chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a friend's daughter who on an unspecified date was vaccinated with a first dose of GARDASIL (Lot number not reported). The physician reported that one month later the patient experienced whole body alopecia. The patient sought unspecified medical attention. Upon the time of the report, the patient's present status was unknown. Additional information has been requested.
Numbness and tingling in hands, feet, arms, and legs. Trouble walking. Trouble with balance .
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 consumer (patient). A 61-years-old female patient received BNT162B2 (BNT1 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EJ1686 and expiration date was not reported), dose 1 via an unspecified route of administration on 16Jan2021 as a single dose and dose 2 via an unspecified route of administration on 06Feb2021 (Lot Number: EN5318 and expiration date was not reported) as a single dose for covid-19 immunization. Medical history included ongoing Rheumatoid arthritis from unknown to ongoing. The patient's concomitant medications were not reported. On 27Jul2021, the patient experienced tested positive for covid virus, after being fully vaccinated (vaccination failure) and (sars-cov-2 test positive). The event was serious (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: positive (tested positive for Covid) on 27Jul2021. The outcome of all the events was unknown.  Follow-up (23Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/ drug/ AE, different patient
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.
Pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 31-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. Patient delivered baby and have no adverse event for both mother and baby. On 31-Dec-2020, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient delivered baby and have no issues and have no adverse events for mother and baby. No relevant concomitant medications reported. No treatment information was provided.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this female with an unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 03-Jun-2021: Added delivery notes and updated pregnancy outcome was updated to retrospective.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female with an unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Swollen arm at the injection site (right arm). Temperature 103. Benadryl, Tylenol Q 4-6, PRN.
20 minutes post injection started to feel clammy, increased heart rate and rash appearance on both arms and hands. Reported to doctor at site and EMS was called. Heart rate was 98, BP 218/110 taken three times by EMS. Administered Benadryl liquid by EMS and monitored for thirty minutes. Rash stopped spreading and improved heat rate and B/P. Was released to go home by EMT. While traveling home had to stop by roadside because of vomiting and nausea.  Next morning rash still present on arms and fingers.
panic attack; Hyperventilation; Shaking; dizzy; Nauseous; This is a spontaneous report from a contactable pharmacist. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via intramuscular route in the left arm on 01May2021 at 09:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol and anxiety. It was unknown if the patient had allergies to medications, food, or other products. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN); all taken from an unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0151) intramuscularly in the left arm on 10Apr2021 at 09:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19.  It was unknown whether the patient had received any other vaccines within four weeks prior to the vaccination. On 01May2021 at 09:30, the patient had panic attack following vaccine - hyperventilation, shaking, dizzy and nauseous. Requested 911 to be called, first responders arrived and took her out on a stretcher. The patient remained conscious the whole time. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and was given water, stayed seated, and was told to take deep breaths/allowed to use inhaler. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events panic attack, hyperventilation, shaking, dizzy and nauseous were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
I had a cough, sinus pressure; loss of voice, diarrhea, nasal congestion and shortness of breath. I went to the urgent care thought it was a sinus infection. Gave me AUGMENTIN for 10 days twice a day. I have gotten a lot better.
Immunizations on 04/15/2002. On 04/16/2002 left arm became red, swollen, painful. Area of redness 4" wide. Recommended Benadryl, Tylenol and cold compresses.
after receiving the booster dose on 26Oct2021 has a sore shoulder patient has continued shoulder pain; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (after receiving the booster dose on 26Oct2021 has a sore shoulder patient has continued shoulder pain) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01721) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced ARTHRALGIA (after receiving the booster dose on 26Oct2021 has a sore shoulder patient has continued shoulder pain). At the time of the report, ARTHRALGIA (after receiving the booster dose on 26Oct2021 has a sore shoulder patient has continued shoulder pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Information on concomitant medications received was reported as unknown.  Patient received booster dose. The reporter stated that the patient after receiving the booster dose on 26Oct2021 had a sore shoulder on X-ray radiographic line. Event description was the patient has continued shoulder pain since the injection and pain was toward lower deltoid on humoral bone. Treatment medications were not reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, solution for injection), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "depression" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "chronic fatigue" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment for COVID-19 Test. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: It was reported as unknown if other medication in 2 weeks. anti viral details: COVID 19 Treatment, brand=Paxlovid, treatment start date=09Sep2022, treatment stop date=14Sep2022, indication=Treatment of COVID-19. Adverse event=Covid rebound, adverse event start date=13Sep2022, if patient recovered=Not recovered, if treatment ae=Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Body aches the night of vaccine. Went away after ibuprofen. Reoccurred on the 8th around 4pm. And then extreme nausea at 6 pm .  quick onset diareah  at 1am with cramping. Vomiting occurred at same time. Just that one session, but nausea remained. Another round of diareah at 8am on 1/9
Permanent headache since the first vaccination on April 2, 2021, uncontrolled blood sugar levels, cardiac arrhythmia, uncontrolled blood pressure, fatigue and dizziness.
