chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine from a vial that was exposed to room temperature for more than 12 hours; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine from a vial that was exposed to room temperature for more than 12 hours) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine from a vial that was exposed to room temperature for more than 12 hours). On 14-May-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine from a vial that was exposed to room temperature for more than 12 hours) had resolved.        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 concomitant medications were reported. It was reported that the patient was fine and did not had any side effects. No treatment medications were reported.   This case was linked to MOD21-090714, US-MODERNATX, INC.-MOD-2021-138701, US-MODERNATX, INC.-MOD-2021-138817 (E2B Linked Report).; Sender's Comments:  MOD21-090714: US-MODERNATX, INC.-MOD-2021-138701: US-MODERNATX, INC.-MOD-2021-138817:
This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # reported as M040141, expiration date: 27-MAR-2018 , lot # M038860, expiration date: 13-MAR-2018, lot # reported as M029931, expiration date: 09-NOV-2017, lot # M018636, expiration date: 11-OCT-2017, lot # M007964, expiration date: 15-AUG-2017 or lot # M006104, expiration date: 07-JUN-2018, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion between 6 and 14 Fahrenheit degrees for 2 days. There were no previous temperature excursions reported. Data logger was involved. No adverse reactions were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. ; Sender's Comments: US-009507513-1703USA009938: US-009507513-1703USA006914:
This spontaneous report was received from a Licensed Practical Nurse via company representative referring to a currently 15 year old female patient who on 10-MAR-2015, was vaccinated with a booster dose of (Oka/Merck) VARIVAX, subcutaneously (lot # reported as K006133, dose unspecified). No pertinent medical history, concurrent conditions and other co-suspect or concomitant medications were reported. In March 2015, the patient experienced injection site swelling and injection site erythema (reported as swelling and redness at the injection site respectively) after receiving the booster dose of (Oka/Merck) VARIVAX. Patient was seen by the physician, but no treatment was provided for the events, and the patient was sent home. The outcome of injection site swelling and injection site erythema was unknown. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of sickness in a elderly female patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2017-2018 season for prophylaxis and SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX, Influenza vaccine Quadrivalent 2017-2018 season at an unknown dose and the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX and Influenza vaccine Quadrivalent 2017-2018 season and not applicable after receiving SHINGRIX, the patient experienced sickness, fever, stomach discomfort and incomplete course of vaccination. On an unknown date, the outcome of the sickness, fever and stomach discomfort were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the sickness, fever and stomach discomfort to be related to SHINGRIX and Influenza vaccine Quadrivalent 2017-2018 season. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported but the patient could be 64 or 65 years old. The patient on Thursday had a SHINGRIX and a flu vaccine at least 6 to 8 months prior to the date of reporting. After the first dose of SHINGRIX, the patient was sick, had fever and sick to her stomach for the weekend following the Thursday she received it on. The patient was told she could get her SHINGRIX vaccine in one dose and would not need to return. The patient had not returned for a 2nd dose of SHINGRIX vaccine, which led to incomplete course of vaccination. The reporter did not know what flu vaccine the patient got, but did believe the shots were given separately during that visit. It was given at a physician office, but caller doesn't know any details of it. The overdose was not reported, as the reporter was unsure if two doses were given at same time. Case number was provided for the patient if she wanted to callback and give additional details.
PFIZER COVID VACCINE ADMINISTERS APPROX 4PM, 4:03PM (APPROX.) PATIENT FAINTED IN CHAIR IN WAITING AREA. MOM & PHARMACIST GENTLY LAID PATIENT DOWN ON FLOOR, PATIENT REGAINED CONSCIOUSNESS WITHIN 1 MIN & WAS ALERT, KNEW HIS NAME, WHERE HE WAS, WHAT WAS HAPPENING. GAVE PATIENT OJ, WATER, GRANOLA BAR, TRIED TO HAVE HIM SIT IN CHAIR AFTER ABOUR 5-10 MIN, BUT PATIENT STATED FEELING LIKE GOING TO PASS OUT, HAD PATIENT LAY ON FLOOR WITH FEET UP ON CHAIR. APPROX 4:30PM PATIENT VITALS: BP 72/48, HR 81, O2 SAT 99%. PATIENT FEELING DIZZY, LAID ON FLOOR WITH FEET UP ON CHAIR, CONTINUED DRINKING WATER AND OJ.  APPROX. 5PM PATIENT SITTING IN CHAIR, VITALS: BP 98/62, HR 95, O2 SAT 98%. PHARMACIST CONSULTED PEDIATRICIAN WHO ADVISED IF PATIENT FEELING OKAY AND NOT DIZZY/FEELING FAINT, OKAY TO LET GO HOME BUT TO REST TONIGHT AND TAKE IT EASY. ADVISED MOM TO TAKE TO ER IF ANY FURTHER FAINTING INTO THE EVENING. APPROX. 5:10PM PATIENT LEFT PHARMACY WITH MOM AND STATED FEELING FINE. MOM ACKNOWLEDGED SHE UNDERSTOOD PLAN FOR EVENING AND TO FOLLOW UP WITH PEDIATRICIAN REGARDING GUIDELINES/HOW TO HANDLD 2ND DOSE OF VACCINE.
