chrisvoncsefalvay/vaers-outcomes huggingface dataset:
improperly stored administered ROTATEQ that was not supported/7/14/2023 1968385 5/22/2024; This spontaneous report was received from customer and refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent conditions, concomitant medications, or relevant medical history.  On 14-JUL-2023, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #1968385, expiration date: 22-MAY-2024, administered orally for prophylaxis (improper storage of product in use). Temperature excursion details: 34.9 degree Fahrenheit for 6 hours 34 minutes (20-JUN-2023); 51.4 degree Fahrenheit for 7 hours 33 minutes (03-JUL-2023); 51.1 degree Fahrenheit for 24 hours (04-JUL-2023); 50.7 degree Fahrenheit for 9 hours 27 minutes (05-JUL-2023). There was no previous temperature excursions reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2307USA009885:
Pfizer-BioNTech COVID-19 Vaccine EUA Day of vaccine - Fatigue 1 day after - Sore muscle in left arm 4 days after - Achy left shoulder joint, sensation of heat, tingling sensation on left arm just above elbow.  Minor swelling just above elbow. 5 days after - Rash on torso, red spotted
This spontaneous report was received from a medical assistant referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not reported. On 12-SEP-2018, the adult patient was vaccinated with a pediatric dose of VAQTA, intramuscular for prophylaxis. No product quality control issues was involved.
soreness at the injection site (persisted 48 hours after injection), tired (persisted for 24 hours after injection), headache (began approximately 14 hours after injection and persisted for 12 hours), body aches (began 14 hours after injection and persisted for 12 hours), fever (began 14 hours after injection and persisted for approximately 12 hours), chills (began 14 hours after injection and lasted for approximately 6 hours), nausea (began 16 hours after injection and lasted for approximately 12 hours)  No treatments were done. No medications were taken at the direction of the vaccine provider who directed that Tylenol should only be taken with a high grade fever in order to promote a full immune response. Mild dehydration 36 hours following injection likely due to nausea decreasing intake of food and liquids.
I had pain in my arm. In the evening I was fatigued and had chills and fever that same night. I got up in the middle of the night and I briefly passed out. I went to urgent care the same day but they just sent me to the ER. They ran some tests and gave me fluids.
Body aches, Fatigue, Stuffy nose. Had to stay home from school for three days and rest.
CAUSING LOTS PAIN IN INJECTION SITE UP INTO SHOULDER, CANT RAISE ARM OR LIFT ANYTHING, HOT, SWOLLEN, RED. GOTTEN WORSE SINCE DATE OF VACCINE UNTIL TODAY 12/30. TRIED APAP (DID NOTHING), TAKING 1/2 OF HER HYRDOCODONE TO HELP WITH PAIN. TOLD HER TO WATCH AND CALL BACK TOMORROW TO UPDATE ME.
I had a headache, body aches, runny nose, and cough. I tested positive positive for COVID-19. I spoke to my doctor and prescribed me medication.
Vaccine kept in refrigerator on 10/29/2021, expiration date is 10/13/2021, administered on 11/08/2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 10/29/2021, expiration date is 10/13/2021, administered on 11/08/2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 10/29/2021, expiration date is 10/13/2021, administered on 11/08/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 10/29/2021, expiration date is 10/13/2021, administered on 11/08/2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was placed in the refrigerator was 29-Oct-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Weeks after my second phizer shot in my left shoulder I get random weird pains there. The pain last for a couple seconds and has a shooting and throbbing sensation. NOT conformable at all.
This spontaneous report as received from a nurse refers to a 17 year old female patient with allergy to Amoxicillin. On 10-OCT-2013, the patient was vaccinated with GARDASIL (lot # J009243, exp. date: 23-APR-2016) second dose, 0.5 ml, intramuscular. There was no concomitant medication. On 15-OCT-2013, about 5 days after onset of therapy, the patient experienced tonsillitis like symptoms with sore throat, redness and swelling of throat. The patient sought for medical attention (office visit). No lab diagnostics studies performed. Treatment was given for the events (unspecified antibiotic in case symptoms persisted). The outcome of the events was not reported. This is one of several cases received from the same source. Additional information has been requested.
