chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt well  for 1.5 months, then I started having colon clearing diarrhea almost every morning and a fever some of the nights.  I was very concerned, but I drink plenty of fluids and lot of food supplements that I was able to endure it.  This situation lasted for a little over a week and I decided to go to the ER, but first  tried taking Zinc.  The zinc was recommended by many of my customers at the pharmacy as a Covid reliver.   It worked on the first DAY!  I feel fine now and the diarrhea is gone.  I may have had Covid again or a reaction to the vaccination.  I had Covid last March that had the same explosive diarrhea, but it only lasted a day!
This case was reported by a consumer via out of hour services and described the occurrence of injection site joint pain in a adult female patient who received Influenza vaccine Quadrivalent. Concomitant products included Levothyroxine. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent, the patient experienced injection site joint pain. On an unknown date, the outcome of the injection site joint pain was recovered/resolved. The reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The patient had annual flu vaccinations for about thirty five years and had only ever experienced achiness at the injection site following administration of those flu vaccines within hours after the vaccine was given each year into her upper left arm. That achiness usually had resolved within no more than a couple of days. The patient was unable to provide further related details about the previous flu vaccines and did not know who manufactured those vaccines. This case has been linked with case US2018GSK028804, reported by the same reporter for the same patient.
Numbness and tingling down left shoulder, arm and into hand.  Numbness and tingling of left side of face (forehead, cheek, mouth, chin).; Numbness and tingling down left shoulder, arm and into hand.  Numbness and tingling of left side of face (forehead, cheek, mouth, chin).; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0169), at the age of 43-year-old, via an unspecified route of administration, administered in Arm Left on 18May2021 10:00 at single dose for COVID-19 immunisation. Medical history included endometriosis, dermatographic urticaria (autoimmune condition), and nonallergic rhinitis. Concomitant medications included progesteron; estradiol (ESTROGEN); diltiazem. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had numbness and tingling down left shoulder, arm and into hand. Numbness and tingling of left side of face (forehead, cheek, mouth, chin) on 18May2021 16:00. Been in contact with her physician. Has not resolved in 24 hrs. Treatment received for the events and included antihistamines, anti-inflammatories. The event resulted in physician office visit. The outcome of the event was not recovered.; Sender's Comments: The causal association between the reported events and vaccine administered cannot be excluded based on a plausible temporal association. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sluggishness; Fluid retention around ankles; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggishness) and FLUID RETENTION (Fluid retention around ankles) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   On 16-Mar-2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) solution for injection in prefilled pen. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (Sluggishness) and FLUID RETENTION (Fluid retention around ankles). At the time of the report, SLUGGISHNESS (Sluggishness) outcome was unknown and FLUID RETENTION (Fluid retention around ankles) had not resolved.       No concomitant medication information provided. No treatment information provided.     It was unknown if patient was enrolled in Covid-19 vaccine trial.
Redness, tenderness at injection site w/in 24 hrs. Referred to PCP - treated with Antibiotics x 10 days.
tested positive for COVID; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Child received DTap #5 IM left deltoid and EIPV #4 Sub. upper arm on 08/10/2005. he also received PPD skin test and MMR #2 sub. left thigh. When he returned for PPD to be read 09/12/2005 his mother asked for nurse to look at his upper left arm. From top of arm deltoid area to elbow the arm was red, warm to touch and some what swollen. He was not complaining about it. The mother was instructed to use cool packs to help with the swelling. The mother was called on 08/15/2005 and she stated the redness and swelling was almost gone by 08/16/2005. She used cool on it.
2 hours after shot, arm soreness, mild sore throat, headache, almost whole body soreness. the next day they soreness got worse, it hurt to try and walk, headache got worse, 3rd day felt better. On 11th day the headache returned and the arm was sore and weaker. It arm started getting a hot red rash, about 3 in round, skin was hard and hot and itchy, had some body aches and bad headache. Due to holiday, went to urgent care, the red rash had grown to about a 6in oval growing around my arm, mild itch, haedache and soreness, arm was weak, my blood pressure was elevated., not normal. Was told this is covid arm, dr more concerned about blood pressure. Today is 14 days after the 1st vaccine, still have the large rash around my arm, arm is warm, not hot, rash has grown, not itchy. headache is mostly gone. Some body aches, especially in the legs and neck. Arm where got the shot is a little weak still. I will not be getting the 2nd vaccine.
hearing loss/Cannot hear in right ear very well; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration in left arm on 24Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included ongoing blood pressure high. Concomitant medication included levamlodipine besilate for blood pressure high. On 27Jan2021, the patient experienced hearing loss in the right ear, she started to feel like she could not hear very well in her right ear. It was like she was underwater or something. Patient went to see the family doctor on 31Jan2021 because of her ear and the doctor looked in ear and did not see anything wrong. The doctor prescribed an allergy medication, something basic that could be picked up over the counter.
pt recv vax 6APR94 & mom called RN 11PAR94 states pt w/elevated temp & having sz like activiyt (jerking of extremities, eyes rolled back, stiffening of body); told to take pt to ER but did not; bilateral otitis acute tonsilitis & poss feb s
Narrative: COVID infection following COVID vaccine series 07/19, Pfizer, dose #1 08/09, Pfizer, dose #2 12/23 COVID swab, result: detected 12/23 pt cc: exposure: unknown 12/23 SARS-COV-2 Variant Sequencing: pending 1/06/22 COVID19 MONITR PANEL: pending
Symptoms - swelling, hard lump, rash, feverish, lump very hot, itchy, heart beating faster than normal, joints hurt horribly. Treatment - ice, ibuprofen, BENADRYL. Time Course - it is now 07/18/2016 and swelling is going down, still itches, and have rash.
