chrisvoncsefalvay/vaers-outcomes huggingface dataset:
face losing volume/Unevenness on left side right below eye between cheek and temple; couple of lumps below left eye more towards center of eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): GL-080222-19087.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 27May2021 as dose 1, single (Batch/Lot number: unknown), on 17Jun2021 as dose 2, single (Batch/Lot number: unknown), on 20Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; poly-L-lactic acid (SCULPTRA), since 13Apr2022 (Batch/Lot number: unknown). The patient's relevant medical history included: "dental cleaning" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Restylane; Voluma. The following information was reported: FACE CRUSHING (medically significant), outcome "unknown", described as "face losing volume/Unevenness on left side right below eye between cheek and temple"; SWELLING (non-serious), outcome "unknown", described as "couple of lumps below left eye more towards center of eye". The action taken for poly-L-lactic acid was unknown. Therapeutic measures were not taken as a result of face crushing, swelling..  Clinical course: Patient was injected with Sculptra on 13Apr2022 in the cheeks, nasolabial, chin, and temple. Noticing unevenness more now in past couple weeks, maybe a month later. Unevenness on left side right below eye between cheek and temple, couple of lumps below left eye more towards center of eye. No treatment received. Injecting provider was contacted. Nurse saw here the other day and was going to try to fix it in the next treatment. She said it had to do with her face losing volume, nothing to do with the treatment. No medical history/allergies reported. Patient has received Restylane and Voluma in the past. No medications used routinely. Patient received Pfizer COVID-19 vaccines. 1st vaccine: 27May2021, 2nd vaccine: 17Jun2021, boosters: 20Dec2021 and 21Apr2021 (as reported). No other vaccinations in past 6-12 months, no illness in month prior to treatment. Patient had a dental cleaning sometime last month.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On and off all day today I have been getting extreme dizziness and vertigo. It feels like the room is spinning and that I am off balance. It hits out of nowhere and has been lasting for about half an hour to an hour at a time.
Cramping in lower legs, fever 102, chills, pain. Pt went to ER. Given antibiotic. Swelling noted in left arm from shoulder to elbow. Pt followed up with primary physician 9/7/15. Reinforced dx of local reaction. 9/18/15, pt still has nodule at site, but resolving.
Mom called 3/17/08 to RN stated - Baby developed red lump where vaccines given 3/12/08 took to Dr. 3/14/08 with no treatment insite to warm areas - or warm bath. Called 3/20/08 by RN no answer left muscle to call SDHD - called RN message from 3/17/08 given (RN on 3/20/08 called again 3/21/08 left message to call SDHD - did not return call. RN called SDHD 3/24/08 with sustain to not use alcohol at site give differ IM send on private practice MD at facility for next shots - called parent 3/24/08 left message to call SDHD
Severe headache, water on ears. Prescribed Elavil, taken for 1 month, no improvement
1st shot of Moderna vaccine 42 or more than 42 days ago; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st shot of Moderna vaccine 42 or more than 42 days ago) 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 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st shot of Moderna vaccine 42 or more than 42 days ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st shot of Moderna vaccine 42 or more than 42 days ago) outcome was unknown.        The action taken with 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated AEs.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated AEs.
vertigo; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (vertigo) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, 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 experienced VERTIGO (vertigo). At the time of the report, VERTIGO (vertigo) outcome was unknown.            There was no treatment medication reported by the reporter.
Pfizer-BioNTech COVID-19 Vaccine EUA No reaction during 30 minutes of wait time after shot 1 hour after shot:  blurry vision for about 30 minutes 3 hours after shot:  itchiness on left side of neck and around hairline 4 hours after shot:  minor outbreak of hives on left side of neck and in/around hairline, slight tingling of tongue.  Treated with 2 TBSP of liquid children's Benadryl, no further outbreak of hives and tongue stopped tingling.  Had slight scratchy throat for 2-3 days afterwards.  No additional liquid Benadryl required.
