chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced erythema of extremities, rash and heart rate abnormal. On an unknown date, the outcome of the erythema of extremities was recovered/resolved and the outcome of the rash and heart rate abnormal were unknown. It was unknown if the reporter considered the erythema of extremities, rash and heart rate abnormal to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The caller declined all questions except what information the reporter provided in his conversation. The caller stated that 4 months before the reporting date, the patient received SHINGRIX and he had redness of arm that lasted longer than the normal. The patient noted the second reaction with his heart rate, but did not specify what happened with it and the rash appeared at the same time as the heart rate issue. The caller was asking about immunity with the 1st dose, as he did not plan to get the 2nd dose of SHINGRIX. The caller was open to receiving a questionnaire from safety to complete on the patient's experience but declined information gathering over the phone. The phone number the reporter provided was incorrect, when it was called back so it was removed. No ID appeared in contact to collect or attempt to call as alternate.
This spontaneous report was received from a pharmacist regarding a patient of an unknown age and gender. Information on patient's pertinent medical history and drug reactions/allergies were not reported. On 31-JAN-2018, the patient inadvertently received an expired dose of ZOSTAVAX (strength, dose and frequency were not reported) (lot # M041087, expiration date: 03-JAN-2018) subcutaneously for prophylaxis. The administered dose of ZOSTAVAX was reconstituted with sterile diluent (manufacturer unknown) (lot# and expiry date were not reported). No adverse effects were reported. There was no product quality complaint (PQC) reported.
1-2 days after receiving the 1st dose of the Pfizer vaccine in my left arm, there was significant swelling, redness, tenderness that lasted and was visible for 3 weeks. From this inflammatory response, I am experiencing muscle wasting/atrophy that is still present today 11/4/21 almost two months from receiving the vaccine and it is NOT improving. I have been told that the tissue will not return to normal. Pain is associated with the site of injection multiple times throughout the day and worsens when exercising or using left arm strenuously.  I noticed this tissue/muscle atrophy  on 15Oct 21 and that it is the same exact area/injection site is now very soft tissue (approximately 3 cm) and painful.
After my J&J vaccine I has soreness to my right arm at the injection site. On 04-08-2021 woke up with a head cold, loss of sense of smell. I  On 04-09-2021, I went to clinic where I got tested for Covid-19 and my results were positive at 11:20pm.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 07-AUG-2017 the patient was vaccinated with an expired dose of GARDASIL lot # L042837 for prophylaxis. No adverse event was reported. The outcome of expired product administered is unknown. The reporter considered expired product administered and no adverse event to be not related to GARDASIL. Additional information has been requested.
7/9 sat. morning I woke up in excruciating pain in my back then later it radiated into my chest I used a heating pad and had my mom rub some capsaicin cream on my back when pain radiated into chest it was very difficult to breath & very painful to breathe so I also rubbed vicks on chest to help the breathing The pain cont. until 7/11
pain in both big toes, severe pain in the left big toe; acute gouty attack; acute gouty attack; This is a spontaneous report from a contactable physician (patient). A 44-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular (left arm) on 17Dec2020 15:30 at single dose for Covid-19 immunization. Patient's medical history included gout and shellfish allergy. Concomitant medications included magnesium glycinate (MAGNESIUM GLYCINATE), colecalciferol (VITAMIN D), and finasteride. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported he got his vaccine on 17Dec2020, a week later on 03Jan2021 (04:30 PM) he started having some pain in both big toes and then 3 days ago, he had severe pain in the left big toe with what appears to be acute gouty attack. The patient reported he has a history of gout previously but had controlled it for a long time. There were no other changes that happened. The patient was treated with ibuprofen and colchicine. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
anxiety was increased within 24 hours of the vaccine dose and it was getting worse; irritability; nervous; jittery; This spontaneous case was reported by a nurse and describes the occurrence of ANXIETY (anxiety was increased within 24 hours of the vaccine dose and it was getting worse), IRRITABILITY (irritability), NERVOUSNESS (nervous) and FEELING JITTERY (jittery) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Anxiety depression, DICYCLOVERINE HYDROCHLORIDE (BENTYL) for Irritable bowel syndrome.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced ANXIETY (anxiety was increased within 24 hours of the vaccine dose and it was getting worse), IRRITABILITY (irritability), NERVOUSNESS (nervous) and FEELING JITTERY (jittery). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg twice a day. At the time of the report, ANXIETY (anxiety was increased within 24 hours of the vaccine dose and it was getting worse), IRRITABILITY (irritability), NERVOUSNESS (nervous) and FEELING JITTERY (jittery) outcome was unknown.        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.   Patient had anxiety  increased within 24 hours of the first dose of the Moderna COVID-19 vaccine and it was getting worst up to 07-Jun-2021 along with other side effects.  Normally, patient has been well-maintained with daily medication.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Due to the IRD  of Follow up being a prior date, it was captured as 08-JUN-2021 due to Argus limitation.             Follow-up received on 08-JUN-2021 contains NNI.
Redness at the injection site of MMRV (LUA). 6 cm x 3 cm.
