chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2022 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Testing positive after having recovered 6 days ago and testing negative. Symptoms include cough and congestion; Positve, notes: Testing positive after having recovered 6 days ago and testing negative. Symptoms include cough and congestion.. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Anti-viral Paxlovid from 14Jun2022 to 19Jun2022.  Clinical course: Anti-viral Paxlovid from 14Jun2022 to 19Jun2022 for Treatment of COVID-19. On 24Jun2022, testing was positive after having recovered 6 days ago and testing negative. Symptoms include cough and congestion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever that lasted for weeks, loss of taste, tinnitus, muscle ache and joint pain, suicidal thoughts, muscle spasms
Pt exp high pitched screaming @ 45min intervals until falling asleep for 3 days;
LeFt Deltoid Injection site  urticaria / Induration / Tenderness
Patient called the evening after Pneumonia shot given to report arm soreness to the pharmacist on duty.  She later called back to report numbness and went to the ER to be evaluated.
Supratrochlear gland is painful during some movements, mainly in left arm, sometimes in right,
Very bad pain in my left leg; It's only the nerve sharp shooting pain; Tingling; Stiffness of my nerves in my shin area.; This case was reported by a consumer via interactive digital media and described the occurrence of pain in extremity in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received Shingrix. On an unknown date, 20 days after receiving Shingrix, the patient experienced pain in extremity, nerve pain, tingling and stiffness. On an unknown date, the outcome of the pain in extremity, nerve pain, tingling and stiffness were unknown.   It was unknown if the reporter considered the pain in extremity, nerve pain, tingling and stiffness to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix vaccine about one month ago and after almost 20 days he/she had very bad pain in his/her left leg. It was only the nerve. Sharp shooting pain tingling and stiffness of his/her nerves in his/her shin area. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Fever or Chills  Cough  Fatigue  Muscle or body aches  Headache  Congestion or running nose
Headache; Fever; Shaking; Chills; This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On 5th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 6th May 2021, 1 days after receiving Shingrix, the patient experienced headache, fever, tremor and chills. On an unknown date, the outcome of the headache, fever, tremor and chills were not recovered/not resolved.   The reporter considered the headache, fever, tremor and chills to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient for himself. The patient received Shingrix in the right arm and had fever, chills, shaking, and headache after vaccination. The reporter did not consent to follow up. All information was not available.
When woke up 8/12/15 it was red and warm to touch and tender. 8/13/15 larger area of redness tender warm to touch. Area 2 x 1 1/2 inches of redness with swelling. Pt instructed to take anti-inflammatory and not warm compresses to area and seek medical advice if it gets worse.
Muscle tightness - soreness - at the arm with the injection and it was for about three and five days. Maybe about 2 weeks from vaccine -  I had some congestion (nasal congestion and sneezing) - it was odd (not allergies) and it lasted a solid with heavy heavy drainage and that lasted about two days. I had to use the Mucinex D for it. Then I had the nose bleed - it wouldn't stop bleeding in right nostril. I went to ER - Sunday, the 28th - started at 10:30 pm and after midnight on the 29th it was after 4 hours of bleeding when  I went to ED in town. The doctor said my nasal passages were really dry because of the weather. I was using a travel CPAP that doesn't have a humidifier.  They cleared a giant clot in the back of my throat - it was the size of a hamburger - it was huge. They used a nasal vasodilator - it looked like nasal spray and they did it and stopped. Vitals were stable and they sent me home. I might have one bloody nose after  - a week after and they had given me the nasal vasodilator and that stopped it. They also prescribed a nasal saline spray and I only use the CPAP with the humidifier now.
Gran mal seizure 19 days after first dose. First ever seizure I have ever had; it occurred in the middle of the night. All bloodwork, CT, MRI, and EEG studies were WNL.