Pain, swelling, itching, and warmth on right deltoid where shot administered. Seen three days after shot-minimal swelling and warmth/firmness, no erythema or tenderness.
This spontaneous report was received from health care professional regarding patients of unknown demographics. There was no information regarding concurrent conditions and historical medication. On an unknown date, patients received improperly stored ROTATEQ (dose strength and route was unknown). No adverse effect was reported. No concomitant medication was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sometime trouble breathing; Suffering from fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Sometime trouble breathing) and FATIGUE (Suffering from fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Sometime trouble breathing) and FATIGUE (Suffering from fatigue). At the time of the report, DYSPNOEA (Sometime trouble breathing) and FATIGUE (Suffering from fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Information has been received from a pharmacist concerning a 48 year old female who on 08-JUN-2009 was vaccinated with a dose of PNEUMOVAX. Concomitant medication was unspecified. On 09-JUN-2009 the patient had an injection site reaction and hypotension. The patient went to the emergency room (hospital information was unknown) but was not admitted. The patient was treated with I.V. BENADRYL and sent home. The patient recovered at the report time. Upon internal review an injection site reaction and hypotension were considered as Other Important Medical Events. Additional information has been requested.
PT STATES ONE WEEK AFTER VARICELLA VACCINE ARM BECAME RED AND SWOLLEN.  MILD,GENERALIZED RASH BEGAN TWELVE DAYS AFTER VACCINE. PATIENT'S PRIMARY CARE PROVIDER CONFIRMED TODAY (3/16/09)A MILD CASE OF CHICKENPOX.
About 5 minutes after shot he said arm is tingling then fell off chair and hit the floor. He passed out for a couple of minutes and then opened eyes and said my throat is closing up. The EMS  gave Benadryl and used  the Epi Pen. He was transported by ambulance to the hospital.
Information has been received from a physician concerning a 14-year-old male who on 23AUG93 was vacinated with varicella vaccine. On 14APR97 tha patient developed a rash on his face. The rash was diagnosed as shingles by a dermatologist on 17APR97. He was treated with valecyclovir HCl (Valtrex). No further details were provided.
noted today 3" red warm patch where varicella was given on 10/31 - patient scratched area - parent did not report to me until today during physical exam
15-20 min after receiving vaccine patient in car became hot, lightheaded, felt like he was going to vomit - had dry heaves x 2 then still in car sat for about 5-10 min then felt better. Since still in parking lot of clinic patient came back in clinic to be check out. At 1:08 pm vitals: BP-120/77, Pulse-70, RR-20, PO2-98%. Patient reports he did not eat anything since dinner night before, usually eats 1 meal a day in afternoon/evening. Patient left about 1 hour after experiencing symptoms that were completely resolved when he left clinic. Attempted to check on patient this am (1/28/2021) at 7:40 am - no answer on phone.  Patient did mention he had work today and may not be able to get to phone, yesterday prior to leaving clinic.
Client in requesting booster dose of Moderna, though  Pfizer was her primary dose. After reviewing pre-vaccination form, it was determined that she is immunocompromised and that she should receive a full dose rather than a booster dose. She was mistakenly given a Moderna dose rather than the Pfizer, which would have been approppriate.
injection area is still hot to touch; injection area is still very red; injection area is still very swollen; This spontaneous case was reported by another health care professional and describes the occurrence of INJECTION SITE WARMTH (injection area is still hot to touch), INJECTION SITE ERYTHEMA (injection area is still very red) and INJECTION SITE SWELLING (injection area is still very swollen) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced INJECTION SITE WARMTH (injection area is still hot to touch), INJECTION SITE ERYTHEMA (injection area is still very red) and INJECTION SITE SWELLING (injection area is still very swollen). At the time of the report, INJECTION SITE WARMTH (injection area is still hot to touch), INJECTION SITE ERYTHEMA (injection area is still very red) and INJECTION SITE SWELLING (injection area is still very swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported.  Treatment information was not reported.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 36-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Gestational hypertension (June7-2017 gestational hypertension- induced ,15-Mar-2019 -gestational hypertension.), C-section (Live-full-term birth) on 07-Jun-2017 and C-section (Live-full-term birth) on 15-Mar-2019. Concurrent medical conditions included Anxiety. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, FISH OIL for Prenatal care.    On 02-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 12-Nov-2020 and the estimated date of delivery was 19-Aug-2021. On 02-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 02-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Dec-2020, Pregnancy test: positive (Positive) Positive. In January 2021, Prenatal screening test: negative (Negative) Negative. On 04-Feb-2021, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Estimated date of conception was reported as 26-Nov-2020. There was no maternal history of subfertility and had established prenatal care.
