chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US025028, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 45-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 20 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period o 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
There was temperature excursion from their freezer on 01Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer on 01Oct2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer on 01Oct2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer on 01Oct2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medication were reported  On 01-Oct-2021, There was temperature excursion from  freezer.   It was stated 10 Number of vials/doses were impacted. Storage condition at the time of the excursion was frozen and Minimum temperatures reached 4.2 degrees F and maximum was 5.7 degreed F and Excursion duration was 6 minutes.
Fever, fatigue, congestion, sore arm, sore muscles.  The fever started the morning after the shot, and lasted all day. On the second day I woke up with the fever continuing, though the symptoms weren't as strong, and by 3pm they were gone.  But that evening when getting ready for bed I experienced extreme shaking and chills, and sweated all throughout the night.  On day three I continue to be fatigued, but no fever.
Guillain Barre Syndrome; paralysis of her feet up to her waist; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On 13th August 2020, the patient received Shingrix (intramuscular). On 1st September 2020, 19 days after receiving Shingrix, the patient experienced paralysis (serious criteria GSK medically significant). On 2nd September 2020, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the guillain barre syndrome and paralysis were unknown.   It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to Shingrix.  Additional detail: The patient received her Shingrix vaccine on 13 August 2020. By 01 September 2020 she developed paralysis of her feet up to her waist and lost the ability to walk. She also lost control of her bowel and bladder; she was terrified. She was rushed to the hospital on her island where they performed a lumbar puncture and then emergency airlifted her from that hospital  she was admitted for a week. She has required extensive treatment and physical therapy for her injury of Guillain Barre Syndrome on 02 September 2020.
he developed lumps into his abdomen and left leg; he developed lumps into his abdomen and left leg; 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 60 year-old male patient received bnt162b2 (BNT162B2), administration date 05Feb2021 (Batch/Lot number: unknown) at the age of 60 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), for Covid-19 immunisation. The following information was reported: ABDOMINAL MASS (non-serious), LIMB MASS (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "he developed lumps into his abdomen and left leg". Therapeutic measures were not taken as a result of abdominal mass, limb mass.  Additional information: 3 weeks ago patient developed lumps into his abdomen and left leg and asking for recommendations on what to do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reported feeling dizzy immediately after administration of first dose. Pt lost consciousness while still seated. Supported in chair by administering nurse, then transported to w/c with assistance of on-site EMTs. Pt was unconscious for less than 15 sec. Pt was diaphoretic, "clammy." VS checked by EMTs and were WNL (BP 118/70, HR 73, SpO2 97% on room air). Pt had some water and rested while seated. Pt stated she did not tell administering nurse she has a hx of vasovagal response to injections. After 20 min of monitoring in observation, VS remained WNL. Pt was alert and responsive, verbalized that she was feeling fine. Pt was told to seek further treatment if symptoms return or if new symptoms develop. Pt verbalized understanding before leaving facility.
no adverse effect; Intramuscular Injection; the possibility of one separate dose of an improperly stored vaccine,VARIVAX, was administered to one patient; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-APR-2019, the patient was vaccinated with one dose of possibly improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) intramuscularly for prophylaxis (lot number R017768, 21-JUN-2020) (formulation and dose were not reported). No adverse effect was reported. The nurse reported the sterile diluent used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored in the correct temperature storage range. The temperature, time frame of excursion and previous excursion were unknown. The call was not because of data logger.
pt stated the morning after she received the covid vax that she woke up  at 4:00 AM very sick.  she stated she had chills, nausea, cotton mouth and he husband was sick from the vax as well so she called 911 .  EMS arrived and check vitals and stated with patient for about 30 mins.  pt stated her symptoms subsided  after about 20 minutes.
migraine; headache; nausea; high heart rate; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (high heart rate), MIGRAINE (migraine), HEADACHE (headache) and NAUSEA (nausea) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced TACHYCARDIA (high heart rate), HEADACHE (headache) and NAUSEA (nausea). On 02-Apr-2021, the patient experienced MIGRAINE (migraine). At the time of the report, TACHYCARDIA (high heart rate), MIGRAINE (migraine), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
Mouth drooping and speech slurring since the vaccine and it has not subsided since then or gotten better
Within 36 hours of injection patient experienced tenderness, edema, and erythema encompassing left deltoid.
Expected side effects such as fever, joint pain, injection site pain, chills lasted from about 8-36 hours after injection. At about 36 hours after injection, broke out in itchy, red, non raised rash from navel up to most of neck. Redness lasted about 36 additional hours, itching is persistent but improving.
