chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; The HCP reports that a patient was administered a dose of PEDVAXHIB after it was involved in an excursion.; This spontaneous report has been received from a medical assistant, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 06-DEC-2022, the patient was vaccinated with improperly storage dose Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular Injection, at a dose of o.5 milliliter (ml), for prophylaxis (lot number: T026066, which was determined to be valid, with an expiration date on 01-APR-2023) (strength dose, route of administration, vaccination scheme frequency, and anatomical site of injection were not reported) Administered doses were stored at a temperature of 101 degrees Celsius (C) during a time frame of 624 hours. There was no previous temperature excursion.  No additional adverse events were reported in the patient.
Information has been received from a physician via a company representative referring to a 62 year old female patient. The patient's medical history, concurrent condition medication were unknown. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (0.5 ml, lot# reported as M018768, expiration date: 15-OCT-2017) subcutaneously. On 19-SEP-2016, the patient experienced warmth and erythema (of the skin). The patient sought medical attention by visit the physicians. The outcome of the events were unknown. The causal relationship between the events and PNEUMOVAX 23 was unknown. Lot number M018768 is not valid for pneumococcal vaccine, polyvalent (23-valent). Additional information has been requested.
Patient presented to the ED and was subsequently admitted for angioedema within 6 weeks of receiving covid vaccination.
GAve this 2 year 8month old .5ml instead of recommended .25ml dose
This spontaneous report was received from a nurse practitioner referring to an unspecified number of patients of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (Lot No. K020758 exp. 31-OCT-2016 and Lot No. L004649 exp. 11-FEB-2016) (dose, frequency and route were not described). No concomitant therapies were provided. No adverse event information was provided. No product quality complaint was involved. This is one of two reports received from the same source (# 1508USA006747). Additional information has been requested.
PATIENT INSTRUCTED BY PHARMACIST TO STAY AND SIT DOWN FOR 15 MINUTES FOR OBSERVATION. SHE STOOD UP AND WALKED AROUND THE PHARMACY, THEN FAINTED BETWEEN 5 AND 10 MINUTES AFTER GETTING THE VACCINE.
Information has been received from a pharmacist concerning an adult patient (age and gender not reported) with unknown medical history and unknown allergies, who in early October 2005, was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot # 644220/1119M) which had expired on 4/9/04. It was reported that the patient developed redness, swelling at the injection site and general malaise 24 hours post vaccination, was treated with cephalexin, and recovered fully in about one week. No product quality complaint was involved. The reporter considered the site reactions including redness at the injection site, swelling at the injection site and general malaise to be other important medical events (OMIC). Additional information has been requested.
Large red area on inside of upper arm as well as lower upper arm (tricep area), also swelling beginning day after immunization. Went to see urgent care two days following immunization.
This is a spontaneous report received from contactable reporter. An 80-year-old male patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 79 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "heart issues" (unspecified if ongoing); "Pacemaker placed", start date: 2021 (unspecified if ongoing); "Atrial fibrillation" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, Manufacturer: Pfizer , NDC: Unknown , LOT: EL3249 , EXP: May2021 , Dose and Route: injected into left arm; dose amount unknown Time: 7PM), administration date: 18Jan2021, when the patient was 78-year-old, for COVID-19 Immunization, reaction(s): "a sore arm at the injection site"; BNT162b2 (Dose 2, single, Manufacturer: Pfizer , NDC: Unknown , LOT: EN9581 , EXP: May2021 , Dose and Route: injected into left arm; dose amount unknown Time: 10AM), administration date: 08Feb2021, when the patient was 78-year-old, for COVID-19 Immunization, reaction(s): "a sore arm at the injection site"; Shingles, for Immunization agains shingles.  Additional information: Patient and his wife both had the primary two doses. Then a 3rd dose that they thought was a booster dose on 11Oct2021 at 8AM-9AM. The 4th dose was actually a booster took on 27Apr2022. The 5th dose was a bivalent COVID-19 Vaccine took on 09Sep2022. Then today (19Jan2023), received another bivalent COVID-19 Vaccine. Patient stated all of their shots were Pfizer. Stated they did not have any side effects with the vaccines but maybe sore at the injection site for the previous vaccines. Medical conditions: Nothing necessarily. He has noticed references to heart issues and he has a pacemaker. Pacemaker placed: sometime in the year of 2021, but he had issues before the COVID-19 vaccines More recently he had atrial fibrillation and was given two medications. The atrial fibrillation was light, so they did not want to shock his heart. Appears the atrial fibrillation is gone. Atrial fibrillation: had symptoms of that at night before receiving the COVID-19 vaccines. Thought muscles were twitching before they discovered it was tied in with the heart. When he would lay on his own left shoulder, it felt like a light vibration. He was given the pacemaker, then had Atrial fibrillation, then given the medicine to take care of it. Investigations: none primary doctor and specialist are really good about keeping bloodwork up. Patient gave blood today (as reported). The report is not related to a study or programme.
