chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rheumatoid arthritis flare up; COVID-19; drug ineffective; This is a solicited report based on information received by Pfizer (Mfr. Control No.: 21K-163-4061179-00). A contactable consumer (patient) reported on herself. A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date: was not reported), dose 1 intramuscular on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number and expiration date: was not reported) to an unspecified date, at unspecified dose for moderate to severe Rheumatoid Arthritis. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rheumatoid arthritis flare up. On 15Jul2021, the patient experienced COVID-19. The patient underwent lab tests and procedures which included COVID-19: positive on 15Jul2021. The outcome for the events was unknown.  The reporter's causality for the events of Neck Procedure, COVID-19, and Rheumatoid Arthritis Flare with RINVOQ (UPADACITINIB) was not provided. Company's opinion is that there is no reasonable possibility that the events of Neck Procedure, COVID-19 and Rheumatoid Arthritis Flare are related to RINVOQ (UPADACITINIB).  The reporter's causality for the events of COVID-19, and Rheumatoid Arthritis Flare with PFIZER BIONTECH COVID-19 VACCINE was assessed as possible.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events, Covid 19, aggravated and suspect drug BNT162B2 cannot be excluded  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.
Patient had her second Moderna vaccine and then nine days later she developed a painful burning/red rash and swelling to the injection site in April, 2021.  Reports that in starting in December of 2021, her periods began to become very irregular- four periods in 2 months
Local reaction to vaccine caused instant swelling about the size of a grape. We gave the patient ice and observed him for 30 minutes. No other reaction occurred. Told him to go directly to ER if other symptoms occur.
I didn't have an immediate reaction. About 5 hours later I started feeling itchy, not at the injection site, but at different spots on my body. Since it wasn't everywhere I didn't immediately put two and two together. That night I started itching all over, and took some otc benadryl I have at home. I felt itchy all day, and continued taking 25 to 50 mg. doses every 4 hours. Surprisingly it did not make me at all drowsy, like it usually has in the past. I just got home and took 75 mg because it is really bothering me.
Patient received Hep A and HPV at 1130 am. Patient then went to get labs drawn. Patient returned to clinic and received MENVEO and IPV at 130. 5 min after receiving MENVEO and IPV, patient became very stiff, eyes were dilated and she was not responding verbally when asked questions. Pt was not responsive for about 15 seconds. Her BP was 85/55 HR was 49 and RR was 16. Assessed by MD. Pt stabilized, dc'd home in stable condition.
first dose on 9/27/2019 / had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No further events were reported. The reporter consented to follow up.
The first week, I had a fever toping at 102, mild body aches. 2 or 3 days in I had a very bad sore throat. I treated that symptomatically. Felt bad and did not sleep well. I took Paxlovid after a brief tele-visit. After the 5th day of Paxlovid, I had my symptoms return as a nasal infection that participant believed to be viral. Lots of nasal drainage, yellow and thick. By 3/18 I tested negative. Nasal symptoms linger to time of reporting.
Within 15-20 minutes of the administration of the immunization, patient felt runny nose and localized redness and swelling occurred at the site around 50mm. Actual measurement of swelling/redness is estimated by NP on site.
Upper respiratory symptoms with probable sinus infection lasting approximately 10 days.  On about day 5, nausea, vomiting, diarrhea, lasting about 4 days. Onset of extreme joint pain in areas where arthritis was already present but not necessarily painful previously.   Blood tests by Dr  06/14/2021, then Dr indicated autoimmune disorder.  This was confirmed by rheumatologist Dr.  06/30/2021.
pt noticed swelling on 1JUL97, red, swollen, sore;approx 2in diameter, warm to touch;all sx @ inj site;
One week post vax, the pt awakened with a rash that looked like measles. It started on the face and eventually affected her limbs and torso. Pt had a low grade fever of 100 - 102.5.  The symptoms lasted for two days.
pt cried twice & then held breath;became cyanotic & floppy;rescue breathing/stimulation restored color; blow-by o2 admin c/pinking of skin color;pt observed in office;episode felt to be secondary to breath holding spell
5-10 minutes after receiving the vaccine, the patient fainted. She regained consciousness within 20-30 seconds. Paramedics were called and made the decision to transport her to the ED. Treatment after leaving the pharmacy is unknown.
