chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had some bruising and swelling at the injection site. The arm was painful upon palpation. Pt was recommended to use ice compresses and report to an MD if her condition worsens.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have given patient an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have given patient an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have given patient an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.
Patient experienced itchiness near the site of injection in the evening on 8/10/18 (the same day as vaccine was given). This morning (8/11/18) patient has hives up and down both arms, torso, back and legs. Patient bought and took Benadryl while here at pharmacy.
Bell's palsy within 24h after receiving the first dose on 06Mar2020; This case was reported by a pharmacist via call center representative and described the occurrence of bell's palsy in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th March 2020, the patient received the 1st dose of Shingrix. In March 2020, less than a day after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional details were provided as follows: The patient did not want to receive 2nd dose because experienced Bell's palsy after receiving the first dose.  The follow up consent was granted.
After administration of vaccine, we were notified that the vaccine had experienced a temperature monitoring event outside of our facility.  Patient was notified of guidelines that recommend revaccination.  As of this report, the patient has not come back for revaccination.
Mild Soreness at sight of injection for 3 days. Tiredness, Dizziness and Nausea AFTER the 3rd day of injection and is continuing to get worse everyday.
Felling of being unwell; Feverish; Diarrhea; Began with a slight headache, then Nausea the first evening. The second day started with Nausea, feverish, diarrhea. Continued with a general feeling of being unwell on the 3rd day (nausea, diarrhea,; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the arm right on 14Apr2021 at 17:30(at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) from an unknown date for an unknown indication and unknown if ongoing. On 14Apr2021 at 20:00, the patient reported that it began with a slight headache, then nausea the first evening and the second day started with nausea, feverish, diarrhea, continued with a general feeling of being unwell on the 3rd day (nausea, diarrhea, but no headache). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events began with a slight headache and feverish was recovered on unknown date in Mar2021. The clinical outcome of the events, nausea, diarrhea and feeling of being unwell was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a 26 year old female with no allergies who on 28-FEB-2008 was vaccinated with the first dose of GARDASIL (LOT #659182/1757U). On 24-APR-2008 the patient was vaccinated with the second dose of GARDASIL (lot # 660387/1967U). On the same day PAP smear test was performed. On 14-AUG-2008 the patient was vaccinated with the third dose of GARDASIL (lot # 660391/0063X). At the time she was informed of the results of the PAP smear test done on 24-APR-2008 which showed Low Grade Squamous Intraepithelial Lesion. There was no concomitant medication. The patient sought medical attention in the office. The patient was scheduled for follow-up and colposcopy. Additional information has been requested.
ADMINISTERED 2.5ML OF THE VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 211A21A expiry: 14-DEC-2021) 2.5 ml, administered on 31-OCT-2020 for prophylactic vaccination. No concomitant medications were reported.  On 31-OCT-2021, the patient experienced administered 2.5ml of the vaccine. On 31-OCT-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered 2.5ml of the vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220129, 20211220146, 20211220916, 20211220152, 20211219926, 20211219871, 20211220301, 20211220145, 20211220527, 20211220250, 20211165041, 20211200723, 20211200752, 20211201046, 20211201228, 20211201963, 20211201450, 20211201443, 20211201392, 20211201351, 20211201304, 20211201286, 20211201179, 20211201168, 20211200994, 20211201082, 20211200723, 20211200717, 20211219681 and 20211200675.
Injection site area was red, hot and swollen. Pt also developed a fever and swollen genitals. Doctor diagnosed mild orchitis.
Headache, migraine headaches, bone pains, nerve conditions, receiving treatment. 8/1/07-records received-DX: Tinea. Hypercholesterolemia. Back pain. Hernia, inguinal with repair. Major Depressive Disorder, Recurrent. Dyssomia. Calcium deposits in tendon and bursa. Osteoarthritis. Hypertension. Headaches. 1/11/2010 I feel with arthritis all over my body, I suffer of depression and have sexual problems (E.D). I feel numbness in my arms and hands and pain all over my body and hypertension, headaches and cholesterol.
Initial soreness of left arm, increased in severity overnight.  Treated with ibuprofen - soreness was more severe than usually experienced with flu shot.  Soreness got better but didn't subside, getting worse over time and now very painful from shoulder to elbow, with painful and/or limited mobility.
Pt. states that after receiving the 2nd dose of Phizer 09/08/2021, started experiencing symptoms 11/08/2021 of nausea, nervousness, confusion, balance issue, vertigo-feeling, and difficulty walking. Scheduled Primary visit 11/30/2021, still continuing to experience symptoms.
