chrisvoncsefalvay/vaers-outcomes huggingface dataset:
some weird stomach; diarrhea; cold feet; My blood sugar went up; my heart raced for 2 or 3 days; freezing; tendinitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergic to PCN" (unspecified if ongoing); "Allergic to Codeine" (unspecified if ongoing); "Allergic to Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "some weird stomach"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; TENDONITIS (non-serious) with onset 21Mar2021, outcome "unknown", described as "tendinitis"; FEELING COLD (non-serious) with onset 22Mar2021, outcome "unknown", described as "freezing"; PERIPHERAL COLDNESS (non-serious), outcome "unknown", described as "cold feet"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "My blood sugar went up"; PALPITATIONS (non-serious), outcome "unknown", described as "my heart raced for 2 or 3 days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller received COVID  vaccine on 03/18 and since she took the vaccine she has experienced Tinnitus and is freezing cold. Her hands and feet stay cold now. Her blood sugar went up as well but has since went back down. She did not take the 2nd dose of the vaccine. She would like to know when the side effects will stop.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills and dizziness for about 3 days after the shot, no medical  treatment required but plenty of bed rest and hot liquid.
We got vaccinated and boosted; we recently tested positive for COVID; we recently tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "We got vaccinated and boosted"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "we recently tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101874487 Same reporter/drug/event for different patients.
He received his flu shot on Nov 3, 2008. States 1-2 days after the shot he had stiffness in his arm (left)... "Can't lay on it"...." have to move it around a lot in the morning to get it going". No changes. Pain comes back stronger after rests for a while.
Patient said he received Janssen vaccine (10/15/21) and soon felt short of breath, so he took his inhaler. He became lightheaded. During my assessment at 1:45 PM he only had complaints of feeling lightheaded. His skin was not cool or clammy. He was jittery. No wheezing audible, no cough noted. No diaphoresis. He was talking in complete sentences. Denied trouble swallowing, lip swelling, and throat tightness. Pulse 71, SpO2 95%. Drinking water sitting in front of air-conditioning fan. Continued to monitor.  At 2:00 PM, patient reports he is feeling better. Advised home to rest and not to return to work. At 2:13 PM, Brandon still feels jittery, but not lightheaded, no SOB, no tongue swelling or trouble swallowing, no dizziness. Will be going home.  EMS was not contacted.
No other AE reported; The product was stored outside of the recommended storage range and administered to patients; PROQUAD administered to an adult patient over the age of 13 years; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.  On 19-MAY-2021, the patient (reported as adult and over the age of 13 years) was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status rHA) (dose and route of administration not reported, lot # T028139, expiry date reported as 15-APR-2022 but upon internal validation established as 15-FEB-2022) for prophylaxis (inappropriate age at vaccine administration). The administered dose of vaccine was stored outside of the recommended storage range, in temperature of 43 degree Fahrenheit (F), for 21 days (product storage error). Digital data logger was not involved. The vaccine did not experience any previous temperature excursions. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA003759: US-009507513-2106USA001912: US-009507513-2106USA003761:
Reports numbness and tingling in fingers and turning white when exposed to cold air. Still present after 4 weeks.
Hospitalized with acute hypoxic resp failure, covid 19 pneumonia, possible bacterial pneumonia, remdesiovir and dexamethasone
Immediately after Tdap & HPV #1 given. Pt became pale & passed out in chair, recovered & passed out again a second time with nausea, was assisted to the floor & began crying. 911 was called to evaluate by paramedics & was able to go home with mother. Antiemetic given by paramedics.
Initial report was received from a consumer on 21 September 2012, who is also the patient. A 39-year-old female patient received an intramuscular injection in the left upper arm close to shoulder of TENIVAC, lot number unknown, on 02 September 2012. On 06 September 2012, the patient developed limited movement of the left upper extremity. The patient took MOTRIN and began to improve until her child accidentally ran into the arm a week ago. The patient developed pain and was unable to lift her left arm up from her side. She resumed MOTRIN and applied Icy Hot per advice from a physician's assistant/friend. She has an appointment on Tuesday for an MRI and with her physician for further evaluation. The patient had a broken toe and no illness at time of vaccination. Patient had no other past medical history. The patient's outcome was reported as unknown. Documents held by sender: None.
Developed  extreme facial redness which was very warm to touch. Also lips were tingly and somewhat numb feeling. I felt very anxious which is not typical for me, I have had several other vaccines with no reaction in past. I had left the facility following 15 minutes of monitoring and took off my mask in the car. I looked in mirror because my face felt so warm. My husband was with me and symptoms did not worsen so we went home which only took 10 minutes and after another 30 minutes it did not subside so I took a low dose of liquid Benadryl. This eventually relieved my symptoms. I took another low dose at bedtime also. I slept through the night and had no further problem the next day. Thus  I did not contact a physician or the facility.
