chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial information received on 2/8/05 from a certified nurse practitioner regarding an adverse event occurring in the USA, it was reported that a 63 year old female patient received her second dose of FLUZONE, lot number U1488AA, administered IM in the left deltoid, and her second dose of PNEUMOVAX, lot number 656UN, administered IM in the left deltoid on 10/14/04 at 6:00 PM. The next day at 9:30 AM, the patient called her physician's office stating that her arm and fingers on her left side were swollen. She also complained of pain in the elbow to shoulder. She was advised to place ice on the area and to keep the arm elevated. She was also advised to take 600 milligrams of Motrin three times a day with food and to start Prednisone 10 milligrams in taper dose. On 10/21/04, the patient complained of pain in her left shoulder and she was seen the next day on 10/22/04. She did not have any swelling or redness and was diagnosed with tendonitis secondary to the vaccines. She was treated with 40 milligrams of Kenalog and 1 milliliter of Marcain injected in the joint and given Darvocet N-100. On 10/26/04, the patient stated that her left shoulder improved 98% and she had pain with abduction. On 11/8/04, the patient started physical therapy for tendonitis. On 12/17/04, she was treated with 40 milligrams of Kenalog injected in the joint and she was scheduled for an MRI. On 12/26/04, the patient was diagnosed with an anterior tear of the supraspinatus tendon for which she will have surgery. It was reported that the patient has not recovered from these events. (OMIC)
I TOOK THE SHOT ON 03/20/2021, FELT BREATHLESS WHILST TAKING A WALK ON THE TRAIL ON 03/27/2021. DIZINESS ABOUT FOUR TIMES ON 03/27/2021 AND I PASSED OUT MOMENTARILY/CHECKED INTO ER. NOT EXACTLY SURE IF THE VACCINE IS THE CAUSE, BUT IT REQUIRES LOOKING INTO BECAUSE I HAVE NEVER HAD SUCH AN EXPERIENCE IN MY ENTIRE LIFE.
This case was reported by a female nurse and described her experience of Stevens Johnson Syndrome after receiving hepatitis B vaccine recombinant.  On an unspecified date, the patient received the third dose of Engerix-B.  At an unspecified time following the administration of the third dose of Engerix-B, a hepatitis B surface antibody titer was negative.  The patient was given a fourth dose of Engerix-B.  The patient stated that she had, some type of reaction following each dose of Engerix-B.  On an unspecified date in 1997, the patient received the fifth dose of Engerix-B.  At an unspecified time following the administration of the fifth dose of Engerix-B, in 1997, the patient experienced Stevens Johnson Syndrome, fluid in the lungs, chest congestion, rash, and itching.  The patient was seen in the emergency room.  The events resolved on an unspecified date.  The reporter stated that she still has scarring.  The nurse considered the events to probably be related to vaccination with Engerix-B.  The nurse subsequently stated that she had two problems as a result of the incident.  She had an underlying pigment change in skin - it appears like a rash all over.  She was also super sensitive to sun exposure.  She turned bright red and burned easily.  She incidentally reported that in April 2000, she was diagnosed with prinzmetal's angina.  It was unknown whether this was genetic or acquired.  As this incidentally reported during the course of follow up of her Stevens Johnson Syndrome, this was not coded as an adverse event.  She did not provide permission to contact her physician; therefore, this case is closed. Comment:  Stevens Johnson Syndrome, fluid in the lungs, and chest congestion were assessed as medically serious by GSK.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 ten 0.5 ml single-dose vial (SDV) (lot # K019561, expiration date 20-APR-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 24, 47 and R; 112, 49 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Pt's left upper arm is swollen, very sore and warm. Symptoms began shortly after vaccination. Pt went to urgent care 9/20 was given steroid shot and hydrocodone for the pain.
24 hours, post vax, had swelling, redness, heat and hardness to left upper arm extending from outer arm (mid) up to shoulder and under arm to mid upper arm.
severe pain in right arm radiating from neck to hand, consistent with brachial neuritis.  Patient did not develop muscle weakness or atrophy.  Responded to course of prednisone, but symptoms lasted 2 months.  Now resolved.
Within 24 hours I felt flu like symptoms. Complete body aches, chills, fever of 102.8 (highest), sweeting and fatigue. Site soreness was present. Severe headache for 2 days.
INJECTION SITE BECAME RED, SORE AND SWOLLEN WITH LARGE RASH AROUND AREA 1 WEEK AFTER RECEIVING VACCINATION.
Pt had redness on 3/6/7 on upper L arm that appears to be cellulitis. DTaP and IPV were Aventis.  Pt also had PPD placed on Left forearm.
9/2 shot 1 was done and within an hour and a half had upper itchy body  Between shot 1 and 2 itching resolved but 4-6 headaches occurred  9/30 shot 2 was done and itching resumed a few hours after 10/1 sore body and extra tired 10/2-15 continued itching, spots/scratches appeared: First on shoulder blades and back of neck, stomach and chest then forearms and by hips is where "hives" developed. 10/15 began Claritan for a few days per Pharmacy recommendations 10/18 saw Dr due to Claritan not working and hives  10/19 rash/hives moved to legs, soles of feet/hands and butt 10/20-25 rash continues on all mentioned areas including face and ears and lasts throughout the day
No adverse event; patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine).    This was the first adult patient case out of reported 4 adult patients.  Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.
occasional ringing in both ears.  Occurs about once a week and lasts 1-2 minutes.
