chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable Non-HCP. This is 9 of 37 reports. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN5318 and Expiry date was not reported), dose 2 via an unspecified route of administration on 06Feb2021 as dose 2, single dose and dose 1 via an unspecified route of administration on 16Jan2021 (Lot Number: EJ1686 and Expiry date was not reported), as dose 1, single dose, both for COVID-19 immunisation. The patient's medical history was not reported. The patient concomitant medications were not reported. She states they are monitoring and tracking the vaccine break through cases in their area, and she had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The caller at the time, did not have the NDC or expiration date, however, was going to work on pulling patient information so that she would be able to have this information available to provide upon transfer. Transferred successfully for further capture of data from the caller regarding breakthrough cases (AE) as well as PQC with lot number involved that has been the cause for concern today. Agent states the caller called because she had some concerns, and the health department was tracking breakthrough cases in her area. Agent reports that caller states 15% of breakthrough cases are from one Pfizer COVID-19 Lot number: EN5318. Agent confirms caller was calling about the Pfizer COVID-19 vaccine. Caller reclarifies later in report that 15% of the breakthrough cases in her county had the same lot number, EN5318, which was concerning. Caller states, reclarified later in report, she had 37 patients with partial identifiers. Caller states she cannot provide some identifying details and that she would need to check with her legal department first. Caller provides the details she was allowed to identify. Caller states she can provide, age, gender, BMI, medical conditions, if reported, and date they tested positive for COVID-19, and the type of COVID-19 test utilized. Partial identifiers provided by Caller. Caller was not allowed to provide some identifying details, at this time. Caller reports 37 breakthrough cases, for fully vaccinated patients testing positive for COVID-19. Some identifying details provided. On 22Jul2021 patient experienced tested positive for COVID-19 virus, after being fully vaccinated (vaccination failure). She states that COVID-19 positive was defined as having both vaccines and testing positive for COVID-19 longer than two weeks after both doses. Testing positive for COVID-19 virus, after both vaccines. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 22Jul2021. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 same reporter/drug/event, different patient.
SEVERE BODY RASH ON BOTH ARMS FROM WRIST TO SHOULDER. SEVERE RASH ON TRUNK, LEFT LEG, FACE, NECK, CHEST, BREASTS. I STILL HAVE THE RASH FOR 6 DAYS AND IT IS ITCHY AND VERY UNCOMFORTABLE AND STINGS.
MILD ADVERSE REACTION: (HIVES) FACE, NECK, CHEST  AND BACK; LASTED ABOUT 3 HOURS THEN SUBSIDED.
Initial report received from healthcare professional on 14-July-2014. A female patient (age not reported) whose medical history and concomitant medication were not reported, had received a dose of FLUZONE, (dose, batch number, route and site of vaccination not reported) on an unspecified date. On an unspecified date, patient experienced urticarial reaction. The patient's laboratory investigations and corrective treatments were not reported. The outcome of the event was unknown. Documents held by sender: none.
Raised rash on both arms near crease of arm where elbow bends and also on chest. Earlier in day he had a fever.
Severe Diarrhea, Parkinson's Like shakes and tremors, Convulsions/Seizures, Inability to nurse, Could not sleep/kept shaking and restlessness, Extreme irritability/Screaming at top of lungs ,for hours on end, Low grade fever, Vacant/distant look/stare.  Did not recognize mother anymore, Could not sit still, constant tremors, Started with just increased irritabilty and diarrhea over 2 days. Third day was onset of convulsions/seizures/inabilty to nurse etc.., 4th day no more seizures but constant tremors and shakes whenevr tried to fall asleep. Still had difficulty nursing. 5th day still very irritable and still diarrhea, less tremors. over next 3-4 days tremors slowly subsided and diarrhea dissipated. He was only 2 months old at the time.  Is now 4 months old. Still has inconsolable screaming fits that are so bad he ends up vomiting and has difficulty breathing, inability to settle down and take naps, mild tremors, difficulty nursing etc...
Patient complained of nausea (nervous before vaccine); BP 120/63 (pulse 70), O2 sat 100%. Better after blood pressure was checked.