Child presented with rash three days after the vaccinations of MMR shot. Rash diminished within 24 hours. 03/19/2014, child started with swollen ankles and bruising at the ankle area. 03/20/2014, rash returned and progressively got worse by 03/22/2014, the rash turned into huge red patches on her underside of her legs and in groin area. Some spots appeared under chin, under arms and lower legs. 03/22/2014, child was unable to walk properly, presented a fever approximately 1:00 pm of 101.7. Administered Motrin (1.25 mL) at 2:15 PM and two hours later, noticed child was unable to bend at the knees and was walking stiff-legged. Knees were red and swollen and legs began to swell. Child was taken to ER where admitted with 103.3 F fever. Many blood tests were performed, urinalysis, EKG, x-rays of chest and legs. One test ALP was elevated to 5000; two days later this test was repeated and was 7000. The child had a fever fluctuating from 03/22/2014 to 03/23/2014. The last fever presented was on 03/23/2014 at 3 PM. The rash was beginning to diminish by 03/23/2014 evening. The swelling of the knees and ankles went down by 03/24/2014. Child was released on 03/24/2014 to follow up with specialist.
No adverse event; 2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Mar-2023, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2023, the patient experienced WRONG PRODUCT ADMINISTERED (2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster) 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 WRONG PRODUCT ADMINISTERED (2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster).    No concomitant medications were provided. The patient had got their 2 primary series. No treatment medication was provided. This case contains information for the 2nd of 2 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716157 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716157:1st Child Female Twin Patient
About 2 days after injection, localized pain at injection site About 3 days pain increased and spread to left shoulder After the 4th day there was major pain in my left shoulder joint, left shoulder muscles,  left shoulder blade, left side of my neck, base of the head and pain radiated down my arm - into my left elbow and hand. It was constant throbbing pain all day and night with our without movement. About a pain level of 6 to 7 and I have a high pain tolerance.  On July 27th and 28th I took two 500 tabs of acetaminophen two times each day for pain. It did not eliminate the pain, only reducing it to tolerable level of 4 with restricted movements and extremely reduced activities. I cannot perform regular activities at this time.   Prescription by Dr.  Prednisone 20 MG one per day for five days Cetirizne hcl 10 MG one per day if needed These are to help reduce swelling and inflammation of the left arm, shoulder, neck and back I am still in discomfort after 2 days on the prescribed medication and acetaminophen. I still wake up and have difficulty using my left arm/ side to us full capacity.
I had a fever of 101 F about 14 hrs after the 2nd dose of Covid-19 Pfizer vaccine. My entire left arm is painful and felt very tired. These side effects continue about one day and all disappear.
Patient developed increasingly worse skin rashes over his entire body.  He also is running fevers on and off.  He has a raspy wet cough that won't go away.  He has mysterious stomach aches unrelated to eating.   He has become allergic to more foods with more severe reactions.
Rt thigh 5cm red, indurated, swelling, mild pain from f/u in 1 wk.
Patient came into the store on Sunday 9/5 to technician to recieve vaccine. Patient came in by himself and presented his drivers license. He told the technician that this was his first vaccine when she asked him. She automatically dropped for pfizer due to habit since that had been what they had been doing all day. She said so you want pfizer is that correct? And the patient specifically said no I want the moderna vaccine. We verified drivers license and asked for ins card. Patient said he did not have it but went to the car to look. When he came back he said he could not find his card and so the technician tried to look it up by his social security number and it came back no coverage so we ran on the no ins plan. Today, Tues 9/8 patient's mom called and said that they had just left the pharmacy and gotten their second pfizer vaccine and they said that we had put in that he got a moderna shot on Sunday. Mom said that son was not at the pharmacy on sunday and there was no way he got it. At this point, I started researching and pulled his record and printed a screen shot of the person at the counter at the time his shot was dropped. The mom said that they were in the parking lot and were coming in the store, but they never showed up. Unsure if son admitted to making a mistake or what but tried to call the number we had for the patient with no answer.
