chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse by phone. This case is linked to cases 2018SA324602, 2018SA324605, 2018SA324604, 2018SA324607, 2018SA324609, 2018SA324606, 2018SA324596 and 2018SA324596 (same reporter). This case involves elderly female patient (age not reported) was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UJ045AA and expiry date: 30-Jun-2019) via intramuscular route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the refrigerator temperature dropped overnight to 29.1 degrees Fahrenheit and was out of range for 11 hours. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Pt reported their arm is still sore, especially when he raises arm high pt says it has been this way all along since vaccine.
8/13/2022: evening--fever100.7 F 8/14/2022: fever 101 F, arm pain begins/ arm red and pain swollen 8/15/2022: fever breaks and arm pain continue 8/16/2022: drops an item weakness in left hand 8/17/2022: swollen, red and hot/warm, hand is hard to use
This spontaneous report was received from a respiratory therapist refers to one among three unspecified patient, age and gender were unknown. Medical history was not reported. The respiratory therapist informed that between 01-FEB-2014 through 31-MAY-2014 the patient was vaccinated with GARDASIL 120Y, injection, lot number T005679 expiration date 27-NOV-2015 (route, strength and dosage were not reported), which was improperly stored. Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) filed. The action taken was assessed as not applicable. The causality was assessed as not related to the suspect therapy. Follow up information has been received. Lot number T005679 is an invalid lot numbers for GARDASIL.  This is one of several reports received from the same reporter. Additional information has been requested.
Extreme muscle pain at location of vaccine. Extreme joint pain in shoulder of arm vaccine given. Decreased range of motion in shoulder. Symptoms lasted more than 1 month.
No additional adverse events reported; Administration of expired VARlVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding patient's medical history, concurrent conditions or concomitant therapies provided.  On 07-DEC-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # S033952, expiration date 24-OCT-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse events reported. No product quality complaints reported.
On April 20, 2021, in the late afternoon I was talking on the phone while doing a presentation for work like I normally do every day. As I was talking, I noticed I couldn't catch my breath, so I ended the call. I was sitting and just talking. I looked at my smart watch and it said my heart rate was 150 bpm at rest. I called an ambulance and when they arrived my blood pressure was 170 over something and it was high. I usually don't have high blood pressure. They took me to ER. The doctors ran test but couldn't find anything, so I was discharged. It kept happening at night where I would be short of breath, have chest pains, and a racing heart rate. I didn't have anxiety or anything like that before. I went to my family Doctor, and he prescribed metoprolol 25mg 1xday to try to calm my heart rate down. I got my second dose on April 24th, 2021. I had a Holter monitor that came back fairly normal. In May my heart rate flew up to 150 again. I went to the doctor again. They did some more test, and everything was normal. I've seen a cardiologist on June 3, 2021. I have been on metoprolol ever since my doctor has prescribed it. I haven't been to the ICU anymore because my doctor said I can just take the metoprolol to keep my heart from racing. Every couple of months I have a flare up, and I have never had this before getting the vaccine. About every 2 months I have been having the flare ups with my heart. I am starting to feel better overtime.
Painful injection, extreme soreness for a few days which turned into an ache, weakness and reduced range of motion which I still have to this day.
Shortness of breath Difficulty breathing  Headache Body aches Trouble swallowing  Elevated temperature
This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 28, via an unspecified route of administration, on Aug 14, 2021, single dose, for COVID-19 immunisation. The patient did not have any medical history. The patient has no known allergies. Prior to the vaccination, patient was not diagnosed with COVID-19. Concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 28, via an unspecified route of administration, on Jul 24, 2021, single dose, for COVID-19 immunisation. On an unknown date in 2021 (after the second shot), patient felt nauseous and lightheaded. He also had hand numbness for just under a month. Reportedly, patient was just hoping for advice on what to do since it seemed to come in waves. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On Sep 5, 2021, patient underwent nasal swab COVID-19 test with negative result. No therapeutic measures taken as a result of the events. The outcome of felt nauseous, lightheaded and hand numbness: not recovered at the time of this report.
Six days after shot I developed rash on the upper right arm that lasted five days.  The rash was about 5inches wide and three inches high. It was painful  mildly itchy hot red. The rash lasted about four days. I tried Benadryl which helped with the itch and redness. The same rash after the second dose but it went away after two days after massage.