Rebound of flu symptoms; Bedridden; Flu symptom; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Rebound of flu symptoms), BEDRIDDEN (Bedridden) and INFLUENZA (Flu symptom) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient experienced INFLUENZA (Flu symptom). On 12-May-2022, the patient experienced BEDRIDDEN (Bedridden). On 12-May-2022 at 12:00 PM, the patient experienced INFLUENZA (Rebound of flu symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 09-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. In May 2022, INFLUENZA (Flu symptom) had resolved. At the time of the report, INFLUENZA (Rebound of flu symptoms) and BEDRIDDEN (Bedridden) had not resolved.            No concomitant medication information was provided.  It was reported that rebound of flu symptoms on day 12 following the start date of 04 May 2022 for the Paxlovid. Patient had symptoms runny nose , sneezing, coughing, low fever and extreme fatigue, bedridden since 04 May 2022 with fatigue on 10 May 2022 most all symptoms were gone.
Dizziness; Sharp pain on her head; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (Sharp pain on her head) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A2113) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Sharp pain on her head). At the time of the report, DIZZINESS (Dizziness) and HEADACHE (Sharp pain on her head) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Patient visited the doctor, where they made some studies, but nothing seems to be wrong. No treatment information was provided.   This case was linked to MOD-2021-090421 (Patient Link).
c/o fatigue, swelling inj site, chills, nausea x 3 days;resolved w/o medical intervention;
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 26-APR-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M029251 with expiration date of 14-MAR-2018; strength and dose were unknown; location was also reported as "2", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
she is scared to get pneumovax23 in a year, though she is about 7 years too late but she took this one; This spontaneous report was received from a physician via Pfizer referring to a 72-year-old female patient. The patient's concurrent condition included chronic obstructive pulmonary disorder (COPD). The patient's concomitant medications were not provided. On an unknown date the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (strength, dose #, route of administration, lot/batch # and expiry date were not reported) for prophylaxis. On an unknown date, the patient was scared to get Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX) within a year, though she is about 7 years too late but she took that one (inappropriate schedule of product administration). It was reported that, the patient was supposed to take that in a year which have the one with 23 different pneumonia things, but she was not sure whether she wants to do if this also happens with the 13.
Initial and follow-up information has been received from a nurse practitioner concerning a 60 year old white female cigarette smoker (40 cigarettes per day) with hypothyroidism who on 30-OCT-2006 was vaccinated, into the right "glute" with a first dose of HPV (lot # 653978/0955F). Concomitant therapy included levothyroxine Na (SYNTHROID). On 04-NOV-2006 the patient experienced stiff neck, myalgia, mild chills, sweats and temperature of 101. On 06-NOV-2006 the patient experienced enlarged cervical lymph nodes. Subsequently, the patient recovered. It was reported that the patient thought that she had the flu. On 12-JAN-2007 the patient was vaccinated, into the right "glute" with a second dose of HPV (lot # 654389/0961F). On 17-JAN-2007 the patient experienced stiff neck, myalgia, mild chills, sweats and temperature of 101. On 19-JAN-2007 the patient experienced enlarged cervical lymph nodes. The nurse practitioner felt that the patient had an "exaggerated immune response." At the time of the report, the patient's stiff neck and myalgia and mild chills and sweats and temperature of 101 and enlarged cervical lymph nodes persisted. The patient refused her third vaccination. No further information is available.
