chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blotchiness; redness; diarrhea; little bit of congestion with her breathing; This is a spontaneous report from a contactable pharmacist via Team. A 19-years-old female patient received first dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, Solution for injection, Batch/Lot Number: FC3180, Expiry Date, NDC number, UPC number: unknown) via an unspecified route of administration on an unknown date in 2021 (last week) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that 2 days after the patient took her first dose she had redness and blotchiness on her arm where she received the injection (on an unspecified date in 2021) and also on other parts of her body. The patient also experienced diarrhea (on an unspecified date in 2021) and a little bit of congestion with her breathing (on an unspecified date in 2021). The patient was evaluated at an urgent care and was advised not to receive a second dose of the Pfizer COVID-19 vaccine. The patient does not currently have a Primary Care Provider. The patient and her mother came back to speak with the reporter on Friday (unspecified date) and asked if she thought the patient should receive a second dose of the vaccine or not. The patient was not treated with any medications by the urgent care provider. The event blotchiness was considered as serious (Medically Significant). The reporter stated that that the patient's symptoms have improved. The outcome of all events was recovering.; Sender's Comments: Based on temporal relationship the causal association between the event blotchiness and the usage of the vaccine cannot be excluded. The case will be reassessed when there is additional information is available. 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.
Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live. On 6/29/04, the patient presented to the physician with breakthrough chicken pox. A product quality complaint was not involved. The reporter also mentioned a second patient who developed chicken pox post vaccination with varicella virus vaccine live (WAES0407USA01590). Additional information has been requested.
Narrative:  Patient received two doses of Moderna COVID 19 Vaccine Feb/Nov 2021. The patient tested positive for COVID 19 on 16 Feb 2022. The presented to the ED on 16 Feb with weakness and respiratory symptoms and was admitted with COVID pneumonia and atrial fib. The patient was treated with remdesivir and dexamethasone. The patient was discharged in stable condition on 23 Feb 2022. Reported per EUA.
My body broke into hives around 5 days after the second dose of the vaccine. It started off in the afternoon and there were very big rashes all over my body. I rushed to the hospital for care and I was monitored for my blood pressure, my throat was checked and my oxygen levels were looked at. I was prescribed Hydroxyz-Hcl (25mg) and I took two tablets that day. After 7PM I was feeling better and by the next day I was okay.
13 weeks pregnant, nausea, vomiting, dizziness, neck pain, and headache following vaccine.
Information has been received from a physician concerning an approximately 9 week old patient with a history of pyelonephritis at 1 month of age and was on 4 days of IV antibiotics and then followed by 12 days of SUPRAX therapy and no drug allergy who on 19-APR-2011 was vaccinated with the first dose of ROTATEQ (dose, route and lot# not reported). On 20-APR-2011 the patient developed diarrhea and vomiting on 21-APR-2011. It was unspecified if the patient sought medical attention. The child was treated with unspecified over the counter medication. Family of child has not called back to the office so it was believed that child was recovering. Additional information has been requested.
In the evening of receiving the vaccine, I started to feel brief sharp pains in my chest/ back.  Overnight, I was awoken by continued shooting  pains all over my body, and also fine shaking.  Around 2AM a headache started and progressed to be the worst headache of my life.  It was received in the morning by tylenol.  In the morning, I experienced extreme exhaustion and dizziness after climbing stairs I almost passed out, had to rest on the floor.  Later in the day I experienced hours of chills, a temp to 103, which came down with tylenol. By the evening I was feeling well but tired.  Today, 2 days after vaccination, I have neck soreness and am a little tired but well.
BREAKTHROUGH COVID: FULLY VACCINATED WITH A HISTORY OF COVID IN 2019. 34-year-old female admitted with sepsis secondary to COVID infection also found to have Epstein-Barr virus (mononucleosis) infection.  Treated with IV fluids supportive care.  She does not have any respiratory tract symptoms and does not have any hypoxia to require any supplemental oxygen. Responded well to treatment.  PT Has been diagnosed with irritable bowel syndrome.2.   No particular treatment indicated for COVID-19 at this time, Monitor temperature, AND empiric cefepime for now.
