chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 55-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In June 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if the patient was enrolled in COVID-19 vaccine trial.  No treatment medications were reported.  Company Comment: This spontaneous case reported by consumer concerns a 55-year-old female patient, who had concomitant use of Adalimumab for psoriatic arthritis, who experienced unexpected, non-serious AESI Covid19 after receiving a dose of mRNA-1273 on an unknown date.  Clinical course, labs, and treatment details not reported.  The outcome was not resolved.  The concomitant use Adalimumab could be a confounding factor.  The ongoing Covid19 pandemic could also be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by consumer concerns a 55-year-old female patient, who had concomitant use of Adalimumab for psoriatic arthritis, who experienced unexpected, non-serious AESI Covid19 after receiving a dose of mRNA-1273 on an unknown date.  Clinical course, labs, and treatment details not reported.  The outcome was not resolved.  The concomitant use Adalimumab could be a confounding factor.  The ongoing Covid19 pandemic could also be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Patient reports developing sores two days post-vaccination that resembled spider bites on her chest, not painful but itchy, eventually they developed into blisters.
Swelling of the throat and ears.  Narrative: Employee states that after taking Benadryl and Ibuprofen she was okay.
Accidentally administered Pfizer Covid vaccine to a 14 year old patient.  Had an outside nurse checking in patients and she was unaware of patient's age when administering the vaccine.  There are no adverse effects to report but current age requirements for the vaccine is 16 years and over so just wanted to report because it was out of scope.  Patient is doing well right now.
Patient had flu and pneumonia vaccines yesterday 10/10/11 around 5:20 pm. Patient called me today 10-11-11 around 4:30 pm and told me she had a swollen arm and she had taken BENEDRYL and was thinking of going to to hospital.
After receiving the flu vaccine patient passed out and fell off the chair. Patient reported after that he has a history of passing out when giving blood.
Welt at the site, redness and swelling, tingling down the Left arm and fine rash with burning sensation on legs. Started within hours of injection.  Continues to have symptoms
pt recv varivax 24NOV97 & 3 days later pt devel a severe case of varicella w/greater than 500 lesions;pt had associated h/a for 3 days, fever for 2 days;also devel secondary oral thrust;
I woke on the morning of Feb 24th unable to move my left leg or arm, general left side numbness.  Went to hospital where I was assessed and a CT scan done, sent by ambulance to another hospital where I was admitted and several tests performed over the 3 days I remained. MRI and CT scan confirmed ischemic stroke.
Mild pain at right superio-lateral deltoid with palpation and abduction to 90 degrees.
fever like 102-degree Fahrenheit; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration date,, via an unspecified route of administration on 07Apr2021at 15:00 hours as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration date,  via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. On Apr2021, patient had fever like 102-degree Fahrenheit. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
When I  received my second dose of Moderna on 4/20 and mentioned the side effects I received from the first shot, the person administering the shot said I should report it to the cdc. I used the vsafe tracker on 4/20 to track any new side effects but I didn?t see a place to report previous side effects. On the night of my first shot (3/23) I had a skin reaction that was VERY itchy, raised, red, hot, and burned when I itched it. The area spread and then shrank but remained localized to the area where I received the vaccine.  This started the day of the first shot and lasted for a week. It started to go down and then a week after I received the shot, I had another skin reaction except this time it grew to the size of my palm. It was itchy, raised, hot, and red. From what I read online, it seems like I had ?covid arm?. I tried calling my health care provider one morning and they offered me a virtual appointment for the early evening of the following day. I felt like they didn?t think it was serious since they were going to have me wait 30+ hours to see someone so I just took Benadryl instead. This helped with the itching, which was the most annoying part. I actually still have a mark on my left arm today, more than a month after the first shot, so the woman advised I get my second shot in my right arm. It seems like I had an initial reaction the vaccine that lasted about a week and then got the covid arm. My arm was itchy and raised for about 3 weeks. I took pictures of my arm a couple of times a day for the first two and a half weeks to document the progression.
Thursday started with sore throat, fever, chills, stuffy nose and headache. We gave him Acetaminophen. Fever continued into Friday with the same symptoms. Hives began Saturday morning and gradually got worse. We gave him Benadryl at that time and the fever went up to 102.5 F. Wheezing in his chest began. Sunday morning the hives were worse and we decided to go to the doctor. We went to a walk in clinic who after an EKG wanted us to go to the Emergency room due to a "blip" and a concern for myocarditis. At the ER they administered Prednisone and more Benadryl through an IV.  They decided to do a CT Scan to look for blood clots. (the ER doctor mentioned he was glad that we brought him into the ER...) No blood clots were found thankfully and they eventually released him, with a prescription for 4 days for  Prednisone, more Benadryl and Pepcid. The hives continue today, the day after, and are barely under control by the Benadryl.