Patient administered dose from a Moderna COVID-19 vaccine vial 18 hours after puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered dose from a Moderna COVID-19 vaccine vial 18 hours after puncture) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, received third 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 12-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered dose from a Moderna COVID-19 vaccine vial 18 hours after puncture). On 12-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered dose from a Moderna COVID-19 vaccine vial 18 hours after puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Date the vial was initially stored in the refrigerator 09 DEC 2021. Date and time vial was first punctured 11 DEC 2021 5:30pm. Date of administration of vaccine 12 DEC 2021 11:30 am.
Redness, swelling 108mm x 103mm, hot, no pain. Right deltoid improving some yesterday.
Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  It was reported that vial was initially stored in the refrigerator on 17-Dec-2021. It was stated that vial did not undergo an temperature excursions. The BUD was on 16-Jan-2022.  Treatment information was not provided.
This spontaneous report as received from a registered nurse refers to a 16 year old male patient. On an unknown date, the patient was vaccinated with a dose of MMR II (dose, dose number, lot/batch number, expiration date and indication not reported). On an unknown date, the had his titers drawn for verification of immunity for measles, rubella, mumps and varicella which came back negative for measles, rubella, mumps and varicella. No adverse effect was reported. It was reported that the patient had proof of vaccination on an unspecified dates for all vaccines prior to the titers being drawn. The outcome of the event was unknown. The related between the evens and MMR II was not reported. Additional information has been requested.
Headache, Fatigue within an hour, 8 hours after Achiness all over, Chills, Fever, Racing Heartbeat, Headache comes and goes, sleepiness, then too hot can't sleep Took 2 Ibuprofen, 2 x 30 suedo-effedrin  , ate bagel and cream cheese, 1/2 a banana 3x2000 D3 vitamin Trying to sleep now
On the third day after the injection,  I had a sudden return of sx previously experienced with medications cleared  3A4/5 and 2C19 including rigid paralysis for >11 minutes,  multiple contractions, numbness/tingling in legs. I had not experienced any of these symptoms for > 3 months.      Also fibromyalgia sx exacerbated to include burning pain in L arm (injection site) For 1 week, my arm turned red, like sunburn and burned.  After week 1, there was no redness but there was more pain than burning and that continued for about 4 weeks. This has since abated. I currently have extreme fatigue, fibromyalgia pain in multiple sites, esp breast, chest and legs.  Numbness and tingling continues in my feet and legs.  I am also experiencing transient numbness in my lower face, periods of severe "brain fog" (this seems to be improving) and GERD sx relieved by antacids.
Immediately upon injection I felt like I had received an electric shock.   A few hours later I began shivering severely and uncontrollably.   This lasted for hours.    Later I developed a severe headache.   I vomited and felt weak and dizzy.   I still feel ill.  I have never had a reaction to any vaccine like this.   I was very frightened until I googled Shingrix reactions and realized my problems were common.
Patient states that  they had chills the next day and then a fever 2 days after shot.  The patient says that the developed a blister on arm 3-4 days after the shot.
Information has been received from a 34 year old female with no medical history and no allergies, who on an unspecified date in 1999 was vaccinated with varicella virus vaccine live for chickenpox vaccination.  Concomitant therapy included vitamins, reported as multi-vitamins.  The reporter stated that she began to experience hives seven days after she was administered the vaccine, approximately 1999.  The hives were described as round raised bumps which often have red around the perimeter of the hive.  She reports that she has experienced them at least once a year for several months.  She reported that blood work was performed and nothing significant was found.  No other information was available.  The patient's outcome was reported as not recovered.  There was no product quality complaint reported.  Unspecified medical attention was sought.  Additional information has been requested.
