chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Flu and MENACTRA 10/31/07. By Thanksgiving he had foot droop of left foot. Seen by primary in Feb. '08 for ankle pain. Referred to Orthopedist and Neurologist. He has subsequently developed foot drop in right and is being treated for an acquired neuropathy.  3/3/09  MR received for DOS 7/21-24/2008 with D/C DX:  Inflammatory Neuropathy as well as multiple out pt visits and diagnostic studies. Pt initially presented in 11/2007 with a L foot drop and inability to move his toes resulting in a limping gait. Genetic testing done and negative for CMT.  EMG/NCS c/w axonal neuropathy, repeat with chronic inflammatory neuropathy.  Developed R foot drop in 5/2008. PE 6/1/08 (+) for decreased strength on plantar/dorsiflexion bilaterally and difficulty with gait and stance. DTRs absent in lower extremities. Admitted for IVIG 7/21/08.  Devloped some H/A with tx. D/C for outpt f/u on prednisone.  Later with DX:  CIDP.  Wearing ankle/foot braces to assist with ambulation.  Muscle wasting noted 10/6/08  and hand tremor 12/24/08. Some improvement in strength noted.  8/25/09 CDC's CISA staff has confirmed VAERS 339882 as CIDP.
HPI:23-year-old male with chief complaint of rash.  He reports it started on Saturday and has spread mildly.  He has red itchy bumps to his hands and elbows and feet.  Denies any new lotions or soaps or changes in detergents.  He did have this happen once on his elbows years ago but it resolved on its own.  He has been taking Benadryl for the itching but it helps for a short period of time.
p/vax pt began to exp h/a, throat pain, exhaustion, muscle pain & pressure to head;pt also reported that glands were sensitive in throat, behind ears as well as abd;pt sought unspecified med attention;
3/4/08 Ph. call from pt. at 10:55 am. Reports she received immunizations 3/3/08 at approx 12 noon. She reports she noticed pain and swelling at approx 4 pm in left arm at and around injection site. She took ibuprofen 600mg by mouth for pain and swelling at 8pm. She continues to c/o pain today 3/4/08 at 10:55 am. Instructed to F/u with her PCP today if no improvement to left arm.
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 17th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There was 13, 11, and 6 different doses given. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:Master case
Cough started soon after 2nd shot and is nagging and still going on. Cold and Hot foods tend to aggravate it. Not because of CoVid but may be because of vaccine. I had a loss of taste and smell that has not returned. Cough is congested and phlegmy. In March went to see the doctor. Rheumatologist did test by X-ray and found nothing. PCP visit was physical and no issue. Symbicort and Albuterol inhaler given but no change in cough. Antihistamine given Montelukast, usually taken as needed at night or early mornings when the cough is bad.
That night she begin to have severe headache. She felt as if she was on fire and she believe her head was melting. Later that night around 10PM, she had a temperature of 102.9. She was not able to sleep because of her head was hurting really bad. That falling Monday she was still experiencing headaches and still not able to sleep. I took her to nearest emergency room.
Pt recv vax on 2/1/99; on 2/8/99 pt exp aching pain in LA from shoulder to elbow; tx=Tylenol #3, ice packs, referred to M.D. for pain control
Systemic: extended and abnormally heavy menstrual cycle-Medium, Additional Details: Patient reports a standard menstrual cycle lasts about 5-6 days. The first cycle after her vaccine came at the standard time but lasted about 11 days and featured heavier than usual bleeding.
The first dose when the shot felt weird. It was very cold through my veins and I felt it in my pinky. I experienced numbness in my pinky and ring finger. The numbing went away in two weeks. I believe the shot went in too deep. I went to the doctor but, was not taken seriously. The 2nd shot, I told them not to do it deep. They pinched my arm and injected it. A giant red, hot to the touch lump appeared hours later. It was the size of an egg. I lasted maybe a week and a half, maybe two weeks.
Expired vaccine used; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided. Vaccine was administered after 8 days from first punctured of vial.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: follow up received on 2-Sep-2021 contains non-significant information
The night of the vaccine, I had the severe chills and unable to get warm. I was shivering everywhere. That passed ultimately and by the next day that was gone. In the next 2 days, the rash appeared. It was initially on my left forearm then got to my right forearm. It got worse over a few days and began to blister so I went to my doctor. He prescribed a course of tapering steroids. I was also given a topical cream, a lotion of sort that was also prescription. It may have been a steroid lotion. Those reduced the symptoms over a period of 4 to 5 days. The rash would come and go in small patches. Nothing severe compared to the initial rash, but that did last for some time.
