chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (unspecified manufacturer), via an unspecified route of administration on an unspecified date at single dose for pneumonia immunisation. The patient medical history and concomitant medications were not reported. Patient got pneumonia shot and 2 days later was very sick. It was turned out to be pneumonia and patient took 3 months to get over it. No follow-up attempts are possible. No further information is expected. Pfizer is a marketing authorization holder of pneumococcal 13-val conj vaccine in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vaccine has submitted the same report to the regulatory authorities.
Diagnosed w/ severe pneumomediastinum involving base of neck and right upper extremity. Emphysematous changes in the airway and vascular structures of the neck.
This spontaneous report was received from other health professional refers to a 76 year old female patient. Patient's concurrent conditions included hypertension, hyperlipidemia, diabetes and asthma. On 29-JAN-2009, the patient was vaccinated with ZOSTAVAX, 0.65 ml in the right upper arm (lot # reported as 1561X; expiration date; 28-APR-2010). Concomitant therapies included Gabapentin (manufacturer unknown), FLOVENT, Diltiazem hydrochloride, Lovastatin (manufacturer unknown), Metformin (manufacturer unknown), Duloxetine hydrochloride (manufacturer unknown), Montelukast sodium (manufacturer unknown) and Oxybutynin (manufacturer unknown). On 29-JUL-2014 (reported as "a week ago"), the patient experienced pain in her left flank "a week ago" and the patient consulted a physician and she was diagnosed with shingles on an unspecified date in 2014. The physician ordered for her "maintenance dose" of Gabapentin to be increased and he also prescribed Valacyclovir for her. On an unspecified date, the patient sought medical attention. No lab diagnostics studies were performed. The outcome of experienced pain in her left flank "a week ago" and she was diagnosed with shingles was reported as not recovered/not resolved. Additional information has been requested.
Hives on back, stomach, arms, back of hands and fingers, palms, neck, face and scalp. Would appear after the slightest touch on my skin, even just from touching my face to wash my face with soap and water, or on my palms after holding a bag. Skin creams find not work particularly well but helped a bit, but the rash would keep coming back. Tried both Benadryl and Zyrtec and they would help to calm hives when they were really bad, but didn?t stop the hives from returning. This reaction occurred after my second does of Moderna in April 2020, and again after my booster (Moderna again) in December 2021. Both times the hives started around a week after the shot, and  it took around 2 full weeks for the hives to go away. I currently still get hives occasionally, but they seem to have mostly gone away.
FATIGUE; LEGS WITH A HEAVY FEELING; LOSS OF APPETITE; ITCHINESS; RASH; ACHING OF LEGS; INJECTION ARM SORENESS; CHILLS; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) once a total  dose was not reported, administered on 05-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-MAR-2021, the subject experienced legs with a heavy feeling. On 05-MAR-2021, the subject experienced loss of appetite. On 05-MAR-2021, the subject experienced itchiness. On 05-MAR-2021, the subject experienced aching of legs. On 05-MAR-2021, the subject experienced injection arm soreness. On 05-MAR-2021, the subject experienced rash. On 05-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced fatigue. Treatment medication (dates unspecified) included: methylprednisolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from legs with a heavy feeling, aching of legs, and chills on 06-MAR-2021, and itchiness on 24-MAR-2021, was recovering from rash, and injection arm soreness, and the outcome of fatigue and loss of appetite was not reported. This report was non-serious.
Elevated heart rate when standing up to 180 and with any postural change like stretching my arms, combing my hair, rolling over in bed, etc was admitted that day. Since then over the months had profound fatigue (was unable to walk long distances or climb stairs without being short of breath) and having elevated heart rate. Fatigue went away in ~May however the elevated heart rate has been a problem when standing up to 170 at times. Thus cardiologist started me on extended release Metoprolol 25 mg once a day (however i take 1/4 tablet each day because 1 tablet makes me hypotensive, and drowsy/fatigued)
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable consumer. An 86-year-old male patient received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Healthy man in (country) received the Pfizer COVID-19 vaccine and 15-16 days later (in 2021), went to the emergency room (ER), had complaints of extreme diarrhea, tested negative for COVID-19 initially when admitted to the hospital but 3 days later, moved to the COVID ward and tested positive for Covid-19 and died a couple days afterwards. The patient died on an unspecified date. An autopsy was performed that revealed spiked protein in every organ of his body.  The event occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: tested positive for Covid-19; tested positive for Covid-19; Autopsy-determined Cause(s) of Death: spiked protein in every organ of his body
After it was administered, her upper extremities became stiff, flexed. She lost consciousness, eyes rolled back into her head. Her upper extremities started shaking. LOC x approx 1 minute. Once she woke up she was oriented, answering appropriately but not alert. Hands were clammy +palor. C/o nausea, especially when standing up. EMS arrived shortly thereafter and pt was transported to Dr. and ER.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 17-JUL-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX the patient began to experience pain, loss of strength in his left leg, and difficulty walking. There after the patient lost the ability to walk. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Lost the ability to walk was considered disabling. Additional information has been requested.
