chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 16-JUL-2015, the patient received the ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. On an unknown date (reported as "shortly thereafter"), the patient started experiencing sciatic pain, numbness in the right leg and hands, cramping, and mild headaches. In or around May 2016, the patient presented to a physician for these injuries. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experiences mental and emotional distress due to the resulting physical conditions and the seriousness of her condition. As a result, the patient sustained severe and lasting personal injuries. Further as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including but not limited to, the following: the patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Sciatic pain, numbness in the right leg and hands, cramping and headaches were considered to be disabling. Additional information has been requested.
HIGH FEVER UNCONTROLLED BY IBUPROFEN (SUBSIDED AFTER 12 HOURS), NAUSEA (LASTED 12 HOURS), NO APPETITE (ONGOING),  SEVERE FATIGUE (ONGOING).
Very light period directly after shot. One day. Then month after 10 day very heavy period and every month since then. Normally period is 7 days regularly and medium flow.
patient had headache within the first 15 minutes after administration and was found to be positive for dural venous sinus thrombosis with unknown etiology
Had the vaccine on 3/10/21, and had no issues.  On Saturday 3/13/21 he woke up and he had a dark, red, raised rash, several large patches across his stomach, around his right side of his body.  Today, 3/17/21 he is uncomfortable with it and it's blistering, painful rash, not itchy.  He has not taken anything for it.
Information has been received from a registered nurse concerning a 12 month old patient who on 05-NOV-2007 was vaccinated with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) instead of a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (MSD).  Secondary suspect therapy on same day included a dose of Varivax (Oka/Merck).  It was reported that both the box and the description of the vaccine was similar.  The labeling was different on both the vaccines boxes but it was not enough to notice the difference.  It was reported that ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (MSD) was stored in the fridge for a least 5 months.  The patient did not experience any adverse symptom.  A product quality complaint was not involved.  Additional information has been requested. Follow-up information was received from concerning a 12-month-old female who was vaccinated with PROQUAD (Merck) (lot# 657265/0293U). The PROQUAD (Merck) was stored where the MMR II was supposed to be stored. Since there was no MMR II (Merck) left in the refrigerator, someone mistook the PROQUAD (Merck) for the MMR II. It was unknown who put the PROQUAD (Merck) in the MMR II spot. Additional information is not expected.
Shingles about 20 days after second dose; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles about 20 days after second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles about 20 days after second dose). At the time of the report, HERPES ZOSTER (Shingles about 20 days after second dose) outcome was unknown.            This case was linked to MOD-2021-081482.
Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26.
pronounced redness at the site of previous dermal fillers; This case was reported by a consumer via call center representative and described the occurrence of erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2021, the patient received the 1st dose of Shingrix (intramuscular). On 18th November 2021, 1 hr after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. The patient received Shingrix vaccine today (on the day of reporting) in the left arm.  About 1 hour after the Shingrix vaccine he noticed a redness at the site of previous dermal fillers. The patient stated that the redness was more pronounced 3 hours post Shingrix injection. The patient did not share his date of birth, address or how many sites were involved or location.  The patient would contact his health care professional. The reporter did not consent to follow-up.  The reporter does not give permission to contact health care professional.
MMR II was administered intradermally to a set of 13 month old twin patients.; No additional AE; This spontaneous report was received from a nurse refers to a 13-month-old patient. No information on patient medical history, current conditions and concomitant medications was provided.    On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), intradermal for prophylaxis (exact dose, lot number and expiration date were not provided) (incorrect route of product administration and no adverse event).; Sender's Comments:  US-009507513-2305USA005015:
Hospitalized with intussusception on 10/24/07.  12/4/07 Reviewed vax record which confirms dose & lot numbers as reported.  Records faxed to CDC.  12/7/07 Reviewed hospital medical records which reveal patient experienced vomiting & bloody stool.  Had been seen at outlying ER & transferred to higher level of care.  Admitted 10/24/2007 & d/c to home same day.   FINAL DX: Intussusception, enema reduced.  Records faxed to CDC.
Headache & Numbness in lips/nose within the 1st hour.  I called to report symptoms and was advised to monitor and if gets worse to call back and go to ER. At this time I am ok and no need to go to ER as I am not having trouble breathing and no swelling.
Pain at injection site that has lasted over a month. Pain is variable, some days severe, some days not noticeable. It has lasted over 6 weeks now.
Right upper extremity noted with papular rash with erythema extending over the entire deltoid region clear demarcation. The area is also with warmth.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. In October 2014 the patient was vaccinated with GARDASIL dose #1 (dose, route and frequency unspecified). In May 2015 the patient was vaccinated with GARDASIL dose #2. Other suspect therapies included in July 2015, GARDASIL 9 dose #3 in the HPV vaccination series (dose, route and frequency unspecified). No adverse effect reported. There was no product quality complaint involved. Outcome of medication error was unknown. Additional information has been requested.
