chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed oral mandibular dyskinesis; This is a spontaneous report received from contactable reporter(s) (Physician).  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: DYSKINESIA (non-serious), outcome "not recovered", described as "developed oral mandibular dyskinesis".  Additional information: It was reported that the product was the Pfizer COVID vaccine, and she did not know the formulation or cap color and stated that after the patient got 1st booster of the Pfizer COVID vaccine, he developed oral mandibular dyskinesis within a day and it still had not resolved and it had been several weeks. Her awareness date was 02May2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
My daughter began having irregular and unusually long menstruation beginning on 06/07/2021.  Pediatrician recommended that I send an adverse reaction report.  My daughter's menstrual cycles have been growing increasingly close together and the last one involved bleeding for an entire month.
sore arm; extreme soreness of muscles around the shoulders and neck area; This is a spontaneous report from a contactable other HCP (patient herself).   A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EC3302), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jan2021 08:30 (at the age of 50-years-old) as dose 1, single for covid-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive the any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 21Jan2021, the patient experienced sore arm extreme soreness of muscles around the shoulders and neck area. The patient did not receive treatment for the event. On 08Feb2021, the patient received her 2 dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration, administered in Left as dose 2, single for covid-19 immunisation. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Significant pain in hands and feet within 24 hours of injection.  Persistent pain in fingers (neuropathy) still lingering and not improving 9 weeks after the second injection.
Body aches, chills, slight fever of 99.8. Rest and fluids. Symptoms subsided and returned to normal within 18 hours.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA311665 and 2018SA314176. This case involves a six patient who received an expired dose of 0.25 ml of vaccine FLUZONE QUADRIVALENT Suspension for injection (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was a actual medication error due to expired vaccine used. Eight doses outdated influenza vaccine being administered, before they realized they were expired. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Myalgia Left cervical lymphadenopathy, muscles feel weak.  Narrative:
After receiving the vaccine I am experiencing a constant outbreak state of HSV-1. I have had to begin taking a medication due to this affliction in order to lessen the amount of outbreaks I experience.
ill; Redness to her arm; Receiving a booster dose that was not good or had time out; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (ill), ERYTHEMA (Redness to her arm) and EXPIRED PRODUCT ADMINISTERED (Receiving a booster dose that was not good or had time out) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043l20a and 025l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving a booster dose that was not good or had time out). On an unknown date, the patient experienced ILLNESS (ill) and ERYTHEMA (Redness to her arm). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Receiving a booster dose that was not good or had time out) had resolved. At the time of the report, ILLNESS (ill) and ERYTHEMA (Redness to her arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  Treatment information was not provided.  Patient received the booster dose at a different location and later she was told to receive another booster dose at another facility as the one she had received was no good or had time out.  Patient went last week to the caller's work site in order to receive another booster dose and the HCPs refused to do so.
On 01/22/2021 I felt feverish, I had hot flashes and a headache and was extremely fatigued and had hard time focusing and I had a runny nose and congestion. On the 23rd I had muscle pains and joint pains and hard breathing. On the 24th I had to call off work I had a sore throat and it felt like my spine was on fire. I spoke with a nurse practitioner who referred me to my PCP. I had a really hard time talking and communicating. My lips went numb at one point and I had muscle tightness. I had a hard time standing up as well. And at one point my right arm went numb it lasted about a minute or so.
Large rash at injection site.  Fist size bump at injection site.  Itching and bump kind of burns
Patient had left the office without complications. Patient was light headed and dizzy and fell to the floor in the elevator. Rest for about 5 minutes and drank some water.  Transferred to wheelchair and regained strength. Ambulance was called. Patient was transferred to ER due to  welts developing on arms. In ER, benadryl was given.  Was released home.
patient is still experiencing  pain and swelling at injections site ( 4 x 6 in area ) 10 days post-vaccination. She also has headaches every day radiating from the center back of head to frontal lobe. She also states the she has soreness in her neck on the left side and that her arm still feels "heavy" 10 days later
This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported). It was reported that the physician administered a first and second dose of GARDASIL according to PI and a third dose of GARDASIL outside of PI timing recommendations on unspecified dates to an unspecified patient. After completing this GARDASIL series, the patient was administered a second series of GARDASIL vaccines on unspecified dates by an unspecified physician. Additional information has been requested.
pt vax 2nd hepta B. 4 dys - pt devel generalized urticaria rash. lab eval revealed anti-hb's pos and ige normal.
Reddened area,size of softball, warm to touch and swollen at site injection.  Further states she used cold wash cloths the day of injection and warm the next day.  Parent called physician and was instructed to use ice to site with Benadryl and Tylenol for symptom relief. Initial notice to clinic on 10/19/07. On 10/22/07 mother states child lethargic all weekend with headache.  Improved this morning and able to attend school.
The injection site on my left arm is red, the skin feels firm and itchy. Reaction occurred 8 days after the injection.
