chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 yr imms given 1-27-12. No rxn noted while in office. Received call on 1-30-12 from pts mom reporting, after leaving office all was well imm sites on legs no redness no swelling until 1-29-12 pt c/o her leg burning, mom observed pts (L) anterior thigh with rash from med thigh up as red, warm with swelling. Mom reports no fever no SOB or wheeze. In office on 2/2/12 with fever and c/o (B) knee pain.
The patient who is 5 years old got the adult amount (1, 440U) of Hep-A vaccine which is double amount of the kids should get.
Fatigue, Chest pangs (not significant enough to call them pains), sensitive spleen / liver, upper body aches, swollen feet, inner thigh pain.    Fatigue started day after 2nd shot and has continued.  Additional systems started ~ 2 weeks post second shot and continued.   Intensity of additional symptoms have reduced over the past 3 weeks.
Red rash and itchy skin around injection sight that spread to both arms and chest and kneck and upper back
neutrophils that was low; eosinophils was slightly high; This is a spontaneous report from a Pfizer sponsored Program from a contactable consumer (patient) reported for himself. A male patient with unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunisation.  Medical history and concomitant medications were not reported. The patient received second vaccine and had blood work done on unspecified date and noticed that blood cell counts neutrophils that was low and eosinophils was slightly high. Wanted to know if was because of vaccine. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient came in on 09/10 /21 and described an excruciating pain  through entire right arm lasting for about 2 weeks  which did resolved by the time of reporting it to pharmacy.
On 06/08/2022 in the morning around 8:00AM . I had fever, body aches, sinus congestion, and  difficulty  breathing. On 06/09/2022 I contacted my doctor he advised me to take over the counter medications and  if symptoms got worse to call him . On 06/29/2022 I went to the urgent care for an ear infection and  sinus infection due to COVID-19.
Patient reported that approximately 12 hours after receiving the flu shot he became ill which he described as being unable to sleep and having a constant urge to vomit. He did not actually vomit, but it seems that he was on wretching all night. He did recover and is feeling better. He also reported having some bruises up his arm that he feels showed up after the flu shot was given. The small bruises are not near the site of the injection and are on the forearm.
vaginal bleeding on and off/Reoccurring vaginal bleeding; Abdominal cramps; Reoccurring vaginal bleeding was reported as worsened/Abdominal cramps was reported as worsened; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 22 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 04Apr2021 11:00 (Lot number: ER8733) at the age of 22 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sensitivity to Gluten", start date: May2021 (unspecified if ongoing), notes: Illness/AE: Sensitivity to Gluten but does not have Celiac. Concomitant medication(s) included: WELLBUTRIN taken for anxiety, depression, start date: May2020. Vaccination history included: Bnt162b2 (Dose number: 1, Batch number: EN6206, Route, Anatomical Location: injected in right arm in the muscle), administration date: 14Mar2021, when the patient was 22 years old, for Covid-19 immunization; Moderna (When counting back to the date of first dose, she stated Pfizer is 21 and Moderna is 28), administration date: 07Mar2021, when the patient was 22 years old, for Covid-19 Immunization. The following information was reported: VAGINAL HAEMORRHAGE (non-serious) with onset 15May2021 09:00, outcome "not recovered", described as "vaginal bleeding on and off/Reoccurring vaginal bleeding"; ABDOMINAL PAIN (non-serious) with onset 15May2021 09:00, outcome "not recovered", described as "Abdominal cramps"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "Reoccurring vaginal bleeding was reported as worsened/Abdominal cramps was reported as worsened". The events "vaginal bleeding on and off/reoccurring vaginal bleeding", "abdominal cramps" and "reoccurring vaginal bleeding was reported as worsened/abdominal cramps was reported as worsened" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.
At 3:15 pm 5/16/2013, vaccine was administered at IM route in (L) arm. Approx 5 minutes later patient fainted. Kept patient in office, no head injury; when able patient walked out on own.