pt recvd vax; fever 103, lasted 6 hrs; onset 1 1/2 hrs p/ immun; screaming;
Fever on 8/22 and diarrhea, taken by car to the ER, and they sent him home. It continued to get worse with diarrhea and fever, severe neck pain and other joint pain. 8/27/20 taken by ambulance to the ER and he never left there. He was transferred to a nursing home on Oct 2nd. He had never been out of bed at the hospital and by Oct was too weak to go home. His stomach and joint pain was better by Oct 2nd,.
Pt recvd vax 3JUN92 & today has 6x6 cm induration & 9x14 cm redness @ site; given meds;
On 8th day after vaccine given, I woke up with itching at vaccination site.  Throughout the day, redness and swelling appeared and  got progressively worse.  The redness ultimately spread over a 4 inch square area.
This vaccine was stored at room temperature outside of 2 hours.  The vial was opened around 11AM and the vaccine was administered around 207PM.  I did not realize this was incorrect until 11/5/21.  I have contacted my managers and the manufacturer who did not have stability data past 2 hours and advised to use clinical judgement.
SEVERAL FAILED ATTEMPTS TO REACH/INFORM PARENT OR GUARDIAN OF ISSUE.
Information has been received from a registered nurse referring to a 29 year old patient of gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date in 2010, the patient was vaccinated with the first dose of GARDASIL (dose, frequency, lot number and expiration date were unknown) for prophylaxis. The patient had not yet received the second dose (drug used for unapproved schedule). On 12-DEC-2016, reported as at the time of the call, the patient was in the office to receive GARDASIL 9 (frequency, lot number and expiration date were unknown, for prophylaxis) as the second dose in HPV vaccination series (Interchange of vaccine products). No adverse effects were reported. Additional information has been requested.
Patient was given COVID19 Pfizer 5-11 pediatric dose for second dose instead of the 12&up Pfizer dose.  No reactions/symptoms noted.
was admitted in the hospital last Friday morning for Pneumonia; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support from a contactable consumer. This female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose  1, single dose via an unspecified route of administration on an unknown date for COVID-19 vaccination. Medical history includes unspecified underlying conditions. The patient was on unspecified concomitant medications. On an unknown date, the patient had pneumonia and was admitted to the hospital on 05Feb2021. The patient is on oxygen at night while asleep. The clinical outcome of pneumonia was unknown. The reporter doubts if it is related to the Pfizer vaccine  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The event pneumonia more likely represent an intercurrent medical condition which was not related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE).
At day 3 patient complained they felt nauseous, their chest hurt and their heart was beating very fast.   Called the clinic to triage and took the patient in.
Headache, Myalgia, Arthralgia, Palpitations,  Palpitations, myalgia & arthralgia started after 1 hour, lasted 2 hours; headache that evening Narrative:
Diagnosed in ER with 4 subsegmental pulmonary embolisms on 18Mar2021 shown with CT Scan with contrast; Shortness of Breath; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: En5318), via an unspecified route of administration, administered in left arm on 04Feb2021 10:00 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient was not pregnant at the time of report. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3249) administered on the left arm on 14Jan2021 10:00 AM for COVID-19 immunization. The patient was diagnosed in Emergency room (ER) with 4 subsegmental pulmonary embolisms on 18mar2021 16:00 shown with CT scan with contrast and experienced shortness of breath on 18Mar2021 16:00. Prior to vaccination, the patient was not diagnosed with COVID. Patient was tested COVID post vaccination. The patient underwent lab tests and procedures which included CT scan with contrast: 4 subsegmental pulmonary embolisms on 18Mar2021, and nasal swab: negative on 14Jan2021. Therapeutic measures were taken as a result of the events and included treatment with apixaban (ELIQUIS). Facility type vaccine was Nursing Home. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent case, life threatening illness (immediate risk of death from the event). The outcome of the events were recovering.
