chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had first Menactra dose on 11-Aug-2018 and received second dose on 29-Jul-2022 with no reported  adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 15 years old male patient who had first menactra dose on 11-Aug-2018 and received second dose on 29-Jul-2022 with no reported  adverse event, for the vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Aug-2018, the patient received first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, with an unknown formulation and strength, ( lot number and expiry date: not reported)  in unknown administration site for immunization. On 29-Jul-2022 he also received the second  dose of the same vaccine  with an unknown batch number in unknown administration site. Information for batch number has been requested   The nurse reported the patient had first menactra dose on 11-Aug-2018 and received second dose on 29-Jul-2022 with no reported  adverse event (inappropriate schedule of product administration) 3 years 11 months 18 days following the first dose administration and (latency: same day) following the second dose administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The patient would turn 16 years old in a month  Action taken : Not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Pt developed 99 degree temp, malaise, nausea onset next day after vaccines.  Also dev. redness and swelling at L arm injection site within 25 min.  Well defined sterile abscess with mild overlying erythema observed.  1/2 reported to be less sore than on days prior.  Also mild c/o soreness in L axilla without palpable nodes.  Temp 98.4 on DOS.  To f/u in 7-10 days.
chills, headache, muscular aches, dizziness, almost passed out, tingling sensation
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On unknown dates, those patients were vaccinated with improperly stored doses of (Merck) VARIVAX injection (lot # L048468 with expiry date: 02-FEB-2017 and lot # L043622 with expiry date: 03-NOV-2017; strength, dose, route and site of administration were unspecified). The administered vaccines underwent the temperature excursion at 25 degree Fahrenheit for 11 hours and at 50 degree Fahrenheit for 3 hours 26 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
12/31/2022 runny nose. Tested positive on an at home COVID-19 test. Binax brand. Tested again on rapid test, negative for Flu A & B. 1/1/2023 severe headache, cough, body aches, fever peaking at 101, chills, brain fog, and digestive issues. This lasted about 8 days tapering off. Tele visit on 1/5. Doctor recommended stopping NYQUIL and see if fever is under control. Fever did not spike. Brain fog lingers.
Patient started to fell dizzy and nauseated.   Talked to her and gave her a trash can in case she got sick .  Then called the  hospital team stat.
Injection that was given 7 days early; A spontaneous report  was received from a consumer concerning a female patient, of unknown age, who reported that injection was given 7 days early/ MedDRA PT: inappropriate schedule of product administration.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received her first of two planned doses of mRNA-1273 (Lot number not provided) on an unknown date. On an unspecified date, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of Covid-19 infection.  The patient stated that injection was given 7 days early. No further information was provided. Treatment information was unknown.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The event, injection was given 7 days early, was considered resolved.; Reporter's Comments: This report refers to a case of a female of unknown age with Inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated adverse events. The event, injection was given 7 days early, was considered resolved.
Chills, Body Aches, Headache, Mild Fever & Diarrhea
04/03/2022 I had my annual physical and had a Pneumonia vaccine. While talking to my nurse, I suddenly became woozy and had lower back pain. They laid me down and gave me an ice back. After I felt better, I had a case of severe diarrhea. I felt weird, went home and rested. I have not had any adverse reactions to the Pneumonia vaccine previously.  I thought this was strange that it happened two weeks after my COVID vaccine.
Vertigo only when moving eyes, not when moving head.  It was intermittent but lasted for days at a time.  This lasted approximately 4-5 months.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-395985 (Patient Link).
pt recvd vax 26MAY94 & states that had a rash under arms & inner aspect of legs, sore joints, stiff neck;
Narrative:  Patient died on Sep 8,2022@00:01 at Rehab, Patient is a 72 yo male with PAST MEDICAL HISTORY Sarcoma of soft tissue Benign essential hypertension Mild chronic obstructive pulmonary diseaPlantar fascial fibromatosis (ICD-9-CM 728.71) Calcaneal spur (ICD-9-CM 726.73) Thrombocytopenia (ICD-9-CM 287.5) Hyperlipidemia (ICD-9-CM 272.4) Benign hypertension (ICD-9-CM 401.9) Pt also hospitalized in Feb 2022 for acute renal failure, acute prostatitis and mental status changes. Pt also had covid infection two times, most recently prior to death in AUG 2022. Per medical chart pt's sister stated her brother was battling another round of COVID and has pneumonia and an infection currently. She indicated that he is receiving tube feeds, oxygen and has Stage IV ulcers on his hip and chest. Pt died 9/8/2022. Pt had received a COVID VACCINE (J&J) on 9/13/2021. Reporting ADE of vaccine failure leading to covid infection and ultimately patient's death on 9/8/2022.
Emergency room physician saw patient on 09/07/21, approximately 4 days after 2nd dose of Pfizer Covid vaccine.  MD reports patient appears to have shingles on nose, lower lip, and left cheek.