SEVERE FEVER , WEAKNESS , AND ACHES THAT LASTED ABOUT 20 HOURS.
Fainted, and convulsions-fire department called and vitals taken released after obervation.
Development of right sided Bell?s palsy, began as numb tongue the morning of 6/28, which developed into partial right sided facial paralysis over the following (roughly) 48 hours  Urgent care facility prescribed oral prednisone 60mg/daily x7 days Patient to follow up with primary care provider
redness and pain at site of injection and medial arm.  Redness approx 5-6 inches medial to injection site.
8 hours after body aches, tiredness and  chills and fever (100.6) for 18 hours
Expired dose administered to a patient.( It was administed out a of vial that was punctured more than 12 hours ago); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient.( It was administed out a of vial that was punctured more than 12 hours ago)) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient.( It was administed out a of vial that was punctured more than 12 hours ago)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient.( It was administed out a of vial that was punctured more than 12 hours ago)) had resolved.        The action taken with 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.   Concomitant medication was not provided  Treatment information was not reported.
I have a history of intermittent Atrial Fibrillation. I had an Ablation procedure in March of 2020. On 05/28/2021 I felt like I was having PACs more frequently and my heart rate dropped markedly. I went to the ER on 06/06/2021. I was diagnosed with Sinus Arrythmia which I have never had before. I also had Bradycardia and it is still happening after two months. I wore a monitor for two weeks and I had PACs and PVCs as well as the Bradycardia. I have had an issue with PACs for 3 months after a Flu Vaccine in the past. I had not had any problems immediately after the vaccine.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 10-SEP-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of the patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not reported and the lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
body aches; chills; headache; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (body aches), CHILLS (chills) and HEADACHE (headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination.     Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (body aches), CHILLS (chills) and HEADACHE (headache). At the time of the report, PAIN (body aches), CHILLS (chills) and HEADACHE (headache) outcome was unknown. Not Provided      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.   Treatment information was not provided.
Nine days after injection - Left arm where injection took place became: Red, Swollen, Itched & warm to the touch.  Tongue felt slightly tingly and a little swollen. Reaction subsided & rash gradually faded within 5 days. Doctor was consulted via a phone call.
Patient developed severe thrombocytopenia to a level of 3K, whereas patient had previously normal level platelet count just 3 weeks prior. Patient presented with diffuse petechiae and bleeding from the gums. She was hospitalized and received platelet transfusion, diagnosed with ITP, followed by high-dose dexamethasone and IVIG, with resolution of platelet count.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 16Mar2021 as dose 2, single (Lot number: EN6708), in left arm, on 30Sep2021 at 10:30 as dose 3 (booster), single (Lot number: EW0179), in left arm and on 03Jun2022 as dose 4 (booster), single (Lot number: EW0179) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "osteoporosis" (unspecified if ongoing); "Past smoker" (not ongoing), notes: quit 40 years ago. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: previously testing negative; (14Aug2022) Positive, notes: Tested positive 4 days after stopping Paxlovid. Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible. No further information is expected.
Patient developed four lesions consistent with pityriasis rosea within two days of receiving the first dose (11/6/21) of the Pfizer vaccine on her chest, abdomen, and groin. Her pediatrician suspected ring worm and treated it with two different types of creams unsuccessfully. Patient received the second dose of the Pfizer vaccine (11/29/21) and developed a fifth lesion on her back within hours of receiving that second dose. Her physician referred her to a dermatologist. The patient has never experienced any sort of skin reactions prior vaccines, all have been tolerated well. The lesions do not appear to change since initial development, but the number has increased by one within 24 hours of the second dose.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Feb-2022) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. It was unknown if patient had acute illnesses and chronic and long standing health conditions. On 05-Feb-2022 at 12:03 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Feb-2022 at 12:03 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Feb-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Ethnicity was report as Hispanic or Latino of any race. The patient received booster dose on 05-Feb-2022 (time: 12:03:44). No concomitant medication was provided. No treatment medication was provided. This case was linked to MOD-2022-542869 (Patient Link).