Soreness in deltoid muscle upon raising arm over head or in pulling arm back past body at waist level.
This spontaneous report as received from a nurse. She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with MMR II. Other suspect therapies included live, oral, ROTATEQ. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patient s is not related to MMR II and live, oral ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide the details when she is able to retrieve the information. SR # provided. It is not known at this time if there have been any adverse effects. MMR vaccine Date given 11/01/2012. Medical record # 19771. Lot # 1571AA. Additional information has been requested.
reported to have slurred speech, dizziness, h/a centered over lt eye, diaphoresis all sx occurred w/in 5min of shot;
Patient received a high dose flu shot from the pharmacy on 10/6/21. She came by on 10/9/21 and stated that the next day after the shot on 10/7/21 her warm was swollen and red and itchy and sore. It has not gotten better since that day. She was advised to apply ice on it and also call the doctor. She said she will call the doctor today.
my parents got sick; Initial information received on 09-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves an unknown age patient for whom reported that my parents got sick (illness), while he/she received vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, for Prophylactic vaccination.  On an unknown date, (Unknown latency) following the administration of Influenza Vaccine, reported that my parents got sick (illness).  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  No further information was reported.
Day of vaccine: Patient felt immediate swelling of right ankle.  Sharp stabbing pain along left shin, which did subside. Twitching of ankles, causing patient not to sleep. Patient reports legs feel heavy and hard to bend. Patient reports headache, injection site soreness, and hard to the touch for over one week. Patient reports taking tylenol to relieve pain only the first evening of the vaccine, which resolved pain. Ongoing: Patient reports twitching from top of knees to feet in both extremities and throbbing sensation in arch of foot.
swelling; redness for 5-6 days; pain for 5-6 days; This case was reported by a consumer via sales rep and described the occurrence of swelling in a patient who received Herpes zoster (Shingrix) (batch number 4ME42, expiry date unknown) for prophylaxis.   On 30th January 2020, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced swelling, erythema and pain. On an unknown date, the outcome of the swelling, erythema and pain were recovered/resolved.   It was unknown if the reporter considered the swelling, erythema and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced swelling, erythema and pain after vaccination.
Possible cellulitis secondary to vaccination two days later was red & sore 1/2 way down to elbow got antibiotics from Dr.
Recurring numbness and tingling in my right arm, including my right hand. I do not yet know if it's permanent, which is why I selected "None of the Above" in response to Item 21.
This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (Concentration impaired), HYPERSOMNIA (Sleep for 12 hours) and COVID-19 (COVID-19, sickness, body aches and tiredness) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jan-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (Concentration impaired), HYPERSOMNIA (Sleep for 12 hours) and COVID-19 (COVID-19, sickness, body aches and tiredness). At the time of the report, DISTURBANCE IN ATTENTION (Concentration impaired) and HYPERSOMNIA (Sleep for 12 hours) outcome was unknown and COVID-19 (COVID-19, sickness, body aches and tiredness) had not resolved. No concomitant medications were reported. On an unknown date in 2022, the patient experienced very tired for at least four hours after taking the Humira and also had body aches. It was unknown whether patient was enrolled in a COVID-19 vaccine Trial. No treatment medications were reported. Company comment: This spontaneous case concerns a 29-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious AESI of Hypersomnia and COVID-19. The exact date of onset of the events was not specified in respect to the administration of a dose of mRNA-1273, hence latency could not be assessed. The initial two doses of mRNA-1273 were given approximately 8 months prior to the third dose of mRNA-1273, the interval between the two doses is 31 days. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 29-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious AESI of Hypersomnia and COVID-19. The exact date of onset of the events was not specified in respect to the administration of a dose of mRNA-1273, hence latency could not be assessed. The initial two doses of mRNA-1273 were given approximately 8 months prior to the third dose of mRNA-1273, the interval between the two doses is 31 days. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.