Wheezing; Throat Pain; Rash on Injection site; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash (injection site)/vaccination site rash, wheezing, throat pain./oropharyngeal pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) Intramuscularly for prophylaxis of COVID-19 infection.  On 7 Feb 2021, the patient experienced the event(s) rash (injection site), wheezing, throat pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash (injection site), wheezing, throat pain was unknown.
the patient was administered improperly stored VARIVAX; This spontaneous report as received from a medical assistant referring to a 1-year-old female patient. The patient's pertinent medical history, concomitant medications, and previous drug allergies or reactions were not reported.  On 24-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (INJ) subcutaneously for "well check" (prophylaxis) (dose, vaccination scheme frequency, anatomical location and anatomical location were not reported; lot number: S032355 with expiration date of 14-OCT-2021). The administered dose of the vaccine experienced multiple temperature excursions which went from -14 degrees Celsius (C) to -10 C for 116 hours; and from -9 C to 8 C for 13 hours, as recorded by a data logger (product storage error).; Sender's Comments:  US-009507513-2009USA005503:
Reported labored breathing and wheezing. EKG normal, history of SVT at birth.
pt recv vax 25MAR97 & the next day devel a fever of 103 & was described as walking, drinking & urinating;27MAR97 pt was brought into ER @ 810AM & was dead on arrival;autopsy results pending @ date of report;suspected pneumococcal sepsis;
Significant redness at the vaccination site, still a large red circle around the injection point now, even 3 days later. Low grade fever onset approximately 24 hours after injection, followed by chills, an generally feeling unwell - lasted for approximately 30 hours. Treated with ibuprofen every 4-6 hours to control fever. Caused me to be home, in bed, for approximately 30 hours. I have recovered from the fever and related symptoms. The red, sore injection site remains. I experienced the red, sore injection site with the first dose of the Zoster vaccine and it took ~1 week to resolve.
Within 4 hours, I had fever, chills and fatigue, this lasted for several days, then may fingers and hands started swelling and became extremely painful. After months of this ongoing issue, I consulted with my doctor. He ran several blood tests and diagnosed me with  Lupus.
This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 11-SEP-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 3072 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Developed a painful lump on my Clavicle.   Body aches throughout my entire body. Fatigue and shortness of Breath.
BLOODY NOSE OFF AND ON ALL DAY, NEVER HAD A BLOODY NOSE PREVIOUSLY.
2 weeks after first shot started having terrible night sweats. The next morning I woke with vertigo so bad I could hardly walk. Actually fell off the toilet reaching for paper. Also started noticing a ringing in my ears. Vertigo, dizziness and nausea lasted 5 days. As the vertigo finally subsided the tinnitus has gotten louder and louder. I have put off my second shot as I'm afraid it will make it worse.
Per mother, child started with fever of 103.7 degrees Fahrenheit on 4/11/09 and she gave him Tylenol and then temperature went to 104 degrees so she took child to E.R. where he was ran through bloodwork and several tests, including a chest x-ray & strep screen.  All tests were normal.  Mother states that child ran fever for approximately 6 hours and once fever broke he never ran fever again.
Breakthrough case after vaccination. C/O runny nose, sore throat, cough, and congestion, onset 1/19/2022
2 days post flu shot, patient developed itchiness around neck then woke up the next day with hives on his body/face.  Has had flu shot 3 times before.  Prednisone 20mg per mouth three times a day 3 days given.
Weakness, cough, dehydration, muscle soreness, spiking temperatures, low blood pressure (90/50). I took the flu shot on Oct 21,2003. Vaccine manufacturer is Aventis-Pasteur Lot #U1076AA(Exp. date 6/30/04. I started experiencing symptoms listed beginning October 23. I was ordered by my physician to the emergency room on October 31,2003. I was admitted and remained in the hospital until 11/8/03. I was treated with antibiotics and steriods. Discharge summary states anemia. msv Medical recoirds state anorexia. msv
01/04/22 presents to ED for "nausea, vomiting, diarrhea". PMHx of "anxiety/depression, HTN, cyclical vomiting"
Pt reports that he began to feel dizzy, lightheaded, very tired, and weak about 30 minutes after receiving GARDASIL. Symptoms were persisting at 2 hours post-vaccination, when he returned to the office. Vital signs were stable, no signs of anaphylaxis. He appeared very weak and tired (required wheelchair for unsteady gait), but was responsive and oriented to person, time, place, and situation.  He was sent home to rest with instructions to take ibuprofen or TYLENOL. He returned to the office the following morning to report that he rested and took ibuprofen and is feeling much better.