Day 8 following first dose of Modern swelling at injection site, indurated when palpated  and itchy about 2.5-3 inches in diameter.  Surface of skin is intact and otherwise unchanged.
fever; chills; her hands were shaking; headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Bnt162b2 (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), administration date: Apr2022, for COVID-19 Immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: CHILLS (non-serious) with onset 27Sep2023, outcome "unknown"; PYREXIA (non-serious) with onset 27Sep2023, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset 27Sep2023, outcome "unknown"; TREMOR (non-serious) with onset 27Sep2023, outcome "unknown", described as "her hands were shaking".  Additional information: The caller said that she got the new vaccine yesterday afternoon. The caller mentioned that this was her fourth booster. The caller stated that she had a bad reaction last night. The caller said that she had a fever, chills, and her hands were shaking. She also had a headache. The caller said that she noticed that she had those bad reactions after taking her second booster shot in Apr2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300313905 same reporter/patient/AE, different dose number (dose 4);
RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/22/2022  &  3/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 19-MAY-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "2", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
benign lesion removed from the leg; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID. The reporter is the patient.  A 68-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "handicap"; "Disability"; "chicken pox", notes: in inner ear; "don't hear well out", notes: right ear. The patient's concomitant medications were not reported. The following information was reported: SKIN LESION (medically significant), outcome "unknown", described as "benign lesion removed from the leg". Therapeutic measures were taken as a result of skin lesion. Additional information: patient stated, can't always hear. It's can't, it's hard to speak when the patient don't hear well out of the right ear. Patient sent a note up to the Neurologist and knows patient is handicap. Patient got vaccine and boosters in Jan or Feb when it first came out and developed a problem. Patient reported something, like a benign lesion removed from the leg. The surgical assistant said patient was going to give an (inaudible) injection and patient has watched as the assistant numb her leg up.  The patient did not specify which vaccine they received. Pfizer-BioNTech COVID-19 Vaccine is being reported out of an abundance of caution.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the temporal relationship, the association between the event "benign lesion removed from the leg" with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
She received her second Covid vaccine and ended up passing out in her bathroom around 5:00 this morning.  Patient was standing and believes she fell and hit her head on both the tub and floor.  EMS came and checked her out and found no concerns on heart monitor.  She was running low-grade fever.  Recommended follow-up today in clinic.  Prior to the fall and through the night she had body aches, chills, and upset stomach.  Upon awakening this morning was mostly just experiencing body aches as well as neck pain.  Has had mild headache for the last few days but there has been no worsening of symptoms since the fall.  Denies any blurry vision.
Initial and follow up information has been received from a medical assistant and a registered nurse concerning a 65 year old male consumer with no known allergies or pertinent medical history who on 06-SEP-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot#658005/1006U) instead of zoster vaccine live (Oka/Merck) (MSD). There were no adverse events reported. This was not a product confusion according to the reporter. Medical attention was not sought. No lab studies were performed. The patient was doing fine. The nurse stated that she was advised that the patient would be permitted to receive the correct vaccine 4 weeks from the time of the incorrect vaccination. The doctor phoned the patient to follow up for any adverse reactions and to instruct the patient to make an appointment in 4 weeks for the correct vaccination. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Patient developed redness, itching and swelling after receiving a ZOSTAVAX immunisation. Patient saw her PCP and was prescribed betamethasone 0.05% ointment and hydroxyzine 25mg capsules which has helped to relieve her reaction.
Case number PHEH2015US023881 is an initial spontaneous report received from a health care professional on 13 Nov 2015. This report refers to a 13 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173989) intramuscularly at a dose of 0.5 ml on 11 Nov 2015. No adverse event was reported following this medication error (drug administered to patient of inappropriate age).
