chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Outer front part of her ear felt swollen; it was uncomfortable; It spread down to her neck /And to her eyebrows; This spontaneous case was reported by a consumer and describes the occurrence of EAR SWELLING (Outer front part of her ear felt swollen), EAR DISCOMFORT (it was uncomfortable) and SWELLING (It spread down to her neck /And to her eyebrows) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 20-Feb-2021, the patient experienced EAR SWELLING (Outer front part of her ear felt swollen), EAR DISCOMFORT (it was uncomfortable) and SWELLING (It spread down to her neck /And to her eyebrows). At the time of the report, EAR SWELLING (Outer front part of her ear felt swollen), EAR DISCOMFORT (it was uncomfortable) and SWELLING (It spread down to her neck /And to her eyebrows) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-257310, MOD-2021-257310 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up  received, Event outcome updated.
suspected vaccination failure; shingles; hurt my back; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and back pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and back pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and back pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient stated that, till the time of reporting, they still bothered and hurt his/her back. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No adverse event) 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 11-Jan-2023, 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 EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients).    No concomitant medications were reported. No treatment medications were reported.  This case contains information for the 35th of 100 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Client experienced facial flushing, severe headache, and labored breathing 15 minutes post vaccination. Pt vital signs were stable. Pt provided oxygen, Benadryl and was transported via EMS to local Emergency department for further evaluation.
Rash on forehead, back of neck, chest/stomach (itchy). Fever up to 103. Upper respiratory S/S of coughing.
Fever inj site pain x1 day; fever 101F, aches, chills, fatigue x4 days Narrative:
She had welts and little red spots all over her back a couple of hours after the second dose of vaccine. She got rubbed down with alcohol and cortisone cream that night. Today, the back welts went away but the red spots are still there. After checking her again around 8:30 p.m. because she complained of her left hand itching, I noticed more welts up her left arms and more came back on her middle and upper back. She was then rubbed down again and given an ibupropean. I am unsure of this side effect because it was not mentioned on any cdc website, so therefore I will be calling her physician to do a checkup. If there is any other information we need to know on how to treat the outbreaks please send email.
Pruitius; Pain in leg; Vaccination site induration; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Pruitius), PAIN IN EXTREMITY (Pain in leg), VACCINATION SITE INDURATION (Vaccination site induration) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart disease, unspecified. Concomitant products included GLIMEPIRIDE, METFORMIN and PRASUGREL for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PRURITUS (Pruitius), PAIN IN EXTREMITY (Pain in leg), VACCINATION SITE INDURATION (Vaccination site induration) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). At the time of the report, PRURITUS (Pruitius), PAIN IN EXTREMITY (Pain in leg), VACCINATION SITE INDURATION (Vaccination site induration) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Patient complained he was not able send the ADR form and write his story due to the limited space on the ADR form On 29-Apr-2021: Outcome of the events was reported as not recovered; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Received a call from mother of patient on 06/14/2023 @ 3:00 p.m. and informed me that patient started fever last night and right upper arm injection site is red, swollen and warm to the touched. Patient mother administered tylenol every 6 hours started 06/13/2023 @ 8:00 p.m. with good relief. At the time when mother called she said that fever has subsided but swelling on the injection site continues. I advised to apply ice pack every 20 minutes and tylenol every 6 hours PRN pain and fever. Take patient to Urgent Care if office is close if fever and pain continues. Call the office the next day during office hours if symptoms continues.
Vaccine given in the (R) deltoid. (R) arm wept up and legs, also arms and legs itching.
Uticaria. Random itchy hives and rashes all over various parts of my body, coming and going at varying intervals
reports fever blister within 1 hour that resolved and didn't require immediate treatment. next day developed myalgias but then came into the ED due to a feeling of tongue swelling and swelling of the neck, no n/v/d, no sob/wheezing/stridor
i receive the moderna vaccine i went to ER on 6-3 2021 because the hives and red and itch does not stop i have been taking benadryl and it is not working the hives come and go it stop when im sleeping as soon as i get up it starts up again it doesn't stay in one place it goes from top of my head to all over right now as im typing is on my lip and eyes itching and redness i also been having heart burn i am not scared to to take the second dose
Severe Left eye pain progressing over 8 day course with Left facial droop and loss of bilateral ocular motor coordination, Nausea, Photo-phobia, Vertigo, Edema to Left eye and orbit.
