chrisvoncsefalvay/vaers-outcomes huggingface dataset:
moved to lower back pain; joint pain first day; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included barretts esophagus. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6201) via an unspecified route of administration in the left arm on 02Mar2021 at 11:00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccine, the patient had not been tested for COVID-19. Concomitant medications received within two weeks of vaccination included pantoprazole (PANTOPRAZOLE) 40mg for unknown indication and from an unknown date. On 24Mar2021 at 08:00, the patient experienced joint pain (first day). Went away and next day moved to lower back pain. Continued and seems to be worsened. The adverse events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of events joint pain and lower back pain was not resolved.   No follow-up attempts are needed. No further information is expected.
Rash diagnosed as eczema by dermatologist; Soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm) and ECZEMA (Rash diagnosed as eczema by dermatologist) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Cold. Concomitant products included IBUPROFEN (ADVIL ARTHRITIS PAIN) for Arthritis, VITAMIN D3 for Cold, RALOXIFENE HYDROCHLORIDE (EVISTA), HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE) and CITRA CALCEMIN for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness in her arm). On an unknown date, the patient experienced ECZEMA (Rash diagnosed as eczema by dermatologist). On 27-Jan-2021, PAIN IN EXTREMITY (Soreness in her arm) had resolved. At the time of the report, ECZEMA (Rash diagnosed as eczema by dermatologist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported in follow up that the original side effects that were previously reported by the agents were incorrect and the patient did not experience it back then.   This case was linked to MOD-2021-211533 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Non-significant Follow up, address updated On 03-Aug-2021: Significant follow up received. Additional event of eczema was added and deletion of previous events of sneezing, runny nose, feeling like a cold.
intradermal dose given. no wheel. dose given 0.5ml subcutaneous successfully.
This is a spontaneous report based on the information received by Pfizer from Merck (Manufacturer control number 00211732). A contactable female consumer reported for herself. This female patient of unknown age and race received PREVNAR 13 for immunization on unknown date in Sep2016 at single dose. The patient experienced injection site pain and a rash on her arm. The patient was being treated with unspecified antibiotics. The outcome of the events was unknown.
Got very sick; Fever almost 104; Feel something different in body; Body was warm; Tonsil area was swollen; Having panic and anxiety; Panic; Sweating a lot / sweating a lot in my armpits; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR HYPERTROPHY (Tonsil area was swollen), HYPERHIDROSIS (Sweating a lot / sweating a lot in my armpits), ANXIETY (Having panic and anxiety), PANIC REACTION (Panic) and FEELING ABNORMAL (Feel something different in body) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced HYPERHIDROSIS (Sweating a lot / sweating a lot in my armpits). On 06-Jul-2021, the patient experienced ANXIETY (Having panic and anxiety) and PANIC REACTION (Panic). On an unknown date, the patient experienced TONSILLAR HYPERTROPHY (Tonsil area was swollen), FEELING ABNORMAL (Feel something different in body), FEELING HOT (Body was warm), ILLNESS (Got very sick) and PYREXIA (Fever almost 104). At the time of the report, TONSILLAR HYPERTROPHY (Tonsil area was swollen), HYPERHIDROSIS (Sweating a lot / sweating a lot in my armpits), ANXIETY (Having panic and anxiety), PANIC REACTION (Panic), FEELING ABNORMAL (Feel something different in body), FEELING HOT (Body was warm), ILLNESS (Got very sick) and PYREXIA (Fever almost 104) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Body temperature: 104 (High) Fever almost 104. In June 2021, Heart rate: 130 (abnormal) rapid heartbeat maybe 130.         No concomitant medication were reported. No treatment information was reported.    This case was linked to MOD-2021-248640 (Patient Link).   Reporter did not allow further contact
This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. The patient's pertinent medical history and concurrent conditions were not reported. On 09-AUG-2014 the patient was vaccinated with PNEUMOVAX23 (Dose/Frequency: 0.5 milliliter (ml), intramuscular (IM))(lot# H014561, expiration date: 21-MAR-2014). No adverse effects were reported. No product quality complaint (PQC) was reported for PNEUMOVAX23. Additional information is not expected.