HIS EYE SHAKES AND HE HAS AN APPOINTMENT WITH EYE DOCTOR IN 2 WEEKS
Immediate red face and neck and chest.  Itchy all over.  Developed into burning pins and needles feeling.  Took 50 mg Benadryl.   12 hours later I went to ER  for intense pins and needle feeling in my face and arm.  Inching on legs too.  Given Pepcid and a steroid shot.  Following day I took Claritin  because symptoms were still bad.
seizure; This is a spontaneous report from a contactable consumer. A 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot Number: EP6955; Expiration Date: 30Jun2021), via an unspecified route of administration on 17Mar2021 as single dose for covid-19 immunisation. Zonisamide, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 800 mg, (600 mg at night and 200 mg on the morning) for an unspecified indication; cannabidiol (CBD OIL), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 7 mL, daily (4ml at night and 3 ml on the morning) for an unspecified indication. The patient medical history included ongoing seizure PMH of temporal epilepsy who has been having break through seizures since July 2020. The patient's concomitant medications were not reported It was reported that patient had received vaccine on Wednesday 17 2021 with no complaints after it until today Friday 19, 2021 at around 7 pm when he developed a seizure while working at his desk. We (the parents saw the end of it which looked more generalized than usual) and gave him 2 mg of Clonazepam, which is his usual rescue medication. He was awake after it and was able to do homework. The action taken in response to the events for Zonisamide and Cannabidiol was unknown. The outcome of the event was unknown.
Extremely sore arm for 3 days Nauseous for 4 days Lymph nodes under left arm swollen and very tender for 5 days
My symptoms have included: fatigue, sneezing and runny nose, body aches, fever
Pain at injection site, extreme heat in face, eyes, head, no fever. 7:00 PM difficulty breathing used CPAP-went to bed. 8-8:30 nausea, vomiting, no diarrhea. Back to bed with chills. No night sweats - difficulty breathing even with CPAP going. 10-4-13-6:00 AM - breathing still difficult expelled mucous through nose and coughing. Ate breakfast-showered mucous discharge from vagina-noticed upon urination -some nausea felt lethargic.
This spontaneous report as received from a nurse practitioner refers to a three unspecified patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date the patient was vaccinated with improperly stored doses of ZOSTAVAX (lot # L035504 and expiry date 16-DEC-2016) (dosing regiment unknown). The vaccine was exposed to temperature excursion of 20 F for 3 hours. Previously the vaccine was exposed to 34 F for 3 hours. The call was due to data digital logger. No adverse effects were reported. No product quality complaint (PQC) was filed. This case was cross linked with the case 1611USA011011 via same reporter link. Additional information has been requested.
Injection site on left arm was extremely bruised and swollen .  After that everyday movements of my injected arm became painful.  When lifting arm out to side, above head,  and when performing every day movements I have experienced on going pain that has not subsided.  Three months later I am still experiencing pain when moving my arm.
high fever, extreme redness at injection site, a lot of swelling at injection site on next day (Sat) after injection; pt had to go to hospital due to pain and fever; pt was given ibuprofen and had been applying ice; symptoms have improved a bit by Monday
Pt vaccinated with FLUOGEN who has severe bronchial asthma seen in MD ofc well VS stable & chest clear, death & respiratory arrest.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 19-DEC-2014 the patient was vaccinated with a dose of M-M-R II which was expired on 18-OCT-2014 (dose and lot# were unknown) subcutaneous. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Arm swelled a bit.; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as 69; unit Unknown) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient reported that when he received Prevenar 13 shot his arm swelled a bit. The outcome of the event was unknow.  No follow-up attempts are needed, Information on Lot/Batch Number cannot be obtained. No further information is expected.
Pt developed fever of 104 degrees, fussy, shallow breathing within 4 hours of shop.  Fever rose and fell for 2 days.  Pt also had a quick heart rate.
