chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of VARIVAX (dose, frequency, route, lot # and expiration date were not reported) reconstituted with properly stored sterile diluent (manufacturer unknown) (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. There were no adverse effects reported. The temperature excursion, time frame, previous temperature excursion were unknown. There were no data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1706USA007786.
Achilles tendon hurts like hell; tingling in chest & left arm; Achilles tendon locked up. bottom 2 inches inches; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in chest & left arm), TENDON INJURY (Achilles tendon locked up. bottom 2 inches inches) and TENDON PAIN (Achilles tendon hurts like hell) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypercholesteraemia (10 years ago) in 2011 and Achilles tendon injury (due to statins intake).   In September 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PARAESTHESIA (tingling in chest & left arm) and TENDON INJURY (Achilles tendon locked up. bottom 2 inches inches). On 21-Oct-2021, the patient experienced TENDON PAIN (Achilles tendon hurts like hell). At the time of the report, PARAESTHESIA (tingling in chest & left arm), TENDON INJURY (Achilles tendon locked up. bottom 2 inches inches) and TENDON PAIN (Achilles tendon hurts like hell) outcome was unknown.            Patient had taken unspecified statins 10 yrs ago for cholesterol. Concomitant information was not reported.  No treatment information was reported.
This case was reported by a consumer and described the occurrence of swelling arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities, pain in arm, nausea, light headedness, tiredness and discomfort. On an unknown date, the outcome of the swelling arm, erythema of extremities, pain in arm, nausea, light headedness, tiredness and discomfort were unknown.  It was unknown if the reporter considered the swelling arm, erythema of extremities, pain in arm, nausea, light headedness, tiredness and discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of the shingles vaccine and she believed that she had a reaction that her arm was very red swollen and very sore. The day after the patient felt nauseas light headed and very tired. The patient asked that is there anything that she could do to elevate the soreness swelling and discomfort. The patient also asked about if she would have the same reaction after the 2nd dose of SHINGRIX.
Fever began at 100.3 at 9am, patient complained of a severe headache and the injection sites were red and raised to the size of a dime, Temperature was taken an hour afterwards and it rose to 102.5. Symptoms began to subside after I put him into a detox bath of lavender oil, bentonite clay and magnesium flakes. Within an hour of the bath (around noon) his temprature dropped to 99.5.
November 9, 2021, I started having pain in my right arm and it started to extend down my right arm into my right hand with tingling and numbness. On Nov 11th, 2021, the pain, tingling, and numbness started to extend up your shoulder to your neck and face all on my right side. I called the doctor office on Nov 11th, and spoke with his receptionist, the doctor was not available so I got a virtual appointment with another doctor, for Friday Nov 19th, 2021. I called the neurologist and I spoke with his NP. She related my symptoms to the doctor. Doctor advised me to do massages and take B vitamins, C, D, Zinc, and rest. I was prescribed gabapentin. I am still having muscles weakness and numbness.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Feb2022 as dose 3 (booster), 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), COVID-19 (medically significant) all with onset 16Sep2022, outcome "recovering" and all described as "tested positive for COVID". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Sep2022) Positive, notes: Tested positive for COVID. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No additional AE reported; the first dose was not documented in the patient record/ confusion/medication error on the HCP part as to if the vaccine was administered since there is no documentation; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On an unknown date in April 2021 (reported as 6 months ago), the patient was vaccinated the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5ml; strength, route, lot # and expiration date were not reported) for prophylaxis. The patient came back to the office on 13-OCT-2021 to receive the second dose. The medical assistant stated that the first dose was not documented in the patient record. The reporter had confusion if the vaccine was administered since there was no documentation (transcription medication error). No additional events were reported.  This is a non-valid report due to lack of patient's identifiers.  Follow up information has been received from a medical assistant on 29-OCT-2021. Upon receipt of follow up it was determined that the case was valid as the patient's identifiers were provided. This case referred to a 11 years old male patient. On 06-APR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) at private doctor's office/hospital. On the same day, the patient was also vaccinated with diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX) and meningococcal vaccine a/c/y/w conj (crm197)(MENVEO) (strength, dose, route, lot # and expiration date were not reported). The vaccines were not documented on that day (transcription medication error). There were no temperature excursions for above vaccines.
Symptoms started by 11pm day of vaccination. Full arm red bumpy rash, 5" diameter hard raised inflamed red area around injection, 2 degree intermittent fever, intermittent headache, fatigue, hot and cold flashes, intermittent unexplained sweating, worsened tendinitis in left arm.
Pt requesting Janssen booster. Pfizer booster given. No adverse reactions observed.
Pts whole left arm went numb and the numbness has only gotten worse the last 2 days. Pt came in today (9/5/2015) and reported the problem to me.  Pt said she was going to urgent care to have a doctor look at her arm.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm and product supply issue. On an unknown date, the outcome of the pain in arm and product supply issue were unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced sore arm after receiving 1st dose. The patient has not been able to receive the 2nd dose due to the shortage of the vaccine. The reporter did not provide any additional details regarding this patient or event.
pt hospitalized with positive COVID test 9/4 - 9/7, received steroid txmt and remdesivir, dc'd to home with O2; returned to hospital (by home health) with low O2 saturation; diagnosed with COVID pneumonia, acute on chronic respiratory failure with hypoxia; pt's condition worsened, placed on comfort measures, pt died in the hospital
I contracted COVID-19 with symptoms of sore throat, cough, congestion, headache, fatigue, and fever of 99.3. I was prescribed PAXLOVID via telehealth on 12/01/22. I was ill for 8 days before my symptoms resolved. I am fully recovered with lingering symptoms.