After getting my second shot, I felt extremely dizzy and disoriented. My vision became blurry and I had trouble breathing. I also threw up several times. I felt lightheaded for a few more minutes and then I was able to stand again.
No problems observed with client - vaccinated after left - Noticed/informed by Data entry staff H1N1 (mist) in "red" checked noticed expired yesterday.
CHILLS (COULD NOT GET WARM), UNCONTROLABLE TEETH CHATTERING, HEADACHE, RAPID HEARTBEAT.
ARM PAIN, REDNESS AND SWELLING AROUND INJECTION SITE, THEN BLISTERS. BLISTERS STARTED TO GO AWAY THE NEXT MORNING. NOW (4 DAYS POST-INJECTION) REDNESS AND PAIN CONTINUES TO A LESSER EXTENT AND LINE WHERE BLISTERS WERE IS STILL VISIBLE. RASH APPEARS TO BE RESOLVING ON ITS OWN.
8 hours after received vaccines experienced fever, chills & sore (R) arm at injection site. Several hours later after pain (R) upper arm, axilla, (R) lateral chest to groin, nausea & vomiting, sore throat. Went to ER 1500 4/21/12 received IV fluids, MS, PHENERGAN. Blood draw, Abd CT scan. Felt ill thru 4/23/12.
The day after receiving her second dose of anthrax vaccine, patient developed pruritic papules which began on the arm where she received the vaccine and then appeared on her other arm, both legs, her back, and abdomen.  Pruritic papules persisted and patient was examined 9 days later.
Next day after vaccine started having a Migraine with a 103 fever that lasted for 3 days.
Pain at injection site, redness at injection site, nausea, fever, chills, headache, very swollen lymph nodes in left arm pit - affecting daily living and sleeping, swollen lymph nodes & redness at injection site continue at time of report, other symptoms have subsided
Got flu shot in early November n been sick ever since n this weekend the worse; Initial information received on 18-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced got flu shot in early November n been sick ever since n this weekend the worse after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, dose, expiration date and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed got flu shot in early November n been sick ever since n this weekend the worse (illness).  Action taken was not applicable.  Corrective treatment was not reported for the event (Got flu shot in early November n been sick ever since n this weekend the worse).  Outcome was Unknown for the event got flu shot in early November n been sick ever since n this weekend the worse.
rt arm turned red & swelled;on 29MAR96 red, raised rash on R/A on upper outer half upper arm;mom used baking soda on rash;also broke out in chicken pox;seen in ER 30MAR96 10PM;MD dx chicken pox but not sure rash;arm painful;muscles hurting
On June 10 I started to develop itches and small red marks that appeared as mosquito bites. A couple days latter rashes and small red vesicles appeared on my torso, back, lower abdomen and thighs. On June 20, PAC, at Health Clinic, diagnosed the harsh as Pityriasis Rosea and prescribed BANOPHEN 25 mg and Hydrocortisone Cream USP 2.5%. As of today the hashes are still itching and seems that it is spreading.
This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers to 11 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
I went to the ER because of the blood clot and they ran blood work and they said I had blood clot in my lungs and they gave me medicine Aloxyce for the rest of my life.
Within 15 minutes of vaccinations developed RASH on trunk of body - primary care called - referred to Emergency room. Child had "stuffy nose/head congestion" when presented at clinic - had seen family MD - no medications given before seen at clinic - ok to give shots - contacted Emergency Room seen by doctor released 11:45 am.
Patient reported tenderness and soreness.  She also had a red circle about 3 inches in diameter where the vaccine was given and her lymph nodes in her left armpit were very tender and sore.
Staff member complained of fast-sharp pain after the vaccine. Dizziness and everything seems very slow
2 days after vaccine administration presented with increased fever 105.6, vomiting, diarrhea.
shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a currently 76-years-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   In or about 2013, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles (herpes zoster) and zoster-related conditions.  On an unspecified date, subsequent to the patient vaccination, the patient was treated by a physician for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) vaccination: Shingles. At the reporting time, the outcome of the event was unknown.   The reporter considered the events of shingles to be related to zoster vaccine live (ZOSTAVAX).
