chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to four patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot# L004754, expiration date: 10-NOV-2016), dose and route not reported. No adverse effects reported. This is one of three reports received from the same source. Additional information is not expected, because there was no consent to contact the physician.
Burning eyes within a few seconds of receiving the injection; Internal twitching / electric sensation in torso, continued for 2 to 3 days afterwards; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 10:15 (Lot number: EW0158) at the age of 60 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Xylocaine, reaction(s): "allergies: Xylocaine", notes: known allergies: Xylocaine. The following information was reported: EYE IRRITATION (non-serious) with onset 26Apr2021 10:15, outcome "recovered" (26Apr2021), described as "Burning eyes within a few seconds of receiving the injection"; ELECTRIC SHOCK SENSATION (non-serious) with onset 26Apr2021 10:15, outcome "recovered" (Apr2021), described as "Internal twitching / electric sensation in torso, continued for 2 to 3 days afterwards". The events "burning eyes within a few seconds of receiving the injection" and "internal twitching / electric sensation in torso, continued for 2 to 3 days afterwards" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of eye irritation, electric shock sensation.  Additional information: It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received New Chapter Plant Calcium within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The most recent COVID-19 vaccine was administered in hospital.  No follow-up attempts are possible. No further information is expected.
I had bad neck pain the day after the first and second vaccine. It lasted 3-5 days. I don't know how soon after, because I don't know if it's related or not but I've had a lot of eye strain and eye pain. I'm up-to-date on my eye exams and I've never had this issue before but several days a week since early in the year, I get very bad eye strain, like my eye muscles are so sore. I also have a harder time changing focus from one thing to another. I can't control it and my eyes adjust/focus/get big, without me trying. The eye problems listed, I still have.
Nausea, fever, chills, dizziness, headache and fatigue. Nausea lasted 3 days. Headache for 2 days. Dizziness off and on for 5 days. Hot and cold for 7 days and still feel fatigued.
Encephalitis; encephalopathy; This spontaneous case was reported by a patient and describes the occurrence of ENCEPHALITIS (Encephalitis) and ENCEPHALOPATHY (encephalopathy) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Measles, Rheumatoid arthritis and Parkinson's disease. Concomitant products included ABATACEPT for Rheumatoid arthritis.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ENCEPHALITIS (Encephalitis) (seriousness criterion medically significant) and ENCEPHALOPATHY (encephalopathy) (seriousness criterion medically significant). At the time of the report, ENCEPHALITIS (Encephalitis) and ENCEPHALOPATHY (encephalopathy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Positron emission tomogram: Positive.         It was reported that patient had encephalitis and encephalopathy from the Moderna Vaccine.  Treatment medication was not reported. Company Comment: This is a spontaneous case concerning a male patient of an unknown age with a history of Measles, Rheumatoid arthritis and Parkinson's disease, who experienced the serious (due to medically significant) unexpected, events of encephalitis (AESI) and encephalopathy, which occurred on an unknown date and with unknown latency after a dose of mRNA-1273.222 (Original/Omicron BA.4/BA.5) vaccine. It was reported that patient had encephalitis and encephalopathy from the Moderna Vaccine. No further information was disclosed. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/BA.5) vaccine is not affected by this report.
On 11-8 patient started with q20min vomiting and diarrhea. In clinic had large bloody stool. Taken from clinic to pediatric ER. Had ultrasound showing intussusception. Reduced with air enema and symptoms resolved.
Noticed right deltoid swelling at area of shot morning of 11/21. It got progressively wore as swelling spread up shoulder and near elbow. Indurated and hot to touch.
Seriousness criteria Other medically significant (OMIC). Initial report received on 3/30/2006 from a physician. A 16 year old male patient injection (site not reported) of Menactra, lot number U1638AA, on 3/28/2006 at 16:00. Five minutes later, he turned pale, began sweating, became confused, his pupils were dilated and his pulse was weak. He was given 0.3 cc of Epinephrine (1:1000) SQ and was taken to the emergency room. Per the reporter, the patient recovered from these events.
Information has been received from a health professional concerning a healthy 9 year old male who on05/20/1997 was vaccinated with a dose of varicella virus vaccine, live. On 03/15/04, the pt experienced breakthrough described as a vesicular rash and itching. Medical attention was sought and 1% cortisone was prescribed. No product quality complaint was involved. The nurse also reported another pt (WAES#0403USA01632) who experienced breakthrough after vaccination with varicella virus vaccine, live. Additional information has been requested.
Had fever 24 hours after vaccine.  Arm is very sore and pain radiates into left shoulder with a lump.  Around noon on Sunday, day after vaccine,  started with high fever, aches and nausea.  Felt like having COVID
Started not feeling well on way home after dose.  By 9pm she had a 102.7 fever, explosive diarrhea and vomiting.  Severe stomach cramps and cold chills.  Vomiting stopped about 4am next morning.
After administering vaccine. Patient indicates that she is seeing cloudy and is observed to be sweaty. Vital signs is taken and the patient is placed in the "Trendelenburg position". Proceeded to call the patient to evaluate her.
