chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 056m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-May-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date).    No concomitant medication was provided.  The BUD of the vaccine was provided was 12May2022.  Treatment medication was not provided by the reporter.
Red, swollen arm where shot given. Approximately 4 by 4 inches. Also itchy.
A couple of days after 2nd vaccine in series, began to develop rash on left side/rib area extending around waist to spine.  Rash was initially maculopapular with erythematous base.  As rash continued to spread around waist, areas became vesicular grouped lesions.   Experienced severe pain, stinging, burning at lesion sites and around flank area to back.  Continuing neuropathic-type pain.   Treated symptoms with calamine lotion,   topical patch, and ibuprofen for discomfort.   Lesions have now crusted for the most part,  rash in various stages of healing with a few vesicular areas remaining.  Continues to have neuropathic pain to area.
Pt developed respiratory illness requiring hospitalization on 3-8-21. She expired on 3-31-21 while still hospitalized.
The Meningococcal vaccination came due 26 Feb 2007 while stationed aboard the USS Bataan. Within 5 minutes post vaccination she experienced similar symptoms of dizziness and wooziness felt with TD/typhoid vaccines in 2004. She returned to medical with increasing dizziness, headaches, nausea w/o vomiting, weakness and "out of body sensation", difficulty breathing with "squeezing lower lungs", and difficulty inhaling. She was placed on oxygen, administered a inhalation treatment without relief. She c/o her chest squeezing and "caving in". She was treated with 2 shots of Epinephrine with slow resolution of symptoms. After several hours observation she was released to her bunk (on ship).  She was treated with oral steroids, albuterol inhaler x 3 days for tightness in chest and shortness of breath. Within 48 hours she reported being "back to normal" and by 72 hours only c/o sore thigh muscles with activity (climbing ladders). She reported no residual effects.
Patient reported double vision and lower back pain within 24 hours after receiving the vaccination. Symptoms resolved within 15 minutes of onset and has not reported permanent symptoms.
Frozen right arm. Pain at injection site. Pain in shoulder and upper arm. Motrin and ice packs.
SHINGLES; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was not recovered.  The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
12 hrs post vaccine - fever - expected  4 days later developed herpes on lower lip, not fully erupted .   10 days later herpes still present , not fully erupted ,  sore , dry , burning  still . Is this to be expected .   Could find no mention in literature of side effects . Please advise.   I?m a nurse and concerned for exposing my patients . Thank you
Received vaccine at 4:30 April 27,2006. That evening had pounding headache, nausea, went to bed. Right arm red and swollen at injection site 2 inch diameter. Temp 101.5 by 9:00 am. Took tylenol. Temp gone, tired and slight headache, went to bed at 9pm. Saturday at 8 am symptoms gone. Left arm injection site tender and puffy for 1 week.
redness, swelling, warmth @ inj site;rx amoxil prescribed by MD;
Fever; Chills; Body aches; Headaches; This is spontaneous report from a contactable Other HCP.   A male patient (age unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 23Dec2020 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On unknown date, after vaccination, the patient had  fever, chills, body aches, and headaches. Fever was high. Sunday night his fever was 102 which went away with ibuprofen (ADVIL). He had no respiratory issues. He had body aches, but they were not severe. He had headaches. He has had 2 negative COVID tests and he was negative for the flu. The patient asked if he could not take the second dose of the vaccine planned for 13Jan2021. Fever resolved on unknown date while the outcome of the remaining events was unknown.  Information on lot/batch number has been requested.
Local redness/swelling/discomfort - persisted x 1 week. Responded to ibuprofen.
Chills; fever; nausea; vomiting; body aches/pains; fatigue; This is a spontaneous report from a contactable healthcare professional (patient himself). A 37-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), (at the age of 37-years-old) intramuscular in the left arm on 25Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history and allergies to medications, food, or other products/known allergies: were reported none.  The patient's concomitant medications were not reported. The vaccine was administered in a hospital. Prior to vaccination, the patient was not diagnosed with COVID-19.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has not received any other medications within 2 weeks of vaccination. On 28Jan2021 at 10:30 AM, the patient experienced chills, fever, nausea, vomiting, body aches/pains, fatigue. The events were considered non-serious. The events resulted in emergency room/ department or urgent care. There was no treatment received for the adverse events. The patient has not been tested for COVID since the vaccination. The outcome of the events was not recovered at the time of report.  Information on the lot/batch number has been requested.
