chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via sales rep and described the occurrence of ophthalmic herpes simplex in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 7th August 2018, the patient received the 1st dose of SHINGRIX. On 7th September 2018, 31 days after receiving SHINGRIX, the patient experienced ophthalmic herpes simplex (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes simplex was unknown. It was unknown if the reporter considered the ophthalmic herpes simplex to be related to SHINGRIX.  Additional details were reported as follows: On 7th September 2018, the patient went to her eye physician and was diagnosed with herpes simplex virus (HSV) in the right eye. On 28th September 2018, the reporting physician became aware of her right eye HSV diagnosis. The reporter agreed to be follow up. No additional information was provided.
Right arm warm and tender after 1st shot; Right arm warm and tender after 1st shot; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 64-Year-old female consumer received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201, Expiry Date, NDC Number: not reported), via intramuscular on right arm (Unable to confirm if given in the muscle) on 10Feb2021 (at the age of 64 years) as dose 1, single for covid-19 immunisation. Medical history included diabetes from 1995 to an unknown date (diagnosed 25 years ago), allergies. She had heart disease regarding that her cardiologist told her that everyone over the age of 50 had a little bit of heart disease. She had kidney disease (diagnosed 2 years ago. It was in the early or beginning stages). Other conditions: diagnosis date not provided. Her son was tested positive for COVID prior to her. AE(s) following prior vaccinations was none. Investigation assessment was done. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA 24 HOUR) taken for allergies from 2020 (took it on a regular basis since end of 2020). She took Allegra and spoke to her Allergists, and she said to continue taking it when she got the vaccine. She was on something else before Allegra, and it made her too drowsy. That medication was Zyrtec. Her allergist said that some medications did not work well with everyone and it was a 24 hour one. She switched her over to Allegra. She threw the Zyrtec out and did not have a lot or expiration for it. She had very bad allergies. When she did not take it, she got sneeze. When she did, it works. She tried not to take it every day to see how long before she starts to sneeze. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. Last vaccines, she received before this were in the fall of 2020. She received vaccination at US clinic and not at military facility. The patient experienced right arm warm and tender after 1st shot on 11Feb2021. She was highly allergic and was afraid she was going to have a reaction but did not. She just had normal reactions. Her arm was warm and tender after first shot. It was reported that vaccination site for both doses were given in two different places. One gave it lower and one higher. She did not think they got muscle on first shot and it did not feel the same on the first shot. With first shot, she got to sit down, and they already had the shots in the hand. So, she did not know if it was sealed or not. Both shots in same arm were not in the same place. She knew that for a fact. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
shooting pain that started in the arm and traveled down to the hand (left); numbness in the hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (shooting pain that started in the arm and traveled down to the hand (left)) and HYPOAESTHESIA (numbness in the hand) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLOMIFENE CITRATE (CLOMID), LABETALOL, LEVOTHYROXINE SODIUM (SYNTHROID), METFORMIN, CETIRIZINE, FOLIC ACID, CITALOPRAM, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), EXENATIDE (BYDUREON), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), OMEPRAZOLE, CEFIXIME (FLEXERIL [CEFIXIME]), NAPROXEN and PANTOPRAZOLE for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (shooting pain that started in the arm and traveled down to the hand (left)) and HYPOAESTHESIA (numbness in the hand). At the time of the report, PAIN (shooting pain that started in the arm and traveled down to the hand (left)) and HYPOAESTHESIA (numbness in the hand) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were provided.
Nontraumatic subarachnoid hemorrhage, unspecified Hemorrhagic cerebrovascular accident (CVA)
1 of 3 pts vaxed from same lots of Tetramune/OPV who exp an adverse event;pt vaxed 6SEP94  & w/in 1 hr began vomiting which persisted through noc & next day;7SEP MD visit lethargic,unresponsive;hospitalized poss viral infect;8SEP recovered
9-11 days post vax, the pt developed a headache, fever, body aches, and morbilliform rash all over body.
