chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 09-SEP-2013, the patient's healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 05-MAY-2016, the patient was treated at a dermatology office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the her injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
TESTED + FOR COVID 9-27-22 AT hospital AFTER presenting with shortness of breath and confusion.  She was a hospice patient  admitted with covid and copd exacerbation and confusion.   finished remdesivir and dexamethasone on 10-1-22 and did not require oxygen .  felt she could go home with hospice to follow.   psych was consulted due to confusion and felt it was medically related.    CXR NEGATIVE FOR PNEUMONIA.     DECEASED 10-11-22 AT HOME.
Information has been received from a nurse concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL. On the same day the patient experienced syncope and vertigo. Subsequently, the patient recovered fully from syncope and vertigo on the same day. The patient saw the nurse practitioner. This is one of several reports received from the same source. Additional information has been requested.
DEC91 ran a fever for 5-6 days, t101 ax very irritable, then broke out in fine red rash, MD question rxn to vax (DTP); referred to MD to give next dose; 21JAN92 mom states DT given w/out any type of rxn following vax;
Vomited blood; Had a problem with internal bleeding; Blood in stool; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATEMESIS (Vomited blood), INTERNAL HAEMORRHAGE (Had a problem with internal bleeding) and HAEMATOCHEZIA (Blood in stool) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2021, the patient experienced HAEMATEMESIS (Vomited blood) (seriousness criteria hospitalization and medically significant), INTERNAL HAEMORRHAGE (Had a problem with internal bleeding) (seriousness criteria hospitalization and medically significant) and HAEMATOCHEZIA (Blood in stool) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 5 days due to HAEMATEMESIS, HAEMATOCHEZIA and INTERNAL HAEMORRHAGE. The patient was treated with IRON for Supplementation therapy, at an unspecified dose and frequency. At the time of the report, HAEMATEMESIS (Vomited blood), INTERNAL HAEMORRHAGE (Had a problem with internal bleeding) and HAEMATOCHEZIA (Blood in stool) outcome was unknown.            Concomitant medications were not reported. The patient reported that about 3 days after his booster he had a problem with internal bleeding. He experienced blood in stool and vomited blood. He went to ER and then they transferred him to ICU where he was hospitalized for 5 days. Hospital gave patient 6 bags of blood transfusions and he was currently taking iron supplements. CC: This is a spontaneous case concerning a 55-year-old male patient with no medical history reported, who experienced the serious, unexpected, according CCDS, events of haematemesis, internal haemorrhage and haematochezia. The events occurred on an unknown date on the same month after the 3rd dose of mRNA-1273 vaccine. The patient reported that about 3 days after the booster dose, he had a problem with internal bleeding. He experienced blood in stool and vomited blood. He went to ER and then they transferred him to ICU where he was hospitalized for 5 days. The patient received 6 bags of blood transfusions and he was currently taking iron supplements. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 55-year-old male patient with no medical history reported, who experienced the serious, unexpected, according CCDS, events of haematemesis, internal haemorrhage and haematochezia. The events occurred on an unknown date on the same month after the 3rd dose of mRNA-1273 vaccine. The patient reported that about 3 days after the booster dose, he had a problem with internal bleeding. He experienced blood in stool and vomited blood. He went to ER and then they transferred him to ICU where he was hospitalized for 5 days. The patient received 6 bags of blood transfusions and he was currently taking iron supplements. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Period stopped on July 3, got 2nd dose July 10, and got a bonus period on the 11-th; Bleeding from uterus 3 days longer than normal; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Bleeding from uterus 3 days longer than normal) and MENSTRUATION IRREGULAR (Period stopped on July 3, got 2nd dose July 10, and got a bonus period on the 11-th) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Bleeding from uterus 3 days longer than normal). On an unknown date, the patient experienced MENSTRUATION IRREGULAR (Period stopped on July 3, got 2nd dose July 10, and got a bonus period on the 11-th). At the time of the report, HEAVY MENSTRUAL BLEEDING (Bleeding from uterus 3 days longer than normal) and MENSTRUATION IRREGULAR (Period stopped on July 3, got 2nd dose July 10, and got a bonus period on the 11-th) outcome was unknown.            No concomitant medications were provided.   No treatment medications were provided.
had breathing issues (difficulty breathing)/ Couldn't breathe; chest discomfort, pressure; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP6955), via an unspecified route of administration, administered in left arm on 23Mar2021 between 09:00-09:30 (at the age of 60 years) as dose 1, single for COVID-19 immunization. The patient's medical history was none. The patients concomitant medications were not reported. Additional vaccines administered on same date of the pfizer suspect were none. Prior vaccinations (within 4 weeks) were none. AEs following prior vaccinations were none. The patient experienced breathing issues (difficulty breathing)/ couldn't breathe and chest discomfort, pressure on 23Mar2021 about 5 mins after she got the injection. She said luckily there were paramedics there that helped her. Her symptoms lasted 3 or 4 minutes it resolved by itself, but she said it was pretty scary and she was concerned about taking the second dose of the vaccine. They checked her out everything was ok, she went to hospital, everything was ok. Event resulted in emergency room visit. The patient was not hospitalised. She stated they took some blood at the hospital, but she doesn't know the results. She had to get that from the hospital. The outcome of the event recovered on 23Mar2021.  No follow-up attempts are needed. No further information is expected.