Patient complains of rapid heart rate. Vaccine given by LPN. Patient walked up to lead nurse and complained of a rapid heart rate. Nurse lead notified LPN and myself. We both asked patient to have a seat and got patient blood pressure and heart rate. Blood pressure 162/98 and heart rate 96 BPM. Patient was taught calming techniques at 14:09. Bottle of water given to patient. Blood pressure was retaken at 14:25 and heart rate 85 BPM. Patient observed for an extra 30 minutes. Patient left building feeling perfectly fine.
diagnosed with the flu 14 years in a row; Initial information received on 08-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer/ non healthcare professional (patient's mother).  This case involves a male patient of an unknown age who diagnosed with the flu 14 years in a row (influenza), after he received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE, the patient spent 14 years working and he was diagnosed with the flu 14 years in a row (influenza) Not 1 single time since he got out. By the way he was forced to take the flu shot.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome for influenza was unknown.  There will be no information on the batch number for this case.
Patient presented to the vaccination observation area at 11:35. At 11:50 patient stated his tongue was numbness and whole body feeling burning and itches. No rash noted on the skin. He requested Diphenhydramine, he refused the Epi-pen and PO 50mg Diphenhydramine was administered. Site Lead came over speak with patient. Site Lead spent 20 minutes educating and encouraging patient to take Epi-pen and the need to call 911 ambulance due to his symptoms. Pt refused the Epi pen and calling 911 and stated that his condition is not getting worse. VS is BP 170/100, P 62, RR 20, O2 99% Pt stated that his BP 170/100 is his baseline on BP medications. Pt agreed to stay in observation for longer.    At 12:50pm, pt stated that his tongue numbness is getting better only the back of tongue feeling numbness and the whole body feeling burning resolved, only the hands and back of ankles are itches. VS has not changed BP 170/100, O2 98%, RR 22, P 61.   At 1:15pm, pt stated that hands itches resolved, back ankles itches are still itches. Only R side of back of the tongue still numbness.L side tongue numbness resolved. VS BP 170/100, RR 22, O2 100%, P 61.    At 1:30pm, pt stated that L side back ankle itches resolved, only R side of back ankle still a little itches. R side tongue still numbness but less than 15min. VS BP 170/100, RR 20, P 61, O2 98%.   At 1:30pm, pt left observation area. Advised pt to take public transportation to go back to work or home instead of self drive due to pt had Diphenhydramine 50mg, pt stated that he will consider the options of public transportation. Pt instructed s/sx when to reach out to PCP or ED.
ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY  1/16/2023 --  RECURRENCE OF SAME SYMPTOMS
Staff member received COVID vaccine on 1/9/21.  Initially post injection, noted swelling and itching at injection site which lasted approx. 48 hours.  Contacted manager today (1/22/21 with report of nausea and headache on 1/20/21 and return of swelling, itching, and hives at injection site on 1/21/21.
Patient states he is still experiencing pain in the arm and is unable to lift his arm above his head.
Admitted for Covid-19 and for atrial fibrillation with a rapid ventricular rate.   She presented to the emergency department, accompanied by her son, for congestion and nausea for the past day.  She has generalized weakness, nausea and coughing. He had an exposure to COVID-19 four days ago. Received dexamethasone and Covid-19 convalescent plasma. Respiratory status remained stable.
Left-sided Bell's Palsy, facial droop, headache syndrome, neck and jaw pain, facial paralysis and numbness, left eye dryness (does not close) Treatment:  ketorolac (TORADOL), followed by 10 days predniSONE 20 mg and 5 days valACYclovir 1gram 2 weeks later, still have all symptoms...  some improvement with facial droop. Numbness remains, headache neck and jaw pain remain fairly constant...  Ibuprofen and Naproxen used for treatment.
Woke up the morning stated and my body was stiff. To be more specific, I could barely move my limbs and when I did; there was pain. This condition lasted for two weeks before it started to subdue. Even after pain subdued I still had a couple days of tenderness when conducting daily activities.
