chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immunocompromised; Psoriasis on feet and face; Got sore on the first covid vaccine from Pfizer; This is a solicited report from a non-interventional (FACILITATED COLLECT) based on the information received by Pfizer manufacture number (21K-163-4144547-00).   This is a non-interventional study report from the marketing program facilitated collect received from a contactable consumer or other non hcp.   A 70-years-old female patient received Tozinameran (BNT162B2), dose 1 intramuscular on 29Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2017 (Batch/Lot number was not reported) and ongoing, at unspecified dose for plaque psoriasis.  Medical history included Could hardly walk from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. On an unspecified date, the patient experienced got sore on the first covid vaccine from Pfizer, immunocompromised and psoriasis on feet and face with Humira (Adalimumab).  The action taken in response to the events for adalimumab was dose not changed.  On May 2021, patient received second dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown.  Causality for Humira (adalimumab): The reporter's causality for the event of got sore on the first covid vaccine from Pfizer with Humira (adalimumab) was no reasonable possibility. the reporter's causality for the events of immunocompromised and psoriasis on feet and face was not provided.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: Based on the information available in narrative the reported  event of  Vaccination site pain is assessed as related to suspected vaccine BNT162B2, However the reported event of Psoriasis, and immunocompromised is assessed as unrelated to vaccine and more likely due to on going condition of Psoriasis and concomitant medication   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
rash developed on 50% of her body; vomiting; nausea; headache; severe muscle aches; This is a spontaneous report from a contactable nurse reported for herself. This 39-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via Intramuscular at left arm on 16Dec2020 at 01:00 PM at single dose (lot number: EK5730) for COVID-19 immunisation. Medical history was unknown. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), zolpidem tartrate (AMBIEN) and vitamins. The patient previously took dicycloverine hydrochloride (BENTYL), amlodipine and azithromycin (ZITHROMAX), all experiencing allergies. The patient experienced rash developed on 50% of her body, vomiting, nausea, headache, severe muscle aches 24 hours post vaccination on 17Dec2020 10:45 AM. The patient was treated with Benadryl, Tylenol, IM Solumedrol. The patient had Covid test post vaccination by Nasal Swab on 28Dec2020 and on 04Jan2021, both with negative results. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of all events was recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the rash and other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pain in upper left arm began the evening of 3/9/2016. Severe pain developed the following day.  Analgesics were taken to alleviate the pain with little effect. Unable to move arm. Unable to sleep.  Unable to use left arm. Less than 2 weeks post-vaccination, I developed symptoms of the flu. I had a fever, dizziness, sore throat, sinus pain/pressure, runny nose, nasal congestion (stuffiness), painful cough, nausea, body aches, difficulty swallowing, raspy voice, loss of taste, smell and hearing, itchy nose and eyes, and abdominal pain. Many of these symptoms persisted over the course of the summer of 2016. To date, I still have the loss of taste, smell and hearing, body aches, and severe shoulder/arm pain.
Sudden onset of tinnitus approximately one week after my second dose. It's been 10 months and I still have it.  I hadn't gotten sick for almost a year before the vaccine (since we were in lockdown), nor did I start any new medications (just on birth control). I wasn't exposed to any loud noises (again, just at home in lockdown), nor were there any other changes in my life in terms of stress. I was extremely ill after the second dose of Moderna, however, requiring me to take 8 Tylenols in 24 hours (and I still felt horrible): just a fever and extreme body aches. I was also very sick after the first dose, but Tylenol mostly took care of it. I felt sick ~15 hours after each dose and it lasted for a full 24 hours for the first dose and 30 hours for the second.