This case was considered medically important (OMIC). Information regarding Hib Titer Vaccine (haemophilus b conjugate vaccine (diphtheria crm 197 protein conjugate) injection) was received from a healthcare professional concerning a 5 year old female pt. The pt received the fourth dose on 04May01. The pt also received the third dose of Hep B vaccine (manf unk) and the first dose of MMR on 04May01. The pt experienced autism at the age of 4. Relevant medical history was not provided. The indication for Hib Titer vaccine was immunization. The product was administered on 04May01. The dose regimen was 1 dose 1 timer per day (IM). Additional suspect medication included Diphtheria and Tetanus Toxoids Adsorbed, Purogenated (diphtheria and tetanus toxoids, aluminum phosphate adsorbed injection), Polio Vaccine inactivated), Varivax (varicella virus vaccine live), and Orimune (poliovirus live oral trivalent solution). Concomitant medications were not reported. Sometime in June 2001, at 15 months of age, the child experienced receptive language and speech delay which did not show improvement at subsequent visits to the physician. By early 2004, the child was diagnosed with autism. The reporter noted that the child is receiving therapy to improve her skills. No additional information was available at the time of this report.
Hot to the touch (4" below the injection site on the right arm); Itching(4" below the injection site on the right arm); Swollen (4" below the injection site on the right arm); red (4" below the injection site on the right arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch (4" below the injection site on the right arm)), VACCINATION SITE PRURITUS (Itching(4" below the injection site on the right arm)), VACCINATION SITE SWELLING (Swollen (4" below the injection site on the right arm)) and VACCINATION SITE ERYTHEMA (red (4" below the injection site on the right arm)) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch (4" below the injection site on the right arm)), VACCINATION SITE PRURITUS (Itching(4" below the injection site on the right arm)) and VACCINATION SITE SWELLING (Swollen (4" below the injection site on the right arm)). 13-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red (4" below the injection site on the right arm)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot to the touch (4" below the injection site on the right arm)), VACCINATION SITE PRURITUS (Itching(4" below the injection site on the right arm)), VACCINATION SITE SWELLING (Swollen (4" below the injection site on the right arm)) and VACCINATION SITE ERYTHEMA (red (4" below the injection site on the right arm)) outcome was unknown. Not Provided          No concomitant medications were reported.
I have had the same that most people complain about, soreness of arm, but nothing that concerned me. I have noticed changes to my vision and after one week, developing headaches that are not going away even with Motrin. I have also noticed after a few days after the shot a strange reaction, like if my heart jumped a beat and I had shortness of breath. It would be only one or two second episodes at a time, so I'm not too concerned, but if it continues, I will discuss this with my doctor. I had never felt that before. This is not chest pains, it's difficult to describe. It's like the heart has to "jump" a beat.. but only once or twice. It's scary, but it does not happen often and it's happening less in the past day. The headaches are not fun, but I hope they will go away after a few weeks. I don't suffer migranes or headaches on  a regular basis.
Information has been received from a registered nurse concerning a patient who was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). The patient developed a varicella outbreak shortly after vaccination characterized by a generalized vesicular rash. It was unknown if medical attention was sought. Subsequently, the patient recovered and the rashes have since resolved. There was no product quality complaint. This is one of several reports from the same source.