On Wednesday 4/14/21, Left Lymph Node area painful. By Thursday 4/15/21 pain was a less but felt like it (the pain) was running down the underneath of my left arm through my elbow.
pt admitted to the hospital, COVID + diagnosis after having received COVID vaccine x2 (2/16/2021 & 3/9/2021) Brief exam:  Mildly acutely ill appearing Lungs w/ faint insp crackles left base Cv rrr nml s1 and s2 Abd s/nt/nd nml bs Skin - incisions healing well without erythema, edema, exudate Neruo MAE   Brief history and medical decision making:  70 yo woman w/ BOLT 6/2020 for COPD and recent laparoscopic hiatal hernia repair with post-op abdominal issues including nausea, diarrhea, dyspepsia, malaise, fatigue.  Now with a few days of exertional dyspnea and fevers.  Home testing + for COVID.  Directed to ED where confirmatory test positive and abdominal CT with patchy ground glass opacities at lung bases compatible with COVID-19 pneumonia.   COVID-19 pneumonia with mild symptoms - onset of symptoms unclear - respiratory symptoms and fevers only have been present for the past few days.  Her GI complaints may be related to her recent surgery or COVID. Given that she is an immunocompromised patient at high risk of progressing to severe disease and who became infected despite receiving the covid vaccine, She should receive the monoclonal antibody.  She does not have severe enough disease at this point for remdesivir or tocilizumab.   Rec: Hold mycophenolate Continue other immunosuppressants COVID- mAb infusion
Patient reports adverse events from time of  immunization and has still been experiencing  symptoms. Patient knew booster dose was given incorrectly as it was administered as it caused pain and was too high up on her arm. She has limited range of motion and cannot fully lift up left arm since time of vaccination. She has swelling in her lymph nodes and pain that has not gone away. Since the time of vaccination, she has been taking Ibuprofen around the clock to help but it has not gotten better.
HARD LUMP/BIG SWOLLEN BLOB FORMED AT INJECTION SITE; ITCHINESS AT INJECTION SITE; REDNESS AT INJECTION SITE; This spontaneous report received from an patient of an unspecified age and sex (reporting on self). The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 12:30 pm to left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the patient experienced itchiness at injection site. On 01-APR-2021, the patient experienced redness at injection site. On 01-APR-2021, the patient experienced hard lump/big swollen blob formed at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hard lump/big swollen blob formed at injection site, redness at injection site and itchiness at injection site was not reported. This report was non-serious.
The fever started on the 6th and sometime after that I got diarrheas. By Friday I had a stiff neck, body ache, huge knot in my right calf. Also had night sweats and a fever. Some of the symptoms are still happening up until yesterday. I've been with a fever for 13 days.
Diagnosed with COVID infection on 4/13/2021. in ICU on 4/18 with severe hypoxemic respiratory failure
I had a slightly swollen red egg-shaped area around the injection site.  The redness got to be about 2 inches in all directions.  It was also itchy.  It started in the evening on Thursday, 4/8 and the redness was completely gone by the morning on Monday, 4/12.  It still does itch a little bit.  I spoke with a nurse on 4/8 and they suggested I use a cold compress to reduce the swelling and Benedryl for the itching.  I did use the cold compress and I used Cortisone for the itching. which did help.
This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. the patient's medical history, concurrent conditions and concomitant medications were not provided. On 26-NOV-2018, the patient was vaccinated with an expired dose of VAQTA 25/0.5 (unit not provided), lot # N026997 with expiration date 10-NOV-2018 (dose, frequency, route and anatomical location were not provided) for prophylaxis. No symptoms reported.