SADDLE PULMONARY EMBOLISM 1/6/2022 SADDLE EMBOLUS PULM ART W/O ACUTE COR PULMONALE ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 1/19/2022 SADDLE EMBOLUS PULM ART W/O ACUTE COR PULMONALE
Mom called 10/10/2018 to report that daughter's right arm at injection site remained achy and puffy since injection. Mom was advised to bring daughter in to have the site/arm examined. Mom made an appt to bring her 10/15/2018. They no showed the appt. They were called today, 10/17/2018, to follow up. Mom is stating they no showed appt. as patient stayed after school for some activities. States arm no longer puffy, but still achy. Asked if she needs to bring her in, and she stated it wasn't necessary. States the achiness now could be due to her rough play in powder puff football or basketball. States will bring her in next week if needed.
DTAP given in left deltoid on 08/16/2004. Pt was seen on 08/19/2004 with a red,warm, swollen left arm almost twice the size of the right arm. No fever.
body ache; headache; slit temperature 99.9F,fever; arm and shoulder are very sore; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN (body ache), PYREXIA (slit temperature 99.9F,fever) and ARTHRALGIA (arm and shoulder are very sore) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (headache), PAIN (body ache), PYREXIA (slit temperature 99.9F,fever) and ARTHRALGIA (arm and shoulder are very sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) had resolved and PAIN (body ache), PYREXIA (slit temperature 99.9F,fever) and ARTHRALGIA (arm and shoulder are very sore) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: 99.9 f (High) 99.9 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported are blood pressure medication and allergies medication
chills - started at 9:30 pm day of vaccination, used heated blanket; fever, headache -started at 9:30 pm ibuprofen; injection site pain
Twin A w h/o IUGR re-admitted to hospital on (3/13/18) for several days' history of poor feeding - found to have elevated transaminases, abdominal distention, severe ascites, respiratory distress.  Transferred to PICU at hospital where he was worked up including exam of CSF, ascites fluid, blood, urine - all negative. Clinical picture c/w DIC but no organism ever isolated. Genetics workup including microarray and WES is pending. Possible underlying metabolic disorder. Discharged home 4/3/18.
RANDOMLY FELT LIKE PINS AND NEEDLES IN TOES,  FINGERS AND FACE; FEVER; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced randomly felt like pins and needles in toes, fingers and face. On 11-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 13-APR-2021, and had not recovered from randomly felt like pins and needles in toes, fingers and face. This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Pfizer/ Dose #4: Moderna/ Dose #5: Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received bnt162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 14Apr2021 as dose 2, single (Lot number: EW0161), in left arm and on 18Oct2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 47 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Mar2022 as dose 4 (booster), single (Lot number: 048L21A), in left arm and on 15Sep2022 as dose 5 (booster), single (Lot number: AS7145B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "known allergies: sulfa drugs" (unspecified if ongoing); "known allergies: cashews, Peanuts, tree nuts" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Zithromax, reaction(s): "known allergies: Zithromax". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Mar2022, outcome "unknown", described as "Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Pfizer/ Dose #4: Moderna/ Dose #5: Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: product- COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 14Oct2023 to 18Oct2023.
Vaccine that was given to patient was expired on 1/10/2016. The date was not checked prior to giving vaccine. Manufacturer was called and recommended that patient be revaccinated. Patient was called. No adverse reactions noted. Patient will return to clinic today for revaccination.
Left thigh swelling since 5/25/04 PM. Seen in follow up 5/26/04 4:00 PM. treated with cool compresses, Tylenol.
Severe muscle pain in entire body, fatigue, off & on headaches/sore throat/nausea & vomiting, off and on fever in the 102-104 degree range. Tenderness/swollen lymph node under left armpit. Adverse effects last five days. Tylenol was taken as needed for those five days, helpful, but did not eliminate effects.
was just tired; the booster knocked her on her butt; her right arm where she had the booster hurt; had headache; chills; fever; couldn''t eat at all; had diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number FC3184), dose 3 via an unspecified route of administration, administered in Arm Left on 12Oct2021 11:00 AM (at the age of 62-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Historical vaccine included 1st dose of the Pfizer COVID vaccine in right arm was on 06Mar2021 09:30 AM with lot EN6206, the 2nd dose was in right arm on 26Mar2021 10:00 AM with lot ER8730, and flu shot on 04Oct2021. Medical history included ongoing chronic obstructive pulmonary disease Verbatim: COPD 10 years ago. There were no concomitant medications. On 12Oct2021 21:00 the patient experienced was just tired, the booster knocked her on her butt, her right arm where she had the booster hurt, had headache, chills, fever, couldn''t eat at all, had diarrhea. The outcome of event the booster knocked her on her butt, her right arm where she had the booster hurt, chills, fever, couldn''t eat at all, had diarrhea was recovering. The outcome of event tired, had headache was not recovered.   Follow-up attempts are completed. No further information is expected.