About 6 months after getting COVID in late December 2021 (I was up to date with my vaccines and boosters), I starting having frequent PVS (about 10 per minute). I went to urgent care to get an EKG, and the urgent care center sent me to the ER, where they told me frequent PVCs are not a big deal and sent me home. I saw Dr. two days later: they did a bunch of tests, including wearing a holter monitor and a stress test, and while I was getting PVCs during the stress test, because they were not too bad (they had subsided after a few days), I was told I was fine. This was June/July 2022. At the time, my doctor said it could be related to COVID (which I had 6 monhts prior), since it can cause electroical issues. It could also be related to myotonic dystrophy, which also can cause electrical issues in the heart.  About 2 months after my bivalent booster in October 2022, I started having frequent PVCs again. There were a few the first two days but they got steadily worse. On the 3rd day I was having at least 10 per minute. I called Dr. and a nurse called me back to speak in more detail. I was told to drink Gatorade or Pedilyte for the electrolytes, and if I didn't get better by that evening to call and make an appointment. I wasn't great that night, but the PVCs were more sporadic: sometimes they were 10+ a minute, sometimes it was 1 a minute. I went to bed and the next morning things were a lot better, so I messaged my doctor and did not go in.
Neck started hurting mainly on her left side; Felt severe pain; Heaviness; sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Apr-2021 and was forwarded to Moderna on 29-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck started hurting mainly on her left side), PAIN (Felt severe pain), LIMB DISCOMFORT (Heaviness) and VACCINATION SITE PAIN (sore arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced NECK PAIN (Neck started hurting mainly on her left side), PAIN (Felt severe pain), LIMB DISCOMFORT (Heaviness) and VACCINATION SITE PAIN (sore arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, NECK PAIN (Neck started hurting mainly on her left side), PAIN (Felt severe pain), LIMB DISCOMFORT (Heaviness) and VACCINATION SITE PAIN (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.
Information has been received from a physician for the Pregnancy Registry for GARDASIL concerning an approximately 23 year old female with a history of seizures who on 16-JAN-2007 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL (lot # 655619/1427F).  Concomitant therapy included YASMIN and CARBATROL.  Subsequently the patient was found to be about 9 weeks pregnant at the time of the vaccination and sought unspecified medical attention.  A pregnancy test was performed which was positive (not further specified).  Follow-up information was received from the physician who reported that the mother developed gestational diabetes and went on to deliver a healthy, normal infant at term.  No further information was available.  Additional information is not expected.
Pain at injection site, became more severe daily and spread down right arm. One week after pain onset blisters developed on finger and then followed nerve all the way up to injection site and into neck. Was diagnosed with Shingles. Treated with pain medicine, Neurontin, and Valtrex.
Case previously recorded as MA2009-4636. Initial case report received from a nurse via agency on 17 NOV 2009. A patient 3-year-old female was vaccinated with FLUVIRIN 2009/2010 (batch no. 1020401P1) i.m on unknown date in 2009. No adverse effect was reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to the foreign and local label: Off label use is unexpected after vaccination with FLURIVIN 2009/2010. No change in benefit-risk-ratio. No measures necessary. Agency reference no.: NA09-008367.
6 hours after her vaccine administration, she started having chest tightness with difficulty breathing. She initially called 911 but did not go to the hospital after her initial evaluation. Then she had prolonged episode of symptoms on 8/6/2021, at which time she presented to ER. CXR and EKG in the ER were normal. Pt was given benadryl and discharged home.    8/11/21 Pt reports she continues to have up to 3 episodes of chest tightness, palpitations and dyspnea per day. Her symptoms may last up to 3 hours at a time. She tried taking benadryl, but it made her drowsy into the next afternoon. She also does not feel safe to drive while on benadryl.  Incentive spirometry 370L/min, estimated based on age and height is ~420L/min. Pt given hydroxyzine 10mg PO QHS and Albuterol 90mcg/act 1inh Q6hrs PRN Wheezing/SOB Pt has not reported continued symptoms at F/u appointments.
Approximately 35 minutes post vaccine administration I noticed a tingling sensation in my left facial area from mycheek area to my temple.  Later the same evening the sensation included the area below my left cheek.  A few days later the affected area appeared to move closer to my nose. On 01/28/2021 I notified Dr office and was recommended to go to Urgent Care to be evaluated, which I did.  Urgent Care recommended I go to Emergency Department for a further evaluation, which I did.  I was given an EKG and a physical exam. Both were essentially normal and my final diagnosis was left facial numbness.
Approx 9 days after receiving booster, experienced hives throughout various parts of body that progressively worsened.  Went to urgent care on Jan 15, 2022.  Was given an injection of prednisone, and a 3 day pill prescription.  Currently taking Claritin, Benadryl and prednisone, with vitamin d and zinc.  Some resolution but still experiencing flare ups.  Also immediately after booster, right ear tinnitus and partial hearing loss. Have not seen a doctor for that issue, yet.
