chrisvoncsefalvay/vaers-outcomes huggingface dataset:
delayed transit of Fluzone HD shipment was to be delivered on 10-Oct-2019 and was not received until 14-Oct-2019 with no AE; delayed transit of Fluzone HD shipment was to be delivered on 10-Oct-2019 and was not received until 14-Oct-2019 with no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA287365 and 2019SA287333.  This case involves a 81 years old male patient who INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot: UJ283AB, expiry date: 29-May-2020), via intramuscular route in the right arm, on 14-Oct-2019.  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of incorrect product storage and product shipment delay due product was to be delivered on 10-Oct-2019 and was not received until 14-Oct-2019.  At the time of reporting, the patient had no adverse event.  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.
swelling in my neck; pain swallowing; This is a spontaneous report from a contactable consumer, patient. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207), unspecified route administered in left arm on 11March2021 at 04:00 pm (at the age of 56-years old) as a single first dose for Covid-19 immunization. The patient medical history includes cholesterol, blood pressure and asthma. Concomitant medications were reported as Statins for cholesterol on unknown date. The patient had no any allergies to the food medication or other product. On 13Mar2021 at 10.00am, The patient experienced swelling in neck and pain swallowing started about the 3rd day after vaccination. The patient did not undergo lab tests and procedures. The patient had not received any other vaccine within 4 weeks prior to the covid-19. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19, Since having the vaccination. Therapeutic measures were not taken for the event. The clinical outcome of the event swelling in his neck and pain swallowing was not recovered at the time of reporting. No follow-up attempts are possible. No further information is expected.
Pt. c/o flushing/burning in vaccinated arm,  nausea and light headed.
Twenty days subsequent to receiving one dose of varicella virus vaccine live pt experienced 3 pink papular lesions at the injection site.
It started a week ago. July 6, 2022. At first, I thought it was just a bad cold. I had gotten all 4 of the shots, so I was pretty confident that I wasn't at too much risk. We had attended a wedding that turned out to be a spreader event. My grandson and son who both live with me both came down with COVID-19. My first evidence that I had it was a scratchy throat. I tried to clear that but I wasn't able to. That turned into what I thought was  a normal cold. Sleeping that night was very difficult. I had a lot of drainage and was really achy. I was also tired and fatigued. I got up the next day and it felt like a bad cold to me. With all the other incidences around me, I took a home test and it was positive right away. That's when we tested my son if he was sick as well. We knew my grandson had COVID-19 and my son had symptoms and he tested positive as well. On Friday, I called the doctor's office and wanted to ask what I should do. I asked if I should get treatment and asked about isolation. I had a telehealth visit and we talked it through, and he mentioned that there was a lot of interactions with medication. By that Friday though, I actually was feeling better, particularly that night as well because I felt like I was on the mend. We decided to let it go for a little bit and it did continue to get better. Today is the first day I've been off quarantine. My body is fatigued and tired. I can't do much without having to sit down and take a rest. Other than that, I feel pretty good. Tomorrow would be a full week since this started.
2.5 days of Chills, severe headache, aches, very sore arm.  Sore arm still apparent on the 4th day.
I got sick at the end of May. I had a fever for 5 days, headache, body aches. Covid like symptoms. 2 covid tests negative, and flu tests negative.   I got sick again 4 days ago. Again high fever for 2 days this time coughing, sneezing, body aches, headache  and now it has been determined I have pneumonia. 2 covid tests negative. I have never been this sick this often in my life to this extent.
pt recvd vax 18DEC92 & 10 days p/vax pt devel pain @ the inject site as well as pain in elbow, shoulder, neck & down back; @ the time of report pt was scheduled to see a neurologist; No further details were provided;
VACCINATED WITH THE JANSSEN COVID-19 VACCINE FOR THE 2ND TIME IN ABOUT 3 MONTHS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-MAY-2021, and dose was not reported, administered on 11-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 11-AUG-2021, the patient experienced vaccinated with the janssen covid-19 vaccine for the 2nd time in about 3 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccinated with the janssen covid-19 vaccine for the 2nd time in about 3 months was not reported. This report was non-serious.
pt devel fever & shaking 24-48 hr p/vax;5 days p/vax pt liver function tests were elevated;no further info was available @ the date of this report;
Blood clots in her  lungs; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Blood clots in her  lungs) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Blood clots in her  lungs) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (Blood clots in her  lungs) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.  Company Comment : This case concerns a 50 year old female patient with no relevant medical history, who experienced the unexpected event of pulmonary embolism.. The event occurred on an unknown date after the second dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-325359 (Patient Link).; Sender's Comments: This case concerns a 50 year old female patient with no relevant medical history, who experienced the unexpected event of pulmonary embolism.. The event occurred on an unknown date after the second dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.
