chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via a sales representative and described the occurrence of knee arthralgia in a 50-year-old female subject who was vaccinated with (TWINRIX, GlaxoSmithKline). Previous vaccination included 1st and 2nd dose of (TWINRIX, GlaxoSmithKline) with the 1st dose started in October 2007. Yellow fever vaccine (manufacturer unspecified) was given in November 2007. Concurrent medications included MALARONE. The subject started the TWINRIX series at 1.0 ml in October 2007. In November 2007, while away for two weeks, the subject developed "syndrome" consisting of knee arthralgia, urticaria, fatigue and joint pain. Various unspecified lab tests were done: non specific-reaction to Lyme, CBC was negative, babasia titers were negative. The subject was placed on antibiotics, but the physician did not believe it helped much. Five days prior to reporting, the physician recommended the subject stop the antibiotics but the events continued, although they improved. The physician considered the events were disabling because they did interfere with her daily activities. She was, however, still able to work. The events were also considered to be clinically significant (or requiring intervention). the physician reported that he was not sure the events were related to TWINIRX because it may be something that she developed while away. The physician stated that the subject completed her Twinrix series,but did not have the dates on hand. Additionally, the physician stated the events were not related to MALARONE.
didn´t feel like myself; sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and feeling abnormal. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the feeling abnormal was not recovered/not resolved.   It was unknown if the reporter considered the sickness and feeling abnormal to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient herself/himself. Age at vaccination was not reported. The patient received one shot and it made him/her sick. The patient have not had shingles anymore but if he/she knew how sick the shot was going to made him/her would not take it. The patient was sick for 2 weeks and did not felt like himself/herself for 2 more weeks. The follow-up could not be possible as no contact details were available.
On 4/13/21, 4 days after my second pfizer dose, I started having what felt like irregular heartbeat/palpitations.  From 4/13/21-4/19/21 there were too many incidents of palpitations for me to count, it was happening all day and night.  On 4/17/21 I went to PCP and had an exam and EKG, which was normal. On 4/21/21 I started experiencing chest pain, nausea, and dizziness along with the palpitations and went to the Emergency Room.  Emergency doctor ordered xrays, bloodwork, and another EKG and all were normal. Diagnosed as heartburn from  taking aspirin. Doctor had ordered a 24 hour Holter test on 4/17/21 and Emergency room doc agreed  I should follow through. I wore the holter on 4/28/21 and results were normal, although I had noted several incidents of feeling the palpitations while I was wearing it. From 4/22/21-5/11/21  the heartburn symptoms and palpitations started lessening.  Starting 5/12/21 I felt no more palpitations and have not felt any since.
Vaccine given on 6/16/08.  Patient called on 6/18/08 with complaint of her L arm swelling/bruising at injection site with some mild pain for past 12 hours.  Also said area was warm.
not adverse event; PROQUAD stored at 10F for 6 hours administered to paitent; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history was not provided. Concomitant therapy included sterile diluent.  On 18-APR-2019, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (OKA-Merck) virus vaccine live (PROQUAD) (lot # R011802, expiration date: 21-OCT-2019; therapy type: rHa, strength, dose and route were not reported) for prophylaxis. The vaccine was were stored at 10 Fahrenheit for 6 hours. A digital data logger was involved. There was no previous temperature excursion. No adverse effects reported.
1st dose of RotaTeq was administered after 8months - was not indicated.  Mother notified by provider denies any side effects at this time.
100.5° F fever, body aches, joint pain, tenderness at injection site.. Took two Tylenol Cold+Flu Severe OTC the next morning Monday. Recovered Tuesday morning. no further symptoms except for injection site tenderness,
not feeling well; BP is 134/112; pulse is 160 lying down.; Loss of personal independence in daily activities; running a fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), BLOOD PRESSURE INCREASED (BP is 134/112), HEART RATE INCREASED (pulse is 160 lying down.), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ( Loss of personal independence in daily activities) and PYREXIA (running a fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 019F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling well), BLOOD PRESSURE INCREASED (BP is 134/112), HEART RATE INCREASED (pulse is 160 lying down.), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ( Loss of personal independence in daily activities) and PYREXIA (running a fever). At the time of the report, MALAISE (not feeling well), BLOOD PRESSURE INCREASED (BP is 134/112), HEART RATE INCREASED (pulse is 160 lying down.), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ( Loss of personal independence in daily activities) and PYREXIA (running a fever) outcome was unknown.            No concomitant medication listed.   No treatment information provided.   This case was linked to MOD-2021-346088 (Patient Link).
Swelling of tongue, swelling and redness at injection site, itching in arm and shoulders.
Tested positive for COVID May 18, 2022. Experienced coughing, sneezing, congestion.  Treated with Paxlovid for 5 days. Feeling better.
Patient presented with diabetic ketoacidosis and acute kidney injury. During his swing bed stay, he developed mild hypoxia and further work-up revealed multifocal bilateral pulmonary infiltrates. He was treated for bacterial pneumonia (hospital-acquired) with Zosyn and clinically improved. Hospital admission within 6 weeks of receiving the COVID vaccine.