Hospitalized (12.16.21); COVID-19 positive (12.16.21); fully vaccinated PLUS booster Admission Date: 12/16/2021 Discharge Date: Dec 20, 2021  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19 HOSPITAL COURSE: Patient is a 75-year-old man who presented to the emergency department due to concerns for fevers and fatigue that started 2 days prior to this presentation.  He has a history of PE, CHF, paroxysmal atrial fibrillation, stage III CKD, prosthetic aortic valve, partial nephrectomy due to renal cell adenoma, Hodgkin's disease.  Patient was fully vaccinated against COVID.  He was found to be positive for COVID in the emergency department and was mildly hypoxic and was placed on 1 L of oxygen.  Chest x-ray showed large left-sided pleural effusion.  Ultrasound of the left lung confirmed the diagnosis of large left-sided pleural effusion.  Patient was started on dexamethasone and remdesivir due to concerns for hypoxia secondary to COVID pneumonia.  He also received azithromycin and Rocephin due to concerns for possible associated community-acquired pneumonia.  He underwent thoracentesis on 12/20/2021 of his left lung which was consistent with transudative pleural effusion.  The cause for his transudative pleural effusion is most likely secondary to his history of congestive heart failure and valvular heart disease.  Patient was recommended to follow up with his primary care physician as outpatient and was told that he might require an echo as outpatient. He was on room air on the day of discharge and was feeling significantly better hence was discharged home on room air after getting evaluated by Pulmonary Rehab Service.  Patient's blood pressures were soft at the time of discharge with systolic in low 100s.  Hence he was asked to continue to check blood pressure at home every day and stop taking blood pressure medications if his blood pressure dropped below 100/60.  And also recommended that he contact his primary care physician's office for close follow-up.
I noticed under my breast I have all these brown spot; My arm still kind of hurts me; It improved after the shot because before I couldn't move it for three days; This is a spontaneous report from a contactable Nurse (patient herself). A 70-year-old Nurse (female patient) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number ER8733 and expiration date was 31Jul2021), via left arm, single on 18APR2021 11:00 as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history includes blood pressure high and only took one pill. The patient's concomitant medications included Valsartan 155/2.5 took one pill. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number ER8732 and expiration date was 31Jul2021), via left arm, single on 28Mar2021 11:00 as single dose for COVID-19 immunization and stated I couldn't move my arm for three days and all that was my first. When probed for concern, nurse stated, Well, I took my last Pfizer shot in May2021 but my arm still kind of hurts me and then yesterday I noticed under my breast I have all these brown spot and I was wondering, If they had anything to do with the vaccine. In 2021, she also stated improved after the shot because before she couldn't move it for three days. When probed for treatment for event, nurse stated, No, only thing I do is give an exercise use my arm. The outcome of event (Arm hurt) was recovering, event of (skin discoloration) was unknown and (could not move arm) was recovered on unspecified date May2021.  Nurse was requested to contact Pfizer
Patient stated she started with a small area of redness, swelling the night she received her vaccine.  She states it has gotten worse since getting the vaccine and reports no that she has a swollen area 3.5 inches in diameter and 2.5 inches in height at the tallest area.  She states area is warm to touch and itches at times.  Denies pain in area.  States a toughened "pimple" type area at where she believes to be her injection site.
I developed redness and a little bit of swelling underneath my left eye. It continued to worsen, so I went to my primary care and was referred to an Ophthalmologist. A chalazion was found in my lower left eye and was drained. I was prescribed antibiotics, Cephalexin and Ciprofloxacin; I am currently taking the antibiotics.
Pt stated he felt an elevated heart rate ten minutes after dosage was administered.  Staff gave the patient bottle water to drink and monitored the patient an additional 30 minutes.  Pt called 4/23/21 stating he slept 13 hours last night but today around 2:00pm his bp was 117/55 and heart rate 121 bpm via his watch.   He states no medication, no other side effects, no history of tachycardia, no physical exam in several years.   He was advised to contact 911 if the elevated heart rate continues for over 45 minutes or go to ER or Urgent Care.