I GAVE THE WRONG DTAP - I GAVE KINRIX WHEN HE NEEDED PEDIARIX
sjogrens; POTS; SSP; anemic; I lost 50 pounds slowly; double vision; leg weakness pain; leg weakness pain; cough; bad back stomach; bad back stomach; chest pain; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, 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: SJOGREN'S SYNDROME (medically significant), outcome "unknown", described as "sjogrens"; BONE TUBERCULOSIS (medically significant), outcome "unknown", described as "POTS"; SUBACUTE SCLEROSING PANENCEPHALITIS (medically significant), outcome "unknown", described as "SSP"; ANAEMIA (medically significant), outcome "unknown", described as "anemic"; WEIGHT DECREASED (medically significant), outcome "unknown", described as "I lost 50 pounds slowly"; DIPLOPIA (non-serious), outcome "unknown", described as "double vision"; PAIN IN EXTREMITY (non-serious), MUSCULAR WEAKNESS (non-serious), outcome "unknown" and all described as "leg weakness pain"; COUGH (non-serious), outcome "unknown"; MUSCULOSKELETAL DISCOMFORT (non-serious), ABDOMINAL DISCOMFORT (non-serious), outcome "unknown" and all described as "bad back stomach"; CHEST PAIN (non-serious), outcome "unknown"; ILLNESS (non-serious), outcome "unknown", described as "sick". The events "sjogrens", "pots", "ssp", "anemic", "double vision" and "leg weakness pain" required emergency room visit. The patient underwent the following laboratory tests and procedures: Weight: 50 pounds. Clinical course: Patient was stated that, i am writing you today to find out how many people complained about (contracting or a flare) of getting sicker and sicker after each vaccine. I followed my paper trail with my primary and I got attacked by sjogrens after my first vaccine. Now I have POTS, SSP, anemic, double vision, leg weakness pain everywhere. Been to ER 5 times now, recent I have developed a cough and bad back stomach and chest pain. I lost 50 pounds slowly at first without trying as I became sick a Bd couldn't leave house.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Low grade fever, severe joint pain and headache 16 hours post injection. Headache for over 72 hours.  Large swollen right supraclavicular lymph node noticed at 72 hours post injection.  Painful and warm to touch approx size golf ball.  Entire right clavicle swollen and painful.
By Sunday evening, left arm pain and general tiredness. I went to bed early.  Monday morning, fatigue, left arm pain with warmth at shot site in left arm. Extreme fatigue set in and left work at 11:20 am. Went to bed by noon with muscle pains, headache, alternating fever, chills and cold sweats. Noticed heart flutters around 7:00pm. BP was 106/63, pulse 98, ox sat 92%. Very uncomfortable night alternating from sweating to chills and back. Muscle cramps and fatigue Very cold feet and hands..   Tuesday had muscle aches and head aches but no fever. Stayed home sick and slept most of the day and night. Did not notice any more heart concerns.  Wednesday still fatigued and home from work. In bed most of the day. Will attempt work tomorrow.
High fever, with acetaminophen of 103 sustained for 2 days. Loss of appetite.
Patient was vaccinated with Pfizer #1 on 3/11/2021 (lot EN6204). He received a second invitation for vaccine in error, signed up, and was vaccinated a second time with Moderna  on 4/2/2021.  No adverse outcomes or symptoms reported;  counseled by Health Department RN that this is not preferred but is acceptable and he will not need additional vaccine. Troubleshooting: This was missed in screening and the vaccinator did not ask for shot card.
COVID-19 symptoms started on 06/08/22 at night time; tested positive on 06/11/22. I had night sweats on the 8th, 9th, and 10th, and on the 11th I felt flu-like symptoms. On the 13th I went to the Doctor and then I recovered on either the 19th or 20th when I had a negative COVID-19 test. I had two nights of bad coughing and that's about it. It wasn't until I had the night sweats that I realized I had COVID-19.
NOTE - The Pfizer shot was my second booster. I received my original 2 - shot vaccine in 2021 (Pfizer). In January I received my first COVID booster (Moderna) and in June 2022 I received my 2nd covid booster (Pfizer). After ~24 hours - severe stomach pain and nausea, then muscle/joint aches, then acid reflux, no appetite, fatigue, weakness; this went on for several days Day 6 - diagnosed with Gastritis Day 7 - urine started turning dark Day 8 - whites of eyes turning yellow Day 9 - diagnosed with non-infectious Hepatitis, jaundice It is now Day 13, energy is better, still have jaundice, some nausea, weakness, fatigue
January 2nd at 7 pm - patient noticed a burning sensation and a red raised area about the size of a quarter, over the past 4 days, the site became the size of a baseball, and a second hive appeared on January 4th.  The second hive is now the size of a baseball and a third hive has appeared today January the 6th and it is the size of a quarter.  All 3 sites are red and raised with some itching and are warm to touch with worsening "heat" in the evenings.