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.  On 20-Mar-2021 at 11:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (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.   Patient age was reported as 64.86  No concomitant medications were reported. The vial underwent temperature excursion on 20-Mar-2021 with temperature 37 degrees Fahrenheit and the vial was initially moved to the fridge on 09-Mar-2021 and proposed beyond use date was 08-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 30 degree Fahrenheit that has been reached by the vial. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
Client presented to the vaccination site with her husband. Client received Pfizer booster, Lot# FK9895 at 1022 on 02/10/2022 (left deltoid). At approximately 1040, client reported, ?My throat feels itchy, and I feel like I want to cough.? Nurse assessed client.  Client was alert and oriented to person, place, time, situation, and sitting in chair. At 1041, client's vital signs were obtained: blood pressure 152/78; pulse rate 61; SpO2 98%, and temperature 97 degrees F. Client denied difficulty breathing, chest pain, blurred vision, and dizziness. Client has no known allergies. Client received the 1st dose Pfizer, Lot# ER8737 on 03/30/2021 and 2nd dose Pfizer, Lot# EW0171 on 04/20/2021. Client denied any allergic reactions with her 1st and 2nd dose of Pfizer Covid vaccines. Client was not taking any medications. At 1043, client was given diphenhydramine 50mg/1mL in left deltoid. At 1048, nurse reassessed patient: elevated blood pressure 160/88; pulse rate 59; and SpO2 97%. Client denied itchiness in throat, difficulty breathing, and blurred vision. Client reported feeling a little drowsy. At 1053, client' s vital signs: blood pressure 148/72; pulse rate 60; and SpO2 98%. Client denied itchiness in throat, difficulty breathing and dizziness. Client continued to report mild drowsiness. Client was educated on side effects of diphenhydramine, follow up with PCP, signs and symptoms of when to seek emergency care, and use of V-safe. Client verbalized understanding. Client's vital signs at 1058: blood pressure 138/80, pulse rate 64, Sp02 97%. Client reported, ? I still feel drowsy, my throat is not itchy.? Client stated that her husband will drive her home. Client left facility with unlabored respirations and a steady gait at 1125.
pt says he has upper arm, shoulder pain, swelling, lost range of motion in his arm. he is getting better slowly.
Moderate asthma attack (allergies to eggs). Treated with a shot and with oral medication. (Hydroxyl HCL 25mg). Dear sirs: It was ridiculous of me to have reported this incident. I've had asthma (diagnosed Jan 1978) and I am allergic to eggs. Very simple. So I've had my last flu shot.
No adverse event; Nurse reported at temperature excursion on GARDASIL 9 was administered; This spontaneous report was received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions,  pertinent medical history, drug reactions, allergies, and concomitant therapies were not provided.   On 03-APR-2021 (conflicting information also reported as "03-APR-2022"), the patient was vaccinated with a temperature excursion of (product storage error) HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 time dose, lot number 1621929, expiration date: 06-DEC-2021 for prophylaxis (route of administration, and vaccination scheme was not provided). No signs or symptoms reported. Administered dose of vaccine experienced the temperature excursion of above 9 degrees Celsius for (°C ) (10.63 °C ) and below2 °C  (0.0 °C ) for 4 hours, 20 minutes and 0 seconds. There was no data logger involved. There were no previous excursions reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Hot flashes, severe body aches all over, armpit pain on arm of injection, watery diarrhea, cramping, painful deep breaths.
On 4/1/2023, I began coughing and having a sore throat. On about 4/4/2023, I had a really sore throat, plus head congestion and a headache. On maybe 4/6/2023, I took a home antigen test and got a positive result. I then stayed home for about three days. I treated my symptoms with DayQuil and NyQuil, both of which seemed to help. After about seven days, I stopped taking NyQuil, but I continued to take DayQuil. On about 4/11/2023, the congestion then went to my chest. I then started taking Zyrtec and ibuprofen. On about 4/16/2023, I went to a minute clinic. I was tested for COVID-19 and strep throat, and the results were negative for both. The doctor told me that I had a respiratory infection, and I was prescribed amoxicillin. I am currently still taking amoxicillin. I'm still hoarse, but I feel fine, and the congestion is gone.
Large 2 1/2 x 2" raised and indurated red, warm lesion on left deltoid muscle.
Rash lasted 4 days (less than 50 bumps (pox) on body). Fever lasted 3 days, highest was 101F. Given Tylenol for 2 days. Month prior to onset, pt. taking Albuterol and Triotann for chronic coughing. No Rx. meds. given for chicken pox rash.
hallucinogenic episodes; This case was reported by a consumer via call center representative and described the occurrence of visual hallucinations in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st May 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced visual hallucinations (serious criteria GSK medically significant). On an unknown date, the outcome of the visual hallucinations was not recovered/not resolved.   It was unknown if the reporter considered the visual hallucinations to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: The case was self-reported by the patient. The patient received the second dose of Shingrix and had been having hallucinogenic episodes in which patient saw people appearing in her house that should not be there. The patient had a doctor's appointment this afternoon (reporting day). The reporter did not wish to provide further information.  The reporter reported that she might call back with further information. The reporter did not consent to follow up.
Trigeminal Neuralgia. Excruciating pain on left side of face. Many treatments tried, none successful. 3 trips to ED.  Time course for acute was approximately 2 months.
24 hours post vaccination - low grade fever, chills, tenderness in arm vaccinated. Hospitalized for 2 days afterwards with cellulitis.