cold symptoms; a little temperature; spot on her arm may be red and the size of a quarter; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "recovered", described as "cold symptoms"; BODY TEMPERATURE ABNORMAL (non-serious), outcome "recovered", described as "a little temperature"; MACULE (non-serious), outcome "recovered", described as "spot on her arm may be red and the size of a quarter".  Additional information: Reporter stated he and his wife both had three doses of the Pfizer BioNTech COVID-19 vaccine. Stated that he had no reactions but his wife had terrible reactions to all of them. Stated that it takes 2-3 days before she got over her reactions. The patient had cold symptoms and a little temperature for a day or two and it was gone. The patient had reactions as just kind of cold symptoms and the spot on her arm may be red and the size of quarter for a little while then eventually goes away. The spot was on her left arm but he was not sure and to just put it as unknown. Wanted to know was there anything a person taking these shots could to do to reduce or eliminate the reaction beforehand.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201378898 same reporter/patient/event, different dose;US-PFIZER INC-202201378899 same reporter/patient/event, different dose;
DECREASED BLOOD PRESSURE; WATERY VOMITING; NOSE BLEED; BODY IS WEAK; SLIGHT HEADACHE; TIRED; DIARRHEA; This spontaneous report received from a patient concerned a 58 year old of unspecified sex. 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, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 07-APR-2021, the subject experienced diarrhea. On 12-APR-2021, the subject experienced watery vomiting. On 12-APR-2021, the subject experienced nose bleed. On 12-APR-2021, the subject experienced body is weak. On 12-APR-2021, the subject experienced slight headache. On 12-APR-2021, the subject experienced tired. On 13-APR-2021, the subject experienced decreased blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 98/89, 144/84. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, watery vomiting, and nose bleed, and decreased blood pressure on 13-APR-2021, and had not recovered from slight headache, body is weak, and tired. This report was non-serious.
Pt fainted in chair while being observed post vaccination.                                                                                                                                                                                                                                                                                                                                                                                                                                                  Date: 3/23/2021  Problem:  Dizziness, fainting Notes: Pt stated he began to feel dizzy and started to lose balance in his chair. VS taken BP 113/70 P102 O2 97 T 97.1 RR 18 BS 104. Continued to monitor pt. No signs of acute distress. Pt able to communicate appropriately. A/Ox4. No bleeding or redness at injection site. Water and granola bar provided to pt. Monitored for 30  minutes. VS remain stable, pt AxO4 and states he feels good. Pt left facility in good condition.
Elevated t103.9 APAP given; screaming (2-2 1/2 hrs); parents notified MD 24APR @ 10PM & talked to MD on 25APR92;
fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications reported.
This report is being submitted by the guidance of the DOH. 61 patients were affected by storage and handling excursions.
9cm x 5cm red, itchy area around injection site 8 days post-injection, resolved after 2 days.
66 y.o. female patient of MD, with history of chronic pain, HTN, HLD, mood disorder, roux-en-Y, essential tremor, recent COVID-19 PNA on 7/20 requiring admission. Presented with hypoxia. Admitted for multifocal PNA superimposed on COVID PNA and acute respiratory failure. Clinically improved, now on NC at 4 L. Will finish course of antibiotics and steroids on discharge, home with services and portable oxygen.   Acute Hypoxic Respiratory Failure, improving Multifocal Pneumonia, likely bacterial COVID-19 Pneumonia COVID + 7/20/23, fully vaccinated S/p Paxlovid 7/21-26 Imaging demonstrated worsening ground glass opacities, multifocal PNA Ferritin 555, CRP 63.4 BiPAP initially, transitioned to HHFNC, then weaned to nasal cannula MRSA probe negative, urine antigens, procal negative Started on Zosyn 7/26, transitioned to oral Augmentin to complete 10-day course (7/26-8/4) Decadron 6mg IV daily, transitioned to PO on 8/2, to complete 10 day course (7/27-8/6) S/p lasix 20 mg PO 7/31, Lasix 20mg IV 8/1 given fluid overload on lung exam in the setting of persistent O2 requirements CXR 8/2 stable  Hypokalemia Potassium dropped to 2.9 on 8/3 likely iso Lasix Repleted with 60 mEq oral Kcl Repeat BMP with improvement to 3.2 Would recommend repeat labs on outpatient follow-up   Encephalopathy, resolving Waxing and waning, suspect 2/2 delirium likely in the setting of acute illness Patient also with multiple sedating/psychoactive home medications Now resolving with improved clinical status  Nightly quetiapine 50mg PRN haldol for agitation   HTN Held ARB in the setting of AKI  Amlodipine 10 mg AKI resolved, BP recovered, restart home ARB on discharge   Chronic Pain Home regimen: gabapentin 300mg TID, dilaudid 4mg q6h prn Follows with pain mgmt Hold metaxalone    Polypharmacy Patient on multiple serotonergic meds (held metaxalone) reglan (held) and pramipexole contraindicated Trazodone 100 mg Qtc 413 from EKG 7/25   Mood Disorder: Continued home buspar, venlafaxine, atarax Insomnia/RLS: Continued home trazodone prn, Ambien prn S/p roux-en-Y: In 2011, Continued home PPI, pepcid  Essential Tremor: Reduced home propranolol from 40 mg bid to 20 mg bid iso low HRs
