chrisvoncsefalvay/vaers-outcomes huggingface dataset:
wave sensations in head; headache; blotchy red rash on face; felt really sick; tired/fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (blotchy red rash on face), MALAISE (felt really sick), FEELING ABNORMAL (wave sensations in head), FATIGUE (tired/fatigue) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced MALAISE (felt really sick) and FATIGUE (tired/fatigue). On 18-Mar-2021, the patient experienced RASH ERYTHEMATOUS (blotchy red rash on face). On 19-Mar-2021, the patient experienced FEELING ABNORMAL (wave sensations in head) and HEADACHE (headache). On 16-Mar-2021, MALAISE (felt really sick) and FATIGUE (tired/fatigue) had resolved. At the time of the report, RASH ERYTHEMATOUS (blotchy red rash on face), FEELING ABNORMAL (wave sensations in head) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were no provided by  the reporter.
Intense abnormal menstrual cramping. I never have menstrual/period cramps but around 6 hours after my vaccine, I experienced very painful cramps. This lasted about 5 hours and then went away, the cramps came back about 2 hours later and lasted another 4 hours. I am fine, just wanted to let it be known that I experienced these side effects for the cdc numbers.
On my appt date Sept 2016 - had flu shot before due date of last one of Nov-Dec 2015. Flu shot given in upper left shoulder by staff who suggested shot. Next AM woke up with severe pain in left shoulder - pain kept migrating through back - shoulders and eventually settled in lower-upper neck and scalp. Painful.
sore & stiff shoulders; body ache;nausea;tightness in chest;
Information has been received from a nurse practitioner concerning a 26 year old female who on 15-FEB-2007 was vaccinated with the first dose of Gardasil (yeast) (lot# 655503/0012U). On approximately 22-February-2007, "approximately one week after vaccination", the patient developed a 10 cm. firm, red area at the injection site, and a low grade fever. The patient was scheduled to be seen by a health care provider on 12-MAR-2007. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Vaccine consent form had date of birth of 0 and was signed by patient's mom. Patient's date of birth is actually . He was 15 years old when we received the Pfizer vaccine on 04/15/2021, however it was reported to us that he was 16 years old at that time. On 04/15/2021, the Pfizer vaccine had a emergency use authorization (EUA) from the FDA for ages 16 and older. The FDA expanded the EUA for the Pfizer vaccine to include ages 12-15 years old on 05/10/2021. This incident was reported to us via email from a pharmacy practice coordinator. This was not reported to us from the patient or patient's parents.
By 9 am the next morning I had body aches, extremely tired, could not get warm and chills.  They lasted until late Sunday night.  On Monday morning I noticed a rash between my breasts.  This was my booster shot.
No adverse event; Dose 1 was received on 4-Feb-2021 and dose 2 on 25-Feb-2021; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was received on 4-Feb-2021 and dose 2 on 25-Feb-2021) and NO ADVERSE EVENT (No adverse event) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if patient was ever been diagnosed with/tested positive for COVID-19. Acute illness at the time of vaccination and chronic or long-standing health conditions were unknown.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was received on 4-Feb-2021 and dose 2 on 25-Feb-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was received on 4-Feb-2021 and dose 2 on 25-Feb-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was received on 4-Feb-2021 and dose 2 on 25-Feb-2021).    No concomitant medication information was reported. No treatment information was reported. No adverse event was reported.   This case was linked to MOD-2022-638098 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2022: Follow up received included non significant information.
Anaphylactic reaction; A spontaneous report was received from a physician, who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction.  The patient's medical history was not provided. No concomitant medications were reported.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, after vaccination, the patient experienced anaphylactic reaction. No treatment information for the event was reported.  The Action taken with mRNA-1273 in response to the event was not provided.  The outcome for the event, anaphylactic reaction, was not reported.; Reporter's Comments: This case concerns a female patient with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced a serious event of anaphylactic reaction. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the onset of the event on the day of vaccination, a causal relationship cannot be excluded and the event was considered possibly related to the vaccine.
Developed mouth ulcers on tongue and cheek. Very painful. Ongoing still, with slow regression of symptom for 4 days now started 2 days after vaccine received worse on tongue.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and 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". Therapeutic measures were taken as a result of drug ineffective, COVID-19.Other medication in 2 weeks were reported as none. Reason for vaccine lot unknown, not available or provided to reporter at the time of report completion.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
after first dose, lump in arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (after first dose, lump in arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ATORVASTATIN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (after first dose, lump in arm). At the time of the report, SKIN MASS (after first dose, lump in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took blood pressure medication (unspecified drug) as concomitant drug.  No treatment drug was provided by reporter.   This case was linked to MOD-2021-281363 (Patient Link).
covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Relevant medical history or conditions, allergy, concomitant diseases and risk factor were unknown.     In December 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 an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.            It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication not reported.   She got COVID-19 twice, both times 6 months after a booster. She was due for a booster and didn't get it in time. Moderna was protecting her up until 6 months. When she got into a crowd or ER (for something else) she got COVID-19 after. It was never super bad. She had a bad cold and fatigue. She thought she had delta and omicron strains. She assumes the effect of the vaccine was waning after 6 months. She got her Moderna COVID-19 Vaccine, Bivalent booster in Dec 2022.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-739236 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739236:monovalent case
Pt called and said that she has a large red, itchy rash that didn't appear until 3 days after the vaccine.