This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 11-JAN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L016202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse on 17-NOV-2017, referring to a 75 year old female patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. Concomitant therapies included an unspecified dose of influenza virus vaccine (unspecified). On 02-OCT-2017, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 for prophylaxis (strength, dose, route, frequency, lot # and expiration date were not reported). On an unknown date in 2017, the patient experienced severe swelling, tenderness and pain at the site of the PNEUMOVAX 23 injection and was diagnosed with cellulitis. At the time of reporting, the outcome of vaccination site cellulitis was unknown. Additionally, the causality assessment between injection site cellulitis and PNEUMOVAX 23 was not provided.
Tingling throat; Sore throat that felt swollen; Sore throat; This spontaneous report was received from a male patient of unknown age, who was reporting on himself. His medical history, concurrent conditions, drug reactions or allergies, and concomitant medications were not provided.  On 09-MAR-2020 (also reported as on an unknown recent date; conflicting information), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly for prophylaxis (dose, anatomical location, lot #, and expiration date were not provided).  Later, on an unspecified date in March 2020 (reported as one day and a half later), the patient developed tingling in throat (pharyngeal paraesthesia) which progressed to a sore throat (oropharyngeal pain) that felt swollen (pharyngeal swelling). The patient did not seek medical attention and did not receive any treatment for the events.  By the time of the report, the patient had not recovered from any of the events.  The reporter's causality assessment between pharyngeal paraesthesia, oropharyngeal pain, and pharyngeal swelling was not provided.
dose 2 in primary series administered too early at 21 days (instead of 28 days)
This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 11-APR-2016, the patient was vaccinated with a dose of (Oka-Merck) PROQUAD lot # L030589, expiration date 10-FEB-2017 (dose and route of administration were not provided) that underwent a temperature excursion at 14 degrees Fahrenheit for 3 hours and 22 minutes. No adverse events reported. Additional information has been requested.
Severe right burning thigh pain; Severe right burning thigh pain; Severe right burning thigh pain and paresthesia; This is a spontaneous report from a contactable Physician. This Physician reported for a 65-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL92666) via intramuscularly, administered in arm right on 14Feb2021 14:45 as single dose for covid-19 immunisation. Medical history included graves disease and prediabetes. The patient had known allergies to Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and metformin were received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient experienced severe right burning thigh pain and paresthesia on 20Feb2021, this resulted in clinical visit (Physician office visit). The patient did not receive the treatment for the events. The patient did not underwent COVID test post vaccination. The outcome of events was resolving.  No follow-up attempts are possible. No further information is expected.
After I received the vaccine. Approx 24 hours after the shot, I started having a headache. As my headache got worse, the ache muscle and joint pain came. When the headache started, I started feeling really tired. I was feeling like I was having flu symptoms. I started taking IB prophen on Wednesday morning. It lasted aprox 2 days, and I started feeling better on Saturday morning. Symptoms lasted about 3 days. Symptoms got better with IBprophen.
Information has been received from a health professional concerning a female pt with no medical history or allergies, who was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649913/0577P). There was no concomitant medication. Subsequently, the pt experienced pain and tenderness, and developed red streaks around her arm near the injection site. Within three to four days, the symptoms abated and the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected. It was also reported that two additional pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (WAES0501USA00539, 0502USA00116) and experienced adverse events.
arm pain; lack of sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and SLEEP DEFICIT (lack of sleep) in an 8-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In October 2023, the patient experienced SLEEP DEFICIT (lack of sleep). On 18-Oct-2023, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) and SLEEP DEFICIT (lack of sleep) outcome was unknown.            Concomitant medication was not reported.  The patient experienced arm pain causing lack of sleep. The patient had to stay home from school also. It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.