Patient injections site was red, swollen, hard, and warm to touch. Patient states the injection site is painful.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 03-DEC-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # H018455 and expiry date: 09-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Fever of 100.9 - 102 for 3 days 24° after - Fatigue - x3 days 2 weeks later Respiratory & Cough symptoms
low grade fever/fever; 100 degrees Fahrenheit/99.2 degrees Fahrenheit/99.8 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) at the public health department via unspecified route of administration at right arm on 28Dec2020 12:30 as single dose to prevent getting the Covid virus. Medical history included medication allergies (allergic to like 3 to 4 medications), allergic to sulfur/sulfa, allergic to penicillin, allergic to "-mycins", allergic to dye (for a CT scan). The patient informed that she was given the Pfizer shot, clarified to Pfizer-BioNTech COVID-19 vaccine on Monday (verified to be the 28th). The patient informed that since then she has had a low grade fever and the patient would like to talk to someone to see if that was normal, since it was still not gone. The patient got her first dose of the vaccine injected into her right arm around 12:30 PM Monday (28Dec2020), and her fever started Monday night and got to 100 degrees Fahrenheit and since then she has been running 99.2 degrees Fahrenheit (Dec2020), it was 99.8 degrees Fahrenheit now (30Dec2020). The patient stated "it didn't say on the vaccine card, but the sheet they gave with it says it is the Pfizer-BioNTech COVID-19 vaccine. All that is on there is the date she got it, 18Nov2020 and the healthcare girl put her initials on it" (unable to clarify discrepancy between the dates provided as caller continued speaking). The patient informed that she was supposed to have turned around on the 18th to get the second shot (unable to clarify statement and the caller may have meant that she was supposed to get the second dose of the shot on 18Jan2021, and misread the card as she seemed to have difficulty reading the nurse's handwriting on it). The reporter informed that the LOT number was written with an E and then either a V or a K, it looks like a V but the girl put a leg on there so maybe it was a K then 9231, or EV or 9231 or 9731. The outcome of the event "pyrexia" was not recovered.
Site: Swelling at Injection Site-Severe, Additional Details: arm very swollen - entire length arm. no other side effects.
I skipped one menstrual cycle following dose 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm right, administration date 26Oct2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "Adhd" (unspecified if ongoing), notes: other medical history: Adhd,; "Anxiety Disorder" (unspecified if ongoing), notes: other medical history: Anxiety Disorder, smoker; "smoker" (unspecified if ongoing), notes: other medical history: smoker. Concomitant medication(s) included: ADDERALL; CITALOPRAM; MARIJUANA. Vaccination history included: Bnt162b2 (Dose Number: 1 , Batch/Lot No: Unknown. Unable to locate or read the details , Location of injection: Arm Left), for COVID-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "I skipped one menstrual cycle following dose 2". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder. Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received within 2 weeks of vaccination was Adderral, citalipran, marijuana.Prior to vaccination, was the patient was not diagnosed with COVID-19.Since the vaccination, the patient has been tested for COVID-19. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender, reported as "college age patient". Pertinent medical history, drug reactions or allergies were not reported. On 13-JUN-2014, the patient was vaccinated past its expiry with MMR II lot # H010135, expiry date: 17-MAY-2015, 0.5 ml subcutaneous. The reporter was unsure if it was the patient's first dose. No adverse effects reported. Additional information has been requested.
2 days after vaccine #2, developed severe vertigo which lasted about 3 days and settled into a swimmy headed dizziness, headache, brainfog, increase in tinnitus, fatigue, and memory difficulty.  There has been modest steady improvement, but symptoms seem to have plateaued 6 weeks out from vaccine
Pt given Tylenol in office at time of shot. Slept during the day, fussy in evening. Crying non-consoling 10-10:30am. Temperature 101 degrees. Gave Ibuprofen + 1.5 hours later temp 103 degrees.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Possible COVID arm
Report fever 103.8 AX even after Tylenol et Motrin. Took to ER Dr at ER put on antibiotic. Mother reports pt improved with in 36 hours.
This spontaneous report was received from a medical assistant regarding a 6 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 08-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
This spontaneous report was received from a registered nurse concerning a female patient who on 04-JUN-2009 was vaccinated with the first dose of GARDASIL (dose, route and lot # not provided), on 13-APR-2011 was vaccinated with the second dose of GARDASIL (dose, route and lot # not provided) and on 31-AUG-2012, the patient was in the office to receive her third dose of GARDASIL (dose, route and lot # not provided). No adverse symptoms were reported. Additional information has been requested.
