chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a published literature article concerning a 7/12 year old male who was vaccinated with Pneumococcal 23v polysaccharide vaccine and varicella virus vaccine live (date unknown). On an unspecified date, the patient developed neutropenia, x linked agammaglobulinemia, streptococcus pneumonia (serotype 18F) meningitis, pneumonia, varicella titer was negative and he did not developed antibody responses to diphtheria, tetanus and pneumococcal antigens. At the time of this report, the outcome of the events were unknown. the literature article reads as follows A well developed, well nourished 7 1/2 year old male was diagnosed with X linked agammaglobulinemia XLA in 2003 by mutation analysis. He was brought to us for follow up and intravenous immunoglobulin IVIG therapy. He had streptococcus pneumonia serotype 18F meningitis at 4 years of age, He had only 2 confirmed episodes of pneumonia, in different areas of the lung at 5 years of age. immunization are up to date including pneumococcal polysaccharide vaccine. Family history was negative for immunological disorders. IVIG was started in NOV 2002 and discontinued due to family relocation in July 2004. He remained free of infections although his IVIG replacement was discontinued for the last 8 months. The patient has been effectively prevented from opportunistic infections with prophylactic TMP SMX. In contrast to the literature, his constant neutropenia was not associated with infections and moreover, neutropenia persisted under IVIG therapy. White blood cell was 3500 ul and absolute neutrophil count ANC was 1200 ul in the last visit. However, he had at least two documented ANC of lest than 1000ul. The patient has low IgG, IgA, IgG1, IgG2 levels and B cell count 1%, but normal IgM, IgE, IgG3, IgG4 levels and T/NK cell counts. Lymphocyte responses to mitogens PHA and Con A and Candida were absent, but response to PWM and tetanus was normal. He did not develop antibody responses to diphtheria, tetanus and pneumococcal antigens. Varicella titer was negative after immunization. BTK mutation BTK Exon 5, G 503T, Trp 124 Leu affecting the PH domain was identified on platelets by flow cytometry. Upon internal review, the streptococcus pneumonia serotype 18F meningitis was considered to be an other important medical event (OMIC). No further information is available. A copy of the published literature article is attached as further documentation of the patients experience.
This spontaneous report was received from a nurse regarding a 76 years old male patient with penicillin allergy, sulfa allergy and streptomycin allergy. On 30-OCT-2012, the patient was vaccinated with dose of 0.5 ml PNEUMOVAX23 intramuscularly in the right arm (lot# reported as H13581, expiry: 15-MAR-2014). Concomitant medications included omeprazole(manufacturer unknown) and LIPITOR. On 30-OCT-2012, the patient developed erythema in his right arm where injection was given. Swelling was noticed in the area little bit lower than injection site and it was red, painful and little hot to touch. Swelling went down to the elbow but in the morning of 01-NOV-2012, the patient called the office again and stated that his lower part of arm was also swollen and noticed fluid in the area. No treatment was given. Patient will be coming into the office again today for examination. The outcome of the events was unknown. Patient sought medical attention(office visit). This is one of two reports received from the same reporter regarding patient #1. Additional information has been requested.
Rash on his chest, back, arms, and the bends of his legs, and his head.  It is itching and painful, it has not gotten worse but it is about the same.
pt was waiting in the post-dose waiting area and came over to let us know he felt like he was going to faint. he was instructed to sit down and keep talking to us and ice packs were applied. he lost consciousness and we laid him down on his back and put his feet up and he regained consciousness and after laying for a few more minutes, he was slowly put back into the chair. he was instructed to sit there for a while longer until all his symptoms resolved.
I had a spontaneous case of foot drop due to acute compartment syndrome in the lower left leg that required immediate surgery. The onset of symptoms had no cause and occurred two days following the first dose of the vaccine. I had a similar event occur 10 years prior on the right leg, with no obvious cause, requiring surgery. And since have been diagnosed with Mast Cell Activation Disorder in 2015.
