chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 24-FEB-2015 the patient was received improperly stored VARIVAX (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Hospitalized in the CCU. Has had significant desaturation with SpO2 in the 70s that did not improve despite BiPAP. He was emergently intubated and placed on ventilator.
tremor activity (@ house) c/w a partial complex sz;nl EEG done 1wk later;
PATIENT SAYS ARM BEGAN TO FEEL PAINFUL THE DAY AFTER VACCINE WAS GIVEN. PATIENT DESCRIBED LOCALIZED REACTION WHICH INCLUDED SWELLING AND REDNESS AND HOT TO THE TOUCH.
UNWELL; TIRED; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (UNWELL) and FATIGUE (TIRED) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 08-Sep-2021, the patient experienced MALAISE (UNWELL) and FATIGUE (TIRED). At the time of the report, MALAISE (UNWELL) and FATIGUE (TIRED) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporters causality for the events of TIRED and UNWELL was not provided.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
she still feels heavy in her chest; She was coughing while talking; Chest hurt; Ovaries area Hurting; Sweats; Heart palpitation; Swollen Lymph  nodes  in the neck; Hurting Lymph nodes in the neck; Headache; She started heving Chills; Body aches; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (she still feels heavy in her chest), COUGH (She was coughing while talking), CHEST PAIN (Chest hurt), ADNEXA UTERI PAIN (Ovaries area Hurting) and HYPERHIDROSIS (Sweats) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She tested positive for COVID-19 disease two weeks prior to vaccination with COVID-19 symptoms, Night sweats and muscle pain) from 22-Aug-2021 to 01-Sep-2021.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced COUGH (She was coughing while talking), CHEST PAIN (Chest hurt), ADNEXA UTERI PAIN (Ovaries area Hurting), HYPERHIDROSIS (Sweats), PALPITATIONS (Heart palpitation), LYMPHADENOPATHY (Swollen Lymph  nodes  in the neck), LYMPH NODE PAIN (Hurting Lymph nodes in the neck), HEADACHE (Headache), CHILLS (She started heving Chills) and MYALGIA (Body aches). On an unknown date, the patient experienced CHEST DISCOMFORT (she still feels heavy in her chest). At the time of the report, CHEST DISCOMFORT (she still feels heavy in her chest) had not resolved, COUGH (She was coughing while talking), CHEST PAIN (Chest hurt), ADNEXA UTERI PAIN (Ovaries area Hurting), HYPERHIDROSIS (Sweats), LYMPHADENOPATHY (Swollen Lymph  nodes  in the neck), LYMPH NODE PAIN (Hurting Lymph nodes in the neck), HEADACHE (Headache), CHILLS (She started heving Chills) and MYALGIA (Body aches) outcome was unknown and PALPITATIONS (Heart palpitation) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Aug-2021, SARS-CoV-2 test: positive (Positive) She tested positive for COVID-19 disease.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported. Patient reported that her doctor (Urgent care) told her that she got her COVID-19 vaccine too early after COVID-19 disease. She does not have a medical history of heart disease.
Developed raised rash with a few small hive-like bumps on her deltoid muscle area approx. 3 inches  W x 3 inches H. I first noticed it on 8/20. She thought it was bug bites and was itching. It went away within 1 day.
