chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 25 minutes after administration, patient reported itching all over, lightheadedness, and "feeling bad".  This progressed to include chest tightness.  Rapid response was activated.  VS were taken.  PE was performed and notable for lip swelling, diffuse skin redness, and diaphoresis.  Lungs were CTAB.  One dose of Epi 0.3 mg IM was given with improvement in symptoms within 2 minutes.  VS repeated with improvement.  Rapid response team arrived and patient was transferred to in-house ER.
Initial:. Fever, chills, nausea, sore arm About one week later developed a dry cough.  Still coughing 4 weeks out; low grade fevers, chills, off and on week 3-4.
Information has been received from a health professional concerning a white male who on 25-FEB-1999 was vaccinated with a dose of Varivax (Lot# 626786/0840M). It was reported that the patient developed a rash of less than 50 lesions. Unspecified medical attention was sought. Additional information has been requested.
This spontaneous case, initially received from a physician on 18-Oct-2018, concerns a 51-year-old, adult female patient. The patient's medical history and concomitant medications were not available. On 11-Oct-2018, the patient was administered an expired vaccine FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195220 and expiry date: 30-Apr-2018). It was planned to revaccinate the patent. At the time of this report, no adverse events were noted after administration of the vaccine. The reporter assessed this case as non-serious. Non-significant follow up received from the reporter on 02-Nov-2018: The reporter confirmed that, the patient had not experienced any adverse events after vaccination. No changes were made in narrative.
This spontaneous report was received from a registered nurse refers to a male infant of 36 weeks gestational age. On unknown date in March 2011, the infant's mother was vaccinated with dose 1 of GARDASIL for prevention of HPV. On 28-SEP-2011, the infant's mother was vaccinated with dose 2 of GARDASIL. On 09-NOV-2011, infant's mother went to the office and had a positive pregnancy test. She was 5.5 weeks pregnant with an LMP of 03-OCT-2011. At 36 weeks the infant's mother was induced due to hypertension and anemia. On 14-JUN-2012 the infant boy was born with birth weight of 4 pounds and 10 ounces at 36 weeks. The infant had no congenital anomalies. There was no information regarding infant's pediatrician. The infant's mother had not received any further GARDASIL vaccines. This is one of 2 reports received from the same reporter. Additional information has been requested.
Patient stated having  covid like symptoms with intense swelling /redness in the injection arm. on 8/27 pt presented with red patch of swelling on the arm down to about the elbow. pt stated itching but was improving from the day of injection.
This spontaneous report was received from a female consumer refers to her 16 years old daughter with none medical history and none drug reaction/s allergies. The patient was vaccinated mistakenly, intramuscularly with a fourth 0.5 ml dose of GARDASIL (Lot# not reported) on 05-JUL-2012, by the office staff, not the treating physician. The consumer explained that the dose was given to the patient mistakenly in lieu of a meningococcal vaccine (unspecified) which had been administered on 12-JUL-2012. There were no concomitant medications. On 12-JUL-2012, the patient experienced nausea, injection site swelling, injection site pain, an ulcer in mouth and headache. It was reported that on an unknown date the patient experienced injection site pain and injection site swelling after previous doses of GARDASIL, (doses, route and Lot numbers not reported). The patient spoken with the physician. There was no treatment given for adverse event. None laboratory test were performed. At the time of the report patient's status was recovering. Additional information has been requested.
irst Moderna vaccine yesterday and today started to have diarrhea and has had it x2 today, and stomach cramps. He denies any other symptoms.
pt recvd vax; exp rxn w/in a couple of hrs p/ vax; exp irritability & low grade fever,lasted 48 hrs;
Complaining of tingling in left arm. Patient able to move extremities and tingling did not worsen. Patient feels safe to go home. Educated on signs and symptoms to look for and going to ER if necessary.
COVID-19 virus test positive; COVID-19 virus test positive; Exposure to COVID-19; Uveitis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4227697-00.  A 16 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 16 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for juvenile idiopathic arthritis. Family history included: "COVID" (unspecified if ongoing), notes: Patient brother had Covid. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19 virus test positive"; EXPOSURE TO SARS-COV-2 (medically significant), outcome "unknown", described as "Exposure to COVID-19"; UVEITIS (medically significant), outcome "recovering", described as "Uveitis flare up". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: positive. Clinical course: Solicited report by a consumer of an adolescent female with events of non-serious patient brother had covid then patient was tested positive and uveitis flare up with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced patient brother had covid then patient was tested positive and uveitis flare up. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. She received first dose COVID-19 vaccine manufactured by Pfizer/Biontech. Causality for HUMIRA (ADALIMUMAB):  The reporter's causality for the event of patient brother had covid then patient was tested positive unknown onset was not provided/reported. The reporter's causality for the events of patient brother had covid then patient was tested positive unknown onset and uveitis flare up with HUMIRA (ADALIMUMAB) was a reasonable possibility.  The reporter's assessment of the causal relationship of the event with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19, Drug ineffective, Exposure to SARS-COV-2, Uveitis. 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
'Covid Arm'  - Rash on Arm, not at injection area but just below, started 1-2" now a few days later 3-4". Itchy, red, circular, warm to touch, a little sore.