Flu-like symptoms, nausea, chills since 3/ 15/2021 to present
CAUSE OF DEATH ON DEATH CERTIFICATE LISTED AS: ACUTE HYPOXIC RESPIRATORY FAILURE, SEPTIC SHOCK, BACTERIAL PNEUMONIA, COVID-19 PNEUMONIA
broke out with psoriasis really bad/ had a little bit of psoriasis on the back of her neck; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient's husband). A 36-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiry date was not reported), via an unspecified route of administration, administered in left arm, on an unspecified date sometime in Jun2021 10:00 (at the age of 36-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiry date was not reported), via an unspecified route of administration, administered anatomical location was not reported, on an unspecified date at the end of May2021 (at the age of 36-year-old) as dose 1, single for COVID-19 immunization. The patient does not receive additional vaccines administered on same date of the Pfizer suspect. The patient visited Physician office (dermatologist) because of adverse event. The patient does not receive any vaccination aside from COVID-19 vaccine within 4 weeks. The patient never had any issues with any type of vaccine. The patient received Pfizer COVID-19 vaccine for travel purpose. On unspecified date in 2021, the patient was broke out really bad with psoriasis and is covered with it now. The patient went to the dermatologist and the dermatologist asked her if she got the vaccine. The dermatologist told her that because she had a little bit of psoriasis on the back of her neck, the vaccine is the reason that she is now covered with psoriasis. The reporter does not have her vaccination card to provide dates of doses, lot numbers, expiration date or NDC. Two weeks after her second dose she noticed the psoriasis starting to spread. It is getting a lot worse. The patient had been to the doctor and was given one type of pill and it does not work and then she was switched to another pill and that did not work either, the psoriasis is getting worse. The reporter does not have the names of the pills she took that did not work. The outcome of the event was not recovered.  No follow up attempts are needed, information about batch/lot number cannot be obtained.
A non-serious spontaneous report of administration to 65 year old was received from a health professional concerning a 65-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 24-Nov-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event was considered resolved.
This spontaneous report was received from a vaccine coordinator referring to unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies or concomitant information were not reported. On 03-OCT-2016, the patients were vaccinated with improperly stored doses of PROQUAD lot # L046509 and expiration date of 17-MAY-2017 (strength, dose and route of administration were not provided). No adverse reactions were reported. This is one of several reports received from the same reporter. Additional information has been requested.
A home dialysis patient who received his first COVID-19 (Moderna) vaccine on 2/4/2021. He was screened prior to admission into the clinic and reported no signs of symptom of COVID-19. This patient was diagnosed with COVID-19 on 2/12/2021 and hospitalized on 2/16/2021 with COVID pneumonia. The patient's spouse and son (who lives with them) also tested positive for COVID-19. This patient developed COVID-19 complications while inpatient including stroke and mechanical ventilation was required. The patient was made a DNR by family and removed from mechanical ventilation and expired on 2/26/2021.
Pt noticed a small bump shortly after receiving the 2nd shot in the shingrix series. Bump slowly grew over the next year. pt went to dr and had is biopsy, diagnosed as basal cell carcinoma.
The pt experienced cellulitis to the left shoulder at the injection site. A rash was noted at some sites. The left shoulder was approximately 5cm larger than right shoulder.
H1N1 and seasonal flu vaccine given on 2-18-10. Raised red blotching rash started 2-20-10 on lower extremities. On assessment pt has rash to arms, back. Pt also states that they are on his buttock area. They are not raised anymore pt states that they are hives and they itch "like crazy". Taking 50mg of Benadryl after 6hrs. Last year after getting a pain injection and the seasonal flu. Pt got the hives again.
patient felt light headed upon standing and fell to the ground; patient hit nose and started to bleed; patient felt fine after consuming a candy and some water
HAD LOCAL RASH, AS WELL AS RASH ON LEGS, & WAIST - DESCRIBED AS A ALLERGIC REACTION. NO BRUISING OR PAIN, JUST ITCHING.
Vaccines were given on 1/21/05. The next day, child developed high fever for two days. After fever subsided, mother noticed that child did not move legs as much as she use to. Flaccid paralysis of lower extremities. Child has new diagnosis spinal cord tremor at hospital. Symptoms can be contributed to spinal cord compression, not vaccine reaction. Per follow up report-Please remove the providers report of vaccine adverse event because on medical investigations and follow up. The child has other medical diagnosis that explains the symptoms reported earlier.
Fever and severe illness for 5 days which included vaginal ulcerations.  This Covid vaccine was given at the same time as the Influenza vaccine.
Body was very hot with no fever, dry cough for 8 days turned into productive cough, left chest pain, blood clot in lung
Shoulder pain and stiffness began and worsened overnight until I could not move the arm the shot was administered to.  Went immediately to clinic and was examined and told I had reacted in muscle tissue to the pneumonia shot.