One with Neuromyelitis Optica Spectrum Disorder (NMOSD) experienced worsening of pre-existing symptoms after influenza vaccine /deemed to have experienced vaccine-related pseudo-relapses; This literature case was received on 14-Mar-2023, reported by other healthcare professional and concerned a patient of an unreported age and gender.   This study objective was to evaluate the prevalence and clinical characteristics of iatrogenic central nervous system (CNS) inflammation in a tertiary neuroimmunology clinic since various vaccines, tumor-necrosis-factor-alpha inhibitors (TNFAIs), immune-checkpoint inhibitors (ICIs), and other immunomodulators had been linked to inflammatory CNS events. However, the prevalence of iatrogenic events in the neuroimmunology clinic is unknown.  The patient's concurrent conditions included neuromyelitis optica spectrum disorder (NMOSD). The patient's concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza vaccine, the patient experienced worsening of pre-existing symptoms of NMOSD with no objective evidence of a new relapse deemed as pseudo-relapse.  The outcome for the event was not reported.   The reporter assessed the event to be related to influenza vaccine. As reported, the patient was deemed to have experienced vaccine-related pseudo-relapse.  The event of 'neuromyelitis optica pseudo relapse' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  The literature citation is of iatrogenic CNS inflammation at a tertiary neuroimmunology clinic. This case is linked with cases 202301976, 202301977 and 202301978 (the same literature article).  Company comment: A patient of an unreported age and gender was vaccinated with influenza vaccine. On an unspecified date, an unknown amount of time after receiving influenza vaccine, the patient experienced worsening of pre-existing symptoms of neuromyelitis optica spectrum disorder (NMOSD) with no objective evidence of a new relapse deemed as pseudo-relapse. Causal role of the vaccine is unassessable, due to insufficient information regarding diagnostic findings and temporal relationship with the vaccine.; Reporter's Comments: As reported, the patient was deemed to have experienced vaccine-related pseudo-relapse.; Sender's Comments: A patient of an unreported age and gender was vaccinated with influenza vaccine. On an unspecified date, an unknown amount of time after receiving influenza vaccine, the patient experienced worsening of pre-existing symptoms of neuromyelitis optica spectrum disorder (NMOSD) with no objective evidence of a new relapse deemed as pseudo-relapse. Causal role of the vaccine is unassessable, due to insufficient information regarding diagnostic findings and temporal relationship with the vaccine.
Information has been received from a physician concerning a male pt who sometime this week was vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently the pt developed swelling, redness and cellulitis. It was not known if this was the first dose of vaccine. The physician gave him cortisone injection and was doing fine now. The pt recovered. Additional information has been requested.
Pain on his arm; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer, the patient, reported a male of unspecified age received the second dose BNT162b2 (solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route in the arm on 08Mar2021 in the morning, for COVID-19 immunisation. There was no medical history or concomitant medications reported. The patient previously received the first dose of BNT162b2 (batch/lot and expiry information not provided) on 08Feb2021. The patient inquired if he can take medication for the pain on his arm after getting the second dose of the vaccine on 08Mar2021, reported as this morning. It was unknown if any treatment was received for the event. The outcome of the event pain in the arm was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Information has been received from a RN concerning a patient who at the age of 14, was vaccinated subcutaneously in the left arm with a first dose and in the right deltoid with a second dose of varicella virus vaccine live on 05/01/1997 and 06/25/1997, respectively. On 12/16/1999, the serum varicella zoster virus antibody test was performed and the results were negative. Unspecified medical attention was sought. Follow up information received on 11/08/2000 indicated that the patient was vaccinated subcutaneously in the left arm with a third dose of varicella virus vaccine live. Additional information has been requested.
Red itchy flaky dry rash on chin, neck, and upper chest. Most has cleared up except neck. I've used Benadryl cream, hydrocortisone cream 1/2 % and 1% with aloe, and went to see primary care's NP and got 2 prescription x 2 days ago. As of now 2/5/21 still have itch red dry rash on neck. Post 2nd shot also had cold sweats, chills, severe fatigue for over 3 days. Started feeling better Friday 1/29/21.
Anytime the temperature is above approximately 70/75 F and the humidity is high, I easily become severely short of breath and, at times lose focus to the point of disorientation.
site pain, next day body aches, joint pain, headache, chills, no fever.  tiredness.  for two days
Double dose of varicella given (PROQUAD & VARIVAX). No adverse reactions within 2 days of vaccination. Parents told to call for rash, fever or other symptoms. Parents have not called with signs, symptoms.
