chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 Vaccine EUA. Patient received first dose of Moderna on 3/10/21 around 9:40 am. During the 15 minute observation, around 945 am, patient started to feel dizzy, lightheadednes, heart palpitations, shortness of breath, both upper extremities were tingling.  When inquired on eating prior to vaccination, patient stated she did not eat nor drink anything prior to receiving her vaccine. (Reporter of event) and post-observers moved patient to a room with a patient table for her to lay down. At this time, orange juice, fruit snacks, granola bar, and water was administered to the patient. Cold compress was applied to patient forehead. Pt noted improvement in dizziness, but still felt heart palpitations, SOB, and then stated then that she felt "itchiness" all over her body. Which then Dr provided her with a tablet of Benadryl 25mg by mouth, which patient took. Patient then stated her head was pounding, at this time around 9:55, Dr, her PCP, stepped in to further assess, and per patient request the paramedics were called. Around 10:15 am EMT arrived and took patient to local hospital for further evaluation.
Information has been received from a registered nurse concerning a 13 year old female who on 18-OCT-2007, was vaccinated with a dose of GARDASIL (possible lot#'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007. No problems were reported. It was unknown whether medical attention was sought. There was no product quality complaint. This is one of several reports from the same source.
About 24bhours after vaccine, I had a fever of 99.4, a slight headache, a slight sore throat and fatigue.  The next morning I still felt fatigue but other symptoms were gone.  Continued to feel better as the day went on.
breakthrough infection; breakthrough infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FJ1620) at the age of 35 years as dose 3 (booster), single, (Lot number: EL9267) as dose 2, single and (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications, he took prescription medication on a regular basis. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "breakthrough infection". Therapeutic measures were not taken as a result of drug ineffective, covid-19. The patient stated she was just calling to 'report' a breakthrough infection after a two dose permanent series and a booster dose that she was aware of.  No follow-up attempts are possible. No further information is expected.
Appointment at 10:15am, pt. called 9:15pm complaining of right arm pain, not red, no fever, vomiting and stomach ache; ate out.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Nov2022 at 17:15 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 58-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included disability. On 23rd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th October 2018, 4 days after receiving SHINGRIX, the patient experienced muscle pain. On 7th November 2018, the patient experienced borborygmus. On an unknown date, the outcome of the muscle pain and borborygmus were not recovered/not resolved. It was unknown if the reporter considered the muscle pain and borborygmus to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient developed abdominal muscle pain 4 to 5 days later. Fifteen days after receiving SHINGRIX, the patient also hears a gurgling noise from her stomach and wonders if it might be related.
started on 4/17 in the evening and lasted through 4/18 called on 4/19 still feeling weak and chills
This spontaneous report as received from a nurse practitioner refers to approximately 14 year old female patient who was allergic to ZOFRAN. The patient had no pertinent medical history. On an unknown date in 2010, the patient was vaccinated with a dose of GARDASIL (lot number was reported as 1378Y, expiry date, dose and route were not reported). Approximately on an unknown date in 2010, the patient developed hives one hour post vaccination. Skin allergy test was performed on an unknown date (details were not specified). The patient sought medical attention and was treated with BENADRYL. On an unknown date, the event hives was resolved. This is one of reports from the Same Reporter Link (MARSS# 1302USA003808). Additional information is not expected.
hard to arouse 1JAN97, limp approx 3hr later;pale, very fussy, rt eye red, high pitched cry;
fever, chills, headache, body ache, anxiety, cough, sore throat - lasting 48 hours. tylenol to aid
pt recv vax & devel an 1/8 inch, red, raised, itchy area @ the site of inj;15 min later pt became pale & exp inc itching, wheezing & lightheadedness;tx w/Epi & DPH;pt recovered;
This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with M-M-R II lot # reported as M045400, expiration date 14-NOV-2018 (dose and route of administration were not reported). It was unknown what was used to reconstitute the vaccine and reported that it was "something other than sterile diluent" (unspecified date). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
12/18/99 upon waking, stated "felt (lips) funny", the night before when attempting to brush teeth, noticed lack of control of mouth.  Saw MD 12/18/99. Steroids prescribed for 7 days, artificial tears and Zantac while on steroids.