sever case of dizziness (vertigo) which has lasted for several days but slowly subsiding
On day 3 after vaccine, I had a large red lump appear about 4inches below my injection.  I did not feel sick, but my arm was warm to the touch and tender at the lump site.  On Friday, 5 days after, I traveled by plane and began to feel swelling in my hands and intense pressure in my head, not a headache, just pressure.  I stayed in the hotel room that night.  The next day, the pressure was worse in my head.  It felt like I had a belt wrapped around my head, and my eyes felt like they were pressured.  On Sunday, I woke to an eye hemmorage and still felt pressure.  I then went to the clinic and was seen by a CNP.  She recommended I go to the ER for further treatment.  I then went to a stand alone ER and was given IV fluids.  The doctor said my eye had nothing to do with the pressure, which I do not find valid.   My blood pressure is usually about 117/58 and that day it was 131/68.  Very unusual for me.  I am a healthy runner and never have felt the pressure the way I did that week.  He prescribed a sinus rinse,  cetrizine HCL 10 MG and BUTALB-Acetamin-CAFF 50-300-40
-MODERATE MUSCLE PAIN SHOULDER TO ELBOW ON INJECTION ARM  STARTING IMMEDIATELY AND LASTING ~12 HOURS  -MODERATE LOWER EXTREMITY MUSCLE PAIN  STARTING ~ 11 HOURS POST-INJECTION LASTING 12 HOURS -SEVERE HEADACHE STARTING  ~22 HOURS POST-INJECTION LASTING SEVERAL HOURS
DIZZINESS, SYNCOPE, LIGHTHEADEDNESS, NAUSEA, WEAKNESS
Pt developed twitching 24 hrs. after immunizations given that progressed into generalized tonic clonic seizure of 19 minutes. Transferred by EMS to hospital where she was admitted for 72 hours. 8/21/07-records received-for DOS 7/16-7/18/07- DCD DX: Status epilepticus seizure. Seen in ED with seizure activity. Two week HX of leg jerking and looking like someone scared her just after waking from sleep worseing in freqeuncy though not severity culminating in seizure on 7/16/07-Intubated for 12 hours secondary to increased respiratory rate, weaned quickly.
Hives all over body 11/07/2021-current (11/18/2021)
anaphylactic reaction; Throat swelling; heart racing; irregular heart rate; gasping for air; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6198) via an unspecified route of administration in Right buttocks, at the age of 67-year-old, on 08Mar2021 10:00 as SINGLE DOSE, for covid-19 immunisation.  Medical history allergies: Sulfites, urinary tract disorder, Birth defect bladder w/ recurrent kidney stones, kidney infection, Grave's disease, and lyme disease. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination and was not tested post vaccination. Concomitant medications included levothyroxine and epinephrine.  The patient previously took sulfur dioxide and experienced drug hypersensitivity.  The patient experienced anaphylactic reaction with throat swelling, heart racing, irregular heart rate, gasping for air on 08Mar2021 10:45. Therapeutic measures taken in response to the events included self administration of epinephrine. The events were assessed as serious (life threatening). Outcome was recovering at the time of the report.
This case was reported by a nurse and described a pt who tested positive for hepatitis B surface antigen after receiving hepatitis B vaccine (manufacturer unknown) for prophylaxis.  The pt's past medical history included renal failure from an unspecified cause, treated with hemodialysis.  Concurrent medications were not reported.  On an unspecified date, the pt received a booster dose of hepatitis B vaccine (manufacturer unknown).  At an unknown time post-immunization, the pt tested positive for hepatitis B surface antigen. The outcome of the event is unknown.
LIGHT HEADEDNESS; SORE THROAT; CHEST HEAVINESS; APPETITE LOST; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced appetite lost. On 21-MAY-2021, the subject experienced chills. On 21-MAY-2021, the subject experienced fever. On 21-MAY-2021, the subject experienced headache. On 23-MAY-2021, the subject experienced chest heaviness. On 25-MAY-2021, the subject experienced light headedness. On 25-MAY-2021, the subject experienced sore throat. The action taken with covid-19 vaccine  was not applicable. The patient recovered from chills, fever, and headache on 23-MAY-2021, and had not recovered from light headedness, sore throat, chest heaviness, and appetite lost. This report was non-serious.
