chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015 the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Began experiencing increased temp of 101.4 on 1/4/2021 at 0701. Temp did not resolve with the use of Tylenol. HR increased to >100 and BP was decreasing below baseline. Increased weakness also noted. Temp increased to 102.9 on 1/4/2021 at 2220. Transferred from SNF to ER for evaluation.
This case was reported by a consumer via call center representative and described the occurrence of nausea in a adult male patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, 5 days after receiving BEXSERO, the patient experienced nausea, feeling unwell, vomiting, headache and injection site pain. On an unknown date, the outcome of the nausea, feeling unwell, vomiting, headache and injection site pain were unknown. The reporter considered the nausea, feeling unwell, vomiting and headache to be possibly related to BEXSERO. The reporter considered the injection site pain to be related to BEXSERO. Additional details were reported as follows: This case was not previously reported to anyone. This case was reported by the patient's mother. The patient's age at the time of reporting was 18 years. The age at vaccination was not reported. The mother reported the patient did not have any allergies and reaction to any vaccine in the past. The information captured was from the comments provided by the patient's mother, related to whether her son experienced a reaction to BEXSERO or caught an illness unrelated to the vaccine. It was not clear on which arm the patient received the vaccine. The arm hurting happened on the same day as the vaccination, date was not provided by the reporter. The patient had denied the permission to contact his physician. The mother declined to provide information for report. The mother was questioning whether the patient would experience this again and she was referred to her son's healthcare provider for discussion.
the patient received an unauthorized vaccine/ patient was not age 12 at the time the vaccine was administered
Patient developed bilateral lower extremity weakness.  Fell and then unable to ambulate. Seen by neurologist who suspected Guillain-Barre. Weakness worsened and developed paresthesia in both feet over following week. Admitted 10/31 and began IVIG treatment 11/1/09.  11/3/09 Hospital records and discharge summary received service dates 10/1/09 to 10/14/09. Assessment: Bilateral lower extremity weakness, probably Guillain-Barre syndrome. Patient presents with a a sudden onset of bilateral lower extremity weakness after a fall. Vague lumbar pain and bilateral leg paresthesias. Gait apraxia. Constipation. Paresthesias both hands.
I HAVE ATTEMPTED TO CONTACT PATIENT YESTERDAY AND AGAIN TODAY.  WILL CONTINUE TO CALL
First COVID Vaccine given on 3/5/2021 at Clinic. Spikevax Lot Unknown. Administration site and route unknown
Left arm started yesterday after injection was completed on 12/28/20 with red itchy rash.
Shingles like rash on my chest; Shingles like rash on my chest; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (Shingles like rash on my chest) and RASH (Shingles like rash on my chest) in a 57-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Concomitant products included TRIAMCINOLONE DIACETATE (PROCTOSTEROID) for an unknown indication.   On 20-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient started INFLUENZA VACCINE (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced HERPES ZOSTER (Shingles like rash on my chest) and RASH (Shingles like rash on my chest). At the time of the report, HERPES ZOSTER (Shingles like rash on my chest) and RASH (Shingles like rash on my chest) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   The patient had no medical history, concomitant disease or risk factor. Patient had shingles like rash on chest appeared on or about 30-Nov-2022. Received the shingles vaccine in Feb 2022 and June 2022 (2 shot regmine). It was unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Applied steroid cream for 2 days 2x per day.
Developed a cold sore (herpes simplex) on my left lower lip after a sun exposure on 6/10/18.  Typically these are very self limiting. In this case the next day I developed pain radiating up the left mandible into my left ear. This progressed through the night to severe ear pain, paresthesias of left side of tongue and entire left side of face (similar to novocaine feeling).
3/1/22: At 6:08PM pt c/o of itching on cheeks and ears (in area where mask and straps were touching) no rashes, no SOB, no change in LOC VSS 104/72, pulse 81, R 18, O2 sat 97% Mother present throughout At 9:25 PM this writer spoke with child's mother who said pt did not develop any new signs/symptoms, no further itching
I have a history of anaphylaxis to allergy testing in 2003 so I had to stay 30 minutes after vaccination. At the 10 minute mark I noticed difficulty swallowing, hoarseness, nausea, shortness of breath and I felt incredibly thirsty. Staff took me to the triage tent and gave me Benadryl. It helped a little but hoarseness returned. They gave me another Benadryl and told me to go to the Er if I needed more Benadryl. I should've went to the Er but I suffered through it and took 3 boxes of Benadryl as prescribed over 3 weeks to help with my allergic reaction and ongoing symptoms. I also did a few steroid tapers for shortness of breath issues and used albuterol prn. It took me three weeks to feel normal again.