I waited in the pharmacy for 15 minutes; soon after I got in my car to drive home and felt a strange sensation on the left side of my face.  While driving, my entire left side went numb.   I kept checking my face in the rear-view mirror to see if it was drooping.  It was not.  My upper lip  appeared and felt swollen.   Six days later, on March 28th, I came down with a really bad migraine.  It started in my left eye and then was a really bad headache.  I called the eye doctor the following day because the pain was not subsiding.  The migraine lasted from Sunday, March 28th to Wednesday, March 31st.   Following the migraine, I have been getting headaches (not as severe, but still painful) almost daily.   The headache is not over my eyes or in the temple.   Instead the headaches are on the top of my head and towards the back.    Today is three weeks and two days after my vaccine, and I am still having headaches on the top of my head.
I started dealing with rashes breaking out all over my body. They were very red and very itchy. Sometimes raised and welty-looking, sometimes only red and itchy skin. The doctor has put me on a 6 day course of prednisone, and that seems to be controlling it for the most part right now. The only new thing introduced to my body was the booster shot.
Patient missed his 42 day window between dose 1 and 2 of Moderna COVID-19 vaccine.  He was out of town and didn't receive elsewhere.   The vaccine coordinator referred to the Medical Director for approval of administration of second dose on day 49.    Vaccine Coordinator called to follow up with patient to find out of any adverse effects and had to leave a message.  Patient has not returned the phone call.
NUMBNESS in BOTH hands to fingertips, BOTH arms to shoulder, BOTH feet/legs to the thigh.  Occurring 3-5/day for 1-3 minuets each.  Still occurring.  PAIN, sudden and focused in forehead between eyes and both temples. Occurring 2-3/day.  Lasting about 10-15 seconds each.  Still occurring.   VISION IMPAIRED.  Once a day.  Still occurring.  LOSS OF BALANCE/dizziness.  Severe to the point of falling - For one week following inoculation.
Extremely cold, muscle aches, headache. Symptoms lasted most of night. I took aspirin to relieve symptoms. Headache and malaise continued most of following day.
This spontaneous report as received from an unspecified reporter via an other company's representative refers to a 38 year old female patient with allergies to amoxicillin, cephalexin, corticosteroids, loratadine (manufacturer unknown), potassium and "valulnate". On 05-APR-2016, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 injection (route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. On 05-APR-2016, reported as that same day she received the PNEUMOVAX 23, the patient developed cellulitis. The patient sought medical attention. The event was treated with unspecified intravenous antibiotics. The reporter requested a lot check for PNEUMOVAX 23, however, no lot# was provided. The outcome of the event was not reported. The relatedness between PNEUMOVAX 23 and the event was not provided. Upon internal review, the event of cellulitis was considered to be medically significant. This is one of two reports received from the same reporter and concerning the same patient. Additional information has been requested.
Allergic reaction; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine and Tdap Vaccine. On an unknown date, an unknown time after receiving Flu vaccine and Tdap Vaccine, the patient experienced allergic reaction (Verbatim: Allergic reaction).The outcome of the allergic reaction was not reported.   It was unknown if the reporter considered the allergic reaction to be related to Flu vaccine and Tdap Vaccine.   It was unknown if the company considered the allergic reaction to be related to Flu vaccine and Tdap Vaccine.   Additional Information: GSK Receipt Date: 12-SEP-2023 The reporter called in to medical information to ask if it was recommended that patients that had prior vaccine reactions to not have Arexvy administered in an outpatient pharmacy setting. The reporter had a patient that had prior allergic reaction to flu and tdap vaccines. The reporter did not know what component of the vaccine that patient reacted to or which brand the vaccines were. No information about the reactions were reported. The reporter did not consent to follow up.
