chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious.
Several hours after vaccine administered, patient developed local reaction at site and diffuse hives.  Was given dose of Benadryl at home and hives resolved.  No other symptoms developed and had no residual hives the following day. Of note, patient has received Quadrivalent Influenza vaccine several times in past (2021, 2017, 2016) without any reaction.
12/5/18 diffuse erythema and edema noted to the uper lateral arm, wheals noted with papules, no drainage noted; pt took benadry every 6 hrs since reaction began.. She is to take the zyrtec daily apply etamethasone cream daily to affected area and add benadryl every 6 hrs as well until arm better; If sxs persist or worsen she is to rtc; 12/11 pt reurned to clinic today for worsening left arm skin rash - now has red,scabbed lesions to area and skin peeling near site. redness is still present. It has improved and is not worse.  .
Shot (Intradermal) administered on 11/8/12. Patient called pharmacy on 11/9/12 describing large red swollen area at injection site ("size of a doughnut"). Warm to touch. Patient instructed to take ALEVE, BENADRYL, and apply ice. 11/10/12: Patient reported redness starting to be lighter, but spreading. Patient instructed to see PCP on Monday.
PATIENT REPORTS SORENESS AT INJECTION SITE AND LIMITED RANGE OF MOTION LASTING GREATER THAN 7 DAYS FOLLOWING VACCINE ADMINISTRATION.
Immediately after administration of Flumist, Pt felt nauseous. Within 15 minutes she noticed tingling in her hands and feet which lasted for a couple hours. Pt noticed intermittent tingling the next morning.
This spontaneous report was received from radiology technician and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. From 30-MAR-2017 to 18-APR-2017, the patients were vaccinated with the improperly stored doses of PROQUAD (dose, route and anatomical location were not reported) (lot # M039448 and expiration date 20-MAR-2018) for prophylaxis. The reporter stated that the sterile diluent (DILUENT MRK) used to reconstitute the vaccine was not improperly stored. There were no adverse effects reported. The administered doses of vaccine experienced a previously temperature excursion of 9 to 8 degrees Celsius for 1 hour and 5 minutes. The last temperature excursion was reported between 9 to 8 degrees Celsius for 1 hour and 2 minutes. Data logger was involved. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA009851.
Sore and achy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Sore and achy".  Additional Context: Consumer refused to provide any information would like to know the inactive ingredients of the bivalent vaccine mentioned that she had the J&J for her primary series and booster dose for the second booster dose she got the Pfizer vaccine. She has lymph node problems from the vaccine. Had high dose flu shot yesterday. Not a very healthy person. Has migraines and fibromyalgia as well. While providing information about herself, caller provided the following details: Nephew was sore and achy after getting the Pfizer COVID-19 vaccine, but so be it if its better than getting the illness. She had so much information stolen in the past and she doesn't want to give out any information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After covid shot my hand swelled up and is numb; After covid shot my hand swelled up and is numb; This is a spontaneous report received from non-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 right, administration date 15Oct2021 17:00 (Lot number: FH8027) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing), notes: Other medical history: HBP/Diabetes/Stroke; "DIABETES" (unspecified if ongoing), notes: Other medical history: HBP/Diabetes/Stroke; "stroke", start date: 2018 (unspecified if ongoing), notes: I had a stroke in 2018, Other medical history: HBP/Diabetes/Stroke; "it affected my right arm and hand", start date: 2018 (unspecified if ongoing), notes: I had a stroke in 2018 and it affected my right arm and hand. In which my right hand was slowly recovering. The patient took concomitant medications. Past drug history included: Asprin, reaction(s): "Allergy: Aspirin", notes: Known allergies: Asprin.  The following information was reported: PERIPHERAL SWELLING (non-serious), HYPOAESTHESIA (non-serious) all with onset 22Oct2021, outcome "not recovered" and all described as "After covid shot my hand swelled up and is numb". Therapeutic measures were not taken as a result of peripheral swelling, hypoaesthesia.  Additional information: Patient didnt affect with covid prior vaccination and not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sweat, body ache, difficulty breathing, body numbness on hands and feet, dry throat, nauseas, ache in muscles.
Description 22 yo male developed sudden onset of lightheadness and paresthesias culminating in a syncopal episode after standing in formation for 5 minutes. Syncope start 9/11/2006 end 9/11/06 pt suffered two syncopal episodes on the am of 9/11. The first occurred while standing in formation for 5 minutes. The second occurred in the ambulance associated with heart rhythm changes of asystole for 10.5 seconds. Paresthesia start 9/11/06 end 911/06 pt developed paresthesias of the face and then whole body prior to his collapse. Headache, general start 9/11/06 end 9/12/06. Pt noted some headache on the am of 9/12. Due to head trauma with falling. Medical records included bradycardia.
no adverse event; Caller reported vaccine administered after temperature excursions.  No additional information provided.  No additional AEs or PQC reported.       ?    Names of vaccines involved (including lot/exp) PROQUAD W038809  6/4/2024         ?    Temperatu; This spontaneous report was received from Other Health Professional and refers to a patient of unspecified age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-AUG-2023, the patient was vaccinated therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5ml im, lot #W038809, expiration date: 04-JUN-2024, administered intramuscularly (IM) for prophylaxis. The caller reported vaccine administered after temperature excursions. Temperature excursion occurred at 18.3F during a time frame of 1 hour and 5 minutes. No previous temperature excursion were reported.  No additional information provided. No additional adverse events or PQC were reported.
