chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Achey all over; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achey all over), CHILLS (Chills) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included VITAMINS NOS and ACETYLSALICYLIC ACID (BABY ASPIRIN) 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 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced MYALGIA (Achey all over), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, MYALGIA (Achey all over), CHILLS (Chills) and HEADACHE (Headache) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant medication included unspecified Blood Pressure medications. No treatment medication details was reported.
inside of mouth swollen with blisters; left bottom lip bumpy like an orange peel; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL BLISTERING (inside of mouth swollen with blisters) and LIP SWELLING (left bottom lip bumpy like an orange peel) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Salivary gland operation (left salivary gland cut out) in October 2019. Concomitant products included DOXYCYCLINE for Eye disorder.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced ORAL MUCOSAL BLISTERING (inside of mouth swollen with blisters) and LIP SWELLING (left bottom lip bumpy like an orange peel). At the time of the report, ORAL MUCOSAL BLISTERING (inside of mouth swollen with blisters) and LIP SWELLING (left bottom lip bumpy like an orange peel) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment given included paste to put on mouth sores.
FLUBLOK QUADRIVALENT was administered to a 16 year old, no AE; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 16 years old female patient who was vaccinated with a 0.5 ml dose  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2016 and expiration date : 30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination on 15-Oct-2020 (PT: product administered to patient of inappropriate age).  Medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration (same day latency).  No adverse event reported at the time of reporting.  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.
This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on Jan-2021 and next dose 6 months later) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Sinus disorder (sinus sufferer for the last 25 years).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on Jan-2021 and next dose 6 months later). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on Jan-2021 and next dose 6 months later) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No information on concomitant medication was reported. No information on treatment medications was reported.   This case was linked to MOD-2022-562493 (Patient Link).
Palpitations, particularly when supine, as well as chest pain and shortness of breath which lasted approximately 2 weeks. She was seen in the hospital ER without cause found and labs were normal. Palpitations self-resolved within 6-8 weeks after initiation.
Approximately one minute after receiving vaccine, the patient felt like she needed to sit down. About 10 minutes later, she felt like she was going to pass out and we helped her lay on the ground.  She passed out,  we lifted her legs as she was lying down, and she came to.  We gave her a bottle of orange juice. She continued to lay down and say she didn't feel well. She drank a whole bottle of orange juice and still wasn't feeling well and her husband asked for a second bottle.  She said she felt cold, so we gave her a sweater.  She had gotten to a sitting position at this point but then said she felt like she needed to lay down again.  She started shivering, visibly shaking from being cold.  We gave her another sweater to put over her legs.  At this point it had been about 25 minutes since we gave the vaccine and we called the paramedics, as she wasn't improving.  They arrived, took her vitals and ended up taking her to the hospital to check everything out more in depth and monitor pregnancy stats.  We called her when she got home from the hospital- they had given her fluids and she is feeling better now.
Arm pain, injection site pain, diarrheah, dizziness, general feeling of unwellness, slight feverr, headache
No adverse reactions. Second booster dose was administered prior to 4 months following previous booster for COVID. Was given 15 weeks following first booster dose.
PFIZER vaccine that was stored in pharmacy refrigerator given outside of 31 day expiration. Vaccine received at hospital on 11/19/2021. Expiration date on vial 02/2022. NDC# 5926710000.
Headache, Fever, NauseaVomiting, HYPERtension, BURNING THROAT Narrative:
Strong body aches; Weakness; Chills; Fever over 101; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 11Apr2021 at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none. The patient had no known allergies to any medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 21Mar2021 at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 12Apr2021 at 02:00, the patient experienced strong body aches, weakness, chills and a fever over 101 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not as a result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events strong body aches, weakness, chills, fever over 101 was resolved on an unspecified date in Apr2021.   No follow-up attempts are possible. No further information is expected.
slight chills; diarrhea; sore; heavy mucus/getting mucus in the back of the throat; weight went down; This is a spontaneous report from a contactable consumer (patient). A 84-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208), via an unspecified route on 09Mar2021 at 13:30 (at the age of 84-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included high blood pressure, high cholesterol. The patient concomitant medications included losartan with dose 100 mg, 1x/day for high blood pressure and rosuvastatin with dose 20 mg, 1x/day for high cholesterol and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021, the patient experienced getting a lot more mucus in the back of the throat. Patient stated it had been getting a lot more in the last couple of days. On 10Mar2021, the patient experienced sore the next day a little bit, on 17Mar2021 patient experienced diarrhoea and at 03:00 in the morning slight chills. He said that his weight went down since the diarrhoea. He said that he usually weighs around 220llbs. He said that he had shrunk with his age. Patient stated that he had to get up every hour at night and found a book called Remedies and it said something about carrot juice and also said something about blueberries. He said that he crushed up some blueberries and ate them and it went through him like roto-rooter. He said that he only had one episode of diarrhoea last night. He said that it seems more semi solid now and had slowed down. He said that the mucus seems to have slowed down now. He said that his second dose is due on the 30Mar2021. The patient did not visited emergency room or physician office. The outcome of events getting mucus in the back of the throat, diarrhoea was recovering, chills was recovered on 17Mar2021 and other events was unknown.  No follow-up attempts are possible. No further information is expected.