I developed pneumonia,  extreme  pain, difficulty breathing, weakness and exhaustion. I was prescrived azithromycin 6 tab pack 250 mg Methylprednisolone 4 mg dose pack Albuterol hfa 2 puffs every 4 hours. I still cant walk around the house without feeling out of air, I still feel pain in my rib cage, i still feel pain.  I?m an athlete, I workout every day. Now I can?t even walk around the block
C/O ITCHY FACE, FEELING OF TONGUE SWELLING  NO RASH OBSERVED  VITAL SIGNS WNL  GIVEN DIPHENHYDRAMINE 50MG PO PER STANDING ORDER  PATIENT REFUSED TRANSPORT TO ER, TRANSPORTED HOME BY FRIEND WITHOUT INCIDENT FOLLOW UP CALL TO PATIENT ON 1/19:  PATIENT "FELT FINE" AFTER 1 HOUR, NO RECURRENCE OF SXS
Individual reported sudden onset dry cough 25 minutes post vaccine. Reported some tightness to upper chest.  Denied shortness of breath.  Handled saliva and PO intake, coughing noted while trying to complete full sentences. No swelling or redness noted. O2 saturation 98%. 911/EMS called, nurse monitored until arrival. On EMS arrival symptoms moderately improved, individual refused further medical treatment or emergency services.
Moderna vaccines on 1/29/2021 and 2/26/2021 ER visit and hospitalization on 11/29/2021 for COVID 19 and hypoglycemia
Bumps all over my body, some big & some small ones; Minimal itching; Some that are patchy, like a rash; Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Bumps all over my body, some big & some small ones), PRURITUS (Minimal itching), RASH (Some that are patchy, like a rash) and VACCINATION SITE PAIN (Sore arm at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). On 14-May-2021, the patient experienced MASS (Bumps all over my body, some big & some small ones), PRURITUS (Minimal itching) and RASH (Some that are patchy, like a rash). At the time of the report, MASS (Bumps all over my body, some big & some small ones), PRURITUS (Minimal itching), RASH (Some that are patchy, like a rash) and VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Approximately 10 hours after receiving vaccines, mother reports swelling of face and hives on trunk, upper extremities. She denied pt had any difficulty breathing, swelling of throat, or wheezing. Mother gave one dose of benadryl, and sx resolved within one hour. No further sx occurred.
Lightheaded and dizzy; I had a migraine for 2 days; Nauseous the first night; First 4 days, my arm was super sore I couldn't sleep on it; 12 days after vaccine my arm got a rash and hot and red at the site about 4 inches circular oval; It started itching a few days ago but there wasn't anything there; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (12 days after vaccine my arm got a rash and hot and red at the site about 4 inches circular oval), PAIN IN EXTREMITY (First 4 days, my arm was super sore I couldn't sleep on it), MIGRAINE (I had a migraine for 2 days), DIZZINESS (Lightheaded and dizzy) and VACCINATION SITE PRURITUS (It started itching a few days ago but there wasn't anything there) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (First 4 days, my arm was super sore I couldn't sleep on it), MIGRAINE (I had a migraine for 2 days), DIZZINESS (Lightheaded and dizzy) and NAUSEA (Nauseous the first night). On 22-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (It started itching a few days ago but there wasn't anything there). On 24-Mar-2021, the patient experienced VACCINATION SITE WARMTH (12 days after vaccine my arm got a rash and hot and red at the site about 4 inches circular oval), VACCINATION SITE ERYTHEMA (12 days after vaccine my arm got a rash and hot and red at the site about 4 inches circular oval) and VACCINATION SITE RASH (12 days after vaccine my arm got a rash and hot and red at the site about 4 inches circular oval). On 12-Mar-2021, DIZZINESS (Lightheaded and dizzy) and NAUSEA (Nauseous the first night) had resolved. On 13-Mar-2021, MIGRAINE (I had a migraine for 2 days) had resolved. On 16-Mar-2021, PAIN IN EXTREMITY (First 4 days, my arm was super sore I couldn't sleep on it) had resolved. At the time of the report, VACCINATION SITE WARMTH (12 days after vaccine my arm got a rash and hot and red at the site about 4 inches circular oval), VACCINATION SITE PRURITUS (It started itching a few days ago but there wasn't anything there), VACCINATION SITE ERYTHEMA (12 days after vaccine my arm got a rash and hot and red at the site about 4 inches circular oval) and VACCINATION SITE RASH (12 days after vaccine my arm got a rash and hot and red at the site about 4 inches circular oval) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
big round red rash near the injection site; injection site red rash; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th May 2019, the patient received the 1st dose of Shingrix. On 31st May 2019, 2 days after receiving Shingrix, the patient experienced injection site erythema and injection site rash. On an unknown date, the outcome of the injection site erythema and injection site rash were unknown.   It was unknown if the reporter considered the injection site erythema and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. On the 3rd day, the patient developed a big round red rash near the injection site. On the 4th day, the patient developed another big round red rash not far from the first rash. The patient asked could this be shingles. The patient asked, what did this rash represent, was this also a side effect as well, should he be concern, what should he do, would this happen with his second shot. The patient thought this new shot did not have a live virus.
