chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20 minutes after receiving Pfizer dose, he had metallic taste in mouth, felt dizzy. Vitals 111/58 HR 46. pulse ox 96% on RA.Patient given Benadryl. Metallic taste improved and dizziness improved. He stated at this point that it felt like his throat was swelling so epi was administered.  He went to the ER as directed but not by ambulance. He was treated there rom 6:15 to 9:15. Received monitoring and decadron IV.
RN(reporter) is the nurse manager of the clinic. RN(vaccinator) informed the manager that she just administered a 2nd booster to a client age 40 without immunocompromised condition who does not qualify for 2nd booster.  Event supervisor is notified. Staff provided counseling and explained situation to the patient. Patient was observed and left without any distress.
Over the past 48 hours, on and off symptoms have been: Headache Nausea  Fatigue Muscle soreness (site of injection-back to normal now) Abdominal pain
c/o headache 5 min after vaccine given initially 4-5/10 then decreased to 3-4/10. vital signs stable 138/91 HR105 no rash, no redness, no induration at site. no resp distress. vital signs recheck 134/91 pulse 97 at 1233, advised to go to ER if symptoms worsened, discharged at 1638. Patient called clinic at 1330 on 1/6/21 c/o continued headache, now improving, Temp 99.2, facial flushing, bilateral arm and leg swelling also now improving. patient advised to go to urgent care or ER however patient refused and said she will go to her new primary MD on 1/8/21 and will go to ER if symptoms worsen. Also patient stated had COVID-19 test by occupational health results pending.
pt recv vax 15AUG96 & 5 to 6 days later pt exp flu-like sx, including fever, nausea, vomiting & gen malaise;WAES 96081699 through 96081702;
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; 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) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 66-year-old male 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 02-Mar-2021 at 1:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 1:34 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Mar-2021 at 1:27 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Vial was stored in cooler 1, on 02-Mar-2021, Excursion duration at 9 am: 27, at 10 am 29, at 11 am 32, at 12 am 33, at 1 pm 36, at 2 pm 35, at 3 pm 36, at 4 pm 37 and at 5 pm 37 taken using a Fisherbrand traceable temperature monitor in F On 02-Mar-2021, total doses given for the day was 177, condition of vaccine; prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vials were moved to clinic. Vaccine BUD date was 26-Mar-2021 for batch number 014M20A.  On 30-Mar-2021, total doses given for the day was 173, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021. 3 vial was moved to clinic. Vaccine BUD date was 22-Apr-2021 for batch number 019B21A.  Vials were only punctured right before administration.Vaccines were not frozen at time of administration Storage condition at the time of the excursion was reported as cooler storage during high-pace COVID-19 vaccination clinic No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Patient complaints of soreness and redness on her right arm. I advised patient to take ibuprofen and if he soreness isn't get better in the next few days, then give us a call back. I explained to her that it's very common side effect and it will go away in few days.
This spontaneous report as received from a Licensed Practical Nurse refers to a 8 week old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 28-JUN-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293.
Narrative: COVID infection following COVID vaccine series 03/25, Pfizer, dose#1 04/14. Pfizer, dose #2 09/27 COVID swab, result: detected 09/27 pt cc: exposure: unknown
The patient was participation in a post marketing evaluation of the safety of influenza virus vaccine live, intranasal flu mist in health children and healthy adults 5 through 49 years of age. A report was received of Bells palsy, neck pain, shoulder pain, and discomfort around the right ear coincident of FluMist. A 40 year old male with a history of migraines, anxiety, arthroscopic surgery, and chronic back pain, received FluMist on 11/25/2006 and developed Bells Palsy on 12/3/05. The patient reported several days of neck and shoulder pain that occasionally radiated to the right arm (no weakness or numbness) and one to two days of discomfort around the right ear. The patient was taking hydrocodone acetaminophen for pain due to recent arthroscopic surgery in 11/21/05. ON 12/14/05, the event of Bells Palsy was considered resolved. The outcome for the events of neck and shoulder pain were not provided. The reporter assessed the event of Bells palsy as possibly related to FluMist. The reporter did not provide a statement of causality for the events of neck and shoulder pain. This case is linked to MEDI0004189 (patient experienced pneumonia after receiving FluMist.