A 77-year-old male with history of COPD, CAD, DMT2, HTN presented with a chief complaint of shortness of breath and severe wheezing over the last 3-4 days. Patient stated he had a severe drop of weight (loss 30 pounds over the last year), which he is concerned about. He felt very weak. He denied any other symptoms. He was taken out of his home due to his roommate being positive w/COVID-19 and directed to go to the ED today by his PCP. Patient stated he has not been eating much for a while.
Patient reports extreme pain in her left arm along with swelling  and redness that spread to her elbow for the past four days. The patient reports that she could not lift her arm without pain for three days. The patient also reports a fever and general malaise.  The patient's arm was observed at the clinic with light redness and slight swelling at the injection site. The  redness spread distally to the posterior arm and stopped just above the patient's elbow. The patient reported that she has been alternating Tylenol and ibuprofen along with cold compresses and that it looks much better today (09/19/2022).
tingling of tongue on day of administration (10/08/21) but resolved by next morning (10/09/21) No antihistamine given. No rash, no swelling, no trouble breathing ever.
This case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. On 21st September 2018, the patient received SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On 27th September 2018, 6 days after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional information was reported as follows: The age at vaccination was not reported. The patient was also vaccinated with a Flu vaccine at the same time of vaccination with SHINGRIX. No additional information was provided by the reporter. The doctors' office was contacted by GlaxoSmithKline and waited for a call back.
Pt seen for laceration left index finger. Last Td 1998. Given Td booster in left deltoid. (This was last full dose in that bottle) At wound and hook on 7/15/04 pt noted to have slight erythema and 2 2-3mm vesicles (clear) at injection site. Pt denied itching, burning, respiratory symptoms, fever.
Initial sore arm at injection site, become slightly swollen and more tender to touch about 12 hours after injection- low grade temp, body aches, headache Treated with alternating ibuprofen and acetaminophen symptoms continued for approximately 36 hours after injection
Significant swelling (15cm in diameter), redness, warmth, pain on left arm worsened at day 8 post vaccination
24 hours later, severe headache and tired.  Also, canker sores in the mouth.
It was discovered that the vaccine  received was stored in a freezer longer than recommended by the manufacturer.  Per the manufacturer, since the potency of the vaccine cannot be determined, it's unclear of the level of immunity this dose was expected to deliver.  After consulting with our immunization experts, and with the vaccine manufacturer, it's recommended to repeat the dose to ensure full protection.
Severe nausea, 102.8 temp, severe chills, odd headache,  arm very sore, fatigue
Upper left torso rash and burning skin;  both front and back, did not cross midline; rash did formed small vesicles  Rash formed over 2 days  and seas seen by provider, diagnosed with Shingles Treatment with 7 day course of valtrex Symptoms of skin rash resolving at time of report, burning sensation has not resolved
patients were given expired Fluzone Quad, no Ae; pregnant patient received Fluzone quadrivalent, no Ae; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA301649.  This case involves a 30 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] in context of patients were given expired fluzone quad and pregnant patient received fluzone quadrivalent.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The reported events occurred at unknown gestation period and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE at 25 weeks of pregnancy, during second pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE.  The date of last menstrual period was reported as 08-May-2019. The estimated due date is 13-Feb-2020. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's previous pregnancy/ies not reported.  no other vaccines were given.   On 25-Oct-2019, the patient received a dose of 0.5 ml suspect INFLUENZA QUADRIVAL A-B VACCINE lot QFAA1816, exp date: 30-Jun-2019, via unknown route in unknown administration site.   It was a case of actual medication error due to expired vaccine used.  It was a case of vaccine exposure during pregnancy.   At the time of report the patient had no adverse event.  The patient outcome is reported as not applicable for both events.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Pt recv vax on 1/8/99; during vax pt cried through to next morning, both thighs swelled & bled
