chrisvoncsefalvay/vaers-outcomes huggingface dataset:
face started hives; Chest started getting tight; heart rate started elevating; face started burning; started wheezing; started coughing; begging to not breath; Weird taste in mouth; itching all over; whole body was sore; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received BNT162B2 (Lot Number: Ewd171), dose 1 via an unspecified route of administration, administered in arm right on 10Jul2021 11:00 at the age of 29-year-old as single dose for covid-19 immunisation. Medical history included asthma. No known allergies. The patient's concomitant medications were none. The patient experienced adverse events on 10Jul2021 at 11:30. Reported Event: Weird taste in mouth, face started hives, chest started getting tight, heart rate started elevating, face started burning. The patient started wheezing then she started coughing she begging to not breath. The patient grabbed her inhaler and took the first pump it did not work, she took another pump it did not work, she took 2 more no luck, 2 more some luck, ambulance assisted. Hour later her whole body was broken out, her chest tight itching all over bumps everywhere, she was wheezing, her whole body was sore and she did not feel good. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included nasal swab for Covid-19: negative on 08Jul2021. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a physician and office manager and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose, route of administration, lot# and expiration date were not reported). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiration dte were not reported). No adverse effect reported. Administered doses of vaccines experienced the temperature excursion between -14 and -10 degrees Celsius for 19 hours. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA011671: US-009507513-1706USA011669: US-009507513-1706USA011668: US-009507513-1706USA011670:
inappropriate schedule of vaccine; pain at injection site; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. In March 2018, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received his 1st dose of Shingrix in March 2018. The patient experienced pain and swelling at the site of injection to the point where he missed one day of work and it was intense for about 2 to 3 days and resolved within 5 days.  Till the time of reporting the patient was not received the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
I have had a chronic vertigo condition that has been mild in severity since 1997.  A few days after taking the Pfizer COVID Booster shot (shot administered on Sep. 24, 2022), I had the worst attack of vertigo since my last severe attack in 1995. I have been out of work on disability the last 2 months but have just been cleared to return to work.  It should be noted that although this is the 4th COVID shot I have had, it was the first time with the Pfizer shot (Local location had run out of the Moderna vaccine). Also, I had my flu shot at the same time.   I have had vestibular therapy prescribed and am doing better after two months of the therapy.
body aches; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced body aches after the first dose on an unspecified date. Event was reported as non-serious. It was reported that the patient isn't getting the "real deal", she does not even have redness, she does not feel sick at all. She wanted to know if it is ok and if she could take the second dose on 03Mar2021 as scheduled. The patient wanted to know if she is protected by the vaccine or not and was querying when she will be tested negative after the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
He woke up to have a bowel movement in the morning and noticed his left gluteal region/perianal area felt numb like he could hardly feel it when he touched it.  As the day progressed, he had a similar feeling on the left chest, particularly related to heat and cold, and then he said the process ultimately involved his left upper and lower extremity.  In his chest, things went to the midline.  He said even his kind of left hemiscrotum seemed to feel numb compared to the right side.  This was not a sudden onset.  He did not have any trouble with vision.  He denied any weakness.  There was no true imbalance.  He thought maybe if he ran, it was not quite as balanced like sometimes his left knee wanted to give way but he thought it was more of a sensory rather than a motor issue.  He did not have any trouble with speech or hearing, no facial numbness/weakness.  He denied any other complaints on review of systems.  No rashes, no fevers, no myalgias.
sweating; very dizzy; nauseous; vomited a little bit; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), DIZZINESS (very dizzy), NAUSEA (nauseous) and VOMITING (vomited a little bit) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Don't have it) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-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 HYPERHIDROSIS (sweating), DIZZINESS (very dizzy), NAUSEA (nauseous) and VOMITING (vomited a little bit). At the time of the report, HYPERHIDROSIS (sweating), DIZZINESS (very dizzy), NAUSEA (nauseous) and VOMITING (vomited a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the concomitant was not reported . the patient taken mecklasyn for the dizziness
This is a spontaneous report from a contactable other healthcare professional via a Pfizer sales representative. A patient of unspecified age and gender started to receive TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had a meningitis diagnosis so the parent was particularly concerned. The outcome of the event was unknown. Sender's Comments: The company agrees with the assessment of the investigator and reasonably does not attribute the case to blinded study therapy, concomitant drugs and clinical trial procedure based on the information currently available, the known adverse event profile of the suspect product and the pathophysiology of the event.
35 weeks pregnant.  Water broke while in bed sleeping.  Son was born premature on 11/11/2011.
Symptoms: Swelling to L Arm and itchy. Treatment: Ice to affected area and was prescribed Ibuprofen 100/5 to take 2 1/2 tsp by mouth every 6 hours or pain.