Painful injection; loss of strength and range of motion in arm; pain radiated to fingers; injection given near top of right shoulder. Pain continues.
left arm is "double swollen"; broke out in hives; Have troubles trying to swallow; feels like "something is cutting" through her throat; This is a spontaneous report from a non-contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the vaccine at 10:30 and then started experiencing "bad side effects" almost 10 hours later. She said her left arm is "double swollen", she broke out in hives, have troubles trying to swallow, and she feels like "something is cutting" through her throat. With this, she wanted to know what temperature should the vaccines be stored in since she noticed that the place where she got the vaccine was "kind of warm". The outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Janssen COVID-19 Vaccine  fever, chills, headache, nausea, bodily pain Tylenol
Assessment and Plan:  45 year old female (pronouns he/him) with a history of ESRD secondary to Alport syndrome, HTN, HLD, chronic pain, and chronic ulcer who presents with cardiac arrest in setting of hyperkalemia.  Hospital course complicated by COVID and cdiff.  Currently on minimal vent settings but mental status precludes extubation.  Neurology following for evaluation of anoxic brain injury with poor prognosis.       Acute Respiratory Failure Secondary to cardiac arrest, now also with COVID and pulmonary infiltrates, further plan as below Continue vent support Pulm/CC consulted and continue care per critical care team Palliative care following Transitioned to DNRCC and compassionate extubation on 1/20 and patient expired   Anoxic Encephalopathy Anoxic Brain injury Refractory Status Epilepticus  Secondary to cardiac arrest as below CT head non-acute EEG consistent with global cerebral dysfunction Non-epileptiform seizures well controlled on propofol and versed gtt Elevated neuron specific enolase indicative of significant neurologic injury Neurology followed: continue Keppra, cEEG MRI 1/6: diffuse anoxic brain injury without evidence of significant mass effect, midline shift or acute intracranial hemorrhage Poor prognosis for neurological recovery.   Palliative care follows, DNR CCA DNI Transition to comfort care only   Cardiac Arrest Low suspicion for primary cardiac event Admission EKG sinus w/ 1st degree AV block, prolonged Qtc Echo: EF 53%, mild AS, mild TR Cardiology signed off, no further recommendations Telemetry Pulmonary Infiltrates Fevers Noted on imaging: chronic fibrosis vs infectious infiltrates Urine antigens negative Completed rocephin, on ancef for chronic wound infection Further recs per critical care   COVID Vent management as above S/p IV decadron for 10 day course Now out of isolation   Cdiff Completed Vanc through tube Remains on contact precautions    UTI E. Coli +1/2 Continue antibiotics  Was on ancef   ESRD  Alport Syndrome Hyperkalemia Cr 4.2, at baseline, K 6.4 on admission, now improved Secondary to Alports syndrome MWF dialysis, started on midodrine, initiate epogen with HD sessions Neph continued to follow
Left arm pain and stiff; left clavicular lymph node swollen and painful; temp max 101; malaise, decrease appetite; loose bowel movement.
01/13/23 presents to ED for "chills, rigors, cough". PMHx of "multiple myeloma"
After my second dose of Pfizer with the recommended amount of time in-between shots (with additional time in between actually) I experienced flu like symptoms within less than a 24hr period. I had a fever, aches and pains, nausea, headaches and loss of appetite.  The fever, aches and pains and headaches subsided after a few days, but the nausea and loss of appetite remained for months on and off.   I would still experience hunger but the majority of the time the nausea would turn me away from food, this got a lot more consistent and I became more ill October 16-28th where I also began to experience diarrhea, nausea lasting for 12 hours every day during this period and loss of appetite.
Has H1Ni flu mist. c/o chest hurting 2-3 hrs later. Next day cold symptoms. H/A - stuffy nose -  body aches. Pain less in chest.