Death 3 days later. Received medical records from ER which indicate patient arrived at ER in full arrest & was unable to be resuscitated. 2/17/06 Autopsy report received which revealed COD as SIDS./ss
On Sunday evening, January 10th, I started becoming increasingly itchy in my face. I noticed it was blotchy and I had hives. My scalp was also very irritated. When I showered later that evening, I noticed that I had red dots on various parts of my body. This has since by diagnosed as dermatitis. On Monday & Tuesday, the 11 and 12 respectively, the hives, blotchiness and general irritation to my face and scalp got worse and I was very itchy.. The dermatitis continued to spread across my body include my torso & arms. My upper thigh also has some red dots but the rest of my legs, to date, appear to be okay. As of this writing, my entire body is itchy, but is general discomfort and hardly debilitating. As a note, I have not changed my laundry soap, bath soap, eaten anything different, etc as possible explanations for my hives and dermatitis. The only thing new in the last week and half has been the first dose of the COVID-19 vaccine
This is a spontaneous report from a contactable consumer reporting for her mother, communicated to a Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single  dose in one arm for immunisation and influenza vaccine (FLU), via an unspecified route of administration on an unspecified date at an unspecified dose in the same arm for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient received both vaccines, pneumococcal 13-val conjugate vaccine (dipht crm197 protein) and influenza vaccine, in the same arm. The patient experienced  a lot of redness, swelling, and pain on an unspecified date. The outcome of the events pain, redness and swelling was recovered on an unspecified date.
PATIENT SLUMPED IN CHAIR, DID NOT RESPOND, BEGAN SHAKING, TURNED PALE AND CLAMMY. EMERGENCY SERVICES CALLED. PATIENT BECAME RESPONSIVE TO QUESTIONS AFTER ABOUT 1 MINUTES. HE DID NOT WANT TO LIE DOWN AND CONSCIOUSNESS WAS NOT LOST. HE REMAINED SEATED AND COLOR RETURNED TO FACE AFTER A FEW MINUTES.
Janssen COVID-19 Vaccine EUA: patient currently hospitalized for COVID-19 disease with acute hypoxemic respiratory failure. Receiving steroids, remdesivir, and oxygen.
Myalgia, Arthralgia, Fever & Diarrhea Narrative:
Pt became cyanotic, limp & unresponsive; given CPR by parent; taken by ambulance to hosp; t104 in ER; dx febrile seizure;
Information has been received from a woman at a health department concerning an approximately 6 year old white and black male who on 27-JUL-2000 was vaccinated with Varivax. Subsequently the patient experienced "suspect vaccine failure." It was unknown if medical attention was sought. No further information was provided. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to an unspecified amount of patients (no patient names or demographics known). The an unspecified amount of patients might had been administered with a dose of MMR II (lot#, dose, route and strength not reported) that were out of temperature range and may of not been supported by Merck's stability data on unspecified date. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of the event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Middle left ear blockage since July 2, 7pm Severe pain in left ear since July 2 Severe headache  Pain was severe enough to disrupt sleep.  There is some relief for a few hours whenever she takes advil.  I went to a CVS Pharmacist on July 4th and she recommended melatonin to help her sleep  As of the time of this report, the ear blockage comes and goes, the ear pain and accompanying headache was still severe. She has taken Advil to ease the pain so she can sleep
Arm is red and swollen and itchy; Arm is red and swollen and itchy; Arm is red and swollen and itchy; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is red and swollen and itchy), PRURITUS (Arm is red and swollen and itchy), ERYTHEMA (Arm is red and swollen and itchy) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm is red and swollen and itchy), PRURITUS (Arm is red and swollen and itchy), ERYTHEMA (Arm is red and swollen and itchy) and PYREXIA (Fever). At the time of the report, PERIPHERAL SWELLING (Arm is red and swollen and itchy), PRURITUS (Arm is red and swollen and itchy) and ERYTHEMA (Arm is red and swollen and itchy) had not resolved and PYREXIA (Fever) outcome was unknown.            No concomitant medication was reported.  Treatment medication was not provided
Pt. complained of fever of 102 degrees, redness, swelling, and heat at injection site, body aches.