uses saline to reconstitute SHINGRIX; uses saline to reconstitute SHINGRIX; This case was reported by a consumer via call center representative and described the occurrence of wrong solution used in drug reconstitution in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patients received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.    Additional Information: GSK receipt date: 25-APR-2022 Reporter's comments:.The reporter stated that her Nurse Practitioner (NP) said she uses saline to reconstitute the Shingrix Vaccine. The reporter could not confirm if the Shingrix in this case was administered. This was information the reporter stated she was told by the nurse at her doctor's office, when the reporter was asking the Nurse Practitioner (NP) about the adjuvant. The reporter did not wish to provide details regarding the Nurse Practitioner contact information. The reporter provided limited information. The reporter did not consent to follow up. Additional Supportive Information: The saline was used to reconstitute the Shingrix vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case has been linked to the case US2022069545 reported by the same reporter. Note: It was unclear about the number of patients but the word uses indicate nurse was using this for many patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022069545:Same reporter
3?diameter red spot.  Sore and little puffy. Little muscle sore neck-shoulder.
Patient experienced a high fever, chills, aches approximately 5 hours after receiving the the vaccine. The symptoms lasted approximately 24 hours. She did not seek medical attention,
Pt developed diarrhea X 6 days, post vax. Pt was fussy and had a low-grade temperature of 100.9F.
Patient was administered COVID Moderna 0.5ml on 10/22/2021 as his 3rd dose. Patient stated he was immunocompromised because he was on Oztela and agreed to receive the full dose. Prior administrations of Moderna were uneventful. 1 week after his 3rd dose, injection site developed a small pimple that would continue to grow until around 3/17/22. Patient states that it grew to the size of a half dollar and was painful without touching. Around 3/17/2022, it popped on its own and was filled with pus and blood. 3/24/2022, patient showed his PCP the pimple to which the PCP told him that it was nothing to worry about. Patient came to the pharmacy on 4/15/2022 and showed me the remaining scar and hard bump the size of a nickel on the injection site.
itching; rash; hives; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), RASH (rash) and URTICARIA (hives) in an adult male patient 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 an unknown date, 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 an unknown date, the patient experienced PRURITUS (itching), RASH (rash) and URTICARIA (hives). At the time of the report, PRURITUS (itching), RASH (rash) and URTICARIA (hives) had not resolved.            No Concomitant medication was reported.  It was reported that Now patient was having rash, hives and itching and he felt it was from Moderna booster.  No treatment information was provided.
after 30 minute wait Pt left clinic only to return with SOB, hives, stridor and itchy throat. Dry cough Given epi 0.3 mg with resolution transferred to ED via EMS
Pt had delayed local reaction around injection. Total size=3 3/4 cm with slightly fluctuance, with 1 1/4 cm with induration. No tenderness. Pt = obese 1" needle. Occurred 6 days post vaccine ? 10 days post vaccine.
redness and pain and soreness at injection site lasting 2 days, Fever, itching, general malaise, nausea, itching in mouth
Pt received vaccines at approx 9:00 am on 9/5/07 at our clinic. By 1:00 pm she was running a fever of 102 deg axillary. Tylenol did not affect fever. Mom came back to us with child, child appeared limp and barely responsive. Mom took pt to the ER. Fever treated with Advil, came down to 100.2 deg. Pt is better next day. Mom also reports a "pimple like" reaction at the injection site on Rt. arm; reddened with white center.
The patient presents with 25-year-old male with no significant medical history presents to the emergency department for evaluation of nausea, vomiting, generalized body aches, headache 1 day after his Covid vaccination.  Reports associated subjective fever and chills.  No diarrhea.  No surgeries.  He has tried no medication pain.  He has had 3 episodes of nonbilious nonbloody emesis..  The onset was 6  days ago.  The course/duration of symptoms is constant.  Location: generalized. The character of symptoms is Malaise, nausea, vomiting.  The degree at onset was minimal.  The degree at present is moderate.  Risk factors consist of Recent COVID-19 vaccination. Therapy today: none.  Associated symptoms: nausea, vomiting, chills, headache and Generalized malaise  Reexamination/ Reevaluation  Re-examination/Re-evaluation: Patient is significant symptoms after Toradol, IV fluids, Zofran.  He was able to tolerate p.o. intake.  Laboratory evaluation was unremarkable.  UA showed likely contaminant. Pt has no urinary symptoms. Discussed postvaccination syndrome with the patient.  Strict return precautions discussed.  Patient expressed understanding and agreement treatment plan.  Will discharge home with a prescription for Zofran to be taken as needed for vomiting.  NSAIDs and Tylenol as needed for generalized pains.  Follow with primary care provider in 3 to 5 days.