chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt with warm, generalized swelling, sore, left deltoid two days after injection. Today, six days after injection area still warm, no redness noted, swelling more confined but higher, around injection sight very firm and still sore per patient.
experienced shingles in September 2023; experienced shingles in September 2021; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (first outbreak of shingles was 2003) and shingles (had a history of recurrent shingles). Previously administered products included Zostavax (vaccinated with Zostavax in 2013) and Shingrix (received Shingrix in December 2016).   In APR-2018, the patient received the 1st dose of Shingrix. In SEP-2021, more than 2 years after receiving Shingrix, the patient experienced shingles (Verbatim: experienced shingles in September 2021). In SEP-2023, the patient experienced shingles (Verbatim: experienced shingles in September 2023).  The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the shingles was not resolved and the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles and shingles to be related to Shingrix.     It was unknown if the company considered the shingles and shingles to be related to Shingrix.   Additional Information: GSK receipt date: 27-Sept-2023 The patient stated that she was vaccinated with the first dose of Shingrix in December 2016 and the Shingrix was not approved for use in this country until 2017.   Patient was made aware, but stated that was what her records show and she was 1 and 1/2 years late with the second dose of Shingrix because it was not available. The patient received a dose of Shingrix and had experienced shingles in September 2021 and September 2023. For the current episode of shingles, the patient was on day 14 of Valtrex in which she had been taking 1000mg daily. It was unclear how the VALTREX was prescribed to the patient. The reporter consented to follow-up.
Cyst/abscess in vaginal area -likely Bartholins gland cyst/abscess
Moderna COVID-19 Vaccine EAU.   A couple of hours after the injection, right leg from knee to ankle became numb in front.  Has remained this way since injection.  Have been do doctors, MRI, etc no one can find anything wrong.  No prior condition, no trauma.  Condition started again within a couple of hours after 2nd Moderna vaccine.
This spontaneous report was received from an administrator and refers to two patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unspecified date, the patients were vaccinated with doses of improperly stored ROTATEQ, orally, lot # K002991, expiration date 12-DEC-2015 (strength, dose and frequency were not provided). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
got for sick for 2-3 days; chills; muscle pain at the site of the shot and all over; muscle pain at the site of the shot and all over; when you're looking at something and you look away, he saw part of that image or flash of that image; weakness; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPSIA (when you're looking at something and you look away, he saw part of that image or flash of that image), ASTHENIA (weakness), VACCINATION COMPLICATION (got for sick for 2-3 days), CHILLS (chills) and VACCINATION SITE PAIN (muscle pain at the site of the shot and all over) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATENOLOL, SIMVASTATIN, FENOFIBRATE, OMEPRAZOLE, SITAGLIPTIN PHOSPHATE (JANUVIA), ZINC OXIDE (ZINC COMPOUND), PARACETAMOL (TYLENOL), DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PHOTOPSIA (when you're looking at something and you look away, he saw part of that image or flash of that image), ASTHENIA (weakness), CHILLS (chills), VACCINATION SITE PAIN (muscle pain at the site of the shot and all over) and MYALGIA (muscle pain at the site of the shot and all over). On an unknown date, the patient experienced VACCINATION COMPLICATION (got for sick for 2-3 days). On 27-Apr-2021, PHOTOPSIA (when you're looking at something and you look away, he saw part of that image or flash of that image), ASTHENIA (weakness), CHILLS (chills), VACCINATION SITE PAIN (muscle pain at the site of the shot and all over) and MYALGIA (muscle pain at the site of the shot and all over) had resolved. At the time of the report, VACCINATION COMPLICATION (got for sick for 2-3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported
It started with a sore throat then a headache and fever. I went to urgent care locally. I was given a COVID-19 test and it was positive. I emailed my PCP and I was emailed back to take PAXLOVID and took it for five days and then I was back to normal.
about 1 day after receiving the first shot, I had soreness at the injection site as well as a rash.  The soreness disappeared after approximately 2 days, but the rash remained for about 5 days.
Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 27-APR-2022; Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 27-APR-2022/ Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 27-APR-2022/ Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 27-APR-2022) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 016B21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 27-APR-2022/ Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 27-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 27-APR-2022/ Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 27-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Patient received first booster dose on 17-Nov-2021.  Date the vial was initially stored in the refrigerator was 11-Jan-2022. The vial did not undergo any temperature excursions. Patient received second booster dose on 27-Apr-2022. Patient did not reported any adverse reactions.  Treatment information was not provided by the reporter.
Within 2 hours of immunization. fevers,  tremulousness, irritability. inconsolably  crying. no alternative source for fever on exam same day.
Daily Headaches; 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 HEADACHE (Daily Headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.     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 HEADACHE (Daily Headaches). At the time of the report, HEADACHE (Daily Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter. No  concomitant medical  provided by the reporter.
sz onset about 3 1/2 days p/vax initially episode felt to be done to gastroesophageal reflux;sz disorder;
Painful sensory neuropathy, burning paresthesias, skin flaring.  Prickly sensation to extremities. Generalized fatigue, occipital headache.
Pt received vaccines during the day, that night pt had a seizure, clawing movement of extremities and rolling of eyes, peri-oral cyanosis; taken to emergency room.
Patient broke out in rash from head to toe covering entire body. No swelling or difficulties breathing. Red, raised, itchy rash. Patient treated with OTC diphenhydramine and aspirin around noon on 5/20/21 with no improvement/worsening of symptoms still at 2:30pm.
Felt fatigue; Body aches; Coughing up a little mucous; Dizzy feeling/ light-headed; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 09-SEP-2023, the patient received Arexvy (intramuscular, left arm). On 09-SEP-2023, 20 min after receiving Arexvy, the patient experienced dizziness (Verbatim: Dizzy feeling/ light-headed). On 10-SEP-2023, the patient experienced fatigue (Verbatim: Felt fatigue), general body pain (Verbatim: Body aches) and productive cough (Verbatim: Coughing up a little mucous).  On 09-SEP-2023, the outcome of the dizziness was resolved (duration 10 min).  On 11-SEP-2023, the outcome of the productive cough was resolved (duration 1 day). The outcome of the fatigue and general body pain were not resolved.   It was unknown if the reporter considered the fatigue, general body pain, dizziness and productive cough to be related to Arexvy.     It was unknown if the company considered the fatigue, general body pain, dizziness and productive cough to be related to Arexvy.   Additional Information: GSK Receipt Date: 11-SEP-2022/ 12-SEP-2023 The patient was self-reported this case. The patient reported that he received Arexvy vaccine and 20 minutes after received vaccine experienced light headed and felt dizzy. The patient sat in his truck for about 10 minutes and the light headed and feeling dizzy was resolved. The patient that on the next day 10th September 2023 he felt fatigue, body aches, and coughing up a little mucous.  The coughing of the mucous resolved 11th September 2023 but the fatigue and body aches are still present. The reporter reported that the patient went to the emergency department and two tests were performed both with negative results. The patient wanted safety to contact him directly so he can send the records from the emergency department. The reporter did not consent to follow up.
delayed reaction red blotchy spot; delayed reaction heat; itches; delayed reaction like a bee sting; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR, INJECTION SITE WARMTH, PRURITUS, and INJECTION SITE REACTION in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR, INJECTION SITE WARMTH, PRURITUS, and INJECTION SITE REACTION. At the time of the report, RASH MACULAR, INJECTION SITE WARMTH, PRURITUS, and INJECTION SITE REACTION outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.
Had 1st Pfizer vaccine on 3/13/2021.  2nd Pfizer vaccine on 4/5/2021.  Both vaccines at stadium.  On 4/6/2021, I noticed a pain in my left clavicle when I put on my seatbelt.  Upon feeling the area, found a lump on clavicle, size of a pea, which would move around.  The lump is not painful, but uncomfortable, especially when wearing my seatbelt.   Went to general physician on 4/8/2021, who said it would disappear in 3 weeks.  After 3 weeks, went to Dermatologist, Dr. on 4/30/21.  She put me on an antibiotic for 4 days, which did not change the lump.  She sent me to a surgeon for a biopsy.  Went to Dr. on 6/2/2021.  After examination and ultrasound, Dr. stated that because the lump moves around, specifically under the clavicle, he would end up doing more cutting than necessary, just to do a biopsy or removal.  Dr. indicated that it would be better to try to live with the lump, but if it continued to be unbearable in 3 months, come back and he would remove it.