Spontaneous spinal epidural hematoma; Initial information received on 22-Feb-2023 by health care professional regarding an unsolicited valid serious case issued from a literature article.  This case is linked to cases 2023SA063143, 2023SA063144, 2023SA063145, 2023SA063146, 2023SA063137 and 2023SA063148.  This case involves a 64 years old male patient (table 1) who experienced spontaneous spinal epidural hematoma while receiving vaccines MODERNA COVID-19 (coronavirus disease 2019) VACCINE and INFLUENZA VACCINE (QUADRIVALENT).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect MODERNA COVID-19 VACCINE not produced by lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious spontaneous spinal epidural hematoma (spinal epidural haematoma) (latency: 3 days).  The patient was hospitalized for this event for 4 days.   Action taken with QUADRIVALENT INFLUENZA VACCINE (INFLUENZA VACCINE (QUADRIVALENT)) and ELASOMERAN (MODERNA COVID-19 VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Spontaneous spinal epidural hematoma).  At time of reporting, the outcome was Unknown for the event spontaneous spinal epidural hematoma. Reporter's causality: Related; Sender's Comments: Company comment dated 27-FEB-2023: This case involves a 64 years old male patient (table 1) who experienced spontaneous spinal epidural hematoma while receiving vaccine and INFLUENZA VACCINE (QUADRIVALENT). Based on information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed.
Aug 26, 2008 5pm Pediatric dose  Hep A was given instead of Adult dose Hep A.   )Patient had no problems after receiving dose or other vaccine give at same time.
Swelling of the face and eyes, high fever, loss of appetite, rapid heart rate. The swelling of the eyes has lasted 5 days now but the face swelling went away after 3 days. I still have a high fever on and off and the rapid heart rate went away a few hours after injections
Headache,  mild intermittent fever, vomiting, fatigue, injection site soreness
Patient notified pharmacy 3 days after vaccine that her arm  starting to get red, swollen, and warm starting a day after vaccination.  She went to urgent care 3 days after and prescriber thought that patient may have cellulitis or an injection site reaction. Prescriber wrote a prescription for antibiotics to treat possible cellulitis.
About 10 minutes after receiving the Pfizer vaccine patient thought she was having an allergic reaction. She said her throat felt tight and like it was closing and she could not take a deep breath. I told the patient to take sips of water but she said that wasn't helping.  Her throat still felt very tight and she couldn't breathe. I gave the patient 1 benadryl 25mg capsule. I continued to ask her to sip water and take deep breaths. After about 10-15 minutes she said she still felt like someone was choking her. I gave her another 25mg benadryl. The entire time the patient's mother was present and consented to provide Benadryl. After 10 more minutes, the patient said she still did not feel well, but did not want an Epi-Pen.  Another pharmacist called WellNow (in our parking lot) and they said the patient could go there to be monitored. WellNow said the patient was just tired and they did not administer any further medication.
Severe chills began about 7.5 hours after vaccine. Followed by headache, body aches, fever, fatigue and nausea. Took both Tylenol & Motrin. Chills came in waves for 24 hours. Fever got up to 101.8 roughly 12 hrs after vaccine. 48 hours after vaccine still have headache and fatigue.
Heart rate was high, felt nauseous, light-headed on and off. BP was high for two after it was given. Took Bendaryl two hours after and heart rate slowly went down to normal. Headache and Sore throat, a little difficult to swallow.
On 1-8-21 I woke with fever 100.4, chills, body aches and headache.  Called my employer.  Had a virtual visit about 2 hours later, fever up to 101.5.  Got rapid covid test and pcr test.  In the end, both negative.  Fever got as high as 102.5 over the five days of being ill.  Headache body aches chills persisted through day 4.  Fatigue lasted through day 8.  Back to work day 6 after 24 hours without fever.  Treated with 1000 MG apap q 6 hours and 800 MG IBU q 8 hours.
pt was vax 9AM DTP/HIB/OPV on 7OCT92; mom called 205PM stating that pt has been crying x 20 mins; now unconsolable & that rt leg was red, swollen to the knee area;
Hospitalized with severe abdominal pain - No diagnosis in hospital - Now diagnosed with Auto Immune Hepatitis
had very bad symptoms and she in 'not well until today; This is a spontaneous report from a non-contactable female consumer reported for her mother. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The adverse events reported in this case belong to the mother of the caller. The reporter reported that her mother received the vaccine from Pfizer and had very bad symptoms and she is not well until today. The reporter reported the event as non-serious. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021703466 same reporter/drug/AE, different patient
12/23/2020 @ 10:20am high blood pressure was high I was kept for observation at the vaccination site for extra minutes. 12am I felt chest pain and SOB that lasted 15 -20 min and it went away by it self and SOB lasted 1 hour and went away by  it self. When I feel A fib I get dizzy daily and that has not resolved.  pre vaccine 5% 24 Holter monitor test and post vaccine 75% 24 Holter monitor test.
I experience an allergic reaction similar to food poisoning (hives and itch all over my body). I took a Claritin and the symptoms seemed to get better then they continued for a whole week. I then went to an urgent care facility to see what they could do and they prescribed me with steroids. They helped calm the allergic reaction but then the allergy still kept coming back. I now have been taking Allegra for over two weeks.