Received Vaccine from Prefilled Syringe which was in Temp Excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Vaccine from Prefilled Syringe which was in Temp Excursion) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Vaccine from Prefilled Syringe which was in Temp Excursion). On 01-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Received Vaccine from Prefilled Syringe which was in Temp Excursion) 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.   Pharmacist states that 2 persons were administered with prefilled syringes. and he doesn't know whether they got any AE..  Contacts and date of birth of both patient's were given moderna.  No concomitant medication nor treatment provided.
sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female 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: Bnt162b2 (Primary Immunization series complete., the regular series of Pfizer I had no symptoms.), for COVID-19 Immunization, reaction(s): "no symptoms". The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "sick".  Additional information: The last booster of the Pfizer Bivalent made her sick for two days. However the regular series of Pfizer she had no symptoms.  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.
One hour after injection started developing numbness and tingling on left side of face, arm, and leg. No other symptoms aside from fatigue from first two vaccines.
Erythematous papular rash gen. over body. No itching, afebrile. Seen by Dr on 3/09/2012; to give Benadryl prn.
No adverse event; All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation).    No concomitant medications were provided. Doses were administered from 24-Apr-2023 to 28-Apr-2023. Patients between 6m-5y of age were involved.  Dosage text reported as unknown. No reported symptoms. No treatment medication was provided. This case contains information for the 12th of 12 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-722123 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722123:1st patient case (Master case)
Muscle aches, extreme fatigue, headache, pain/ pressure behind eyes, excessive thirst, lightheadedness.
A report has been received from a Health Professional concerning an 18 year old, female patient. Concomitant medications included vitamins NOS. On 30-Sep-2014, the patient had received FLUMIST QUADRIVALENT (intranasal) while she was pregnant. The outcome of the event of FLUMIST administered to pregnant patient was unknown. The patient was pregnant in her second trimester. Her last menstruation was on 25-Apr-2014, and the delivery date will be 28-Jan-2015. The report was considered to be non-serious by reporter.
Pt. recieved Tdap in L deltoid on 8/21/2007 - returned to office on 8/24/07 with c/o high fevers ( up to 103-T ) - injection site sl. tender & warm to touch. dx'd as 1- local reaction vs. 2- injection site infection. On f/up call by phone, pt. states much improved w/o completion of abx.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 23-MAY-2016, the patient was vaccinated with an improperly stored dose of PNEMOVAX 23 injection (lot# M006141, expiry date 28-MAY-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (-1.11 degrees Celsius) and the second one lasting for 32 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt devel tetanus 8 hrs p/last TTox booster (MFR  unk); pt was treated w/tetanus immune globulin & recovered;
Patient reported swelling (small) itching, and pain, and a 2" diameter red area. Patient was asking if tylenol and hydrocortisone could be used. Patient will circle the area with a marker to track progress and report to pharmacy and doctor if it doesn't improve
Four months post vax, the pt developed arthritis symptoms in hips and knees; along with stiffness and soreness. Pt was put on anti-inflammatory meds and has greatly improved.
Pt has knot size of a silver dollar and also a bruise 4-6" in diameter. Does not hurt.
I developed Bell's palsy on 2/21/2021, I do have a previous hx of this . It's a very mild case . On 3/01/2021 I suffered a TIA.  Waiting on getting MRI  to see if there's any blockage. All my vital signs were within normal limits. Not for sure there's a correlation .
(ZOSTAVAX site). Redness around injection site, swollen around injection site for 48 hrs following injection (resolved 3/12/17).
Information has been received from a health professional concerning a 13 month old female, with no medical history and no allergies, who on 28-AUG-2007 was vaccinated with a first subcutaneous dose of ProQuad (Oka/Merck upgrade process) (Lot# 657782/0612U). Concomitant vaccines, administered on the same day, included a fourth intramuscular dose of Prevnar (Lot# B53981A) and a fourth intramuscular dose of ActHib (Lot# UF024AB). There was no illness at the time of vaccination and no adverse events following prior vaccinations. On 04-SEP-2007, at 6:00 a.m., the patient experienced a seizure, as stated by the patient's mother, and a high temp of 103.2, measured rectally. The patient was diagnosed with pneumonia of the lower right lung and was hospitalized for three days. Subsequently, the patient recovered. Additional information has been requested.
ABDOMINAL SPASMS; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient had no known allergies, no drug abuse or illicit drug usage. The patient had no spasms before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204D21A expiry: 11-DEC-2021) dose was not reported, administered on 06-OCT-2021 for covid-19 prophylaxis. Age at time of vaccination 35 years old. No concomitant medications were reported. On OCT-2021, the patient experienced abdominal spasms. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal spasms. This report was non-serious.