Varivax wa adminsitered on 02-asep-2021 and expired on 18-AUG-2021; No further AE reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 02-SEP-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 milliliters (ml) as prophylaxis (lot number S025608, expiration date reported as 18-AUG-2021) (route of administration and anatomical site of injection were not reported) (expired product administered). In addition, the reporter mentioned that the administered dose of the vaccine did not go through any temperature excursions. No additional adverse events were reported in the patient.
14 yo female has not had period for 2 months, since getting the vaccine.  Patient menses started at 12 years old, has been regular, every month for 2 years.  Since getting the Pfizer vaccine, has not had period
Fever of 102 A follow up report received 9/9/2002 adds: No site reaction. No Rx.
3/24/21 3:05 PM  15 min. following injection of Covid -19 vaccine client complained of a scratchy throat and the feeling of a lump in her throat.   First aide provided with observation of vital signs, O2 saturation and one dose of Epi Pen to right thigh. Client's mother and daughter were onsite at the time of the incident. Client remained alert and conversant throughout the event.   Vital signs remained stable at 130/72 - 138/60. Pulse 94-83. O2 sat 92% improved to 95%  post Epi Pen.  911 called at the onset of symptoms. EMT Team responded and transported client to emergency Department at 3:20 PM.    3/25/21 2:30 PM TC to client. She reports feeling well, returned home by 6:30 PM on 3/24.  Stated she was treated with prednisone and Benadryl.
5 cm x 6 cm area of erythema at injection site, mild tenderness & warmth.
Dyspnea on exertion, R sided chest pain, fatigue (all chest imaging normal)
I awoke in the middle of the night with sudden nausea, headache and confusion. I had difficulty sitting up and walking to the bathroom to first check my blood glucose level (slightly elevated) and to take  two 500 mg tablets of Tylenol . I drifted back into a restless sleep. When I tried to wake up at my usual time of 7 am I found I could not rouse myself to sit up. It took extreme effort to walk. I had difficulty managing a short shower and had to return to bed. All day I felt mental confusion, pounding headache, severe muscle aches and weakness, and continued nausea, very intense, and nothing like respond I had to the first Shingrix vaccine that I had in August. I emailed my doctor that evening to alert her that if I was not feeling better in the morning I would need to come to her office. By next morning (today),  to my relief, I awoke feeling better. My symptoms have declined throughout the day although my blood glucose levels are much higher than usual.  My response to the vaccine was unlike any other I have ever received. It was frightening.
Headache; Mild fever; Sore arms; This is a spontaneous report from a contactable consumer or other non hcp. A 35-years-old male patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Left on 01Mar2021 09:00 (Age at vaccination:35-Years-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't had covid prior to vaccination. Patient didn't receive other vaccines within 4 weeks prior to vaccination. The patient medical history and concomitant medications were not reported. Patient had no allergies. The patient experienced sore arms on Mar2021, headache on 03Mar2021 09:00, mild fever on 03Mar2021 09:00. No therapeutic measures were taken for the events. Patient was not tested to covid to post vaccination. The outcome of the events pain in extremity, headache, pyrexia was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
right arm felt like needles and sensitive to the touch; all joints hurt more than usual; difficult to concentrate; The right arm felt a little dormant with a little tiredness and pain; The right arm felt a little dormant with a little tiredness and pain; This is a spontaneous report from a contactable female consumer reported for herself. A 55-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EN5318) in left arm 14:15 on 17Feb2021 for Covid-19 immunization. The patient had her first injection (lot number EN5318) in left arm 2:15PM on 27Jan2021. The patient had a history of some age related arthritis and had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had not received other medications within 2 weeks of vaccination. The vaccine was applied in the left arm, close to shoulder. About one hour later, the right arm felt a little dormant with a little tiredness and pain. 18 hours later the right arm felt like needles and sensitive to the touch. Additionally, all joints hurt more than usual and it was difficult to concentrate. No headache nor fever. After 48 hours patient felt normal. No Tylenol was taken. No treatment was received for the events. The patient had recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The reporter considered all events were non-serious.