5-10 minutes after vaccines, pt became flushed and less responsive; never unconscious. HR 120, BP 100/60. L eye & upper lip swelled and nose - began to un and become blocked. Benadryl given, observed for 1 hour. Became playful, alert, eye swelling resolved, nose remained congested. Pt d/c'd to home. Time in office from vaccine administration to d/c: 11:50a - 1:30p
When preparing the Covid vaccine for a patient in clinic, The bivalent Pfizer Vaccine had been left in the Monovalent Pfizer basket. I did triple check but I over looked the "Bivalent", written on the bottle. (One other MA and MD were there when pulling the vaccine for preparation and no one caught the error.) At approximately 2:00pm, when preparing to draw up for another relative, I then read the bottle thoroughly and read that it was indeed, Bivalent. Not Monovalent.
pt recvd vax & FEB95 pt exp hives all over body;hives were treated w/DPH;pt was observed & released;
This spontaneous report as received from a other certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of incorrectly stored RECOMBIVAX HB (dose and route were not reported) lot # K012874, expiration date 09-JUN-2016. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient developed chest pain at rest that was worse while supine and exercise intolerance.  He developed troponin elevation and ST elevations on EKG, but had no effusion or wall motion abnormalities on echocardiogram.  He was treated with activity restriction, colchicine and indomethacin.  Troponins quickly trended downwards and he was discharged to home with activity restrictions and follow-up.
Patient who is not 18 yet received the vaccine. Patient age at the time of vaccination is 17yrs and 6 months. Patient did not experience any immediate symptoms after receiving the vaccine in the 15 minutes wait period. Parent was contacted for the patient and he is aware that the son received the vaccine.
Case number PHEH2014US025375, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 59 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 21 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error.
Patient has large red/inflamed area (approximately 3 inches across) in area where vaccine was administered.
The patient was vaccinated in March and April 2000 with a first and second dose of varicella virus vaccine live. In August 2000, the patient sought unspecified medial attention and was found to be seronegative. Additional information has been requeste.d
8/16 approximately 2 PM 3 hours post vaccine fever of 103 degrees , flushing, arm soreness, aches, chills, rash, headache. TYLENOL at 5 PM temp same 2x500 mg to 102 degrees, 8/17 next morning 2x500 mg x 6 hrs 101 degrees, back to 100 degrees then 8/18 100 degrees 48 hours post vaccine. Loss of appetite - only water, juice. Nausea/not vomit.
flu-like symptoms; general malaise; lethargy; severe diarrhea; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), MALAISE (general malaise), LETHARGY (lethargy), DIARRHOEA (severe diarrhea) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A, 12M20A and 062E21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), MALAISE (general malaise), LETHARGY (lethargy), DIARRHOEA (severe diarrhea) and NAUSEA (nausea). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), MALAISE (general malaise), LETHARGY (lethargy), DIARRHOEA (severe diarrhea) and NAUSEA (nausea) outcome was unknown.
Chest pain-mild to moderate.  Intermittent  pInching and tightness
07/03/13 Left arm swelling with golf ball size knot developed immediately after injection. Right arm injection site bruising. 07/04/13 increased swelling and redness Left arm. Seen by family physician. 07/05/13 seen by family physician. Instructed to use warm compresses on left arm.
Bell's palsy like sx's since 1/9/13 & continued. Pt said clinic thinks this is result of flu vaccine. Only labs she has is herpes simplex virus.
This spontaneous report was received from a healthcare worker regarding a 14 week and 5 days old patient of unknown gender. There was no information about patient's concurrent condition and historical condition. On 23-FEB-2015, the patient was vaccinated with ROTATEQ dose 1, 2 ml, oral at the age of 14 week and 5 days. No adverse event was reported. No concomitant medication was reported. No product quality complaint was involved. The outcome of the event was unknown. Additional information has been requested.
Blurred vision; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision) and NAUSEA (Nausea) in a male patient of an unknown age 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Blurred vision) and NAUSEA (Nausea). At the time of the report, VISION BLURRED (Blurred vision) and NAUSEA (Nausea) outcome was unknown.            The patient received their 2nd dose and about 3-4 days later the patient developed nausea and blurred vision.  No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
pt recvd vax;adm to hosp due to dec activity & pancreatitis (amylase 650,lipase>1700);t of 99.5;recovered,no tx x/ acetaminophen;devel mild systemic rxn(fever, arthralgia) to Rubella vax & pancreatitis due to MMR vax;
I have been having tightness in my chest on 9/6/21. I also started to have shortness of breath on 9/7/21 and decided to go to the hospital. They did an Ekg, Chest Xray, as well as tested me for Covid. I went to an Cardiologist and she didn't do anything but tell me to go back to the hospital to be tested for blood clots. Dr also had me make an appointment to have pictures taken of my heart as well. My appointment it 9/10.
Low-grade fever and Right arm red, hot and swollen from shoulder to elbow. Painful to touch.
He got the vaccine, had no reaction.  The following morning around 4:00 he felt real dizzy and his arm real sore, and still feels nauseous and felt like vomiting but did once.  He is trying to work with this continued reaction.   He did run fever of about 100 for 2 nights, but most things seem to give him nausea.  He has not taken anything for the reaction.
29DEC95 shot given;30DEC95 t101R; 2JAN96 4-5cm red;17JAN96 2cm w/dimple