chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; double vision in his left eye; 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. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 (Lot number: 30145BA) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: OLMESARTAN taken for hypertension; AMLODIPINE taken for hypertension. Vaccination history included: Bnt162b2 (Dose 1), when the patient was 64 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2), when the patient was 64 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; DIPLOPIA (non-serious), outcome "unknown", described as "double vision in his left eye". The events "headache" and "double vision in his left eye" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, diplopia.  Additional information: Patient didn't have any other vaccine (within 4 weeks) before Pfizer Covid 19 vaccine (Captured as suspect) until now after the 2 first Pfizer shots.   Follow-up attempts are completed. No further information is expected.
Ended up with MRSA, treated with oral and topical antibiotics . Red, oozing painful sores lasted over 2 weeks after receiving the covid vaccine.
Dry mouth, couldn?t swallow; BP 141/82, HR 83; RR18 -- > 123/72, 72, 18 Temp 97.5F; Hx of CKD; Patient stable and released from vaccination site
Patient's daughter states that the patient developed an infection after receiving the vaccine.  I donned gloves and sterilized the patient's arm with an alcohol pad in accordance with standard practice.  The patient went to the doctor's office and was diagnosed with  a skin infection.  Her arm was erythematous and she stated it was painful.  The doctor prescribed a 10-day course of Bactrim DS, which the patient is still taking.
3 days of crying (screaming) w/inc irritability, dec PO intake, dec sleep; fever up to 102 R on 3rd day; no assoc neurologic findings or other abnormalities on H&P;
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of PROQUAD lot number M042501, expiration date 17-APR-2018 (strength, dose, frequency, route of administration, and anatomical location were not provided), were administered to an unspecified number of patients from 04-APR-2017 to 12-MAY-2017, for prophylaxis. It was reported that the vaccine was reconstituted with a sterile diluent (manufacturer unknown) lot number reported as N007760, expiration date reported as 31-JUN-2018 (strength, dose, frequency, route of administration, and anatomical location were not provided), which was not improperly stored, also for prophylaxis. The vaccine was exposed to a temperature between - 14 and -10 Celsius degrees for 72 hours. There was no previous temperature excursion and the call was not because of a "data logger". No adverse reactions reported. There was no product quality complaint involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA010445.
On 01/06/21, I noted itching in the area and hives.  Throughout the day, the hives appeared to resolve and left a reddned area.  I outlined the area with a marker and it has increased.  It appears to be cellulitis; however, as I am a healthcare provider, I know that the area was thoroughly cleaned prior to injection.    I am starting a dose of Keflex today (01/08/21).
This spontaneous report as received from a nurse refers to a 59 year old female patient. No medical history or drug allergies were reported. No concurrent medications were reported. In November 2015 (reported as either on 16-NOV-2015 or 17-NOV-2015), the patient was vaccinated with ZOSTAVAX (Lot # and expiration date were not provided)(0.65 ml) intramuscularly instead of subcutaneously, in November 2015, after vaccine administration the patient experienced soreness around injection site. There was no treatment given for soreness around injection site. The patient did not seek medical attention. The outcome of injection site pain was unknown. The relatedness between injection site pain and ZOSTAVAX was not reported. Product quality complaint was not involved. Additional information has been requested.
Felt incredibly tired immediately afterward.  This continued for 5 days and was accompanied by feelings of severe depression and anxiety.
At 15 minutes post injection patient noticed swelling at injection site, lips and throat. I administered 2 doses of EPIPEN.
Patient is a 61 year old MALE who received the  1st dose of COVID vaccine 3/3/21. Spoke w/pt today RE: adverse reaction related to the vaccination. ------------------------------------------------ ------- SYMPTOMS: Fever NO If yes temp: n/a Fatigue No Myalgia No Arthralgia No Rash/Hives No SOB No Bell's Palsy No Injection Site Reaction Yes Other No If yes describe: sore arm x1-2 days
Patient's teacher observed that he was staring and unresponsive for around 5 minutes, was altered and not himself for 25 minutes, no memory of the event.  Mom felt he was sleepy and "out of it" until dinner time that night.