After the vaccine I waited and went home. I was having hot and cold flashes and numbness in my body. As I moved around I caught cold and had to sit down where I would get hot again. I went to bed and felt numbness and had the hot and cold feelings. The next day I was dizzy and the same thing would jolt me out of bed. My heart was pounding. I have numbness and flushing. It was elevated the my blood pressure and heart rate.  I experience numbness all up and down my body.  I went to the ER on April 20th, April 5th, April 13th, May 18th, April 12th March 19th, August 19th. They have no answers as to what is going on with me. I have been told it is anxiety. I am now very sad and short tempered.   I get shaky through out the day. It feels as if the floor is actually moving. I have pounding in my chest like my heart is racing constantly off and on. My heart sits at 108 to 112 on my poll at rest.
VERTIGO, NYSTAGMUS, BILATERAL LOWER EXTREMITY WEAKNESS, AND URINARY RETENTION.
The next day (4-05-17) at approx. 12:00 pm - 2:00 pm child appeared to have a seizure in daycare. An ambulance was called. Guardian denied she had a fever in the morning, but the daycare personnel said she was "hot" when she was taking her nap. Pt. discharged home.
Information has been received from a licensed vocational nurse (L.V.N.) referring to a male patient of unknown age. On 22-MAR-2016, the patient received his first dose of GARDASIL 9 (route, lot# and dose were unknown). On 20-APR-2016, the patient receive his second dose of GARDASIL 9 (route, lot# and dose were unknown) in the reporter's office, which was outside of the recommendations in the GARDASIL 9 prescribing information (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
extremely painful ribcage, shoulder blades and collar bones; extremely painful ribcage, shoulder blades and collar bones; sore neck and muscles; Bad headache; painful injection site; extremely painful ribcage, shoulder blades and collar bones; sore neck and muscles; This is a spontaneous report from a non-contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732), via an unspecified route of administration in the left arm on 26Mar2021 on 11:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 02Mar2021 at 15:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not 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 COVID vaccine. On 26Mar2021 at 19:00, the patient had bad headache, painful injection site, extremely painful ribcage, shoulder blades and collar bones and sore neck and muscles. 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 events bad headache, painful injection site, extremely painful ribcage, shoulder blades and collar bones and sore neck and muscles. The clinical outcomes of the events bone pain, rib pain, neck pain, headache, vaccination site pain, shoulder blade pain and muscle soreness were recovering at the time of the report.   No follow-up attempts are possible. No further information is expected.
Patient presented to ED on 3/13/21 and was hospitalized on 3/19/21; within 6 weeks of receiving COVID vaccination.
mostly stomach nausea; covid; flu; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a Patient.  This case involves an Adult and unknown gender patient who experienced mostly stomach nausea, covid and flu after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (lot number, strength, dose, expiry date, formulation not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed stomach nausea (nausea), covid (covid-19) and flu (influenza) at the same time (unknown latency) following the administration of Influenza vaccine.  It was reported "I got mine last month just because my doctor had it and covid 2 weeks ago."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
Patient was given whole vial 1.8 ml instead of 0.3 ml. Medical asst thought it was a single dose vial. Called Pfizer, they said no harm should come to patient, may have a sore arm, more that usual. Called patient to inform. She is complaining of headache and having hard time catching breath. Spoke with doctor, would like to see her in office or go to emergency room. Patient refused both, saying she does not have a ride. Daughter was there but left and went to work. Patient wasnt to take tylenol, rest an dcall back. I offered to call 911 to take her to ED. She again refused. I will call back.
Diagnosed with minimal change disease- nephrotic syndrome on 6/24/21. Received Moderna vaccine on 5/18/21 and 6/15/21. Had minor symptoms related to minimal change disease in early May but not significant enough to warrant medical evaluation. Increase BLE swelling starting 6/9/21 and became progressively worse with associated weight gain of almost 20 pounds in two weeks after onset of symptoms on 6/9. Oliguria, proteinuria, ascites, abdominal distention.
