chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Now I feel good, Feel a little better than I did; Felt a little woozy-like; Arm hurt; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt a little woozy-like), PAIN IN EXTREMITY (Arm hurt) and FEELING OF RELAXATION (Now I feel good, Feel a little better than I did) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Diabetes, COPD and Allergy (Seasonal in the morning.). Concomitant products included AMLODIPINE for Blood pressure high, HYDROCHLOROTHIAZIDE for Diabetes, METFORMIN HCL and ALBUTEROL SULFATE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Felt a little woozy-like) and PAIN IN EXTREMITY (Arm hurt). On 04-Mar-2021, the patient experienced FEELING OF RELAXATION (Now I feel good, Feel a little better than I did). At the time of the report, DIZZINESS (Felt a little woozy-like), PAIN IN EXTREMITY (Arm hurt) and FEELING OF RELAXATION (Now I feel good, Feel a little better than I did) 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.
Patient developed right foot wound and was referred to Dr. for peripheral arterial disease.  Patient underwent right lower extremity angiogram 2 weeks ago and upon follow-up visit on February 1st, 2022 he was noted to be lethargic, febrile and having shortness of breath.  Patient was subsequently sent to the ER for further evaluation. Patient had tested positive prior to admission for Covid-19 at NH. Patient was diagnosed with Covid-19 pneumonia. Patient was able to wean off oxygen. Patient received IV antibiotics. Patient was discharged back to SNU
Information has been received from a Licensed Practical Nurse referring to a 26 year old female patient. Information about medical history and concurrent condition were unspecified. On 27-JAN-2016 the patient was vaccinated with her first dose of GARDASIL 9 (lot # L045711, expiration date 08-MAY-2017, 0.5 ml, intramuscular in the gluteal muscle) (Vaccine administered at inappropriate site). No adverse effects were reported. Additional information is not expected because the reporter did not want to be contacted.
Immediately after the vaccine on 3/20/21, I had some injection site muscle soreness.  Later that evening around 8:00 p.m., I developed episodes of vertigo- several per hour.   developed a fever overnight. The next day I was fatigued, achey, and continued to have vertigo.  I slept most of the day.  I continued to have episodes of vertigo and have been fatigued.  My vertigo is getting worse and it is 8 days post vaccine.
Fever, intermittent inconsolable screaming, extreme lethargy & hypotonia; Started day p/immun & lasted approx 36hrs;
might have gotten Covid around time booster; might have gotten Covid around time booster; headaches; GI trouble; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, single, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "might have gotten Covid around time booster"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "GI trouble".  Clinical course: Patient was eating out and stuff but did not think it was the vaccine. Caller stated that she did not have any further information to provide regarding her mother-in-law and her experience with the Covid vaccine. She stated that she thought she got the Pfizer but did not know.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Resident was sent to hospital for  exacerbations of multiple co-morbidities unrelated
16MAR93 mom states pt was taken home early from school c/o feeling dizzy, achy, stiffness in neck & arms; c/o pain in chest; 17MAR93 mom states pt has fever 102, dizzy, achy w/stiffness in neck & arms, c/o chest pain, denies vomiting; weak
the mother reported her daughter has a doctor's appointment on 10/1/2019 for an "unrelated issue"; This spontaneous report was received from a the patient's mother, referring to a female patient of unknown age. No information was provide regarding the patient's medical history, current conditions, concomitant medications, drug reactions or allergies.  On 22-APR-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophyylaxis (dose, route of administration, anatomical injection site, lot number and expiration date were not reported). On an unknown date in May 2019 (also reported as "one month later"), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophyylaxis (dose, route of administration, anatomical injection site, lot number and expiration date were not reported).   On 12-OCT-2019, the patent had a doctor's appointment for an "unrelated issue" (adverse event) and she wanted to know if her daughter could be administered the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The reporter didn't want to share the reason for the doctor's appointment.  At the time of the report, the outcome of the event was not reported. The reporter considered the event to be not related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 02/14/21Lot#EM9810 2nd dose03/08/21,lot#EN6206 Diagnosed covid positive:08/05/21 Symptom onset:08/03/21 Exposure:Home Symptoms:Fever, cough, fatigue, muscle aches,sore throat,chills,runny nose,headache.
NAUSEA; FEVER; MUSCLE PAIN AT INJECTION SITE (LEFT ARM)/AT INJECTION SITE FEELS VERY HOT; SWELLING AT INJECTION SITE (LEFT ARM); DROWSINESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroid, high blood pressure, and restless legs.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced drowsiness. On 15-JUN-2021, the subject experienced muscle pain at injection site (left arm) /at injection site feels very hot. On 15-JUN-2021, the subject experienced swelling at injection site (left arm). On 16-JUN-2021, the subject experienced nausea. On 16-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drowsiness on 14-JUN-2021, and had not recovered from nausea, fever, muscle pain at injection site (left arm)/at injection site feels very hot, and swelling at injection site (left arm). This report was non-serious.
a couple minutes after receiving the vaccine the patient reported nausea.  was directed to have a seat, provided with a bag in case of vomitting (not needed) and a bottle of water.  a few minutes later she was feeling better.  had patient remain at pharmacy for 30 minutes post vaccination. and she continued to be fine.