She states she received the first dose of the Moderna vaccine on 3/10/21, and received the second dose on 4/8/21. She states she started developing delirium, chills, dizziness, nausea and fatigue within 1 hour of receiving the second vaccine. She states she felt like she had a high fever, but did not check it. She reports that she did not leave her bed for 26 hours following second vaccine. She states that she started experiencing intermittent chills and having palpitations intermittently on 4/13. On 4/14, she reports waking up with swollen lymph nodes, fever blisters, and a swollen and "puffy" face. She states she has a prescription for Valtrex that she took for the fever blisters, and took ibuprofen. On 4/18, she states she developed a red, raised, generalized rash all over her body, but it was more pronounced on her arms and legs. On 4/21, she states she woke up with ulcers on the inside of her mouth. She states her husband is a dentist, and called in Magic Mouthwash and doxycycline which she has been taking. Today, she states she vomited 6-7 times but it was just bile/stomach acid. She states she took her doxycycline this morning on an empty stomach, and felt that this contributed to the vomiting. She is also complaining of intermittent brain fog. She does not have any significant past medical history, and does not take any daily medications.
Patient complains of right in her right ear and lymph node swelling on her left side of neck.  Vaccine was received in her left deltoid.
Immediately broke out in a itchy, raised, rash all over his body. Screaming in pain. After given a large dose of Benadryl he calmed down enough to nurse and after a few of hours the rash faded.
scratched himself in the nose and saw little blood from inside but not dripping for more than 30mins and is still there; congestion in my nose; very dizzy; Fever 100F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (scratched himself in the nose and saw little blood from inside but not dripping for more than 30mins and is still there), NASAL CONGESTION (congestion in my nose), DIZZINESS (very dizzy), PYREXIA (Fever 100F) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     Concurrent medical conditions included Low platelets.   On 20-Jul-2021, the patient received second 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-Jul-2021, the patient experienced PYREXIA (Fever 100F) and CHILLS (Chills). On an unknown date, the patient experienced EPISTAXIS (scratched himself in the nose and saw little blood from inside but not dripping for more than 30mins and is still there), NASAL CONGESTION (congestion in my nose) and DIZZINESS (very dizzy). At the time of the report, EPISTAXIS (scratched himself in the nose and saw little blood from inside but not dripping for more than 30mins and is still there), NASAL CONGESTION (congestion in my nose), DIZZINESS (very dizzy) and CHILLS (Chills) outcome was unknown and PYREXIA (Fever 100F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, Body temperature: 100f (High) Fever.         No relevant Concomitant medications were reported.   patient took dayquil 3 times for treatment of fever
9:45 patient received vaccine, at 9:52 she announced to EMT she was having a "panic attack". Patient lost consciousness briefly, and convulsed for about 1-2 seconds. Patient woke up quickly, 911 was called to evaluate. BP 98/80 at 9:52. 9:58 911 medics arrived, all vitals were within normal limits, patient declined transport. Patient was monitored for another 30 minutes and was able to walk to her car on her own with steady gait .
Pt reports that several hours following administration of the flu vaccine she noted decreased sensation in her right arm, from the base of her deltoid to her wrist. "Feels like my hand and arm are asleep". Has some mild injection site pain. No self tx last pm, noted symptoms had increased this am. Has FROM, decreased sensation, +2 radial pulses and mildly decreased hand strength compared to left. Given 400mg ibuprofen advised ice 15 minutes tid. F/U in ER if symptoms continue.
Patient was given a Pfizer booster on 11/17/21, but had received her #2 Pfizer dose on 06/19/2021, 5 months prior.  The booster was given 1 month too early.  This was discovered when the entry into the employee's health record was being completed.  Booster dose was administered by an RN at an employee vaccination event held at a school campus on 11/17/21.  On the consent form, the employee documented that she had received the Pfizer COVID-19 vaccine, but there were no dates listed.    However, it is entered in the employee's health record that the 1st dose of Pfizer was given on 5/29/2021 and the second dose was given on 06/19/2021, both at another medical facility. Regulatory authority confirms these dates and locations.  Patient states she did not experience any side effects or complications post vaccination.
Pounding headache, about a 6/10, light headedness the past two days, stayed at home and slept as treatment