A few moments after getting Moderna vaccination, patient reported not feeling well. After asking a few questions, patient stated that she had fainted after shots before and had a severe fear of needles. We recommended that she stay seated in the IMZ room rather than getting up to wait in the waiting area. Her hands began to quiver and her head started to slump. I held her shoulders so she would not fall and asked if she was ok. She said she wanted to lie down.  Her friend and I were able to gently lower her to the ground.  She appeared to pass out for a brief moment, then awoke and was able to answer questions but still did not feel well.  We raised her feet and offered to call 911 for evaluation. Patient felt continually better over the next 30 minutes.  We checked her blood pressure and it was low.  We rechecked about every 5-7 minutes and it was climbing.  After feeling better for awhile, we helped her into a chair to see if she was well enough to go home.  She mentioned that she had started feeling ill again.  We checked her blood pressure and it had dropped again.  She started feeling better within a few seconds and 5 minutes later her blood pressure was back up.  Eventually she felt well and headed home with her companion who was very attentive.
Patient felt dizzy and fainted after her 3rd vaccine (varicella). Palms were sweaty, skin was cool. HR 60, BP 70/palp, SpO2 96%. Patient was responsive to voice commands within 30 seconds of fainting but was still disoriented. She was given some sips of water and moved to a supine position. BP was then 108/60, HR 60. Within 5 minutes her BP had returned to 120/70, HR 80, SpO2 98%. Patient rested and was closely monitored for another half hour, during which time she spoke to her father and her grandmother was at her side. Her father stated that she had been extremely anxious about getting the vaccine the night before and had not slept well. She has the same fear of needles that her father has, although this was not expressed prior to the injections. Sent home with her grandmother with instructions to speak with her primary care about the incident.
Within 18 hrs of administration of DTaP, left deltoid and upper and lower arm and chest became red and swollen, non-painful and afebrile.
Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster).    No concomitant medications were reported.   It was reported that, nurses had no standing orders other than what they had for the second booster, when first administering Bivalent boosters. So, they assumed the same dose as the second booster, hence they were administering 0.25 ml instead of 0.5 ml to uncompromised adults.  It was reported that approximately 100 patients were administered an invalid dose of the Moderna COVID-19 bivalent booster.  No treatment details were reported.
My left arm has not stopped throbbing since I have gotten the Janssen J & J shot. This is an all day every day occurrence.
headache at the base of my skull; I have had a stiff neck; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-May-2021 and was forwarded to Moderna on 30-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (I have had a stiff neck) and HEADACHE (headache at the base of my skull) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (I have had a stiff neck). On an unknown date, the patient experienced HEADACHE (headache at the base of my skull). At the time of the report, MUSCULOSKELETAL STIFFNESS (I have had a stiff neck) and HEADACHE (headache at the base of my skull) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant drugs included no treatment drugs included
Diarrhea, nausea, abdominal discomfort, injection sight was very sore.  Anti- diarrhea over the count medication taken.  Bed rest for 2  days.
acute stroke secondary to intraventricular bleed in left hypothalamus and intraventricular blood with no mass effect; acute stroke secondary to intraventricular bleed in left hypothalamus and intraventricular blood with no mass effect; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 01-DEC-2011, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration dates were not provided) for routine adult health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the pt suffered slurring speech, development of facial droop and loss of consciousness and was later diagnosed with an acute stroke secondary to intraventricular bleed in left hypothalamus and intraventricular blood with no mass effect (haemorrhagic stroke and intraventricular haemorrhage). As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, the pt symptoms had resulted in physical limitations not presented prior to using Zoster Vaccine Live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence the pt 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, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Outcome of the events was not recovered. Causal relationship of the events was reported as related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered intraventricular haemorrhage and haemorrhagic stroke to be disabling events.  Upon internal review, intraventricular haemorrhage and haemorrhagic stroke were determined to be medically significant event.
Excruciating pain in arm of the injection; achiness and pain in her legs and feet; experienced some soreness in the injection arm (left); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achiness and pain in her legs and feet), VACCINATION SITE PAIN (experienced some soreness in the injection arm (left)) and VACCINATION SITE PAIN (Excruciating pain in arm of the injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (achiness and pain in her legs and feet) and VACCINATION SITE PAIN (experienced some soreness in the injection arm (left)). On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (Excruciating pain in arm of the injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (achiness and pain in her legs and feet), VACCINATION SITE PAIN (experienced some soreness in the injection arm (left)) and VACCINATION SITE PAIN (Excruciating pain in arm of the injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.