pneumonia; inflammation to the heart; Shortness of breath; chest pain; This is a spontaneous report from a contactable consumer (patient).   A 14-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0150, expiration date not provided), 1st dose via an unspecified route of administration, administered in Arm Left on 22May2021 08:00 at age of 14 years old as a single dose for covid-19 immunisation. Medical history included pericarditis with inflammation. The patient's concomitant medications were not reported.  The patient previously took vancomycin and experienced allergies. The patient experienced pneumonia, inflammation to the heart, shortness of breath, chest pain, all on 23May2021 07:00.  The outcome of the events was not recovered. The patient was not pregnancy at time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events resulted in emergency room/department or urgent care. The patient received treatment for the events included Antibiotics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
A report from a physician concerns a patient of unknown gender. No relevant history or concomitant medications provided. The patient received FLUMIST (intranasal) on an unknown date. MD reported that a patient received FLUMIST then tested positive for the flu later that season and was hospitalized, MD stated the patient received FLUMIST again another season and also tested positive for the flu again. MD reported both these occurrences were a few years ago-he did not remember exact season. The outcome of patient tested positive for flu was unknown. The reporter assessed the event of patient tested positive for flu to be serious due to hospitalisation. Laboratory values are available.
Patient woke up having chills and a fever of 101 degrees Fahrenheit. She felt ill and stayed in bed for the day following the vaccine. Two mornings following vaccine administration, she reports that her arm turned red and painful. Her whole arm ached. She took TYLENOL to relieve the pain. Her arm was swollen and appeared as a rash which then turned red. Patient saw Dr. who prescribed Cephalexin 500mg three times daily. He did not know if the condition was an adverse reaction or infection. He advised patient to contact the office again if the condition does not improve in two days.
Redness below injection site, pain into elbow, fever in arm. Patient states it is better today than last night and she is taking TYLENOL to help with the redness/fever. She was told to report back if it gets worse. This was the second dose in the series and she did not have this reaction the first time. I administered both doses.
This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (depressed feeling again), TRIGGER FINGER (trigger finder which was better was all bent when I woke up), PAIN (little achy), MYALGIA (achy/sore arm) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071FZ1A, 027821A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Penicillin) and Food allergy (Chilli). Concomitant products included THYROID (ARMOUR THYROID) from 01-Jan-2000 to an unknown date for Thyroid therapy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEPRESSED MOOD (depressed feeling again), TRIGGER FINGER (trigger finder which was better was all bent when I woke up), PAIN (little achy), MYALGIA (achy/sore arm) and HEADACHE (headache). The patient was treated with LORAZEPAM at a dose of .5 mg twice a day and DESVENLAFAXINE at a dose of 50 mg. At the time of the report, DEPRESSED MOOD (depressed feeling again) and TRIGGER FINGER (trigger finder which was better was all bent when I woke up) had not resolved and PAIN (little achy), MYALGIA (achy/sore arm) and HEADACHE (headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-375495, MOD-2021-375488, MOD-2021-380319 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: significant follow up Included- Concomitant Medicine, Treatment Medicine, Patient Demographis and medical History and also events are Updated.
Hives, fever no resp distress. MR and Vax record received. Healthy apprearing 20 month old male with 4 day hx. of diarrhea (improving) who received Dtap, Prevnar, and Flu vax on 11/15/2006, presented to MD with c/o rash which developed the evening of his vax. Assessment:  Urticaria-probably secondary to flu vaccine, but can be related to viral illness, tylenol admin., or other immunizations.
Shingles rash; did have lethargy and was dragging; did have lethargy and was dragging; This is a spontaneous report from a contactable healthcare professional reporting for self. This 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via intramuscular on 11Jan2021 at left deltoid at single dose for COVID Prevention. Medical history and concomitant medications were none.  Her health had improved over the last six months and she was on no medications, and her labs had been good. The patient previously received first dose of BNT162B2 (lot number: EJ1685) via IM injection into the left deltoid on 23Dec2020 at single dose for COVID Prevention. She stated that she may have had some dragging after the first dose, but it was after the holidays and she was laying around anyway, so if she did, it was not of note to her at the time.  She confirmed that she received no other vaccines on the same day as either her first dose, nor her second dose of the vaccine. The patient experienced shingles rash starting on 14Jan2021. It was reported that the patient received her second dose of vaccine last Monday (11Jan2021). The Thursday following that (14Jan2021), she noticed a small patch of a rash on her right side, and she did not think much of it at first, because she had been gardening. But she stated that by Friday, it was clear that she had the initial onslaught of Shingles. She stated that over the weekend, the rash had taken a very predicable course, where it is now in circles around her body. She had had no other sentinel events, she had not been sick, she was not stressed, the only thing was that four days prior to the rash, she got the last COVID shot. She just wanted there to be accuracy in known side effects because she was 56 years old, but she was not immunosuppressed at all, and she knew that it would be given to people 65 and older soon. Patient stated that she was no sick as a dog, but two days after receiving the second dose, she did have lethargy and was dragging on 14Jan2021. She thought after the second dose, the vaccine may have hit her immune system. The outcome of shingles rash was not recovered and reported as worsened, outcome of other events was unknown. The reporter considered the event shingles rash was serious as medically significant and was related to the vaccine.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of shingles rash cannot be 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.,Linked Report(s) : US-PFIZER INC-2021092332 same patient/drug, different event separated with time
The next day after about 24hrs later I felt feverish but did not have a temp.   I developed a lower arm pain in the elbow to wrist area which caused me to not be able to use it,  it had no strength  and hurt very bad which lasted for about 3 weeks and finally went away on its own with no other symtoms.