Information has been received from a registered nurse concerning a 71 year old male patient with penicillin allergy and SULFONAMIDE allergy, who on 22-JAN-2009 was vaccinated with the second dose of PNEUMOVAX 23 (Lot # 662785/1124X), 0.5ml intramuscularly. Concomitant therapy included ALPRAZOLAM, FLOMAX, FLUOXETINE, OMEPRAZOLE and TRAMADOL HCl. The registered nurse reported that on 22-JAN-2009, the patient experienced fasciitis after receiving a dose of the vaccine. At the time of the report, the patient had not recovered. The patient sought medical attention at the emergency room. Follow-up information from a certified medical assistant revealed that the patient was a 71 year old male patient, weighing 120 pounds and 65 inches in height, with penicillin allergy and sulfonamide allergy, who was vaccinated in the left deltoid with the second dose of PNEUMOVAX 23, (Lot #662785/1124X), intramuscularly. There were no illnesses at the time of vaccination. The certified medical assistant reported that in the afternoon of 22-JAN-2009, the patient developed severe cellulitis and myofascial swelling (by CT scan) in arm where shot administered. The patient was hospitalized for 3 days and received intravenous antibiotics to which he responded. At the time of the report, the patient had recovered. No further information is available.
Lightheadedness. Patient is to report to MD and pharmacy should any further symptoms present themselves.
Post vaccination, recipient became diaphoretic.  Skin cool/clammy.  Recipient reported that she normally "passes out" after injections.  Layed recipient on floor.  Ice pack applied to forehead.  VS stable.  Left in good condition at 1450.
mouth swollen up; This is a spontaneous report from a contactable consumer or other non-hcp (patient himself). A 33-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration in Arm Left on 22Jul2021 (Lot Number: EW0198) as dose 1, single for COVID-19 immunisation. Medical history was he had previously been on a regimen of blood thinners several months ago. The patient's concomitant medications were none. The patient experienced mouth swollen up on 22Jul2021. Patient's mouth was swollen up, more along the line of the jaw, it was swollen up to the size of maybe a small cherry, and it keeps going up, sometimes it was all the way and he can still see the area in his mouth where it's swollen up. He was calling because it's been longer than a week, the swelling was still there, he kind of has no feeling, he can feel the part of the mouth, but has no feeling where the swelling was, and it literally started maybe about 30 minutes after the shot. It's worse because he doesn't have feeling on that side, there's nothing there, it actually feels kind of hard as well. The patient underwent lab tests and procedures which included blood test: ok, urine analysis: ok. The outcome of the event was not recovered.
This spontaneous report was received from a registered nurse concerning on multiple unspecified patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the multiple unspecified patients received improperly stored doses of GARDASIL 9 injection, (lot # M030380 ; expiration date: 01-FEB-2019), (lot # M028323; expiration date: 26-SEP-2018), (route of administration, strength and dose were not reported) for prophylaxis. The temperature excursion with GARDASIL 9 was at 58 Fahrenheit degrees for 28 hours. The temperature excursion was detected by a data logger. There were no prior excursions. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010295: US-009507513-1612USA010293: US-009507513-1612USA003446: US-009507513-1612USA010291: US-009507513-1612USA010292.
Immediately after receiving the vaccine I started to have an increased heart rate and blood pressure.  I was watched for close to an hour, and let go.  I experienced muscle and joint pain, which was to be expected.  Approximately 2 days afterwards, I started to experience dizziness, low blood pressure, and pressure in the middle of the back of my head.  The pressure became worse and worse, while continuing to experience the above side effects.  Since that time, I have been to the emergency room for pain all over, pressure in the back of the head, memory issues, blood in the stool, and extremely cold hands and feet without explanation.
no adverse effects; administered a dose of PROQUAD that expired on 7/30/2019; This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 02-AUG-2019 the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # R002931, expiration date reported as 30-JUL-2019 but upon internal validation established as 29-JUL-2019) (dosing details and route unknown) for prophylaxis. It was reported that the used vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was already expired on 30-JUL-2019 (also reflected as 29-JUL-2019) (expired product administered). No adverse effects reported (no adverse event). Therapy type involved was rha.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 66-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 9th February 2023, the patient received Havrix. On 9th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 13-Feb-2023. Reporter's Comment: The reporter asked if the patient had to be revaccinated. The reporter consented to follow-up. Additional Supportive Information:Patient received an expired Havrix dose, which led to expired vaccine used.
Lesions like mosquito or flea bites on breast, back and stomach; Feeling tired; Pain on joints (left hand); This spontaneous case was reported by a consumer and describes the occurrence of SKIN LESION (Lesions like mosquito or flea bites on breast, back and stomach), FATIGUE (Feeling tired) and ARTHRALGIA (Pain on joints (left hand)) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     The patient's past medical history included Joint pain and Shingles in October 2020. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN and IBUPROFEN (ADVIL 12 HOUR) for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced FATIGUE (Feeling tired) and ARTHRALGIA (Pain on joints (left hand)). On 07-May-2021, the patient experienced SKIN LESION (Lesions like mosquito or flea bites on breast, back and stomach). At the time of the report, SKIN LESION (Lesions like mosquito or flea bites on breast, back and stomach), FATIGUE (Feeling tired) and ARTHRALGIA (Pain on joints (left hand)) outcome was unknown.        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.   Treatment given included cream containing Cortisone.