Fever 103.6 degrees F; TYLENOL/MOTRIN. No other source found site without redness/swelling only LN.
3 days p/MMR devel skin rash, pruritic, maculopapular, multiforme, joint pain & fever;
PATIENT DESCRIBES AS SEVERE FATIGUE, SORE MUSCLES, AND FLU-TYPE SYMPTOMS AND WAS STILL EXPERIENCING THE SYMPTOMS ON REPORTED DATE OF 10/9/12.
07.25.2021-Body aches, headache, exhaustion 07.26.3021-Body aches, pain in back when breathe deep, chills, exhaustion, 07.27.2021- Body aches, headache off and on, chills, low grade fever of 95.4, sweating, ears hurting, sore throat, diarrhea, abdominal pain, moody
Heart pain woke me up at 3 am in the morning. Pain was a dull ache that did not subside with heartburn tablets (I don't normally experience heartburn). Symptoms were like a toothache in the heart?dull, persistent. Did not subside until 3-4 days after the initial onset. Have not experienced this type of pain before.
About 12 hours after my shot, I was having aches and pains my skin was starting to hurt. This was similar to what has happened when I have had my COVID shots. Around 9:30PM I started throwing up and was very nauseous and was having a horrible headache. I then started having severe stomach pain and it was across my abdomen and it was this dull and sharp pain happening conqueringly. I was doubled over and not able to do hardly anything. My husband helped me into the car and took me to the ER while we were driving to the ER, I needed to throw up again and I did this out of the window and that stopped my pain that I was having. I was worried it may be something with my appendix, kidneys or my gallbladder. Since I had thrown up the horrific pain was gone but I was still sweaty, achy, and my skin was still sensitive to touch and causing pain when I was touched. They did an EKG to make sure nothing was wrong with my heart, but it came back normal. They gave me a medication for my nausea and also something to help with the headache as well. The next day after being discharged I did follow up with my PCP. I have been going through menopause and I have been having bad cramping and my thoughts are that maybe I had some sort of intestinal involuntary cramping which was causing the pain and vomiting. The next day I still had a headache and the nausea but the pain in my abdomen was gone, but I was still achy and not feeling 100% but I was able to go to work later in the day after taking the morning easy. The headache lasted throughout the day, but I was a little better. The headache has been constant and last night I was still having the headache and while the stomach pain has not come back but the nausea lasted a little longer. Today I am feeling great. All of the symptoms are gone, and I am really feeling much better. I did have my flu shot that same day and at the moment I do not have the information on that shot, flu shots do not normally affect me, but my COVID shots have always made me feel poorly after getting them.
Patient got Boostrix on 9/3/20,  she said right after her arm is sore and it is hard to move. On 9/7/20, it started bruising, the bruising is about 7cm in diameter, no fever. I have advised the patient to use cold compress and have called GSK at 430pm for more recommendations but they are closed. Will follow up on 9/9/20
facial pain, redness, pins and needles like fiberglass been run across face Narrative:
DEATH; This spontaneous report received from a consumer concerned multiple patients of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient's had no underlying issues. The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, reporter lost 3 friends (death). On an unspecified date, the patient's died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0. 20211112489-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patient came into office Friday 11/3/2017. Has a 46mmX15mm red area to back of left arm. Stated it is "kinda itchy but very tender to touch. No wheals noted. No raised or blistered area noted.  Client was instructed to take some Benadryl, apply warm moist packs. Client was also instructed if area go any bigger over the weekend to go to ER or Urgent Care. Client has had no fever.
Got vaccines last Thursday 9/20/18 and now has lump on left upper thigh that is warm to the touch and red. Cephalexin 250/5 ml 2.75 ml PO BID, 10 days for cellulitis.
Rash/redness/irritation at injection site 2 weeks after receiving first dose of COVID vaccine.
Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 10:45 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atorvastatin calcium (LIPITOR) for unknown indication and birth control (MANUFACTURER UNKNOWN) medication; both from unknown dates and unknown if ongoing. On 07Apr2021 at 13:00, the patient experienced extreme fatigue. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme fatigue was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
DEATH; STROKE; EXTRA DOSE ADMINISTERED; This spontaneous report received from a consumer via social media concerned a male of unspecified age. 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: Unknown and expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient administered extra dose and had a bad stroke within 12 hours of the 2nd dose. Later, the patient died. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of extra dose administered was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210506977- Covid-19 vaccine ad26.cov2.s- Death, Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: STROKE
dizzy spell on 11/07/21, 11/10/21 dizzy spell and low blood pressure BP90/60 (hold Propranolol until blood pressure get better), 11/12  almost passed out while driving to work, got to work and start getting dizzy/ pressure on back of head. 11/12 when to hospital, stayed for 2 days and got released 11/14 still having dizzy/ pressure on back of head (I still have symptoms). In the hospital they gave me some pain killers and did not help 100%. At hospital they add Atorvastatin 40 mg once a day, they put me on Propranolol ER 60 mg once a day and still feel dizzy.
Rhumatoid arthritis; Hand/wrist swelling; Mild shoulder pain; Osteophytosis; Neck pain; Polymyalgia Rheumatica; This case was reported by a lawyer and described the occurrence of polymyalgia rheumatica in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for an unknown indication.   The initial information was received on 31 March 2021 via medical record (case is medically confirmed) The patients current condition included Polymyalgia Rheumatica onset date 26 June 2019, Rhumatoid arthritis, Hand/wrist swelling, Mild shoulder pain, Osteophytosis and Neck pain. family medical history includes Mother had Hypertensive disorder and father had heart disease. Additional patient details include Nonsmoker and Alcohol uses around 12 beers per week. The patient was used Shingrix 0.5 ml via Intramuscular route on 27 June 2016. The patient was hospitalized on 11 August for patient had right total knee replacement / total join replacement performed on right femur with Stryker triathlon PA knee system.
Acute onset urticaria 4 hours after flu-mist administered.  No dyspnea or dysphagia.  No new exposures otherwise.  Concurrent allergic coryza (patient has history of this).  No medications at time of vaccine.  Patient has received flu-shot previously without reaction.  Suspect urticaria related to flu-mist and will not administer in future.
The patient was vaccinated 07/19/2000. Subsequently, the patient learned that she was pregnant. It was noted that the patient's husband developed shingles and that the patient was tested for varicella antibodies on 06/29/2000 and the result was negative. On 08/01/2000, it was reported that the patient has developed "3 pock marks that she thinks might have been chickenpox". The patient sought unspecified medical attention. Additional information has been requested. This report is part of the pregnancy registry. F/U 6/17/02: received from an MA reported that on 7/31/01, the pt delivered a healthy, full term male, 8lbs 1oz (39 weeks from LMP) via normal delivery. The pt had no complications during labor/delivery. The infant did not have any feature of congenital varicella zoster syndrome. Additional info has been requested.
This is a spontaneous report from a contactable medical assistant (calling from physician's office) and from a contactable nurse, reporting on behalf of physician. A 65 year-old female consumer received injection of PREVNAR 13 (Lot#:H13995, Expiration Date: Mar2015) on 28Apr2014 at 0.5 ml single dose for immunization at private doctor's office. Relevant medical history included ongoing depression since an unknown date, the patient had not known drug allergies, she did not abuse of drug and alcohol, her father had died at 70 year-old due to pancreatic cancer, her mother had died at 96 year-old due to dementia. Patient concomitant medications included ongoing CYMBALTA since an unknown date at 60 mg daily for depression, IMITREX and pantoprazole. It was reported that on 05May2014 the consumer experienced swollen lips. This event did not result in emergency room or doctor visit. Relevant laboratory data was none. Therapeutic measures were taken in response to the reported event and included the administration of prednisone 50 mg oral tablet once daily for 5 days. The patient recovered from the reported event on 07May2014. Follow-up (28May2014): New information reported from a contactable nurse on behalf of physician includes: additional details on medical history and familiar history, additional concomitant medications, reaction data (event was changed from angioedema to swollen lips, outcome of this event), details on therapeutic measures, seriousness (event swollen lips was reported as non-serious). Follow-up attempts completed. No further information expected.