Dropped her off at daycare and the provider noted she had a runny bowel movement at 9 AM and then another at 9:25 am. She was very lethargic and her temperature was 100. She slept for about an hour and then I picked her up. She was given Tylenol and took another nap for 1.5 hours. I woke her to eat. She ate very little. Her temperature remained the same although medication had been administered. She slept most of the afternoon/early evening.
A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 09-Jan-2014. The patient was given 3 doses of expired FLUMIST QUADRIVALENT. The outcome of the event of administration of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Pt received IPV, DTaP, & MMR on 4/13/12 in the am. At approximately midnight on 4/14/12 pt observed to have a generalized T-C seizure with a fever to 102 degrees.
Febrile seizure  for 5 mins; typical sz for 3min w/postictal phase for 10min;
Injection given on 12/21/20 at 0830 - Injection site pain noted for 12 hours.  12/22/20, tiredness, nausea, swollen lymph nodes noted and continued through 12/23/20.  All side effects resolved by 12/24/20.
After the vaccination I have developed AFib. My heart has been stable for 15 years after a bypass Operation. My Echocardiogram as been stable for 15 years.
Extreme discomfort/pressure in chest for 4 hours. Three weeks later the same intense pressure with nausea and cold sweat. Low energy and short of breath.
I have Multiple Sclerosis; dose received 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing); "Chronic Migraines" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS. Vaccination history included: Bnt162b2 (Dose Number: 1, prev dose lot unknown reason=Other,, Location of injection: Arm Left), administration date: 22Mar2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, prev dose lot unknown reason=Other,, Location of injection: Arm Left), administration date: 12Apr2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: MULTIPLE SCLEROSIS (disability), outcome "recovering", described as "I have Multiple Sclerosis. I had the worst MS attack of my life after getting the Vacinnes.  I''m on Ocrevus and have been stable for quite some time.  Because my immunotherapy is a T-cell depleting therapy"; IMMUNISATION (non-serious) with onset 01Oct2021, outcome "unknown", described as "dose received 3". Therapeutic measures were taken as a result of multiple sclerosis.  Clinical indication:I had an exacerbation of MS symptoms after getting the 3rd dose, and my doctor ordered a blood test that measures the amount of antibodies in my system to fight and hopefully protect me from COVID-19.Ae treatment: Solu-medrol and other high dose steroids  The lot number for bnt162b2 was not provided and will be requested during follow up.
2 days after receiving the H1N1 flu vaccine the patient developed flu like symptoms such as a severe sore throat, chills with body aches. The patient was also spitting blood. Patient went to her doctor who dx her with pharyngitis and prescribed cefprozil caps 500 mg 2 x a day.
Rash began to appear on wrists, knees, and ankles 6 days after injection. On day 7, large itchy patches of hives developed over both legs. Treated with antihistamine and hives were gone on day 8.
Both hands turned blue from 7:30pm to 1:30 am 6 hours. No other symptoms at all. Came second dat after booster vaccine.
Patient states 30 minutes after vaccine felt dizzy and headache when standing up, no improvement with sitting down. Patient alert, denies shortness of breath, or wheezing, but still lightheaded even with monitoring and fluids, so taken to ER
Patient received vaccination and states he was dizzy 3 hours after the 1st injection (which was April 30th).  Said dizziness lasted about an hour then he had a sore arm for about 2 days.  After that he was fine.
actinic keratosis removed from head back; tested positive for COVID-19; tested positive for COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4336958-00.  A 68 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) (at the age of 68 years), as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1155990) at unk (citrate free) for psoriasis. Relevant medical history included: "Actinic keratosis removed form head back" (ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Feb2022, outcome "unknown", SARS-COV-2 TEST POSITIVE (medically significant) with onset Feb2022, outcome "recovered" (2022) and all described as "tested positive for COVID-19"; ACTINIC KERATOSIS (medically significant), outcome "not recovered", described as "actinic keratosis removed from head back". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Feb2022) positive. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of actinic keratosis.  The reporter's causality for the event Actinic keratosis with Comirnaty and COVID-19 virus test positive was not reported. The reporter's causality for the event of actinic keratosis removed form head back with Humira(Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of tested positive for covid-19 was not provided. Agency's opinion is that there was no reasonable possibility that the events of actinic keratosis removed form head back and tested positive for covid-19 are related to Humira(Adalimumab).   Clinical Course: It was reported that the patient was tested positive for covid-19. In Mar2022, he had actinic keratosis removed form head back and had some more in march. He was not sure if this was related to Humira or not. He had these removed over the years before starting Humira. It was unknown if patient was enrolled in a covid-19 vaccine trial.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely 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.
sore, red arm at site of injection. went away the next day but on 1/24/21 redness came back and moved down arm. Can't raise it above her head.
pt recvd vax;w/in 1/2 hr p/ shot, had glassy eyed look,had behavioral changes & tongue kept protruding out;next day had high T,stopped breathing & had sz;