chrisvoncsefalvay/vaers-outcomes huggingface dataset:
just stopped breathing; syncope; hypertonic; limp; crying uncontrollably; Initial information regarding an unsolicited valid serious case was received from a physician (Pediatrician) via Medical Information (Reference number- 00323540) and transmitted to Sanofi on 20-Oct-2020.  This case involves a 2 month old male patient who just stopped breathing (apnoea), had syncope, limp (gait disturbance) was hypertonic (hypertonia), and crying uncontrollably (crying), while he received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment(s), past vaccination(s) and family history was not provided.  At the time of the event, the patient had ongoing abdominal pain and irritability (the patient was generally a cranky colicky baby).  Concomitant vaccinations included POLIO VACCINE (POLIO) and HIB VACCINE (HIB) for prophylactic vaccination (not sure if they were given on same day).  On an unknown date (in Jun or Jul-2020), the patient received a 0.5 ml once dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (batch number and expiry date not reported, strength: standard) once via intramuscular route in the left leg for prophylactic vaccination.  On an unknown date, the patient just stopped breathing (apnoea) and had a syncope (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.   These events were assessed as medically significant.  On an unknown date, the patient was hypertonic (hypertonia), went limp (gait disturbance) and was crying uncontrollably (crying) (unknown latency, non-serious events) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.   The doctor was able to immediately stimulate him and he came back very fast. She did not have his chart with her and was at home. She had given Daptacel to other children and they were fine. She was asking if she should give the patient his next Daptacel dose and was concerned and unsure if she should. The patient is due for his next dose.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events were unknown.  The information on batch number was requested for this case.; Sender's Comments: This case concerns a 2 month old male patient who had apnoea, syncope, hypertonia, gait disturbance and was crying after vaccination with DAPTACEL. The time to onset is compatible. At the time of the event, the patient had ongoing abdominal pain and irritability. Concomitant vaccinations included POLIO and HIB VACCINE. Additional information regarding medical history and lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Patient came in to pharmacy the following day after receiving vaccine and the entire upper arm was red and hot to the touch.
1-2 days afterwards he was experiencing hives, chills, flu symptoms; 1-2 days afterwards he was experiencing hives, chills, flu symptoms; 1-2 days afterwards he was experiencing hives, chills, flu symptoms; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a male Patient. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Formulation: Solution for injection,Batch/Lot number was not reported), via an unspecified route of administration on 12Feb2021 at 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced 1-2 days afterwards he was experiencing hives, chills, flu symptoms. Verbatim and Event Description included 12Feb2021 was his first dose of the covid vaccine, 1-2 days afterwards he was experiencing hives, chills, flu symptoms. He is looking for advice about how to treat the symptoms and if he should take the second dose. He would not provide anything but his phone number. Read ISI, long hold in a phone queue, AE for reaction to the vaccine faxed to a company. CEP 159558. The outcome of events were unknown.   Information on the lot batch number has been requested.  Follow-up attempts are completed. No further information is expected.
I woke with my arm itching at the vaccination site.  Later it became red.  The next day my arm had a swath of redness, heat, and itch from my shoulder to my elbow.  This was a Saturday and my doctor's office was closed.  Since I did not have a fever and felt fine except for the arm, I decided to wait until the doctor's office returned my call.  By Monday, I could clearly see that the problem was resolving itself, so I did not see the doctor.  By Tuesday, it was entirely back to normal.
It was reported that a patient (2 of 2) received a Fluzone SV '00-'01 vaccination. Sometime after the injection the patient complained of induration, swelling and redness and injection site. Further information is requested.
Moderna COVID-19 Vaccine EUA. Approximately 11 hours after receiving the vaccine I developed mild chills, body aches, headache, and fever to 100.9F (temp checked about 14 hours after vaccine was given). I was able to sleep at and was afebrile the following day. My left arm (where the vaccine was given) was also sore for about 2-3 days. (After the first Moderna COVID vaccine my left arm was sore more so than for any other vaccine for about 24 hours). Of note, this is the first time I've had a fever in my adult life, despite extensive travel to developing countries and working in hospital settings.
