chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the Pfizer booster vaccine on December 1, 2021 and approximately three-four days later I began experiencing menstrual cramps and pain in the nipples.  I am 59 years old and I have been in menopause for about four years.  Had an endometrial ablation at age 45.  This continued every day, but the pain was manageable and about two weeks later I began experiencing the same ovulation pains I used to have prior to menopause.  The pains got so bad, I ended up in my doctor's office on January 13 and saw the Nurse Practitioner (NP).  I was having almost non-stop spasms in the uterus which were very painful, vaginal discharge and intense nipple pain.   Continued below  At that appointment I was prescribed Macrobid because the urine specimen showed possible infection.  The next day, the pain got worse and called the office.   The doctor on call said the results of the vagina swab were back and I had Gardnerella, told me to stop the Macrobid and prescribed Macrogel for the vagina.  I began using it that same day for five days.  I also read that this can be caused by hormonal changes.  On Monday January 17, the NP called me to say they urine specimen also showed strep in the bladder and prescribed Amoxicillin.  Neither one of these two medications helped the symptoms, but I finished both of them.    On January 19 I called the NP again because I was still in so much pain, and she prescribed Uribel to rule out bladder problems and she suggested an ultrasound and a mammogram.  She told me to stop taking it if it did not help, which was the case so I did not finish the medication.  At that time, I also began having pain on the outside of the vagina area.    They were able to get me an appointment for the ultrasound on January 26.  I also mentioned to the NP that my hot flashes had stopped and I felt like all this was related to hormones.    Reading the CDC website, I was very surprised by how many reports have been submitted by either patients or doctors on behalf of their patients describing every detail of what I have been experiencing. Hundreds of women saying they have been in menopause for multiple years and they have started menstruating again, plus all the other issues with vaginal infections, nipple pain, ovulation, etc.  On January 24, I could tell I was done ovulating, I did this for over 40 years and I know what it feels like and what comes out after ovulating and not getting pregnant.  Two weeks later I felt like I was getting my period, but since I had an endometrial ablation, I was not actually bleeding.  I even had a hormonal headache just like I used to have during my period prior to menopause.  I received my first dose on March 29, 2021, the second dose on April 19, 2021 and the booster on December 1, 2021.  Today is February 20, 2022 and I have been in pain for about 11 with no apparent cure for this, I just have to hope that my body goes back to normal one day.  The saddest part is that my N.P. and doctor do not believe me that this is related to the vaccine even though it's very clear in the CDC website that this is happening to some women.  Their last offer was to come in to get pain medication.
Information has been received from a registered nurse concerning a 8 year old male who was vaccinated on 01/17/1996 with a dose of varicella virus vaccine live (Oka/Merck).  The patient was seen in June 2003 with over 50 lesions on his body following a known exposure.  The child was noted to have chickenpox breakthrough.  Unspecified medical attention was sought.  There was no product quality complaint.  The reporter indicated that 19 other patients were vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and developed chickenpox breakthrough/shingles.  No further information is expected.
Prolonged Seizure less than 24 hours after administration.  12/17/2007 MR received for DOS 11/14-15/2007 with D/C Dx: Seizure, prolonged.  Hx of recent admin of routine 4 month vaccinations.  Fever, resolved.  ER record also received for 12/05/2007 with DX: Pediatric fever with likely febrile seizure. On 11/14/07 infant presented to ER with generalized seizure activity.  Clonic seizure activity and blinking continue despite initial dose of Diastat.  VS WNL including a temp of 98.7'F. No further seizure activity but temp went up to 102'F 1 day post seizure. Infant returned on 12/5/07 with recurrent seizure.  Pt had temp of 100.8'F.  Pt continued with some myoclonic jerking then became post ictal. EEG to be obtained at a later time.
dental emergency; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller was reporting on behalf of her husband. After receiving their first shot of the Pfizer vaccine, her husband (patient) now had a dental emergency for which the dentist had requested he took antibiotics; clarithromycin (BIAXIN), in order to extract a tooth. Outcome of event was unknown.    Information on the lot/batch number has been requested.
headaches/Waking up with really bad headaches; her head feels like a water balloon that weighs 50 pounds. She struggles to take her head off the pillow.; nightmares; Her left arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 (Lot number: EW0150) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Scleroderma" (unspecified if ongoing), notes: Verbatim: Scleroderma. Family history included: "lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovering", described as "headaches/Waking up with really bad headaches"; HEAD DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "her head feels like a water balloon that weighs 50 pounds. She struggles to take her head off the pillow."; NIGHTMARE (non-serious) with onset 2021, outcome "not recovered", described as "nightmares"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Her left arm was sore".   No follow-up attempts are possible. No further information is expected.
102 Fever, Hives, muscle aches, joint pain, dizziness, lethargy, nausea, chills, diarrhea,  eye pain, headache, neck/back pain, swollen at injection site and armpit, loss of bladder control 1st night, excessive urination.