Administered after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine moved to fridge on Date of administration. Published expiration Date on 25-Mar-2022. The vial did not undergone any temperature excursions. There were no adverse events reported by the patients after the administration error.  No Concomitant information was reported. No Treatment information was reported.
a knot size lump appeared which was hard and very itchy, since then it has been getting bigger and bigger, size of an egg, itches horribly.; a knot size lump appeared which was hard and very itchy, since then it has been getting bigger and bigger, size of an egg, itches horribly.; a knot size lump appeared which was hard and very itchy, since then it has been getting bigger; nausea; arm pain for about a week; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain for about a week), INDURATION (a knot size lump appeared which was hard and very itchy, since then it has been getting bigger and bigger, size of an egg, itches horribly.), PRURITUS (a knot size lump appeared which was hard and very itchy, since then it has been getting bigger and bigger, size of an egg, itches horribly.), PERIPHERAL SWELLING (a knot size lump appeared which was hard and very itchy, since then it has been getting bigger) and NAUSEA (nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain for about a week). On 24-Mar-2021, the patient experienced NAUSEA (nausea). On an unknown date, the patient experienced INDURATION (a knot size lump appeared which was hard and very itchy, since then it has been getting bigger and bigger, size of an egg, itches horribly.), PRURITUS (a knot size lump appeared which was hard and very itchy, since then it has been getting bigger and bigger, size of an egg, itches horribly.) and PERIPHERAL SWELLING (a knot size lump appeared which was hard and very itchy, since then it has been getting bigger). At the time of the report, PAIN IN EXTREMITY (arm pain for about a week), INDURATION (a knot size lump appeared which was hard and very itchy, since then it has been getting bigger and bigger, size of an egg, itches horribly.), PRURITUS (a knot size lump appeared which was hard and very itchy, since then it has been getting bigger and bigger, size of an egg, itches horribly.), PERIPHERAL SWELLING (a knot size lump appeared which was hard and very itchy, since then it has been getting bigger) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ?   This case was linked to MOD-2021-136899 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Updated email Id.
Vaccines adminsitered on 1/31/03 in clinic, pt had a seizure less than 24 hours post administration.
Starting the morning after the vaccine, a bad headache that felt like I was wearing a heavy, constricting helmet. On Sunday, I woke up with flu-like symptoms -- fever, body aches, fatigue, nausea, lack of appetite, chills.
tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced tiredness (Verbatim: tired). The outcome of the tiredness was resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.     It was unknown if the company considered the tiredness to be related to Shingrix.   Additional Information: GSK Receipt date: 26-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received 2nd dose of Shingles vaccine and experienced tired the following day but over it quickly.  Follow up was not possible, as no contact details were available.
Discovered 11 year old received the 12+ adult dose of pfizer covid vaccine for 2nd dose, instead of the Pediatric Pfizer vaccine indicated.
Vaccine Adm.  3/18/09 for 6 mos. well visit 3/19/09 Temp. 101 degrees per mom Temp. in office 99.7 (Ax) Dx: Vaccine reaction
At about midnight after the first dose of the covid vaccine that I received on 2/11/2021 at 8:00am, I experienced a migraine and pain in my spine, shoulders, hips and knees that kept me up trembling in excruciating pain. I was sore and fatigued 2 days after. At about 2:00pm after the second dose of the covid vaccine that I received on 3/4/2021 at 8:00am, I experienced fatigue, headaches, and the same excruciating pain in my spine, shoulders, hips, and knees. The fatigue and pain in my spine and joints after the two shots never went away. I also noticed a rapid regression in my muscle strength in my arms and legs at the gym. I went to my PCP on 3/5/2021 and he ordered labs that were completed on 3/11/2021. He noticed that my ANA screen was negative, my sed rate was negative, but my C-reactive protein was abnormal and wanted it repeated. On April 7,2021 my C-reactive protein level was even higher, to which he referred me to a Rheumotologist. After my referral finally went through, I was able to see the Rheumotologist on  July 6, 2021. He ordered labs that were completed on July 16, 2021. My ANA screen came back positive with a titer of 1:80 and the pattern was Nuclear, Speckled, and my HLA-B27 was positive. On my follow up appointment on 8/12/2021 at 10:45am he told me that my labs and symptoms are consistant with Ankylosing Spondylitis. He ordered X-rays on my spine and hips to determine the damage as well as my treatment plan. On 8/26/2021 at 2:30pm, I went to my follow up appointment and was prescribed Humira shots that I will now have to take for the rest of my life.