5NOV98 pt recv vax & sx occurred on 1DEC98-blister-like bumps to forehead, back, chin, scrotum area;
Blood pressure increase; Heart rate increase; Vasoconstriction; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure increase), HEART RATE INCREASED (Heart rate increase), VASOCONSTRICTION (Vasoconstriction) and FATIGUE (Fatigue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20a) for COVID-19 vaccination.     Concomitant products included MONTELUKAST SODIUM (SINGULAIR), ETHINYLESTRADIOL, NORGESTIMATE (TRINESSA) and CHLORPHENAMINE MALEATE (CHLORPHENIRAMINE C) for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure increase), HEART RATE INCREASED (Heart rate increase), VASOCONSTRICTION (Vasoconstriction) and FATIGUE (Fatigue). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure increase), HEART RATE INCREASED (Heart rate increase), VASOCONSTRICTION (Vasoconstriction) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included pepsid, bendryl, symbicort, albuterol inhaler, allegra, prednisone steroid, solumedrol and epipen.
This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling (swelling in arm) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced peripheral swelling (swelling in arm). At the time of the report, peripheral swelling (swelling in arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Delayed cutaneous hypersensitivity, red, raised, itchy, painful area near vaccine site.
Narrative:  COVID infection following COVID vaccine series 03/08, Pfizer, dose #1 03/27, Pfizer, dose #2 12/22 COVID swab, result: detected 12/22 SARS-COV-2 Variant Sequencing: pending 12/22 pt cc: exposure: unknown
Information was received from an office manager concerning an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of oral ROTATEQ (dose and route not reported, lot number L027070, expiration date: 30-APR-2017). The vaccines were stored in 33 Fahrenheit degrees for 5 hours. They were back in range. There was no previous temperature excursion. The report was made because of digital logger. There were no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Day of vac developed fever 103-104(F) lt leg at inj site red w/rash. Admitted to hosp. Tx w/IV & IM antibiotics. D/c'd on oral antibiotics 6JAN91. Rash fine red (like a hive) at inj site spread to lt buttock.  8Jan91, temp to 106.5
large red, hot, knot on arm-lasted 3 1/2 weeks, pain at injection site, radiating down to elbow and wrist-lasting 4 weeks
Patient given first Anthrax vaccination 1 Feb 03, along with Smallpox vaccination.  On 16 Feb 03, developed typical symptoms of L sided Facial nerve palsy (Bell's Palsy).  Had a persistant L otitis media treated with antibiotics at the time.  On 1 Mar 03, developed substernal chest pain, similar to pain evaluated less than one year prior and diagnosed non-cardiac; this episode determined to be benign process.
Moderna on 2/24 and 3/26. Positive on 11/3
Information has been received from a registered pharmacist (R. Ph.) concerning a 62 year old female patient who on 09-MAY-2011 was subcutaneously vaccinated (the pharmacist stated that the injection was given subcutaneously and the patient stated that the injection was given intramuscularly) with one dose of 0.65 mL of ZOSTAVAX (Merck) (Lot# 670384/0253AA, expiration: 18-MAY-2012). The pharmacist reported that around this week, on approximately 16-MAY-2011, the patient experienced a lesion on her lip, urinary tract infection and flu-like symptoms after ZOSTAVAX (Merck) injection. The patient sought unspecified medical attention. It was reported that the patient's physician was performing a culture on the lesion and the results would be in the next week to determine the cause. At the time of reporting the patient was recovering. Additional information has been requested.
Extreme fatigue by 1:30pm 1/27/21 Headache and pain/swelling at injection site by 3:30pm 1/27/21 Rigors, chills fever 100.9 by 11pm 1/27/21 (even with Tylenol on board) Moderate joint pain throughout entire body starting evening of 1/27/21 and still experiencing on 1/29/21 but milder Pain sensation on skin when clothing would rub with movement began middle of the night 1/27/21 and was gone by night of 1/28/21
Mom states redness on R upper arm. Area 1 1/2 in diameter. Warm to touch. "Looks like 2 bugbites side by side." Afebrile. No complaints pain.
8/01/12 approx 2:40pm client, post vaccination, c/o lightheaded, dizzy, fainted & observed having possible seizure x 5 secs, while sitting on chair. Clinic staff assisted client onto floor in sitting position. EMS contacted, client refused transport to ER at hospital. B/P 130/80, R=24 P=88, non cyanotic observed. Client states gets anxiety episodes, had last episode last night & EMS was contacted. Client contacted mother took to ER at hospital released home no TX needed. FU with his PCP as needed & future vaccinations need lie down.