Right after the shot I felt my legs weak so I went to the recovery room where they say stay for 15 minutes, as I'm sitting down about 5 minutes after the shot my vision went totally blurry for about a good 5 minutes then my vision was coming back to normal after 30 minutes, then everything was fine, as I'm walking to my car I was having lower stomach pain but that only lasted 30 minutes .
Flu-like symptoms, back pain mimicking kidney stone pain, severe dehydration, headache.  Severe day one, lessened day two,  resolved day three.
This spontaneous report was received from a healthcare worker refers to her 72 year old mother. On an unknown date in October 2008 (reported as 5 years ago), the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date and route was unknown). The patient had pneumonia in the past year on an unspecified date in 2012. The reporter stated that pneumonia was directly related to her mother's physical state and complete inability to walk and sit in an upright position. The reporter also believed that her mother aspirates fluid. The outcome of the events were unknown. The reporter did not believe pneumonia was related to vaccine failure. It was unspecified if patient sought medical attention. Upon internal review the event complete inability to walk was considered to be disability. Additional information has been requested.
approximately 30 minutes after leaving office,(45 minutes after receiving vaccine) patient was very lethargic, not answering questions-?out of it? she returned to office and had normal vital signs, blood sugar
Miscarriage at 10 weeks. At the time of receiving vaccine, I was about 2.5 weeks pregnant (had not tested positive for a pregnancy test yet but did shortly after). Spotting started at week 6 and continued. Fetal growth stopped at about 8.5 weeks.
ADMITTED TO MEDICAL CENTER WITH BILATERAL LOWE EXTREMITY WEAKNESS AND DECREASED SENSATION. SHE HAD DIFFICULTY WALKING , GETTING UP FROM THE TOILET ANS SOME WEAKNESS IN HER HANDS SHE WAS VACCINATED ON 10/01 WITH PFIZER VACCINE BOOSTER  DOSE
Pt c/o throat feeling tight, high pulse 112, O2 99, Respirations 21.  25mg benadryl given. pt stated she felt better and was more calm.
Erythema, Aching R upper arm developed 10/25/05. Macular vesicular rash developed 10/26/05, generalized. Treated with oral Benadryl.
Patient's mom called on phone 9/29/19 at 10PM to say her son got flu shot yesterday and developed some concerning symptoms. We are not sure if it is from the flu shot or something else. Symptoms included: sore throat, swollen lips, hives on body. Symptoms have been gradually developing since yesterday.
pt devel a swollen thigh w/pain & limping about 12 days p/vax; pt worsened over a couple of days & then slowly improved;
Reporting it was due to the preservatives in the COVID 19 vaccine; Swelling of lymph nodes under her arm pit; Fever 104/ fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of REACTION TO PRESERVATIVES (Reporting it was due to the preservatives in the COVID 19 vaccine), LYMPHADENOPATHY (Swelling of lymph nodes under her arm pit), PYREXIA (Fever 104/ fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, 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 started INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) at an unspecified dose. On an unknown date, the patient experienced REACTION TO PRESERVATIVES (Reporting it was due to the preservatives in the COVID 19 vaccine), LYMPHADENOPATHY (Swelling of lymph nodes under her arm pit), PYREXIA (Fever 104/ fever) and CHILLS (Chills). At the time of the report, REACTION TO PRESERVATIVES (Reporting it was due to the preservatives in the COVID 19 vaccine), LYMPHADENOPATHY (Swelling of lymph nodes under her arm pit), PYREXIA (Fever 104/ fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) High.         No concomitant medications reported. No treatment medications reported.  It was reported that patient had the symptoms happened with the 2nd and 3rd shots and it was due to the preservatives in the COVID-19 Vaccine. She also reports issues with the flu vaccine with preservatives,but has no issues with the flu vaccine if it does not have preservatives in it.   This case was linked to MOD-2021-411912 (Patient Link).   Reporter did not allow further contact
Rash at site of injection, on arm. Itch. Break out at site. Benadryl cream applied but ineffective at healing reaction.