Narrative: COVID infection following COVID vaccine series 03/03, Pfizer, dose #1 03/24, Pfizer, dose #2 08/14 pt cc: exposure: unknown 08/14 COVID swab, result: detected
devel red raised lesions, some vesicular various parts of body s/s consistent w/chickenpox;
Vaccinated on 10/31/06 with Tdap and also Tb test that day. The next day she woke to find her upper arm red, hot and swollen. When seen in clinic on 11/3/06, the s/s were starting to very slowly resolve, but arm was still causing some discomfort. Recommended OTC Ibuprofen, cold compress to injection site as needed for pain. Reviewed s/s of severe allergic reaction and the need to seek emergent medical attention, should this occur.
bud 04/07/2022 administered 04/14/2022. Consulted Pfizer who could not provide stability beyond 04/09/2022 and recommended revaccination provided another  booster05/13/2022
This spontaneous report as received from a registered nurse refers to a 13 year old female patient. On 15-JUL-2014 the patient was vaccinated with a dose of PROQUAD (lot # K004418, expiration date: 25-SEP-2015), 1 single shot, injection, when the age limit for the product was 12 years old. This was an "other than indicated" adverse event (AE). No side effects reported. Additional information has been requested.
Extreme fatigue, sweating profusely, chills, mild nausea, weakness, muscle pain
shivers/ teeth chattering; feeling miserable; This case was reported by a medical representative via call center representative and described the occurrence of shivers in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shivers and feeling miserable. On an unknown date, the outcome of the shivers and feeling miserable were unknown.   It was unknown if the reporter considered the shivers and feeling miserable to be related to Shingrix.  Additional details were provided as follows: Adverse event receipt was given to the sales representative during the call. The adverse event which was made known to medical representative by a physician via email sent in March 2019. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The physician's email reportedly quoted an email sent to him by a patient, which stated that the patient felt miserable and experienced shivering and teeth chattering after receiving Shingrix. The reporter did not consent to follow-up. The sales representative was reportedly on medical leave at the time and did not notice the email until recently. The sales representative stated that she wanted to call the adverse event into Medical Information instead to report the adverse event due to the adverse event being reported late. No other information was available, besides the healthcare provider's details. This case has been linked with US2019139663, US2019AMR141888 and US2019AMR141889 reported by the same reporter.
loose bowels; flu like; abdominal discomfort; bloating; loss of apetite; headache; tiredness; This spontaneous case was reported by an other and describes the occurrence of DIARRHOEA (loose bowels), INFLUENZA LIKE ILLNESS (flu like), ABDOMINAL DISCOMFORT (abdominal discomfort), ABDOMINAL DISTENSION (bloating) and DECREASED APPETITE (loss of apetite) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A-214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included FAMOTIDINE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIARRHOEA (loose bowels). 21-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like), ABDOMINAL DISCOMFORT (abdominal discomfort), ABDOMINAL DISTENSION (bloating), DECREASED APPETITE (loss of apetite), HEADACHE (headache) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 500 milligram. On 25-Jan-2021, DIARRHOEA (loose bowels), INFLUENZA LIKE ILLNESS (flu like), ABDOMINAL DISCOMFORT (abdominal discomfort), ABDOMINAL DISTENSION (bloating), DECREASED APPETITE (loss of apetite), HEADACHE (headache) and FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient also used Blood pressure medications concomitantly.
Overall feeling of "unwellness".  On 7/7/11 was told during sports physical that she had an irregular heart beat,mother states this was new information, also had a sore throat and head ache. October of 2011 was seen at med express and was told she no longer had an irregular heart beat. Mother states she is sure these symptoms are a result of the vaccines received 7/6/2011.  Was not told by health professional any of these symptoms were vaccine related.
Muscle pains; muscle cramps; head feels like it is stuffed with cotton; chills; weakness/listlessness.