Bloated/ bump on his stomach like a  squishy ball with something inside; Tender, bothering while sleeping; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (Bloated/ bump on his stomach like a  squishy ball with something inside) and ABDOMINAL PAIN UPPER (Tender, bothering while sleeping) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced ABDOMINAL DISTENSION (Bloated/ bump on his stomach like a  squishy ball with something inside) and ABDOMINAL PAIN UPPER (Tender, bothering while sleeping). At the time of the report, ABDOMINAL DISTENSION (Bloated/ bump on his stomach like a  squishy ball with something inside) and ABDOMINAL PAIN UPPER (Tender, bothering while sleeping) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pain in shoulder which received the injection (left) when lifting arm out and away from body and when lifting straight. On going issue as of 9/29/2013.
On 4/18/01, given MMR injection #2 as mandated. On 4/24/01, started left parotid swelling with temperature of 99F.
I had my period for 2.5 weeks following the vaccine, which is not normal for me. I already had my period for the month previous to getting the vaccine.
MISSED ONE OR TWO DOSES OF VIVOTIF; This spontaneous case report was received from a nurse (PVX2019-185) on 18-Jan-2019. The report describes a consumer who "missed one or two dose of Vivotif". The consumer was receiving Vivotif for unknown indication.  It was reported that the consumer missed one or two dose of Vivotif in this week. The reporter did not know how many doses were missed or when they were missed.  The action taken with Vivotif with respect to the event "missed one or two dose of Vivotif" was not applicable.  The clinical outcome of the event "missed one or two dose of Vivotif" was unknown.  Company's Comment: The causality of the event "missed one or two dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed one or two dose of Vivotif" was considered as not applicable.
The child was noted to have erythema with edema and redness in the rash occurring a few minutes after Prevnar administration.
had the 4 Pfizer Covid19 vaccines/ still tested positive for Covid; had the 4 Pfizer Covid19 vaccines/ still tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had the 4 Pfizer Covid19 vaccines/ still tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Caller states that she had the 4 Pfizer Covid19 vaccines but she still tested positive for Covid on Monday and her Covid symptoms started last Wednesday and today is day 8 of her Covid infection. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: The patient called for information on Paxlovid. She stated that she had the 4 Pfizer Covid19 vaccines but she still tested positive for Covid on Monday and her Covid symptoms started last Wednesday and today was day 8 of her Covid infection. Caller (patient) stated that she had been feeling worse and not better. Caller stated that, she asked her primary doctor to be placed on Paxlovid but she was reluctant to give it to her. Caller asked "even though Paxlovid works best within 5 days of Covid symptoms, it should still be effective if it is given after the 5 days right?" and "can my doctor still give it to me or should I go to the ER to get it there?" Caller stated, "my friend's Covid symptoms cleared up after taking Paxlovid."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Since receiving the vaccine, I have suffered constant tinnitus which ranges from mild and tolerable (on good days) to  overwhelmingly irritating and intolerable (on bad days).  The sound is similar to the high pitches that you are asked to listen for during a hearing test, except the sound is at a constant pitch and never subsides.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included drug allergy (to Neomycin and Erythromycin). In July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced pain in arm, muscle tightness, muscle pain and tendon pain. On an unknown date, the outcome of the pain in arm and muscle tightness were not recovered/not resolved and the outcome of the muscle pain and tendon pain were unknown. It was unknown if the reporter considered the pain in arm, muscle tightness, muscle pain and tendon pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported that he received the SHINGRIX vaccine on left arm at approximately 3:00 PM and his left arm throbbed for one week and then it went into a phase where his muscles were tight and hurt. He seemed to believe that it was his tendons because if he stretched it would slightly subside, however, if he rolled over at night during sleep, it would wake him up. The pain had progressed to his forearm area and his arm hurting was still unresolved till the day of reporting.
Pt recv vax on 1/26/99; on 1/28/99 pt exp rash on body, swollen lips; tx=Caladryl lotion
arm soreness; swelling at injection site; white dot at injection site; can't lift arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain in arm, injection site swelling, injection site hypopigmentation and injected limb mobility decreased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, injection site swelling, injection site hypopigmentation and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injection site swelling, injection site hypopigmentation and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not reported. 5 weeks ago from the date of reporting, the patient received 2nd dose of Shingrix. The patient experienced soreness in arm, on which the inajection has been received, since from the day of vaccination. At the time of reporting, the events were unresolved, and the patient stated that she can not lift her arm above shoulder. The patient did not consent to follow up. This case was 1 of 3 linked cases.
Injection site appeared like a "spider bite" with a red ring around the injection spot.  This developed into a mild rash all over the arm the vaccine was administered in and a small rash on the other arm as well.  The rash never itched but is unsightly for the patient.  The patient says that the injection spot is still tender and feels as if there is a capsule under her skin.
