chrisvoncsefalvay/vaers-outcomes huggingface dataset:
racing heart; dizziness; disorientation; blurred vision; forearm muscle pain/lower leg muscle pain; fatigue; loss of strength and coordination in fingers and arms/ residual arm & leg weakness; loss of coordination.; right lower lip became numb; difficulty with concentration; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient (non-pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in the right arm on 26Apr2021 at 02:30 AM as single dose for COVID-19 immunisation. Medical history included lumbar disc degeneration, spinal surgeries x2, stem cell injection (lumbar disc) a little over a year ago, allergies to shellfish. Concomitant medications reported as none. No other vaccine in four weeks. None other medications in two weeks. No Covid prior vaccination. No Covid tested post vaccination. On 26Apr2021 at 14:30 PM, (reported as after approx 15 min), racing heart, dizziness, disorientation, blurred vision (inability to focus), forearm muscle pain, fatigue affecting ability to perform my job, loss of strength and coordination in fingers and arms, right lower lip became numb, lower leg muscle pain and loss of coordination. Symptoms that continued to persist after 10 days were right lower lip numbness, difficulty with concentration and fatigue that was affecting my ability to perform my job, and some residual arm & leg weakness and coordination. Events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Unknown if treatment received for events. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
itching turned into more of a slight prickly sensation, almost burning; itching; red rectangle 2 x 3.5 inches; arm was a bit sore; A spontaneous report was received from a Reporter concerning about a 68 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list.  The patient's medical history was not provided. No relevant concomitant medications were reported.  Patient had Moderna first dose vaccine given to him on 08Jan2021. He developed at the injection site a little bit of a side effect. He would like to discuss this with somebody to see if it's dangerous or something he needs to be concerned about. Upon calling 22Jan2021 1003 EST: Patient confirmed he received the Moderna COVID19 vaccine on 08Jan2021 on left arm as IM injection. His arm was a bit sore. On 15Jan2021 patient states he started with the itching. Later he noticed he had a red rectangle 2 x 3.5 inches. The itching went on for about 2 days and then it subsided. On 18Jan2021, the itching was gone but the red area had increased in size. On 20Jan2021, the itching started again and the red area had increased to about 4.6 x 6 inches. Today 22Jan2021, the red area hasn't increased in size, but the itching turned into more of a slight prickly sensation, almost burning. It's not severe, not something that he can't stand, but it's noticeable. He states he never had a reaction like this before. Lot number of vaccine was not on patient's vaccination card. Consent given for safety to contact patient and his HCP. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.
Patient was received Moderna vaccination and was given 1 ml instead of 0.5 ml dose. The patient did not note any side effects at the visit or before departing the clinic.
Received call 04/27/19 from mom in regards to final HPV and first Trumenba vaccine given 04/26/19 and possible reaction concern.  Per  mom Patient began with fever, temp 101 yet felt much higher, HA and some muscle and joint pain all over, neck pain. Mom states no rash, no signs of respiratory distress, this morning resting in bed HA better, alert, does not feel warm to touch and unable to take temp., some soreness at injection site only.  Parent advised if symptoms worsened to bring in for evaluation, currently out of town, and may continue to monitor symptoms, cool compress at injection site, Tylenol PRN and to encourage fluids, physician reviewed and agreed with recommendations, and to follow up if symptoms worsened.  Received call on 04/30 with progress report for symptoms. Mom described overall symptoms. Had 2 days of fever with tmax of 102, body aches all over " neck back and shoulder" described by mom " on scale from 1-10 his body aches were a 6", HA. Mom states today is asymptomatic as well as yesterday, fever free x 3 days now and no longer with body aches x 2 days. Currently at school and doing well.
possible keratitis iritis;pt has had a bilateral peripheral keratitis & mild anterior uveitis in both eyes intermittently for the past 3mo;seen by MD & lyme test & PPD done & negative;poss scleritis, conjunctivitis;shotty nodes
Painful blotch, painful spot; Red blotch; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and red blotches. On an unknown date, the outcome of the pain and red blotches were unknown.   It was unknown if the reporter considered the pain and red blotches to be related to Shingrix.     Additional Information: GSK Receipt Date: 6-May-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine into unknown arm and experienced painful red blotch on the same arm but not at the injection site. The patient asked was it normal to had a painful red blotch on the same arm but not at the injection site for the first dose of Shingrix vaccine.
Slight reaction to type HIB vaccine just a mild one; Initial information was received on 25-Jun-2021 regarding an unsolicited valid non-serious case received from a patient.  This case involves a male patient (unknown age) who experienced slight reaction to type HIB vaccine just a mild one (vaccination complication) while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided   On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious slight reaction to type HIB vaccine just a mild one (vaccination complication) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  The reporter wants to know that if he can get the Pfizer vaccine and if any common ingredients with type B HIB vaccine. It is unknown if patient's physician provided consent to be contacted.  It was unknown if the patient experienced any additional symptoms/events.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
pt recv vax 24MAY95 & exp severe asthma attack & was NOT hospitalized; addtl details are being requested;F/U OF 26JUL CORRECTED REPT--PT NOT HOSP.