Light Sweat; Pain; Low grade fever; sore arm; rear of neck/rear of shoulder; rear of neck/rear of shoulder; eyes were painful; muscle pain; injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Light Sweat), PAIN (Pain), PAIN IN EXTREMITY (sore arm), NECK PAIN (rear of neck/rear of shoulder) and ARTHRALGIA (rear of neck/rear of shoulder) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Myocardial infarction on 16-Dec-2016. Concurrent medical conditions included Sulfonamide allergy, Drug allergy (Torodol) and Back pain (L5-S1OR 1985; L4-S1 Fusions 1999 & 1999 twice) since 1972. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Clot blood, LAMOTRIGINE, TIZANIDINE and AMITRIPTYLINE for Nerve pain, ALFUZOSIN for an unknown indication.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), NECK PAIN (rear of neck/rear of shoulder), ARTHRALGIA (rear of neck/rear of shoulder), EYE PAIN (eyes were painful), MYALGIA (muscle pain) and INJECTION SITE PAIN (injection site soreness). On an unknown date, the patient experienced HYPERHIDROSIS (Light Sweat), PAIN (Pain) and PYREXIA (Low grade fever). The patient was treated with RANOLAZINE (RANEXA) (oral) at a dose of 500 mg twice a day; ROSUVASTATIN at a dose of 20 mg once a day; CARVEDILOL at a dose of 3.125 mg twice a day and LOSARTAN POTASSIUM (LOSARTAN POTASSSIUM) at a dose of 25 mg once a day. At the time of the report, HYPERHIDROSIS (Light Sweat), PAIN (Pain), INJECTION SITE PAIN (injection site soreness) and PYREXIA (Low grade fever) outcome was unknown and PAIN IN EXTREMITY (sore arm), NECK PAIN (rear of neck/rear of shoulder), ARTHRALGIA (rear of neck/rear of shoulder), EYE PAIN (eyes were painful) and MYALGIA (muscle pain) had resolved.            This case was linked to MOD-2021-300126 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: FU received on 30 Aug 2021,Contains no new information
tingling in my finger, toes, my pinky and ring finger went numb on my right hand for several hours , cold spurting sensation on the sides of my tongue, hands and feet and wrists,numb lips , numb spots on my face, large hives , loss of appetite still on going. I haven't gotten the rest of the shots because , I can't find a doctor who will even talk to me about all of this
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer, Case MOD22-013894. The manufacturer tested the lot number 084J21A. Data revealed that the vaccine administered on April 1 to April 8, 2022 from lot number 084J21A likely maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The vaccine administered on April 9 to May 11, 2022 from lot number 084J21A likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration. We are working on contacting the patient and recommending re-vaccination. No ill effect post #18 vaccination has been reported to our practice.
pt passed away in the nursing home; had a positive COVID test on 1/16/22; per death certificate, COVID 19 was a condition contributing to cause of death
I experienced extreme muscle and body ache for 2-3 days after both injections. Low-grade fever, fatigue, and injection site pain radiating throughout my entire arm.
Pt complained of redness and swelling began few hours after Pneumovax given. The area of redness and swelling is at injection site and with inferiority on right upper arm. Area of erythema/ edema/ center approximately 11cm length by 17 cm width.
12/5 sudden ataxia and elevated temp.  To ED and diagnosed with pneumonia and admitted to Acute Care and started on antibiotics.
Patient developed cough about one month after the second dose of his vaccine.  He does not have history of underlying lung disease.   His CT scan showed diffuse ground glass appearance.  Developed progressive and rapid respiratory failure.  He was admitted to hospital on 5/13 and expired 5/30.
I experienced extreme fatigue, congestion, slight cough, sore throat after my vaccination.  I had a virtual telemedicine.  I was instructed to take a decongestion that had a anti-decongestion and Tylenol for pain.  I was down for quite a bit for few days.
This case was reported by a consumer via out of hour services and described the occurrence of pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (developed shingles in December of 2017). Previously administered products included ZOSTAVAX, Swine flu shot (received in 1976), Chemotherapy and flu shots. On 4th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 4th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain. On 7th June 2018, the patient experienced chills and fever. On 8th June 2018, the patient experienced light headedness. On 9th June 2018, the patient experienced sore throat. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the light headedness and fever were unknown and the outcome of the sore throat and chills were recovering/resolving. The reporter considered the pain to be related to SHINGRIX. It was unknown if the reporter considered the light headedness, sore throat, chills and fever to be related to SHINGRIX. Additional details were provided as follows: The patient stated that, she had another shingles shot years before the date of reporting and developed shingles in December of 2017. On 4th June 2018 Monday, at 14:09 the patient received SHINGRIX. The patient experienced a sharp pain above her elbow while driving home. On 5th June 2018, Tuesday, the patient was fine. On 6th June 2018, Wednesday, 2 days after vaccination, the patient woke up in the morning with some soreness. On 7th June 2018, Thursday, 3 days after vaccination, in evening the patient had some chills but she did not feel sick and at first thought her air conditioning was too low but then developed a fever of 101.5, her temperature usually runs around 97.4. On 8th June 2018, Friday, 4 days after vaccination, the patient started to experience some lightheadedness. On 9th June 2018, Saturday, 5 days after vaccination, one side of the patient's throat was sore. She said when she first woke up, her temperature was normal but then it was spiked later in the day. The patient did not have a fever so far on the reporting date. The patient was not sure if she wanted to provide the name of her physician so a letter should be sent to her. Lab Comments: The patient's body temperature usually runs around 97.4.