I just felt out of it, like I couldn't focus. That went on for several weeks where I didn't feel like myself at all. I'm not sure if the irregular heartbeat started then, but if not, it started shortly after. I've had irregular heart beats in the past, but haven't had any issues in several years. This irregularity became more frequent and accompanied by pain. By early February, I became concerned and saw a cardiologist. He did an EKG and informed me that I was in A-fib. It wasn't as severe of an issue due to the fact that I was already on a beta blocker. The cardiologist doubled my beta blocker and added a blood thinner and I have felt much better since then.
This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 15:00 (at the age of 64-years-old), as single dose for COVID-19 immunisation. The patient medical history included depression, GERD, PTSD, mild seasonal and dust allergies, rosacea, mild asthma, cancer survivor (15 years), and allergy to sulfa drugs. Concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 20:00, the patient experienced mild soreness in his left arm at injection point, fatigue, body aches. Arm pain noticed about 5 hours after inoculation. He awoke the next morning with aches and fatigue, about 18 hours after injection. Therapeutic measure were not taken as a result of the events. The clinical outcome of soreness in left arm at injection point, fatigue, body aches was resolving.   No follow-up attempts are needed. No further information is expected.
I'm not sure if that is the correct lot number (it was hard to read).  Low fever of 99.1 (I'm always below 98.6) with some chills. My hands and joints swelled up so much and hurt and my rib cage was extremely painful.  These are common symptoms of RA when I am in a flare.  I felt better on April 3rd.
Patient felt dizzy, and briefly passed out. Pale lips. She said she couldn't see. This happened within seconds of shot
Developed symptoms of COVID-19: pharyngitis, rhinitis, cough 5/25/2022 Symptomatic treatment: Decongestant, cough suppressant, acetaminophen, steroid nasal spray Antiviral: Paxlovid for 5 days 5/27-31/2022 Symptoms much improved by 6/2/2022
Patient presented with swelling, redness in the upper arm of injection site one day after administration with body ache and feeling unwell. Starting day 2, patient experienced swelling, redness below the elbow and tingling in her fingers. Symptoms resolved 5 days after administration.
Already had ongoing shoulder pain after 3rd COVID-19 vaccine that was diagnosed as Frozen Shoulder. After 4th vaccine the shoulder pain was more intense. Went to my doctor, and had an X-ray of my shoulder. Doctor referred me to a Physical Therapist and was again diagnosed with Frozen Shoulder. Under went Physical Therapy.
The side effects bothered him so much that he could not do anything.; pain in his arm; swelling in the part of his arm were he received the vaccine; tiredness; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 11Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, first two doses he did not experience any side effect), for COVID-19 Immunization; Bnt162b2 (Dose 2, first two doses he did not experience any side effect), for COVID-19 Immunization. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Oct2021, outcome "unknown", described as "The side effects bothered him so much that he could not do anything."; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "pain in his arm"; VACCINATION SITE SWELLING (non-serious) with onset Oct2021, outcome "unknown", described as "swelling in the part of his arm were he received the vaccine"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "tiredness"; ASTHENIA (non-serious) with onset Oct2021, outcome "unknown", described as "weakness".  Additional information: Patient received the third dose of the Pfizers COVID-19 vaccine yesterday and presented the following side effects: pain in his arm, swelling in the part of his arm were he received the vaccine, tiredness and weakness. The side effects bothered him so much that he "could not do anything". Caller refused to make a report with DSU.  When he received the first two doses he did not experience any side effect. He also wants to know if he should wait for a couple of days before going to his physician. According to the CDC these side effects should go away on a few days. Referred to his physician for additional treatment recommendations.  Follow-up (21Oct2021)This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever (102) for 24 hours, chills for 48 hours, headache, dizziness
Pt. got vaccine SHINGRIX and Flu at local grocery store on date listed, later that PM reported heart palpitations, tachycardia, weakness/fatigue, arm pain lasting 4 days, improved after taking DAYQUIL.