3/27/2021   Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  urticaria.   Assessment : Time of assessment 1045. Urticaria.   Actions taken:  Benadryl 25mg po x 1 given , VS taken at 1045,  BP- 123/81, P- 72, water givwn and consuming, VS rechecked at 1110- BP- 126/80, P- 65 O2- 99%       Medications administered: Diphenhydramine (Benadryl) 25 mg capsule, by mouth. Time: 1045. Administered by RN.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Moderna COVID-19 Vaccine 3/27/2021 10:14 AM 0.5 mL 12/1/2020 Intramuscular   Manufacturer: Moderna
Local reaction at site of injection. In 1979, I received a Flu shot, at that time, it was to counteract the Swine Flu. I contracted what is now called CIPD or Chronic Inflammatory Demyelinating Polyneuropathy. The problem was unknown at that time and I'm nor sure even now, whether the reaction can be explained. My concern is not with the disease itself but with the treatment. I was put on a regimen of prednisone, at that time, I don't think the Neurologist (now deceased) was aware of the long lasting and devastating effect that prolonged usage of prednisone has. I suffered a cerebral hemorrhage, due ultimately to weakened blood vessels caused by prolonged use of prednisone. My concern is that this does not happen to someone else. Being confined to a wheelchair is not a pleasant alternative. I should also point out that while I was on prednisone, I became a temporary diabetic and it was only when I desisted using the drug, that my blood sugar levels returned to normal. A copy of this letter is being forwarded to my own physician, who is aware of my condition.
This spontaneous report was received from a physician via company representative, referring to a currently 11 year old female patient. The patient's historical drugs and medical history were not reported. The patient's concurrent conditions included asthma. The patient's concomitant therapies included influenza virus vaccine (unspecified) (reported as "Flu"), meningoccal vaccine unspecified and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (reported as "tdap"). On an unspecified date, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, for prevention of human papillomavirus infection (HPV) (strength, dose, frequency, lot# and expiration date were not reported). On the same date, immediately after withdrawal the needle used for the GARDASIL 9 injection, the patient experienced clonic, tonic movements, described as a seizure. The patient was in doctor's office and did not receive any treatment. Diagnostic laboratories were not performed. The patient recovered from the event on the same day, within one minute. Additionally, the causality assessment between generalised tonic-clonic seizure and GARDASIL 9 was not provided. Upon internal review generalised tonic-clonic seizure was determined to be a medically significant event.
On 1/27/21, 8 days post injection, developed full body hives, including on mouth, throat and tongue. Prednisone  1x/day for a week starting 1/28. Benadryl before sleep on 1/27/21 and 1/28/21. Zyrtec on 1/30. Urticaria unresolved.
arm is sore at injection area. More concerning I woke up before 5 AM heart was pounding and the left side of my face was swollen and my left I was hooded and almost shut, all subsided around 11 AM My lymph nodes in my left arm pit and outside of breast and inside rib cage started  tingling  swelling  about an hour after shot , and left forearms feel tight today.  Today is day 2 and left and right lymphnodes are sore in arm pits and joint pain in ankles and elbows,
Myocarditis, pericarditis, tiredness, headache, chest pain, fast heart beat, fluttering, eyeball pain, runny eyes-matted in corners in morning, swelling of hands and feet
Patient was administered a covid 19 vaccine at the wrong concentration.  The vial was mixed with 0.8ml of diluent instead of 1.8ml of diluent.
Bell?s Palay - given steroid and nerve blocker for pain still suffering diagnosis given after 3 days intense headache with facial droop and paralysis occurring on June 2, 2021
I had the vaccine and in 01/31/21 my oxygen level dropped to 75-76 I had difficulty breathing so I went to the hospital,  they did a CT Scan and it showed ground glass opacity which is pneumonia in both lungs, they also did a Bronchoscopy, echocardiogram and blood tests. I was admitted on the same day, I was there for 4 days. They gave me anti-inflammatory meds, doxycycline, Lasix.
(L) arm deltoid. Pain, itchy, warm to touch. 7cm x 5 1/2 cmw.
Had vaccine 10/20/11 at 12N by 2 PM started to feel a sore throat. By 10 PM could not swallow anything. Went to ED at 12 M -> 3 AM. Was given IV & PO prednisone.
38 year old G2P1001 at 22 weeks and 4 days presents with hydrops fetalis. Known anti-D antibodies. Titer initially <1 at 11 weeks. Rapid rise seen with increased anti-D antibody to 1:16 on 1/15/21, and 1:512 on 2/21/2021. Fetus treated with umbilical cord transfusion at 22 weeks 5 days. Fetal death diagnosed at 23 weeks and 0 days. Fetal autopsy consistent with hemolysis in fetal organs. Fetal blood type RHD positive. Immunofixation studies show no monoclonal protein detected.