My Arm started throbbing at first (about 3 hours) after the injection,  then became (severe) stabbing, burning pain.  My arm swelled up twice the size about 5 hours after the injection.  It was Hot and Painful to touch.   I started chilling for several hours.  I could Not stand to have my arm touch the bed covers.  I couldn't lay on my right side.    I couldn't sleep the 1st night because of the pain.    The swelling, hot to the touch and pain lasted for 3 days.  The chills lasted for about 24 hours.   For 3 days I couldn't lift my arm past my chest without cramps starting.     My right hand is still weak in the grip 6 days later.  There is still slight swelling and  tenderness at the injection site 6 days later.
Five minutes after receiving dose, stated he started to feel warm and light headed, so he sat down. He then lost consciousness, falling out of his chair and hitting his head. Staff at his side immediately; pale and extremely diaphoretic; started to come to after 10-20 seconds. He sat up immediately on his own. He was oriented to self, place, date. After about 30 seconds, stated he thinks he should lay down again. Lowered his head to the floor, blanket placed under his head and feet elevated using a chair nearby. BP 120/52 Sats 100%, HR 72. Cool packs applied to his neck and forehead. After 2-3 minutes requested to move him to the medical area. Got up to wheelchair, but lost consciousness again; head fell forward, appeared as if upper extremities stiffened and contracted, like sz activity. When in medical evaluation area, client was conscious, but starring blankly and not responding verbally. At 3:02, with assist of 2, moved to the cot to elevate his feet, but again, not responding to requests, such as lay down or elevate your feet, so assisted client to this position. Continues to be diaphoretic, pale and ashen. 911 called at 3:07. Informed him of this and the plan. Friend is by his side. Client denies allergies, states he takes meds for hypertension. 3:15 BP 100/56, HR 52, Sats 92%, hands cool to the touch. EMS here at 3:23; report given and client transferred to Hospital via ambulance.
Pt experienced fever of 103.8 and 20 second seizure 2 days post vax. Pt treated with Motrin and Tylenol. Pt experienced additional seizures and temperature of 103.3 5 days post vax.
shingles; second dose not administered; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 28th September 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported for the first dose and not applicable for the second dose. The patient received the first dose and experienced an episode of shingles. Till the time of reporting, the patient did not receive the second dose, which led to  incomplete course of vaccination. The reporter wanted to know when could get 2nd dose. Lot number and expiration date of 1st dose of Shingrix was asked but health care professional confirmed she did not had that information. The reporter consented to follow up.
This spontaneous report was received from a physician via company representative and refers to a male patient in his sixties. The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were unknown by the reporter. On an unknown date, the patient was vaccinated with ZOSTAVAX subcutaneously (strength, dose, lot number and expiration date were not reported) for prevention of shingles. Other suspect therapies included sterile diluent (strength, dose, frequency route, lot number, expiration date and indication were not reported). On an unknown date, the patient experienced "extreme itching in his eyes (eye pruritus) and all over his entire body (pruritus generalized)". The patient sought medical attention by contacting the physician's office and he received unspecified treatment for the events. At the time of reporting, the patient was 90% recovered. The causal assessment between the events and the suspect therapies ZOSTAVAX and sterile diluent was not provided. Additional information has been requested.
Employee began with localized symptoms of warmth and burning at injection site. Progressed to headache and nausea then tingling and SOB. Employee brought to ED where she was given BENADRYL and I believe a steroid shot. Symptoms subsided and employee was allowed to return to orientation. Still not feeling well employee went home. I spoke to employee later in the day and she reported feeling much better.
Rashes all over body = given BENADRYL (liquiud) - over the counter.
Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    Concomitant drugs were not reported.  It was reported that there was a dark blue cap vial with a dose of 25 mcg for age group 6 months to 5 years instead patient was administered with 10 mcg dosage from the dark pink cap and a label with a yellow box.  Treatment medications were not provided.  This case was reported for patient 4 Out of 18(12 Patients-Initial Dose).   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
This spontaneous report as received from a office manager refers to a 67 years old male patient. Pertinent medical history, Drug reactions and allergies were reported as none. On 19-SEP-2012, the patient was vaccinated with PNEUMOVAX 23 0.5 milliliter (ml) intramuscularly once. Dose number was unspecified. Lot number was 0225AE and expiry date was 03-JUN-2013. Concomitant medications included lovastatin and LUMIGAN. Approximately on 19-SEP-2012, the patient experienced redness and swelling at the injection site after he was administered PNEUMOVAX 23 on 19-SEP-2012. BENADRYL was not effective. The patient was seen in the emergency room on 21-SEP-2012 and blood count and blood chemistry tests were performed (results were not specified). Then the patient was diagnosed with cellulitis and was treated with CLEOCIN and piperacillin and ZOSYN. The patient was not admitted but was only seen in the physician's office on 25-SEP-2012 and the injection site was improving. The outcome of cellulitis was reported as recovering/resolving. This is one of several reports from the same source (MARSS#12010USA000140, MARSS# 1210USA012892): Additional information has been requested.
pt recvd vax 19NOV93 @ 1530; 22NOV t99.6, h/a, sore throat, achy joints, congestion & chest, throat, tired;
Menstrual spotting/bleeding 5 days after first shot, and 6 days after the 2nd shot.  I am postmenopausal, so haven't had a period in 2+ years.  First spotting lasted 1 day.  Spotting after the 2nd shot has lasted for 4 days so far, also cramping and breast tenderness.