Information has been received from a registered nurse concerning a male with a past medical history of fibromyalgia, asthma, gastroesophageal reflux disease and hepatitis C who on 07/20/1999 was vaccinated with a dose of hep B vaccine. Concomitant therapy inlcuded albuterol, Valium, Percocet and Zantac. It was reported that three months after the second dose, in approximately October 1999, the pt was titered and showed negative. It was also noted that the pt was tested for hepatis C antibodies and was positive on December 1998 and then negative on October 2001. The pt sought unspecified medical attention. Additional info has been requested.
Itchy, hot very red rash, approximately 7x9cm and nasal congestion and scratchy throat and fatigue.
Fainted 5 days after booster.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2022 at 14:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) or other medication in two weeks included: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM; LISINOPRIL. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin"; Visipaque, reaction(s): "Known allergies: visipaque". Vaccination history included: BNT162b2 (Dose 3, Lot number: EW0170, Location of injection: Arm right, Vaccine administration time: 12:00 pm), administration date: 03Sep2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot number: El9265, Location of injection: Arm left, Vaccine administration time: 14:00 pm), administration date: 01Feb2021, when the patient was 67-year-old, for COVID-19 immunization; Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant) with onset 2022, outcome "unknown", described as "Fainted 5 days after booster". The event "fainted 5 days after booster." required emergency room visit. Therapeutic measures were not taken as a result of syncope. The facility where the most recent vaccine was administered was Pharmacy or drug store. The patient did not receive any other vaccine in four weeks. The patient did not receive any other vaccine on the same date.
This spontaneous report was received from the Vaccine Coordinator referring to a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 14-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
The arm was sore for several days and then things went back to normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Feb2021 15:30 (Lot number: EL9269) at the age of 71 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE; TYLENOL; OMEPRAZOLE. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "The arm was sore for several days and then things went back to normal". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and has no allergies. Since vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Expired vaccine used; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 41-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 (Expired vaccine used).    No concomitant medications were reported. The patients age was reported as 41 Year 5 Month. Treatment information was not provided.
Patient reports feeling a little dizzy, pressure on his head, ringing in his right ear. Felt better after a few minutes. Cleared by EMS
On the evening after receiving the shot, his legs became very weak. He could not hold himself up, stand or walk. He had a high fever. He was able to walk and stand the next morning.
I received Pfizer dose 1 on 3/17/21 I received Pfizer dose 2 on 4/7/21 The following weekend (4/10 or 4/11) bruises began appearing on my legs. A very large round shaped swollen bruise appeared on my forearm.  I work in an elementary school and our school nurse noticed the bruise on my arm and asked how it happened. I told her it just appeared and that I had them on my legs too. She looked at them and told me I needed to get in touch with my doctor ASAP. He sent me for blood work Thursday morningat 7:00 am on 4/15/21. At 4:30 pm that same day I received a call from my PCP office telling  me to get to the ER because my platelet level was dangerously low and I was a risk for brain bleed. Got to the ER and my platelets were at 3,000. I received a platelet transfusion and platelets went to 55,000. Next day they were down to 46,000. Next day down to 24,000. Steroids started and Sunday my count was at 30, 000 and they let me go. Got blood work done today to see where I stand.
Fever, NauseaVomiting, runny nose, body ache Narrative:
TD given on 7/11/02. On 7/16/02, client noticed area was itchy. On 7/17/02, a red, raised reaction developed around the injection site with the immediate site itself remaining "white". The muscle was somewhat swollen in general on 7/17/02. Reddened area was "also warmer to the touch". On 7/19/02, the area is less reddened and a "bumpy" character has appeared. Client describes as "much improved". Has used ice on area. Greatest improvement noted when a cortisone cream was used.
Patient reports on 04/07/21 that after receiving her vaccination on 03/31/21 in her Left Deltoid she felt like she had a heavy arm. Reports s/s of rash, skin discoloration, and swelling starting on Saturday 04/03/21 with itching to Left hand and later similar s/s to her Right hand. Reports s/s have improved. Reports not having a medical provider and is unable to afford urgent care for follow-up. Denies any airway involvement. Reports she does work with cleaning chemicals at her place of employment, but that she wears gloves when using cleaning agents.