Fever; JOINT PAIN; Vomiting; Diarrhea; This case was reported by a consumer and described the occurrence of fever in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) solution for injection for joint pain.   On an unknown date, the patient received Shingrix and Humira (subcutaneous) at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, vomiting, diarrhea and joint pain. The patient was treated with paracetamol (Tylenol). The action taken with Humira was unknown. On an unknown date, the outcome of the fever, vomiting and diarrhea were recovered/resolved and the outcome of the joint pain was not recovered/not resolved.   The reporter considered the fever, vomiting and diarrhea to be probably related to Shingrix. It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. From  2015 till 2018, the patient received Humira. The patient experienced throwing up and diarrhea. In 2018, the patient experienced fever and Humira did not hel for joint pain. In 2018, the fever resolved.  In December 2019, the patient experienced fever, temperature 103.8 degrees F. On unknown date, the events were recovered. There was no reported medical history. The patient was treated with Tylenol. Primary reporter did not have the lot number information, because the packaging was discarded. The reporter considered the fever, vomiting and diarrhea to be not related to Humira. It was unknown if the reporter considered the joint pain to be related to Humira.
Lymph nodes on her neck (under her ear/jaw line) swelled up; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes on her neck (under her ear/jaw line) swelled up) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes on her neck (under her ear/jaw line) swelled up). At the time of the report, LYMPHADENOPATHY (Lymph nodes on her neck (under her ear/jaw line) swelled up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medications Antibiotic
ELEVATED HEART RATE; MUSCLES FELT LIKE ATROPHIED; SWEATS; DRY HEAVING; CHILLS; WEAKNESS IN LEG; DIARRHEA; SEVERE HEADACHE THAT WAS FROM SHOULDERS TO BACK OF HEAD LIKE HIT WITH A 2 BY 4 (LINGERING PERMEANT HEADACHE IN THE BACK OF HEAD); FEVER (102); NAUSEA; FATIGUE; SEVERE ARM PAIN AND COULD NOT LIFT ARM; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's past medical history included: migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: UNKNOWN) dose was not reported, administered on 25-SEP-2021 10:30 for prophylactic vaccination. No concomitant medications were reported.  On 25-SEP-2021, the patient experienced severe arm pain and could not lift arm. On 26-SEP-2021, the patient experienced elevated heart rate, muscles felt like atrophied, sweats, dry heaving, chills, weakness in leg, diarrhea, severe headache that was from shoulders to back of head like hit with a 2 by 4 (lingering permeant headache in the back of head), fever (102), nausea, and fatigue. Laboratory data included: Body temperature (NR: not provided) 102. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 71, 80's/88, 90's. Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscles felt like atrophied, sweats, dry heaving, chills, diarrhea, fever (102), nausea, and fatigue, and severe arm pain and could not lift arm, and weakness in leg on 27-SEP-2021, and had not recovered from severe headache that was from shoulders to back of head like hit with a 2 by 4 (lingering permeant headache in the back of head), and elevated heart rate. This report was non-serious.
Mom reporting rash about 2 inches by 1 inch, upper right outer thigh, small red bump at injection site, size of a pea. Complaining of itching. Denies fever. Denies SOB, wheezing. No rash elsewhere on body. Playing, normal disposition.
I woke up 4/26/21 with what looked like 2 bug bites on my left cheek.  By morning of 4/27/21, it was completely swollen.  I experienced itching, pain & vibrating pulses in this area.  The swelling enlarged over the next several days.  On 4/22/21, I had gone to my annual dermatology appt at Derm.  I had to have 2 spots frozen off my face.  One on my left cheek & one on my forehead.  Since the swelling was occurring near the area I had frozen on my left cheek, I called Dr at Derm & was seen by them for a wound check follow up on 4/28/21.  She did not know what it was but did not think it was related to her procedure.  She took a culture & had it tested.  Her best guess was that it was either an infection or Shingles.  Since the results of the culture was going to take several days, she gave me a RX for ValACYclovir.  This was just in case it was shingles.  Even with this medication, the swelling, itching, burning & pulsating continued.  On 5/4/21, I woke up & noticed a significant reduction in the swelling on my left cheek.  I also received a follow up message from Dr that the results showed negative for Shingles.  However, they have no idea what caused the issue on my left cheek.  She recommended that I notify CDC as it may or may not be related to the Covid shot.
