chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (318 patients received dose from vials beyond 30 day use by date) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jul 13, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 13, 2021, patient administered expired product (318 patients received dose from vials beyond 30 day use by date). On Jul 13, 2021, administered expired product (318 patients received dose from vials beyond 30 day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Numbness and tingling went down the arm. It resolved in less than 24 hours.
8 yo given Varivax RLE, Hep A LVE, with swelling redness and itching - predominantly RUE - starting 2 days after vaccine. Improved with Benadryl and Atronix.
Began experiencing ringing in ears and pressure in ears about 48 hours after receiving first dose, accompanied by mild dizziness. The pressure lessened another 48 hours later. The following week the pressure in ears became greater along with headaches and more dizziness.
Initial unsolicited report received from a other non-health care professional on 21 October 2017. This case involves a 12-year-old female patient who was vaccinated with a dose of FLUZONE QUADRIVALENT (frequency once, batch number and expiration date was not reported) intramuscularly in left deltoid on 21-Oct-2017 at 12:00 PM. Patients medical history and concomitant medication were not reported. On 21-0ct-2017, approximately one-hour post vaccination, the patient began complaining of dizziness and general malaise. On the same day by 3:00 PM, three hours post vaccination, patient had spiked a fever of 104 F, heart rate was 148 and visibly pounding through her chest, had chills, was very dizzy and tired. Other relevant lab tests were not reported. The corrective treatment included tylenol and ibuprofen every 2 hours and placing ice packs on her. It was reported that fever remained for over 24 hours despite corrective treatment (not recovered) and her heart rate continues to race when standing and she continues to complain of dizziness (not recovered). Outcome for other events was reported as unknown. Documents held by sender: none.
After 30 minutes, patient complained of tingling on right side of tongue and feeling of fullness on right side of throat. Te=reated with 25mg of oral benadryl, symptoms improving but not resolved so 25mg PO repeated at hour later.  Symptoms completely resolved approxiamtely 2 hours after onset of symptoms. Patient was under direct observation during this time. Patient discharged in stable condition. Patient provided additional oral benadryl to take home and use prn. Additional home epi pens provided with instructions on use if needed. Patient instructed to not be alone during next 24 hours. Sone would be staying with patient. On site health aide provider available during after hours and emergency response in village. Provider from team NP, contacted patient later evening and checked on patient status, reported to be doing well.
104.5 fever for 4-5 days, uncontrollable screaming for 3 days, stopped babbling/talking/ making eye contact for about 6 weeks afterwards, noticeable neurological changes /regression.
Information has been received for the Merck Pregnancy Registry for the GARDASIL via a medical assistant concerning a 15 year old female with no pertinent medical history who on 15-MAY-2007 was vaccinated intramuscularly with the first 0.5 ml dose of the GARDASIL (Lot # 656051/0244U). Concomitant therapy included PROTONIX, PROZAC, magnesium supplement (unspecified), SEROQUEL and ZONEGRAN. A blood HCG test was performed on 15-MAY-2007 and was negative. The blood HCG test was repeated on 31-MAY-2007 and was positive. An ultrasound was performed on approximately 15-JUN-2007 which showed that the patient is approximately 4.5 to 6.5 weeks pregnant. The patient's last menstrual period was approximately 17-May-2007 and the estimated due date was 21-Feb-2008. The reporter stated that "the patient will not be having a therapeutic abortion." Follow up information has been received from a health professional at the pediatrician's office and from a registered nurse at the obstetrician's office, concerning the outcome of the pregnancy. There were no complications or illnesses during the patient's pregnancy. The health professional and the nurse reported that on 27-JAN-2008, the patient gave birth to a healthy and normal male infant, apgar: 8/1; weight: (3668gms), 8lbs 1oz; length 21; and head circumference: 14. The health professional noted that the infant had no congenital anomalies. The baby however experienced respiratory distress and fever during delivery. No further information was provided. Additional information was provided. Additional information is not expected.