It is not deep red, it is a light red rash that seems to be spreading; Rash below injection site; Itches; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (It is not deep red, it is a light red rash that seems to be spreading), VACCINATION SITE RASH (Rash below injection site) and VACCINATION SITE PRURITUS (Itches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced RASH ERYTHEMATOUS (It is not deep red, it is a light red rash that seems to be spreading), VACCINATION SITE RASH (Rash below injection site) and VACCINATION SITE PRURITUS (Itches). At the time of the report, RASH ERYTHEMATOUS (It is not deep red, it is a light red rash that seems to be spreading), VACCINATION SITE RASH (Rash below injection site) and VACCINATION SITE PRURITUS (Itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Irritation to inject site, redness, swelling, and warm to touch, pain at injection site.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately August 2016 (it was reported that vaccines were administered on 22-AUG-2016, 23-AUG-2016, 24-AUG-2016 and 25-AUG-2016, but it was unknown which patient received doses on which date), the patient was accidentally vaccinated with 2 doses of RECOMBIVAX HB, intramuscularly, lot # M023892, expiry date 17-SEP-2017 (strength, dose and site of administration were not reported). No adverse reactions were reported. This is one of several cases received from the same reporter. Additional information has been requested.
IT hurt getting the shot more than the first timr  Felt a burning sensation. Then sore arm all day and after abour 8 hours very sore arm. Noticed blood on the band aid when I removed it and arm was so aore at night that was unable to sleep on my keft side. woke up the next morning and cannot lift my left arm. it has started to bruise slightly so far and injection sight  is a little swollen. it is warm to the touch . I feel okay except for a little fatigue. it is now 6:30 am. not sure if symptoms will get worse before they get better
I was having really bad cramps, bad chest and stomach pains, I thought I was having a heart attack and had called 911 an ambulance had arrived and took me to the ER. They had suspected and were treating me as if I were having a heart attack. They did not find anything showing that it was my heart but were showing that it was something more gastroenterological. I was only there for a few hours before I went home. We are still investigating what the cause was and I am following up with a specialist.
The mother called the office 41 minutes after vaccine administration stating the child was "covered in hives" and that his throat was "itchy, scratchy." Advised to activate EMS/911 immediately.
Severe chills and body aches on first day. Second day tingling, burning tongue/gums, body aches
patient complained of arm burning and light headedness. 11:38 patient was tearful, sweating, requested to lay down. 11:44 patient given Benadryl and EMS called.  11:46 patient reported feeling nauseous. EMS arrived 11:54
soreness at the injection site; fever of 101; shivering; fatigue; headache; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Concurrent medical conditions included hashimoto's disease.   In September 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. In September 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site pain, fever, shivering, fatigue and headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, fever, shivering, fatigue and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever, shivering, fatigue and headache to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: The patient had 1st dose of Shingrix n September 2020 in her right arm. The patient experienced soreness at the injection site that lasted 24-36 hours. The patient  received the 1st dose late morning and by bedtime, she started to experienced symptoms fever, shivering, headache and fatigue. The patient took tylenol and the symptoms resolved 8-10 hours later. The patient had also had a flu shot at the same time when she received her 1st dose. For tolerance with 2nd dose refer the case US2021003181. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021003187:same reporter
1st day- pain in area where injected  2nd day- pain in area where injected, muscle pain throughout the top half/left side of my body, headache; chills and hot flashes 3rd day- less pain but now experiencing nausea and still have headaches; chills and hot flashes
The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  The Vial was initially stored in the refrigerator on 20-Apr-2021.  HCP said that none of the patients experienced side effects so was not sure if should send the form anyways. Also mentioned that there were 14 patients instead of 18 because of some duplicates (4 of which received both dose 1 and 2 from aff ected lot). None of the pati ents have reported adverseevents.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Significant Follow up received HCP confirmed that Patient's does not experienced any side effects after receiving dose On 05-Nov-2021: Significant FU received  HCP  mentioned that there were 14 patients instead of 18  (4 of which received both dose 1 and 2 from affected lot).
Patient developed hives, itchiness, dizziness within about 15 minutes of receiving the vaccine.  We administered 0.5 cc mg of epinephrine and paramedics were called.  Patient made a full recovery within 20 minutes.
Patient received Men CWY not reconstituted; Patient received Men CWY not reconstituted; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date:14-Sept-2022 Reporter's comment: The patient who received a dose of Men CWY before it was reconstituted with the lyophilized Men A component.  The reporter asked that what potential adverse effects could arise from this. No further details available, provided all details as submitted via form The reporter consented to follow-up. Additional supportive information: The patient received Men CWY before it was reconstituted with the lyophilized Men A component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. As per clarification email suspect product was coded.