Infection of total knee replacement, Surgical evaluation led to Procedure(s): Right - irrigation and debridement  right knee with poly exchange. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous report as received from a registered nurse (also an office manager) refers to a male patient of unknown age. No information about the patient's medical history, concomitant medications or concurrent conditions was provided. On 16-NOV-2016, the patient was vaccinated with a primary dose of VARIVAX lot # M027886, with expiry date of 03-JUN-2018, 0.5 ml, intramuscularly in an unknown site. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On 29-MAY-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous (dosing regimen unspecified). Other suspect therapies included: approximately on an unknown date in May (also reported as 2 weeks ago), PNEUMOVAX23 subcutaneous (dosing regimen unspecified). No concomitant therapy was reported. Approximately on 29-MAY-2014 the patient experienced a small spot of erythema at the ZOSTAVAX injection site after the injection of ZOSTAVAX and medication error was reported that patient received PNEUMOVAX23 2 weeks ago, and then received ZOSTAVAX on 29-MAY-2014. There was no product quality complaint (PQC) involved. The patient's present status was unspecified. No further data was provided by the caller at the time of the call. The outcome of a small spot of erythema at the ZOSTAVAX injection site and patient received PNEUMOVAX23 2 weeks ago, and then received ZOSTAVAX on 29-MAY-2014 is unknown. Causality of the event small spot of erythema at the ZOSTAVAX injection site after the injection of ZOSTAVAX was not provided. Additional information has been requested.
101 temperature, chills, nausea and itchiness.  Temp back to normal in 24 hours.  Itchiness and slight nausea still there 48 hours later.
pt recv vax &had fever of 103 & cried cont for 3hr p/vax;APAP given;
my daughter (a nurse) gets sick for 2-3 weeks every time she gets it; Initial information received on 27-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient).  This case involves a female patient of unknown age who (a nurse) gets sick for 2-3 weeks every time she gets it (Illness), while she received vaccine Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported.   On an unknown date, the patient received influenza vaccine (Strength, formulation, dose, frequency, route, batch number and expiry date were unknown) for prophylactic vaccination.  On an unknown date (unknown latency), after started therapy with suspect vaccine, the patient gots sick for 2-3 weeks every time she got it (Illness).  Action taken with the suspect drug was not applicable.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown.
incredibly tired; not even able to get out of bed; started having trouble with his blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 75 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Parkinson's Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 IMMUNISATION, reaction(s): "fast asleep with drool coming out of his mouth shortly", "was sleepy for a couple days after receiving his first COVID-19 Vaccine". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "incredibly tired; not even able to get out of bed"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "started having trouble with his blood pressure". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter stated that when her husband received his second COVID-19 Vaccine, he was incredibly tired. She said her husband was not even able to get out of bed, and he started having trouble with his blood pressure. She said she was wondering if anyone else had reported being severely tired for over 2 weeks after getting the COVID-19 Vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 54-year-old female patient who received FLULAVAL QUADRIVALENT (batch number C92E7, expiry date 1st July 2016). On 13th October 2015, the patient received FLULAVAL QUADRIVALENT .5 ml. On 13th October 2015, immediately after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site erythema, injection site swelling and wrong injection technique. On 15th October 2015, the patient experienced injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were recovering/resolving and the outcome of the wrong injection technique was unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to FLULAVAL QUADRIVALENT. Additional details were received as follows: On 15th October 2015, 2 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site warmth. The patient received FLULAVAL QUADRIVALENT, at four inches down from the acromium process, base of the deltoid, and the reporter was unsure of whether the route of administration was intramuscular, which led to wrong injection technique.
Lip and tongue tingling, throat tightness, nausea.   Took benadryl before arrival.  Treated with dexamethasone with improvement.
I was sick for one day after receiving the vaccine with body aches. I began not feeling well on 12/26/2022 with a cough. I tested positive for COVID-19 on 12/27/2022.  I never went to the doctor, so I took over the counter medication to relieve my symptoms. I tested positive for fourteen days. I did go to the doctor because my cough was so bad, I got a steroid prescription.  As of today, I still have inflammation and coughing.
Information has been received from a pharmacist concerning her 1 year old daughter who on 11/01/2001 was vaccinated with varicella vaccine. It was noted that she has developed a rash described as one lesion on her forearm and one lesion on her neck. The reporter was unsure if they were varicella lesions. A doctor's appointment was scheduled for 12/17/2001. Unspecified medical attention was sought. Additional info has been requested.