Immediate after the shot i had a weird taste  and slight feeling of nausea  which soon went away. Around 6 pm on the day of the injection I noticed that my taste buds were more sensitive. Following that I became very sluggish. So I went to bed shortly afterwards. The following morning I was still sluggish and there was a feeling of openness in my upper chest area. The feeling of tiredness an no energy started and continued until Wednesday the 3rd of March.  That morning I awaken feeling better. I still have a feeling of openness in my upper chest area. But overall I feel great.
I had sore throat, slight headache, fatigue, and fever.  These lasted for about 2 days but the fatigue was longer.  On Jan 8th, I tested positive for COVID-19.
12:18pm: received vaccine, 12:43pm: complained of facial itching, denies any other symptoms, no medications given, continued monitoring, 1:03pm recipient reported symptoms have subsided and was released from clinic.
Patient received JYNNEOS 0.1mL intradermally. While sitting at observation station, auxiliary RN saw patient convulsing mildly while seated on chair. Lead RN & auxiliary RNs immediately gathered around patient to support (but not restrain) body to prevent fall. Convulsions lasted for a few seconds then patient exclaimed "I'm OK everyone! I'm OK. This happens sometimes."  ~12:40 BP 124/78, HR 80, RR 14, AOX4, Lung Sounds Bilateral Clear  ~12:45 BP 124/80, HR 80, RR 12, AOX4, Lung Sounds Bilateral Clear  Patient kept at observation station for another 30 minutes. Given snacks and water. RN assessments prior to discharge = AOX4, no gross neurological deficits, normal gait, pleasantly conversational. Counselled to always disclose history of seizures/convulsions to any future healthcare clinic or organization. Counselled to monitor for further adverse effects and to call 911 if such occurs. Discharged ~1315.  Telephone F/U next day 9/2/22. Patient reported that he felt well today. Felt well night before. Standard side effects at injection site. Counselled to monitor for further adverse effects and to call 911 if such occurs. Left cell # to Ops Deputy for future questions.
Over the week after my shot I started to get a headache which isn?t abnormal for me but by Sunday April 18 I was having the worst headache I have ever had in my life. II was bed ridden and in tears and unable to function. I went to the ER to make sure I was not having the blood clot issue seen after some j&j shots. I was not having one they said and I was sent home to have further testing done and visit a neurologist. By Tuesday April 20 I began having neurological symptoms such as pain and numbness in my left side. I feared I was having a stroke so I went back to the Er where I was admitted and they ran many tests including multiple brain MRI. They found nothing and said that I was having a complex migraine. I saw a neurologist shortly after my hospital visit and he has been treating my headache with gabapentin and fiorecet for emergency medication.  The whole duration of symptoms lasted weeks after my shot and I still struggle with this headache episode today.
myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: elevated (High) Elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported. Patient received supportive care. Reportedly patient visited hospital for chest pain.  Symptoms begun few days after receiving the product. Patient presented with acute onset of marked chest pain Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiogram.  Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.   Author conclusion: the clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-245527, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015, MOD-2021-245527 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 it was found that Incorrect reports were generated. Hence new reports generated. On 05-Jul-2021: Follow up received 07-Jul-2021 included the full text article added with no new information. On 07-Jul-2021: Follow up received 08-Jul-2021 included the full text article added with no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.
13x15cm local reaction, warm, erythematous, indurated 24 hrs after vaccine. Rx: ice, ibuprofen, cephalexin.
pt devel redness & swelling of arm in which recv DT shot; req ER visit
pt received #1 dose on  1/26/21 # 2 dose on 2/18/21 #3 dose on 9/30/21 #4 dose on 11/30/21.    On a routine audit of our logs on December 7, 2021, we discovered that patient had received #4 shots with only 2 months between #3 and #4.  Pt had brought in her vaccine card that DID NOT have the 9/30/21 dose listed on it, so until the audit, we were unaware that she had received dose #3.  When we realized that patient had a third and fourth dose, and that they were only 2 months apart, we contacted patient to see how she was doing.  She reported that she had NO side effect from the vaccine.
Itchy, hot and burning red lump the size of a half dollar.; Itchy, hot and burning red lump the size of a half dollar.; Itchy, hot and burning red lump the size of a half dollar.; Itchy, hot and burning red lump the size of a half dollar.; Itchy, hot and burning red lump the size of a half dollar.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 21Jul2021 at 10:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19.  The patient received unspecified medications within two weeks of the COVID-19 vaccination. The patient previously took duloxetine hydrochloride (CYMBALTA) and experienced a drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 21Jul2021 at 11:00, the patient experienced itchy, hot and burning red lump the size of a half dollar. The patient reported that she started to feel it within "15-20 afterwards". She thought it was the band aid that made her arm feel that way. The patient reported that she still had a small lump and it was a little red and itchy but tolerable (at the time of reporting). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events itchy, hot and burning red lump the size of half a dollar were resolving at the time of this report.