11 am.-Second dose of RabAvert vaccine administered 11:45 am.- started feeling flushed, faint, lightheaded, nausea 12 noon- ate lunch 1pm- headache started, diaphoretic, continued to be lightheaded and have nausea. Taken to clinic BP 135/94 p-86 temp. 97.8 F 1:20pm-started 1000cc NS, headache 5/10 on pain scale 1:26 pm- given 125 mg of Solu Medrol 3:45pm- Feeling better, headache 2/10, discharged from Urgent care. 114/62 - 80- 12- 97.6 F.
Pt. had a reaction to MENACTRA injection given in the left deltoid 0.5 ml on 9/3/2015. Was seen in office - hospital for redness, swelling, hardness at site. Temperature 99.9 degrees F. Swelling the size of a baseball. 6x6.5 in.
She had fallen ill; Spontaneous report received on 22JAN2020.  A female consumer reported that "she had fallen ill" (PT: Ill-defined disorder), while being on Vivotif capsule for immunization. The consumer took only first dose of Vivotif a week and a day ago. She believes that she had fallen ill due to being close to other family members who were sick during that time. It was reported that she did not complete her Vivotif course. Action taken with Vivotif with respect to reported event was vaccine withdrawn. The outcome of the reported event was unknown.  Company Comment: A consumer had fallen ill (Ill-defined disorder) after taking first dose of vivotif. The consumer was being around her family members who were sick during the time when she took the first dose of Vivotif and the consumer might have fallen ill as well. The consumer stopped taking further doses of Vivotif. Information on the type of family member's sickness and signs and symptoms of consumer's illness is limited. Considering the case information, the causality of ill-defined disorder is assessed as unlikely with Vivotif.; Sender's Comments: A consumer had fallen ill (Ill-defined disorder) after taking first dose of vivotif. The consumer was being around her family members who were sick during the time when she took the first dose of Vivotif and the consumer might have fallen ill as well. The consumer stopped taking further doses of Vivotif. Information on the type of family member's sickness and signs and symptoms of consumer's illness is limited. Considering the case information, the causality of ill-defined disorder is assessed as unlikely with Vivotif.
About 24 hours after first dose of Vivotif, heart rate accelerated, nausea set in, and stomach cramped.   Symptoms worsened over next 4 hours.  Took one Ambien pill as sleep aid, 20 minutes later sensual perception became mildly distorted.  Experienced shortness of breath and vomited once, then fell asleep and had muscular twitches for 15 minutes, every 3 minutes.
Case previously recorded as MA2009-4217. Initial case report received from a nurse via MedCom on 11 NOV 2009. A patient under 4 year-old was vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. 102046P1) i.m on 10 NOV 2009. No adverse events were reported. MedCom reference no.: NA09-008010.
Flu like symptoms on day 2 and puffy under the eyes. I could find flu like symptoms in the "normal" category but not puffy under the eyes. Is this a problem?
A report was received from a health care professional in the USA on 10/20/2006 concerning a female vaccinee. No other patient identifiers or details regarding the vaccinees past medical history or concomitant medications were provided. On the 10/13/06 the vaccinee received a dose of influenza vaccine (potentially Fluvirin). Later that day, the vaccinee developed severe pain in her arm and flu-like symptoms. The pain progressed and emergency medical care was summoned. The patient was eventually placed in the intensive care unit due to blood pressure instability. Outcome of the events is not yet known. Further information is requested.
Terribly sick by the end of the day on 07/04/2021. Muscle aches, fever of 102, vomiting, and headache. I recovered from most of these symptoms except for the headache. I am now longhauling with constant head pressure, sinus pressure, ear pressure, and tinnitus. I have also developed acaphelgic migraines, fireworks in vision, and visual floaters. I am going on 5 months now with these symptoms and no relief, in constant pain.
Child received Hep. A #2 at 9:30 AM and had a febrile seizure at 2:30 PM.  Temp. was 104.9.  Child taken to ER and diagnosed with otitis.