PT CAME BACK TO CLINIC 11/2/10 STATES HE HAD A RASH WITH BLISTERS ONLY ON HIS HANDS AND FEET AFTER FLU SHOT 2 DAYS LATER.
Hepatitis B vaccine given at 10 AM and 2 PM she felt itchiness, and reported to medical staff.
This is an initial spontaneous report from a contactable nurse practitioner. This is the first of two reports by the same reporter. A 15-month-old, male patient received PREVNAR 13 on 08Apr2011. The relevant medical history and concomitant medications of the consumer were unknown. On 08Apr2011, night after receiving PREVNAR 13 the patient experienced high fever, extreme irritability and febrile seizures and was taken to emergency room. The relevant laboratory data included unspecified blood work on an unknown date in Apr2011 and th results were unknown. The status of the PREVNAR 13 therapy was unknown at the time of the report. Treatment included unspecified medications int he emergency room as therapeutic measures. The patient had recovered from the high fever and febrile seizures on an unknown date in Apr2011 however the clinical outcome of the other event was unknown at the time of the report. Follow-up (07Jun2011): Follow-up attempts completed. No further information expected.
Myalgias; arthralgias; fever; malaise; This is a spontaneous report from a contactable physician. A 64-years-old male patient received Second dose of bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection (Batch/Lot Number: Not reported), via an unspecified route of administration, administered in Arm Left on 15Mar2021 10:00 as, single for covid-19 immunisation. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. No known allergies. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021, the patients had concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced myalgias, arthralgias, fever, malaise. The patient underwent lab tests and procedures which included body temperature: 100 farenite.  As treatment medication naproxen sodium were taken as a result of myalgias, arthralgias, fever, malaise. facility type vaccine Workplace clinic. The outcome of the patient was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Red, hot spot developed around and below the injection site, approximately 3 inches in diameter. Doctor's office said it was normal and not to worry.
patient stated that she felt like she had no control over her muscles and felt like it was a neurological thing happen
Right after vaccine experienced pain and itching at injection site with a raised bump, severe numbness in hands and feet, difficulty breathing, shortness of breath, fatigue, loss of energy, etc.
Severe pain left deltoid - was given Tylenol 3 by doctor. 9-14-07 Telephone pain completely gone.
Covid-19 vaccine JJ: 32 y.o. male w/ no PMH presenting 2 weeks after receiving his Johnson & Johnson COVID vaccine after having severe L calf pain found to have thrombocytopenia.    From H&P on 4/21, Patient reports that he had both fevers and aches after his vaccine (4/8/2021). Several days later developed low back pain radiating into his left leg which he initially attributed to sciatica. However, several days later, he went for a 6 mile hike, and felt that his left leg was hurting more. He went to PCP, where he received a blood test and was found to have a platelet count in the low 60s. This was initially thought to be a lab error, but he noticed that his left leg was swollen, somewhat red, and appeared that his blood vessels were swollen. This swelling resolves when he is lying down, and is worsened when he is standing. He received an US to r/o DVT, which was negative. However, after his repeat platelet count demonstrated thrombocytopenia, he was sent to the ED. He denies any recent leg trauma, though he has broken his leg before nearly 15 years ago.  He denies weakness or issues going to the bathroom. Denies chest pain or shortness of breath. Denies chills, fevers, but did wake up last 2 nights drenched in sweat. He also reports a petechial rash on his legs.   As of 4/22, medical team suspects Vaccine-induced thrombocytopenic purpura (VITT). VITT requires 1) thrombocytopenia, 2) documented clot, 3) positive PF4 Ab, and 4) recent AstraZeneca or J&J vaccine. He meets criteria 1, 3, and 4. He has clinical signs of DVT but does not have a documented clot. Patient has L calf tenderness and prominent pooling of blood and vein engorgement of the L leg when he stands up. Possible that he had a DVT or multiple that cleared and now he has post-thrombotic syndrome. This is consistent with the pooling of blood with gravity and relief of symptoms with elevation. As he has had 2 negative US for DVT, unlikely that he has an unresolved DVT. abdominal and head CT are neg for thrombosis.
