chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An expired Covid-19 pfizer vaccine was administered to the patient on 4/18/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient's parent on 5/9 and patient does not plan to get revaccinated.
Patient experienced lower abdominal pain about 1 week after 2nd dose of SHINGRIX. The abdominal pain subsided and a new pain in the stomach area began ("similar to peptic ulcer"). This turned into extreme acid reflux. The patient then experienced painful coughing. Finally, the patient's left side of face had swelled with a toothache for the past week. Currently, his dentist prescribed PENICILLIN VK, ibuprofen and acetaminophen. All of these symptoms occurred over the course of 3 weeks (5/8/18-6/1/18).
This spontaneous report as received from a physician via a company representative refers to a 24 year old female patient. The patient had no pertinent medical history and no known drug allergies. On 24-NOV-2015, the patient was vaccinated with the first dose of GARDASIL 9 (lot # L016429, expiration date 09-AUG-2017, intramuscularly in the left deltoid (dose and frequency were not reported). Concomitant therapies included XANAX and unspecified birth control pills (manufacturer unknown). On 25-NOV-2015, the patient experienced a swollen lymph node in the location of left supraclavicular. On 24-JAN-2016 (also reported as today), the patient came to the reporter's office to be administered the second dose of GARDASIL 9 in the series and stated she was still able to feel the swollen node if she turned her neck in a certain way (also reported that the swollen node went away on approximately 02-DEC-2015, reported as after a week). On 25-JAN-2016 (also reported as today), the reporter could not palpate any swollen lymph node on the patient and did not administer the second dose of GARDASIL 9 (also reported as the therapy with GARDASIL 9 was not discontinued. The patient sought medical attention as she called the reporting physician on 25-NOV-2015 and reported the event during the office visit on 25-JAN-2016. Apart from physician examination, no other lab diagnostic  studies were performed. No treatment was given for the event. Product quality complaint was not involved. The outcome of the event was considered unknown. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
On April 28,2021 I started to have a twitching in my left cheek. The first couple days, it happened several times within a 30 minute period and was quite visible. It is brief twitching that is painless. The frequency has decreased to a few to several times a day, with no apparent reason. It still continues. On or around July 28,2021 I started to have this same type of twitch  at my right knee and right elbow joint. These are brief and sporadic.  These twitches occur at random times throughout the day.  There does not need to be a trigger for them to start. As I said, they are brief and intermittent. I had never had this type of twitching prior to the Covid 19 vaccination.
Within 48 hours of second Moderna vaccine but after 24 hours from time of shot, while casually sitting and noticing that my body was uniformly extremely cold to the touch, I experienced flashing colored dots in my right eye and for several days after a "floater" in my right eye.
Pt recvd 1st Engerix-B vax 28JUN91 & 2 hrs p/receiving the inject pt noticed stiffness lt side of neck; Pt exp slight swelling of arm @ inject site; swelling inc & worked its way to the hand; unable to remove rings, hand turned white;
received the first dose / on 3/18/2019  and 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 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th March 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 received 2nd dose, which led to  incomplete course of vaccination. No further information was reported. The reporter consented to follow up.
I woke up on the morning of Dec 26th with significant eye swelling. It was somewhat relieved with loratidine anithistimine 10 mg po daily x 3 days . The swelling was bilateral, symmetrical and was not accompanied by significant reddening of the eyes. Swelling was above and below the eyes. Swelling is slowly resolving but still present  today 12/29. A small amount of skin sloughing occurred below the eyes and on the eyelids. Swelling was accompanied by watery eyes,  itching with foreign body sensation.
Chills at 75 degrees; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA COVID-19 VACCINE; Lot number: ER8727), via an unspecified route of administration in left arm on 24Mar2021 at 07:00 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes. There were no known allergies. The concomitant medications included sitagliptin phosphate (JANUVIA), metformin (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN) for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA COVID-19 VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since receiving the vaccine. On 24Mar2021 at 18:00, the patient experienced chills at 75 degrees. The patient had not received any treatment for the event chills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event chills was unknown at the time of the report.  No follow-up attempts are needed. No further information is expected.
Very dizzy, nausea, rapid heartbeat lasting for about 20 minutes. 12/9/2009 OB records, no side effects of vaccine noted in records.
Red circle with diameter of 2 inches, swollen, hard, and itches with moderate intensity. Two days so far.
After second dose- I experienced worsening Inflammation and intense pain within 2 days of getting VX. This lead to inability to move head/neck side to side or lift arm. tingling sensation traveling down arm and into fingertips. Numbness of fingertip "pad".  Muscle knots/maybe lymph node knots peaked at 6  weeks and slowly decreased by week 12. Numbness and tingling started around week 4 peaked at week 7 and slowly slowly went away by week 12.
Systemic: Chills-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: patient blacked out and fell off observation chair to floor   He awoke almost immediately and started to sweat and was very pale.  EMS was called and patient denied care.