His dad took the shot and died 3 days later, mucked up his arteries, his heart; This is a spontaneous report from a contactable consumer (patient son).  A 64-year-old male patient received second dose of BNT162B2 on 15May2021 (at age of 64-year-old) at single dose for COVID-19 immunization. Medical history included Heart Condition (around 1997-1999), High Blood Pressure (all about the same time), Aneurysm (about 2017, 2015-2017 area. He wants to say 2015, because he was there when he found out about them) and open heart surgery (about 1997, 1995, somewhere around there). Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 05Apr2021 (at age of 64-year-old) for COVID-19 immunization. Family Medical History Relevant to AE(s): Caller states not that he knows of. All he knows from the emergency technician is that it looked like he went back to his car and his dog was in the car and he dropped dead. According to you guy's thing, it says muscle cramps, muscle pains and chest pains are all side effects of this and he does believe that the vaccine contributed to the chest pain which contributed to the heart attack that exploded his heart. He states his dad took the shot and died 3 days later (18May2021, also reported as died on Memorial day weekend. He died on Sunday). Caller stated the coroner's has already stated that he died by the coronavirus shot and mucked up his arteries, his heart. It is pretty sad. He was doing something he enjoyed, watching the races, gets up takes two steps, falls dead in his tracks. Vaccination Facility Type was hospital. He does not know Additional Vaccines Administered on Same Date of the Pfizer Suspect, but he highly doubts it. Events not require a visit to Emergency Room or Physician Office.   Information about lot/batch number is requested.; Reported Cause(s) of Death: His dad took the shot and died 3 days later, mucked up his arteries, his heart: Death
This case was reported by a healthcare professional and described the occurrence of hepatitis b surface antigen positive in a 28-year-old female subject who was vaccinated with ENGERIX B. Concurrent medical conditions included depression. Concurrent vaccination included ADACEL given on 24 November 2008. There were no concurrent medications. On the afternoon of 24 November 2008 the subject received 1st dose of ENGERIX B at 1.0 ml in the right arm. On 25 November 2008, 1 day after vaccination with ENGERIX B, the subject had lab work done that showed her to be hepatitis b antigen positive. At the time of reporting the outcome of the event was unspecified. Follow-up information received on 08 January 2009 indicated that the subject had/has no risk factors for hepatitis B and no signs of illness. The subject's physician plans to follow her antigen and antibody levels and to complete the three dose series of ENGERIX B. No additional information was provided and no additional information is expected.
starting having flu; This case was reported by a consumer via interactive digital media and described the occurrence of influenza in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, less than a year after receiving Meningococcal B vaccine, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown.   It was unknown if the reporter considered the influenza to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter just gave that shot all together with other three that she needed and the reaction was horrible. The reporter never got any kind of reactions before to any other regular vaccine but for this new one. Since that garbage she started having flu very often which never had happened.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-JUN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # L040460, expiration date 27-MAY-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 80 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Pt states the day after her vaccination she had body aches, headaches, flank pain, severe fatigue, hematuria and proteinuria most symptoms resolved 3-4 days after onset.
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 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 1:33 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 1:31 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milligram. On an unknown date, the patient experienced 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). 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 42.12 for dose administered on 27-02-2021 and 42.20  for dose administered on 27-Mar-2021. Batch number 014M20A underwent temperature excursion on 27-Feb-2021, with temperature 35 degrees Fahrenheit from 09:00 AM to 12:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021. Batch number 019B21A  underwent temperature excursion on 27-Mar-2021 with temperature 35 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-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. No concomitant medications were reported.   This case was linked to MOD22-013597 (Patient Link).
A 76 year old male experienced cough approx 6 hrs after a maintenance dose of 1/3 vial OncoTICE and Intron A. Reportedly the pt had a cold in the week prior to this maintenance but without cough.
First dose received on 4March2021, Second dose received on 21April2021; she still has soreness in her arm from April./The soreness is in the same arm where she received the injections; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (she still has soreness in her arm from April./The soreness is in the same arm where she received the injections) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 4March2021, Second dose received on 21April2021) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027AZIA) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INJECTION SITE PAIN (she still has soreness in her arm from April./The soreness is in the same arm where she received the injections). On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 4March2021, Second dose received on 21April2021). On 21-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 4March2021, Second dose received on 21April2021) had resolved. At the time of the report, INJECTION SITE PAIN (she still has soreness in her arm from April./The soreness is in the same arm where she received the injections) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.