Myalgia & Fever Narrative:  body aches, lethargy, Chills, low grade  fever
Fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever of 102). At the time of the report, PYREXIA (Fever of 102) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: 102 (High) Fever of 102..         Concomitant product used was not provided by the reporter.  Treatment information was not provided by the reporter.
Sore throat, slight cough,started less than 3 hours after injection. Paleness, weakness, blurring of vision, dizziness, chills 4 1/2 hours after injection chills. , Tx. Slept 3 hours, still flush & red complexion, elevated temperature so I took 200 mg Ibuprofen. will call MD in AM to report.
Had a urinalysis that tests for alcohol and he tested positive in that test; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration on 29Mar2021 as single dose for Covid-19 immunisation. Patient had to have a urinalysis this past Monday on 05Apr2021 due to having a DUI, urinalysis came back positive for alcohol, he stated he has not had any alcohol and the only other thing he has had are stool softeners. He wanted to know if the Pfizer COVID-19 vaccine could interfere with the urinalysis and He did not want another positive urinalysis. The outcome of the vent was unknown. A review of the Prescribing Information for Pfizer COVID-19 vaccine (LAB-1457-7.0; Revised: 06Apr2021) failed to find any information regarding interaction of the Pfizer COVID-19 vaccine to urinalysis and causing people to test positive for alcohol. Please consult with doctor or health care provider for further guidance, as doctor/healthcare provider is the most familiar with medical condition.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This is a spontaneous report from a contactable pharmacist. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose. Medical history included pneumonia. The patient's concomitant medications were not reported. It was reported that the patient got PREVNAR 13 six months ago and had pneumonia on an unspecified date with outcome of unknown. Follow-up (17Jun2016): Follow-up attempts completed. No further information expected.
Numbing upper lip and end of nostrils extending horizontally to cheeks.  Burning in nostrils; hoarseness; mild hives, facial redness, itching from buttocks to top of head.  Dizziness. After treatment, the numbness moved into the right jaw and R ear. Tingling feeling as numbness began to wear off. No pain or redness at injection site.
Nausea, headache, chills, and the very scary racing of my heart and pressure on my chest like it was hard to breathe. It lasted for about 3 hours starting almost exactly 24 hours after the shot. And it came on slow and steady, it then got very intense for a good 30 mins. And then it slowly waned.
broke out in a rash on her arm right where the injection was given; on her arm right where the injection was given, and had a 2 inch slough; The site also itched, it was sore sore and it hurt; The site also itched, it was sore sore and it hurt; Felt hot; Tired; little sore arm; This is a spontaneous report from a contactable Consumer or other non-health professional (patient).  A 65-year-old female patient bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ lot number: EN6208) via an unspecified route of administration in right arm on 10Mar2021 (at the age of 65-year-old) as dose, 1 single for COVID-19 immunization. Medical history included ongoing osteoporosis (diagnosed in 2018 or 2019) and thyroid from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for thyroid from 1977 and ongoing. Patient did not receive any prior vaccinations within 4 weeks of vaccination. No Family Medical History Relevant to AE. No Additional Administered Vaccines on same day. On 11Mar2021, After the first vaccine patient broke out in a rash on her arm right where the injection was given, and she had a 2-inch slough. The site also itched, it was sore, and it hurt. It lasted for about two weeks. She still had remnants of an itch and marks when she got the second injection. On an unspecified date in Mar2021, after the first vaccine she felt hot, tired, and had a little sore arm. She needs to get Temlos injections for her osteoporosis, she was supposed to start, but she refrained from doing so because she was afraid it might affect the covid vaccine or the covid vaccine will affect these injections. AEs did not require a visit to ER or physician office. Investigation Assessment was reported as No. No relevant Tests provided. Outcome of the site also itched, it was sore sore and it hurt was recovering and outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Presented with erythematous skin lesion on L lateral thigh 24 hours after vaccine injection at the site on 8/12, with development of fluid filled blisters in middle. No drainage, but lesion is firm and warm to the touch.Pt had elevated temperature of 99.8 with development of rash. The rash is 10cm by 7.8cm this morning per measurement by home-health nurse, who reports that it has gotten more red since this morning. The pt is bearing weight on the leg and very active during the interview. The site is tender to palpation. Denies rhinorrhea, cough, pale extremity, change in behavior, decreased voiding, decreased stooling, vomitting, diarrhea, or similar lesions elsewhere on body.
Injection into subcutaneous tissue overlying tricep area of lateral arm, not into muscle.  Patient rapidly developed cellulitis left upper extremity.
arm sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm sore at injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced INJECTION SITE PAIN (arm sore at injection site). At the time of the report, INJECTION SITE PAIN (arm sore at injection site) had not resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
TIA, RASH, BLURRED VISION, MOUTH TINGLING, TROUBLE WITH SPEECH
This spontaneous report as received from a nurse refers to multiple unspecified patients. No information regarding the patients' concurrent conditions, medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23, injection (dose and route of administration were not provided; lot # M022086 and expiration date: 09-OCT-2017). No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003299: US-009507513-1611USA010369: US-009507513-1612USA003298.