12 Jun 09/1:32pm-Anthrax vax rec'd IM L. Delt.  13 Jun 09/2:00am-Sore throat/fever/chills/flu-like symptoms noticed.  Went to ER later in the day when symptoms got worse.  The Hospital gave "IV fluids, Benedryl pills, & pills for headache" They also took blood for testing and X-rays - results weren't made known to patient.
I have had pityriasis rosea going on 6 months now.  I was diagnosed by Dr. in June of 2023, but had it since May 1.  This diagnosis was confirmed in August by a dermatologist who took a biopsy from two places, one from back of left shoulder and a very new one from my buttock.  Oddly, the one biopsy from the back of my shoulder had been there for about six months prior to May and only appeared as a small, rough spot on my skin which kept changing in size but had been dormant for six months.  Since it is a virus and there is no treatment for it and it predominantly occurs with babies, it seems very likely that the correlation may be one of the vaccines because babies are also receiving their vaccinations.  I have heard of a few other adults having this and their dermatologists have said they are seeing more and more cases of late.  Since it has been happening for so long, it is constantly in my thoughts, and this seems to be the most plausible, so I thought it would be prudent to pass this information along to the CDC.
Respiratory issues; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (Respiratory issues) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESPIRATORY DISORDER (Respiratory issues). At the time of the report, RESPIRATORY DISORDER (Respiratory issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported   Reporter did not allow further contact
shortness of breath; This is a spontaneous report from a contactable other health care professional (Nurse reported about herself). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EL1283; Expiration Date: 30Apr2021) via intramuscular, administered in Left Arm on 21Jan2021 (at the age of 77-year-old) as dose 1, single for covid-19 immunization. Medical history included polymyalgia rheumatica, Giant Cell Vasculitis from 2020 to an unknown date, congestive heart failure, chronic obstructive pulmonary disease, hypertension, pulmonary hypertension. Concomitant medication included prednisone 60mg once daily. Historical Vaccine included flu vaccine and experienced sick. She said each time she got the flu vaccine, she would get sicker, so she doesn't take the flu vaccine anymore. She said it has been quite a few years since she took the flu vaccine. Reported she got a pneumonia vaccine about a year or so ago and she is due next month for her blood work. No further details provided. On an unspecified date in Jan2021, the patient stated that her shortness of breath is worse since she got the COVID-19 Vaccine. She said she was doing better before she received the COVID-19 Vaccine and she is unsure if her side effects are because of the COVID-19 Vaccine, or if it is because she has been on Prednisone. Event assessed as non-serious by reporter. Therapeutic measures were taken as a result of shortness of breath. Outcome of event was not resolved.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
CLIENT IS UNDER THE AGE OF 65 AT THIS TIME AND RECEIVED THE HIGH DOSE IN ERROR AT A SENIOR CITIZEN EVENT. CLIENT DID NOT SHOW ANY ADVERSE EFFECTS AT THIS TIME.
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 05-NOV-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016, (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
No adverse effect; Patient was administered with Improperly stored dose of VARIVAX; This spontaneous report as received from a medical assistant refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported.  On 25-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S015460, expiry date: 20-MAY-2021) (dose, frequency and route were not reported) for prophylaxis. The sterile diluent was properly stored.  The vaccine was stored in temperature of -12.3 degree Celsius (C) for 13 hours and 15 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.
Flu like systemic symptoms. Dark-red raised at injection site. Line of blisters from site on arm down to elbow.
Vaccine administration error:  Patient received 2 dose too early, only 15 days apart. - 1st dose in series:  6/05/2021 in L Gluteus Medius - 2nd dose in series:  6/20/2021 in arm.
