chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  40 yo female with a relevant PMH history of sever allergies and allergies to many medications received her second dose of Pfizer covid vaccine in August 2021 in the community. Patient called telephone triage a week later stating she had a "bad allergies, bad headaches, weakness, and hives" after her vaccine. PCP was notified and a appointment was scheduled. PCP noted "reactive lymph nodes in left supraclavicular area." Patient stated that she took diphenhydramine to relieve the hives and itchiness. During the appointment, PCP documented that the patient had gone to her community GI provider two days after receiving the vaccine where the provider stated she was reacting to the  polyethylene glycol in the vaccine. A couple weeks later during a follow-up appointment, PCP documented that the rash on her arm had completely improved.
My left check began to spasm this past weekend ( April 17/18). It may be unrelated to the vaccine - looking into HFS, since it could also be related to an eye spasm that I had 2 months ago.    My spouse,  also had the same vaccine same day, has been extremely tired this past week.
Approximately 15 minutes post vax, the pt was brought back into clinic with difficulty breathing, running nose and flushing. Found to have wheezes throughout lung fields. Given albuterol nebulizer treatment twice, chlorpheniramine and transported to ER via ambulance. Pt was given steroids and observed.
Lethargic; Flu like symptoms; Lower part of my leg, I have little bit rash, a redness; Lower part of my leg, I have little bit rash, a redness; I have few spots on my right forearm; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration at the age of 75 years, on 22Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing and anticoagulant therapy from an unknown date and unknown if ongoing. Concomitant medication included dronedarone hydrochloride (MULTAQ) at 400mg, twice daily and apixaban (ELIQUIS) at 5mg, two times daily. The patient stated, "Both my husband and I took the Covid the first shot on 22Jan2021 which was week ago today. I noticed about 4 days later (Jan2021) like I started feeling you know flu like symptoms but they were mild, if I took two an Extra strength Tylenol it went away. You know what I mean. So that one for about may be one, two may three days and that was it. I was very lethargic. The only thing I did notice that on both my legs from the ankles of about midways I have you know my leg, the lower part of my leg, I have little bit rash, a redness. It does not itch, it was not hard to the touch. My body temperature was normal. It was little red or pinkish to a little bit of red. Now, I noticed tonight that I have few spots on my right forearm. Like I said we have shot on 22nd, everything was fine, no immediate reaction or anything else and everything is okay. I just you know I feel fine but is this normal?" The patient stated, "No, they are healthy and safe about 20-25 minutes. Everything was fine and then let us go and I said couple of days later it hasn't progressed, it is very, it is on both of my lower legs from ankles midway up my legs and I noticed couple of spots on my left forearm but it hasn't gotten any worst and it hasn't gotten spread on any place other than right forearm." The patient also stated, "You mean the rash or any other the symptoms. We have the shot Friday, Saturday, Sunday, Monday. I was say this past Tuesday, around 26th (further not clarified)." The patient stated, "It was there on my legs. It hasn't moved. It hasn't gotten any worse and it is only on front it is not back on my legs. The only thing I noticed tonight that it is couple of spots on my right forearm." The consumer stated, "No, I went to see my doctor the other day for her to take look at it. I went to see PA at my doctor's office, I saw her and she said if it doesn't get worse it would probably go away." The patient also stated, "The only thing that I had done right before the Covid Vaccine. I had injection in my knee of amniotic fluid for a torn meniscus but that should not affect it." The patient underwent lab tests and procedures which included body temperature: normal on an unspecified date. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
post-herpetic neuralgia; persistent strain of herpes zoster or shingles; The vaccine did not prevent shingles as intended; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 29-OCT-2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 23-SEP-2013, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as shingles. The patient was was prescribed tramadol for management of his painful symptoms and chronic pain. On or about 10-OCT-2012, the patient sought subsequent treatment for the diagnosis of post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. The patient was prescribed gabapentin for management of his painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
I am not able to get pregnant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2022 as dose 2, single (Lot number: Fe3599) at the age of 24 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot NO: Fe3599, Vaccine location: Left arm), administration date: 05Jan2022, when the patient was 24-year-old, for COVID-19 immunization. The following information was reported: INFERTILITY FEMALE (non-serious) with onset 01Sep2022, outcome "not recovered", described as "I am not able to get pregnant". Therapeutic measures were not taken as a result of infertility female.  Additional information: Patient did not received any other vaccine in four weeks. Patient did not had covid prior vaccination and after vaccination patient did not tested for COVID. Patient had no known allergies.
