chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The first thing I started noticing was it felt like a neural flaring like my nerves were on fire. It would feel like they would flare up. It was specifically in my lower back...not the back nerves but more like the pelvic nerves. That in turn would cause me to have tightness in the muscles in the pelvis including my tailbone, pelvis, upper thigh and especially the right groin. It would come and go and would get weak. My upper thigh strength was weakening over the summer. I kept trying to stay active by hiking and taking walks and biking, but my recovery period was taking days instead of the next day. When I got to the middle of October, I was doing yardwork. That's when it developed into a full blown groin sprain on the right side. I called the Dr. to schedule an appointment but I couldn't get in until after the holiday. At this point, I couldn't even walk to the end of my block without being in severe pain. They took an x-ray and referred my to an orthopedic surgeon. I did get a corticosteroid injection in my hip but I told the tech where my issue was and he moved it closer to the groin area. It alleviated the swelling to where I could tell where the pain was. I, on my own, scheduled appointments with a PT person. I had 4 or 5 sessions with them and I'm still having problems.
Adacel given. Numbness and tingling beginning at 7:30 am on 6/14/2006; nausea beginning at 8:30 am on 6/14/2006; lightheadedness beginning 8 pm on 6/13/2006; vertigo beginning 8:30 on 6/14/2006.
Administered expired vaccine to patient, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Date the vial was initially stored in the refrigerator was unknown. It was reported that vials had not undergone any temperature excursion.Total of 102 doses/vials were given for LOT 026C21A.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non significant information.
This case was reported by a nurse and described the occurrence of fever in a 4 month old infant who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hep B recombinant and inactivated poliovirus vaccine combined (Pediarix). Medical history included prematurity at 29 weeks gestation and respiratory distress syndrome status-post intubation. Concurrent medication included palivizumab. On 19 January 2005, the patient received the first dose of Pediarix (lot AC21A007AA). Concurrently on the same day, the patient also recevied injections of haomophilus influenza type B conjugate vaccine (manufacturer unknown) and 7 valent conjugate (Prevnar). On 20 January 2005, one day following the administration of Pediarix, the patient experienced "a fever greater than 103 degrees Fahrenheit." The patient was seen at a physician's office. The fever resolved on 21 January 2005. The reporting health professional considered the fever to be clinically significant requring medical intervention (OMIC), and possibly be related to vaccination with Pediarix.
sinus headaches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reporting for herself that a 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated: "first dose was on 30Mar2021, scheduled second dose of the vaccine tomorrow 20APR2021. Yesterday (18Apr2021) woke up with sinus headaches, last night was scared to take sinus-headache medication because of getting fully vaccinated - is it okay to take: a store brand by Equate for severe allergy, maximum strength, Acetaminophen and diphenhydramine" When referred to HCP for treatment recommendations caller stated: "got it at a pharmacy (Vaccination), they are not doctors". The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This patient was given the first dose of Moderna covid vaccine on 4/14/21, He was given another dose of Moderna vaccine on 4/21/21. No immediate side effect noted  but patient will be checked again in next few days this week. We plan of giving him his 2nd real dose on May 14, 2021
Fever, Headache, Chills, Body Aches, Sore Throat
Site: Pain at Injection Site-Mild, Systemic: Tingling (specify: facial area, extremities)-Mild, Additional Details: Patient reported back for 2nd dose today. Her left arm, where she received the 1st dose on 1/25/2022, has been tingling since the 1st administration.