6/17/2022 overnight sore throat. I had a runny nose as well. 6/18 the sore throat was worse. 6/20 I got more head cold symptoms. 6/21, tested positive with an at Home COVID 19 test. Congestion got worse. Televisit with doctor who prescribed Paxlovid. 6/22 symptoms started to get better, but Paxlovid left horrible taste in mouth and insomnia. I experienced excruciating pain in my teeth over the course of the Paxlovid, which I was using with my Pulmicort inhaler.  Paxlovid seemed to suppress appetite. This pain seemed to have been triggered by extreme temperatures, hot or cold.  Finished Paxlovid and confirmed with dentist that nothing was wrong with teeth. 7/1 I tested positive with an at home COVID 19 test because I had a slight cough and some chest congestion. Runny nose and sneezing as well. Televisit with doctor on 7/1 who prescribed Paxlovid again, but stopped the Pulmicort while I was taking Paxlovid. I had really bad back and neck muscular pain for the second course of Paxlovid.  Second course of Paxlovid did not have appetite or bad taste issues.
got really bad chills last night; couldn't stop shaking; This case was reported by a consumer and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2020, the patient received Shingrix. On 14th October 2020, less than a day after receiving Shingrix, the patient experienced chills and tremor. On an unknown date, the outcome of the chills and tremor were recovered/resolved.   It was unknown if the reporter considered the chills and tremor to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not reported. The patient received one dose of Shingrix and experienced really bad chills last night and shaking. The reporter stated that the patient couldn't stop shaking until I got in bed with a hot pad. The information regarding consent to follow up was not reported. No further information was reported.
The pt received vaccines at about 10:15 and by 1:30PM the pt started getting a rash on the side of his face. The following day, the mother states that she noticed the rash all over the infants body. Tylenol was given and Pedicare was also given.
Pt. came in on 11/7/07 with Lt shoulder pain x6 days.  Lt intrascapular pain radiates into Lt shoulder, down arm.  Pain lasting 1 month, severe.  R/O thoracic outlet syndrome.  Toradol 60 mg IM, Neurontin, Vicodin, ibuprofen.  EKG done WNL, X-ray and eval of cervical spine, Varicella titer.  Ret to physical therapy.
less than 24hr p/vax pt devel in lt deltoid area warm to touch, induration  2/2" x 4" erythema was greater than induration;
My left arm muscle located on underarm between elbow and injection site, halfway between elbow and injection site higher up became extremely sore to the touch and prevented me from lifting my arm to preform functions.  Today is much better and function has mostly returned. The reason I am reporting is because I just (jan.29 2021) tore my rotator cuff on right  shoiulder and the loss of function is similar. Function is returning on left arm so no worried, the right shoulder will need shoulder replacement surgery.  But that was the effect on this adverse event. Loss of function to left arm about 3 days with improvement after 36 hours. Kind of a delayed response, so not sure its related. But I didn't injure the left so probably related.
Information has been received from a medical assistant(also reported as office manager) referring to a 12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 03-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. ; Sender's Comments: US-009507513-1704USA014784:
Information has been received from a physician concerning a patient was vaccinated with a dose of GARDASIL on an unspecified date. Subsequently the patient developed lupus after getting GARDASIL. The patient went to a rheumatologist who thought this was related to the vaccine. No information was known after how many doses this occurred. Upon internal review, lupus was determined to be an other important medical event. Additional information has been requested.
Patient came in 6 days early for his second Pfizer covid vaccine appointment. Patient received first dose of Pfizer on 04/15.
Mother states that 1 week after receiving his Kinrix vaccine, he developed a large (baseball size) read area with "blotching" around the injection site. No fever or other sx.
pt recv vax 12APR99 & over next few days painful acute rt torticollis, irritability, inc sleeping full work up EEG, LP, MRI head neck, CXR dec head control noted during episode;
Fever started 5-6 days post vaccination/ Fever up to 104.8 (rectal) within one day. Dosed with alternating Tylenol and Motrin. Fever was present for 7 days. On 5th day of fever, a slight and dotty rash appeared on body trunk. Rash lasted for part of a day. Fever broke on 7th day. No other signs of illness.
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. In 2017, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the  prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2017, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine 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.
gall bladder inflamation and shortness of breath days after 2nd injection. iburophen for 3 days to get rid of gall bladder. Shortness of breath lasted 6 months. oct 2021 burcitis in left arm injection site started. do not play sports or any reason for it.
The Amorphous Aluminum contained in the HPV GARDASIL 9 Vaccine manufactured by Merck provoked an intense & potent immune response in patients immune system. This immune response involves a prolonged attack on the "B" cells in patient's pancreas. The attrition of her "B" cells diminished her pancreas's ability to produce insulin naturally. This decrease of natural insulin production was expressed throughout the 3 phases of Diabetes Type 1 eventually resulted in patient's chronic disease diagnosis of Diabetes Type 1. Patient was admitted on 12/01/22 @ Hospital ER. She was discharged 12/02/22.