Headache. Nausea. Body aches. Low fever. Chills. Sweats
Dizziness and weakness started the morning after vaccination, and gone by that late afternoon Treated with not moving and laying down
I got shingles; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 81-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: en9581), via an unspecified route of administration, administered in arm right on 09Feb2021 at 10:00 AM (at the age of 80-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 9037765622), via an unspecified route of administration, administered in arm right on 19Jan2021 (at the age of 81-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. On 23Feb2021, the patient experienced I got shingles. AE resulted in emergency room/department or urgent care. The patient received Gabapentin as a treatment medication for the event. Outcome of the event was recovering.  Follow-up (15Sep2021): Follow-up attempts are completed. No further information is expected.
Feb 2nd, experienced mild headache and hot flashes 10 hours after vaccination. On Feb 6, had chills, headache, and fever of 100.5. Went away without medication after about 6 hours.
her niece is "icy cold on the inside."; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER: 1, his niece had the COVID 19 vaccine), for COVID-19 Immunization; Bnt162b2 (DOSE NUMBER: 2, his niece had the COVID 19 vaccine), for COVID-19 Immunization. The following information was reported: FEELING COLD (non-serious), outcome "unknown", described as "her niece is "icy cold on the inside."".  Additional information: Caller was a consumer who was calling for her niece who got the booster dose of the Pfizer Biontech COVID19 vaccine yesterday. Caller said her niece was "icy cold on the inside." Caller was asking for any information available on this and if they should go to the doctor. She needed to talk to someone to see what they should do. She doesn't want to do a report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt started having focal sz approx 48 hrs post vax; neurologist states does not want anymore pertussis given but does not believe @ this time seizures were from immun; placed pt on Tegratol; Pt cont to have seizures, tumor was discovered;
Fully vaccinated with booster on 10/14/21. Vaccine breakthrough 11/13/21. Inpatient hospital stay on a general medical unit.
Back, neck, knee and hip pain, headache, low grade fever, fatigue, chills, arm pain at, above, and below injection site . All symptoms were off and on for two days.
Subsequent to receiving first and second doses of Lymerix the pt began experiencing joint pain and fatigue. She was prescribed antibiotics for a presumed flu. Physician stated that he had treated the pt from 11/02/99 to 03/15/00 for joint pain, sore throat, post nasal drip, and abdominal pain. In addition the pt had head and chest congestion. Pt was clammy with activity. Pt was treated with Entex during November. 12/3/99 assessment and plan: Pt with osteoarthritis of her hand, no evidence of inflammatory arthritis or connective tissue disease. Physician stated that he believed the pt had fibromyalgia and referred the pt to physical therapy. The pt denied joint swelling. The pt indicated that she experienced pain, clicking, weakness and loss of motion. Pt was treated from 12/3/99 to 02/4/00 for osteoarthritis and fibromyalgia. On 12/16/99 an elevated sed rate was found and attributed to a sinus infection. On 01/02/99 pt complained of having achy joints for a few weeks. on 01/23/99 pt was treated with Amoxil 500 mg tid for ongoing sinus pain and increased post nasal drip. Physician prescribed Celebrex 100mg bid as needed. Celebrex bothered pts stomach so she was switched to Vioxx 12.5mg gd as needed. 02/04/00: pt felt better with physical therapy, with less fatigue, less insomnia and less pain. She experienced weight gain. After shoveling snow pt felt a recurrence of symptoms, but felt well overall. Pts ASO titer and rheumatoid factor were negative. On 02/24/00 physician noted a bad stiff neck associated with headache, tennis elbow, and myalgias. 03/15/00: Left elbow symptoms responded well to physical therapy. The most recent information reports the outcome as unknown.
I went to bed the night of the vaccine I felt a sensation that was from the left side of my breast and i couldnt sleep. the next night I felt that sensation in the right side. Research said it might be my lymph nodes. It went on for 3 weeks and i waited to see if it would go away. I read something of a lady with this. Now its been almost 6 months and I still have this sensation. It feels heavy, like there is something not right with a dull pain. It wakes me up and I am very scared. I can't sleep on my stomach anymore. Nothing else was wrong, I was fine. It has caused me a lot of anxiety and I am so scared that something is wrong with me now.
arm tender; generally being run down; slight fever (lasted for a day); This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (arm tender), FATIGUE (generally being run down) and PYREXIA (slight fever (lasted for a day)) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (arm tender), FATIGUE (generally being run down) and PYREXIA (slight fever (lasted for a day)). At the time of the report, TENDERNESS (arm tender) and PYREXIA (slight fever (lasted for a day)) had resolved and FATIGUE (generally being run down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported for dose 1. No concomitant medications were reported.   This case was linked to MOD-2021-322691 (Patient Link).
Coughing, Wheezing and Trouble Breathing and a body Rash. The next two days, I could not go to work. I also had fluid in my lungs. I never had this before.
I had a sore arm which I had to ice. I also had a little bit of fatigue.
After the first shot, I experienced tongue numbness after about 20 minutes after the shot. In the following  weeks I developed a frozen shoulder on my left shoulder, the same side I received my vaccination.   On my second shot (4/14/2021, 032B21A), I once again experienced tongue numbness after about 20 minutes after the shot. This time for a week after and intermittently since then I have experienced numbness on the left side of my face, my left arm, and pins and needles in my left feet and hands.
