chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (feeling tachycardia), INSOMNIA (insomnia), MUSCLE TWITCHING (muscle twitch at night when going into a deep sleep), TREMOR (shakiness) and PYREXIA (fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) 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) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced TACHYCARDIA (feeling tachycardia). On an unknown date, the patient experienced INSOMNIA (insomnia), MUSCLE TWITCHING (muscle twitch at night when going into a deep sleep), TREMOR (shakiness), PYREXIA (fever), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills/chills at night). At the time of the report, TACHYCARDIA (feeling tachycardia), INSOMNIA (insomnia), MUSCLE TWITCHING (muscle twitch at night when going into a deep sleep), TREMOR (shakiness), PYREXIA (fever), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills/chills at night) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.No concomitant medication was provided. No treatment information was provided.
Right arm - site of injection reddish-pink color - almost looks like a birthmark, not bruised, swollen or warm to touch. Patient said not bothersome - she didn't even know it was there until a friend pointed it out to her the other day.
The normal discomfort - chills, fatigue, head pounding/ache, nauseas and dirreaha.  what I am concern about is my lymph nodes under my arm and in my neck are swollen, sore/painful to touch and redness,  Had not read any information regarding this type of side effect, so thought I would report
6/11-patient had dizziness, headache fatigue, 6/13 ringing in both ears dizziness
Mom states has vaccine Friday 12/02/22, was fine all weekend, dropped her off at school this morning 12/05/22, they contacted about 1 hour later, she "paused, stared, and they helped her down to the floor, and was down for about 7 minutes" no loss of consciousness, was her "absence seizure" states she came and picked her up, carried her to her to her vehicle,  and took her home,  she napped for about an hour, woke up crying, pointing to her head, no facial swelling, no trouble breathing, no hives,  did have slight rash around her neck "but unsure if from her tussling around" looked like blotches,  not raised, not hives, nowhere else, gone now.  Still slightly tired, but "normal"
pt recv vax & devel numbness, pain in lt arm radiating to lt arm started paralysis has improved p/3 days;
Later in the afternoon after my second dose by 01:00PM I felt like I had the flu. I woke up the next morning with a lemon size swelling in my armpit. From there I contacted the nurse at a hospital. She said it was not unusual and if it did not go back down in 2 weeks to seek medical attention. From there it did go down but from there it went into the top of my breast. After that, I did hear on the news it was not a unusual side effect and to wait 4 months before getting mammogram. Between 3-4 months it felt like dense tissue in my breast. It felt like a sheet of metal and felt like a plate if I was laying on but it did not hurt. I then had mammogram and ultrasound but after that I didn't have anymore issues. The flu-like symptoms disappeared within 24 hours but that is when the swelling happened In armpit and moved to breast.
Injection site it was pink; Little bit bulging out, of swollen up; Soreness only when she presses it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site it was pink), VACCINATION SITE SWELLING (Little bit bulging out, of swollen up) and VACCINATION SITE PAIN (Soreness only when she presses it) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site it was pink), VACCINATION SITE SWELLING (Little bit bulging out, of swollen up) and VACCINATION SITE PAIN (Soreness only when she presses it). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site it was pink), VACCINATION SITE SWELLING (Little bit bulging out, of swollen up) and VACCINATION SITE PAIN (Soreness only when she presses it) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.
