chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At the age of 61, one month following my 2nd shot,my menopause ended temporarily leading to two surgical procedures to rule out cancer and to stop or reduce VERY HEAVY menstrual flow. My postmenopausal phase was fi st identified at my health center in April or March of 2018, but hormone testing on May 14 revealed that I was "mid-cycle". This is highly irregular considering my age and considering how long I had been post menopausal.   My first symptoms actually were the week before the bleeding began on May 14 with the strange return of premenstrual symptoms which confused me. NP/DR eval for cancer.  TWO SURGERIES followed, outpatient, described below.
Headache, Fever, Diarrhea, Local Symptoms: Pain- discomfort, redness, swelling, itching. General Symptoms: Chills, fever, headaches, muscle pains, diarrhea. Narrative:
24JUN97 pt reported very large lump @ least 6 inches @ varicella inj site;swollen, painful indurated area first noticed while showering the morning p/vax & lasting approx 1wk;not observed by provided but pt considered reliable historian;
Giant lipoma 10x15x5 cm developed on upper abdominal wall. Tender, sharp pains.  Also 50 cysts now on ovaries as opposed to prior imaging consistently being at 9 on one side 12 on the other.
pt reported that he had hives or allergic reactions a couple hours fater the vaccine was adminsited to him. no treatment made by the pt.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. Co-suspect products included VALTREX unknown for shingles. The patient's past medical history included shingles (on the lower back). On 21st June 2018, the patient received SHINGRIX. On 24th June 2018, the patient started VALTREX at an unknown dose and frequency. On 24th June 2018, 3 days after receiving SHINGRIX and not applicable after starting VALTREX, the patient experienced shingles and lack of drug effect. On an unknown date, the outcome of the shingles was unchanged and the outcome of the lack of drug effect was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: In the morning the patient experienced shingles outbreak which occurred on the lower back, which was where the patient historically notices when a shingles attack was present. The patient did not had the VALTREX filled at the pharmacy reporting. The patient reported an unknown formulation or manufacturer of VALTREX was not helping her shingles symptoms.
The pt developed rash and low grade fever for three days. Also the child was fussy and drowsy. The papular rash spread to all over the body; non-pruritic.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A 24-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 intramuscular, administered in Arm Left on 02Apr2021 (at the age of 24-year-old) (Batch/Lot Number: EP6955) as dose 2, single for covid-19 immunisation. Medical history included covid-19 (Covid prior vaccination). The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 via intramuscular, administered in Arm Left on 11Mar2021 (Batch/Lot Number: EL3247) for covid-19 immunisation. On 11Jul2021, patient tested positive for COVID and experienced Loss of sense of smell and taste, cough, congestion and fatigue symptoms. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was diagnosed with COVID-19. Patient tested positive post vaccination. Patient did not receive any treatment for adverse event. Post vaccination patient underwent Nasal Swab test. On 11Jul2021 Nasal swab result as positive. The outcome of events was Recovering.   No follow-up attempts are possible. No further information is expected.
My left ear has been ringing nonstop. I have been to urgent care, an audiologist and an ENT. I have had an EKG and a an MRI. I wad totally healthy 38 year old woman until I did this and now I cant sleep or focus due To the ringing. This should absolutely be listed as a side effexf.
Hives/rash appeared about 20-30 min after immunization on entire body. Child treated with Solumedrol 40mg IM and Orapred 1 1/2 tsp qd x 4 days.
Some of the liquid got onto her right hand; Exposure via skin contact; Blisters on the right hand; Itchy; This case was reported by a nurse via call center representative and described the occurrence of blister in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2019, the patient received Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced blister and pruritus. On an unknown date, the patient experienced inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the blister, pruritus, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the blister and pruritus to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The nurse was mixing a dose of Shingrix to administer to a patient, some of the liquid got onto her right hand, which led to inadvertent exposure to vaccine and exposure via skin contact. Afterwards, the patient developed blisters on the right hand and at the time of reporting the blisters had increased in number, although they remain localized.  At the time of reporting, some blisters were open, while others were closed. Blisters were on the crease of thumb and index finger and itchy.  The patient had not sought medical treatment and had not applied any treatment herself. No further details provided during the call. The reporter consented to follow up.
Pt reported swelling and redness of left thigh immunizaton administration area. Was seen 8/1/14 by same provider, no fever, no complications, Tylenol given in case of fever and discomfort.
