse hotline around 11:45pm. The nurse told me to make sure I was hydrated and to  schedule an appointment the next day. The next morning I called and set up another nurses appointment and  she encouraged me to set up an appointment on "doctor on demand". I had an appointment with a doctor from Doctor on Demand and she told me to immediately go to the ER as this could be a sign of blood clotting.   I was driven to the ER were they did some blood tests and said to come back if it persisted past the 72 hour mark.   It is now 4/21/21 and I am still experiencing the tongue  twitch, numb lips, headache, bodyaches.
A Pfizer vaccination was administered as a booster series on a patient on 01/28/2021 who originally received the Moderna vaccine as their primary dose on 01/08/2021.  Upon discovering the medication error, the patient was contacted via telephone to explain what had occurred.  Discussion with the hospital pharmacist resulted in the decision to offer the patient antibody testing on 02/11/2021 to determine if antibodies were successfully established.  The patient reported no side effects experienced with the booster vaccination.  If antibodies exist on the test scheduled for 02/11/2021, no further action will be taken.  If no antibodies exist, then a follow-up booster Pfizer booster shot will be administered on 02/18/2021.
Feet have been burning; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of burning foot in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced burning foot (Verbatim: Feet have been burning). The outcome of the burning foot was not reported.   It was unknown if the reporter considered the burning foot to be related to Shingles vaccine.     It was unknown if the company considered the burning foot to be related to Shingles vaccine.   Additional Information: Receipt date: 29-Jul-2023 This case was reported the patient via interactive digital media. If anyone could told the patient, if the vaccine had effect on them. The patient had both vaccines and since then the soles of the feet had been burning a lot.
intermittent arm pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number E523B, expiry date unknown) for prophylaxis.   On 29th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). In July 2019, 1 day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on an unknown deltoid. The pharmacist reported that the patient had experienced intermittent arm pain after receiving Shingrix. The reporter consented to follow up. Exact site of administration was unknown. Symptoms was in same arm.
This is a spontaneous report from a contactable consumer. A male patient, of an unspecified age, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The reporter stated her doctor said his second dose of the vaccine gave him body aches. The outcome of the event: unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Saturday, May 1:  - woke up around 9:00am with slight headache, body felt tired and sore like after doing a hard workout, injection site was very sore, took 200mg ibuprofen every 4 hours which eased symptoms  - ran 4 miles at 1:30pm and body felt very tired, breathing was fine - no new symptoms until 8:00pm when I started shivering but did not feel cold, shivering stopped before I went to bed at midnight  Sunday, May 2  - no significant symptoms, maybe feeling tired still
head felt flushed; back pain; trouble breathing; seeing black spots; headache; weakness; fatigue; temperature of 100.6; Initial information received on 10-Oct-2022 (with live follow-up processed together) regarding an unsolicited valid serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 80 years old female patient who reported head felt flushed, back pain, trouble breathing, seeing black spots, headache, weakness, fatigue and temperature of 100.6 while receiving vaccine influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Contrast media allergy, Lung cancer, Heart disorder and Macular degeneration.  Concomitant medications included paracetamol (Tylenol) for Headache and Body temperature abnormal; and aflibercept (Eylea) for Macular degeneration.  On 07-Oct-2022, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine (with an unknown dosage, formulation, route, expiry date, batch number) in unknown administration site for Immunization.  Caller reporting she received Fluzone high dose quadrivalent last Friday, on 07-Oct-2022. Caller reporting within 2 or 3 minutes she experienced a reaction and the paramedics came and transported her to the emergency room where she was kept overnight. Caller reporting symptoms including seeing black spots (loss of consciousness), head felt flushed (flushing), had trouble breathing (dyspnoea), back pain. Patient reporting while in the emergency room her treatment included fluids and bloodwork. She is currently experiencing weakness (asthenia), fatigue, headache, and temperature of 100.6 (body temperature abnormal). Currently she is taking Tylenol. The patient was hospitalized on the same day. The patient was discharged on 08-Oct-2022 (hospitalization during 1 days).  Caller again called back and stated that she also has Macular Degeneration and receives eye injections for her eye called Eylea. Patient was supposed to receive an injection tomorrow. However, the patient still doesn't feel well and is exhausted. She cancelled the appointment and is rescheduled for 21-OCT-2022.  Relevant laboratory test results included: Body temperature - On an unknown date: [100.6]  Action taken - not applicable.  A corrective treatment with fluids and bloodwork was received for the events. Currently she is taking Tylenol.  Outcome -Unknown; Sender's Comments: Sanofi company comment dated 16-OCT-2022: This case involves a 80 years old female patient who reported head felt flushed, back pain, trouble breathing, seeing black spots, headache, weakness, fatigue and temperature of 100.6 while receiving vaccine influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent]. Although the role of suspect cannot be denied for the events, however lack of information regarding details surrounding the events, clinical course precludes the comprehensive assessment of this case. Furthermore, medical history of patient is also a confounding factor.
Two-inch red circle around the bandage; Spontaneous report received on 23MAR2012.  A consumer reported that he developed a "two-inch red circle around the bandage" (PT: Injection site erythema) following the administration of ACAM2000 (smallpox (vaccinia) vaccine, live). The patient was received Smallpox vaccine and bandaged it up. Later, he had noticed two-inch red circle around the bandage. Outcome was unknown at the time of report.  Company Comment: Local injection site reactions like erythema could happen after ACAM2000 vaccination, and the causality of the event is assessed as possible. The case is considered non-serious as per medical assessment and case information.; Sender's Comments: Local injection site reactions like erythema could happen after ACAM2000 vaccination, and the causality of the event is assessed as possible. The case is considered non-serious as per medical assessment and case information.