Patient reported rash on her inner thighs and abdomen; Patient reported hives mostly on the right side of the body on her right arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Patient reported hives mostly on the right side of the body on her right arm) and RASH (Patient reported rash on her inner thighs and abdomen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DOXYCYCLINE for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) COVID-19 vaccine. On 02-Feb-2021, the patient experienced URTICARIA (Patient reported hives mostly on the right side of the body on her right arm). On an unknown date, the patient experienced RASH (Patient reported rash on her inner thighs and abdomen). At the time of the report, URTICARIA (Patient reported hives mostly on the right side of the body on her right arm) was resolving and RASH (Patient reported rash on her inner thighs and abdomen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fatigue, headache, dizziness, nauseous, diarrhea, sore arm
On Sunday 10/17/21  around 6:00 pm, I began to experience moderate soreness under my left armpit. On Monday 10/18/21 the soreness has increased and I would consider it to be painful at this point. It is too painful to close my left armpit (lay my arm completely against my side). I am also now aware that I experienced the same pain after receiving my second dose on the same arm, but at the time I did not link it to the vaccine because I assumed it was due to an ingrown pimple (although there was no visible ingrown pimple). Now the left armpit pain (and what feels like internal swelling)  has arisen (more prominently this time) once again after my third vaccine dose. I would also like to note that the pain in my left armpit also burns a bit from time to time.
Patient complained that FLUZONE HD made her sick (flu-like symptoms: fever, chill, muscle ache). Patient called on Saturday (Nov 10) to inform us the adverse event.
Lethargy; Aches/ pain; Mind fog; Rapid heart rate all week; Skin rash; All torso in hives; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 25Feb2021 14:15 (at the age of 42-year-old) (Lot Number: EL9267) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included heart arrhythmia and had known seasonal allergies. Concomitant medication included ethinyl estradiol  taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced lethargy, aches/ pain, mind fog, rapid heart rate all week, skin rash and had all torso in hives on 25Feb2021 16:00. The patient did not receive treatment for the events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
On the evening of 8/12/21 I noticed increasing discomfort in my right axilla/right lateral breast.  This is what I am assuming are some swollen/irritated lymph nodes.  Symptoms still persistent today.
Treatment of COVID-19 with Paxlovid; Treatment of COVID-19 with Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8730), in left arm and on 22Apr2021 as dose 2, single (Lot number: EW0170) at the age of 36 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Nov2021 as dose 3 (booster), single (Lot number: 033F21A), in left arm and on 22Sep2022 as dose 4 (booster), single (Lot number: A57162B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19 with Paxlovid ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive RAT continued. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that patient had no other medication in 2weeks. Patient was treated with Paxlovid. Rebounded. Negative RAT on 4th day (30Nov2022) of paxlovid course and positive RAT again 4 days (06Dec2022) after paxlovid course had completed accompanied by worsening C19 symptoms. Positive RAT continued until neg test again on 10th day (12Dec2022) after paxlovid course finished.
Expired Engerixadministered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 74EM4, expiry date 31st December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th February 2023, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 15th February 2023, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Feb-2023 Reporter's comment: The health care professional reported that a patient received an expired dose of Engerix B. Reporter consented to follow up. Additional supportive information: As patient received expired Engerix B vaccine which led to expired vaccine used.
Large local reaction started about 6 hours after the vaccines were administered.  Urticaria developed two days later.  Patient was seen in the Emergency Department for this reaction.
No adverse event was reported until now when the law office file a motion for intention to file a law suit stating pt suffer, pain, loss of amenity,guillain-barre syndrome, paresthesia, severe sensorimotor polyneuropahty, numbness, paralysis, sensory and motor nerve damage. Patient never reach out to us.
low grade fever of 99.6 Fahrenheit and 99.7 Fahrenheit. She said it was 100.1 Fahrenheit only once; chills; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3247) via an unspecified route of administration on the arm left on 18Jan2021 11:00 at single dose for COVID-19 immunisation. Medical history included thyroid. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid and ongoing. The patient did not receive other Vaccinations within 4 weeks. The patient had low grade fever of 99.6 Fahrenheit and 99.7 Fahrenheit. She said it was 100.1 Fahrenheit only once on 19Jan2021, chills on 19Jan2021. The event did not require a visit to physician or emergency room (ER). The caller stated she took the first dose of the vaccine yesterday (18Jan2021) and today (19Jan2021) has had a low grade fever of 99.6 Fahrenheit and 99.7 Fahrenheit. She said it was 100.1 Fahrenheit only once. Fever was reported as worsened. Today 19Jan2021, she first noticed the chills, now she did not have chills but she had a fever that was going up. She is scheduled to receive the next dose of the vaccine 08Feb2021. The outcome of the event fever was not recovered, of the event chills was recovered on 19Jan2021.