Patient received the Prevnar vaccine 9/14. She then noticed a red bump on her right arm the following Sunday, 9/17. Over the next days, it extended to wrap around her right upper arm. It was itchy and swollen, not painful. She was having some chills on Monday 9/18, but didn't take her temperature. Did not persist into Tuesday. No body aches. No shortness of breath. She has tried topical hydrocortisone without help. She was taking Tylenol and Advil to help reduce inflammation. No known allergies to vaccinations or their ingredients. Patient was started on cefadroxil and reported improvement in symptoms. Has since resolved.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 14-OCT-2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. Upon information and belief, on or about 14-OCT-2010, a physician recommended and/or administered the ZOSTAVAX to the patient for its intended purpose of long-term prevention of shingles and zoster-related injuries (unclear if administered at a pharmacy or by the physician). The ZOSTAVAX did not prevent shingles or zoster-related injuries as intended. In or about 2013, the patient was treated at an urgent care center for shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
I was held for approx 30 minutes. Drove out and when driving home started to get short of breath, so turned towards the hospital rather than home and called them. My significant other also had his shot, so we switched spots driving at that time. I called the hospital on my way when I started to feel my throat start to close at exactly 1829 on my phone (6:29 pm.). Appointment was at 6pm for shot. Hospital was 13 minutes away. Half way there my tongue started to swell and my lips slightly with tingle. My breathing was more labored to keep up effort as I could not expand my lungs to capacity. I was always able to breath and speak, my voice did become more raspy.    Upon ER, Blood Pressure was very Hypertensive around 140s/120s with my respiratory effort to get in. Pulse was stable around 70-80. O2 was 97-99.  I was able to lay down and relax my breathing which relaxed my blood pressure to 140s/ 80s. I was given IV Benadryl, IV Dexadron, PO Pepcid with a liter of fluid. Monitor up until after 8pm when I was released with still mild tonge swelling but breathing ok. Continue Benadryl at home with my Epi pen for bees stings available.    Did go to work today 07/08/2021. Was wheezy, SOB, no throat swelling, tongue swelling at base. Kept up with Benadryl. Made it 1/2 day and went home. Walking and movement makes increase lung workload. My staff concerned with effort and flush skin while getting supplies. But flush and redness does subside some with rest. When talking need to take a break to breath. But can today notice when Benadryl kicks in. No history of Asthma ever or breathing issues ever. Very active on my farm and at work.
MMR given to child; while documenting vaccine noticed expiration date of 4-6-07, checked all doses in box as well as exp. date on box, lot # was 0150F; exp 4/09.  Need to repeat MMR after 28 days.
no adverse event; got the Moderna Bivalent Booster yesterday instead of the first dose of the Moderna vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (got the Moderna Bivalent Booster yesterday instead of the first dose of the Moderna vaccine) and NO ADVERSE EVENT (no adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (got the Moderna Bivalent Booster yesterday instead of the first dose of the Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (got the Moderna Bivalent Booster yesterday instead of the first dose of the Moderna vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      No relevant concomitant medications were reported.  Caller did not have vaccination card assessable at the time of call. Caller said first the vaccination provider told her she couldn't get another shot until 6 months passed. They also called the CDC and they gave 2 options to either get the first Moderna. Primary shot immediately or wait an get a second dose in 1 month.  Treatment medication was not provided by the reporter.
I had a fever, chills, and a headache. My symptoms started around 10 pm the night I received the 2nd vaccine( 6/2) and lasted until the next morning (6/4) I couldn't get out of bed.
Event 02/13 got vaccine 02/15: woke up feeling sharp pain in gut "like a tear" then had black stool  for 2 days.   Treatment: She took her own natural medicine [slippery elm tree powder, meadowsweet, licorice root, oregon grape fruit, and yarrow], and famotidine   montelukast and cromolyn sodium  Outcome: No more black stool
1st shot 4/22/2021 No immediate adverse reaction. Sudden facial paralysis on left side started aprox 2½ weeks later (5/9/2021). Hospital diagnosed me with Bells Palsy on 5/10/2021 after I went to the emergency room . The bells palsy has corrected itself and now I owe $13,872.05 to the hospital because I have no insurance and cannot afford to pay it.
Induration, redness and heat to right anterior thigh about 4"x2" area.
Pain ( left arm) soreness, so headache, chills Fever ( 99,8 oF)  Tiredness, full stomach, thirsty, Dry mouth
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA304966, 2018SA304965, 2018SA304964 and 2018SA304935. This case involves a 77 years old male patient and reported that accidentally gave an expired (4/4/2018) FLUZONE HIGH DOSE, while he received vaccine FLUZONE HD. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 22-Oct-2018, the patient received a dose of 0.5 ml suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UI842AB and expiry date: 04-April-2018) via intramuscular route in left upper arm. It was a case of actual medication error due to expired product administration. It was unknown if the patient had any 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. List of documents held by sender: none.
Patient complained of facial flushing approximately 10 minutes post vaccination.  Patient was cleared by EMS.  Instructed patient to call her family physician, 911, or go to the nearest emergency room for any further issues.
Sore arm; Fever; Chills; Diarrhea; loss weigh; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2019, the patient received the 1st dose of Shingrix. On 5th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, fever, chills and diarrhea. In August 2019, the patient experienced weight loss. On 6th August 2019, the outcome of the pain in arm, fever and chills were recovered/resolved. On an unknown date, the outcome of the diarrhea was not recovered/not resolved and the outcome of the weight loss was unknown.   It was unknown if the reporter considered the pain in arm, fever, chills, diarrhea and weight loss to be related to Shingrix.  Additional case details were reported as follows: In the night of getting Shingrix the patient experienced sore arm, fever, chills and diarrhea.  The patient recovered from everything by next day except the diarrhea which has been persistent. Due to diarrhea patient had lost weight from 110 pounds to 106 pounds. No further details were provided. The reporter gave permission to follow up.