Itchy; Redness; Warm; Hard; Arm was stiff for the first couple of days after the shot but then it stopped / makes her arm feel stiff; Then a bump showed up and it's the size of a golf ball; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), ERYTHEMA (Redness), FEELING HOT (Warm), INDURATION (Hard) and MUSCULOSKELETAL STIFFNESS (Arm was stiff for the first couple of days after the shot but then it stopped / makes her arm feel stiff) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy), ERYTHEMA (Redness), FEELING HOT (Warm), INDURATION (Hard), MUSCULOSKELETAL STIFFNESS (Arm was stiff for the first couple of days after the shot but then it stopped / makes her arm feel stiff) and JOINT SWELLING (Then a bump showed up and it's the size of a golf ball). At the time of the report, PRURITUS (Itchy), ERYTHEMA (Redness), FEELING HOT (Warm), INDURATION (Hard), MUSCULOSKELETAL STIFFNESS (Arm was stiff for the first couple of days after the shot but then it stopped / makes her arm feel stiff) and JOINT SWELLING (Then a bump showed up and it's the size of a golf ball) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Fever, chills, aches, headache, fatigue. Felt like I was hit by a truck. Felt like I had the flu. Last two full days.
Employee had first Covid-19 on 01/19/2021. On the night of 01/20/2021, she began to experience uncontrollable shaking and chills. The next day, 01/21/2021, employee developed a total body rash and wen to urgent care where she received intramuscular steroids, oral steroids, and oral anti-pruritic medication.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided. It was reported that the vaccine was stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient had similar response to the first dose in her left arm.  She recovered from that episode and came back for second dose.  Had the same reaction in the opposite arm.  I spoke with patient and indicated to use cold compress, hydrocortisone and benadryl.  Told patient to follow up with MD or ER if it gets worse.  Patient stated she understood and we will follow up with patient.
Received dose at 11am on 6/17 by 9pm had pain in arm, headache, and fever. Woke up on 6/19 8am with redness all over back, stomach, chest, neck, and shoulders.
Hours after the vaccination, I was nausea, very thirsty, my mouth was very dry. I felt a lot of air in my stomach. I felt desperate and agitated. I couldn't sleep that night. After 25 hours I already felt better.
today, breaks out with shingles; This case was reported by a pharmacist and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th January 2023, the patient received the 1st dose of Shingrix. On 30th January 2023, 21 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-JAN-2023 Reporter's comments: The pharmacist had given a patient a Shingrix vaccine (first dose) and at the time of reporting,  she breaks out with shingles.  The reporter had asked whether the vaccine could cause an outbreak or it was just coincidence.  The patient had called our pharmacy, and asked to speak, we had answered the phone unlike other pharmacies.  The reporter had consented to follow-up.
We received the following information from a health care professional via agency on 3 DEC 2009: A 39-year-old female patient was vaccinated i.m with FLUVIRIN (batch no. unknown) on an unknown date in 2009 (about 5 weeks before reporting date). She developed abdominal pain, diarrhea and fever (106F) four to five hours after vaccination. Two and a half weeks later the patient suffered from ulcers in the colon and colitis was diagnosed. She had not recovered at reporting date. Agency no.: NA09-009099.
This spontaneous report was received from a 62 year old female patient, regarding herself. Patient's pertinent medical history and drug allergies were not reported. On 29-DEC-2014 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included REMERON and alprazolam. On 01-JAN-2015, patient noticed two pimple like bumps on her forehead that were red and had a white dot in the middle of them after receiving ZOSTAVAX. The bumps were located around her hair line and at her left temple. The bumps were itchy from time to time but were not consistently itchy. The patient did not seek medical attention. Outcome of the event was not reported. No product quality complaint (PQC) was involved. Causality assessment was not provided. Additional information has been requested.
Ran 103 fever, arm hurt really bad, itching all over, lack of energy, very weak and stayed in bed. Started feeling better 3 or 4 days later.
PT WAS FEELING DIZZY AND PASSED OUT (SYNCOPE)  FOR ABOUT 20 SECONDS
Deep, vague pain in Right chest, Right upper torso and Right upper back, followed by numbness tingling in these areas, sensation of tight band in the torso, weakness of the R leg. Right foot drop at 3 a.m. on 12/02/15. Numbness tingling of both feet, and Right upper thigh. Cold sensation to Right leg. At 6 a.m. on 12/02/15, unable to move Right leg. Foot drop R>L foot. Decrease tone to anal sphincter. Some anal leakage. Treated with high dose IV steroids for 5 days, followed by tapering steroids by mouth. MRI of brain, C spine, T spine and L spine negative, Cat scan of chest negative, spinal tap and many lab tests have not found an etiology. Treated from 12/2/15 to 12/9/15, then transferred to another Hospital, acute inpatient rehab from 12/9/15 to 12/18/15. Followed by Neurology at the second hospital. Repeat MRI revealed lesion at T4-T5, and T6. Repeat spinal tap negative. MRA of spine negative for bleed. Now undergoing outpatient rehab. Using a walker for short distances, and wheelchair for long distances. Weakness in R leg continues, and neuropathic pain experienced throughout the body, R > L. Global fatigue continues. Neuropathic pain treated with Gabapentin.