Ordered MMR and VZV separately. MMRV was given instead of MMR. Patient was also given VZV. so received two doses of VZV.
Headache, muscle soreness, body aches.  It?s been about 90 minutes.  Took some ibuprofen and am going to face the day.
Sudden, acute, severe pain left arm/hand/wrist  for 2 months,  very limited mobility in arm, hands and wrist,  swelling , stiffness and numbness  in fingers.    Symptoms very slowly resolving after 4 months!
HEADACHE; CHILLS; NAUSEA; ON AND OFF TENSION HEADACHE; TIREDNESS/FEELING DRAINED; WARMNESS; FEVER; LIGHTHEADEDNESS; LITTLE SHORT OF BREATH BUT ABLE TO BREATH; BODY ACHES; BACK FELT ON FIRE; HEART RACING ON SECOND DAY; DIZZINESS; LITTLE NUMBNESS IN FINGERS; COULD NOT STAND; LACK OF APPETITE; FEELING DIFFERENT THINGS; WEAKNESS ON LIMB; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 170 pounds, and height was not reported. The patient's concurrent conditions included hypertension, penicillin allergy, non smoker, and no alcohol use, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on left arm on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for hypertension, and lisinopril for hypertension. On MAR-2021, the subject experienced lightheadedness. On MAR-2021, the subject experienced little short of breath but able to breath. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced back felt on fire. On MAR-2021, the subject experienced heart racing on second day. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced little numbness in fingers. On MAR-2021, the subject experienced could not stand. On MAR-2021, the subject experienced lack of appetite. On MAR-2021, the subject experienced feeling different things. On MAR-2021, the subject experienced weakness on limb. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced on and off tension headache. On MAR-2021, the subject experienced tiredness/feeling drained. On MAR-2021, the subject experienced warmness. On MAR-2021, the subject experienced fever. Laboratory data included: Stress test (NR: not provided) Unknown. On 01-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 25-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little numbness in fingers, could not stand, lack of appetite, chills, warmness, and fever on MAR-2021, was recovering from headache, tiredness/feeling drained, weakness on limb, heart racing on second day, dizziness, and nausea, had not recovered from lightheadedness, little short of breath but able to breath, body aches, back felt on fire, and on and off tension headache, and the outcome of feeling different things was not reported. This report was non-serious.
Patients is fully vaccinated.  COVID+ on admission to ED. Presents with cough, fever, shore throat. body aches for the past 3 days.Positive for headaches. She works in healthcare and has other members of her department test + COVID recently.  Medications given:  toradol, tessalon, cepacol, lozenge. Supportive care. referred for monoclonal ATB clinic. Discharged from ED. Presented back to the hospital on 1/10/2022.  51-year-old female with past medical history of lupus, hypertension, asthma, recently diagnosed with COVID in January 3rd, received monoclonal, presented to the hospital with shortness of breath, some fever, chills, cough.  X-ray of the chest, no acute process.  EKG showed sinus tachycardia. Received treatment with Decadron and Lovenox. Improved in presentation and discharged home.
Case number PHEH2012US009589 is an initial spontaneous report received from a health care professional on 04 May 2012 with a follow-up received on 05 Jun 2012: This report refers to a 14-years-old male patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A10135) intramuscularly on 20 Mar 2012. On the same date, he experienced localized swelling and redness in arms as abnormal reaction at vaccination site (out of normal parameters). The outcome of the event was reported as complete recovery on 21 Mar 2012 and the causality was not provided. Follow-up received from a health care professional on 05 Jun 2012: Updated event description and recovery date.
Syncope about 30 minutes after the injection during venipuncture for lab draws; dizzy symptoms the following week after residual pain from venipuncture site was disturbed that caused a chain reaction of dizziness, facial flushing and tachycardia symptoms.  The patient endorses "feeling off" since receiving the vaccine, but has made improvements in returning to baseline status.