This spontaneous report as received from a pharmacy technician refers to a 67 year old patient of unknown gender. On 03-DEC-2015, the patient was vaccinated with a dose of improperly stored ZOSTAVAX lot # L023118, expiration date: 24-SEP-2016 (dose, route and site of administration were not reported). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Presented to ED from SNF d/t malfunctioning peg/jejunosotomy tube; incidental finding of COVID-19 and asymptomtic
Improperly stored vaccines administered.; This spontaneous report was received from an administrator referring to a male patient of unknown age (reported as baby boy). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-JUL-2021, the patient was vaccinated with improperly stored first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # T022566 was confirmed to be valid, expiration date: 03-NOV-2022; exact dose, route of administration, anatomical location were not reported) for prophylaxis.    The administered dose underwent a temperature excursion of -1.4 degree Celsius (C) for 1 hour and -26.4 C for 4 hours. There were no previous excursions reported. The digital data logger was involved.   This is one of several cases received from the same reporter; Sender's Comments:  US-009507513-2108USA001905: US-009507513-2108USA001815:
On 6/19/01, child woke up from sleep with fever of 104F, crying and cranky.
pt recvd vax;w/in 5 min,passed out & had slow heart rate;w/in 1hr p/ vax she exp n,lightheadedness & flu like sx;observed for 2 hrs in the er;no tx necessary;sx lasted approx 3 days;
I got the shot at 10:30am.  My arm was mildly painful at the injection sight. During the next early morning (~2:00am Friday, Feb 19) I had the chills for about 2 hours. I had intermittent muscle pain, nausea, and fatigue. These symptoms resolved during the day Friday, February 19th.
everything going black & fell backwards onto floor; pale, sweating; VS BP 116/78, P80, R16;
Vertigo; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and DIZZINESS (Dizziness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MECLOZINE for an unknown indication.    On 27-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 VERTIGO (Vertigo) and DIZZINESS (Dizziness). At the time of the report, VERTIGO (Vertigo) and DIZZINESS (Dizziness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Patient received the second dose on 27MAR2021and the lot number is 002B21A or 002R21A.
for the first 48 hrs , I had the usual sore arm post vaccine. it resolved. on the 7th day, injection site is warm, raised and can palpate a knot like localized swelling bigger than a quarter and very itchy.
This spontaneous report was received from a pharmacist refers to a 62 year old female patient. The patient had drug allergies towards BACTRIM, LEVAQUIN, CODEINE and iodides. The patient had no pertinent medical history. On 01-DEC-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX, (lot number reported as H013946, expiration date 25-OCT-2013). Concomitant medications included FLUVIRIN(unknown manufacturer) which was administered on 01-DEC-2012, but not the same arm as of ZOSTAVAX, Other concomitant medications included XANAX and sertraline hydrochloride. Approximately on an unknown date in December-2012, the patient developed a knot at the injection site approximately 2 inches in diameter which was red and hot to touch. There was no treatment rendered for the events. No laboratory diagnostic studies were performed. At the time of this report the patient had not recovered from the reported events The patient sought medical attention (called pharmacist). Additional information has been requested.
Blood pressure  high  the next day 2/28 ; 246/177 @7 AM; 159/99 @1600 PM; 3/1 6 AM  161/114; 3/1 7 AM 176/107  while taking regular blood pressure meds. 3/5 6:30 AM 174/115
Redness, sore, swollen left arm only. I spoke to PCP office's nurse. They were going to set up an appointment today. Nurse believes it's cellulitis from description of the injection site.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: <10 mins post moderna booster pt reported "feeling faint and tingling lips." pt received previous vaccine doses 5/12/21+6/9/21 without issue. h/o anaphylaxis to lactose. symptoms began to worsen: pulse faint, bp undetectable, loss conciousness (<1min). came to upon arrousal, still weak pulse/tingling mouth. administered epi x 1, ems arrived and took over care. transported to er.
5 yr old received AFLURIA 0.5cc preservative pre-filled syringe, parent notified of incident. Parent reports child not having any problems or reactions post vaccine. Report received do not indicate any adverse event, they were apparently submitted because Afluria was given in each instance to a child prior to FDA's approval for use in persons as young as 6 months of age.
sore arm, could barely move her arm, fatigue, fever 100.5,  vomiting diarrhea
has metastasis breast cancer; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced has metastasis breast cancer in Mar2021 with outcome of unknown.    Information about Batch/Lot number has been requested.
Arm pain Swollen  General weakness Like having COVID again Dizzy Nausea Symptoms have continued past 2 weeks
This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ANTIBODY TEST NEGATIVE (antibody test was negative 2 weeks after the second dose), MYALGIA (body aches) and FATIGUE (fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 032L20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure and Diabetic. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced MYALGIA (body aches) and FATIGUE (fatigue). On 01-Feb-2021, the patient experienced ANTIBODY TEST NEGATIVE (antibody test was negative 2 weeks after the second dose). On 31-Jan-2021, MYALGIA (body aches) and FATIGUE (fatigue) had resolved. At the time of the report, ANTIBODY TEST NEGATIVE (antibody test was negative 2 weeks after the second dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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 treatment information was provided. No concomitant medication was provided.
Information has been received from a physician concerning a 7 year old white male who on 20-APR-2007 was vaccinated subcutaneously into the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 656279/1503F). On 22-APR-2007 the patient developed swelling and redness at injection site and pain underarm. On 25 APR 2007 the patient was considered recovered. Unspecified medical attention was sought. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information is not expected.