Patient has swelling and discoloration at injection site. Patient is also dizzy and itchy. Came in to the clinic the day after injection for evaluation.
The injection site it's swollen, but not real painful; just a little swollen nothing big.; took a ibuprofen 600mg around 8am in the morning then took first dose in the around 2:30 in the afternoon, any effect because of the ibuprofen; This is a spontaneous report from a Pfizer sponsored program (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on 20Mar2021 at 14:30 at single dose for covid-19 immunization. Medical history included arthritis. Concomitant medication included ibuprofen 600mg taken for arthritis. On 20Mar2021 at14:30, patient took her first dose but before that she took ibuprofen 600mg around 8:00 on in the morning then took first dose in the around in the afternoon. Patient was wondering if her arm hurts and if she can take anything for it. Patient experienced the injection site was swollen but not real painful, just a little swollen nothing big. She was asking that anything she can do for that or put an ice on it. Patient stated that she had waited already a long time or had been on the phone a long time and did not want to wait longer to speak with a safety team member.  The outcome of event vaccination site swelling was not recovered and contraindication to medical treatment was unknown.  Follow up(21Mar2021): No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt received Pfizer Covid 19 vaccine.  Pt ambulated to monitoring area and sat down.  After sitting down, pt lost consciousness and fell onto the floor from her chair.  Pt had abrasion over right eye.   Pt regained consciousness and staff assisted pt to seated position.  Pt lost consciousness again briefly and was lowered to floor.  HR 51, BP 83/44, SPO2 100% RA.  EMS arrived and transported pt to hospital.
Pt recvd 3 doses of Engerix-B, 3rd dose given 5NOV90; It was determined that pt was not immune to Hep B; Booster given 21JAN91;
Expired Twinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 80-year-old patient who received HAB (Twinrix) (batch number unknown, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 31st January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 1-Feb-2023 Reporter's comment: The reporter reported that one of their medical offices administered an expired Twinrix vaccine to a patient.  They were looking to see if there were any recommendations in regards to revaccinating the patient. That was reporter's office location address, the previous address might had been from one of their locations. They had 15 locations. That was the address for the corporate building. Additional supportive information: The patient received a dose of Twinrix, which led to expired vaccine used.
Administration of expired ROTAVIRUS (expiration was 6/7/16) admin ROTAVIRUS on 6/13/16. Mother of child aware and agreeable to bringing in child for repeat ROTAVIRUS
Adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse event) in a female 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 ADVERSE EVENT (Adverse event). At the time of the report, ADVERSE EVENT (Adverse event) outcome was unknown. Not Provided          Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
muscle aches; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 64-years-old female patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date (at the age of 64 years-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported, and concomitant medications was none. Patient historical vaccine was flu vaccine. The patient experienced muscle aches. States she wanted to throw in she usually gets muscle aches like after the flu vaccine last year and after her 1st dose. States after the 1st time it lasted 6 days. The outcome of muscle aches was unknown.  No follow-up attempts are Possible. Information on lot/batch number cannot be obtained.
A non-serious spontaneous report of "administration of expired product" and "vaccine given to a patient" was received from a non healthcare professional concerning a 66-year-old female out of 18 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 20-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Mom states child broke out w/rash generalized body on Sun & had fever of 102; States rash lasted 3 days;
No additional adverse event reported; Administration of improperly stored ROTATEQ; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 28-DEC-2021, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (Lot# 1741817 and expiration date 30-JUL-2022) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of 50.5 Fahrenheit for a period of 57 minutes. There was no previous temperature excursion. No additional adverse event reported.
Fever, chills, headache, sore muscles sleepy, dizzy, brain fog increased
Febrile convuls with t105 2 1/2 hrs p/vax;
C/O pain R arm, swelling, ROM decreased, redness, warmth. Iced and reaction did resolve a few days later. She did not have this evaluated nor did she call office. Her daughter works in office and reported the reaction.
she experienced soreness at injection site; This is a spontaneous report from a contactable consumer.   A female patient of unknown age received Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) at single dose for immunization on unknown date. Relevant medical history and concomitant medications were not reported. After her injection, she experienced soreness at injection site. The outcome of the event was unknown.   Information on the lot/batch number has been requested.  Pfizer is a marketing authorization holder of [Pneumococcal 13- Val Conj Vac (Dipht CRM197 Protein] in the country of incidence. This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13- Val Conj Vac (Dipht CRM197 Protein] has submitted the same report to the regulatory authorities.
12/17/21 developed bilateral leg pain. Increasing pain over the next coming days and unable to walk. Presented to hospital 12/19, creatinine kinase level  3089.  Admitted to Hospital, started on maintenance IV fluids and worked with Physical Therapy. Creatinine  kinase downtrended to 2289, ambulation improved and pain resolved. Also found to be positive for Parainfluenza 2 infection, but no respiratory symptoms or fevers. Etiology for myositis viral infection vs post-vaccination. Discharged from hospital 12/21/2021.
This case was considered medially important. Information regarding PREVNAR (unspec) was received from a healthcare professional regarding a patient who developed a pneumococcal infection. The patient received a dose in 2007. Relevant medical history was not provided. Product was administered on an unspecified date in 2007. Dose regimen was 1 dose 1 time per day. Concomitant medication were not reported. On an unspecified date 2007, the patient developed a "strep infection" (drug ineffective). The outcome is unknown. No additional information was available at the time of this report.
Localiized pain started on 1/13/21  Left arm induration of 5-10cm started on 1/14/21 at noon time Left arm induration of 15-20cm noted 1/15/21 at 8am