Pt devel swelling under lt arm (inject site lt arm), nausea, vomiting @ approx 48 hrs post vax; also c/o fever (not measured);
increased respiratory difficulty  beginning at 2pm on 4/7/2021. unable to improve or control  respiratory distress overnite despite a change in meds and aggressive treatment at home. sent to emergency room at 0700 on 4/8/2021 at 0700 with acute respiratory distress and intubated.  discharged to inpatient hospice on 4/12/2021, did have a prior intubation on 3/20/2021.
three people died; the flakes of rubber and little pieces of steel found in the vials; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (three people died ) and PRODUCT CONTAMINATION PHYSICAL (the flakes of rubber and little pieces of steel found in the vials) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEATH (three people died) (seriousness criteria death and medically significant) and PRODUCT CONTAMINATION PHYSICAL (the flakes of rubber and little pieces of steel found in the vials) (seriousness criterion death). The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant product was reported. No treatment medication was reported.  This case concerns a patient with no details on age, gender and past medical history, who presented with unexpected event of death on an unknown date after receiving the second dose of mRNA 1273 vaccine. It is unknown if an autopsy was performed. Product contamination physical was considered as an additional event. The event was considered related to the product per the reporter's assessment. The benefit risk relationship of vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient with no details on age, gender and past medical history, who presented with unexpected event of death on an unknown date after receiving the second dose of mRNA 1273 vaccine. It is unknown if an autopsy was performed. Product contamination physical was considered as an additional event. The event was considered related to the product per the reporter's assessment. The benefit risk relationship of vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
At 11:49 am after first shot my lips itched and when I looked in the mirror my upper lip and area under my nose were swollen. My tongue and face swelled and tongue was bright red. Inside of my cheeks where bright red, throat was itching and roof of mouth itching and had hives on them. Inside of my nose and eyes itched. Then my whole upper body itched and had random red rashes on arms, especially my right arm. I had problems breathing, like my asthma, kicked in. I used my inhaler and that helped. Then my allergies kicked in and my right ear hurt from my sinuses being swollen and for a week it was like I was having a bad allergy n asthma attack. I took 2 Benadryl at night and that helped on top of my inhaler and all my allergy medicine.
same pains flared up; severe pain across back, arms/hands, feet/legs; back pain started; same pains flared up; severe pain across back, arms/hands, feet/legs; This is a spontaneous report from a contactable consumer. This 46-year-old male consumer (patient) reported that:  A 46-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: FA6780), via an unspecified route of administration on Jul2021 as DOSE 2, SINGLE for covid-19 immunization. Patient medical history included migraine from an unknown date and unknown if ongoing (other medical history migraines, kidney stones), Kidney stones (nephrolithiasis) from an unknown date and unknown if ongoing (other medical history migraines, kidney stones). Patient concomitant medication(s) included Topiramate (Topiramate) taken for an unspecified indication, start and stop date were not reported; Clomid (Clomifene Citrate) taken for an unspecified indication, start and stop date were not reported; Vitamin C (ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported; calcium carbonate, colecalciferol (VITAMIN D 2000) taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin, morphine and experienced drug hypersensitivity (Known allergies erythromycin and morphine-based medications). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection;Lot number: unknown), via an unspecified route of administration, administered on unspecified date as single dose for COVID-19 immunisation .It was reported that  If other vaccine in four weeks was no. Covid prior vaccination was no. Covid tested post vaccination was no. The patient experienced same pains flared up; severe pain across back, arms/hands, feet/legs and back pain started on 15Apr2021. After second dose, same pains flared up. 3 weeks ago, back pain started. Became so bad 1 week ago that I was rushed to the emergency room (Friday). Went home that night after pain medications. Had to go back Sunday morning - no relief. Was in the hospital until Thursday with severe pain across back, arms/hands, feet/legs. The patient was hospitalized for same pains flared up; severe pain across back, arms/hands, feet/legs for 5 days. Therapeutic measures were taken with Pain medications as a result of same pains flared up; severe pain across back, arms/hands, feet/legs and back pain started. The outcome of events was Not recovered.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected; Sender's Comments: Linked Report(s) : PFIZER INC-202101119239 same patient/drug, different dose/event
**lot number above may be incorrect, the writing was illegible   strong reaction in lymph nodes in armpit, swollen to the size of a golfball
5 second "tremor" over entire body occurred 1 day after FLUMIST. 100.5 temperature.
PT came in to get his first Moderna Covid shot. After patient was done, patient walked out and sat in the waiting room chair. 7 minutes into sitting down patient passed out and fell out of the chair and hit the floor. When the pharmacist came out to the patient, to assure their safety, moments after getting his safety assured. Pt informed the staff that he had not eaten anything in 12 hours before getting the shot. Pt was given Orange juice, to get his sugar back up. The Pharmacist check his blood pressure and it was 117/78. Pulse was 53 so it was low as expected post- syncope episode. Pt waited for his mother before leaving allowing him to be safe afterwards.
This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 20-JAN-2017, the patient was vaccinated with an improperly stored doses of M-M-R II recombinant human albumin (rHA), lot # M015931, expiration date 30-MAR-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113.
Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified Vaccine program Administrators.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministered.  An email was sent with the following info to verify that there is 2 additional days for expire time but the vaccine expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured and all staff have met and will place visible expire labels on each box upon receiving and monitor expire dates daily to prevent further occurrences.
After the second shot the next morning I had bad chills and assumed it was fever, but when I took my temperature it was actually very low, dangerously low at 91.4, it took about 15 minutes to increase to 94 and the rest of the day it was 97.5