chrisvoncsefalvay/vaers-outcomes huggingface dataset:
edema on my legs; 6 inch long and 2 inch wide patch of pink rash/ rash on my back/rash on my legs; sore; 2 little circles around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore), VACCINATION SITE REACTION (2 little circles around the injection site), RASH (6 inch long and 2 inch wide patch of pink rash/ rash on my back/rash on my legs) and OEDEMA PERIPHERAL (edema on my legs) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore) and VACCINATION SITE REACTION (2 little circles around the injection site). On 22-Feb-2021, the patient experienced RASH (6 inch long and 2 inch wide patch of pink rash/ rash on my back/rash on my legs). On 02-Mar-2021, the patient experienced OEDEMA PERIPHERAL (edema on my legs). At the time of the report, PAIN IN EXTREMITY (sore), RASH (6 inch long and 2 inch wide patch of pink rash/ rash on my back/rash on my legs) and OEDEMA PERIPHERAL (edema on my legs) outcome was unknown and VACCINATION SITE REACTION (2 little circles around the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Blood pressure was very very high; Felt terrible; Itching; Rash goin gall the way to elbow; Left arm was hot; Swollen; allergic reaction unspecified/adverse allergic reaction; Didn't feel good; Feel very tired; Left arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Didn't feel good), SKIN WARM (Left arm was hot), VACCINATION SITE SWELLING (Swollen), HYPERTENSION (Blood pressure was very very high) and FEELING ABNORMAL (Felt terrible) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high (Unspecified blood pressure) and Glaucoma. Concomitant products included HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN HCTZ) for Blood pressure abnormal, NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Glaucoma, SIMVASTATIN for an unknown indication.  On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 12-Jan-2021, the patient experienced INJECTION SITE PAIN (Left arm was sore). On 18-Jan-2021, the patient experienced MALAISE (Didn't feel good) and FATIGUE (Feel very tired).   On 21-Jan-2021, the patient experienced SKIN WARM (Left arm was hot), VACCINATION SITE SWELLING (Swollen), RASH (Rash goin gall the way to elbow) and HYPERSENSITIVITY (allergic reaction unspecified/adverse allergic reaction).   On 22-Jan-2021, the patient experienced HYPERTENSION (Blood pressure was very very high), FEELING ABNORMAL (Felt terrible) and PRURITUS (Itching). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency; PEPSIN for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency.   At the time of the report, MALAISE (Didn't feel good), SKIN WARM (Left arm was hot), VACCINATION SITE SWELLING (Swollen), HYPERTENSION (Blood pressure was very very high), FEELING ABNORMAL (Felt terrible), PRURITUS (Itching), INJECTION SITE PAIN (Left arm was sore) and FATIGUE (Feel very tired) had resolved, RASH (Rash goin gall the way to elbow) was resolving and HYPERSENSITIVITY (allergic reaction unspecified/adverse allergic reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Blood pressure measurement: 166/100 166/100.   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.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: NNI No specific follow-up information recorded.
5 minutes after vaccine administration ( Moderna COVID19 vaccine, Lot 009C21A) in LA via IM, the patient started feeling warm, dizzy, and unwell. Complained of burning in the chest, flying dust in his eyes, and feeling very hot.