Case number PHEH2015US024487, is an initial spontaneous report received from a health care professional on 20 Nov 2015. This report refers to a 46 year old female patient. Past medical history was not reported. Current conditions included wheezing, allergies, migraine preventative, migraine, headache, edema, back pain, pain, seasonal allergies, seasonal rhinitis, nausea and vomiting. Her vaccination history included administration of FLUVIRIN (batch number: not reported) last year on 24 Sep 2014, which was well tolerated. Her concomitant medications included ADIPEX-P, Albuterol HFA, ALLEGRA, ALLEGRA-D, DEPAKOTE, EZFE, FIORICET, FROVA, LASIX, Hydrocodone/Acetaminophen, Ibuprofen (manufacturer unknown), NASACORT, PHENERGAN, K-DUR extended-release, RELPAX, Vitamin B6 and ZOFRAN. She was vaccinated with FLUVIRIN (batch number: 157402) 0.5 ml intramuscularly in left arm on 16 Nov 2015. On 17 Nov 2015, she experienced facial edema, angioedema and itchy skin. She was given dexamethasone injection and MEDROL dosepak. She returned to office fully swollen on 20 Nov 2015. She was given an unspecified steroid which was stronger and another dexamethasone injection. The outcome of the events was reported as complete recovery on 27 Nov 2015. The seriousness of the events was reported as non serious by the physician, but the event angioedema was upgraded as medically significant based on Novartis Important Medical Events list and events facial edema and itchy skin were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported. Follow up report received from physician on 15 Dec 2015: Updated date of historical vaccination, concomitant medications, current conditions (wheezing, allergies, migraine preventative, migraine, headache, edema, back pain, pain, seasonal allergies, allergic rhinitis, nausea and vomiting), recent vaccination information (dose and vaccination site) and event information (seriousness and outcome of the events).
This spontaneous report was received from a medical assistant and refers to a 13-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-JUN-2018, the patient was vaccinated with an with improperly stored doses of VARIVAX lot # N029632, expiry date 23-OCT-2019 and lot # N022980, expiry date 23-AUG-2019, subcutaneously for prophylaxis. The doses of vaccine were stored between 15 degrees Fahrenheit (°F) to 46°F (-9 degrees Celsius (°C) to 8°C)) (-7.5°C) for 2 hours 30 minutes. Previous temperature excursions were detected: 15°F to 46°F (-9°C to 8°C) (-5.8°C) for 4 hours 19 minutes. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1807USA011374.
Patient called the pharmacy a few hours after receiving the vaccine and said her arm was red, warm, swollen, and she was having chills. I asked if she had a fever, if the pain was radiating down her arm or towards her chest; she answered no to both. No difficulty breathing. I told the patient to call back if things did not improve. Next morning, 10/4/18 I called the patient to check on her and she said she was doing better. She no longer had chills but her arm was still swollen, red, and warm. She was taking ALEVE and applying an ice pack to the site. Her son is a doctor so he looked at her arm on 10/4/18 that afternoon. Patient called and said her son also agreed that this was caused from the shot. I reinforced that anytime we administer a vaccine the arm could be sore, red, and swollen around the injection sire. She said she understood and she would monitor it. Today, 10/5/18 patient reported to her PCP because her arm was still red, swollen, and sore. They called in Cephalexin 500mg BID X 5 days. When the patient came into the pharmacy she asked to talk with me and she said that the doctor informed her that she received a Pneumo 23 back in 2014 and that she should not have received this vaccine. Our records indicated at the time that the patient had only received a PREVNAR 13. The patient showed me her arm and the redness and swelling was all the way down to her elbow but on the inside of her arm. It was not red at the injection site. Patient said she is going to go back to her PCP on Monday and that she would let me know after her appointment how she is doing.
temperature 98.8; oxygen is at 94; Chest pain/The pain is when he breathes and they are in the center of chest, they are very strong pains; have been same for past 8 hours; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (Husband). A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: unknown) via unspecified route of administration on 27Jan2021 as UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient had taken the Pfizer Covid-19 vaccine yesterday at 6pm. By 12 that night he had chest pains. The pain was when he breathes and they were in the center of his chest, they were very strong pains. It had not got worsened but continued to be the same for about the past 8 hours. His oxygen was at 94, temperature 98.8 and he had no other symptoms. The outcomes of the event chest pain were not recovered and other events was unknown. Declines to provide an address or email. Declines report. Just wants to speak to someone. Also recommended if husband does get worse to seek emergency care/provider care.   Information about lot/batch number requested  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a registered nurse referring to a 25 year old female patient who on 11-APR-2013, was vaccinated with a dose of GARDASIL, 0.5 ml, intramuscular in the left arm (supplied lot # H020002 expiration date, 08-AUG-2015). The registered nurse reported that the patient had a persistent arm pain after administration of GARDASIL the patient developed immediate pain in the left deltoid muscle after vaccination. The pain had continued since then. The patient called the office on 23-APR-2013 to report that the pain in the area of the left deltoid was the same as the day she got the shot. Additional information has been requested.