Event occurred after 2nd vaccine. First vaccine was on 2/5/21 and the second one on 3/5/21. Pt tested positive for COVID-19 on  1/24/22.
pt recv vax 5FEB97 mom called clinic 10FEB97 & reported red, inflamed hard & streaked w/pt crying constantly & pain;referred to PMD;MD told mom to use cold packs to site today, warm tomorrow & give APAP;
8 days p/vax pt devel t105-106 per mom;pt was @ sitter @ that time;also said to have shaking episode, forming of mouth & being sleepy afterwards;taken to ER via amb;poss febrile sz;ears red, diaper dermatitis, sleepiness;
she ran a fever of 101.4 F and felt un-well enough to be bedridden for two days; she ran a fever of 101.4 F and felt un-well enough to be bedridden for two days; This is a Spontaneous report from a contactable consumer. This consumer reported for both mother and baby. This is a mother report. A 34-year-old non-pregnant female received first dose of BNT162B2 (Pfizer COVID vaccine, Lot number: unknown, expiration date: unknown) via an unspecified route on 29Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that my neighbor informed me through casual unsolicited conversation. At 6:30 PM Pacific, on 02Feb2021, my neighbor reported receiving the Pfizer COVID vaccine through her place of employment she was a pediatric nurse in the Emergency Department) on Friday 29Jan2021. She stated that on Saturday (30Jan2021) and Sunday (31Jan2021) she ran a fever of 101.4 F and felt un-well enough to be bedridden for two days (through Sunday, 31Jan2021). I do not know her exact date of birth, but I believe she was 34 years old. Although she was not currently pregnant, she was lactating, and was currently weening her 19-month-old son. Patient underwent lab test and procedure which included body temperature 101.4 Fahrenheit on 30Jan2021.The clinical outcome of the event was recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021153907 mother/baby
Flu like symptoms, very bad body aches.  Day 3 all my joints hurt, slight fever.
After getting both of the shots, I got ill and delirious with fever. My brain felt like it was fire. I had really bad achy and throbbing headache. It felt like it was on fire for two days after each shot. Since then I have gone to the doctor for spikes of blood pressure and throbbing blood pressure in head.
Pt recvd 4th dose of vax on 28APR92 & 3 to 4 days later devel a generalized rash; rash was pruritic & described as being brown scaly type rash that looked like scabies; rash was dx scabies;
Nauseated; Fatigue; Headache; Arm where shot was given red; Arm where shot was given swollen; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 23Feb2021 at 14:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, prediabetes, gout, hypertension, obstructive sleep apnea and sulpha drugs allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications taken within two weeks included atenolol (MANUFACTURER UNKNOWN), budesonide/formoterol fumarate (SYMBICORT), folic acid (MANUFACTURER UNKNOWN), vitamin b12 (CYANOCOBALAMIN) and multivitamin (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Em9810) via an unspecified route of administration in the right arm on 02Feb2021 at 15:15 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. The patient previously also received allopurinol (MANUFACTURER UNKNOWN) and ciprofloxacin (MANUFACTURER UNKNOWN) and experienced allergy to the medications. On 24Feb2021 at 01:00, the patient experienced nauseated, fatigue, headache, arm where shot was given red and swollen. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nauseated, fatigue and headache was resolved on an unknown date in Feb2021, after the duration of 72 hours, while arm where shot was given red and swollen was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a consumer concerning a 12 month old female with a history of urticaria pigmentosa (at her 3 months of age) and with no drug reactions/allergies, who on an unspecified date was vaccinated intramuscularly with VARIVAX (Merck). On an unspecified date the patient experienced lyken striatus which was a high pigmented area on her right arm. The patient also reported that M-M-R II and VARIVAX (Merck) were injection into her leg, not her arm. The patient did not seek any medical attention and did not perform any laboratory test. No further information is available.
Patient received a second dose of Moderna Covid vaccine when his first dose was Pfizer.  No adverse events are known.
Information has been received from a Registered Nurse concerning a 15 week old patient who on 01-MAY-2009 was orally vaccinated with the first dose of ROTATEQ, "1 tube", at an age later than recommended. The child was not experiencing any known symptoms. Additional information has been requested.
Administration error 71-year-old female patient receives her second booster dose of Moderna's vaccine (0.25 mL) 7 days before the day on which she was due to receive it according to established and published guidelines for subsequent booster doses for COVID-19 vaccines. According to the guidelines the second booster dose can be given 4 months after the administration of your first booster dose.
Face swelling mainly around the eyelid/eyes that started 9 days after the vaccine was given to me. I emailed my GP with pictures and took antihistamine and went through it.  It lasted ~ 5 days.  Important to note that I have had 2 episodes of face swelling in July and August 2020 of unknown cause. Swelling is gone and
After receiving PPV23, HPV, and Flu vaccine, the patient experienced dizziness, throat swelling, tightness in her chest, and pain in the area where she received the vaccinations.
Almost immmediately after the vaccine was administered, started experiencing involuntary vocal and motor tics, at first small but has steadily grown and become quite severe over the past couple of months. Tics seem to be triggered by sources of bright light and only disappear after prolonged absence of light.
Patient received Pfizer COVID vaccine dose on 4/25/2021, 6/23/2021 and 8/5/2021. Lot number for 8/5/2021 dose #3 listed on this report.