This is a spontaneous report obtained from a contactable consumer (patient) through a Pfizer sales representative. A male patient of an unspecified age received PREVENAR 13 intramuscularly, in the arm, on an unknown date, in 2017, at 0.5 ml, single dose, for immunization. Relevant medical history included acid reflux (esophageal) and the patient had no spleen (splenectomy). Concomitant medications included unspecified drugs for acid reflux. On an unspecified date, in 2017, the patient experienced allergic conjunctivitis. Clinical outcome of the event was recovering at time of this report.
Symptoms started 30 minutes after injection: Shortness of breath, chest tightness and pressure, difficulty breathing, throat tightness, all over body pain, nausea and vomiting, extreme diarrhea, stomach cramps
Woke up with large erythematous circle at injection site. Tender and warm to touch 7.5 cm x 5 cm.
one week after 1st dose shoulder blade sharp pain . Fingers begin to go numb. Waiting for dr appointment.
I had the vaccines still got the shingles/suspected vaccination failure; Got the shingles, not the rash but other symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-JUN-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had the shingles vaccines and still got the shingles not the rash but other symptoms. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EH9899, expiration date: unknown), intramuscularly on the left arm on 31Dec2020 at 11:00 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. The patient had no known allergies; no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Jan2021, the patient experienced left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection. The reporter assessed the events as non-serious. The patient did not receive any treatment for all the events. The patient was not recovered from the events "left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection."
Severe itching and sharp pain x1 hour from his parachute harness on 12 December 2010. 11 December 2010 -> redness and soreness. 13 December 2010 muscle soreness, joint pain (shoulder, elbow, fingers) headache, dull aches on left arm and trouble focusing. Redness 15 x 16cm on left arm extending to elbow, 12cm induration. Treated symptomatically with TYLENOL and cold compresses. Sent home to rest for 72 hrs.
Case number PHEH2012US013093 is an initial spontaneous report received from a nurse on 28 Jun 2012: This case refers to 12-years-old male patient. He was vaccinated with MENVEO (batch number: A11071 and expiry date: Dec 2013), at dose 0.5 ml intramuscularly on 25 Jun 2012. On unspecified date after vaccination, he experienced localized reactions at injection site as red swollen, hard and hot. The outcome and causality of the events was not reported.
Woke up Friday morning with inflamed left armpit - lymph nodes are inflamed on left side slightly painful. I did not find this as a side effect on the CDC listing of Pfizer booster side effects. Concerning as this did not happen after my 1st or 2nd dose. Suggests to me that the 6 month post 2nd dose recommendation may be too soon for younger healthier individuals. Maybe needs to be revised to 12 months. My wife also is experiencing same symptom but much worse (like armpit is on fire).
Felt burning and itching at site of injection---removed blouse to inspect area and noticed a long/broad area of redness that measured 7 inches long by 1 inch wide.  Started at injection site and extended all the way down arm. The large reddended area remained there for a little over a month.  It has just finally started to fade out now.  It still itches quite a bit but is no longer red.
This non-serious spontaneous case, initially received on 22-Dec-2017, from a pharmacist and concerns a 35-year-old adult female patient. On an unspecified date, the patient was administered with FLUCELVAX (dose: 0.25 as reported (units: not reported), route of administration: intramuscular, batch number: 195242, anatomical location: right arm and expiry date: 30-Jun-2018) (explicitly coded as incomplete dose administered). During administration, the vaccine dripped from the needle where it was attached the syringe (explicitly coded as product leakage). The PTC number was reported as 1026861). The health care professional was not exposed to the vaccine. It was reported that, the patient did not experience any adverse event after vaccination.
Unusual painful rash; This case was reported by a consumer via call center representative and described the occurrence of painful rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced painful rash. On an unknown date, the outcome of the painful rash was not recovered/not resolved.   It was unknown if the reporter considered the painful rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-NOV-2022 Reporter's Comments: The case was self reported by the patient. The patient received a dose of Shingles vaccine and now had developed an unusual painful rash.
Approximately 10 minutes after receiving vaccine, patient reports feeling "very hot"-this started gradually and escalated to the point where "I felt like I was on fire".  She soon developed weakness of her lower extremities (within 20 minutes), making standing difficult.  She reported trouble with her thought processes and verbalization.  Within 30-40 minutes, she became somnolent; difficult to engage in any conversation, but answered simple questions appropriately.  She was taken to the ER at that time.