12/14/2022 diagnosed with Bronchitis and Flu.  COVID was negative. Previously was vaccinated for the flu on 10/25/2022 with FLUAD QUAD 2022-2023 Syr
pt recv vax 21APR95 & parent described swelling upper lt leg for 1mo w/dimpling;felt pt favored leg & leg buckled when running;dimple area approx 1cm;exam revealed hypopigmentation 1.5-2cm w/depression;dx localized atrophy of lt quad muscle
red puffy arm at injection site; itchy at injection site; tiredness and headache; tiredness and headache; bad chills for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red puffy arm at injection site), PRURITUS (itchy at injection site), CHILLS (bad chills for 4 days), FATIGUE (tiredness and headache) and HEADACHE (tiredness and headache) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no adverse event reported).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced CHILLS (bad chills for 4 days). On 28-Jan-2021, the patient experienced ERYTHEMA (red puffy arm at injection site), PRURITUS (itchy at injection site), FATIGUE (tiredness and headache) and HEADACHE (tiredness and headache). On 22-Jan-2021, CHILLS (bad chills for 4 days) had resolved. At the time of the report, ERYTHEMA (red puffy arm at injection site), PRURITUS (itchy at injection site), FATIGUE (tiredness and headache) and HEADACHE (tiredness and headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no treatment information provided
Pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her arm) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in her arm). At the time of the report, PAIN IN EXTREMITY (Pain in her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
This spontaneous report as received from a medical assistant refers to a identifiable patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with improperly stored VARIVAX (dose and frequency were unknown by reporter) from lot N022979 expiry date 23-AUG-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MRK) (lot/expiry date unknown by reporter). Temperature was reported as 15 degrees Fahrenheit to 46 degrees Fahrenheit (32 degrees Fahrenheit). Time frame was reported as 7 hours. There was no previous temperature excursion involved. The call was because of a data logger. No product quality complaint was involved. This is one of the three reports linked via same reporter link. Sender's Comments: US-009507513-1803USA012301: US-009507513-1803USA012517.
Case number PHEH2015US014708 is an initial spontaneous report from a pharmacist received on 28 Jul 2015. This report refers to a 18-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M14133) in her left arm on an unknown date. On an unknown date after the vaccination she had red spot where injection was given on her left upper arm. The outcome of the event was reported as condition unchanged. The seriousness and causality assessment was not reported.
within 5 minutes of vaccination the patient became diaphoretic, passed out and fell from the exam table to the ground striking the right side of his head. He regained conciousness within 10 seconds of falling and was obsereved in the  office for an additional 30 minutes.
Within about 24 hours of receiving the vaccine patient experienced a seizure.  Patient has been stable on his current medication for many months without any seizure activity and denies any changes to his regiment prior to acute seizure activity.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 22-MAY-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 for prophylaxis, lot # L017265 with expiration date of 10-FEB-2017 (dose, route and frequency were not reported). No adverse effect was reported. No Product Quality Complaint was involved. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patient of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. The patients were vaccinated with the doses of PNEUMOVAX 23 injection, lot # L003227, expiration date 13-OCT-2016 (dose and route of administration were not reported), which were exposed to temperatures outside of the recommended range for much longer than originally realized, and had been administered to the patients since these excursions began to occur on an unspecified date in July 2015. The refrigerator, in which the vaccine was stored, had been "losing power" each night for 8 hours since an unspecified date in July, 2015. The vaccine was exposed to temperatures as high as 66 Fahrenheit (F) for as long as 8 hours each night since an unspecified date in July, 2015. The reporter's facility started to use a data logger, which was the daily  (also reported as each night) power interruption was discovered. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
pt recv vax;exp inc joint pain, dizziness, palpitations, general malaise & flushing; no hosp or lab analysis required;pt recovered same day, refused further immunizations;
I had the normal soreness in my arm, slight nausea the first few days. On Wednesday, February 17 all my joints started to hurt. When I woke up on the 18th I could barely walk. My right knee was swollen, both hands were swollen, I had pain in my neck to the base of my skull.  I called the doctor's office and told this was normal and to take Tylenol. I spent the weekend barely able to move by the following Thursday, February 25th I went to my doctor, who immediately sent me to the ER. I was admitted to the hospital. My inflammation was high.  I was dehydrated. I spent the night in the hospital. Doctors say there is not enough research to say this vaccine did this but  I know it did. I am still having problems, still can barely walk, pain in the joints of my hands and pain radiating up my neck to the bottom of my skull.
Swelling, soreness, redness and itching at the injection site noticed 3 days after injection. Recommended cold compress, Acetaminophen for the pain and Diphenhydramine for itching.
headache; diarrhea; joint hurting; not feel good; sore muscles; ears ringing; This is a spontaneous report from a contactable consumer (Patient).   An unspecified age male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Lot Number: unknown; Expiration date: unknown), via an unspecified route of administration on 08Mar2021 as first dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 08Mar2021, the patient experienced headache, diarrhea, joint hurting, not feel good, sore muscles, ears ringing. It was reported that the patient did not take Tylenol or Aspirin to mess up the shot.  The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a physician via a company representative and refers to 66 years old a male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date in 2016, reported as "two years ago", the patient was vaccinated with a dose of ZOSTAVAX vial 19400 PFU, for vaccination (dose, route of administration, anatomical location, lot number and expiration date were not reported), other suspect therapies included sterile diluent (manufacturer unknown) (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unspecified date in 2016, reported as "a day after receiving ZOSTAVAX", the patient developed zoster ophthalmicus. It was reported that the patient visited an ophthalmologist and subsequently recovered from the event on an unknown date. It was unknown by the reporter if treatment was given for the adverse event and also if laboratories were performed. The reporter did not assess the causal relationship between therapy with ZOSTAVAX and the aforementioned event. Upon internal review the event ophthalmic herpes zoster was considered to be medically significant.