Injection site swollen protruding red and hot having trouble with left arm and hand pain throbbing
Strange feeling in the eyes over several hours.; Dry eyes.; Watery eyes; This is a spontaneous report from a non-contactable consumer.   A male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Mar2021 as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if the patient diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. On 04Mar2021, the patient experienced strange feeling in the eyes over several hours. Dry and watery eyes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown, if the therapeutic measures were taken as a result of the events. The clinical outcome of the events strange feeling in eyes, dry eyes and watery eyes were recovered on an unknown date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient initial updated from PRIVACY to UNKNOWN, Treatment Received updated in event tab, Narrative "The patient did not receive any other vaccines within four weeks prior to the vaccination" should be removed since it was provided in source document and Final sentence should be updated as : No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given a SHINGRIX IMZ on 6-19-18 at 2:57. She came back on 6-21-18. She showed me her arm. It was red (about the size of an oblong orange) and had some darker red spots which she said were painful. I told her to place a cold compress on her arm and take some ibuprofen or Aleve. She stated she cannot take NSAIDs because she is on a blood thinner. She stated the redness started the night I administered the immunization. I drew a marker around the area and told her to keep on eye on it to make sure the area was not getting larger. I also told her to call her doctor she he has record of the adverse reaction. I tried phoning the patient a few times throughout the day and again tonight (8:20pm) but I could only leave a message.
Rheumatoid Arthritis Flare Up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4177742.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 29Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 19Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1168552) at 40 mg daily (40 mg, daily (40 mg/0.4 ml)), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid Arthritis Flare Up". The action taken for adalimumab was unknown.  The reporter considered "rheumatoid arthritis flare up" related to BNT162b2.  Clinical course: Solicited report by a consumer of an adult female with an event of and non-serious Rheumatoid Arthritis Flare Up with Adalimumab Solution for Injection, Single Dose Pen. There was no reported medical history. On unknown date(s), the patient experienced Rheumatoid Arthritis Flare Up. Pfizer/BioNTech Covid-19 Vaccine was also considered suspect. Causalities: The reporter's causality for the event(s) of Rheumatoid Arthritis Flare Up with Adalimumab Solution for Injection was No Reasonable Possibility. The reporter's causality for the event(s) of Rheumatoid Arthritis Flare Up with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. Agency's opinion was that the causality for the event(s) of Rheumatoid Arthritis Flare Up with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Agency's opinion was that the causality for the event(s) of Rheumatoid Arthritis Flare Up with Adalimumab Solution for Injection was Not Provided. Medical History: Not reported. Assessment Results: Humira 40 mg/0.4 ml:  Rheumatoid arthritis flare up, Non-Health Care Professional, Global Introspection, Not Related. Humira 40 mg/0.4 ml: Rheumatoid arthritis flare up, Agency. Assessment Results: Pfizer/BioNTech Covid-19 Vaccine: Rheumatoid arthritis flare up, Agency. Pfizer/BioNTech Covid-19 Vaccine: Rheumatoid arthritis flare up, Non-Health Care Professional, Global Introspection, Possible. Did Reaction Abate After Stopping Drug? N/A. Did Reaction Reappear After Reintroduction? N/A.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events    and the 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.
Muscle pain where injection was, chills, red rash, a little swelling and hardness of arm.
Patient was given an MMR inoculation at 4:40 PM.  Within 15 minutes patient reported feeling unwell.  Patient developed hives, facial swelling, tachycardia and a change in spot from 99% - 86%.  BENADRYL 50 mg 5 & 5 .3 mg epinephrine given at 5:13 PM.  Patient went to ER by ambulance at 5:20 PM.
Severe Headache starting approximately 9 hours after vaccine received. Lasted about 24 hours. Mild on and off headaches since.
Pt reports 24 hours after receiving vaccine having chills, fever of 101.9, arm pain. lethargy, and HA Pt reports she had to miss a day of work and never misses work.   At time of interview on 1/14/21 patient was feeling back to normal and said she felt fine.
Patient called and stated back of Right arm at immunizations site was reddened and swollen-patient went to MD-received antibiotics, BENADRYL, MOTRIN - MD stated normal AR. reaction. No temperature.