chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Periods of fluttering/rapid heart beat; Periods of fluttering/rapid heart beat; Periods of shortness of breath; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration, administered in Arm Left on 26Aug2021 12:00 (at the age of 33-year-old) (Batch/Lot Number: FD8448) as DOSE 1, SINGLE for covid-19 immunization . The patient's medical history and allergies were not reported. Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS) and cetirizine hydrochloride (ZYRTEC). The patient experienced periods of fluttering/rapid heart beat and periods of shortness of breath on 29Aug2021, with outcome of unknown. Therapeutic medications remained unspecified. The patient underwent lab test included Heart rate showed rapid. It was reported that no any other vaccine was administrated in four weeks, the patient didn't have COVID prior vaccination or test post vaccination. The patient was nonpregnant. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit.  No follow up attempts are possible. No further information is expected.
painful irratation swelling  and  alot of itching on my left breast .which started few days after my second dose of vaccine. My skin around my nipple got sore and started peeling off from the itching . This has contiuned up to date. I got a telephone Consultation from my doctor mention above  and he prescribe me an antifungal cream stating that its could be an allegic reaction. unfortuntily the cream hasnt help yet till this date. i used the cream for a month. Addational to this my Menses has been heavy than before.
On 2/17/2021 presented with rash/lesions to torso minimally to extremities with no itching noted. Once the lesions dry they present in a darker hyperpigmentation color.  Consulted with dermatologist on 2/22/21 was prescribed oral meds (Atarax) and topical steroid (Triamcinolone) to apply  to lesions. Was not able to consult sooner due to increment weather and no open medical facilities to consult.  2/23/21 rash continues with no itching but redness has mildly improved.
Information has been received from a registered nurse (director of nursing at administering facility) concerning a 51 year old male with alcoholism and no known drug allergies and a history of pneumonia, malnutrition and hypokalemia who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (0.5 ml), in the left upper forearm. The patient developed a local reaction 5x4 cc red raised area which was reported as red, warm, and painful. There were no additional details provided. The patient sought unspecified medical attention. Additional information has been requested.
No adverse event; 20 patients who were over 65 years old. They were given today 25-May-2023 0.25 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (20 patients who were over 65 years old. They were given today 25-May-2023 0.25 mL) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 25-May-2023, the patient experienced UNDERDOSE (20 patients who were over 65 years old. They were given today 25-May-2023 0.25 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (20 patients who were over 65 years old. They were given today 25-May-2023 0.25 mL) 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 UNDERDOSE (20 patients who were over 65 years old. They were given today 25-May-2023 0.25 mL).    No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 12 out of 20.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Elderly Patient - 1
Approximately 10 minutes post-vaccine, patient fainted (while sitting in chair for observation) and fell to the floor. Bystanders stop to help, and I grabbed my IMZ cart to go on scene; one bystander called 911 for EMS. Patient was breathing, conscious, and had a pulse; she was coherent and able to talk. She denied hitting her head or losing consciousness. Her mother, who was with her at the time, said the patient "shook" a little after she fell. Patient stated she had not eaten all day and thought that may have contributed to her fainting. We provided patient with water, and she was able to sit up on floor and lean against the wall. EMS arrived on scene to take over. The reported her blood sugar and blood pressure were within normal limits. This may have been a vasovagal reaction. Patient was standing after EMS evaluated her, and they approved for her to leave. The patient and her mother left the pharmacy. I told them to call the pharmacy if they have any questions or concerns and to report the event to patient's MD.
Pt recvd Engerix-B on 26APR90, 30MAY90, & 23OCT90 subsequently found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Patient fully vaccinated (Moderna) and boosted (patient received Moderna booster dose on 09/10/2021) , admitted to the hospital with COVID-19 and associated hypoxia on 01/07/2022. Patient was discharged on 01/10/2022.
CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021, in the left arm, for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, Laboratory data included: Culture nose (NR: not provided) COVID-19 positive. On 26-MAR-2021, the subject experienced confirmed covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection. This report was non-serious.