Cramping; Swollen lymph node in right armpit/swollen lymph node in left armpit; can't close her arm pit without pain/The right is not as painful and a little bigger than when it started; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 12:30 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing), notes: went to her oncologist for her chemotherapy on 10Mar2021, gets 2 medications for chemotherapy. The patient took concomitant medications. Past drug history included: Steroid. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Swollen lymph node in right armpit/swollen lymph node in left armpit"; LYMPH NODE PAIN (non-serious) with onset 12Mar2021, outcome "not recovered", described as " can't close her arm pit without pain/The right is not as painful and a little bigger than when it started"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "Cramping". Therapeutic measures were taken as a result of muscle spasms.  Additional information: Patient had no prior vaccinations within 4 weeks. On Friday, 12Mar2021 she developed a swollen lymph node in her left armpit. Then the next day on Saturday, 13Mar2021 she had a swollen lymph node in the right armpit. The one in the left armpit has gotten so big that she can't close her arm pit without pain. She doesn't know if that's the shot because it's been a week and a half. The right armpit lymph node is much smaller than the one on the left. The right is not as painful and a little bigger than when it started. The right side is not as big as the one on the left. The left used to be bean size it's almost now the size of a large grape. The patient also went to her oncologist for her chemotherapy on Wednesday, 10Mar2021. The chemotherapy gets hooked up on Wednesdays then they unhook it on Friday. She was told at the oncologist that the patients have been getting swollen lymph nodes with the Covid 19 vaccine and it's normal. The patient gets 2 medications for chemotherapy, she does not recall the names. She also gets a steroid, and another medication to help with cramping, she does not remember the names of the medications.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Experiencing  more joint pain and then starting in May 2021, started having issues with redness / inflammation in my eyes
48 hours after vaccine (10/28/09 am), noticed left shoulder with "reddish blotch" ("not bumpy").
VERY itchy hives and rashes  of all sizes and shapes all over the body. It started on the chest and scalp, then began to appear in different spots.  Today is the day 6 after the onset of the symptoms and day 16 after the booster. Covid test on 12/27/21  (done in clinic) was negative. Prescribed hydroxyzine HCL pills, benadryl and claritin doesn't help. It's a constant struggle and torture. I perform my daily activity or can't sleep. I can't take a "normal" shower - it provokes more hive. I get periodical shivering and feel like I'm freezing. Thu the body T is low. Tachycardia.
localized swelling, redness, warmth, hives, and itching >4-5 inches radius around site.
NOV94 pt r4cvd MMR; 1wk later onset of urticaria which has persisted though FEB95; has had occasional angioedema & tongue swelling;
arm shot area was itching; arm shot area swelled up like a golf ball; Flu like symptoms; achy; Extremely tired; nauseated; 101 degree fever; Throbbing headaches on forehead; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (achy), VACCINATION SITE PRURITUS (arm shot area was itching), VACCINATION SITE SWELLING (arm shot area swelled up like a golf ball) and PYREXIA (101 degree fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hives. Concurrent medical conditions included Drug allergy (Allergic to Q Var), Drug allergy (Oral Voltaren), Asthma and Lymphatic disorder (Lymphedema).   On 20-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Mar-2021 at 3:30 AM, the patient experienced HEADACHE (Throbbing headaches on forehead). On 21-Mar-2021 at 8:00 AM, the patient experienced PAIN (achy), PYREXIA (101 degree fever), FATIGUE (Extremely tired) and NAUSEA (nauseated). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PRURITUS (arm shot area was itching) and VACCINATION SITE SWELLING (arm shot area swelled up like a golf ball). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PRURITUS (arm shot area was itching) and VACCINATION SITE SWELLING (arm shot area swelled up like a golf ball) outcome was unknown, PAIN (achy), PYREXIA (101 degree fever), FATIGUE (Extremely tired) and NAUSEA (nauseated) had resolved and HEADACHE (Throbbing headaches on forehead) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) Fever. Concomitant medication was not provided by the reporter. This case was linked to MOD-2021-075110 (Patient Link).
Patient is GCS 15, A&Ox4, with skin that is flushed, warm, and dry and a strong radial pulse. Patient is coughing. Patient states she received her vaccine about 30 minutes ago. She states 20 minutes after the vaccine was administered she began to feel itchy and as if something was stuck in her throat. Patient denies any allergies or respiratory history. The Vaccine Clinic standby units have already administered 50mg Benadryl PO prior to arrival. Lung sounds are clear in all fields. No stridor noted to auscultation. No redness or angioedema noted to patient's airway. Patient's skin is flushed on the chest. No urticaria noted. Patient denies and GI symptoms. An 18G IV is established in the RAC. 125mg Solumedrol administered IV. Patient requests transport to Rex ER. Transport is initiated non emergent to Rex ED. Enroute 0.3mg IM epi is administered. Patient reports her itchiness is gone after Epi administration but is still coughing and states she still feels like something is in her throat. Upon arrival to the ED care is transferred to the RN at triage.