Pt was hoarse the morning after receiving vax. He had severe diaper rash and congestion noted in the morning 4 days post vax. He had a double ear infection and was treated with Amoxicillin 6 days post vax. He developed a yeast infection.
muscle aches; This is a spontaneous report from Pfizer-sponsored program. A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 15May2021 (lot number and expiry date: unknown) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced muscle aches on 15May2021. The patient wanted to know if she can take ibuprofen. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information has been expected.
Myalgia, Malaise Narrative: Soreness at injection site and mentally foggy/tired
Headache, Sedation, Myalgia, Arthralgia, Fever, Chills Narrative:  Other Relevant History:
N, stomach, dizzy, HA, backache, chills fever 102 degrees, Pt. just started monthly menstruation.  Water, ice one head, ibuprofen.
Client became pale and nauseous about 3-5 minutes after vaccine administration. He was asked to lay down on exam table in clinic and vital signs were taken. Pulse and BP were lower than his baseline. Pulse and BP began to increase slowly after about 10-15 minutes. Client verbalized feeling well and ok about 15 minutes after incident began.
Rash on back, neck, arms/hands, feet. Benadryl 25mg PO given at 9:15 am.
Chills; Fever; Cough; Ear pain; This is a spontaneous report from a contactable consumer (medical assistant and patient herself). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 04Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received BNT162B2 vaccine last Monday (04Jan2021). However, the patient started having symptoms of chills, fever, cough, and ear pain today (08Jan2021). The patient already did the rapid test twice, but tested negative on both tests. The patient wanted to know if it is normal to experience these symptoms even if it has been 5 days already since she received the vaccine. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
This spontaneous report was received from a physician and refers to a 4 month old patient of unknown gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 18-MAY-2016, the patient was inadvertently vaccinated with unspecified dose of VARIVAX (lot number L045954 with an expiration date of 17-NOV-2017 (strength, dose, route of administration and anatomical location were not provided) (Inappropriate schedule of drug administration). No adverse effects were reported. Concomitant medications were not provided. No product quality complaint (PQC) was involved. Follow up information has been received on 17-AUG-2016 for an unspecified reporter concerning a patient with no known drug allergies and no illness at the time of vaccination. The patient was vaccinated with the first dose of VARIVAX on 17-MAY-2016 at 11:00, subcutaneously, in the right thigh. Additional information has been requested. The reporter details, the patient details, product, event and narrative were update.
Sore arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after first dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history information provided.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), PREDNISONE and PENTOXIFYLLINE for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm after first dose). On 10-Mar-2021, PAIN IN EXTREMITY (Sore arm after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product also included lymphatics.  Patient confirmed that no treatment was provided.   This case was linked to MOD-2021-138804 (Patient Link).
difficulty breathing; strong internal chest pain that gradually subsided; chills; fever; body pain; exhaustion; This is a spontaneous report from a contactable health care professional (patient's mother). A 16-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via intramuscular in the right arm on 14Jun2021 03:45 PM (at the age of 16-years-old) at single dose for covid-19 immunization. The patient medical history included that prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant. The patient was not pregnant at time of vaccination. There was no concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced approximately 24 hours of difficulty breathing and strong internal chest pain that gradually subsided, along with chills fever, body pain, and exhaustion on 15Jun2021 06:00 AM. No treatment was received for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered in Jun2021. The report was reported as non-serious.   Information on the lot/batch number has been requested.