Pt. became pale, nearly LOC, off in w/d and given Rx by EMT - juice box, snack, rest. After 10-15 minutes, pt. was fine and back to class.
seasonal allergies; scratchy throat; Drainage; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (seasonal allergies), THROAT IRRITATION (scratchy throat) and DRAINAGE (Drainage) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management. Concomitant products included LOSARTAN and AMLODIPINE for Blood pressure management, POTASSIUM for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced SEASONAL ALLERGY (seasonal allergies), THROAT IRRITATION (scratchy throat) and DRAINAGE (Drainage). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Throat irritation and Drainage, at a dose of 1 dosage form. At the time of the report, SEASONAL ALLERGY (seasonal allergies), THROAT IRRITATION (scratchy throat) and DRAINAGE (Drainage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The second dose of Moderna COVID-19 vaccine was scheduled for  20 May 2021.
This was a booster shot to my J&J which I received in March of 2021.  I have a large  itchy welt (2 inches in diameter) that is hot and painful at injection sight. Shooting pains into shoulder and down arm. Also I have tendon pain in my wrist that is moving into my elbow that developed 48 hours post vaccine with no injury to cause it (right limb). I am unable to flex my wrist or close my hand without pain. I visited the walk in clinic was told it is possible the vaccine triggered something.  I am now wearing a brace, rotating ice and heating pad also ibuprofen and Tylenol.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old patient received bnt162b2 (BNT162B2) (Lot number: FK9894) at the age of 40 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as  "lot of itching under my skin; I got some itching before the COVID shot very worse, it is reduce some since the COVID shot but it's still pretty bad."  Additional information: Consumer stated, I have been learning about, for artificial intelligence since been years for a long time and I'm lot of itching under my skin itself, quite a while I reported it with the last questionnaire (Further clarifications unknown) I have got from you guys but I just also got a COVID shot 'from one' and trying to help with the itching over time (Further clarifications unknown). On paraphrasing: Consumer stated, "I don't have lot of yes, I have had itching before it though too from other things (Further not clarified hence captured as unspecified product) from Pfizer (Hence manufacturer checked). I had, my dad died a few years ago (Further clarifications unknown) and I was, When was it, when was it '2000' that's the case I have, the claim I have right now but I claimed with Pfizer that's what I 'kind of like send you is to' talk somebody with artificial intelligence divisions by the way from Pfizer, so that's kind of who I was trying to talk with but alright (Further clarifications unknown)." When probed to clarify if consumer has any questions regarding it or consumer wants to report it: Consumer stated, "Yes I want to report the issue, yes I got some itching before the COVID shot very worse, it is reduce some since the COVID shot but it's still pretty bad, 'since reported' and I finally got my first one."  No follow-up attempts are possible. No further information is expected.
Patient presented to a local District Health Department to receive a Pfizer Bi-Valent booster vaccine. Patient was inadvertently administered a Pfizer Mono-Valent vaccine.
swelling of face and right side of the head as the shot was administered on the right arm. lump under armpit and lymph node swelling along with nerve inflammation and loss of sensation of right side of face tongue and head for over several weeks since the day of 2nd dose of Pfizer vaccine.
Sores inside nostrils after receiving Flu Mist.  Slight bleeding with blowing of nose. Sores clear in one location and new ones occur in other locations inside both nostrils.
No adverse event reported. Patient vaccinated with vaccine licensed for 3 years old and older, and he is only 20 months old.
Mother called 1/7/03 stated that client was having severe abdominal cramping and headaches. Client had taken 3 caps of typhoid in 6 days - (T qod) The rest of the family had minor side effects but felt that client was reacting severely.
SUPERIOR CEREBELLAR ARTERY SYNDROME CRYPTOGENIC STROKE 2/25/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Case number PHEH2013US017772 is an initial spontaneous report received from a nurse on 19 Aug 2013. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. It was reported that the patient was possibly vaccinated only with an intramuscular dose of MenCYW-135 liquid component of MENVEO (batch number: not reported) without being reconstituted with Men A lyophilized conjugate on 15 Aug 2013. It was reported that the nurse could not confirm this as she had two different lot numbers (lot number A12026 for the MenA vial she had in her hand and batch number 10133 in documentation) and she was unsure who the patient was. No adverse reactions were reported following the maladministration.
Almost immediately, my left arm (injection site) became very sore; hard to lift and somewhat swollen. I also experienced an upset stomach and difficulty sleeping. After being awake until 2:30 a.m., I finally slept until 9:30 a.m. Very unusual for me. Arm is better today (08-09) and stomach is calmer. I have never experienced such a sore arm/shot site from other injections. The stomach issues was new too.
Approximately 5 minutes post second vaccination:  Hot flashes, sweating, blurry / dark vision, ear ringing / loss of hearing,  loss of color in face, slumped to the floor near fainting. That night: Extreme arm pain. Could not sleep. Next morning: Arm and armpit pain, neck, jaw / TMJ pain, myofacial pain, headache,  fatigue, right hip / joint pain (still present 7 days later and never had this issue before).
