chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 61-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that there have been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. Reporter said that they were filling out a temperature excursion assessment with the State at this time and she was calling in to report the same to Moderna. Reporter confirmed that patients have been administered doses while the temperature excursion assessment has been ongoing.  It was reported that no adverse reactions were reported by any patients.  No Treatment information was provided.
Right -side neck pain (injection was given in right arm).  Unresolved as of today.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 15-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot #K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 888 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Collapsed into father's arms; body stiff; finely shaking, torso arched backwards, eyes rolled into her head.
This spontaneous report was received from a medical assistant and refers to a 15 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 10-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M005921, expiration date 02-FEB-2018; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
patient got vaccine on Thursday evening. She came in to store on Saturday morning and said her are was very sore.  The soreness started on Friday and she still had soreness on Saturday. It was hard sleeping on her arm at night. She told me the pain was not getting worse. I told her if the pain continues or gets worse she should call her doctor immediately
Onset of Petechial/purpural rash along BLE starting in thighs B/L with spread to abdomen and BUE. Probable Type III Hypersensitivity vs vasculitis. Came to hospital 01/28/2021. Treated with PO steroids 60 mg  PO prednisone with rapid improvement. Testing still pending.
On 5/1/99, the pharmacist developed a varicella-like rash that consisted of approximately thirteen lesions and a 102 fever taken orally. Follow-up information from a physician reported that the fever lasted 2 days and the varicella-like rash lasted approximately one week. The pt recovered.
Started with my arm being in a lot of pain and spreading through shoulder into neck. Then got dizzy and really tired with a headache. It turned into hot/cold flashes and an inability to regulate my body temperature with whole body aches and  body shakes.
Low grade fever, pain. Shot received on 11/4/02. On 11/11/02 shot boosted immune system. Could not use arm, shoulder shot was given in. MD removed fluid-? of infection. Had arthroscopic surgery on 11/14/02-surgeon MD. Still has pain from shoulder.
Mom reported by phone that child had swelling & redness at injection site on right arm on the back of arm 1st noticed the next morning on 3/7/12.
Injection site back of left arm became red and swollen.  Prescribed clindamycin 300 mg TID for 10 days.
she was administered with the dose from a vial which was punctured and kept in the refrigerator for approximately 30 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (she was administered with the dose from a vial which was punctured and kept in the refrigerator for approximately 30 hours) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced PRODUCT STORAGE ERROR (she was administered with the dose from a vial which was punctured and kept in the refrigerator for approximately 30 hours). On 27-May-2021, PRODUCT STORAGE ERROR (she was administered with the dose from a vial which was punctured and kept in the refrigerator for approximately 30 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
severe Chills/shakes lasting ~ 2 hrs, starting 7 hrs. after shot low grade fever, fluctuating between 99 and 101, beginning 12 hrs. after shot and still continuing  headache, beginning 3-4 hours after the shot and continuing diarrhea beginning 12 hours after shot nausea, weakness, dizziness, beginning a few hours after shot and still continuing
Vaccinated wrong patient; Case reference number BN-2022-000855, initially downloaded on 28-Mar-2022, is a spontaneous case received from a health professional via Health authority (ID: 2178214-1) and concerns a 43-year old female patient.  The patient had no medical history.  On 14-Mar-2022, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus vaccine; batch number: BNYRBA821A), at an unknown dose, intramuscularly, in the right arm, for unknown indication.  The reporter stated that the wrong patient was vaccinated, the client answered to wrong name and the client tolerated vaccine well (explicitly coded as 'Wrong patient').  At the time od this report it was unknown if the patient experienced any adverse event.  No further information was provided.; Reporter's Comments: A 43-year old female patient was vaccinated with the first dose of RabAvert, but reporter stated that the wrong patient was vaccinated. Reportedly the client answered to wrong name and the client tolerated vaccine well. No associated adverse events were reported. Wrong patient is listed per company convention. The patient had no medical history. Giving vaccine to a wrong patient is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A 43-year old female patient was vaccinated with the first dose of RabAvert, but reporter stated that the wrong patient was vaccinated. Reportedly the client answered to wrong name and the client tolerated vaccine well. No associated adverse events were reported. Wrong patient is listed per company convention. The patient had no medical history. Giving vaccine to a wrong patient is not related to RabAvert, but to a human factor. The case is non-serious.
I do not know for sure if this is a side effect of the vaccine, but wanted to report.  I experienced uncontrollable, whole body shivering, severe headache, and fatigue. The shivering was accompanied by alternating chills and fever.  I received the vaccine on Monday, 5/6/2019.  I started shivering Wednesday, 5/8/2019, after being in bed for about 45 minutes of sleep.  The shivering lasted about 3 hours.  The headache lasted through the night and into the next day (Wednesday, 5/8/2019-Thursday, 5/9/2019).
pt recvd vax 27JUN95 & 18JUL95 pt mom phoned & reported pt devel an area which looked like chicken pox on leg;14JUL95 3 more areas appeared on neck, temple, & near inj site; pt seen by MD for an unrelated problem;MD dx insect bites
I received the shot at 4:50pm on 1/19/21. At 7:00am on 1/20/21, I felt nauseated and vomited a few times. I called in sick to work, and proceeded to have severe body aches and mild chills for the next 24 hours. The aforementioned symptoms lasted 24 hours. Pain at the injection site was moderate-severe and lasted over 24 hours. Mild fatigue and headaches lasted over 36 hours.