If he could get the second shot; Vertigo; Fatigue; Increase in severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), FATIGUE (Fatigue), HEADACHE (Increase in severe headaches) and PRODUCT DOSE OMISSION ISSUE (If he could get the second shot) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Traumatic brain injury in December 2020. Concomitant products included NAPROXEN SODIUM (ALEVE) and PARACETAMOL (TYLENOL) for Headache.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VERTIGO (Vertigo), FATIGUE (Fatigue) and HEADACHE (Increase in severe headaches). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (If he could get the second shot). At the time of the report, VERTIGO (Vertigo) and FATIGUE (Fatigue) outcome was unknown and HEADACHE (Increase in severe headaches) and PRODUCT DOSE OMISSION ISSUE (If he could get the second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment medication was provided.
Loss of consciousness & jerking of arms & legs lasting less than 1 minute. Skin pallor & clammy. 10:40 am B/P 88/40 P. 52 in supine position. 10:42 am B/P 90/60 P. 50. 10:44 am P. 56. 10:46 am B/P 98/58. 10:52 B/P 98/58 P. 56. 11:00am B/P 98/58 P. 56 sitting down.
The reporter believes both doses were administered while the patient was pregnant; gained weight; feeling tired; This report has been received from a registered nurse, referring to a 16 years old female patient with depression. The patient has no drug reactions or allergies. Her concomitant therapies included sertraline hydrochloride (ZOLOFT) and meningococcal b rfhbp rnada rnhba omv vaccine (e. coli) (BEXSERO).  On 30-APR-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R023607, expiration date was unknow by the reporter, but upon internal validation established as 06-MAY-2021) 0.5 milliliter, injection on left deltoid. On 03-JUN-2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R028762, expiration date was unknow by the reporter, but upon internal validation established as 21-JUN-2021) 0.5 milliliter, injection on left deltoid, indication was reported as routine vaccination due to age. It was reported that on the same day (03-JUN-2019), the therapy ended.   The nurse reported that the patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) while pregnant. The reporter believed that both doses were administered while the patient was pregnant. However, the pregnancy gestation was not provided. The date of last menstrual period and Estimated date of delivery were unknown. At the reporting time, the outcome of the pregnancy was unknown. In addition, on an unspecified date in 2019, the patient experienced feeling tired and had weight gained. The patient sought medical attention and on 05-JUL-2019, a urine pregnancy test was performed in physician's office. In addition, on an unspecified date, blood work and hemoglobin test were also done. However, all the results were not provided. No treatment was given for the adverse events (AE). The outcome of feeling tired and weight gained were unknown. The reporter did not provide the causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Member reported unilateral left sided tingling to cheek.  Also reports increased rapid heart rate.
Was informed by mother after the vaccine was administered that as a child I had bad reactions w/fever and headache.  I immediatly began taking ibuprofen to ward off fever.  Went to bed around 10pm and woke up suddenly at 3am with severe chills.  Had a fever of 103.5. Took more Ibuprofen, broke fever after about 15/20 minutes.  Upon waking up at 6:30am had severe headache and low grade fever of 99.0.  I have continued to take ibuprofen to help with syptoms.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Nausea-Mild
Within one hour of getting my Pfizer booster shot I had a problem with my vision. Looking at a word in a line of words, I could see the word I was focused on but the words to the left of that focus word were not visible. It appeared as if I had a "tear" in my vision just off to the left of my visual field. Closing one eye then the other made it evident that it was in both eyes. Then closing my eyes I could still see the area of tear in the same field of vision. As a physician and knowing the history of clots with this vaccine, I took two aspirin and laid down for an hour. Once getting up, my field of vision had cleared and the area of vision distortion was gone. In the week since this event, I have had no recurrences.