20 hrs p/3rd dose exp ache in joints, felt tired, had a burning/tingling area in the back of lt thigh; blisters appeared; red skin 3 inches in diameter; blisters dried p/few days; 14JUL93 confirmed dx of herpes simplex;
10 days after, severe rash and burning that began on hands and feet. Itching all over body . Took Benedryl and it helped. Next morning same severe symptoms and Benedryl began helping after an hour 1/2. Went to urgent care and received a Steroid shot. Now taking Benedryl and Prednisone for the next week and a 1/2.
My adverse event started on 02/01/2023 in the morning. I couldn't move my right arm. It was frozen. I had Calcific tendonitis of the shoulder according to my doctor. I went to my doctor's office first time on 02/17/2023 where they ruled out this diagnosis. They gave me a cortisone shot and prescribed me ALEVE 2 times a day for 2 weeks. He prescribe me some exercises to do for my right arm. He also advised me to put ice pack 3 times a day.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. On 19-MAR-2015, the patients were vaccinated with improperly stored dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
No issue on date of vaccine. Minor muscle soreness in left arm the following day. No further issues following days. On 01/31/2020 at approximately 2130hrs, numbness and tingling of right side of face began while on work duty. Completed shift, drove home and went to bed. The following morning lips were covered in blisters, right cheek and under eye was extremely swollen. Attempted to drive to work and began experiencing brain fog and blurred vision. Returned home and facial swelling worsened along with severe headache and itchy dry skin. Took a bath and was unable to determine water temperature by touch. Intense leg muscle aches and nerve pain in right side of face. Remained calm and slept the following two days. Went to PCP as soon as possible on 01-04-2020 and was advised symptoms to be delayed adverse reaction to Moderna Vaccine. Patient was prescribed Alegra, Tylenol and methylprednisolone at this time. PCP advised inability to receive secondary dose on 01/28/2021 due to steroid treatment for allergic reaction to Moderna Vaccine. Swelling retreats and returns throughout the day following Dr visit. Voice changes occur during swelling (gurgled). The patient has no appetite but maintains a scheduled healthly diet. The patient has been unable to sleep for 24 hrs straight even after taking melatonin. There has been no shortness of breath however the patient experiences muscle spasms, dizziness and blurred vision while reading. The patient's right side of face  has slower reaction timing than the left, the right eye closes frequently (not in tandum with the left) and is unable to smile. The patient has not experienced vomiting nor stool issues. The patient is unable to return to work until 01-11-2021 or until symptoms remain undetected for 48 hrs.
Past the 42 day mark; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark). On 26-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
(sharp excruciating pain at moment of injection in high upper arm), strong aching arm pain next day and significant range-of-motion limitation due to sharp pain, greater pain at nights, pain and range-of-motion limitation persists until today (eight days later), Tylenol helps only a little.
No appetite; Very painful body aches; Felt really crappy; A little nausea; Fever up to 101 degrees F; Headache; Sore arm; This spontaneous case was reported by an other health professional and describes the occurrence of DECREASED APPETITE (No appetite), PAIN (Very painful body aches), PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt really crappy) and NAUSEA (A little nausea) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2021.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). On 14-Sep-2021, the patient experienced DECREASED APPETITE (No appetite). 14-Sep-2021, the patient experienced PAIN (Very painful body aches), FEELING ABNORMAL (Felt really crappy), NAUSEA (A little nausea) and PYREXIA (Fever up to 101 degrees F). The patient was treated with PARACETAMOL (TYLENOL) in September 2021 for Fever, at an unspecified dose and frequency; IBUPROFEN in September 2021 for Fever, at an unspecified dose and frequency and MENTHOL (BIOFREEZE PAIN RELIEVING) in September 2021 for General body pain, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (No appetite), PAIN (Very painful body aches), PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt really crappy), NAUSEA (A little nausea) and HEADACHE (Headache) outcome was unknown and PYREXIA (Fever up to 101 degrees F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, Body temperature: 101 (High) Fever up to 101 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Headache, Myalgia, chills Narrative:  Employee stated after receiving 2nd vaccine around 1800 that evening she had chills, body aches, and headache. states she is feeling better today but not 100%  Other Relevant History:
In minutes after injections infant had a 2 minute generalized tonic-clonic seizure followed by a post ictal period.
Information has been received from a physician concerning a female (age not reported) who on 30-MAY-2007 was vaccinated with her first dose of Gardasil (lot number 654741/1208F) IM. The physician reported that the patient fainted after receiving her first dose of Gardasil IM. Patient also fell down and hit her nose and felt woozy for about 10 minutes. Medical attention was sought. The patient did not eat anything prior to getting a vaccine. At the time of reporting the patient recovered from the adverse events and no further information was provided. Additional information has been requested.
Pt vaccinated with MMR developed fever and sore throat on 19AUG90. On 26AUG90 developed swollen glands in neck area. (Parotitis?)