My mom received the Covid 19 vaccine on Jan 5, 2021 and became very about a week later. I was informed that she tested positive for Covid 19 on January 14th. One January 17th she became very tired and weak and would not eat. Hospice called me and told me that she was in a decline state. I saw her on January 25 and 26 and she was just sleeping and could not open her eyes. Her vitals were good and she seemed to understand when I talked to her - she would squeeze my hand and moan but she could not talk or open her eyes. My mom passed away on January 27, 2021 just 22 days after receiving the Covid 19 vaccine. She was very think to begin with and being to weak and tired  to eat resulted in her losing even more weight. Some of the other residents were given fluids to help and they recovered. My mom was not given fluids. I believe there were 20 deaths in her care home for the month of January when they vaccinated. This was an alarming number of deaths for the home. The facility had very few Covid deaths in 2019 and 2020. I asked every week if they had any Covid and or Covid deaths and this amount was shocking to me and the workers there.
Information has been received from a nurse practitioner concerning a 23 year old male patient, with no pertinent medical history and no drug allergies, who is a foreign exchange student who on 27-Aug-2003 was vaccinated SC into the right arm with a dose of MMR virus vaccine live (lot #643497/0770M). Number of previous dose unknown but it was reported that the patient "had disease." There was no concomitant medication. On 13-Sep-2003 the patient developed myalgia, polyarthralgia, pain in lower extremities (anterior bilateral calves and thighs); tender in knees and ankles and low grade fever of 99.3. There was no discomfort in the upper extremities and no rash or joint effusions were reported. Anti-inflammatory (ibuprofen) and rest was recommended for treatment. There were no diagnostic tests or laboratory findings. It was reported that there was no illness at the time of vaccination. Subsequently, the patient recovered spontaneously from his experiences on 27-Sep-2003. Additional information is not expected.
achy p/vax over course of day became more swollen, reddened parents gave APAP x1;c/o numbness in fingers lt hand;taken to clinic;dx local rxn to immun, locally tender lt deltoid region poss early cellulitis;8JAN sl reddened & swollen, warm
Cellulitis at site of injection. T=99.6. Reported onset of itching, then redness/pain. Swelling began after 24 hours. Seen in office at 48 hours. Started on Keflex 500mg PO QID, warm soaks with slow improvement. 8 x 11cm of erythema. Warmth, pain, swelling around injection site.
I started having random hives on my torso, arms, hands and feet that started on 2/24. It has progressed to joints that at times causes severe swelling. I have taken some antihistamine and Benadryl which helped at first but no longer does anything to alleviate the issue.
Donor stated he woke up at approx 1:00 am 9/6/06 with pain behind left collarbone noted at 7 on 0-10 pain scale with inhalation, 4 on pain scale otherwise, fairly constant, not relieved by use of aspirin. Slight swelling palpated just above left collarbone by this MSA, some tenderness noted.
local pain & inflammation lasting 2 wk in addition sore throat & flu like sx that persisted-subsided but represents fatigue, joint achiness no energy;dx affective disorders;dysfunction disorder & cont to persist memory & sensory problems;  Per follow-up, pt still continues to have both suppressed immuniological problems, cognative , memory, CFS and neurological problems all of which are severe enough that pt remains disabled under SS guidelines.
Child received Prevnar, MMRV, PedvaxHib on 6/21/07. On 6/23/07, 6/25/07 and 6/26/07 child had 5" "spell" with staring, unresponsiveness. Possible absence seizure.
Patient received shots 10/20/2008 woke up 10/21/2008 with, fever 101, dizzy, achy and sore arms fever lasted all day till approximately 8:30 pm. Treated with Benadryl and Tylenol as told by Hospital.
Retinal eye bleed   Floating blood in eye.  This has happened within a week of each dose I have received.
Paramedics were called when I woke with extreme headache and  extreme shortness of breath and extreme pressure in chest followed by loss of consciousness and loss of bodily functions that lasted 35-40 mins for entire duration.  Heart rate dropped to 39
Exactly 1 week after the injection I experienced swelling in the muscle at the injection site. The area was also itchy. That was this past Saturday 1/16/2021 in the evening I noticed the swelling and minor pain. The swelling went down but the itching turned into a red rash (slightly raised) just in the area around the injection site. No other symptoms other than the itchy rash and slight swelling.
pt recvd vax NOV92; hospitalized DEC92-dx GBS presented @ hosp w/viral sx; pt was transferred to a rehabilitation center; no other clinical info available;
Left side of chin/neck developed a red rash with a yellow pimple on them. My wife compared them to fire ant bites. Researching on line it looks like erythema multi forms which is apparently being investigated as a possible side effect.  It is getting better but the redness is still there but not as many yellow pimples. I saw no reason to go to the doctor but obviously do not think it wise to get second dose as could trigger worse case or reactions. I have no allergies per say but am very sensitive to poison ivy. This is not poison ivy though.