Metallic taste in mouth, nausea, vomiting, diarrhea, bodyaches ,headache injection site soreness
Lot FL2757 Expiration Date: 9/30/2022 administered to patient by staff on 10/06/2022 07:06 pm
on 02/12/2021 I was having achy joints on my wrists and ankles, I had started a antibiotic that day and took it for 3 days due to a urine infection , I also had rash all over my chest and then a week after that I continue to have muscle aches and muscle twitching. These symptoms haven't gotten away. I had an extensive evaluation. I went to see the Doctor a week or two after my symptoms and he requested a lot of blood work which everything came negative but he wanted me to continue to monitor.  I continue with symptoms so I referred to Neurologist, numerologist, who he thought it was more related to the medication not the Vaccination but yet not completely sure, He referred me to Neuromuscular which everything was okay.
3 kids who get sick after the shot; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious social media case through global digital media received from a consumer.  This case involved adult patient for whom 3 kids who get sick after the shot (Illness) was reported, while patients received INFLUENZA VACCINE.  The patient's 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 produced by unknown manufacturer (lot number and expiration date not reported) via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the 3 kids who get sick after the shot (Illness) was reported, unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.  Final diagnosis was 3 kids who get sick after the shot.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown at the time of reporting.  There will be no information available on the batch number for this case.
No additional AE reported; MMR II involved in temperature excursion on 01/01/2021; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.     On 01-JAN-2021, the administered dose experienced a temperature excursion at 47.01 Fahrenheit for 1 minute 30 seconds. There was no previous temperature excursion. The temperature excursion was detected by a data logger. On 26-JAN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status recombinant Human albumin (rHA) (strength, dose and route were not provided; lot# was S037500 and expiration date was 20-NOV-2021) involved in temperature excursion for prophylaxis (product storage error). No additional adverse event reported.   This is one of the 16 cases received from the same reporter.; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA007556: US-009507513-2102USA007557: US-009507513-2102USA007558: US-009507513-2102USA007559: US-009507513-2102USA007568: US-009507513-2102USA007561: US-009507513-2102USA007562: US-009507513-2102USA007564: US-009507513-2102USA005227: US-009507513-2102USA005228: US-009507513-2102USA005229: US-009507513-2102USA005230: US-009507513-2102USA005231: US-009507513-2102USA005232:
Fussy, irritable, red rash (not bumpy) all over body, restless, fever of 101 degrees, vomiting. Rash started 1 hour after injection. Fever started 4 hours after injection, lasted 12 hours (administered Tylenol).
Developed paresthesias in legs and urinary retention; Developed paresthesias in legs and urinary retention; This is a literature report.  A 31-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: One year ago; "transient leg paresthesias" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: URINARY RETENTION (medically significant), PARAESTHESIA (medically significant), all with latency 4 weeks after the suspect product(s) administration, outcome "not recovered" and all described as "Developed paresthesias in legs and urinary retention". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: T2 hyperintensity from lower medulla to the conus; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of urinary retention, paraesthesia.  Clinical course: A year prior, he contracted COVID-19 and had transient leg paresthesias. MRI demonstrated T2 hyperintensity from lower medulla to the conus. He received five days of intravenous methylprednisolone followed by oral prednisone. He remains symptomatic requiring gabapentin, baclofen and tamsulosin.; Sender's Comments: Based on the available information, the causal relationship of the reported serious events URINARY RETENTION (medically significant), PARAESTHESIA cannot be excluded for the suspect product COVID-19 Vaccine - Manufacturer Unknown. 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-PV202200110398 Same Article/event/drug and different patient.;
Janssen COVID-19 Vaccine EUA led to Nausea, severe headache, severe pain throughout entire body (legs, back, neck, head), vomiting for 12 hours. I took Tylenol and Migraine Medication but both were to no avail.
Influenza vaccine provided to RIGHT deltoid. Tolerated well. HPV to LEFT deltoid. Immediate after HPV vaccination patient became pale and passed out. He was laid down with feet elevated and he came to within 4 seconds.  BP100/68 P 68. Water and crackers provided. After 15 minutes BP 110/78 P89 Sp02 99.