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received 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 adverse reaction and infection. The patient was treated with antibiotics nos. On an unknown date, the outcome of the adverse reaction and infection were recovered/resolved. It was unknown if the reporter considered the adverse reaction and infection to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In 2018, the patient got 1st dose of SHINGRIX 3 months before the reporting time. The patient had a reaction that her doctor thought was an infection. The patient took antibiotics and got better. Caller disconnected before the patient could clarify what the reactions were she experienced. This case was 2 of the 2 cases, reported by the same reporter.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 8 weeks old infant patient of unkonwn gender. On 26-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
I woke up 3 days prior to my vaccination body extremely aching like deep to my bones, i have an insane headache, and ive been having the feeling of nausea all day and have been vomiting but no Fever.
Hives, 1 - 3 inches; This is a spontaneous report from a contactable consumer (Patient). A 54-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an intramuscular route on 10Mar2021 at 02:30 pm, in the left arm as a single dose for COVID-19 immunization. The patient had no known allergy. The patient's medical history included No spline, blood disorder, diabetes. The patient concomitant medications were Metformin 500mg, Lisinopril 2.5 mg, Rosuvastatin 5. Patient was not tested positive for Covid prior vaccination and post vaccination. Patient's 4 weeks prior vaccination included Hepatitis B 2nd shot on 18Feb2021. On 11Mar2021 at 04:00 pm, the patient experienced hives of size 1 to 3 inches. The patient was treated with Cetrizine 10mg and Hydroxyzine 25 mg for the events. The outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Fever; Chills; Myalgias; Weakness; This case was reported by a other health professional and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, chills, myalgia and weakness. On an unknown date, the outcome of the fever, chills, myalgia and weakness were recovered/resolved.   It was unknown if the reporter considered the fever, chills, myalgia and weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient had adverse events to Shingrix like fever, chills, myalgias, weakness and was evaluated in Emergency Room and symptoms had resolved in 24 hours.  The patient had asked if there was risk for same reaction for future vaccines like coronavirus vaccine. The reporter consented to follow-up.
Extreme Body Cold, Eyes Red and secreting mucus, Head Ache, Legs extreme muscle shooting pain, lasting until 11:00 PM.    Extreme tiredness next day.  By this time on 10/9/2015 at 8:45 PM feelings of tiredness only.  I will see my Neurologist Monday 10/12/2015.
Patient inadvertently received vaccine after published expiration date.  Moderna  Company analyzed lot 007B21A and advise d vaccine maintained  activity necessary to protect against covid 19 at time of administration. Also patient did not call in to complain of adverse event.  This is administrative error without adverse event.
Covid19 breakthrough.  1st vaccine received on 09/21/2021.  66 y/o with PMHx of Asthma, Lupus and depression presents to ED with c/o worsening SOB and cough.  Py Hypoxic and was originally placed on 6L NC-sats 90%.  Pt then on 15L NRB and shortly after placed on 30L Heated High flow O2.  Pt was originally diagnosed with Covid19 on 2/9/2022 but returned with progressive symptoms.  Pt afebrile, CTA chest shows worsening extensive ground glass airspace disease with scarring.  Pt treated with IV ABX and IV steroids.
Site injection pain the following day; This is a spontaneous report from a non-contactable other health care professional. A 31-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via unspecified route of administration, at right arm on 19Mar2021 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included CENTRUM WOMEN. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6021) via intramuscular route of administration, at right arm on 26Feb2021 at 12:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, the patient experienced injection site pain. No therapeutic measures were taken for the reported event. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event vaccination site pain was resolved on an unknown date. No follow-up attempts are needed. No further information expected.
6 hours after immun's child had (L) facial swelling & rubor per torso & extremities - no compromise to breathing & neuro status - no reaction at injection sites - took BENADRYL.
Persistent muscle ache at the site of injection.  Chills beginning about 12 hrs. after injection. Fever with some sweating.  Temperature above 38C for at least 3 hrs. Nausea but no vomiting.  Lethargy.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-NOV-2015 19:36, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L004754, expiry date: 10-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 12.1 and 2.6 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
12 hours after receiving the MMR vaccine she developed a large red hard knot on R leg. Had previous type of reaction at 18 mos. of age when 1st MMR was given. The reaction with 1st MMR was more severe in the fact that she had some necrosis in injection site that had ruptured a few days before a surgeon was to cut out the dead tissue. Right now is stable.