Myalgia, Arthralgia, Fever, RespDepression, NauseaVomiting, Malaise, Skin sensitivity, Swollen and tender arm, Rigors Narrative:  Received 2nd dose morning of 1/20/21. Noted nausea that afternoon, and malaise and SOB with activity that evening. Noted skin sensitivity with a shower that evening. Arm was swollen and tender and reported chills and rigors. Awoke that night with severe muscle and bon pain, drenched in sweat. On 1/21/21 noted increased hip pain and fatigue, as well as dizziness. Missed work x 2 days, symptoms resolved by evening of 1/22/21. No known prior COVID infection.
Received injection in a left upper arm near shoulder joint.  Individual complained of pain in shoulder area.  Later developed numbness, in left thumb but resolved after a few weeks.  Received steroid injection from his physician, used hot packs and massaged area and now has seen great improvement.
10/18/10 patient called in to say she felt lightheaded, a little short of breath and some wheezing. Dr ordered patient to take BENADRYL 50 mg po. Call back in one hour. Go to ER if she becomes worse.
shingles on RIGHT side; backache; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valtrex) unknown for shingles.   On 5th August 2022, the patient received the 1st dose of Shingrix (intramuscular). On 19th August 2022, the patient started Valtrex at an unknown dose and frequency. On 14th August 2022, 9 days after receiving Shingrix and not applicable after starting Valtrex, the patient experienced shingles and back pain. The action taken with Valtrex was unknown. On an unknown date, the outcome of the shingles and back pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and back pain to be related to Shingrix. It was unknown if the reporter considered the back pain to be related to Valtrex.     Additional Information: GSK Receipt Date: 23-AUG-2022 Reporter's Comments: The reporter was the patient. The patient reports he received his first Shingrix vaccine in the left arm. On 14th August 2022 patient started getting a backache which had not resolved. On 18th August 2022, patient had a shingles on his right side. The patient went to the urgent care and the doctor placed him on Valtrex on 19th August 2022. The patient pain had gotten worse since starting the Valtrex.  The patient would contact his HCP (health care professional) to see if he should continue taking Valtrex. The reporter did not consent to follow up.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified dates in approximately 2014 (also reported as since May 2014), an unspecified number of patients were administered PNEUMOVAX23 (dose, route of administration, lot# and expiration date were not provided) that fell to a temperature of 33F. This excursion was supported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Mild, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Mild, Additional Details: took blood pressure lying down 130/80 and again sitting up 130/90 within normal limits. patient also reported having history of anxiety. pt counseled to monitor symptoms while at home (has driver) and to go to urgent care or ER if symptoms worsen. offered to call 911 but pt said he is okay for now.
Miscarriage; spotting; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular at right deltoid on 04Feb2021 at single dose for COVID-19 immunization. Medical history was reported as none. She has no known allergies and has no COVID prior to vaccination. Concomitant medications included folic acid, iron (PRENATAL) and fluoxetine. The patient has no other vaccine in four weeks. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231) at the age of 31-years-old, intramuscular at right arm on 14Jan2021 at 12:30 at single dose for COVID-19 immunization. The vaccine was administered in a hospital. The patient was pregnant, her last menstrual period was on 19Dec2020. Her expected due date is on 25Sep2021 and gestational period was 7 weeks (also reported as 3). The patient experienced miscarriage and spotting on 09Feb2021 which resulted in doctor or other healthcare professional office/clinic visit. She was not tested for COVID post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of  miscarriage and vaginal hemorrhage  due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.   There is limited information provided in this report.  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.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In August 2007, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-JUN-2009, the patient was treated by a physician, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damage's. Additional information has been requested.