We received from a consumer the following information on 14 May 2009: A female patient was vaccinated with Influenza virus vaccine (batch no. or manufacturer unknown) in Nov 2007. In November 2007 she experienced two grand mal seizures. On 07 Nov 2007 she was placed on Tegretol to treat the seizures. In 2007 the patient also experienced a rash all over her body. In Jan 2009 she was switched to Tegretol XR and the event continued (unclear which of both events continued). No further information had been provided. Company assessment : Serious criterion: medically significant. Causality: Insufficient data. The amount of data is not sufficient to finally assess causality. Expectedness assessment according to product information: Grand mal seizure is unexpected, rash all over the body is expected after vaccination with Fluvirin, Begrivac, Agrippal, or Fluad. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary. Ref no:NA09-001601. On 01 JUN 2009 we received the following information: Made several unsuccessful attempts to contact the reporter to obtain additional information. On 02 JUN 2009 we received the following information: Due to an internal mistake we have to correct the initial receive date from 14 MAY 2009 to 13 MAY 2009. We received the following information from a physician on 13 MAY 2009 (due to an internal oversight identified only on 17 JUN 2009). A 19-year-old woman was vaccinated with influenza virus vaccine (batch no. and manufacturer unknown) in NOV 2007. On 02 JUN 2009 we received the same information as on 13 MAY 2009 (due to an internal oversight identified only on 17 JUN 2009). Other no.: PHEH2009US. Other no.: S2009US.
Patient had been home approximately half hour. Started to become short of breath. Returned to clinic; was breathing very shallow of rapid. Left arm at injection site was red and very swollen. BP increased (180/102). Very shaky and weak. Was given Benadryl with no relief with epinephrine. Entire episode lasted approximately 5 hours.
Accidentally received second dose about 1.5 weeks early; A spontaneous report was received from a health care professional concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine and accidentally received second dose about 1.5 weeks early (inappropriate schedule of product administration).  There were no medical history concomitant medications provided by the reporter.  On 21-Jan-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection.  The HCP stated that, they were currently vaccinating their employees with Moderna's COVID-19 vaccine and on 21-Jan-2021, patient had accidentally received second dose about 1.5 weeks early due to a scheduling error. No additional information was available at the time of this report. No treatment information was provided for the event.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the event accidentally received second dose about 1.5 weeks early (inappropriate schedule of product administration) was considered to be resolved on 21-Jan-2021.; Reporter's Comments: This report refers to a case of a patient who experienced non-serious event of the accidentally received second dose about 1.5 weeks early (inappropriate schedule of product administration) for administration of  mRNA-1273 (lot # unknown, Exp date-unknown). There were no reported AEs associated with the event of accidentally received second dose about 1.5 weeks early (inappropriate schedule of product administration).
Injection site was warm to touch; Arm was sore; Injection site Induration; Tired; Really high fever (101-102 F); Queasy; Injection site swelling; Chills; Headache; had some swelling on her arm and redness; Eyes were burning; Unbalanced; Experienced shortness of breath; This spontaneous case was reported by a nurse and describes the occurrence of EYE IRRITATION (Eyes were burning), BALANCE DISORDER (Unbalanced), DYSPNOEA (Experienced shortness of breath), VACCINATION SITE WARMTH (Injection site was warm to touch) and PAIN IN EXTREMITY (Arm was sore) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced EYE IRRITATION (Eyes were burning), BALANCE DISORDER (Unbalanced), DYSPNOEA (Experienced shortness of breath), PAIN IN EXTREMITY (Arm was sore), INJECTION SITE INDURATION (Injection site Induration), FATIGUE (Tired), PYREXIA (Really high fever (101-102 F)), NAUSEA (Queasy), INJECTION SITE SWELLING (Injection site swelling), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (had some swelling on her arm and redness). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site was warm to touch). On 23-Jan-2021, PYREXIA (Really high fever (101-102 F)) was resolving. At the time of the report, EYE IRRITATION (Eyes were burning), BALANCE DISORDER (Unbalanced), DYSPNOEA (Experienced shortness of breath), VACCINATION SITE WARMTH (Injection site was warm to touch), PAIN IN EXTREMITY (Arm was sore), INJECTION SITE INDURATION (Injection site Induration), FATIGUE (Tired), NAUSEA (Queasy), INJECTION SITE SWELLING (Injection site swelling), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (had some swelling on her arm and redness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Pyrexia: 101-102 (High) Degree F, had fever that lasted till 23Jan2021.     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.   No relevant concomitant medications were reported. Patient used acetaminophen and ice packs to treat symptoms.