developed a "large red raised area" on his arm that was painful; developed a "large red raised area" on his arm that was painful; This spontaneous report has been received from a pharmacist via a company representative referring to an 82 years old male patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.       On 24-OCT-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date, strength, frequency and dose details were unknown) intramuscularly for prophylaxis.         On 25-OCT-2019, the patient experienced a "large red raised area" on his arm that was painful (not detailed further).  The outcome of the events and the causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
multiple reoccurrences of pneumonia; shingles; postherpetic neuralgia; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition and concomitant medication was not reported. The pt's historical condition included pneumonia. On or around 14-FEB-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered a severe painful rash on the left side of the buttocks wrapping around to the left anterior thigh and on to the left side of the penis. The pt also experienced a severe, persistent cough. The pt was diagnosed with shingles, postherpetic neuralgia and multiple reoccurrences of pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events shingles, postherpetic neuralgia and multiple reoccurrences of pneumonia was considered to be not recovered and causal relationship was assessed as related.     The lawyer considered the events shingles, postherpetic neuralgia and multiple reoccurrences of pneumonia to be disability.  Upon internal review, multiple reoccurrences of pneumonia was determined to be medically significant.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles (herpes zoster). On an unspecified date, the patient was treated by a two physicians for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Fatigue beginning a few hours after injection and lasting through most of the following day. No other symptoms noted.
Presented to ED ~ 12 hours after receiving 2nd Covid vaccine. Chief Complaint: FEVER.  (Pt had second COVID vaccine around noon. He presents via ambulance " feeling terrible" with fever, malaise. He is somewhat confused and uncomfortable here. Daughter in law here).  No muscle aches, chest pain or cough.  He has had loss of appetite.  He has had dyspnea (chronic).  He has had altered mental status (mild confusion).  He has had skin rash (chronic LE).    Pt was kept for observation x3. He was given IV fluids and a started 4.5 gm of Zosyn (Piperacillin Sod-Tazobactam So). Diagnosed with pneumonia - switched to oral augmentin at discharge. On home oxygen.
Got Pfizer COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Got Pfizer COVID-19 vaccine) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Got Pfizer COVID-19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Got Pfizer COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported by the patient No treatment was received by the patient
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient passed out around 10 minutes after injection. This particular patient fell forward in chair in observation area, and it led to a fracture in lower leg that was diagnosed that evening.
A spontaneous report was received from a consumer concerning an 86-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events  woke up on the middle of the night extremely dizzy/dizziness, interrupted her sleep/insomnia and sore arm/vaccination site pain. The patient's medical history was not provided. No relevant concomitant medications on use were reported. On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025120A) intramuscularly for prophylaxis of COVID-19 infection. On 9 Feb 2021, the patient experienced the event sore arm. On 16 Feb 2021, the patient experienced the events woke up on the middle of the night extremely dizzy and this interrupted her sleep. No laboratory data was provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The event sore arm was resolved on 11 Feb 2021. The events  woke up on the middle of the night extremely dizzy and  this interrupted her sleep were recovered on 17 Feb. 2021.
Some people experience noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea.; Some people experience noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea; Some people experience noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea.; Some people experience noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea.; Some people experience noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea.; Some people experience noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea.; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain, headache, shivering, fever, stomach pain and nausea. On an unknown date, the outcome of the muscle pain, headache, shivering, fever, stomach pain and nausea were recovered/resolved.   It was unknown if the reporter considered the muscle pain, headache, shivering, fever, stomach pain and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Post vaccination with Shingrix some people experienced noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea. This is 1 of the 3 cases reported by the same reporter.
Product storage error/Refrigerator door left open for six hours/had three syringes; Fatigue; Injection site pain/Sore at injection site; Pain in arm/Entire arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Product storage error/Refrigerator door left open for six hours/had three syringes), FATIGUE (Fatigue), INJECTION SITE PAIN (Injection site pain/Sore at injection site) and PAIN IN EXTREMITY (Pain in arm/Entire arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Unknown. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error/Refrigerator door left open for six hours/had three syringes), FATIGUE (Fatigue), INJECTION SITE PAIN (Injection site pain/Sore at injection site) and PAIN IN EXTREMITY (Pain in arm/Entire arm). At the time of the report, PRODUCT STORAGE ERROR (Product storage error/Refrigerator door left open for six hours/had three syringes) and FATIGUE (Fatigue) outcome was unknown and INJECTION SITE PAIN (Injection site pain/Sore at injection site) and PAIN IN EXTREMITY (Pain in arm/Entire arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, she received first dose COVID-19 Vaccine manufactured by Moderna. The reporter's causality for the event of product storage error was a reasonable possibility and the reporter's causality for the events of fatigue, Injection site pain and in in extremity was no reasonable possibility with HUMIRA(ADALIMUMAB).  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Was awaken by whole body weakness, achiness, and a "sunburn" feeling.  Took regular dose of ibuprofen at 5 AM and again at 10 AM for pain associated with sunburn feeling.