Initial medication error report received from a healthcare professional on 11 October 2013. Several patients had received FLUZONE which was expired on 03 April 2013. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
This spontaneous report as received from a pharmacist refers to a 48 years old female patient. The patient was vaccinated with ZOSTAVAX (lot # and dose not reported) on 02-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 02-AUG-2012 the patient experienced red, sore area, raised and swollen at the injection site. The patient sought unspecified medical attention-called the pharmacist. No treatment was given. The outcome of patient was not reported. The reporting pharmacist did not assess the causality of the events. Additional information has been requested.
sore throat; runny nose; terrible headache off and on; nauseated like I was going to pass out; muscle body ache, it's like somebody beat me with a bat and put me back in bed; fatigue / it's like somebody beat me with a bat and put me back in bed; hurt my body to walk, like every bone had been beat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (hurt my body to walk, like every bone had been beat), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), HEADACHE (terrible headache off and on) and NAUSEA (nauseated like I was going to pass out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN (hurt my body to walk, like every bone had been beat). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), HEADACHE (terrible headache off and on), NAUSEA (nauseated like I was going to pass out), MYALGIA (muscle body ache, it's like somebody beat me with a bat and put me back in bed) and FATIGUE (fatigue / it's like somebody beat me with a bat and put me back in bed). At the time of the report, PAIN (hurt my body to walk, like every bone had been beat), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), HEADACHE (terrible headache off and on), NAUSEA (nauseated like I was going to pass out), MYALGIA (muscle body ache, it's like somebody beat me with a bat and put me back in bed) and FATIGUE (fatigue / it's like somebody beat me with a bat and put me back in bed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Pulmonary embolism; This is a spontaneous report from a contactable consumer (patient's cousin). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 27Jan2021 (at the age of 83-year-old) as dose 1, single for covid-19 immunisation. Medical history included controlled hypotension. The patient's concomitant medications were not reported. The patient experienced pulmonary embolism on 12Feb2021. The consumer is calling about the Covid 19 vaccine, on behalf of her cousin (the patient) that used to live with her when they were children. The patient received the Covid 19 vaccine in Jan2021 and he died afterward of a pulmonary embolism. This has been a touchy subject talking to the patient's wife. The patient did not have any other health issues. He was getting ready for work and he died. The only reason he got the Covid 19 vaccine was so he could visit the caller's 97 year old mother. An autopsy was performed by the funeral home and it states cause of death, pulmonary embolism. She reports the coroner with Rolling Hills has the autopsy information. The patient only received one dose of the Pfizer Covid 19 vaccine. The caller reports that the patient was very good at going to his doctor's appointments. She reports the patient did have controlled hypertension on medications, no big deal. He wasn't overweight or diabetic or even prediabetic. His death just seems very random. She reports the date of death as 12Feb2021 early in the morning. The patient was in the bathroom getting dressed for work. The caller is glad the patient's children wanted an autopsy because the patient did not have any preexisting conditions. The evet did not require a visit to Emergency Room or Physician Office. There is no relevant tests. The patient died on 12Feb2021. An autopsy was performed, autopsy-determined cause of death was pulmonary embolism.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pulmonary embolism
refrigeration excursions identified; No Adverse Event; Vaccine have undergone several temperature excursions and was administered to the patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine have undergone several temperature excursions and was administered to the patient), PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration excursions identified) and NO ADVERSE EVENT (No Adverse Event) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Sep-2022 at 10:49 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 17-Sep-2022 at 10:49 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine have undergone several temperature excursions and was administered to the patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration excursions identified) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine have undergone several temperature excursions and was administered to the patient), PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration excursions identified) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine have undergone several temperature excursions and was administered to the patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration excursions identified).    No concomitant medications were reported.  Vaccination site was deltoid muscle.  On 07-Sep-2022, the vials were initially moved from freezer to refrigerator.  The nurse reported that, Moderna Monovalent and Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back in Aug-2022. It was reported that, refrigeration excursions were identified, and state vaccines were housed in these units. The manufactures were notified, and the state department made aware of the situation. The storage condition of vial at the time of excursion was in refrigerator. The vials were not visually inspected.  No adverse reactions reported for the patient.  No treatment medications were reported.
I never had arthritis. Now I do. My right knee swelled that I needed it to get drained with a cortisone shot. Now I'm  being put on  medication.  I have psoriasis on my hands and feet.