A non-serious spontaneous report of irritated nose, irritated throat and sneezing has been received from a non-health professional concerning a female patient, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On an unknown date, the patient received FLUMIST. The next morning of receiving FLUMIST, the patient experienced irritated nose and throat, and sneezing which lasted for six hours. The outcome of the events irritated nose, irritated throat and sneezing was resolved. Additional information was added on 31-Jan-2011: A correction was made in the narrative to correct an error in the country where the reporter was located.
Patient got his flu shot on 10/1/18. Patient's wife came to Pharmacy to pick up prescriptions and informed us that patient still had pain in the arm and they were thinking of possible muscle injury. Tried to reach patient couple times but he had not returned our calls. I am reporting this on the basis of what wife told me.
Patient started to develop a frozen neck a couple of days following the vaccination. It had started on her left side and moved to the other side. She saw her doctor and was instructed to go to physical therapy.
Systemic: Fainting / Unresponsive-Moderate, Additional Details: 911 first responders came to help her, she did not go the the hospital, she was released after the first responders made sure her vitals were stabilized. she has pain on her back and head from falling from the chair.
When is the onset of Guillain-Barre symptoms after a Shingrix shot?; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was asked about onset of Guillain-Barre symptoms after a Shingrix shot.
mom reports that irregularly shaped red rash (not raised) began on 16JUL & spread to cover entire body by 18JUL; mom took pt to ER because of concern about rash; MD told it was reaction to MMR; no tx;
mild pain in eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (mild pain in eye) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Unilateral blindness (at age 40; eye sight did come back), Viral meningitis (at age 40 (diagnosed via spinal tap)) and Optic neuritis (at age 40). Concurrent medical conditions included Rosacea, Degenerative disc disease and Prolapsed disc NOS.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced EYE PAIN (mild pain in eye). At the time of the report, EYE PAIN (mild pain in eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
feeling of unwellness remained; then irradiated to the back of the patient and down the shoulder; then irradiated to the back of the patient and down the shoulder; pain at the site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 28th August 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, back pain and shoulder pain. On 30th August 2020, the patient experienced malaise. On 30th August 2020, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the malaise, back pain and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, malaise, back pain and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient presented severe pain at the site of injection for Shingrix which then irradiated to the back of the patient and down the shoulder.  The pain left after two days but a general feeling of unwellness remained with the patient.  The reporter consent to follow up.
Patient came in and asked for Pfizer vaccine, stated on consent she had not received a previous dose of COVID vaccine but in actuality had already received Moderna.  Doctor had told her to go get Pfizer but she did not tell us till after.
Husband called this morning 9:38am. Reports pt has Right arm swelling, weakness, limited ROM, Nausea, blacked out. Treatment -rest. Spoke to pt at 10am, pt reports feeling better, denies any SOB, some nausea and swelling. Instructed to go to urgent care but pt did not go. Pt was instructed to come in this afternoon to see Dr., 10/1/15, at 2PM. Pt was advised to take Benadryl 25mg as needed but hold until she sees Dr. for evaluation.
Same week behavioral/emotional changes began. Angry, combative, physical aggressiveness, crying. Very moody, sad, depressed. Other symptoms occurred - at 6 years began to develop body hair/odor, in 3-4 months after vax went from size 6 to 3-5 in teenagers, grew tall, there was weight gain. Bed wetting daily after vaccine and now continues to 2-3 times a week. Was potty trained at about 2-3 years normally. Took her to doctor due to weight gain and encouraged to remove dairy. Remove dairy but did not impact changes. She is about 10 now and she is probably going to have her period by the summer. Siblings did not present these puberty-like symptoms until 12. Schedule for next dose of vaxs at 11.
3/7, fatigue, 3/8 severe back ache, diharea, 3/9 headache, mild cough with flem, red itchy rash on arm.
doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided. It was reported that vaccine was removed from freezer at 8 am on 25-OCT-2021.
Hives throughout Arms, legs, trunk, face.  Slight itching.  Denies trouble breathing, swelling, or any other symptoms.
injection site itching; Injection site rash; spread down his arm to his elbow; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (injection site itching), INJECTION SITE RASH (Injection site rash) and RASH (spread down his arm to his elbow) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included GLIPIZIDE, METFORMIN, SIMVASTATIN and LISINOPRIL for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced INJECTION SITE PRURITUS (injection site itching), INJECTION SITE RASH (Injection site rash) and RASH (spread down his arm to his elbow). At the time of the report, INJECTION SITE PRURITUS (injection site itching), INJECTION SITE RASH (Injection site rash) and RASH (spread down his arm to his elbow) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient take Benadryl as a Treatment medication
pt recvd vax OCT95 & w/in first four days, devel flu-like sxs;pt devel extreme muscle weakness;has been hospitalized 3x, & had not recovered as of the date of this report