tested positive for COVID-19; Fever; Fatigue; Nausea; Diarrhea; A spontaneous report was reported by a physician and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event. Concomitant product use was not provided by the reporter.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.      On 16-Feb-2021 that  patient arrived at the ER department with fever, fatigue, nausea , diarrhea among others. These symptoms started 4 days ago, The physician wants to know if this patient is a good candidate for Monoclonal antibodies treatment. He has consulted with his colleagues and nobody is able to give him an answer. He would greatly appreciate if Moderna can give a call him as soon as possible.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
3:40 PM Tdap was given pt felt weak and lightheaded pt was placed on bed to lie down. Vital signs stable. 3:45 PM pt given 5.5 oz orange juice-pt lying down. Mother in room. 3:55 PM pt lying down on bed-feels fine vital signs stable. 4:05 PM pt was placed in chair-feels fine-vital signs stable. 4:16 PM pt walked out with mother. Pt felt fine.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Additional Details: pt was given bivalent as a primary series.... 1st dose as this pharmacy dc-ed all the monovalent. pt has no complaints. pt was advised to wait for 4 weeks to get the monovalent as primary series.  pt will see the primary doctor to discuss getting monovalent series
Swollen lymph nodes that throb with sharp pain from time to time under left armpit, beginning the morning after the shot.  I took aspirin on Saturday, Tylenol Saturday night and Sunday.  It persists until today. Sore arm, beginning from time of the shot to Sunday afternoon.
Instantly after receiving my first dose, the taste in my mouth changed to metal or copper. It felt like there was a penny in my mouth. They sat me down for my 15 minutes, waiting on approval to go. I told them about the taste in my mouth. They told me that they think it's normal. I was waiting around and someone asked me something. I tried to respond, but I couldn't talk or speak. I started to get very scared and they gave me some Benadryl right away. They kept me for another 30 minutes. They tried to get me to talk again, and I was able to a little, but not much. They sent me home after that, where I was experiencing a fever and chills for the following 48 hours. My main worry through all of this was the taste in my mouth and the fact that I could not speak.
Approximately 6 hours post vax, the pt started running a high fever. The area became red, elevated and hot to the touch.
PATIENT REPORTS FEELING TINGLING OF THE TONGUE, 50MG BENADRYL IM GIVEN, TOLERATED WELL, SYMPTOMS RESOLVED, PATIENT STABLE. ENCOURAGED TO FOLLOW UP WITH PCP
Injection site redness/warmth, have a knot and is itchy. Originally redness went away and now came back over a week later
C/o pain, 3"-4" redness to LUA & 1"-2" swelling on day of vaccine & all resolved 2 days later. The c/o pain intermittently to "deep inside" (L) upper arm in OCT. On 11-5-11  & 11-6-11 -> c/o pain LUE all above elbow to shoulder. 11-7-11 c/o decreased sensation (L) arm & (L) hand. 11-9-11 pain less - sensation better with chiro appt. Has recurring s/s.
10 days post vaccine swelling bilaterally hands with hives and itching and peeling hands. Swelling also noted in bilaterally feet/ankles currently ongoing for 6 weeks.
I did not wheeze or have any allergic issues at all; 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 female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: I have had asthma all my life (cats and horses and dust). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I did not wheeze or have any allergic issues at all".  Additional information: Question: Hi, I have had asthma all my life (cats and horses and dust). I got two pfizer vaccines last year (no booster). I just got back from a family visit where I was around cats and smoke/cats all week. I did not wheeze or have any allergic issues at all. Please read the article below. Maybe the covid shots would HELP people with asthma? # Thanks - (name). Regulatory Authority: E- transmitting potential AE. Non Phone Case.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
expired vaccine receved; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine receved) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 06-Dec-2021 at 2:20 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 06-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine receved). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine receved) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.
Information has been received from a registered nurse concerning a 5 month old female with no known medical history or allergies who on 19-FEB-2007 was vaccinated IM with a first dose of hepatitis A virus vaccine inactivated (Lot number 653616/0511F). Concomitant vaccinations administered that day included a dose of ROTATEQ, a dose of Hib conj vaccine (OMPC) (MSD), and a dose of PREVNAR. There was no illness at the time of vaccination. It was reported that the patient should have been vaccinated with PEDIARIX instead of hepatitis A virus vaccine inactivated. No laboratory tests were reported. No product quality complaint was involved. The patient had no adverse events following prior vaccination.
Patient was extremely anxious, agitated and crying prior to receiving her vaccination.  Directly after receiving her vaccination and while sitting in the waiting area, the patient fell on the ground.  The patient's mother was speaking to the immunizer and did not see her fall.  The patient was awake and attentive after the incident, but began to cry as she was upset by falling on the ground.
A spontaneous report has been received from a Health Professional concerning a 13 year old, Female patient, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. EXPIRED FLUMIST was ADMINISTERED to the patient on 27-Jan-2015. The outcome of the event of EXPIRED FLUMIST ADMINISTERED is unknown. The report was considered to be non-serious by the reporter.