if she has COVID but is just asymptomatic; if she has COVID but is just asymptomatic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "if she has COVID but is just asymptomatic". The patient wanted to know if she could take the new vaccine if she has COVID but is just asymptomatic.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
I had a sore throat and later that day I had chills and sweats and I have a cough that comes once in a while. I had a fever 102.0 . The second week my chest got really sore and I went to the ER. The doctors gave me a antibiotic IV drip. I have bronchitis now. They gave me and inhaler. They gave me Paxlovid.
This spontaneous report was received from a medical assistant and refers to a currently 17-year-old patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M037642 with an expiration date 01-SEP-2018 for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of VARIVAX experienced the temperature excursion of 19 degrees Fahrenheit for 102 hours. There was previous temperature excursion of 9 degrees Fahrenheit for 15 minutes. A digital data logger was not involved.  This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA005658:
Developed sore throat and muscle aches. She became febrile on 11/08/2009 with temp 103.5 po, headache,congestion, cough.
difficulty breathing; chest pain; the second dose of HPV series was not administered in the dosing schedule; This spontaneous report as received from a physician refers to a 19-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in July 2019 (reported as one or two days ago), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), for prophylaxis (frequency, route of administration, lot # and expiration date were not reported). The second dose of the vaccination series was not administered in the appropriate dosing schedule for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On an unknown date in July 2019 (reported as the next morning), the patient had difficulty breathing and chest pain. The patient went to the emergency room on an unknown date. The outcome of the events was unknown.  The causality between the suspect vaccine and the dyspnea and chest pain was not reported.
Pt had influenza @ time of receiving vaccine. She had been given Tylenol prior to the vaccine appointment, per her foster parents. She was febrile in the evening and also today 4/7/06.
Urticaria on inner thighs, neck up into the face and on inside of left arm.
After pt receive Pfizer first dose, pt admitted to receiving Sinovac full series to nurse. RN previously screened pt if they have gotten a different COVID vaccine before and pt stated "no". RN notified HC and ML.
Rash at injection site 8 days later, mild itching, mild swelling starting day after for 3-4 days.
Systemic: Dizziness / Lightheadness-Mild, Systemic: patient had loss of consciousness for approximately 5 seconds-Mild, Additional Details: patient has bruising to right temple and both knees from chair fall.
pt had red rash & inflammation around inj site;pt was detained x30 mins, ice to site, MD examined pt
About 3 minutes after vaccine, he turned pale and fainted, he felt weak for 10 minutes. He denied chest pain, SOB, nausea, or vomiting. His BP was normal 10 minutes after event.
Shot burned severely going in and for about 30 minutes after.  Developed low grade fever that night and arm was very sore.  Some mild body aches.  The next day, I felt fine other than my arm was sore.  I had a very large, firm lump at the injection site for about 8 days.
edema V-L rt thigh duration 3 days; hyperemia V-L rt thigh duration 3 days; induration V-L rt thigh duration 3 days; severe tenderness x 3 days; t39.3 R x 2 days;
patient stated that she was itching in both arms/wrists/hands - she was given 5ml of bendaryl 15 minutes later - pt stated that she felt fine but still had the itching feeling.   no sign of difficulty of breathing -  I called the patient later tonight to check on her and she was doing fine
Narrative:  Pt is a83y.o. male who died on 04/15/2021 w/ h/o PTSD, AFib, CHF, HTN, CAD, GERD. Patient received Pfizer Covid-19 Vaccination 2/2 on 01/20/2021. Pt died on 04/15/2021 at LTC/hospice facility. Unlikely that Pfizer COVID-19 Vaccine caused/contributed to pt death.
administered an expired ADACEL to a patient with no reported adverse event; Initial information received on 08-Jul-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 44 years old male patient was administered an expired diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-May-2022, the patient was administered an expired 0.5 ml dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection, (strength unknown) (lot U6638AA and expiry date: 12-Apr-2022) via intramuscular route in the left arm for Immunization with no reported adverse event (expired product administered).  Action taken : not applicable.  Outcome : Unknown.   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 the guidelines. 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.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient administered vaccine beyond past use date) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient administered vaccine beyond past use date). On 01-Jun-2021, EXPIRED PRODUCT ADMINISTERED (1 patient administered vaccine beyond past use date) had resolved. 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. Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up information received on 29 Jul 2021 contains significant information. Added patient details; Sender's Comments:  :MOD21-104689.