I developed burning, numbness, and pain in both feet. Nerve conduction studies done the following month (November) showed nerve damage indicative of peripheral neuropathy. I was admitted to hospital in early December 2009 to receive a 5 day/dose course of IVIG. Symptoms seemed to slightly improve but then returned within a few weeks. I still have the sensory symptoms and now, in addition, am experiencing muscle symptoms in my feet such as cramping and pain upon standing for any length of time, especially on hard surfaces. My hands have developed some numbness as well. I drop things more often and my grip seems to have weakened. I have been seen at a local neurology group, (who did the first nerve studies in November 2009) as well as another hospital who did a second round of nerve studies April 20, 2010. There does not appear to be improvement in the nerve damage. In fact, it appears it may have worsened over time.
day after vaccine patient c/o pain/ soreness at injection site as well as erythema. C/o bodyaches, fever and fatigue.
Groin pain; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 02Apr2021 at 12:00 PM (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 06Apr2021, the patient experienced groin pain 3 days after the vaccine dose. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event groin pain was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient stated having major pain in her right arm. Was warm to tough and unable to life arm. Patient had achy feeling since the night on the third.
Local redness, pain within 24 hrs. Nausea, fatigue 24 hrs later. Swelling around eyes, pain around eyes - Day 4.
Patient had history of anxiety with previous vaccines, started to become anxious when she though she lost her vaccine card. Patient experience the shakes, increased blood pressure 179/131 with pulse 111 pm, shortened breathing. We called 911, took her blood pressure, took her mask off to view face, offered water and ice pack before EMS arrived. Epinephrine not administered.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had received antiviral for COVID-19 Treatment which was started on 30Jan2023 and stopped on 03Feb2023. The reason for vaccine lot unknown was reported as not available/provided to reporter at the time of report completion. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. Had no known allergies.  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.
Lip swelling/ numbness, face numbness/ redness/ itchiness,  trouble breathing, chest pain/ tightness, drop in blood pressure
Information has been received from a pediatrician concerning a 15 month old male patient who on 14-APR-2008 was vaccinated with a dose of MMR (lot number, dose, and site not reported) along with several other unspecified vaccinations. On 22-APR-2008, the patient started to have fevers of 103 and 104 degrees with a red throat. The patient sought unspecified medical attention. At the time of the repot, the patient had not recovered. The physician thought it may be a viral infection. There was no product quality complaint. No further information is available.
Patient had developed swelling around the Left axillary area and was prescribed a course of prednisone from an urgent care facility.
Symptoms started yesterday day 11 after having vaccines. Face, ears, belly, back, started off as red dots, changed to blister and now some are scabbed over. Do not seem to be very itchy. Advised mom can give BENADRYL if they do get itchy, or some CALADRYL LOTION. TYLENOL for a fever. Patient is still consider contagious until all of the lesions are scabbed over. He doesn't need to come in unless mother is concerned and he is not well or having any complications other than the rash (i.e. high fever, hydration concerns, etc).
The expected fever, aches, and joint pain started around 11pm on 4/14 and led to a very restless overnight. I got up around 5am on 4/15  feeling very thirsty and went to the bathroom to get a drink of water. I remember feeling extremely dizzy, nauseous, and lightheaded standing at the bathroom sink with a cup to fill with water. The next thing I remember is sitting on the bathroom floor with the bathroom cup next to me but I didn't know right away where I was (I hadn't turned on the bathroom light so it was dark) and I still don't know how I got there. I must've passed out. It was so difficult getting back to the bed that I had to ask my husband to help me. The fever, aches, and chills continued all day on 4/15 but the lightheadedness improved.
5 year old vaccines given 5/3/06. DTaP and MMR given in left arm. On 5/4/06 child awoke with redness and edema of left deltoid where DTaP was administered. Treated with Augmentin and Tylenol.
Pain in left shoulder since vaccine.  His surgeon suspects possible vaccine administration into the fluid filled sac.  MRI scheduled to confirm
No adverse effects noted.  Pt was given pediatric dose of Pfizers Covid 19 vaccine
Pt recvd DTP/OPV/MMR/HIB 3MAR92 & sl redness & warm to touch; next day larger redened area & warmer to touch; pt running low temp; (did not take temp-momm guess) sleeping alot 1st 2 day;
Pt came to ER after recent hospital admission for Covid Pneumonia .  C/O SOB, shaking, chills, fevers, productive cough.