chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2010, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 29-SEP-2011, the patient was treated for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. The patient was prescribed gabapentin for management of her painful symptoms and chronic pain. 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
I was attending a musical performance when I became very warm and passed out for approximately 1 minute. Bystanders called EMS. EMS took my vitals including an EKG and said everything was reasonable except the blood pressure was high (157/105). My BP is normally 120-130/80. I sat in a cooler place and felt much better except for a very sore arm that got the inoculation.
At 1600 both influenza vaccine and Gardasil were given. Patient was left in room with parents to monitor for reaction. At 1610 mother came and got the nurse stating that patient had developed hives and having jaw pain. This was reported to provider and 50mg of Benadryl was given and ice packs were put on injection site. Patient was monitored continually in the room with nurse. Patient then started to complain of it being hard to swallow and having a hard time breathing. This was reported to provider and provider order epi pen. 1635 0.3mg of epinephrine was given via epi pen. Pt was then transferred to the ER.
Patient complained of being lightheaded after immunization.  Patient checked out by EMS, began feeling better shortly thereafter.  Patient advised to call 911 or go to the nearest emergency room for any additional issues as needed.  Also advised to sign up for v-safe.  Patient left site stating he felt better.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma (allergy+chest infection induced)" (unspecified if ongoing); "Chest infection induced" (unspecified if ongoing); "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received the treatment Paxlovid from 18Jan2023 to 22Jan2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse concerning a female pt who was vaccinated with a first dose of Varicella-Zoster virus vaccine live. The pt suffered a stroke within 24 to 48 hours after the vaccine as administered. Unspecified medical attention was sought. A product quality complaint was not involved. Upon internal review, stroke was considered to be an other important medical event (OMIC). Additional information has been requested.
One episode of vomiting; Leg spasms; Severe back pain; Chills; This is a spontaneous report received from a contactable consumer (reporting on himself) via Pfizer sponsored program.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: E087217 and Expiration Date was not reported) via intramuscular route of administration in Arm Left on 22Mar2021 10:00, as 2nd dose, single dose for COVID-19 immunization. Medical history included: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Incomplete Quadriplegic and in a wheelchair since 1972.  Immune and respiratory system are probably compromised since 1972. He was ambulatory up until 15 years ago. Concomitant medication(s) included celecoxib (CELEBREX) taken for arthralgia, myalgia from an unspecified start date to 2016.  Previously patient took first dose of BNT162B2 Injected intramuscularly in left arm on 01Mar2021. Patient stated he has 8 separate reactions since the second dose. Reported leg spasms, Severe back pain, chills and one episode of vomiting. Stated he was two months out and still getting them every 2 weeks. Reported that he was an incomplete quadriplegic since 1972. The dates as 25Mar2021, 30Mar2021, 04Apr2021, 05Apr2021 noting had the leg spasms, 06Apr2021 reported vomiting, 15Apr2021 had the fourth reaction that continued for 3 days noting they usually last 24 hours, 21Apr2021, 2May2021, 19May2021 and 21May2021. Patient stated he thought the frequency was getting longer up until last week. Wanted to know what type of doctor if any should he be talking to and if any-thing could be done other than taking Tylenol and if there have been reports of reactions continu-ally happening before. She received their first vaccine 01Mar2021, and second dose 22Mar2021, but was having same side effects 2 months out every 1 -2 weeks.  He was having leg spasms, severe back pain, and all kinds of side effects.  He was trying to figure out who can he talk to and how to manage these symptoms. Celebrex was the only thing he heard of that may have interacted.  He did not have a lot or expiration for that. NO ER or physician's office required. The outcome of the events was recovering.   Information on Lot/Batch number was available. Additional information has been requested.
My period began 2 weeks early and cramps were more severe than usual. I am also experiencing significant bleeding. The blood is very bright red; heavier flow than usual. I am also experiencing migraines and arm soreness.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles. In June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain and product supply issue. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm. The patient states she experienced pain at the injection the second day post vaccination. The pain lasted for total of 2 days. The patient had denied permission to contact their physician. No further details were provided by the patient. It was reported that the SHINGRIX went onto backorder, and the patient need his second dose of SHINGRIX at the time of reporting. The had already called hundreds of places for SHINGRIX vaccine and he could not get it, which led to product supply issue.
Pt received DTaP/Polio vaccines on 2/1/16, mom noticed swelling and redness, went to ED, received BACTRIM Rx and to monitor site.
Patient is experiencing worsening pain in her shoulder that radiates to her elbow. Has difficulty lifting her right arm and has trouble dressing herself.