Day 5 - developed soreness in left armpit. Tender to touch & move. Quarter size welt at injection site, itchy, hot, red & hard.  Day 6 - armpit still painful & injection site redness, etc had increased & doubled in size  Day 7 - still experiencing armpit pain & injection site is reaction is larger  Day 8 - armpit still sore,  injection site is now measuring 3 x 3.5 inches. Still hot, red, itchy & hard
This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 11-DEC-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Look like a ringworm; Itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching at the injection site) and TINEA INFECTION (Look like a ringworm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for Diabetic.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching at the injection site) and TINEA INFECTION (Look like a ringworm). At the time of the report, PRURITUS (Itching at the injection site) and TINEA INFECTION (Look like a ringworm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drugs were reported. Safety consent to follow up with the patient received
This spontaneous report as received from a treating physician's nurse via field representative refers to a 22 year old female patient. On 16-JUL-2013 the patient was vaccinated with her first dose of GARDASIL (injection, intramuscular, standard dose, strength, lot# were unspecified). On 17-SEP-2013 the patient was vaccinated with her second dose of GARDASIL (injection, intramuscular, standard dose, strength, lot# were unspecified). Concomitant medication included unspecified birth control pill that had been taken for the last couple of months. Patient complained of nausea and vomiting that began 24 hours after the injection. Patient had sought medical attention via office visit. Treatment of "Dramomil" was given for the events. The outcome of nausea and vomiting was reported as not recovered. Additional information has been requested.
left patient diplegic and in a wheelchair; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was left diplegic and in a wheelchair on an unspecified date. The clinical course was as follows: Received call from lady who wanted to know if Comirnaty is supposed to be component BNT162BT. She tried to look in the protein data bank which is how the scientific community speaks to each other. There is nothing on the human expression on that protein. She was left in shock. The only thing she has on the # is the protein expression of this Pfizer MrNA is based on mouse spleen cells. But she is not a mouse. There is an individual with 2 children who was left a diplegic and in a wheelchair. Prior to this, he could run 7 miles in a day. Pfizer left him in a wheelchair. He has been more than 6 months like that. She then started stating something about getting vaccinated with Moderna. The caller kept over talking call handler and would not allow call handler to ask questions or clarify information. The outcome of the event was unknown.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
The measles part of the MMR titre showed it was low; This spontaneous report was received from a consumer via Pfizer referring to a 63-year-old patient of unknown gender. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.      On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported).       It was reported, on an unspecified date in 2009, the patient last titer test done showed to be positive. However, on an unknown date (reported as 3 weeks after first shot of Pfizer covid vaccine), her measles part of the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) titer showed it was low (measles antibody negative).      The outcome of measles antibody negative and the causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the aforementioned event was not reported.
Pain, inflammation and swelling of L breast consistent with mastitis.  Also had significant L arm pain, body aches, headaches and fatigue, no fever or adenopathy, specifically no axillary adenopathy.   Naproxen taken daily beginning 8/27 and for 3 days.  No antibiotics.  Symptoms began improving 8/29, resolved by 8/31
Immediately after administration of TDaP Patient fainted for about 10 sec, and recovered her own. She was on exam table sitting and her mother was with her. No injury. Patient had late breakfast but no lunch.
I actually started to show symptoms after my first vaccine. I went to see my doctor after my second dose vaccine which was on 01-04-2021. I experienced fluid in my ears after both of my vaccines. I went to see my ENT doctor, Dr. who performed hearing tests on me. He also prescribed Prednisone medication. I had very painful conjunctivitis which ended up being an auto-immune system in my outer ears. I also took OTC Pataday medication which helped with my pain. I also was exposed to Covid through a patient. I will call in to provide lot# for both my vaccines when I find my vaccine card.
Vaccine administration errors, not associated with an adverse event,  Manufacture was contacted Moderna is not providing any specific recommendations at this time.
Administration of an invalid dose; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an invalid dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 22-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 22-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an invalid dose). On 22-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Administration of an invalid dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment medication was reported.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 031M20A)  with no associated AEs.