10 minutes after injection, reported trouble breathing, tight chest, generalized itching, hives on chest and trunk, swelling of tongue and throat. Epi given to outer thigh, 8L O2 NC placed, Benadryl given IM. 911 called and transported to GS ED via ambulance
Appearance of a 2" X 3 and I/2 " oval, red, itchy blotch at injection site, darker in color on outer edges ,which persists to present time
Renal failure; Hypercalcemia; Missed Dose; A spontaneous report was received from a pharmacist concerning a 73-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypercalcemia (hypercalcaemia) and renal failure.  The patient's medical history was not reported. Concomitant medications taken by the patient were not provided.  On 13 Jan 2021, 20 days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient was hospitalized for hypercalcemia and renal failure. The reporter reported that these events were not related to the vaccine. The patient did not see her regular doctor for this. The patient did not receive her second dose since she was hospitalized at the time and was at day 61. Treatment for the events was not provided. The patient was discharged from the hospital on 21 Feb 2021.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, hypercalcemia and renal failure, was unknown.  Follow up: Follow-up received on 15 Mar 2021, included email id of reporter, the hospitalization details, cause of hospitalization.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Rash on inside of elbow on same arm as injection; This is a spontaneous report from a non-contactable consumer report for self. This 27-year-old not pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at arm on 20Jan2021 16:00 at single dose for COVID-19 immunization. The patient's medical history and patient's concomitant medications were not reported. The patient experienced rash on inside of elbow on same arm as injection on 22Jan2021. Event recovered on 24Jan2021.  No follow-up attempts are possible. No further information is expected.
3 hours after shot Left arm felt heavy and sore, fever, and achy, chills. Arm painful from midnight on. Muscle felt knotted up. 2nd day arm turned really red and was better within 4 days. Went to doctor and started on anti-inflammatory medication. Chest tight and hard to breathe, Dr. Prescribed Z-pak.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated at the same visit with an unknown dose of PNEUMOVAX 23 (route, lot# and expiry date were not reported) and with an unknown dose of PREVENAR 13 (route, lot# and expiry date were not reported). No adverse effect was reported. Additional information has been requested.
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use).    No concomitant medications were reported.  Pharmacist reported that they had more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 days beyond use date.  The lot number for the monovalent vaccines with their corresponding BUD dates were 027C21A (BUD - 21-May-2021), 053C21A (BUD - 01-Jul-2021), 939902 (BUD - 02-Sep-2021), 011F21A (BUD - 04-Nov-2021), 012H21B (BUD - 23-Dec-2021), 056M21A (BUD - 12-May-2022), 082B22A (BUD - 08-Sep-2022).   The lot numbers for the bivalent vaccines with their corresponding BUD dates and the interval period of administration. 052D22A (BUD - 17-Nov-2022), dates of administration 18-Nov-2022 to 28-Nov-2022, 023H22A, (BUD - 15-Dec-2022), dates of administration 16-Dec-2022 to 20-Dec-2022. It was reported lot 042J21A should had been reported with a BUD of 17-Feb-2022.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live significant Follow-up contains narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Day of vaccines, fever of 99 degrees, vomited day after vaccine. 4 in red induration around one vaccine site.
This spontaneous report as received from a medical assistant refers to an infant patient of unknown age. It was reported that on an unknown dates the patient was vaccinated with VAQTA (dose and lot# not reported), VARIVAX (Merck) (dose and lot# not reported) and MMR II (dose and lot# not reported) before the age of 12 months. No adverse effect reported. Additional information has been requested.
anemic; WBC was 3.4 and has been dropping since; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WHITE BLOOD CELL COUNT DECREASED (non-serious) with onset May2021, outcome "unknown", described as "WBC was 3.4 and has been dropping since"; ANAEMIA (non-serious), outcome "unknown", described as "anemic". The events "anemic" and "wbc was 3.4 and has been dropping since" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anaemia, white blood cell count decreased.  Additional information: The patient's White Blood Count was 7.8 before the patient got the vaccine in early 2021. In May of 2021 the patient's WBC was 3.4 and has been dropping since. It reached 1.5 of Jan2023. The patient had to quit teaching job in summer of 2021 as an adjunct math instructor at College because the patient was anemic. The patient was seeing a hematologist and rheumatologist and was on Prednisone.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Tingling; Tachycardia; This is a spontaneous report from a contactable nurse. A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported), intramuscularly on the left arm on 17Dec2020 at 1 DF, single for Covid-19 vaccination at the hospital. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination; and reportedly did not have Covid-19 prior to receiving BNT162B2 vaccination. On 17Dec2020 (03:00), the patient had tingling and tachycardia. The patient did not receive any treatment for the adverse event. The outcome of the events, tingling and tachycardia, was recovered in Dec2020. The patient was tested for Covid-19 post-vaccination.  No follow-up attempts are possible. No further information is expected.