Rash starting from injection site on right arm extending down arm to wrist with heat and some edema.
patient was administered expired dose of Fluzone Trivalent High Dose, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Agency (Reference number- 00368960) and transmitted to Sanofi on 23-Nov-2020.  This case involves a patient (unknown demographics) who was vaccinated with 0.5ml of an expired dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (lot number and expiry date: not reported) once via an unknown route at an unknown administration site for prophylactic vaccination(expired product administered) on an unknown date.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   It was a case of actual medication error due to expired vaccine used (latency on same day).  The pharmacist stated that the event occurred possibly due to Coronavirus Disease 2019 (COVID-19) the refrigerator not being cleared out appropriately of expired stock, that the event occurred at a nursing home serviced by the Pharmacy and the expired syringe used had been placed in a sharps container for disposal. The consumer and vaccine information was unknown to the reporter and reporter did not have any more information on this report due to just being the person researching solutions for the event. The reporter wanted guidance on how to proceed   Reporter relationship: health care professional (HCP), Product used: used, still using product: no  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
ARM SORE AT INJECTIO  SITE;  ARM SORE FROM ELBOW TO SHOULDER WITH INTERMITTEN SHOOTING PAINS FROM INJECTION SITE TO SHOULDER.
After receiving my second dose, I had a really bad rash that was about 3 x6 inches long. It was more area than around the injection site. I ended up with a raised area. My doctor is not sure if it was swelling or something else. There is a hard knot that was about an inch tall that raised from my leg and took up almost the entire circumference of my leg. I tried Benadryl and Hydrocortisone cream, but it didn't help. My doctor put me on Keflexan and it helped tremendously. The initial swelling had gone into my hip. I was experiencing general body aches as well. It was 18x3x1 and that is the size it got to after about a week after injection. I'm mildly immunocompromised and I'm not sure if that has to do with my reaction.
This client received a dose of J&J on 5/27/21, after having already received a dose on Moderna on 1/5/21 unbeknownst to the vaccinator.
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On or about 22-APR-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at a clinic for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would 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 would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Inconsolable crying for at least 3 hours.  MOP took child to the emergency department who reported as stable, normal vital signs and normal exam.
first Shingrix dose 2 years ago / never received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter asked, if the patient would need just 1 dose to complete the series even though it had been so long since her first dose. The first dose was not administered at the pharmacy where the pharmacist was calling from therefore, she did not have any further information such as the exact date of administration, the lot number, or the route of administration.
Pt recvd vax 1030AM 9OCT91; pt convulsed @ 130PM mom took pt to Hosp was dx as febrile sz;
Swollen arm pit lymph node for three weeks, about a week in, psoriasis appeared on forehead, behind the hairline, which I have never had before.
Hives developed same evening of receiving vaccines. Affected areas included chest, neck and face. Patient took antihistamines (Benadryl) and other antihistamines the day after. It has not worsened by the time the patient reported it to the pharmacy on 9/23/22 at 9:30 am but it remains itchy. Recommended for patient to continue antihistamines, continue with fluids, add an acid reducer like Zantac or Pepcid.
Vaccine made back pain worse; Extreme muscle pain; Extreme joint pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Vaccine made back pain worse), MYALGIA (Extreme muscle pain) and ARTHRALGIA (Extreme joint pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Back injury.    On 10-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 BACK PAIN (Vaccine made back pain worse), MYALGIA (Extreme muscle pain) and ARTHRALGIA (Extreme joint pain). The patient was treated with Physical therapy (uses physical therapy for her back pain) for Back pain. At the time of the report, BACK PAIN (Vaccine made back pain worse), MYALGIA (Extreme muscle pain) and ARTHRALGIA (Extreme joint pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       P atient has history of back injury which occurred about 10 months ago, back pain was getting better, but the vaccine has made it worse.Does not take any medications, and uses physical therapy for her back pain.
pt recvd vax & 6 hrs after vax was pale, gray lips w/ ice cold extremities; was screaming inconsolably then listless; vomitted & had explosive diarrhea;
My daughter woke up around 5:00 am crying for help.  I ran to her room where she had collapsed but was conscious.  She vomited and lost control of her bodily functions.  She peed on herself.  She was shaking and asking me to call 911.  She was saying she was dying.  I ran to get my phone and when I was calling 911 she said she was feeling ok after vomiting.  She is better now but the only symptom is she has a sharp pain in her whole arm, not only the point of needle entry.  Its hard for her to move her arm and she describes it as "excruciating pain."