Patient stood up after the vaccine and became flush, pale, he briefly loss consciousness about 10 seconds and then jerked awake.  He remembered the incident.  Did not hit his head.  He drank  a bottle of gatorade and was monitored for an hour before leaving.  He felt fine at discharge per patient.
Information has been received from a registered nurse (R.N.) concerning a 69 year old female who on 11-AUG-2008 was vaccinated with a dose of VARIVAX (Merck) (lot # 0319X) instead of ZOSTAVAX (Merck).  It was nurse error not product confusion.  No adverse effect reported.  No product quality complaint was involved.  Follow up information was received from a registered nurse (R.N.) which reported that this case was not a case of product confusion.  It was a case of human error.  The reporter did not elaborate on this.  The reporter simply said that the nurse made an error and offered no feedback or suggestions to help prevent this happening in the future.  The patient had not experienced any adverse events, and she would return in 28 days to be vaccinated with ZOSTAVAX (Merck).  Additional information has been requested.
Hot and cold flashes; Couldn't sleep last night; Couldn't go to work due to fever; Joint pain in fingers, so it was difficult to grab things; Joint pain in fingers, so it was difficult to grab things; High fever, spike to 103 F; Body aches; Vaccine received in shoulder and it hurts very bad there; Swollen in shoulder at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Hot and cold flashes), INSOMNIA (Couldn't sleep last night), IMPAIRED WORK ABILITY (Couldn't go to work due to fever), MUSCULAR WEAKNESS (Joint pain in fingers, so it was difficult to grab things) and ARTHRALGIA (Joint pain in fingers, so it was difficult to grab things) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Heart disease, unspecified.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccine received in shoulder and it hurts very bad there) and VACCINATION SITE SWELLING (Swollen in shoulder at injection site). On 06-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot and cold flashes), INSOMNIA (Couldn't sleep last night), IMPAIRED WORK ABILITY (Couldn't go to work due to fever), MUSCULAR WEAKNESS (Joint pain in fingers, so it was difficult to grab things), ARTHRALGIA (Joint pain in fingers, so it was difficult to grab things), PYREXIA (High fever, spike to 103 F) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Hot and cold flashes), INSOMNIA (Couldn't sleep last night), IMPAIRED WORK ABILITY (Couldn't go to work due to fever), MUSCULAR WEAKNESS (Joint pain in fingers, so it was difficult to grab things), ARTHRALGIA (Joint pain in fingers, so it was difficult to grab things), PYREXIA (High fever, spike to 103 F), MYALGIA (Body aches), VACCINATION SITE PAIN (Vaccine received in shoulder and it hurts very bad there) and VACCINATION SITE SWELLING (Swollen in shoulder at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Tingling of lips and hands. Burning of eyes, throat swelling, shortness of breath, dizziness, nausea.
Significant increase in depressive and anxiety symptoms. Menstrual cycle is also a week and counting late
20 minutes after vaccine, patient became tired, mottled, Temp >102F. Resolved with Motrin and Benadryl. Temp still present after 12 hours. Still with fever after 12 hours.
Fever of 101 at 4am the morning after receiving shot. Fever lasted for two days. Chills and extreme fatigue for two days. Pain at injection site in the arm that I still have now. It felt like I had a horrible flu and could barely get out of bed for two, almost three days. I also had breakthrough bleeding and had a period. I don't have periods because I take continuous cycles of birth control pills. So it's like it made the pills stop working.