A report has been received from a registered nurse concerning a 4 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 04-Dec-2012. The nurse reported that they gave patient a dose of FLUMIST on Dec 4, 2012, the dose of FLUMIST expired on Dec 3, 2012. RN reported that patient had not reported any adverse effects. The outcome of the event of gave patient FLUMIST on 04-DEC-2012 and the FLUMIST dose expired on 03-DEC-2012 is unknown. The report was considered to be non-serious.
INCREASINGLY WORSE DIFFUSE PRURITIC RASH WITH EACH DOSE OF ORAL TYPHOID; This spontaneous case report was received from a nurse on 14-Aug-2019. It described a 35-year-old consumer who experienced "increasingly worse diffuse pruritic rash with each dose of oral Typhoid" (PT: Rash pruritic), during therapy with oral Vivotif for an unknown indication.  Case report: The consumer had experienced increasingly worse diffuse pruritic rash with each dose of oral Typhoid. Hence, the consumer took only three doses of Vivotif and held the fourth dose.  Action taken with Vivotif was vaccine discontinued.  The clinical outcome of the event was unknown.  Company's Comment: In this case, it was reported that the consumer experienced "increasingly worse diffuse pruritic rash with each dose of oral Typhoid". There seems to be a temporal association between the intake of the vaccine and the event.  Hence, the causality of the event with Vivotif is assessed as possible. Also, rash is labelled as per CCDS. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced "increasingly worse diffuse pruritic rash with each dose of oral Typhoid" . There seems to be a temporal association between the intake of the vaccine and the event.  Hence, the causality of the event with Vivotif is assessed as possible. Also, rash is labelled as per CCDS.
4/5/18- pt c/o headache, hip pain, knee pain, leg pain, abdominal pain, decreased appetite, lethargy. 4/6/18- Low grade fever (100.5), nausea and vomiting. Reported symptoms along regressive behavior and agitation continued through 4/10/18. Pt had 3 day course of orapred beginning on 4/11/18. Caregiver reported pt back to self by 4/11/18.
high blood sugar above 200 mg/dl; warm; thirsty; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP).  An 85-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Organ-limited amyloidosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; Manufacturer unknown), for COVID-19 immunization. The following information was reported: BLOOD GLUCOSE INCREASED (medically significant), outcome "unknown", described as "high blood sugar above 200 mg/dl"; FEELING HOT (non-serious), outcome "unknown", described as "warm"; THIRST (non-serious), outcome "unknown", described as "thirsty". The patient underwent the following laboratory tests and procedures: Blood glucose: high blood sugar above 200. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of subject  vaccine cannot be excluded for the reported events, based on temporal relationship. There is limited information provided in this report.  This case will be reassessed upon receipt of follow-up information.   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.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild
pt recv vax;swollen,red lt upper arm all the way to elbow;c/o red rash & pruritus;states lt shoulder hurt & arm burns;will start NSAID daypro x 5 days & see MD if not improved;
Patient states she felt hot and cold, couldn't sleep, she had vomiting and diarrhea. She went to hospital on 11/10/2022.
Patient developed a cough a week or so after getting the vaccine. Unclear if clots were starting to develop at the same time.
(forehead and neck pain); mind isn't right/little bit crazy/feels congested; She isn't in the mood to do anything; headache (forehead and neck pain); body aches; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN ((forehead and neck pain)), FEELING ABNORMAL (mind isn't right/little bit crazy/feels congested), MOOD ALTERED (She isn't in the mood to do anything), HEADACHE (headache (forehead and neck pain)) and MYALGIA (body aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced NECK PAIN ((forehead and neck pain)), FEELING ABNORMAL (mind isn't right/little bit crazy/feels congested), MOOD ALTERED (She isn't in the mood to do anything), HEADACHE (headache (forehead and neck pain)) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, NECK PAIN ((forehead and neck pain)), FEELING ABNORMAL (mind isn't right/little bit crazy/feels congested), MOOD ALTERED (She isn't in the mood to do anything), HEADACHE (headache (forehead and neck pain)) and MYALGIA (body aches) outcome was unknown.      Concomitant medications were not provided.   This case was linked to MOD-2021-403180, MOD-2021-403181 (Patient Link).
Case previously recorded as MA2009-4265. Initial case report received from a nurse via agency on 13 NOV 2009. A 19 month-old female patient was vaccinated with FLUVIRIN (batch no. 102125P1) i.m on 13 NOV 2009. No adverse events were reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to foreign and local label: Administration to a child younger than 4 years is unexpected after vaccination with FLURIVIN 2009/2010. No change in benefit-risk-ratio. No measures are necessary. Agency reference.:NA09-008218.