Pregnancy on 4/1/21. Pregnancy confirmation ultrasound on 5/13/21 showed missed abortion. D&C performed 5/14/21.
When I woke up the next, I had severe muscle pain for the whole body, chills, nausea,  headache, sharp pain to the back of the head. Today (3/10/2021) I don't feel muscle pain for the whole body, chills, nausea but I have sharp pain inside left ears, headache and dizzy.
If she lightly touches or rubs her skin, skin gets red or breaks out Also happens with hotter temperature such as heat or shower makes it worse as it brings it out; Dermographia/Started developing itchy skin/Hives, Hives reaction; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Dermographia/Started developing itchy skin/Hives, Hives reaction) and SKIN DISORDER (If she lightly touches or rubs her skin, skin gets red or breaks out Also happens with hotter temperature such as heat or shower makes it worse as it brings it out) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 046E21A) for COVID-19 vaccination.     Patient had no allergies in past.  Concomitant products included SERTRALINE for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, the patient experienced MECHANICAL URTICARIA (Dermographia/Started developing itchy skin/Hives, Hives reaction). On an unknown date, the patient experienced SKIN DISORDER (If she lightly touches or rubs her skin, skin gets red or breaks out Also happens with hotter temperature such as heat or shower makes it worse as it brings it out). The patient was treated with PREDNISONE for Adverse event, at a dose of prednisone for 6 days. and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MECHANICAL URTICARIA (Dermographia/Started developing itchy skin/Hives, Hives reaction) and SKIN DISORDER (If she lightly touches or rubs her skin, skin gets red or breaks out Also happens with hotter temperature such as heat or shower makes it worse as it brings it out) had not resolved.            The concomitant medication was Birth control medicine. Patient reported that she had Covid-19 in December2021(after the first 2 doses of Moderna Vaccine).  The patient stated that if she lightly touches or rubs her skin, skin gets red or breaks out and it also happened with hotter temperature such as heat or shower made it worse as it brings it out. The patient stated that she could not wear makeup or wear scented products and stated that she had a reaction to the booster dose.  The patient stated that she was taking Zyrtec daily and the doctor said it could take weeks to months to improve per the patient.
Patient experienced nausea and dizziness some time after her vaccinated booster Moderna Bivalent dose.  Started to experience dry mouth/cotton mouth.  Some water was provided and patient was observed further for safety until patient was able to tolerate her symptoms and left on her own without any assistance.
Woke up next morning with low-grade fever, headache, upset stomach, body ache all over.  Seemed to get worse as the day progressed.  Took sleeping aid Sunday night and was able to sleep through the night.  Monday morning, felt much better, but symptoms began to return around noon and by night fall they were worse than ever.  Took sleeping aid again and was able to sleep through the night.  Tuesday morning, felt much better and continued to feel much better, except very fatigued.
Patient experienced 5-6 bouts of diarrhea within 10 months of vaccination.  After she was about 18 mo the bouts of diarrhea seemed to stop.  She was totally breastfed until she was twelve 11 months old, and she was not in any sort of childcare outside of the home, norr was her older sister, yet she kept getting 3-4 day diarrhea viruses.  As of today she has no food allergies, I am convinced it is vaccine related.
Late on day 7 post vaccine,  I noticed a small red rash about 3 inches below the site of injection. On day 8 the red rash doubled in size, was bright red and hot to the touch. I made an appt with urgent care and they put me on Keflex and told me to follow up with my primary.
Stiffness joints; Mobility decreased; runny nose; pain; wrist pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Stiffness joints), MOBILITY DECREASED (Mobility decreased), RHINORRHOEA (runny nose), PAIN (pain) and ARTHRALGIA (wrist pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 003A21!,) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JOINT STIFFNESS (Stiffness joints), MOBILITY DECREASED (Mobility decreased), RHINORRHOEA (runny nose), PAIN (pain) and ARTHRALGIA (wrist pain). At the time of the report, JOINT STIFFNESS (Stiffness joints), MOBILITY DECREASED (Mobility decreased), RHINORRHOEA (runny nose), PAIN (pain) and ARTHRALGIA (wrist pain) had resolved.            No treatment medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received on 28-Jul-2021 and contains no new information.
Stiffness; Swelling; Left shoulder became sore; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness), SWELLING (Swelling) and ARTHRALGIA (Left shoulder became sore) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness), SWELLING (Swelling) and ARTHRALGIA (Left shoulder became sore). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness), SWELLING (Swelling) and ARTHRALGIA (Left shoulder became sore) outcome was unknown.            No concomitant medications was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Non significant FU- updated Mailing Address