Ringing in ears.  Has been constant since about 10 min after receiving vaccination - 4 days now.   I have experienced tinitus before but it goes away after a short period of time.  I have had no reprieve from the constant ringing sound.  I also experienced vertigo when the ringing started, lasted only a few minutes.  Has not returned.   No other side effects besides sore muscle around injection area.
8x9cm red induration area on day following immunization. Mild pruritis. Treatment with BENADRL (12.51) for 1 day by mouth , TYLENOL or MOTRIN OTC for pain.
swollen lymph nodes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes".  Additional Information: a doctor said it is likely a vaccine side effect and she works with a woman who still has swollen lymph nodes three months after getting the vaccine.  No follow-up attempts are possible. No further information is expected.
100 PERCENT IN BED; FELT ALMOST DIED WHEN HE GOT SINGLE DOSE OF VACCINE; SHORTNESS OF BREATH; SLEPT FOR 18 HOURS; SICK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number No concomitant medications were reported. No concomitant medications were reported. On an unspecified date, the subject experienced 100 percent in bed, felt almost died when he got single dose of vaccine, shortness of breath, slept for 18 hours, and sick. The action taken with covid-19 vaccine  was not applicable. The patient recovered from sick, and the outcome of felt almost died when he got single dose of vaccine, shortness of breath, slept for 18 hours and 100 percent in bed was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Patient came into the pharmacy at around 3 pm 9/7/2022 to receive COVID-19 Pfizer bivalent booster vaccine for his second booster shot. He had 3 shots of Pfizer (2 doses for primary series and one booster dose). Patient monitored after vaccine administration for any adverse effects. None were shown. Patient returned to the pharmacy next day, 9/8/2022, at around 11:30 am, and showed signs of lip swelling/angioedema. He reported symptoms started during his work meeting around 10:30 am - 11 am. Patient recommended to take Benadryl to help with the reaction and to continue monitoring for worsening symptoms. The pharmacy followed-up with patient later in the day around 4 pm. Patient's wife picked up the phone due to patient not being able to speak. He had gone to urgent care due to more lip swelling. Urgent care gave patient an injection (unknown since wife didn't remember the name) and prescribed Pepcid, Allegra and prednisone. Patient currently resting. Pharmacy will follow-up in the next days to monitor patient.
throat pain; Swallowing issue; This case was reported by a consumer via interactive digital media and described the occurrence of throat pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   In October 2020, the patient received the 2nd dose of Shingrix. In October 2020, several hours after receiving Shingrix, the patient experienced throat pain and swallowing difficult. On an unknown date, the outcome of the throat pain and swallowing difficult were unknown.   It was unknown if the reporter considered the throat pain and swallowing difficult to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable to this report. The age group was not reported but it was selected as an adult as per vaccine indication. The patient had a very unusual painful throat and swallowing issue which started a few hours after 2nd dose of Shingrix. The patient inquired that was this an adverse response. No other information was available.
HEART RATE INCREASED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced heart rate increased. The action taken with covid-19 vaccine  was not applicable. The outcome of heart rate increased was not reported. This report was non-serious.
maculopapular rash on bil;ateral arms and legss and mildly also on abdomen, starting ~30mins after vaccines in left arm. No anaphylaxis (no hives, no hypotension, no GI sx, no wheezing). Rash started to fade over next 20-30. Not fully gone at  1hr when discharged
Information has been received from a physician concerning a 14 year old male who on 19-MAR-1997 was vaccinated with the first dose of MMR II. On 07-JUL-1999 the patient received the second dose of MMR II. On 12-NOV-2009 the patient had a fever and his temperature was 100.5 F and experienced left parotitis. On 12-NOV-2009 laboratory test results showed IgM 1:10:00, IgG 5.42 and serum amylase 581. On 28-DEC-2009 the patient experienced mumps. At the time of the report, the outcome was unknown. Follow up information has been received concerning a 14 year old male who on 19-MAR-1997 was vaccinated with the first dose of MMR II. On 07-JUL-1999 the patient received the second dose of MMR II. On 01-DEC-2009 (previously reported as 28-DEC-2009) the patient experienced mumps. On 03-DEC-2009 the patient was afebrile and was diagnosed with mumps. The patient experienced left parotitis. Laboratory tests performed on 03-DEC-2009 showed IgM <1:10, IgG 7.22 and serum amylase 67. At the time of the report the outcome was unknown. No further information is available.
(L) shoulder pain since flu shot 2 weeks ago. Pt. expected soreness, but he still has trouble lifting it. Pt. states injection given fairly high in his deltoid. Pt. referred to physical therapy.
This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 19-NOV-2015 the patient was vaccinated with improperly stored GARDASIL, lot # K011215, expiration date 05-MAY-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt was given MENACTRA and had a vasovagal reaction 5 minutes after shot was administered.