Patient received a booster dose of Moderna from a vial that had been expired for 3 days. Per Moderna, the dose was valid.
This spontaneous report was received from a registered nurse via company representative and refers to a 9-month-old patient of an unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, when the patient was 9 months old, the patient was vaccinated with the first dose of ROTATEQ orally (dose, lot# and expiration date were not reported). The patient received the second dose of ROTATEQ on an unknown date, when the patient was 11 months old. No adverse effects were reported. The action taken with ROTATEQ was not reported. The relatedness between the event and ROTATEQ was not reported.
This spontaneous report was received from a nurse practitioner refers to a multiple patients of unknown ages who on an unknown dates, were vaccinated with the third dose of GARDASIL (doses, routes and lot numbers not reported). The third dose of GARDASIL was administered eight weeks after the second dose. No adverse symptoms were reported. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information is not expected.
Myalgia, Arthralgia, fatigue, brain fog Narrative:  flu like symptoms after second dose of vaccine, missed an afternoon of work  Other Relevant History:
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026120A and 041L20A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) for Allergy, MACROGOL 3350 (MIRALAX) for Constipation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, DOCUSATE SODIUM (COLACE), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 02-Jul-2020 and the estimated date of delivery was 08-Apr-2021. On 04-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy.  On 04-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2020, Pregnancy test: positive (Positive) positive. In December 2020, Oophorectomy: abnormal (abnormal) minor surgery- ovary removed -prior to vaccination. In January 2021, Glucose tolerance test: unknown (Inconclusive) unknown. On an unknown date, Ultrasound uterus normal: normal (normal) 18 week done, choroid plexus cyst , resolved..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Estimated date of conception reported was 20-Jul-2020.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up received on 28 April 2021. Informations on patient demographics and concomitant medications were added.
Mild Fever after first primary shot for 1 day; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild Fever after first primary shot for 1 day) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (Mild Fever after first primary shot for 1 day). On 05-Mar-2021, PYREXIA (Mild Fever after first primary shot for 1 day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-569419, MOD-2022-569417, MOD-2021-225686 (Patient Link).   Reporter did not allow further contact
received 2 doses experiencing HZ breakouts or HSV2 breakouts; received 2 doses experiencing HZ breakouts or HSV2 breakouts; This case was reported by a physician via call center representative and described the occurrence of off label use in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised and herpes zoster.   In January 2022, the patient received the 1st dose of Shingrix. In February 2022, the patient received the 2nd dose of Shingrix. In January 2022, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced off label use. In February 2022, the patient experienced off label use. On an unknown date, the outcome of the off label use and off label use were unknown.   Additional Information: GSK Receipt Date: 30-Mar-2022 Reporter's comments: Doctor of medicine reported that the patient who had been experiencing ongoing breakouts and was immunocompromised thought they were Herpes Zoster breakouts.  The reporter got diagnosis, did not have information and just took patient's word for it and told the patient to get Shingrix vaccine.  The patient received 2 doses of Shingrix somewhere between January 2022 and end of February 2022 since the MD saw the patient on 27th December.  The patient then brought back lab work from 2018 that showed positive herpes simplex virus type 2 (HSV2). Biopsy from 2019 showed 2 resolving lesions of herpes viral infection but was not specific for herpes zoster (HZ) or herpes simplex virus (HSV).  There was no varicella zoster virus detected in a cell culture from 2017.  The patient's lesions were not in her genital area, rather they are on her back and buttock area.  The reporter was unsure if the patient was experiencing HZ breakouts or HSV2 breakouts. The consent to follow up was given. No lot or expiration dates for vaccine nor dates for administration of vaccines were given since administered by pharmacy. Additional Supportive Information: The patient who had been experiencing ongoing breakouts of herpes zoster received Shingrix, which led to off label use.
Patient reported ringing in ears and nausea less than 30 minutes after receiving vaccination.  VS 108/64 HR 68 at that time. He was given 35 mg liquid Benadryl orally by mouth at time of event and reported that he was starting to feel better by 1035.  follow up BP was 110/62. He had reported having the same issue with the first dose that resided on it's own. Followed up later in the afternoon and he stated the ringing was still present, but had diminished greatly and he was feeling a bit tired and nauseous.