Systemic: Patient started to hear noises in his head after receiving covid19 2nd dose.-Medium, Additional Details: Patient started to hear noises in his head after receiving covid19 2nd dose on 10/14/2021. Patient claims he started to hear noises in his head the night of the day he got his 2nd dose. The symptom is going on constantly and it didn't get any better. He said the noise is less when he is talking and gets louder when he is quite. He doesn't have any other complaints bedside the noise in his head.
sore arm, swollen armpit gland, headache, fever 101, chills, nausea, tired
Child has had a fever since the day following the vaccination. He had the vaccine Wednesday and still has a fever Saturday. His arm is hard to move and painful. He was feeling dizzy and low energy for the first 2 days. He now has a rash below the vaccine injection site on his right arm
Information has been received from a certified medical assistant, for the Pregnancy Registry for GARDASIL, concerning a 17 year old female who on 30-OCT-2007 (also reported as 18-JUL-2007) was vaccinated intramuscularly with the first dose of GARDASIL (655165/1425F). Per the reporter, the patient was pregnant at the time of vaccination (Gestation = 36 weeks; LMP approximately 04-Mar-2007). The pregnancy was confirmed by a pregnancy test. Concomitant therapy included vaccination with the first dose of VAQTA (653616/0511F) on 18-SEP-2006 and the second dose of VAQTA (654514/0304U) on 30-OCT-2007 (dose, duration not reported). The patient is not experiencing any known symptoms. No further information is available. It was reported that on 02-DEC-2007 the patient delivered a baby girl via vaginal delivery that is normal, no congenital anomalies. "but has had some illnesses". Birth weight was 6lbs 10oz, Apgar scores were 9 and 9. The baby did have a right parietal cephalohematoma at birth due to probable vacuum use during delivery. The baby also experienced some illnesses, most respiratory issues including RSV pneumonitis which has resolved. The reporter indicated that the patient has a high level of exposure to school aged children family members. There was also some jaundice at birth which has also resolved. The baby has also had some thrush. On 04-APR-2008 it was indicated by the physician that the baby was a "healthy baby girl with some eczema. No additional information is expected.
nausea; headaches; body aches; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. An elderly female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot number- ER8730), via an unspecified route of administration in right arm, on 24Mar2021 as a single dose for COVID-19 immunization. The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Medical history included cancer a few times, blood pressure and cholesterol abnormal.  Concomitant medications included Vitamin D, Magnesium, selenium, multivitamin and unspecified medication for blood pressure and cholesterol. The patient experienced nausea, headaches and body aches on 25Mar2021. The patient did not receive any treatment for the events. The outcome of the events was recovering.
URTICARIAL LESIONS ON FACE, EXTREMETIES (+)PRURITUS ON SET OF RASH < 24 HOURS WITH VACCINE ADMINISTRATIO. NO HISTORY OF NEW SOAPS, LOTIONS, FOODS, MEDS, DETERGANTS.  TREATED WITH ATARAX 10MG/5ML 5ML TID (+) PREDNISOLONE 5MG/5ML 10 ML BID X 5 DAYS.
12/17 vaccination 12/18 within 24 hours, arm was hurting. Immense pain to arm. Flu like symptoms. Took Motrin. Symptoms lasted for 3 days.
Information has been received from a registered nurse (R.N.) concerning a 9-year-old male with attention deficit disorder, who on 25-MAR-1999 was vaccinated subcutaneously with a 0.5 ml dose of Varivax (Oka/Merck). There was no concomitant medication. On 13-FEB-2007 the patient developed 75-100 scattered raised red papules on his back, chest, upper legs and groin area. It was reported that he did not have a fever or any other symptoms. The patient was seen by a physician. No laboratory or diagnostic test were performed and the physician diagnosed the patient with atypical varicella or pityriasis. The patient recovered on 20-FEB-2007. No product quality complaint was involved. Additional information has been requested.
allergic reaction; swelling of her eyes and face; swelling of her eyes and face; headaches; nausea; fever; body aches; This is a spontaneous report received from a contactable consumer (patient).  A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number-unknown, Expiry date-unknown) via an unspecified route of administration, on unspecified date of Apr2021 as Dose 1, Single for covid-19 immunisation. The patient's medical history and concomitant medication were not reported. Patient experienced headaches, nausea, fever, bodyaches after first dose of the vaccine. On 14Apr2021 patient experienced allergic reaction that was manifested in swelling of her eyes and face. The patient received treatment with taken Tylenol, Ibuprofen and Aspirin it was reported that the medication had helped with 60% of the symptoms but have not eliminated them completely. The outcome of all events were recovering.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
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 providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's 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, 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; 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.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), on 24Sep2021 as dose 2, single (Batch/Lot number: unknown) and on 19Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing), notes: HBP. The patient's concomitant medications were not reported. Past drug history included: Quinine, reaction(s): "allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 20Apr2023 to 24Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175975 same reporter/patient, different drug/event;US-PFIZER INC-202300176021 Same patient/product, different dose/events (Dose 2);
pt recv vax 11FEB98 & on 17FEB pt exp inc redness,swelling, & hot to touch @ site of inj towards elbow;
2 weeks of severe left deltoid muscle pain radiating down arm and up into neck. Difficulty abducting left shoulder.