Narrative: Pt treated skin rash with diphenhydramine 25mg prn and prednisone tapering dose.  Symptoms: UrticariaPruritus
2nd dose COVID Moderna vaccine given 5/4/21 (1st dose on 4/6/21), admitted on 6/28/21 w/ DKA and E.coli bacteremia, found to also be COVID+ via PCR. CXR showed infiltrates, but patient only with minimal respiratory impairment (up to 2L NC for a couple of days). Patient was admitted to ICU, but due to other illnesses (not respiratory infection).
This is a spontaneous report obtained from a contactable pharmacist. An 81-year-old female patient received, on 11Nov2017, at the age of 80 years, PREVNAR 13 (Lot. T08483, Expiration date: Sep2018, NDC number: 00005197102, UPC number: N300051971022) at single dose, for immunization. Relevant medical history included blood pressure and cholesterol. Concomitant medications included oral valsartan, tablet, 80 mg, once daily, from an unspecified date and ongoing, for blood pressure abnormal and oral lovastatin tablet, 40 mg, once daily, from an unspecified date and ongoing, for blood cholesterol abnormal. On 18Nov2017, the patient's arm was very red, swollen and warm to touch. Clinical outcome of the events was unknown at time of this report.
approx 2-3 hr p/ recv vax pt devel a ``tic'' & it was rpt pt exp exaggerated blinking & head nod simultaneously occurring approx 10-12 times per hr. addl info requested
Heartbeat racing five minutes after shot (but stopped before the 15 minute waiting period at clinic) Woke up next day around 9am and felt like I had a fever and chills, but checking temperature verified I did not. I also had a sore left arm, a headache, body aches, and some fatigue (general grogginess). I went to work that day and woke up the next day feeling fine again.
Hot red swollen arm. Water blistes. Fever. Achy. Dr 11/26/14 starting to clear but blister still there.
Return of injection site soreness at rest but increasing with range of motion,  swollen lymph nodes in axilla injection side (L).  And limited range of motion due to pain.  Pain continues currently but lymph node seem to have returned to normal.  Pain mainly with movement today but does intermittently occur at rest.   I haven?t seen the physician because I felt this would resolve after researching the side effect awesome online medical resource sites.
Temperature excursion; Product got expired on 13-Jul-2022 and store in refrigerator on 17-Jul-2022; Administer expiry vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expiry vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and PRODUCT STORAGE ERROR (Product got expired on 13-Jul-2022 and store in refrigerator on 17-Jul-2022) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third 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 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expiry vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and PRODUCT STORAGE ERROR (Product got expired on 13-Jul-2022 and store in refrigerator on 17-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expiry vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and PRODUCT STORAGE ERROR (Product got expired on 13-Jul-2022 and store in refrigerator on 17-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that five patients received vaccination which has undergone temperature excursion. Dates of administration of vaccine was 18-Jul2-022 and 19-Jul-2022. The vial was initially stored in the refrigerator on 17-Jul-2022 and 18-Jul-2022.The maximum temperatures reached at a maximum of 5.8°F. The vial undergone a temperature excursions duration of 15 minutes.The vials were  moved from freezer to refrigerator on  17-Jul-2022 and 18-Jul-2022. On visual inspection there was no change in state of vaccine.   This case was linked to MOD-2022-611805, MOD-2022-611848, MOD-2022-611864 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2022: Follow-up Received: Reporter email address, last name updated.
10/17 light headed, slight headache began, 10/21 temp 99.4, sleeping more naps, 10/22 severe diarrhea onset 4am diarrhea has continued to this day. uniformed stools, hyperactive bowel stimulated every time I eat or drink. Unimproved diarrhea for one month. Treated with Pepto Bismol, Loperamide, BRAT diet, fluids with electrolytes. Diagnosed as post injection inflammation.
No adverse event; dose of Moderna Covid-19 Vaccine, Bivalent was given to a patient who didn't have the primary series.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (dose of Moderna Covid-19 Vaccine, Bivalent was given to a patient who didn't have the primary series.) and NO ADVERSE EVENT (No adverse event) in an 88-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 07-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (dose of Moderna Covid-19 Vaccine, Bivalent was given to a patient who didn't have the primary series.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (dose of Moderna Covid-19 Vaccine, Bivalent was given to a patient who didn't have the primary series.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (dose of Moderna Covid-19 Vaccine, Bivalent was given to a patient who didn't have the primary series.).    No concomitant medications were reported. No treatment medications were reported.
Headache and fatigue immediately following shot. Starting 11 days later, diarrhea, nausea, loss of appetite, photosensitivity, fevers, body aches, chills, extreme fatigue, continued headaches, abdominal pain. These symptoms and fevers continued for 18 days,. Treated for presumed Lyme disease with 6 weeks Doxy.
pt recv vax 30SEP97 & approx 2hr p/vax pt exp hives on trunk & was given DPH;