Patient got rash all over her body a few days after she received the vaccine. This rash lasted for about 10 days and then self-resolved.
Patient Reports that immediately after patient received vaccine in right arm that she started exhibiting pain running up and down her arm. Patient reports that pain is 10/10. Describe the pain as " Feels like when cold water hits a sensitive tooth". Blood pressure was taken (119/78) with a heart rate of 93. Ice pack was given. Monitored the patient for 30 min.
expired dose of the Pfizer-BioNTech COVID-19 Vaccine/ The paper said 30Apr2022, and yesterday was 05May2022; felt sick after getting the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 73-year-old male patient received BNT162b2 (COMIRNATY), on 05May2022 as dose number unknown, single (Batch/Lot number: unknown, Expiration Date: 30Apr2022) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "severe diabetes" (ongoing), notes: he has severe diabetes and has other health issues; "He's had a stroke and a heart attack" (unspecified if ongoing); "He's had a stroke and a heart attack" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 05May2022, outcome "unknown", described as "expired dose of the Pfizer-BioNTech COVID-19 Vaccine/ The paper said 30Apr2022, and yesterday was 05May2022"; MALAISE (non-serious) with onset May2022, outcome "unknown", described as "felt sick after getting the shot".  Additional Information:Caller states that yesterday 05May2022 her husband (73 years old) received an expired dose of the Pfizer-BioNTech COVID-19 Vaccine."The paper said 30Apr2022, and yesterday was 05May2022.He felt sick after getting the shot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
armpit got swollen but within a week, it was pretty much gone; fever went up to 100.5/dealing with this for 10 days; This spontaneous case was reported by a patient and describes the occurrence of SKIN SWELLING (armpit got swollen but within a week, it was pretty much gone) and PYREXIA (fever went up to 100.5/dealing with this for 10 days) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Brain injury. Previously administered products included for Drug use for unknown indication: Pfizer shots (fever of 102), Pfizer booster (Pfizer booster) and Pfizer shots (fever of 102). Past adverse reactions to the above products included Fever with Pfizer shots and Pfizer shots; and Skin swelling with Pfizer booster. Concurrent medical conditions included Allergy to nuts (cashews) and Sulfonamide allergy (sulfa).    On 10-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced SKIN SWELLING (armpit got swollen but within a week, it was pretty much gone) and PYREXIA (fever went up to 100.5/dealing with this for 10 days). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, SKIN SWELLING (armpit got swollen but within a week, it was pretty much gone) and PYREXIA (fever went up to 100.5/dealing with this for 10 days) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2022, Body temperature: 99 on third day temperature was dropped down to 99. In July 2022, Body temperature: 98.5-99.6 F. and 100.5 100.5 F.         Concomitant product use was not provided by the reporter. Patient did not have other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient did not have COVID-19 or diagnosis with COVID-19 positive.  Patient initial body temperature was 97.5-98.5 . Patient symptoms  slightly improved on the tenth day as 21-Jul-2022. Patient took phone appointment with doctor on 21-Jul-2022  for adverse event. Patient  took treatment medication first couple of days. Patient stopped treatment medication as treatment medication not helped to patient.
This is a spontaneous report from Pfizer sponsored program Pfizer RXPathways, from a contactable consumer reporting for herself. A 59-year-old female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain in the upper right arm and shoulder since the day of vaccination. The outcome of the events was unknown.
The patient developed severe numbness and tingling in her extremities, she was then diagnosed with chronic demyelinating  polyneuropathy.
Indurated, reddened area approx. 7"x5" area around vaccine site. Tender to touch. Pt seen by PCP and put on 5 day antibio course.
9-17-09 Bright red blood in stool.  9-21-09 low grade fever.  9-19-09 3:49 AM went to hospital ED blood noted. 9-13-09 Explosive diarrhea.  Sx resolved with BARIUM enema no intussuscaption noted.
3/13/21 Received first Pfizer COVID vaccine to right arm. The next day on 3/14/21 she developed ringing in the ears.
Information has been received from a physician concerning his daughter with no known drug allergies and no past medical history who on 08/15/2001 was vaccinated in the left arm with a first dose of varicella vaccine. There was no concomitant medication. Two or three days later, the pt developed hives. It was reported that the child has no history of hives. The hives were very itchy and covered several parts of her body. They appeared on one part of the body, went away, then appeared on another part of the body. It was noted that there were no other complications. The child's father reported that "he can not think of any other reason for the hives other than the Varivax." The pt's pediatrician suggested that she see an allergist. Unspecified medical attention was sought. Follow-up info from a physician indicated that the child had a "fleeting rash" that started 4-5 days after the vaccination and lasted about 3 weeks. She reported that she did not see the pt in her office. The pt's father reported it. It was reported that the pt recovered one month later. No further info is available at this time.