105 fever-twitching @ 2AM 21JUL98, stared out in space-would wake up & go back out to ER dx w/UTI;prescribed bactrim by MD;24JUL98 phone f/u pt well now;
I was not feeling well, I had congestion, blowing my nose, felt feverish. We had been out enjoying the winter sights, we came home early because I was not feeling well. On November 16, 2022, I used a home COVID-19 test that came back positive. I called my doctor's office to let them know I had tested positive and to discuss my symptoms. I was prescribed the antiviral Paxlovid that my husband picked up for me that afternoon. Within a couple of days, the congestion and coughing went away. I was also going through the grief of losing my Mom so I am not certain when I really started to feel more like myself.
Increase of 6 days in menstrual cycle, has continued for three consecutive cycles, accompanied by increased ovulation pain and breast tenderness, and headaches (never a prior symptom).
This spontaneous report as received from a other health professional refers to a patient of unknown age.  On an unknown date the patient was vaccinated with VARIVAX for prophylaxis. On an unknown date the patient experienced incorrect product storage and poor quality drug administered. The outcome of poor quality drug administered is unknown. The reporter considered incorrect product storage and poor quality drug administered to be not related to VARIVAX.    ; Sender's Comments: US-009507513-1707USA001044: US-009507513-1707USA001046: US-009507513-1706USA007156:
Medication error. Moderna vaccine given. 2nd dose supposed to be pfizer. Patient had her vaccine card with pfizer sticker, but was directed in to Moderna line. Does not speak english. Husband very little English. Vaers report and patient taken back to ADA for accessing language line to explain. If pt. was given Pfizer, lot # would have been EW0186. Patient went home. recorded by RN
<5min after receiving pfizer covid vaccine, he had syncope. unconscious for <10 sec, HR initially 50, BP 97/58, rapidly improved to HR in 70s-80s. hit R frontal head and under R chin with no lacerations. complained intermittently of dizziness. discharged home from clinic 50 minutes later. called back 1.5 hrs after event stating he had vomited twice, so was sent to ER, where exam was similarly normal and no testing/imaging was done.
Fever, chills, insomnia, aches, headache. Duration 12 hours
Itching and raised redness, but then a day later it was a sharp pain just under where the shot was given, and STILL if I raise my arm it feels like it is going to crack deep inside my upper arm, I can't brush my hair, or lift anything over my head the pain is just to much. I am not sure if this shot has given me arthritis, or tendonitis. I do not have any insurance right now so I can't go back to see the Dr but I have never had a problem with my arm before. This is going on three months now. I can't even sleep on my side due to this upper arm pain.
Vaccination given in right gluteoid area.  Rash later diagnosed as Sweet Syndrome began in right thigh on April 13, 2021 and then spread to both legs, upper arms, and shoulders. Though Sweet syndrome is usually accompanied by fever, in this case there was no fever. Began prednisone on April
Sharp pain in the left side of skull, bad headaches and  rash on the left side of the face.
The office practice was to draw up all vaccine from vial at the beginning of the day and discard vial. They used a sticky note with the bivalent booster NDC, lot number and expiration to enter all data into the EMR At some point the realized that they were missing vials of monovalent vaccine and that they had administered it instead of the bivalent as intended.
Information has been received from a RN nurse concerning an 18 month old male who was vaccinated with a dose of varicella virus vaccine live (lot 647269/1101N). Within seconds of being vaccinated, the site became red and a raised welt appeared. The reporter left the room to draw up a diphenhydramine hydrochloride (Benadryl) injection but when she came back to the room, the welt had gone away but it was still red. Oral diphenhydramine hydrochloride (Benadryl) was given instead. The records of testing prior to release of this lot have been checked by QA and found to satisfactory. The lot complies with the standards and was released. The nurse also reported a second child that had a similar reaction after therapy with the same lot number of varicella virus vaccine live (WAES0409USA02228). The nurse noted that she had never had a pt react to vaccination in the past and then to have to pt's so close together concerned her about the lot. Additional information has been requested.