Retinal detachment, August 9.  Retinal reattach,ment, Vitrectomy surgery with bubble. Successful. Second retinal detachment on November 15, two days after second dose of Shingrix. Second surgery with gas bubble. Still recovering.
does shingrix cause insomina; This case was reported by a consumer via interactive digital media and described the occurrence of insomnia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced insomnia. On an unknown date, the outcome of the insomnia was unknown.   It was unknown if the reporter considered the insomnia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.
Gracianna still has an injection site reaction one month post injection. There is a very hard nodule at the injection site. The IFU doesn?t report this as an adverse event (long term reaction), even though my pediatrician has noticed this is a common occurrence. Perhaps there is a manufacturing problem with this drug.
shingles episodes after receiving dose one, past october broke out again; 1st dose on 2018, went back for 2nd but facility didn't have it, received 2nd dose on 03 Mar 2022; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster.   In April 2018, the patient received the 1st dose of Shingrix. On 3rd March 2022, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and product supply issue. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and product supply issue were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR042360  Additional details were reported as follows: The patient who was Member of public reported case for herself. The age at vaccination was not unknown but it could be 75 or 76 years at the time of 2nd dose. She received 1st dose of Shingrix in April 2018 but when she went back for 2nd dose in 2018, facility did not have the vaccine so she went without it until receiving second dose on 03rd March 2022, which led to product supply issue. The patient had an episode of Shingles after the 1st dose and was taking Valtrex for it. The patient stated this past October was very stressful and she forgot to take Valtrex for a couple of days and broke out with shingles again. The dose of Valtrex was then increased from 500 mg to 1 g. The reporter did not have lot number or expiration date information for the doses. The reporter gave permission for follow-up. This case has been linked to US2022AMR042360, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR042360:same reporter / Shingrix
Immediate severe pain in left shoulder. Continuous intense deep pain in left shoulder, affecting my bicep function. Although I have full ROM my shoulder has been incredibly sore for 5 WEEKS! Pain has been between 6-8 on a 1-10 scale and has kept me up at night and has hurt both with and without movement.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, drug reactions or allergies, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M018957, expiry date 22-NOV-2017; lot # M014544, expiry date 27-NOV-2017; lot # M004885, expiry date 23-OCT-2017 (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 27 degrees Fahrenheit for 1 hour and 20 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact physician.; Sender's Comments:  US-009507513-1703USA007944:
I had a not under my left arm for over a week; extremely tired; I still have sharp pains from my elbow to my mid part of my hand.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: ER8730) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "knownallergies :pencycline" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; PROZAC; CLARITINE; BIOTIN. Past drug history included: Allergies: codine, reaction(s): "Allergies: codine"; Allergies: sulfar, reaction(s): "Allergies: sulfar". Vaccination history included: Bnt162b2 (Dose:1, lot number: EN6198, administration time: 08:00 AM, vaccine location: Left arm), administration date: 14Apr2021, when the patient was 54 years old, for COVID-19 Immunisation, reaction(s): "sever headache", "fatigued". The following information was reported: NODULE (non-serious) with onset 2021, outcome "recovering", described as "I had a not under my left arm for over a week"; FATIGUE (non-serious) with onset 2021, outcome "recovering", described as "extremely tired"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "I still have sharp pains from my elbow to my mid part of my hand.". Therapeutic measures were not taken as a result of nodule, fatigue. Therapeutic measures were taken as a result of pain in extremity.  Additional information:The patient did not receive other vaccine in four weeks. No COVID prior vaccination and tested post vaccination. Facility type vaccine was workplace clinic. Patient had taken tylenol for the pain  No follow-up attempts are possible. No further information is expected.
feels feverish; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feels feverish) and NAUSEA (nauseous) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced PYREXIA (feels feverish) and NAUSEA (nauseous). At the time of the report, PYREXIA (feels feverish) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. No treatment details were provided
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:08 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:08 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 63.21. No concomitant medications were reported. Batch number 030B21A administered on 03-Apr-2021 underwent temperature excursion with temperature range of 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).