Big lump where I got the shot; Itchy and red; Itchy and red; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (big lump where I got the shot), VACCINATION SITE PRURITUS (itchy and red) and VACCINATION SITE ERYTHEMA (itchy and red) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE MASS (big lump where I got the shot), VACCINATION SITE PRURITUS (itchy and red) and VACCINATION SITE ERYTHEMA (itchy and red). At the time of the report, VACCINATION SITE MASS (big lump where I got the shot), VACCINATION SITE PRURITUS (itchy and red) and VACCINATION SITE ERYTHEMA (itchy and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Information has been received from a registered nurse concerning a male patient who on an unspecified date was vaccinated I.M. with a dose of PNEUMOVAX 23 (lot# 665300/1314Y). Subsequently, the patient complained of reaction on his arm. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of the report, the patient's status was unknown. This is one of several reports from the same source. The nurse has requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
have been sick for the last 2 days; running a fever; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (have been sick for the last 2 days) and PYREXIA (running a fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (have been sick for the last 2 days) and PYREXIA (running a fever). At the time of the report, ILLNESS (have been sick for the last 2 days) and PYREXIA (running a fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information was provided.
That night - flu like symptoms. Next morning - swelling, pain, yellow - all the way to armpit.
Extreme swelling, redness, and tenderness to injection site - reaction involved the entire left thigh as the reaction progressed it included a red streak around the back of the thigh. Patient first treated in ER, given oral steroids. Followed up at our clinic 2 days later - thigh still swollen and red but with some improvement per mom, Doctor recommended Benadryl.
This case was reported by a physician, via a sales representative, and described the occurrence of body pain in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline), VARIVAX (non-gsk). On 14 May 2012 at 16:30 the subject received 1st dose of CERVARIX (.5 ml, unknown route) and on 14 May 2012 the subject received 2nd dose of VARIVAX (Non-GSK) (details unknown). On 14 May 2012, 1 hour after vaccination with CERVARIX and VARIVAX (Non-GSK), the subject experienced "overall" body pain, swelling arm, flu like symptoms, fatigue and nausea. The physician considered the events were disabling. The events lasted for 3 days. On 17 May 2012, the events were resolved. The subject consulted her healthcare provider. The vaccination course with CERVARIX was discontinued.
Patient received Pfizer Primary Dose instead of 12yrs+ bivalent booster. Patient will return in 2 months for correct vaccine.
Pt. rec'd 12 mo imm. on 05-11-15. Redness and knot appeared on Lt arm at site on 05-21-15. Pt. seen in office on 5/22/15. (+) Lt upper posterior arm with linear redness; afebrile; non-tender; no other rashes present. Area = 2.5 cm x 0.5 cm. TX = ibuprofen, ice pack; to return prn.
missed 2nd dose, and now its more than 42 days; Flu like symptoms; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed 2nd dose, and now its more than 42 days) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS and CALCIUM for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 02-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed 2nd dose, and now its more than 42 days). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 02-Mar-2021, PRODUCT DOSE OMISSION ISSUE (missed 2nd dose, and now its more than 42 days) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved.        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.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Updated information included date of birth of the patient, date of the 1st dose of the drug is given on 12-02-2021, batch number, anatomical location, new event Flu like symptoms,concomitant medications and  treatment medication.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown, with no associated AEs.
Redness, swelling (hard lump) and itching at the injection site. Small white lesion 1" from injection site.(Not sure if it's associated. Not noticed before.)
fatigue, weakness Narrative: Patient contacted telephone triage nurse today requesting to speak with PCP clinic-states she received her first moderna covid vaccine 6 days ago, developed fever (highest 100.6), body aches, joint pains, fatigue, weakness, "just tired out, feels like I have the flu." + Sinus pain, clear drainage. Patient states she has not been out of bed for 7 days.