Body aches and pain; severe fatigue; This non-serious case was reported by a consumer and described the occurrence of general body pain in a 65-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 25-OCT-2023, the patient received Arexvy. On 27-OCT-2023, 2 days after receiving Arexvy, the patient experienced general body pain (Verbatim: Body aches and pain) and fatigue (Verbatim: severe fatigue). The outcome of the general body pain and fatigue were resolved.   It was unknown if the reporter considered the general body pain and fatigue to be related to Arexvy.     It was unknown if the company considered the general body pain and fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-OCT-2023 It was reported that patient suffered from body aches, pain and severe fatigue after receiving Arexvy vaccine. The reporter consented to follow up.
33 y/o female with no medical history seen today complaining of dizziness, diaphoretic, and numbness in the left arm. Patient reports history of allergy to PCN.  Patient denies being pregnant. Per patient this is her second dose.  Patient states that she felt like that when she took her first dose of the vaccine series. She didn?t report it because she had water with her, she drinks it and felt better. NP and paramedics at patient side. Water provided to patient. She states that she felt better after drinking the water. Patient discharge home with her husband.
On 5/28/99 and 7/1/99, the pt received his 1st and 2nd doses of Lymerix, respectively. During 2000, the vaccinee had 2 wood tick bites: one on his head and one next to his navel. In both instances, he experienced swelling the size of a dime and severe itching at the site of the bites which lasted for 2 weeks. He is an outdoor person and has never had such a reaction to a wood tick bite prior to receiving Lymerix. However, he has had this type of reaction to black fly bites. On 5/30/00, the pt received his 3rd dose of Lymerix. The most recent information, received on 5/30/00, reports the condition of the vaccinee as resolved.
Woke up in the morning on March 10, 2021 with asthma symptoms. It continued through the day. Barely able to control with antihistamines and continuous usage of the antihistamines. Saw an allergist approximately March 20, 2021 because the asthma was constant. Doctor did pulse oximeter reading, listened to lungs, sent me home with inhalers. Inhalers helped take the edge off, but certainly did not cure the asthma symptoms, was slightly improving.  Had the 2nd shot 3/27/21, and symptoms got worse again. Asthma continued for another several weeks; continued round the clock antihistamines and inhalers.
a cluster of hemangiomas like a big thick red blood-like area around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (a cluster of hemangiomas like a big thick red blood-like area around the injection site) in a 92-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Bruise.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (a cluster of hemangiomas like a big thick red blood-like area around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (a cluster of hemangiomas like a big thick red blood-like area around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.   The caller stated that patient, bruises easily and this could be contributing to her injection site issues. Caller stated that she had been seen by her PCP and a dermatologist.  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.
Information has been received from a physician concerning a 29 year old female patient who on 01-JUL-2009 was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not reported).  Four days later, on 05-JUL-2009, the patient started having chickenpox on her knee and neck and as of 13-JUL-2009, the patient continued to develop more vesicles.  At the time of reporting, the patient had not recovered from the event.  The patient sought medical attention by contacting the physician.  Additional information has been received from a physician concerning a 29 year old female patient who had about ten to twenty lesions and it had been two weeks since breaking out and the patient was continuing to break out with new lesions.  The physician reported that the place where the most lesions occurred was at the injection site which has five lesions and was experiencing swelling and pain at the injection site.  The Physician reported that the patient also had a few lesions on her scalp, leg, arm and stomach.  The physician provided the patient with ZYRTEC to help the itching and instructed her to use calamine lotion and another cream (name and manufacturer unspecified) to put at the injection site.  Additional information has been received from a physician concerning a 29 year old healthy female patient who had no known exposures to wild-type VZV.  After vaccination on 01-JUL-2009 with VARIVAX (Merck) the patient broke out into a varicella type rash.  She developed classic vesicles at the injection site and elsewhere on her body, approximately 20 vesicles.  The patient was continuing to develop more vesicles so the health care professional was estimating that the patient had approximately 40 plus vesicles.  The patient had no fever or other complaints, but was concerned that the lesions are still appearing.  At the time of reporting, the patient had not recovered.  If this continues for another couple of days the primary physician may send the patient to a dermatologist and also request an identification whether the lesions are in fact due to vaccine strain.  The physician also discussed possible T cell abnormalities with this patient given the atypical course of the rash.  Follow up information has been received from the physician concerning a 29 year old healthy young female patient who on 01-JUL-2009 was vaccinated with the second dose of VARIVAX (Merck) (Lot : 660336/0108X) subcutaneously in the left deltoid.  On 05-JUL-2009 the patient developed a limited outbreak of chickenpox.  Most pronounced vesicles at the injection site, but had 20-40 vesicles/pox diffusely.  Otherwise the patient felt well, with no fever and no other viral symptoms.  On 20-JUL-2009, all the symptoms resolved without intervention.  Additional information is not expected.