I have a swelling under my left arm; like about the size of half of an orange; it hurts; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810, Expiry date was not reported), via an unspecified route of administration on 09Feb2021 in Arm left as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL0142 and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization. On 10Feb2021, patient received the second dose of her/his vaccine (Covid-19 Vaccine by Pfizer) on Tuesday morning and he/she felt yesterday and this morning, he/she have a swelling under his/her left arm where it was given on the left arm like about the size of half of an orange and he/she know its listed swollen lymph node as possible side effects but he/she expected something like size of an almond not an orange, so he/she wondering if that was a problem and it hurts, so patient wondering if there was something that he/she can do about it and also stated that Well, patient assuming he/she can still go to work or probably patient should be getting ready do that So,he/she can take Ibuprofen. The outcome for the events was unknown.  Follow-up attempts are completed. No further information is expected.
SEVERE BODY ACHES; METALLIC TASTE IN MOUTH LASTING 5  DAYS; Fever; Fatigue; Headache; This spontaneous report received from a parent concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included has severe allergies to many foods.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced severe body aches. On 08-APR-2021, the subject experienced metallic taste in mouth lasting 5 days. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste in mouth lasting 5 days on 13-APR-2021, fever on 09-APR-2021, and fatigue, and the outcome of severe body aches and headache was not reported. This report was non-serious.
axillary and arm pain on date of immunization and also myalgias and low grade temperature of 100.1 on 1/5/21 develop facial and neck swelling and redness
Experienced frozen shoulder; Unable to raise arm; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIARTHRITIS (Experienced frozen shoulder), VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to raise arm) and PAIN IN EXTREMITY (Arm pain) in a female 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 PERIARTHRITIS (Experienced frozen shoulder), VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to raise arm) and PAIN IN EXTREMITY (Arm pain). The patient was treated with Physical therapy for Periarthritis and Physical therapy for Pain in extremity. At the time of the report, PERIARTHRITIS (Experienced frozen shoulder) and VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to raise arm) outcome was unknown and PAIN IN EXTREMITY (Arm pain) was resolving.            Concomitant information was not provided.  It was reported pain is resolving but is still there.  The patient was treated with steroid injection.  Company Comment: This case refers to a male patient with no known medical history who experienced the unexpected adverse event of special interest (AESI) of Periarthritis at an unspecified interval of time after receiving the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender's Comments: This case refers to a male patient with no known medical history who experienced the unexpected adverse event of special interest (AESI) of Periarthritis at an unspecified interval of time after receiving the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.
Patient received two Varicella vaccine in 1999 and 2009. Recently went out of country, exposed to Chicken pox and was diagnosed this week with them.
No additional AE reported; administered expired diluent with MMRlI that was not expired; administered expired diluent with MMRlI that was not expired; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 17-AUG-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) 0.5 ml injection, lot #T016197 was confirmed to be valid, expiration date 11-MAY-2022 (route of administration and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with expired sterile diluent 0.5 ml, lot# S008565 was confirmed to be valid, expiration date 09-AUG-2021. No additional adverse event provided.
Leg and ankle swollen after 2nd dose; Leg and ankle swollen after 2nd dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jun2021 14:00 (Lot number: EW0191) at the age of 83 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies : PENICILIN" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: VERAPAMIL taken for blood pressure measurement. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EW0181, Administration time: 02:00 PM), administration date: 15May2021, when the patient was 83 years old, for COVID-19 immunization, reaction(s): "Foot swollen after 1st". The following information was reported: PERIPHERAL SWELLING (non-serious), JOINT SWELLING (non-serious) all with onset 14Jul2021 08:00, outcome "not recovered" and all described as "Leg and ankle swollen after 2nd dose". The event "leg and ankle swollen after 2nd dose" and "leg and ankle swollen after 2nd dose" was evaluated at the physician office visit. Therapeutic measures were taken as a result of peripheral swelling, joint swelling. Additional information: The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. AE treatment was water pill.   No follow-up attempts are possible. No further information is expected.
administered FLUBLOK QUADRIVALENT to a 15 year old patient with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist via agency (Reference number- 00326437) and transmitted to Sanofi on 21-Oct-2020.  This case involved a 15 year old female patient who received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] by the pharmacist (lot number: UJ487AA and expiry date: 17-Apr-2021) via unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age).  Relevant medical history, past medical treatments, concomitant medication, vaccinations details and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  At the time of reporting, patient had not experienced 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.