Fast heartbeat pounding I can feel my heartbeat pounding so fast it's scary has happened 6 times
Pimples around face, on forehead, in random spots, around chest/breast area soreness in arm around the injection area fogginess  shaky on the inside for 40 minutes
Moderna vaccine given on 09/02/2021 and the expiration date was 08/31/2021.
Eye pain starting 6/20 ( 12 days after vaccine). Continued for a total of 4 days. No redness, discharge, or blurry vision.  Low fever starting 6/21 (13 days after vaccine), ranging from 99 - 100.2 degrees F, continuing for 3 days Mild headache 6/21 Swollen lymph node behind right ear, noticed 6/22. Sister (who received same vaccination at the same visit) also had a swollen lymph node in the same location, but no other symptoms.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-MAY-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Had varicella vaccine 1-13-10 (Lot MSD0804Y) and on 1-14-10 pt. started developing erythema type reaction. Pt states it is sore warm to touch, pt. denies pain. Pt states had a fever earlier.
Flublok Quadrivalent was administered to a 14 year old, no adverse event; Initial information received on 25-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to case 2019SA269551 (same reporter).  This case involves a 14 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] QFAA1913, exp date (06-Jun-2020)  via intramuscular route in the right deltoid on 23-Sep-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  no other vaccine was given.    It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Full vial of undiluted Pfizer vaccine was administered to patient. On 1/20/2022, called mother of patient, to inform of incident. Phone call was placed by Clinic Operations. MOM expressed son had a sore injection site but does not know if it has gotten better. Patient is in school and mother will follow up with him. MOM stated that son expressed having chest pains and is curious to know if that is related to this.   Contact information will be given to Chief Clinical Officer, for a call back. MOM was informed that due to this being sons second covid vaccine nothing needs to be done and he can get her booster in 5 months.   Dr. called mother on 1/20/2022. Mother said that son's chest was hurting on 1/18/2022, a few hours after the shot.   Then his head was hurting on 1/19/2022.  He felt better after eating pizza and slept.  Mom texted him at school today and he responded that he was fine.   That his symptoms have resolved.  Mom concerned still as he is a child.  Dr. discussed rare SE of myocarditis post vaccine.  He recommended to watch for return of chest pain or SOB and to go to ED for that. Offered to see his PCP tomorrow for evaluation.  Scheduled at 10:30am tomorrow, 1/21/2022, to check exam, evaluation for chest pain, cardiac exam, as a precaution/for reassurance.      1/21/2022- Patient missed his appointment.  According to mother he had finals at school.  He's okay.  No pain, no fever.  no SOB.  He's totally fine.   Advised mom to call if anything comes up or any questions. Follow up call was placed by Dr.
2 hours after physical exam and 2 vaccines given, flu #2 and Hep B #3, child was at home, refused to feed and proceeded to have a febrile seizure, lasted 2-3 min, EMS arrived and noted T 102, afebrile before vaccines and exam 2 hours prior.
1/04/2021, 1/25/2021 Pfizer ej1685, en5318 Reports that he "passed out" on 1/6 at work, taken to ER and was diagnosed with kidney failure & hyperkalemia, also positive for covid. Hospitalized till 1/13, underwent dialysis. Received 2nd vaccination 1/25, once again "passed out" in breakroom while at work. Pt was awoken after approx 1 hour, unable to move arm at that time, went home and did not seek medical care at that time. Pt was re-hospitalized on 2/2/2021 due to difficulty breathing & AMS. Dx with pneumonia & hyperkalemia at that time, discharged home 2/11/2021. Continues on hemodialysis 3x/week.
My daughter had the MMR Vaccine Mon Jan 14, 2008.  On Wed Jan 16, 2008 she broke out in a rash.  I spoke to the dr on call at medical center and she said it was probably nothing.  On Wed Jan 23, 2008 my daughter was rushed to the hospital due to seizure and high fever.  She had a second seizure at the hospital.  It falls right in the timeline of the risks of the MMR shot.
The day after the shot severe coughing, fatigue.  Pain in the left shoulder.  I haven't completely stopped coughing to this day.  Its alot less severe usually only in early morning and evenings.  The cough is dry
diarrhea; light headed; nausea; fatigue; fever of 99 F; body aches; chills; dull headache; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (diarrhea), DIZZINESS (light headed), PAIN IN EXTREMITY (Sore arm), PYREXIA (fever of 99 F) and MYALGIA (body aches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (dull headache). On 10-Mar-2021, the patient experienced CHILLS (chills). On 12-Mar-2021, the patient experienced PYREXIA (fever of 99 F), MYALGIA (body aches) and FATIGUE (fatigue). On 13-Mar-2021, the patient experienced DIARRHOEA (diarrhea), DIZZINESS (light headed) and NAUSEA (nausea). At the time of the report, DIARRHOEA (diarrhea), DIZZINESS (light headed), PAIN IN EXTREMITY (Sore arm), PYREXIA (fever of 99 F), MYALGIA (body aches), HEADACHE (dull headache), CHILLS (chills), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 (Inconclusive) 99 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.   This case was linked to MOD-2021-045281.