Starting at 10pm April 24, Severe headache, migraine level, both eyes watering, ears ringing, could not look at light.  Fever just under 101, rash on scalp starting around 12 midnight.  Aches, exhaustion, slight stomach upset.   Took Tylenol.  Headache did not go away, felt likeTylenol did nothing.  Fever and severe headache lasted 4 days.  Aches lasted 5 days.  On DAY 2 after vaccine, 2 hard, golf-ball sized lumps under left arm appeared, and some others slightly smaller (lymph nodes).  Lumps were too painful to sleep on that side or do any normal physical activity.   Fever and most aches resolved after Day 4, but  Lymph nodes stayed golf ball size and painful for 3 weeks.  At time of this report, it has been 4 weeks, postponed 2nd shot one extra week hoping nodes would improve, they have reduced in size but are still very swollen and sore.  Also ache at sternum (??) has not resolved at all.
no adverse event; incorrect product storage, -10.7 degrees Celsius, 192 hours; This spontaneous report has been received from an office manager referring to an unknown age and gender patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On 25-AUG-2021, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength, route of administration and anatomical location were not provided; lot # U009260, expiration date reported as 19-SEP-2022, albumin status recombinant Human albumin (rHA)) for prophylaxis. The vaccine underwent temperature excursion of -10.7 degree Celsius for total 192 hours. It was reported that there were no previous temperature excursions. At the time of report, there was no adverse event (AE) reported.
Crying, fever, increased crying with movement of legs no redness. Localized reaction to Imm.
This spontaneous report was received from a nurse refers to a 13 year old male patient. On 14-JUL-2016, the patient received first dose in vaccination series of GARDASIL 9 (lot #: L037554, expiration date: 25-DEC-2017), second dose in vaccination series of GARDASIL 9 (lot #: N020353, expiration date: 28-APR-2020) on 22-MAR-2018, and third dose in vaccination series of GARDASIL 9 (lot #: N022727 expiration date: 12-JUN-2020) on 12-APR-2018 (dose, unit and route not specified) as prophylaxis. No adverse effects reported. Product quality complaint was not involved.
Headache, Myalgia, Arthralgia, Fever, Diarrhea & NauseaVomiting
Woke up early on Tuesday and felt like I had the virus all over again.  Bad headache, very tired; Slept all day Tuesday, and most of Wednesday.  Symptoms all lasted through Wednesday.  The headache is less now but still there after 1 week.
Extreme nausea, followed by a migraine like headache, sensitivity to light and sound. Intense All Over Muscle ache. 18 hours blurred vision and unsteady gait, patient slept in vehicle, unsafe to drive.  Injection arm unable to lift. Symptoms worsened over 48 hours. Unable to eat, unusual thirst, extreme fatigue. 16 hours after injection patient left work, unable to continue.  Once home patient took 800mg ibuprofen, 10 mg phenegren, 10mg norco and slept for 18.5 hours before pain, nausea and standing stability returned and patient felt confident to function.
Large, itchy, painful rash at the injection site. The doctor prescribed ice, antihistamine, and prescription steroid ointment.
Patient began to "stare off" and was not responding to interaction as she usually does. Seconds later, she began to have a seizure. Described as head turning/twitching and extremities shaking. Family called 911/ambulance. Reports that seizure lasted approximately 30 seconds. When EMS arrived, patient was interactive, but sleepy. Transported to local ER and upon arrival, temp noted to be 104.4 degrees. Partial workup for seizure and dx as febrile seizure. Discharged from ER in stable condition.
At 1712 pt complained of tinging in her throat and numbness in her RA. She stated she was able to swallow. Benadryl 50mg PO given at 1712. O2 99%, HR 82, and BP 140/82. Pt told to stay for further monitoring. Pt then c/o " throat tightening" at 1726 and 0.3mg epi pen given in RT at 1727 after pt was laid supine with legs elevated. Vitals taken again at 1732: BP 170/100, O2 99%, and HR 105. Pt stated her throat felt "much better". EMS was called at 1727 when Epi was administered. Pt called her mother to notify her of situation. Pt also called father and he did not want pt assessed by EMS or taken to hospital in ambulance. When EMS arrived, father was not present and pt did not refuse treatment, so they did perform an assessment. After that, pt refused tx and continued to feel "well" with no other complaints other than "shakiness", which is a common side-effect of epinephrine. EMS left and pt's father arrived. Pt was able to sit and stand on her own. Before she left, she complained of "tightening" and "tingling" again in her throat. Told her she should receive another epipen. Pt's father said he had one in the car and that he would give it to her and drive her to the hospital.  Pt nodded in understanding. Pt vitals taken at 1750, BP 162/84, HR 113, O2 99%.
About 24 hours I started feeling nauseated, joint pain in left hand, arm pain at injection site, acid reflux.