Pt reported developing rash aproximately 50hours after vaccination.  She describes the rash as very itchy and reports it breaking out on both arms, upper body and lets.
Mild achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Mild achiness) 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 information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN (Mild achiness). At the time of the report, PAIN (Mild achiness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-073375 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Additional Information received and Event Mild achiness outcome was updated from Unknown to Resolved; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073375:2nd dose case
Her arm was swollen and it hurt.; Couldn'get out of bed; Body aches all over; As if she had the flu; her arm was swollen and it hurt.; Excruciating headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Her arm was swollen and it hurt.), BEDRIDDEN (Couldn'get out of bed), PAIN (Body aches all over), INFLUENZA LIKE ILLNESS (As if she had the flu) and PAIN IN EXTREMITY (her arm was swollen and it hurt.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PERIPHERAL SWELLING (Her arm was swollen and it hurt.), BEDRIDDEN (Couldn'get out of bed), PAIN (Body aches all over), INFLUENZA LIKE ILLNESS (As if she had the flu), PAIN IN EXTREMITY (her arm was swollen and it hurt.) and HEADACHE (Excruciating headache). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Prophylaxis, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Her arm was swollen and it hurt.), BEDRIDDEN (Couldn'get out of bed), PAIN (Body aches all over), INFLUENZA LIKE ILLNESS (As if she had the flu), PAIN IN EXTREMITY (her arm was swollen and it hurt.) and HEADACHE (Excruciating headache) outcome was unknown. Not Provided          Concomitant product use was not provided.
One of three children immun fr the same vial & experienced an inject site reaction; Reaction included swelling, redness & pain. Tx included tylenol & ice packs.
"I got my first Anthrax vaccine and a Typhoid immunization on 4 April 2008.  That same night I noticed a reddish, warm lump the size of my fist on the lateral aspect of my left upper arm at the AVA #1 injection site.  There was no swelling or redness at the Typhoid injection site (left deltoid).  By day #3, the lump on the side of my left upper arm (AVA #1 injection site) was about the size of a grapefruit.  I had nausea and dizziness for about a week after receiving the anthrax and typhoid vaccines.  Now, the lump on the side of my left upper arm has gone down to about the size of a marble, is reddish-purple and is a little tender to touch- otherwise, I feel fine at present.  I was told to call you with this information."
Information has been received from a hospital microbiologist concerning a 20 month old male patient with a history of a recent liver transplant who on 11-AUG-2005 was vaccinated with a history of a recent liver transplant who on 11-AUG-2005 was vaccinated with a 0.5 ml dose of Varivax (lot # 645164/0064R) in the left leg. The patient did not have a rash at the injection sie or elsewhere within 42 days of the vaccination. Concurrent medications included tacrolimus (PROGRAF), lansoprazole (PREVACID),  "florinet" and sulfamethoxazole (+) trimethoprim (BACTRIM). Subsequently the patient experienced herpes zoster like rash on his right thigh. It was reported that the patient was hospitalized. At the time of the report the patient was recovering. Additional information from the physician indicated that on 12-MAR-2006 (also reported as 13-MAR-2006) the patient experienced herpes zoster, dermatome right leg. The patient's maximum temperature was 100.4C and his pain was rated as "3". On 13-MAR-2006 a specimen was collected from a vesicle and was positive for VZV. It was reported that the patient had no recent exposure to chickenpox or herpes zoster. Subsequently the patient recovered. Information received on 04-MAY-2006 indicated that the VZV test was positive for vaccine type strain. The reporter considered the herpes zoster to be an other important medical event. Additional information is not expected.