(L) arm and shoulder pain, decreased ROM (L) shoulder, fever started approx. 10-12 after vaccine administration.
Myalgia, Fever, NauseaVomiting, CHILLS, LIGHTHEADEDNESS, FATIGUE Narrative:
R arm at injection. Reddened area not raised 2-3 small white pox noted at/near injection site.
Very dizzy; Felt suffocating/ Oxygen level got to 92 and is fluctuating; Temperature was 73; Weird pain; Headache; Tiredness and fatigue; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVI-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunization. Medical history included Chronic obstructive pulmonary disease, Asthma both from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on 05Feb2021 for covid-19 immunization. It was reported that had second COVID-19 Vaccine on 26Feb2021. Was ok on Friday, fine on Saturday. Sunday, when she woke up was feeling very dizzy, suffocating, and had a headache. When she checked her temperature, it was 73. Caller did not provide a unit of measurement for her temperature. Her oxygen level went down to 92. Yesterday, her body temperature began to be normal. Her oxygen level is fluctuating. She is having too much dizziness and shortness of breath. It was also reported that First dose was on 05Feb2021 and second dose was 26Feb2021. She was fine on Friday and Saturday. Began suddenly on Sunday. She is worried about it. It is weird pain, tiredness, and fatigue. Cannot express what is going on. Worried about fluctuation of oxygen level. She is a COPD and asthma patient. Asked what she should do. Should she contact her PCP or the vaccine facility. Stated it is a weird thing. Feeling too tired to complete report. The patient underwent lab tests and procedures which included oxygen consumption: 92, body temperature: 73. The outcome for the events was reported as unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
refrigerator temperature reached 32.5 degrees Fahrenheit and the excursion lasted for 6 hours and 41 minutes with no ae; Initial information received on 31-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient with unknown demographics whos refrigerator temperature reached 32.5 degrees fahrenheit and the excursion lasted for 6 hours and 41 minutes with no ae while receiving vaccines [ACT-HIB], [ADACEL],[MENACTRA],[DAPTACEL], [PENTACEL] [FLUZONE HIGH-DOSE QUADRIVALENT] and with the use of medical device FLUZONE QIV-ID PRE-FILLED SYRINGE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient started using FLUZONE QIV-ID PRE-FILLED SYRINGE Unknown dosage unknown (with an unknown batch number) for Immunization.  On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot ASKU via unknown route in unknown administration site.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot ASKU via unknown route in unknown administration site.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot ASKU via unknown route in unknown administration site.  On an unknown date the patients refrigerator temperature reached 32.5 degrees fahrenheit and the excursion lasted for 6 hours and 41 minutes with no ae (product storage error) (unknown latency) after starting use of FLUZONE QIV-ID PRE-FILLED SYRINGE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (refrigerator temperature reached 32.5 degrees Fahrenheit and the excursion lasted for 6 hours and 41 minutes with no ae).  At time of reporting, the outcome was Unknown for the event refrigerator temperature reached 32.5 degrees fahrenheit and the excursion lasted for 6 hours and 41 minutes with no ae.  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.
her arm was hurting immediately after,it was very painful; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm was hurting immediately after,it was very painful) and HEADACHE (headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B-2A and 045B21A) for COVID-19 vaccination.     The patient's past medical history included Menopause, Migraine, Mood swings, Hot flashes and Insomnia. Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (her arm was hurting immediately after,it was very painful) (seriousness criterion disability) and HEADACHE (headache) (seriousness criterion disability). At the time of the report, PAIN IN EXTREMITY (her arm was hurting immediately after,it was very painful) and HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events after the patient´s first vaccination, a causal relationship cannot be excluded.   This case was linked to MOD-2021-287660, MOD-2021-287660 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events after the patient´s first vaccination, a causal relationship cannot be excluded.
Information has been received from a registered nurse concerning a 29 year old female patient who on 26-SEP-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot # 658449/0989U) 0.5 ML "interdermally" instead of tuberculin purified protein derivative (PPD) (manufacturer unspecified), (human error/no PQC involvement). After the vaccination, the patient developed severe injection site reactions causing arm pain. She was given BENADRYL and prednisone. Subsequently the patient developed anxiety. The patient's pain in arm, elbow continued. On 05-OCT-2008 the patient experienced purpura which lasted 24 hours. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information is not expected.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N003703 with expiration date of 29-OCT-2019 (doses and route of administration were not reported). On 04-AUG-2017, the administered doses of vaccine underwent a temperature excursion of 48.79 degrees Fahrenheit for 38 minutes which was detected by a digital data logger. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005778: US-009507513-1708USA005890: US-009507513-1708USA005891.
Severe arm pain and stiffness.  Arm was hard to lift, however, I could move it well enough to function. Arm can ache at rest and is still very sore to touch.
Patient experienced anaphylaxis around 20 minutes post vaccination with both moderna and flu vaccines. An epi pen was administered and patient was able to recover.