Patient was given vaccine that expired on 2/26/2023.  No adverse reactions noted.
No adverse event; Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose) and NO ADVERSE EVENT (No adverse event) in a 3-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2022, the patient experienced ACCIDENTAL OVERDOSE (Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose) 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 ACCIDENTAL OVERDOSE (Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose).    This case contains information for the first patient (first child) of the two patients described by the reporter.  No concomitant medications was reported.  The pharmacist states that, 0.25ml of vaccine was pulled out of the Red Cap vial and administered to the patient on 17-Aug-2022.  No treatment drug details was reported.   Reporter did not allow further contact
second dose of vaccine had cold sweats; second dose of vaccine had headache; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (second dose of vaccine had cold sweats) and HEADACHE (second dose of vaccine had headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COLD SWEAT (second dose of vaccine had cold sweats) and HEADACHE (second dose of vaccine had headache). At the time of the report, COLD SWEAT (second dose of vaccine had cold sweats) and HEADACHE (second dose of vaccine had headache) had resolved.      No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   The reporter causality for the events of second dose of vaccine had cold sweats and second dose of vaccine had headache was not provided.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.   This case was linked to MOD-2022-623259, MOD-2022-623262 (Patient Link).
2 minutes after vaccine administratios started  Saying she did not feel right. She stated to  develop Pallor, blue immediately went to her couch where  she lAid down, she expressed feeling dizzy. Cold  cloth to heAd, OJ given. VS 130/74 BP P70 colored returned within 40 miN . VS stable started she felt better
Case number PHHY2012US051594 is an initial report received on 12 Jun 2012. Authors searched VAERS for reports of adverse events (AEs) in pregnant women who received INFLUENZA from 01 Jul 1999 though 30 Jun 2009. This case refers to a baby born (sex not specified) to mother (age not specified). The mother was vaccinated with INFLUENZA (manufacturer and batch number: unknown) at an unknown gestational age, on an unspecified date between 01 Jul 1999 through 30 Jun 2009 (see linked mother file: PHHY2012US051588). The fetus was exposed to this vaccine via transplacental route. On an unknown date at an unspecified gestational period, the baby was born with birth defect, patent foramen ovale and peripheral pulmonic stenosis. The causality was not reported. Authors stated that the VAERS system does not allow for active follow-up of adverse events among pregnant women; thus, pregnancy outcome data are not available for women who had an adverse pregnancy event. Authors concluded that no unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of INFLUENZA.
Consistent altered smell, especially of soaps, lotions, deoderants, detergents, shampoos., etc.  All have a consistent smell that is wrong, and unpleasant.  It is even present walking past people or down drug store or grocery aisles.  I am trying to "train" and correct my olfactory neurons by smelling cloves, eucalyptus, lemon and rose odors.  I had lost my sense of smell with Covid in December 2020.  It did return, but became altered after the second shot.
Breakthrough case admission after 4 vaccines Pfizer 1/27/21 Lot# El9264;  Pfizer 2/17/21 Lot# En6200;   Pfizer 10/12/21 Lot# FF2590; Pfizer 4/26/22 Lot# FP4554
About 11 hours after dose I started to get intense chills and a headache that lasted throughout the night.
Slight cold symptoms that night then next day arm had swollen up and was extremely painful to touch and continued to be so for over 1 week
Patient complained of dizziness at 11:13 after receiving first dose.; This is a spontaneous report received from a contactable pharmacist. A 44-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6200) via intramuscular route of administration in the left arm on 22Feb2021 (at the age of 44-years-old) for COVID-19 immunisation. The patients medical history included dizziness. Concomitant medication was not reported. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. It was unknown if prior to the vaccination, the patient was diagnosed with COVID-19 and unknown if patient was tested for COVID-19, since the vaccination. On 22Feb2021 at 11:13, after receiving first dose the patient experienced dizziness, patient had history of dizziness not on medications. The patient vital signs were normal. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment taken as a result of reported event included drinking of water 8 oz of water at 11:15, then another 8 oz at 11:29. The clinical outcome of the event dizziness was recovered on 22Feb2021 at 11:40 at the time of reporting.   No follow-up attempts are needed. No further information is expected.