Stiffness in injection site, next day, mild pain when lifting arm and mild cold symptoms.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received SHINGRIX. On 9th April 2018 14:00, the patient received the 2nd dose of SHINGRIX. On 9th April 2018, 5 hrs after receiving SHINGRIX, the patient experienced injection site pain, exhaustion, joint pain, headache and myalgia. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the exhaustion, joint pain, headache and myalgia were unknown. It was unknown if the reporter considered the injection site pain, exhaustion, joint pain, headache and myalgia to be related to SHINGRIX. Additional details were provided as follows: The health care professional's husband (also a family practice doctor) received the 2nd dose of SHINGRIX yesterday a day before the reporting date. The patient felt wiped out for the evening. The patient took some TYLENOL and that helped a bit. The patient woke up in the middle of the night complaining of the same symptoms and took additional TYLENOL. The patient was better and went to work today.
This spontaneous report was received from a Medical assistant refers to an unspecified number of patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. An unspecified number of patients were vaccinated with improperly stored dose of PROQUAD lot # L016394 (expiry date: 08-NOV-2016 and therapy type HSA) or lot # M003434 (expiry date: 19-JUL-2017 and therapy type: rHA) on the following dates: 27-JUN-2016, 28-JUN-2016, 01-JUL-2016, 05-JUL-2016, 06-JUL-2016, 12-JUL-2016 and 15-JUL-2016 (dosages not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Left arm pit and areas south of the arm pit painful.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 10:15 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient received unspecified prescribed medications within two weeks of vaccination. Medical history was not reported. The patient was allergic to codeine and penicillin. Prior to the 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 four weeks prior to the COVID-19 vaccine. The patient had received other prescribed medications within 2 weeks of vaccination. On 13Apr2021 at 14:30, the patient felt her left arm pit and areas south of the arm pit were painful. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event painful armpit was recovering at the time of the reporting.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 5OCT95 & w/in 24hr p/vax pt exp lt peripheral neuropathy in gluteus & leg, & weakness;
7 patients have been administered from an expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose) in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The vial Didn't undergo any temperature excursions The vials initially stored in the refrigerator on 08March2022 & The dates of administration of the vaccine - 3/29/22 gave 1 dose and 3/31/22 gave 4 doses. The vials initially stored in the refrigerator on 30March2022 & The dates of administration of the vaccine? 4/5/22 gave 2 doses  No Concomitant Medications were provided by the Reporter      No Treatment Medications were provided by the Reporter   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Live Follow up received contains Significant information of Dates of vaccine  Administration updated
Within 3 hours -Left arm pain, limited ROM, weakness. Patient evaluated. Physical therapy is improving symptoms, but still present at this time.
Moderna COVID-19 Vaccine EUA Fever, Vomiting  Symptoms lasted about 18 hours Took Tylenol extra strength 2X
Tender blue/reddish nodules forming on lower legs bilaterally (diagnosed as erythema nodosum).   Moderate to severe headaches daily, some of which woke me up in the middle of the night and could not be controlled with over the counter NSAIDs and Tylenol alone, even at maximal doses.  The headaches and nodules were only resolved after several courses of oral prednisone, total time for treatment from beginning to the full resolution of symptoms was 4 months.
Numbness and tingling at bottom of toes starting 12/30/13 and continuing. Neurologist diagnosis "Symmetric (small and large fibre; length-dependent, sensory axonal) polyneuropathy".
Had flu shot.  Approx 1-2 hours later, I developed dry hacky persistent cough.  My chest grew tight.  The cough increased in intensity & frequency.  As I was leaving, I felt my throat closing & my tongue grew numb.  My lips began to tingle & my eyes turned bright red.  I went to ER.  They listened to my chest and placed pulse ox on me.  my stats were in the 80's.  They placed a nasal canula in my face & started an IV of NaCl (I think).  They left it wide open & gave SOLUMEDROL, PEPCID & BENADRYL via IV.  Shortly, after I felt my chest opening & my throat wasn't as irritated.  After reassessment, they let me leave and placed me on PREDNOSONE (5mg)  X 3d.  B10.  It took about 10 days to completely overcome the symptoms.  I followed up w/ my doctor & he suggested / see an allergist.