10 minutes after vaccine pt complained of throat tingling and lip tingling. No swelling present, no trouble breathing, no drooling and no trouble speaking.  Pt states with her previous allergic reactions this has happened and she needed a steroid shot or a shot of bennadryl (pt couldnt remember which one). Pt had no derm reactions and denied pruritis.  We added 15 minutes to her observation time. Symptoms did not progress and they improved a little. She went home and was advised to take an oral benadryl when she got home if symptoms persisted. Pt in agreement with plan.
PHARMACIST IN CHARGE FAILED TO BOTH DILUTE CONCENTRATED COVID-19 BIVALENT UPDATED BOOSTER FOR 4 11 YEARS.  ALSO THE  VACCINE  SELECTION WAS NOT APPROPRIATE FOR AGE.   PHARMACIST ADMINISTERED  0.2 ML  IM TO PATIENT.  RESULTING IN 28.6 MCG GIVEN.    NO REPORTED ADVERSE REACTION REPORTEDC AT THIS TIME FROM PARENT.   PARENT ADVISED TO NOTIFY DOCTOR AT THERE EARLIEST CONVIENENCE.
blood on the band aide and on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HAEMORRHAGE (blood on the band aide and on the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced INJECTION SITE HAEMORRHAGE (blood on the band aide and on the injection site). At the time of the report, INJECTION SITE HAEMORRHAGE (blood on the band aide and on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Reporter'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.
There is no reported adverse event. Patient  received the formulation intended for children 5 to 11 years, resulting in underdoses. Patient received 0.2mL instead of 0.3ml.
Fever/chills, cough, muscle aches, fatigue, headache, itching and redness on lower legs.
Medical assistant administered 0.2 ml of undiluted dose. No immediate adverse reactions noted.
Headache; swollen lymph glands under the left armpit as well as on the left side of the neck; Same feeling of unwellness; Full body aches; This is a spontaneous report received from a contactable consumer (Patient) reported in response to HCP letter sent in Cross-Referenced case. A 29-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via intramuscular, administered in left arm on 24Jan2021 16:00 (at the age of 29 years old) as single dose for Covid-19 immunization. The patient medical history reported as none. Concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number/Expiry Date: EJ1686), via intramuscular route, administered in arm left on 03Jan2021 for covid-19 immunization and experienced body Aches and feeling of unwellness. On 24Jan2021 16:30, the day patient got 2nd dose, she experienced the same feeling of unwellness, full body aches, and had the side effects of a headache and swollen lymph glands under the left arm-pit as well as on the left side of the neck. Gradually the symptoms became more pronounced through-out the day but started within an hour of receiving vaccine. No test was performed. Therapeutic measures were taken as a result of full body aches and swollen lymph glands. Patient took Tylenol /Ibuprofen for swelling & aches. It was reported that there is reasonable possibility that the events full body aches and swollen lymph glands are related to suspect product. The outcome of events body Aches and feeling of unwellness was recovering and events headache and swollen lymph glands under the left armpit as well as on the left side of the neck was unknown.  No follow-up attempts are possible. Information on batch/lot number cannot be obtained. .
Nauseous 24/7 ,,arm still hurts like I was stabbed,,very tired I only want to sleep,,cold then hot then cold chills,,whole body hurts and I walk very slowly now,,diarrhea started today 4/22/2021..my daughter said I have slurred speech at times since the vaccine
Severe itchy bumps under the skin on fingers and toes, and base of fingers and toes.  From 4/9/21 - 4/18/21.   Worst in the mornings, like a flare up, and then subsided as the day progressed.
Arm hurt before I even got home from the shot.  Covid 19 Pfizer booster was given at the same time, same arm.  By next day I could hardly move my arm due to deep pain.  Arm constantly aches, or hurts, or has stabbing pain at injection site. Use of left arm has been limited for the past FIVE months.  Now the ache has affected my shoulder and neck and ache has gone down past my elbow into forearm. I have currently been experiencing a constant headache for approximately 3 days as the ache has crawled up my shoulder and neck. I have spoken to my orthopedic doctor in Oct. I believe, as well as my primary doctor (in Dec.) with no action taking place.