Woke up middle of the night with a rapid, sustained heart rate of 174 bpm. Had some chest pain on left side below armpit, numbness in hands, fever of 100.4 in spite of ibuprofen, apiked blood pressure of 160/100 and extreme thirst.
Wrong Route of Administration / was given subcutaneously instead of IM; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 56-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 59TH3, expiry date 30th September 2022) for prophylaxis.   On 6th August 2021, the patient received Boostrix (subcutaneous). On 6th August 2021, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional case details were provided as follows: Boostrix vaccine was given subcutaneously instead of intramuscular route which led to intramuscular formulation administered by other route. No other details were given. The reporter consented to follow up.
Flu like symptoms ( fever, body aches, nausea) then followed by large, hard red spot at injection site.
Patient received her second Hepatitis B vaccination at 3 pm on 1/30/06. As per her mother patient exhibited nausea, vomiting and abdominal pain starting at 4:00 am on Tuesday 1/31/06. She was taken to the ER at 10:00 pm 1/31/06 an ultrasound was inconclusive. Mother reported above to public health 2/02/06.
development of urticaria symptoms which have now become chronic; no angioedema or other symptoms suggestive of systemic anaphylaxis
Pt received a dose of DAPTACEL on 9/23/08. Pt presented today for 15 month exam and received a 5th dose of DAPTACEL today.
COVID symptoms while still maintaining negative test result for COVID. Fatigue, sore throat, congestion, runny nose, difficulty breathing, low blood oxygen levels, chest tightness. X-Ray showed clear lungs, send home with albuteral which made chest tightness and breathing worse. Trying to get appointment for cardiac monitoring and checking for heart issues.
Pt developed a sore arm after injection which has never improved and has worsened over the weeks, decreasing and restricting his range of motion.
No adverse event reported.  Pfizer vaccine expired on 10/8/21, 5pm.  Vaccine was administered on 10/9/21, 11am.
vertigo where the room was spinning really bad; sensation is still happening especially in the early morning as she changes positions from; headache; some nausea; soreness in the arm; little redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), VACCINATION SITE ERYTHEMA (little redness at injection site), VERTIGO (vertigo where the room was spinning really bad), FEELING ABNORMAL (sensation is still happening especially in the early morning as she changes positions from) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm) and VACCINATION SITE ERYTHEMA (little redness at injection site). On 10-Mar-2021, the patient experienced VERTIGO (vertigo where the room was spinning really bad), FEELING ABNORMAL (sensation is still happening especially in the early morning as she changes positions from), HEADACHE (headache) and NAUSEA (some nausea). On 22-Mar-2021, PAIN IN EXTREMITY (soreness in the arm), VACCINATION SITE ERYTHEMA (little redness at injection site), HEADACHE (headache) and NAUSEA (some nausea) had resolved. At the time of the report, VERTIGO (vertigo where the room was spinning really bad) and FEELING ABNORMAL (sensation is still happening especially in the early morning as she changes positions from) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Arm soreness, muscle aches, fatigue, nausea, temp. 102.5
Severe swelling lower legs / feet (looked like balloons ans like ribber bands) around ankles. Started one day after vaccine lasted 6 days toe bruised from swelling; Rash several parts of body; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old of unknown gender patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 23Mar2021 at 17:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, diabetes, fibromyalgia, obesity, sicca syndrome, rheumatoid arthritis, chronic migraine and unspecified allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021 at 18:15 the patient experienced severe swelling lower legs/feet (looked like balloons and like ribber bands) around ankles which started one day after vaccine lasted 6 days and toe bruised from swelling. The patient also experienced rash on several parts of the body. Therapeutic measures were taken as a result of events and included treatment with muscle relaxers from severe cramping, off fleet c and Benedryl. The clinical outcome of the events swelling in leg was recovered on 30Mar2021 and rash were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Red rash appeared at injection site one week after receiving vaccination. Slight tenderness if lying on the side of the injection. No other issues noted at this time.
Lost senses of smell and taste other than extremely strong tastes and odors (vinegar) for approximately 24 hours. Noticed symptoms improving and completely recovered about 26 hours after initially noticed
REDNESS AT INJECTION SITE NOW 6-7 INCHES WIDE, WARM TO TOUCH. AREA RAISED AND SWOLLEN.
Information has been received from a physician concerning a female who was vaccinated with a 0.5 mL dose of Gardasil.  It was reported that the patient had fainted after vaccination.  The patient sought unspecified medical attention.  Subsequently, the patient recovered.  This is one of two reports received from the same source.  Additional information has been requested.
Pain and weakness due to pain in the arm that injection was placed in. Pain has lasted 2 weeks.