Woke up approx. 64 hours into second dose vomiting with chills.  Residual left arm pit pain from first vaccine.
Information has been received from a physician concerning a 63 year old female patient who on 6/2/03 at 15:00 was vaccinated with a 0.5 ml dose of pneumococcal vaccine 23 polyvalent intra-articularily. It was noted that the patient developed intense pain/warmth at site and was treated symptomatically. It was noted that the patient went to the emergency room. Additional information has been requested.
Initially reported severe severe shaking/trembling and very painful gripping in my jaw. Later developed fever aching and some chest pain on turning from side to side
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 22-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 528 hours, the lowest recorded temperature was 20 degrees F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complain involved. This is one of several cases received from the same reporter. Additional information has been requested.
Pt was ok day of injections, got low grade fever 24 hours later and very tired. By 5 pm did not want to walk or eat and fever 102. Fever came down 48 hours later and recovered by 72 hours later.
Swollen lymph nodes, swollen left testicle, testicular pain fever, sore joints, headache, sore ears, sore jaw, chills.
I am unsure if this is a direct result or correlation with the vaccine but have been encouraged to report after the significant healthcare experience I've had since the vaccine.  I was diagnosed with intersticial cystitis in my 20s and have spent the majority of this time since (20 years) in remission.  I was in full remission when i recieved the 2nd moderna vaccine on 3/4/21.   My immediate symptoms over the next 24 -48 hours were chills and body aches as well as a severely sore arm (much more than tetnus) but in line with what some folks were experiencing.   Over the course of the next few weeks i began having issues with my GI system (random severe constipation and abdominal pain) and more frequent urination.  It became significant enough that I thought i may have a blockage and was having difficulty urinating.  Went to see my PCP for this and the CT scan showed no blockage or kidney stones.  Was referred to GI specialist and Urologist after issues continued and i was having severe frequency and pressure.  Colonoscopy was clear,  and set up a hydrodistension with urologist to treat the symptoms of intersticial cystitis.  Have had two successful procedures by same Dr. that put me into remission for 10 years each.  This one did not work and i spent a month and a half in severe pain until I found a Dr. who could do installations.  I believe that it is very possible that the vaccine triggered me out of remission and as it was a significant health event I wanted to report.  I am now managing well  but not back in remission.  After my booster on 12/6/21, having symptoms again and going back for treatment this Friday.
60 year old female with hx HTN, CVA, craniotomy for aneurysm and MS who presents for evaluation of fever of 102, dry cough, weakness, fatigue. She was found to be COVID 19 positive in ED, is fully vaccinated with Moderna x 2. She has no shortness of breath. Chest xray free from infiltrates. She was started on IVF and is being admitted to medical COVID unit. She denies loose stool, changes in taste or smell or nausea. NO PCP in area. Non hypoxic.
Information has been received from a registered nurse concerning an outbreak of chickenpox in child, between the ages of kindergarten to 4th grade, who had vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected. This is one of several reports received from the same source.
This is a spontaneous report from a contactable consumer reported for himself. A 65-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration in the arm, on an unspecified date (2 years ago) at single dose for immunisation. The patient received also PNEUMOVAX 23 at the end of Sep2016 and influenza vaccine on unknown date. On unknown date the patient experienced that his arm was very sore.
Presented for SOB & cough. Admit for hypoxic respiratory failure due to COVID pneumonia & sepsis. Tx: O2 via NC, dexamethasone x10 days, zinc, Vit C, abx; remdesivir not indicated. DC to home.
Breakthrough case admission after 1 Janssen vaccine Janssen 5/8/21 Lot# 042A21A
experiencing colds; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 12Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 03Mar2021, outcome "unknown", described as "experiencing colds".  Additional information: The patient was due to have the second shot on 12Mar2021 (which was more than the 21-day time interval). He has been experiencing colds since the previous day (he thought that he got it from his son who had colds too). He was asking if he could still take the second shot of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.