Persistent numbness, left hand, two fingers and side of hand Persistent elevated resting heart rate, tachycardia
feeling weak; feeling jittery; shaking; nervous; coughing; headache; fever; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (feeling weak), FEELING JITTERY (feeling jittery), TREMOR (shaking), NERVOUSNESS (nervous) and COUGH (coughing) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever). On 16-Feb-2021, the patient experienced ASTHENIA (feeling weak), FEELING JITTERY (feeling jittery), TREMOR (shaking), NERVOUSNESS (nervous) and COUGH (coughing). At the time of the report, ASTHENIA (feeling weak), FEELING JITTERY (feeling jittery), TREMOR (shaking), NERVOUSNESS (nervous), COUGH (coughing), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment was taken by patient for events.
In July I had surgery and my blood pressure went low. I went to the ER and then stayed at the hospital. A doctor monitored my blood pressure medicine Losartan and lowered the dosage. It was stable for a while and then it was low and my blood pressure medicine was reduced again to 25mg. Gradually my blood pressure went up each week until it hit 190. Then the doctor at the urgent care center increased my medication to 50mg. Today 10/18/2021 I saw a doctor and my blood pressure was still high 144/78. Then he had changed my medication but I haven't started it yet. He ordered two test next week. One is a kidney ultrasound and the other is a corroded duplex.
I was exposed on a Thursday at someone's home. I had my mask off while eating. They called us on Saturday to let us know the person tested positive for COVID-19. On Monday morning, I tested positive for COVID-19. I woke up that morning feeling unwell. I had a slight headache, joint pain, and a 99.5-degree fever. I had an occasional sneeze as well. After that, the symptoms turned into a giant head cold with a runny nose. I had a decrease in energy. My transplant coordinator prescribed molnupiravir. I took four 200MG capsules twice a day for 5 days. I had no ill effects from the medication. I was told that I had to isolate for 10 days. I tested positive for COVID-19 again at 10 days. My doctor told me to isolate for 20 days total. On days one through six, I felt like I was gradually getting better. On days seven, eight, and nine, the symptoms had a mild return.
Painful, swollen left axillary area, fatigue, "dizziness" lightheadedness.
Within a few hours became feverish, nauseated, diarrhea.  Indescribable headache and severe eye pain.  Severe fatigue, dizziness, severe joint and muscle pain.  severe pain in bladder area.  Injection site became extremely swollen from just above elbow to shoulder.  Became bright red, painful, and itchy.  Vacillated between chills and excessive sweating from onset of symptoms.  Lasted from approx. 1pm Saturday, Jan 30th 2021 until Monday, Feb 1st 2020 at 6pm.
Severe headache; Slight fever; Left arm ached; About 25 hours after the 2nd vaccine, my ankles swelled up noticeably by Monday night.; About 25 hours after the 2nd vaccine, tops of the feet swelled up noticeably by Monday night.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW-169) via an unspecified route of administration in the left arm on 18Apr2021 at 15:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, low thyroid and ADHD (attention deficit hyperactivity disorder) and known allergy to latex and lavender. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 28Mar2021 at 13:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 19Apr2021 at 17:00, about 25 hours after the second vaccine, the patient's ankles and tops of the feet swelled up noticeably. The left ankle got worst. The swelling reduced overnight, but both ankles were partially swollen throughout 20Apr2021. The patient also had left arm ache. On 20Apr2021 at evening, the patient experienced a severe headache and a slight fever too. On 20Apr2021 at night, the patient's ankles got fully swollen and again, the swelling lessened overnight. On 21Apr2021 at morning, though the left ankle was puffy and on the same day at night, the left ankle got a little more swollen, but there was just barely perceptible swelling in right ankle at that time. Some minor swelling remained in the left ankle through 23Apr2021, but it was totally gone by 24Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events ankles and tops of the feet swelled up was recovered with sequelae on 24Apr2021 and severe headache, slight fever and left arm ache were recovered with sequelae on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
6 month to 5 year old vial used to be given to an 8 year old/0.25 dose was given; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (6 month to 5 year old vial used to be given to an 8 year old/0.25 dose was given) in an 8-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (6 month to 5 year old vial used to be given to an 8 year old/0.25 dose was given). At the time of the report, INCORRECT DOSE ADMINISTERED (6 month to 5 year old vial used to be given to an 8 year old/0.25 dose was given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Varicella lesions-various stages x 3 days. Rx-symptomatic.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concomitant products included TELMISARTAN, ROSUVASTATIN CALCIUM, DUTASTERIDE, ALFUZOSIN HYDROCHLORIDE, VITAMIN D NOS, ZINC and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2021, SARS-CoV-2 test: positive (Positive) positive.         It was reported that currently patient was experiencing minor cold like symptoms.  Treatment medication was not reported.  .   This case was linked to MOD-2021-330449, MOD-2021-330550 (Patient Link).