Came down with Covid-19. Symptoms started 1-23-22. I had a spit test 1-24-22 which was negative. Symptoms: severe sinus pain, congestion, coughing, and fatigue. Went to urgent care 1-25-22 and given PA-C test for Covid-19. Results positive on 1-27-22. Was given amoxicillin to take if no better after 7 days. Started 10 day course on 2-01-22, no effect. Congestion, coughing, fatigue, and mild sinus pain, and some SOB with going up steps or walking a distance continued into 3rd week. Video visit with Dr. on 2-10-22. Did not feel back to normal until end of February.
PATIENT CALL 01/05/21 TO LET US KNOW SHE HAS BEEN HAVING CHEST PAIN AND SHORTNESS OF BREATH SINCE SHE HAS RECIEVED THE VACCINE ON 12/14/21.  SHE WENT TO EMERGENCY ROOM  12/28/21 HAD X-RAY AND EKG.  PATIENT SAYS HAS HAD ELEVATED BLOOD PRESSURE.    WENT TO EMERGENCY ROOM AGAIN 01/04/21 FOR SAME REASONS.  STAYED FOR 7 HOURS WAS NEVER SEEN. STILL COMPLAININ OF CHEST PAIN.  PATIENT TOLD TO FOLLOW UP WITH PCP
triggered rheumatoid arthritis flare up; This is a spontaneous report from a contactable consumer. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular on 15Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced triggered rheumatoid arthritis flare up in Apr2021 with outcome of unknown. It was reported that within 24 hour after receiving the second does of her COVID-19 vaccine, the patient claimed that the shot triggered rheumatoid arthritis flare up. No other symptoms reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Moderna COVID vaccine #1 given 03/04/2021, lot #010A21A; Moderna COVID vaccine #2 given 04/07/2021, lot #030B21A; pt had an admission to Medical Center from 11/1/21 - 11/6/21 and was treated for COVID pneumonia; had a positive COVID test 11/1/21; was given dexamethasone, remdesivir, and O2 supplementation; transferred to Hospital where she had an increase in O2 demands; intubated, steroids, and ABX given; transferred back to Medical Center for further care; experienced recurrent A Fib; AKI; sputum culture with S. Aureus and GNR; on ABX; DNR; pt's condition worsened and she went into cardiac arrest and passed away in the hospital
On March 28th, started noticing symptoms. There was pain in my entire right leg, shin swelling; calf- swelling and skin discoloration; and right foot - swelling. On 4/1, I went to Urgent Care where I was seen, evaluated and treated by Dr. She ordered blood tests and an ultrasound within 20 minutes. I had 4 blood clots in 3 veins in my right leg/DVT. My blood platelet value was 267 and the standard range is 130 to 400. They didn't consider it low, but it's still an issue. I was given an injection of Enoxaparin Sodium Injection--1 ml injection twice a day for 5 days, which was started in the ER. I then switched to Pradaxa 150mg pill twice a day. I took that until around the 6th of this month when I noticed my right leg had gotten worse. I was instructed to go back to the urgent care. Another ultrasound was ordered and it showed I still had the 4 blood clots in 3 veins that seems to have worsened, so the meds were not working. He consulted with a vascular surgeon and they put me back on the injection once a day, which I am currently still on. I was told to follow up with my PCP in two weeks and that appt is on Thursday with Dr.
Left arm red, swollen, warm to touch. Area of redness approximately 5X3 CM. Pain from shoulder to wrist.
24 hrs. post vaccine - bloodshot eyes worsened over next 2 days. Dx - Iritis prescribed eye drops.