No additional AE; vaccines that underwent a temperature excursion evaluated; a patient was administered ROTATEQ and MMR-II; This spontaneous report was received from a healthcare business professional (HBP) referring to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On 06-JUN-2023, the patient received improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter once orally (strength not reported, lot # 1837119, expiration date: 25-SEP-2023) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) 0.5 milliliter once (strength and route not reported, lot # W035040, expiration date: 10-MAY-2024) for prophylaxis (product storage error, product administered to patient of inappropriate age). Both vaccines were exposed to 48.8 degrees Fahrenheit (F) for 0 hours 40 minutes 0 seconds. The vaccine of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) had a previous temperature excursion 58.2 F for 8 hours 7 minutes and 50 seconds. No data logger was involved. No additional adverse events were reported.; Sender's Comments:  US-009507513-2306USA008245:
bright red knot on her arm (at injection site) the size of a baseball; bright red knot on her arm the size of a baseball; pharmacist "made a mistake" / by administering the Shingrix, Tdap, and flu shot all in one arm; This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Shingrix, Influenza vaccine Quadrivalent unspecified season and Tdap Vaccine. On an unknown date, unknown after receiving Shingrix, Influenza vaccine Quadrivalent unspecified season and Tdap Vaccine, the patient experienced injection site induration, injection site erythema and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site induration was recovered/resolved and the outcome of the injection site erythema and vaccine administered at inappropriate site were unknown.   The reporter considered the injection site induration and injection site erythema to be related to Shingrix, Influenza vaccine Quadrivalent unspecified season and Tdap Vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that the pharmacist made a mistake by administering the Shingrix, Tdap, and flu shot all in one arm which resulted in a bright red knot on her arm (at injection site) the size of a baseball and vaccine administered at inappropriate site. The reporter was the husband and patient were the wife and provided email address but did not want to provide a personal fax number. No further information gathered and did not specify if it was the right or left arm. The reporter did not consent to follow up. The reporter did not want to provide his wife's MD contact information because says her doctor was retiring and did not yet know who new doctor would be.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020220484:same reporter (reporter´s case)
Rash on the back - looked like small pimples.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 29Apr2021 at 14:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, lichen sclerosis and psoriasis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included colecalciferol (VITAMIN D), naproxen sodium (ALEVE), multivitamin (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL) all from unknown date for unknown indication and unknown if ongoing. The patient previously took morphine(MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. On 30Apr2021 at 11:00, the patient experienced rash on her back - looked like small pimples. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash on the back - looked like small pimples was recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Mom reported dystonic movements such as twitching & jerking of the body and pain associated with the uncontrolled body movements.
patient had a syncope episode 8 minutes after taking the 1st dose of Pfizer covid 19 vaccine. He fell from his chair while seated in the observation area. He passed out for less than two minutes and regained mild consciousness. he was aware of his environment. His vitals were stable. RRT was called while vitals were being taken. RRT arrived within 3 minutes of being called. Patient was assessed by MD ad taken to ED for further assessment.
Dizziness, Headache, Myalgia, Diarrhea, NauseaVomiting & Tachycardia Narrative:
I had a rash that started in my both arms and grew over my entire body. It started 3 days prior to my second vaccination. Once I received my second vaccination, I had the rash for a full six months. This rash made me very hot. After the rash went away, I have gotten it about five times now.
Patient self described starting to have pain/swelling/bruising at both injection sites. Patient went to the hospital received x-rays. States was told both injections where too high and ended up in the bursa of both arms.
Large welt formed on her arm that started out small and grew in size then got smaller a week later but still present.
Patient was administered dose outside of recommended storage range. Vial was left out 23 hours from first puncture at room temperature while the labeled expiration is 12 hours at room temperature. Patient has experienced no reported adverse effects as of 6/13/22.
Patient complained of (L) arm being very sore. By 8/9/13 entire upper arm - shoulder to elbow hard, swollen, hot and red. Took BENADRYL and ALEVE by mouth routinely for 3 days. By 8/10/13 area of redness only 4 inches of upper arm and deltoid, pink and swollen but not hard or hot to touch.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with ZOSTAVAX injection. On an unknown date, the patient experienced injection site reaction of redness and swelling for two days that went down. The outcome of the events was not reported however the patient's present status was reported as "fine". The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
had an outbreak of shingles, tx with gabapenten, oxycodone (pain), acyclover
Swelling under arm gradually lessened but biopsy showed Lymphoma which was not present in prior CT scans; Swelling under arm gradually lessened but biopsy showed Lymphoma which was not present in prior CT scans; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 10:00 as dose 5 (booster), single (Lot number: Gj3277) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Stage 4 small cell lung cancer" (unspecified if ongoing); "AAA stent" (not ongoing); "Hay fever" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; SODIUM. Past drug history included: Codeine, reaction(s): "Allergy", notes: known allergies Codeine. Vaccination history included: Covid-19 vaccine (Dose 1, Single), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Single), for COVID-19 immunisation; Covid-19 vaccine (Dose 3 (Booster), Single), for COVID-19 immunisation; Bnt162b2 (Dose 4 (Booster), Single, Batch/Lot number: Fp4554, Anatomical location: Left arm), for COVID-19 immunisation. The following information was reported: LYMPHOMA (medically significant), PERIPHERAL SWELLING (medically significant), outcome "not recovered" and all described as "Swelling under arm gradually lessened but biopsy showed Lymphoma which was not present in prior CT scans". The event "swelling under arm gradually lessened but biopsy showed lymphoma which was not present in prior ct scans" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: (unspecified date) Lymphoma; Computerised tomogram: (unspecified date) Unknown Results; SARS-CoV-2 test: (28Sep2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of lymphoma, peripheral swelling. Clinical Course: Swelling under arm gradually lessened but biopsy showed Lymphoma which was not present in prior CT scans. Adverse Event resulted in: Doctor or other healthcare professional office/clinic visit. If patient was recovered: Not recovered. If treatment of adverse event: Yes. Adverse event treatment: Observation via CT (Computerised Tomography). If COVID prior vaccination: No. If patient tested for COVID post vaccination: Yes.