Swelling at injection site, hives near injection site, malaise, fatigue, headache, stomach ache.
Pt given rabies immunoglobulin 2ml around wound site. Tdap and then vaccine...pt stated her chest hurt and then eyes rolled back and pt stiffened (poss seizure vs syncopal episode).
Narrative:  85 yo mail patient died on 1/12/2022 during inpatient admission. Death was caused by: Cardiac arrest secondary to acute hypoxic respiratory failure secondary to pneumonia (covid negative). Pt had received covid vaccines on 2/23/2021 & 12/23/2021. This death is not related to covid vaccines. Pt's Medical Hx: HTN, T2DM, CAD s/p PCI, obesity, TIA.
injection site swelling; itching at injection site; She now has a lump under her skin near the injection site; This is a spontaneous report from a contactable consumer (patient herself). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient had received vaccine a week ago. Patient reported that on an unspecified date in Mar2021 she began to have injection site swelling for about 3 days, she had itching at injection site and also had a lump under her skin near the injection site. Caller reported that she had placed a cold compress and took ibuprofen (as a treatment for AEs). She reported the lump started as a size of pea and now it was the size of a date. Patient reported that she did not get vaccines and that she did not require to take medications. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a registered nurse and refers to 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 04-MAY-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # L046506, expiration date 17-MAY-2017 (dose and route of administration were not reported). The vaccine was reconstitute with properly stored sterile diluent (MERCK). Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees Fahrenheit for 30 minutes (the reporter also stated that there were two separate temperature excursions: the first on 03-FEB-2017 and the next on 18-APR-2017, and the vaccine was deemed to still be viable). No previous temperature excursion occurred. No product quality complaint was involved. No adverse effects were reported. Digital data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1704USA010916: US-009507513-1704USA009837.
Healthy 27 year old female with no medical history developed premature ventricular contractions approximately 7 days after second Moderna COVID vaccine. Developed shortness of breath and dizziness upon exertion (walking). Went to emergency room on 5/22/21 and diagnosed with PVCs and cardiomegaly.
Developed pain, warmth, swelling to left deltoid area 7/20/06 after having vaccination DTaP 7/19. Used Tylenol and cold compresses with results. Went to ER 7/20/06. Was told she had a moderate reaction after given Benadryl and Ibuprofen. On 7/21/06 arm is still swollen and warm but improved.
1.) Redness, pain, and swelling of arm several inches *below* the needle-puncture site (starting within hours of injection) 2.) Transient tachycardia with heart rate to the 130s.  Lasted a few minutes.  Spontaneously resolved (occurred 31 hours after injection)
A nurse reported that a 60 year old male received an injection of Flu Shield (2000-2001) on 11/27/00 and subsequently, developed chest pain and arm pain. He called his family physician who advised him to call 911. This event is considered "Medically Important".
Redness, hardness, pain, warm, fever. Left deltoid 8cm, 10cm.
Night/sleep sweats; Fever; headache; This is a spontaneous report from a contactable consumer, the patient. A 51-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 (also reported as left shoulder) on 28Mar2021 at 15:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any allergies to food, medications, or other products. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was 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 vaccination. On 30Mar2021 at 09:00, within 48 hours of the vaccine, the patient experienced fever that went away on 31Mar2021 (reported as next day). The patient also experienced night/sleep sweats and headache within the 48 hours which were still present. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events fever, night/sleep sweats and headache. The clinical outcome of the event fever was resolved on 31Mar2021 while that of night/sleep sweats and headache was not resolved at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 60-year-old male patient who received SHINGRIX. On 4th February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site rash and erythromacular rash. On an unknown date, the outcome of the injection site swelling, injection site rash and erythromacular rash were unknown. It was unknown if the reporter considered the injection site swelling, injection site rash and erythromacular rash to be related to SHINGRIX. Additional details were reported as follows: The patient had little raised red spots around the injection site. The reporter reported that it was not itchy. The pharmacist refused to go through the adverse events.
rt arm red, hot, swollen to 7 1/4" from where shot was given to elbow;lt arm 6";saw to MD p/talking w/on-call nurse 6/11/99;took DPH & Motrin;child had ant bites;