Sore arm, after first vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 19Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm, after first vaccine".  Additional information:She is concerned about the potential side effects from the second dose being much worse and would like to know if she delayed her second dose beyond the recommended 3 week interval would it lessen the chance of having side effects from the second dose. caller know that the recommended interval is 3 weeks and that there is no data to suggest that potential side effects would be lessened if the second dose is delayed.Caller wants to know more information about taking medications like Tylenol or Ibuprofen either before or after the Pfizer COVID-19 vaccine to help with potential side effects. and if people should take antihistamines to help prevent an allergic reaction to the Pfizer COVID-19 vaccine.Reporter seriousness for Sore arm, after first vaccine: Unspecified.Reporter seriousness for At risk: for not taking second vaccine, or as scheduled:   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day one: first 10 mintues after the vaccine - red spots around the site of injection. Gradually it started getting swollen being painful as if it was overtrained and by the end of the day the pain got too severe, arm movements were restricted. I had to take nimesulide 10 mg which relieved the pain and easened arm movements but the swelling was growing. Day 2: arm swelling increased, general malaise, difficulty breathing, feeling cold, strong headache. The injection site was surrounden by approximately 2 sm hot red spot. I took nimesulide 10 mg but my general well-being got too severe after 5 hours, so I took also montelukast sodium 10 mg. Day 3: arm swelling increased to approximately 5 sm in length, 2-3 sm in height, the red spot increased to 4x3 sm, the arm is painful and extremely hot, my left side of face feels hot waves from the arm. It's day 3 now.
several days after 1st injection, patient developed hoarseness of voice that continued to worsen. Seen in clinic has paralysis of true vocal cord.
Severe, debilitating whole body aches, uncontrollable chills, headache....chills and headache lasted for 7 hours, body aches lasted 20 hours but became less severe with time.....took Tylenol every 4 hours.
I received the first vaccine on Jan19th 2021. About a week after I experienced a small flare of my ulcerative colitis that I was able to get back under control with diet and medication.  Received the second vaccine on 7/21/21. About a week after this vaccine, my Ulcerative Colitis flared even worse and is now worse than I have ever experienced it. No medications are helping at the current time.
Case number PHEH2015US021034 is an initial spontaneous report received from a health care professional on 15 Oct 2015. This report refers to a female patient whose age was not reported. Her current condition included allergy to shell fish. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer: Novartis, trade name and batch number: not reported) intramuscularly on 15 Oct 2015. It was reported that on the same day she came back in with a rash and stated that her throat was closing up. The events outcome was unknown. The seriousness of the event was not reported, but the events were upgraded as medically significant based on the information available in the source document. The causality of the events was not reported.
Spondylitis ankylosing aggravated; Wearing off effect; Tiredness; Ache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 21K-163-4182773-00.  A 34 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Jan2021 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single and intramuscular, administration date 05Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk(cf (1 in 2 wk)) for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "not recovered", described as "Spondylitis ankylosing aggravated"; THERAPEUTIC RESPONSE SHORTENED (non-serious), outcome "not recovered", described as "Wearing off effect"; FATIGUE (non-serious) with onset Jan2021, outcome "unknown", described as "Tiredness"; PAIN (non-serious) with onset Jan2021, outcome "unknown", described as "Ache". The action taken for adalimumab was unknown.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN)  Reporter's causality for events not reported for adalimumab and BNT162B2. The case would be managed based on company assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Ankylosing spondylitis, Therapeutic response shortened, Fatigue, and Pain and BNT162B2.  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.
A spontaneous report (United States) was received from a consumer concerning a 65-year-old, male patient who received Moderna's COVID-19 vaccine and experienced tightness in the stomach that was kind of painful, felt unwell, weakness, feverish and soreness at the location of injection.  The patient's medical history, as provided by the reporter, included diabetes, high blood pressure and triglycerides. Concomitant medications reported included drugs for diabetes, high blood pressure, triglycerides and vitamin D with fish oil supplement.  On 28 Dec 2020, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, after receiving the mRNA-1273 vaccination, the patient felt tightness in my stomach kind of painful and feeling unwell. He went to the bathroom to relieve. The pain in stomach felt better. However, the weakness and feeling unwell stayed. He developed soreness at the location of injection. He felt feverish. The patient's fever was reported as 97.5 F.  On 30 Dec 2020, he felt better but still weak. Treatment for the event included acetaminophen and aspirin. Now he was feeling better.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events, tightness in the stomach that was kind of painful, felt unwell, weakness, feverish and soreness at the location of injection was considered resolving.  The reporter assessed the events as possibly due to food poisoning or the mRNA-1273 vaccine.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
My leg and foot swelled on Thursday.  We elevated and treated with heating pad & Advil.  The swelling went down, so we started for home, drove 4hrs.  My leg & foot swelled back up.  We went to the ER they gave me an ultrasound, and said I had 2 blood clots in my leg.  They prescribed, Eliquis.
MD reported pt devel rash & dyspnea following vax w/Hep B vax; No further details were provided;
Warm, Hot, Swollen arm. Patient applied ice pack and took BENADRYL.