can't eat; smells it when she breaths; Smell is nauseating; she has metallic taste and smell; everything smells and tastes like metal\Everything tastes gross; smell and tastes like coins; she has metallic taste and smell; everything smells and tastes like metal; she as a weird aluminum foil foul smell in her mouth.; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (she has metallic taste and smell; everything smells and tastes like metal\Everything tastes gross; smell and tastes like coins), PAROSMIA (she has metallic taste and smell; everything smells and tastes like metal), ORAL DISCOMFORT (she as a weird aluminum foil foul smell in her mouth.), EATING DISORDER (can't eat) and BREATH ODOUR (smells it when she breaths) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had loss of smell and tastes like metal). Concurrent medical conditions included Ulcerative colitis and Colitis (interstitial colitis). Concomitant products included OXYBUTYNIN and ALMOTRIPTAN MALATE (ALMOGRAN) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DYSGEUSIA (she has metallic taste and smell; everything smells and tastes like metal\Everything tastes gross; smell and tastes like coins), PAROSMIA (she has metallic taste and smell; everything smells and tastes like metal) and ORAL DISCOMFORT (she as a weird aluminum foil foul smell in her mouth.). On 08-Mar-2021, the patient experienced EATING DISORDER (can't eat), BREATH ODOUR (smells it when she breaths) and NAUSEA (Smell is nauseating). At the time of the report, DYSGEUSIA (she has metallic taste and smell; everything smells and tastes like metal\Everything tastes gross; smell and tastes like coins), PAROSMIA (she has metallic taste and smell; everything smells and tastes like metal), ORAL DISCOMFORT (she as a weird aluminum foil foul smell in her mouth.), EATING DISORDER (can't eat), BREATH ODOUR (smells it when she breaths) and NAUSEA (Smell is nauseating) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included natural holistic remedy tea with ginger and turmeric. Also, said her sister gave her a natural holistic remedy.
Day 1 after vaccination, left arm achy, sore, left wrist/left hand swelling, deep ache to left hand wrist, left eye floater, blurry vision.   Day 2 after vaccination, continued with same symptoms, left eye "puffiness".  1/4/2021Today continues with left eye floater and constant blurry vision.  Left hand soreness to and left shoulder
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 26-APR-2017 the patient was vaccinated with expired dose of ROTATEQ (dosing details were not reported) (lot # L023870, expiry date: 20-APR-2017) orally for prophylaxis (expired vaccine used). No adverse effects were reported. There was no product quality complaint.   Additional information has been requested.
10-12 mm induration, 25mm inflammation in left arm. Attached page adds (after giving immunization record):  Pt reports to BMC c/o rash to left shoulder, + pruritic, + inflammation with approx 10-12 mm induration. Inflamed area is 25mm, pt scratched area slightly yesterday. A) Allergic reaction x 1099. P) 1) Consult with pt; 2) Obtain numbers to contact; 3) Benadryl 25mg PO TID for 3 days #9; 4) RTC PRN.
left arm redness, induration, warmth, consistent with cellulitis, approximately 10 x 8cm
Vaccine was administered higher than recommended. Noted red, raised and irritated at site of injection. Hot/warm to touch. Pt describes pain with palpation and warmth that travels from injection site to the shoulder. Induration is approximately 2 inches in length and 1 inch in width. This patient is being reported in case her reaction gets worse through the month.  Instructed patient to go to her primary clinic if symptoms worsen.
On 1/15 developed Fatigue, headache, fever, chills and body aches.   Employee health swabbed her by PCR and test was Positive for Covid.  On 1/16 had no symptoms and was retested by PCR and was Negative.
No additional AE; VARIVAX underwent a temperature excursion, and the VARlVAX was administered to a patient; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.       On 01-MAR-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # U016063 with expiration date 20-MAY-2023, for prophylaxis (strength, dose, route of administration and anatomical location were not reported). No additional adverse event (AE) was reported. It was sated that the vaccine was exposed to a temperature of -14.3 °C for 40 minutes. There were not previous temperature excursions.
Sedation, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, injection site discomfort, fatigue, and tiredness Narrative:
Temperature, swollen upper left arm, hot to touch, sore. Shots received 8/4/10.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2 NOS), on 25Nov2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 23Apr2023 to 28Apr2023. Clinical course: Patient was not taking any other medications in 2 weeks. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300181341 Same patient, different product, different event;
Patient said next day she couldn't get out of bed. she felt terrible and developed a rash on her neck and upper chest. 2 days later she was able to come into pharmacy by still has rash and doesn't feel well
After receiving dose 2/2 of the Shingrix  vaccine, patient noticed a rash that started the next day. She reports that the rash was from head to toe and was not itchy or burning. She said it resembled a heat rash. She also had a fever (patient did not actually take her temperature but could tell). This lasted for 3 days. The rash then peeled. During the rash phase, she applied cetaphil to her skin. After receiving the first dose of Shingrix, patient said she got a mild rash on the areas around her joints, thighs, chest, and had a mild fever for 24 hours. Because of this, the pharmacist recommended the patient to take Aleve and Benadryl as prophylaxis for the second shot.