6/30/2017  note: Patient is here with mother for a sick visit. She received Tdap vaccine along with HPV and MCV4 on 6/28 which was 2 days ago. The left upper arm where Tdap was placed started to swell yesterday and redness today. Still painful but able to move arm. BP 102/69 | Pulse 91 | Temp 99.5 °F (37.5 °C) (Oral) | Wt 95 lb 6.4 oz (43.3 kg). Physical Exam Constitutional: She appears well-developed and well-nourished. She is active. Neurological: She is alert. Skin: Skin is warm. There is erythema. Erythematous tender induration 6x4 cm left upper arm.
patient reported feeling dizzy and weak, admitted to local hospital. Continued to be weak and dizzy for several weeks Narrative: Patient reported not eating breakfast the day of his first vaccine, 02/7/21. He stated he waited the full observation time and upon leaving was told if he had any symptoms/side effects to call 911 or go to the ED. On his way home he pulled over because he was very dizzy and felt like passing out. Stated almost called but instead proceeded to drive to the ED. There he was admitted for cardiac workup. He states he continued to be weak and dizzy for several weeks, just now feeling better in the past week. He is currently wearing a holter at home. He reports never having any other reaction to any other drug or vaccine. States "that was a powerful shot"
After receiving the COVID vaccine (2nd shot), the patient experienced some lightheadedness and lost consciousness and then regained consciousness after a couple of minutes. This has occurred in the past with other shots. A rapid response was called, the patient was evaluated and did not wish to go to the ED. Vitals were taken and were within normal limits. Patient remained in observation for 30 minutes and left.
Benadryl 25mg intramuscular one time. Given in right deltoid. No driving. Watch for fever. If develops go to ER.
Patient called to complain because of pain from flu shot. Patient stated pain was caused by pharmacist giving injection too high on arm. Doctor visit was done.
Felt dizzy immediately after vaccine and passed out. EMS stated low heart rate and blood pressure after waking up.
OBSTRUCTIVE SLEEP APNEA ACUTE ST ELEVATION MI, LEFT ANTERIOR DESCENDING CORONARY ARTERY ACUTE ST ELEVATION MI, ANTERIOR WALL ACUTE NON ST ELEVATION MI HYPOTENSION
Low grade temp 99.1; diarrhea; body aches; chills; migraine; sweats; severe fatigue; Dose Number 1, Date of start of drug 21Dec2020/ Dose Number 2, Date of start of drug 20Jan2021; This is a spontaneous report from a contactable nurse (patient). A 32-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 20Jan2021 07:30 at left arm, at single dose for covid-19 immunization. The patient medical history was not reported.  Concomitant medication included isotretinoin (ACCUTANE), cetirizine. The patient previously took pediazole and experienced Known allergies: pediazole. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 21Dec2020 09:15, at Left arm, at single dose for covid-19 immunization. The patient experienced low grade temp 99.1, diarrhea, body aches, chills, migraine, sweats, severe fatigue at 20Jan2021 12:00. No treatment was received for events low grade temp 99.1, diarrhea, body aches, chills, migraine, sweats, severe fatigue. The outcome of the events low grade temp 99.1, diarrhea, body aches, chills, migraine, sweats, severe fatigue was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
SHORTLY AFTER RECEIVING THE VACCINE, PATIENT REPORTED A SLIGHT TIGHTENING OF THE THROAT.  PATIENT TOOK DIPHENHYDRAMINE 25MG AND REPORTED FEELING BETTER SHORTLY THEREAFTER.
swollen lymph nodes in neck on left, saw her md and was given keflex 5 days after vaccine. no swelling or redness at injection site
received the bivalent booster before the primary series of the Moderna vaccine; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the bivalent booster before the primary series of the Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received the bivalent booster before the primary series of the Moderna vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the bivalent booster before the primary series of the Moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received the bivalent booster before the primary series of the Moderna vaccine).    Concomitant product use was not provided by the reporter.   Patient didn't received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.
A report has been received from a Health Professional concerning a 2 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 05-Dec-2012. The reporter stated that the patient was given expired FLUMIST on 05-Dec-2012. The outcome of the event of GAVE EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
This spontaneous case, was received from other health professional (registered nurse) on 01-Jun-2017 and concerns students in an academic campus, who received flu vaccine. This case deals with first of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns a 17-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 14-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the  2016-2017 FLUCELVAX Commercial season. Therefore no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not assess the seriousness and did not provide the causality between events and suspect vaccine. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (QAIR  number: 1022277) received from quality assurance department on 29-Jul-2017: QA investigation results were updated. Narrative amended accordingly. Non significant case correction received on 10-Aug-2017: The narrative and case comment were corrected.
pt recv vax 430PM on 30SEP96;7PM that day pt had a sz lasting 45min;pt was adm to hosp where was found to have a fever to 103;the following day pt exp another fever to 102 & a sz lasting 30min;