Arm swollen to wrist; Could not feel fingers; Tight chest; Burning throat to chest; Lethargy and pain is worse since shot; Palpitations; Nasal congestion; Lethargic hair loss; Joint pain; All around sick; Overheating; Lethargy and pain is worse since shot; This is a spontaneous report from a contactable healthcare professional, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Sep2021 at 09:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to an unknown date in 2021, ongoing lethargy and pain from an unknown date. The patient was a long haul COVID-19 sufferer. The patient had phantom, distorted and no smell since Feb2021. The patient had unspecified allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included tetracycline (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and unspecified allergy nasal and pill; all for unknown indication from unknown date and unknown if ongoing. On 09Sep2021 at 09:00, the patient had arm swollen to wrist, could not feel the fingers, tight chest, burning throat to chest, lethargy, palpitations and nasal congestion. The patient felt as if she had COVID-19 all over again. On the same day, the patient experienced lethargic hair loss and joint pain. The lethargy and pain were worsened since the shot and the patient was all around sick. The patient also experienced overheating. The events resulted in emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 16Sep2021, the patient underwent COVID-19 test (reported as blood test) and result was negative. On 20Aug2021, the patient underwent COVID-19 test (reported as blood test) and the result showed antibodies 16.4 positive (greater than 0.8). Therapeutic measures were taken as a result of events and included treatment with an unspecified "recommendation" and testing. The clinical outcome of the events arm swollen to wrist, could not feel fingers, tight chest, burning throat to chest, lethargy and pain is worse since shot, palpitations, nasal congestion, lethargic hair loss, joint pain, all around sick and overheating were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
29FEB92 grandma reported pt devel fever t102 ax on 27APR92 then 104.8 R; called ER instructed to given APAP; fever cont, wouldn't eat;
She got her 3rd vaccine, not initial issues.  About 2 weeks or so later she had palpitations, fast heart rate and hard time breathing especially doing something strenuous or getting dressed.  The fast heart rate is now every day, which was not going on before the vaccine.  She has an appointment to see her PCP soon.  She may go to the ER as the condition is getting worse.   She feels that this may have accumulated over a period of time, but is just noticing it now as it is worse.
Lichen Striatus - Seen by pediatrician and dermatologist.  Line shaped red rashes on neck on the left side (the side she received the vaccine on).  The rash worsens and lessens throughout the day. It does not respond to allergy medications.
Joint and muscle pain in his right arm, shoulder, hand, and neck; Joint and muscle pain in his right arm, shoulder, hand, and neck; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint and muscle pain in his right arm, shoulder, hand, and neck) and MYALGIA (Joint and muscle pain in his right arm, shoulder, hand, and neck) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 006M21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Post-traumatic stress disorder. Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), OXYBUTYNIN, BUDESONIDE, SALBUTAMOL (ALBUTEROL HFA), ATORVASTATIN, VITAMIN B12 NOS, VITAMIN D3, OMEPRAZOLE, METFORMIN, FISH OIL (OMEGA-3 FISH OIL), TRAMADOL, FLUOXETINE, BUSPIRONE, SERTRALINE, BUPROPION, PREGABALIN (LYRICA), ZIPRASIDONE, MAGNESIUM OXIDE and FERROUS SULFATE (IRON SULFATE) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced ARTHRALGIA (Joint and muscle pain in his right arm, shoulder, hand, and neck) and MYALGIA (Joint and muscle pain in his right arm, shoulder, hand, and neck). At the time of the report, ARTHRALGIA (Joint and muscle pain in his right arm, shoulder, hand, and neck) and MYALGIA (Joint and muscle pain in his right arm, shoulder, hand, and neck) had not resolved. Not Provided          Patient took Tylenol as treatment drug.   This case was linked to MOD-2021-089115 (Patient Link).
After receiving the Pfizer COVID-19 vaccine approximately three hours later I had extreme pain from my lower back to my ankle. Contact the doctor office they prescribed me a steroid and pain medicine .The The symptoms continued for another six weeks then on the second shot the condition worsened again extreme pain down my right side leg to my ankle.  Again contact the doctors office prescribed another course of steroids pain continued for another 6 to 8 weeks and now every day I have pain And numbness and pins and needlesFrom my knee to my ankle
Saturday morning, tremendous chills, shivering, fever over 100 degrees, bad body aches including neck pain. The malaise was so bad that had to stay in bed all day.  By 9 PM fever finally broke, took ibuprofen for pain and fever--took a couple of doses and lots of fluids. Had no stomach problems or congestion. By Sunday much improved--felt really bad 12 hours after vaccination only; recovered completely except for being exhausted. Recovered completely by late Sunday.