Mild headache and extreme difficulty mentally focusing at 5 days and counting.; extreme difficulty mentally focusing at 5 days and counting. This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 25Mar2021 at 11:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. The patient previously received loratadine (CLARITIN) on an unknown date and experienced allergy. On 04Apr2021 at 22:00, the patient experienced mild headache and extreme difficulty in mentally focusing at 5 days and counting. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room or department/urgent care. Therapeutic measures were not taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild headache and extreme difficulty in mentally focusing was not recovered at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 15Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. No follow-up attempts are needed. No further information is expected.
Soreness in our injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in our injection site arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in our injection site arm). At the time of the report, VACCINATION SITE PAIN (Soreness in our injection site arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment products information was provided.
Admit 6/12 for  weakness, SOB, acute on chronic HF. CXR shows interstitial lung dx not COVID PNA, WBC WNL. Minimally symptomatic, mildly hypoxic. Treated w/abx and steroid, Vit C. Pt DC'd back to SNF on RA.
This spontaneous report was received from a nurse and healthcare worier and refers to a 5 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Arm became achy first. Then body aches, fatigue, fever, and naseau. Fever wasn?t very high, only got up to 101.2, but I kept getting hot and cold. Then on 12/31 around 11:00 pm I noticed my arm started to get Covid Arm rash. Today on 1/1 it has gotten larger, more raised, hard, and my arm is extremely sore.
Hallucinating, Fever, Chills, Sweating, loss of appetite, muscle aches and pain, all joints hurts
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28May2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19; COVID 19 Treatment included Paxlovid from 19Aug2022 to 22Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT EXPERIENCED DIZZINESS AFTER  10 MINS HE HAD RECEIVED MODERNA VACCINE. NO BREATHING DIFFICULTY, PATIENT WAS ALERT. HAD PATIENT SIT DOWN AND REST, HAD HIM DRINK WATER AND CONTINUED TO MONITOR PATIENT. PATIENT REMAINED IN THE PHARMACY FOR ATLEAST 45 MINS AFTER AND FEELING MUCH BETTER. SPOKE WITH PATIENT ON SUNDAY 04/18/2021 AT 11.30AM, PATIENT MENTIONED HE WAS DOING WELL WITH NO ISSUES AND  HE DID NOT SEEK ANY MEDICAL ATTENTION.
Headache, Myalgia, Angina, Fatigue, Chills Narrative:
Fever (101 degrees with taking Tylenol extra strength), shivering, chilling, headache, sore muscles, weakness, fast heart rate, trouble swallowing, redness, swelling, pain at injection site (approximately 2-inch x 3-inch in size), still had fever on 5/3/2018, finally began feeling better by 5/4/2018.
common cold; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "common cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1348 Pt reports burning up her arm and neck above injection site.  VS obtained by BP 150/86 Sp02 100% HR 64. No redness noted at injection site or affected area.    1354 Pt reports feeling "gland" swelling on right side of neck. Benadryl 25 mg tab given.  No SOB or hives noted.   1404 Repeat VS BP 136/70 Sp02 100% HR 73. Pt states burning in affected area has decreased and neck feeling better. Pt able to swallow without difficulty.  Pt and her husband states they were both comfortable leaving.  Pt advised to seek emergency medical treatment with worsening symptoms.  Pt states she has epipen at home for known shellfish allergy and knows how to use if needed.
12MAr93 twitching of extremities then apnea episodes x 2-1 1/2 hrs apart; no fever;
This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP), Program ID: (176890). A 51-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1; Lot number: unknown), for COVID-19 immunization, reaction: "I  was reminded of my booster which made me sick for two days just like the first two shots of the vaccine, and then I still got Covid"; Bnt162b2 (Dose: 1; Lot number: unknown), for Covid-19 immunization, reaction: "I  was reminded of my booster which made me sick for two days just like the first two shots of the vaccine, and then I still got Covid", "I  was reminded of my booster which made me sick for two days just like the first two shots of the vaccine, and then I still got Covid"; Bnt162b2 (Dose: 2; Lot number: unknown), for Covid-19 immunization, reaction: "I  was reminded of my booster which made me sick for two days just like the first two shots of the vaccine, and then I still got Covid"; Bnt162b2 (Dose: 2; Lot number: unknown), for Covid-19 Immunization, reaction: "I  was reminded of my booster which made me sick for two days just like the first two shots of the vaccine, and then I still got Covid", "I  was reminded of my booster which made me sick for two days just like the first two shots of the vaccine, and then I still got Covid". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I  was reminded of my booster which made me sick for two days". Additional information: Patient was reminded of her booster which made her sick for two days just like the first two shots of the vaccine, and then she still got Covid and thought she might not make it. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.