Achy, feeling cold, headache, TMAX 99.8.  No treatment and no improvement. Outcome: Will continue to monitor symptoms.
Patient stated during shot that it was painful. Pharmacist told her that her muscle was extremely tight. Patient stated that within 30 minutes after she had trouble driving. She reported that for the next 4-5 days she could only lift her arm a few inches and was in pain. She stated that the symptoms gradually improved and is now fine. She feels that no medical intervention was or is warranted.
Patient received Flu shot 11/15/07,came back to office 11/16/07 injection site ed,swolle,hot to the touch. Given Keflex 500mg.BID for 10 days and Benadryl-OTC.PRN.
DOSE OF VACCINE GIVEN TO PATIENT FROM A VIAL THAT HAD BEEN PUNCTURED PREVIOUS MORNING; This spontaneous report received from a pharmacist concerned a 71 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced dose of vaccine given to patient from a vial that had been punctured previous morning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose of vaccine given to patient from a vial that had been punctured previous morning was not reported. This report was non-serious.
low energy confused, foggy memory bumps on tongue and in mouth tired heart rate was high 120,150- high 160s
This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout), HYPERSENSITIVITY (Allergy), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 63-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.        Concurrent medical conditions included Hypothyroidism, Kidney stones, Testosterone low, Enlarged prostate, Sleep apnea and Allergy (Patient had muscle weakness when treated with statins).   In 2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 03-May-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). In 2022, the patient experienced GOUT (Gout) and HYPERSENSITIVITY (Allergy). At the time of the report, GOUT (Gout), HYPERSENSITIVITY (Allergy), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.             The reporter's causality for the co-suspect for event Gout, Re-vaccination with different COVID-19 Vaccine and allergy was possible.  No concomitant medication reported. No treatment medication reported.
Sever underarm pain on side of injection barely manageable with acetaminophen and ibuprofen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 13:30 (Batch/Lot number: unknown) at the age of 42 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 16Apr2021 12:00, outcome "not recovered", described as "Sever underarm pain on side of injection barely manageable with acetaminophen and ibuprofen". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: Vaccine administered at Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior and other medications 2 weeks prior to the COVID vaccine. Patient had no known allergies. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain and swelling that was reported to be the worst on the day of the vaccine and decreasing in the 2 days post vaccination. Patient reported on pain on 10/11/17, but reported some swelling at the injection site still.
an MRI of her brain that shows extensive  demyelination; her doctor thinks she has Multiple Sclerosis; This is a spontaneous report from a contactable Nurse (patient).  A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose, for covid-19 immunisation. Family history included sarcoidosis from an unknown date and unknown if ongoing (daughter is 40 years old). The patient medical history and concomitant medications were not reported. Since the patient was vaccinated, she had an MRI of her brain that showed extensive demyelination and her doctor thinks she has multiple sclerosis. They don't know for sure if she has it, but they are pretty sure she does. They are doing extensive test work. The patient is scheduled for a spinal tap next week to confirm the Multiple Sclerosis (patient had no history of Multiple sclerosis). Outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new 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.
Expired vaccine by the time of administration. No harm done. Patient will come in for a replacement dose.
Patient felt faint after receiving the 1st dose of Pfizer, her blood pressure became elevated and she laid on the floor for approximately 30 minutes until she felt better.