ED to Hosp-Admission Discharged   9/21/2021 - 9/26/2021 (5 days)  Hospital  MD  Last attending ? Treatment team Pneumonia due to COVID-19 virus  Principal problem Hospital Course This is a 64-year-old lady with history of anxiety depression who came to Hospital emergency department with a chief complaint of cough fever and shortness of breath.  She was recently tested positive for COVID-19 on September 18.  Because of worsening shortness of breath she ended up coming to the hospital.  On work-up she was found to have COVID-19 pneumonia.  On admission she was hypoxic and requiring supplemental oxygen.  She was treated with IV remdesivir and dexamethasone and now changed to p.o.  Her symptoms are getting better.  We did home oxygen evaluation she need 2 L with exertion only.   Day of discharge patient feeling better.  Denies any shortness of breath at rest.  Denies any chest pain palpitation.  She has some occasional dry cough.  Denies any pain/swelling in the legs.  Afebrile.  No other new symptoms or acute event as per nursing staff
Patient had lower edema swelling, tachycardia, chest pain on exertion, shortness of breath, when presenting to our office on 8/20/21.  Was sent to ED for evaluation and was admitted.
rash all over the body. it is red dots mainly on the trunk of my body.  puffiness in face. 11/13/09:  Primary Care records received for date of service 11/6/09.  Dx:  Morbilliform eruption rash. Assessment:  Underwent septoplasty surgery and finished perioperative antibiotics 5 to 6 days before visit.  He received H1N1 vaccine two days before visit.  The day before visit he woke up with a generalized body rash.  He feels swollen all over and somewhat bloated.  He denies fever, chills or asthma sx.  Pt. to continue antihistamine and begin prednisone.
This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On unspecified dates since 08-JUL-2015, the patients were vaccinated with GARDASIL (lot # J011272 and expiration date 21-APR-2016) (dose and route were not reported) which were exposed to temperatures outside of the recommended range. No adverse effects were reported. No Product Quality Complaint (PQ) was involved. This is one of the two reports received from the same source. Additional information has been requested.
Information has been received from a certified medical assistant concerning a female patient between the age of 15 to 18 who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient complained of stinging. It was noted that the stinging was only for a moment and resolved quickly. The reporter felt that the stinging could be from the vaccine being cold. No other problems were noted with the administration. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Within five minutes of receiving vaccine I broke out in a cold sweat and was dizzy. That lasted for about ten minutes. The next day I woke up to pain running from the right side of my jaw to my right ear. The injection site in my right arm was more sore than any other vaccine shot I have ever had. The glands in my neck were swollen and my right side shoulder and neck area were sore. I experienced waves of fatigue over the next four days. The pain to my ear that seemed to mimic a really bad ear infection continued for six days. I went to the minute clinic at the Pharmacy where I received the shot and was checked out. There was nothing wrong with my ear and they could not find anything wrong with me other than my glands were swollen and I had a general amount of swelling on the right side of my next going into my shoulder. While the pain in my ear has lessened some it is still there now eight days after the vaccination. I have also experienced some GI issues. I am extremely regular and do not have issue going to the bathroom. My gut was not normal and I did not have normal bowl movements for more than a week. I also have had something akin to a rash on my arms that looks like prickly heat. It seemed to me that my immune system overreacted to the vaccine. I have contended for months now that I had Covid back in March of 2020 right before the shutdown. I believe I caught it during business travel at the very beginning of March 2020. My concern is whether I should get the second Moderna shot if my immune system is already this revved up with antibodies.
Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SA092508, 2015SA092509, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092723, 2015SA092724 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of TDAP (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. As Tdap vaccine was exposure in utero, thus 526 numbers of neonate patients out of which 99 (1 percentage) patients gestational age at delivery was 34 or less weeks and 427 (6 percentage) patients gestational age at delivery was 36 or less weeks. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
pt recvd vax; chills, sweats; arthralgia; myalgia, some itching 10-13 hrs p/ dose 2,3,4 4nov93,8nov93 & 15nov93;19jan94 no tx, rapid recovery;
No adverse etfects reported; patient received improperly stored dose of MMR II; This spontaneous report was received from a nurse and refers to a 23-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 15-JUL-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R024905, expiration date 30-AUG-2020, albumin status rHA (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the highest temperature excursion of above 47 degrees Fahrenheit (54 degrees Fahrenheit) for 17 hours and 15 minutes on 12-JUL-2019. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA004662:
Throat swelling, coughing, rapid heartbeat of 130/bpm.  Took max dose of liquid Benadryl with about 50% improvement.  About 9pm that same night fever of 100, chills, body ache lasting 1 day.
Hives; A spontaneous report was received from a physician concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received his first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, it was reported that the patient experienced hives. The reporter inquired about second dosing for the patient. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, hives, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Right arm she has swelling the size of a baseball, the area is very red, warm to the touch, and pt reports she is experiencing severe pain.