Client got a migraine type headache around 5:00 pm. that night.  Headache continued for 24 hours.  No problems with infection site.
Family members report the individual felt confused and presented with slurred speech. They took the individual to a local emergency room where it was determined their blood pressure was significantly elevated. The individual has since been transferred to a different hospital.
Patient was accidentally given COVID booster shot intradermally in left forearm at 10:45 am this morning. Slight blotchiness to left forearm noted at injection site. Nursing will continue to monitor. V/S stable Mom is at residence and was advised of the incident. Patient received the correct PPD in right forearm as well as the Gardasil immunization in left deltoid at 10:50 am. Re-assessed 1 hour later;  No negative findings at injection site.
I test positive for COVID on 06/28/2021. I have had a slight fever, congestion, sore throat, coughing, pain in the lungs.
Numbness in face, neck and mouth.  Red Rash on face and neck.  Dizzy.
Stroke  in the hospital for 2 days now taking High Blood Pressure medication, Sugar  is high, and had  to  do Speech, Physical, and occupational Therapy.  Now  taking medication for blood pressure and checking blood sugar daily.
Seems like I developed mild/slight louder tinnitus in my right ear. Ringing/whining sound
(L) arm cellulitis. KEFLEX got Clindamycin in hospital.
This spontaneous report was received from a pharmacist, and refers to a 26 year old female patient. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 30-JUL-2018, the patient was vaccinated with a second dose of GARDASIL 9 lot # N028092 with expiration date on 28-MAY-2020 for prophylaxis (dose and route were not reported), an unspecified number of months from November 2017.
BODY ACHE; FEEL AWFUL; CHILLS; HEADACHE; BODY TEMPERATURE (101.0 TEMPERATURE); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, feel awful, chills, headache, and body temperature (101.0 temperature). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.0 temp. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body ache, chills, headache, feel awful and body temperature (101.0 temperature) was not reported. This report was non-serious.
pain/ pain in her arm and from her waist to her knees; pain/ pain in her arm and from her waist to her knees; pain/ pain in her arm and from her waist to her knees; fatigue; myalgia; arthritis; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic (allergies to cephalosporin, penicillin, and macrolides).   On 21st May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm, lumbar pain, knee pain, fatigue, myalgia and arthritis. On an unknown date, the outcome of the pain in arm, lumbar pain, knee pain, fatigue, myalgia and arthritis were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, lumbar pain, knee pain, fatigue, myalgia and arthritis to be related to Shingrix.  Additional details were provided as follows: This case was reported by the pharmacy intern. The reporter did not have the lot number and expiration date of vaccine. The patient received the vaccine at different site and experienced pain in her arm and from her waist to her knees, fatigue and myalgia. The patient also stated that it feels like she had arthritis.
At 2am I woke up with severe headache 9/10, sweating chills, fever on three different thermometers. 100.5, 100.6, 100.8, my right arm I couldn't not move it was just hanging there dead, I called my dr the AM of 31st, he prescribed solumedrol pack for the headache, acitomenaphine,, he asked me to get covid tested, I got results on the 1/2/2021 I was positive, I retested on 1/5/2021 and results were negative on the 6th, I retested again on 1/7 and reported 1/8 I was negative,  I went to local pharmacy that did antibody testing: they marked IGM and IGGM  positive - resulting in I had Covid, I quarantined and took 5-6 days to feel better.  I think I already had covid and that may be why I had that reaction  I get a monthly allergy shot - because I'm allergic to a lot
After 1 1/2 hr. after covid vaccine Tongue swelled with sores went to Urgent care 2 weeks tleso GBS - (Guillente Bane Syndrome) came on strong- Dr. Prespript Prednisone-needed hospital but full of Corona Virus. Urgent Care.