Swelling, fever near injection. Knot larger than softball around the area of injection. Hot to touch. Severe infection in shoulder, arm down to hand. Infection had spread to back.of my arm and down into my elbow. Have photos if needed. This was my 2nd injection
Patient given vaccinia vacine on 19NOV then deployed on 23NOV, began having symptoms on 29NOV. Patient states he noted body aches, headache, chills but no rash on Friday 29NOV13, then on Saturday 30NOV he noted a small rash on his forearms, which progressed to a pruritic rash over posterior neck, lower forearms, and lower legs.  Rash was raised but not purulent or scaly. The patient was seen by the clinic provider who took the patient to the Hospital. At hospital the patient was evaluated by Neurosurgery, had a brain and C spine MRI performed, both of which were normal with no sign of encephalitis. He was discharged with Acyclovir, Amitryptaline, and Lyrica.  The patient was placed on isolation precautions for 7 days and was maintained in quarantine.  From SAT 30NOV until 06DEC the patient was kept in quarantine with follow up at least twice a day. On Sunday 01DEC, rash was very pruritic and the patient has a small pruritic lesion on the medial sclera of right eye that did not involve the cornea or effect on vision maintaining 20/20 vision in both eyes. The fever symptoms resolved by MON 02DEC, the eye pruritis and lesion resolved by WED 04DEC.  The rash on the forearms and lower legs primarily resolved by 05DEC, the rash on the back of the neck flattened out and became asymptomatic by 06DEC.  At no time were there any open sores, pustules, weeping, scaling, or sloughing of skin.
Reported observing redness and swelling at injection site the morning after the Tdap was administered. Swelling and pain has increased today (day two after administration) to arm, front of shoulder/clavical, and swelling up to neck. Also reports itching at the site. Reported having "chills" earlier; denies elevated temperature.
Patient received flu shot on 9/26/08, 3 days later right arm was swollen, red, warm to touch, itchy and had a rash at the site of injection. She came to clinic on 10/20/08 and was treated with benadryl and prednisone 60mg po daily x 3 days.
THE NEXT DAY 5/18/21 AT 900 AM WHEN PT WOKE UP NOTED TO HAVE ANGIOEDEMA ON THE FACE, BOTH CHEEKS  ARE SWOLLEN. Pt took Zyrtec per advise of provider, for 2 days, edema resolved but came back. after 4 days, then she took Zyrtec again for another 2 days.
p/vax pt exp redness & swelling of the arm;the swelling noted to be 1 to 1/2 time the nl size;1 day later pt recovered;
Difficulty breathing, hoarse voice, dizziness, nausea, wheezing, cold and clammy skin.  Treated with epinephrine 0.3 mg IM x 2, diphenhydramine 100 mg IM x 1, transported to ED. First dose of epi administered within 2 minutes of presentation.  ED physician reported swelling of uvula, no signs of shock with stable BP.  Admitted for observation at Medical Center. 11/3/2009 records from ED visit 11/2/2009.  DC DX Anaphylactic reaction, ICD-9 code 999.5  Patient with c/o's of throat, tongue, uvular and facial swelling, wheezing, dyspnea, respiratory distress with stridor. Tx: IV Solu Medrol, Benadryl, Famotidine, O2.
Fainted; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fainted.   The patient's medical history included diabetes, cholesterol, hypertension, and osteoporosis. Concomitant product use reported included unspecified medications for diabetes, cholesterol, high blood pressure, and osteoporosis.   On 08 Jan 2021, approximately three days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: VW7392) intramuscularly in the arm for prophylaxis of COVID-19 infection.  On 11 Jan 2021, the patient fainted at 3:00 am and again at 7:00 pm. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported .   The outcome for the event, fainting, was not reported.; Reporter's Comments: This case concerns a 79 year old female subject, with medical history of diabetes, cholesterol and hypertension, who experienced a serious unlisted event of syncope.   The event occurred 3 days after the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  However a definitive assessment is confounded by the patient's history of diabetes and hypertension.
Hives, fever and rash developed 2 days, post vax. Pt also complained of tightness in chest. Mom called nurse triage then was advised to give Benadryl and go to ER. Atelectasis in chest improved with steroids and antibiotics.
I had a fever and body aches until approximately from 4am the day after the vaccine to 4am the next day.
7/12/21 G1P0 at 40w1d by 1TUS presenting to triage due to elevated BP of 130s/90s and low fluid