This case was reported by a nurse and described the occurrence of injection site cellulitis in a 5 year old male who received Infanrix for prophylaxis. On an unspecified date in July 2003, the pt received the fifth injection of Infanrix (590B9) packaged in a prefilled syringe. The injection was made IM into the right deltoid. On 7/15/03, "within a couple of days" post-immunization, the pt developed an injection site reaction. The pt was seen by the physician, who noted an area of erythema and induration measuring 2.25 inches by 2.75 inches on the right deltoid; the area was tender to palpation. The physician made a diagnosis of injection site cellulitis and prescribed a 7-day course of Omnicef. The event resolved on 7/25/03. The nurse considered the event to be serious (OMIC) because it jeopardized the pt or required intervention. The nurse considered the event was possibly related to vaccination with Infanrix.
Arm pain and swelling at injection site about 2 inches in diameter, full body aches with low grade fever. Extreme fatigue. Mental slowness when it came to simple daily tasks.
a rash in my supraclavicular area; 2 swollen supraclavicular lymph nodes with 6.4mm and 5.3mm in their lower diameter/  2 supraclavicular lymph node of size 1.02 cmx0.69cmx0.38cm; 09Sep2021 Dose Number: 1/30Oct2021 Dose Number: 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received bnt162b2 (BNT162B2), on 30Oct2021 at 10:00 as dose 2, single (Lot number: FJ1618) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Cherries" (unspecified if ongoing); "known allergies: Pollen" (unspecified if ongoing); "known allergies: Dust mites" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: bnt162b2 (lot number: FF2153, dose number: 1, prev dose vaccine location: Left arm, Time (24hr): 13:25), administration date: 09Sep2021, when the patient was 37-year-old, for Covid-19 immunization, reaction(s): "Left Supravascular lymph node swollen". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Oct2021, outcome "unknown", described as "09Sep2021 Dose Number: 1/30Oct2021 Dose Number: 2"; RASH (non-serious), outcome "unknown", described as "a rash in my supraclavicular area"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "2 swollen supraclavicular lymph nodes with 6.4mm and 5.3mm in their lower diameter/  2 supraclavicular lymph node of size 1.02 cmx0.69cmx0.38cm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient did not receive prior vaccinations (within 4 weeks). On 19Sep2023, it was reported that days after each doses of Pfizer Covid-19 vaccine, patient felt a rash in his supraclavicular area. After his second dose, he had a cervical ultrasound in which the doctors found 2 swollen supraclavicular lymph nodes with 6.4mm and 5.3mm in their lower diameter. This swelling situation persisted for more than 6 weeks after his second dose, so he had 2 second ultrasound where the doctors found 2 supraclavicular lymph node of size 1.02 cmx0.69cmx0.38cm.  Follow-up (28Mar2023): Follow-up attempts are completed. No further information is expected.  Follow-up (19Sep2023): This is a spontaneous follow-up report from a contactable consumer. Updated information includes: dosing regimen, vaccination history details, lab data, new events (lymphadenopathy and rash) and clinical course.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300047485 same patient different dose/drug/event;US-PFIZER INC-202300047420 same patient different dose/drug/event;
knee pain; knee swelling; This case was reported by a consumer via call center representative and described the occurrence of knee pain in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix. In May 2022, 1 day after receiving Shingrix, the patient experienced knee pain and swelling of knees. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the knee pain and swelling of knees were not recovered/not resolved.   It was unknown if the reporter considered the knee pain and swelling of knees to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-May-2022 Reporter's comments: This case was reported by the patient. On 3rd or 5th May 2022, the patient received Shingrix. The patient woke up the next morning with severe knee pain and swelling in both knees. It had not resolved. An ice had no effect. The patient would like for someone to call the representative as the patient have a surgery next week and concerned about this reaction with anesthesia.
patient received the SPIKEVAX vaccine three weeks after getting another SPIKEVAX dose. The patient is currently fine but we told her to follow-up with any adverse events since she essentially received two doses of spivevax
Developed a fever of 102.7 at 2000 on 1/21/2021 with a headache and chills with sweating.  Noticed generalized weakness.  When she work up on 1/22/2021 she noted hearing loss bilaterally with a "ringing" sensation.  This lasted approximately 1 minute.  She has never experienced this sensation before.