Received Pfizer vaccines on 4/5/21, 4/26/21 tested positive for COVID-19 by PCR on 7/21/21. Hospitalized on 7/21/21. 3 weeks of pulmonary symptoms, fever, H/A, fatigue, dry cough, CT chest shows peripheral ground glass infiltrates. Diagnosed w/ pneumonia d/t COVID-19 but has not required oxygen.  Plan on administering monoclonal antibodies as an outpatient as patient is not a candidate for remdesivir. Patient has h/o kidney transplant in 2019.
Truncal rash 7 days post MMR and vesicular rash at injection site due to VARIVAX.
experiencing diarrhea after getting the second dose of the Pfizer BioNTech covid vaccine; headaches; fatigue; 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 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 15:10 (Lot number: EN6202) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Lot number: EM9810 for the first dose, Anatomical location: right arm), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 03Mar2021, outcome "not recovered", described as "experiencing diarrhea after getting the second dose of the Pfizer BioNTech covid vaccine"; HEADACHE (non-serious) with onset 03Mar2021, outcome "not recovered", described as "headaches"; FATIGUE (non-serious) with onset 03Mar2021, outcome "not recovered", described as "fatigue". The event "experiencing diarrhea after getting the second dose of the pfizer biontech covid vaccine" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated that she got the second dose four weeks ago and since the day after the vaccine she has had pretty bad diarrhea for 4 weeks. She is just curious the main reason she is calling to see if they have heard of other people having this and is it supposed to go on this long. Diarrhea, outcome of event: She has good days and bad days, she does not think it has gotten better but some days are worse than others. Headaches, outcome: It comes and goes a lot of times in the morning she will wake up with a headache. She says it is ongoing. Fatigue: She has really bad days sometimes where she was not able to getting off the couch and then sometimes she wakes up with a little more energy, that fades really quick. The facility where the most recent COVID-19 vaccine was administered is Hagerty Center, there was a vaccine clinic set. No other vaccine was administered on same date of Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not experience any AE prior to vaccination.  No follow-up attempts are possible. No further information is expected.
I got awake ~12:15 am on 8/11/21, felt sweaty, took off the blanket.  Checked my phone for messages.  Could not make out anything on the screen.  Put on my reading glasses, still could not make out anything on the screen.  Objects in the distance appeared blurry, could make out silhouettes but not detail.  Both eyes had blurred vision, left eye had no peripheral vision, both eyes had "spider webs".   Got up to wash my face in case that would clear the disturbance; it did not.  Called a neighbor to take me to the hospital E.R.  Arrived there around 1:15 a.m..  By then the vision was mostly returned but still not my normal.
pt feels, weak, passed out @ school x 2, devel h/a, CT, MRI of head negative;exam nl, chem & CBC nl, neurologist eval nl;pt exp w/med w/o help;mom w/migraines;
1 red puffy itchy eyes, 2 nausea, 3 itchy throat, 4 itchy ankles with hives, 5 swollen ankles, 6 itchy at site, redness.
a fever of 103; muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (a fever of 103), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PYREXIA (a fever of 103), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). At the time of the report, PYREXIA (a fever of 103), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided
hx of receiving DTP/HIB 16JUL92; 2-3 hrs later devel fever; about 10 hrs later had generalized sz (tonic clonic) lasting about1 min; mom did not call & report; during resp illness had 2nd sz; pt hospitalized 24JUL92;
red "blister-like" papules on leg; petechiae on legs; Trauma; This is a spontaneous report received from a contactable nurse, the patient. A 52-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9261) via an unspecified route of administration in left arm on 25Jan2021 (at the age of 52-year-old) as single dose for COVID-19 immunisation. The patient was allergic to tetracycline, lasix and penicillin. The patient was not diagnosed with COVID-19 prior vaccination and since vaccination the patient was not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included metoprolol (MANUFACTURER UNKNOWN), levocetirizine (XYZAL), cyclosporine (RESTASIS), vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN) since from an unspecified date for an unknown indication. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1686) via an unspecified route of administration in left arm on 04Jan2021 at 14:00 (at the age of 52-year-old) as single dose for COVID-19 immunisation. On 15Feb2021, the patient experienced red blister like papule on toes. It started with second toe (beside the great toe) on right foot. Later in Feb2021, it has spread to the same toe on left foot. There was little petechiae on toes, it sometimes itches and stings and dermatologist said it was trauma and not COVID toe. No therapeutic measures were taken for the reported events. The clinical outcome of events blistery rash, petechial rash and trauma was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
No additional AEs; administration of PROQUAD to a patient which had expired on 25MAR2021 and was administered, today, 27APR2021; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 27-APR-2021, the patient was vaccinated with and expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number S030211, expiration date 25-MAR-2021 (route of administration was not reported) for prophylaxis. No adverse event was reported.