NP called into room at 2:50 pm after receiving Hep A and MCV4 in left arm. Patient felt lightheaded & crying that arms hurt. Alert & Ox3, appeared pale, HR-88, BP 116/62, pulse ox 98%. About 3pm pt sat up and Gardasil given in right arm. Had pt lie flat til 3:08pm. Verbalized feeling better & sat up. Pt felt dizzy again HR-96, BP 88/60. Had pt lie flat again & BP 98/56. At 3:20 pm pt felt better and sat up BP 110/70, HR-84. Had pt sit for a few minutes and then stand for a few minutes before walking. Steady on feet. Only complaint of arms sore.
This initial spontaneous report was received from a registered nurse regarding multiple unspecified patients of unknown demographics. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On an unknown date, the patients received a doses of improperly stored M-M-R II lot # L005290, expiration date 17-FEB-2017 and lot # L024264, expiration date 01-JUL-2017 dose and route were not provided. It was exposed to temperature of 50.3F for 1 hour and 20 minutes. Previously it was exposed to temperature of 48.9F for 2 hours. The call was because of a data logger. No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: en6202), in left arm, on 22Mar2021 as dose 2, single (Lot number: En6204), in left arm, on 26Sep2021 as dose 3 (booster), single (Lot number: ff2587), in left arm and on 11Apr2022 as dose 4 (booster), single (Lot number: fl3197) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details for COVID 19 Treatment included paxlovid, treatment start date: 04Jul2022, treatment stop date: 08Jul2022.
Very heavy menstruation with several clots. I?ve never had clots during menstruation or a heavy flow.
Received HBV and HAV on 1/28/05. Developed spontaneous Bell's palsy during the first week of March, 2005.
Information has been received from an administrator referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with a dose of ROTATEQ (lot # K011948 with expired date on 07-JUN-2016, lot # K013861 with unspecified expired date, lot # reported as K014820 with unspecified expired date, dose and route was unknown) which were post temperature excursion. No concomitant medication was reported. No adverse effects were noted. Lot number K014820 is an invalid lot number for ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested.
About 12 hours after injection began feeling chills, developed a fever, and felt nauseous.  Symptoms lasted through the night and resolved by about 1100 the following dat
Cerebral infarction unspecified; Unspecified mononeuropathy of bilateral upper limbs; Neuralgic amyotrophy/Parsonage-Turner syndrome; neuromuscular disease; neuropathy of the upper extremities; idiopathic brachial plexopathy; coordination issues; numbness; tremor; moderate right/Carpal tunnel syndrome; Vaccine reaction; This case was reported by a lawyer and described the occurrence of cerebral infarction in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included turner's syndrome and drug allergy (The patient was allergic to shingrix (varicella-zoster)).   The initial information was received on 13 May 2020, via medical records (The case was medically confirmed). As per pharmacy records the patient used Shingrix powder for suspension from 12 July 2018 to 14 September 2018. As per medical records the patient had used varicella-zoster gE-AS01B, PF, (SHINGRIX, PF) injection with frequency once 10 July 2018 to 1 occurrence. As per medical records, the patient was allergic to shingrix (varicella-zoster). On 11 May 2016 the patient was hospitalized with diagnosis Cerebral infarction, unspecified. On 22 November 2019 the medical records stated patient had diagnosis of parsonage Turner syndrome which caused neuropathy of the upper extremities which was caused progressive weakness of the upper extremities and pain, She continued to have reduced functionality of her arms at that time, the patient was positive for coordination issues and numbness. As per medical records the patient was hospitalized on 29 November 2019 with diagnosis Neuralgic amyotrophy and Unspecified mononeuropathy of bilateral upper limbs, the patient also had medical history of bilateral motor neuropathy of upper extremities. As per medical records on 16 January 2020 the patient had problems with swallowing has neuropathy on both her arms and her muscles on side of neck were started to be affected by it. As per medical records, the patient stated the symptoms started about 1 year ago after receiving the Shingrix vaccination. As per medical records, the patient underwent Nerve conduction test and EMG, that study was performed on an EDX neurophysiology instrument for evaluation of complaints of bilateral upper extremity weakness and tremor following shingles vaccine showed Nerve conduction studies were consistent with a moderate right carpal tunnel syndrome and a mild left carpal tunnel syndrome and vaccine reaction. The patient must have a neuromuscular disease on 03 December 2019. As per medical records reviewed, the patient suffered from Parsonage-Turner syndrome (aka idiopathic brachial plexopathy or neuralgic amyotropy).