Developed hard bump in arm that grew in size. She felt itching in the arm of injection that spread over entire body. She had the previous two hepatitis vaccinations with a different manufacturer.
stated that she feels weak; has a bad pain in her left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 (Batch/Lot number: unknown) at the age of 67 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ACETAMINOPHEN taken for pain. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "has a bad pain in her left arm"; ASTHENIA (non-serious), outcome "unknown", described as "stated that she feels weak". Therapeutic measures were taken as a result of pain in extremity.  Additional information: Patient reported that she got her vaccine 03Mar stated that she knows that the pain in the arm for most people is supposed to be 2-3 days. Stated that she still has a bad pain in her arm. Stated she feels weak. Stated that she takes Acetaminophen for pain and it does not help. Stated that she is to receive the second one 25Mar. Patient clarified that it is her left arm. Patient reported that the pain started two weeks after the vaccine. Stated that she feels relief when she puts something hot on it or takes pain killers.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Palpitations, tachycardia, chest pains after 2 days, orthostatic intolerance requiring wheelchair. 6 days post-vaccine fever 38C, diarrhea with cardiac sx. Outcome to be monitored still.
Information as received from a nurse concerning unspecified number of unspecified patients of unknown age and gender. Concurrent condition, concomitant medication and medical history were not provided. On an unknown date, the patients were administered improperly stored doses of M-M-R II (lot # L036851, expiration date 23-SEP-2017; lot # L039551, expiration date 07-OCT-2017; lot # M004063, expiration date 25-JAN-2018; lot # M004063, expiration date 16-FEB-2018) (strength, dose, frequency and route were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Gardasll victim's 25(0H)vitD to decllno so badly that his spinal column began to fracture; Gardasll victim's 25(0H)vitD to decllno so badly that his spinal column began to fracture; This spontaneous report was received from an unspecified and refers to an 18-year-old male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced 25(OH)vitamin D decrease so bad that his spinal column began to fracture. At the time of reporting, the outcome of the event s was not known.  The causal relationship between the events and suspect therapies was unknown  Upon internal review, the event spinal fracture was determined to be medically significant.
Feet began to hurt 3/1/10. With steadily increasing discomfort over several days. Feet and fingers progressively became numb. By 3/10/10 hands and feet to mid calves were numb and weak.
I got some sore arm, and high fever after couple hours, followed by headaches , chills and body aches, tiredness. Took paracetamol and ibuprofen otc. That cause me unable to go to work.
Caregiver Health Manager, reporting a med error on behalf of the vaccine administrator, LVN, On 1/8/2021, employee received Moderna COVID vaccine dose #2 when her dose #1 was Pfizer.  Date of first dose was 12/21/2020.  From reviewing the process and witnesses in the vaccination area, this employee missed the check-in desk in lobby prior to going to the vaccination area.  There was no validation of her 1st dose date and manufacture; this step is usually done at the front check-in desk .  She did not bring her CDC vaccination card of dose #1 of COVID-19.  She was not able to recall the name of her dose #1 COVID-19 vaccine which was later validated as Pfizer.  LVN, administered the Moderna COVID vaccine for dose #2 in error as today.  She should have received Pfizer for dose 2 instead.  There is no harm at this time.  As of today, 1/12/2021, no adverse effect is reported from this employee.
15 month old patient was given expired Daptacel/ no AE; Initial information received on 16-Apr-2019 regarding an unsolicited valid non-serious case received from a physician by phone.  This case involves a 15 months old female patient who was vaccinated with 0.5 ml expired fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5171AA and expiry date: 23-Mar-2019) via intramuscular route in the left thigh on 16-Apr-2019  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  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 holders 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.   Documents held by the sender: none.
Hives-on DTaP arm raised 2 x 3 inches.  IPV arm: few hives, hives on back and abdomen.
Alopecia Areata- Full scalp involvement  which began approximately 1 week post dose # 2, full symptoms w/in 3 weeks at time of dose # 3.; 0 treatment to dose.