Vaccine may have been store under condition that depart from the manufacture's recommended specification, so the manufacturer deem vaccine not viable and recommends repeated dose.
Severe generalized body aches from the day of injection to present. Describes pain in all her muscles and bones. Also c/o intermittent headaches.
3 days p/vax pt devel an inj site rxn characterized by 2cm area of induration & fine papulovesicular rash;pt was seen by MD & treated w/cool compresses & DPH;as of 29OCT the rash & induration were beginning to resolve;
Patient in clinic for COVID vaccine. Vial was 1 dose short. Rescheduled patient for the following day to receive vaccine.
extra dose of ACTHIB was administered to a patient on the same date with no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who  was administered  extra dose of acthib on the same date with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Oct-2022, the patient received a once booster dose of suspect HIB (PRP/T) VACCINE (lot UJ637AAA  and expiration date: 30-Nov-2022) at a dose of 0.5ml (twice)via intramuscular route in the left thigh for prophylactic vaccination.  On 13-Oct-2022 (latency: same day), the patient was administered extra dose of acthib on the same date with no reported adverse event (extra dose administered)   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcomes: Unknown   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 the 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.t
Initial and follow up information has been received from a physician and a nurse practitioner concerning a 17 year old female no past medical history reported, and no previous pregnancies, who on 21-MAY-2008 (also reported as April 2008) was vaccinated with a 0.5 mL dose of GARDASIL and then discovered that she was pregnant. No concomitant medications were reported. No adverse effects reported. The patient sought unspecified medical attention in the office. The patient was referred to an obstetrician for obstetrical care. The patient's last menstrual period was 01-APR-2008 and estimated date delivery is 07-JAN-2009. A urine pregnancy test in the office on 17-MAY-2008 was negative and on 21-MAY-2008 the urine pregnancy test was positive. On 03-JUN-2008 ultrasound results showed that the patient was 8 weeks and 5 days pregnant. On 19-JUN-2008 the patient had a spontaneous abortion at nine weeks. Pathology and chromosomal testing was pending. Spontaneous abortion was considered to be an other important medical event. No further information is available.
This case was reported by a physician via a representative and described the occurrence of non-seroconversion in a subject of unspecified age and gender who was vaccinated with TWINRIX, (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of TWINRIX (unknown).  Approximately one month following the last dose of TWINRIX, hepatitis B titers were checked and it was noted that the subject was not seroprotected to hepatitis B.  Outcome was not provided.  The physician reported that 1 out of three subjects vaccinated with TWINRIX do not obtain seroprotection.  The physician works at a hepatitis C clinic and they use standard dosing of TWINRIX (0, 1 and 6 months).  They check hepatitis B titers 1 month after the last dose.  They vaccinated about 10 subjects a month and about 2 to 3 do not obtain seroprotection.
Increased resting heart rate,according to wearable Oura ring.; Fever 100.4, normal temp 96; Fatigue; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6203), via an unspecified route of administration in right arm on 18Mar2021 at 11:00 (at the age of 50-year-old), at single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient had no history of allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included multi vitamin and fish oil. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration in right arm on 25Feb2021 at 11:00 (at the age of 50-year-old), at single dose for COVID-19 immunisation. On 19Mar2021, the patient experienced Fever 100.4, normal temperature less than 96 on unspecified date; Fatigue and body aches; Increased resting heart rate, according to wearable Oura ring. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any treatment for the reported events. The clinical outcome of the events was unknown. This report was reported as non-serious.  No follow-up attempts are possible. No further information is expected.
Broke out in hives/red welts. along my torso. Under treatment for fungal infection.