After 2nd dose: Body aches, joint pain, chills, fever, nauseated, headache, rash for 3 days.
14 hours after the shot, woke up in the middle of the night with some chills, followed by difficulty breathing. Throat felt narrowed. Lasted for about 2 hours. The next 8 days chest feels heavy and have to catch a breath here and there. Today is day 8
Tested Positive for COVID-19. No severe symptoms. Mild symptoms. Feels like really bad allergies. Lots of sneezing.
SIDE EFFECTS WERE EXAGGERATED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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 not reported, batch number: Unk) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On JUL-2021, the subject experienced side effects were exaggerated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from side effects were exaggerated. This report was non-serious. This case, from the same reporter is linked to 20210741809 and 20210740931.
on her left forearm she had 5 new petechiae spots in a row; This spontaneous case was reported by a consumer and describes the occurrence of PETECHIAE (on her left forearm she had 5 new petechiae spots in a row) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Petechiae. Concomitant products included LISINOPRIL for an unknown indication.    On 10-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 PETECHIAE (on her left forearm she had 5 new petechiae spots in a row). At the time of the report, PETECHIAE (on her left forearm she had 5 new petechiae spots in a row) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count: normal (normal) Normal.     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 medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Significant followup document was received on 15-JUL-2021 and it includes outcome of the event (on her left forearm she had 5 new petechiae spots in a row)
Left arm reddened, warm to touch from shoulder to elbow. Upper left arm twice the size of upper right arm.
received the 2nd dose of Havrix 14 months after the 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (1st dose received on 7th August 2019).   On 2nd October 2020, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On 2nd October 2020, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that a patient received the 2nd dose of Havrix, 14 months after the 1st dose of vaccine. The patient received 2nd dose of Havrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up via  email.
Long term painful arm, then a crazy fluctuating fever with headache and chills for 5 days 3 weeks after shot, followed by congestion, coughing and then a growing red rash patch at sight of injection.  Now 5 weeks later, hives all over my body including rash at injection site. Becoming itchier daily, not responding to antihistamines.
On 5/12/01, low-grade fever, runny eyes, coughing and runny nose. On 5/14/01, placed on antibiotic for "pus pocket" throat. On 5/16/01, rash and antibiotic stopped. On 5/18/01, clear.
Blood Sugar spike; This is a spontaneous report from a non-contactable consumer. A non-pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Feb2021 (Batch/Lot number were not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On 11Feb2021, the patient experienced blood sugar spike. The patient underwent lab tests and procedures which included blood sugar with a result of "spike" on 11Feb2021. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. got vaccination on 8/21/14, and is still complaining of arm soreness and tenderness. She claims there is something in there that feels like a clot. Pt. is calling complain today 11/20/14.
After giving 3rd immunization, client went stiff in father's lap and appeared to lose consciousness.  Client moved to exam table and feet elevated.  Client immediately responsive but sleepy, able to answer questions but sleepy.  Oxygen saturation levels 99-100%.  Client given sips of water and fruit snacks and after eating several fruit snacks, client returned to baseline.
fatigue; real tired; swelling at the injection site - left arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), FATIGUE (real tired) and INJECTION SITE SWELLING (swelling at the injection site - left arm) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for an unknown indication.     The patient's past medical history included No adverse reaction.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced FATIGUE (fatigue), FATIGUE (real tired) and INJECTION SITE SWELLING (swelling at the injection site - left arm). At the time of the report, FATIGUE (fatigue), FATIGUE (real tired) and INJECTION SITE SWELLING (swelling at the injection site - left arm) outcome was unknown.        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.   Reporter did not allow further contact
Pt with a history of tinnitus and hearing loss in her left ear.  Seen at ENT in February of 2022.  Per note, "This is a 65 year old female reporting slight itchiness in ears that comes and goes. (Referral for tinnitus/beeping, but she denies this symptom repeatedly) Normal exam of ears bilaterally. They had an audiogram 2/2/22 which showed, in brief, normal hearing sensitivity through 2000 Hz sloping to a mild sensorineural hearing loss in each ear. See audiology note for full details. Recommended she stop Qtips use. Can trial dermotic ear drops as needed for ear itchiness. Do not use more than 1 week per month. Follow up in 1 year for audiogram to monitor hearing loss. " She received her moderna booster on 8/10/22 then returned to facility on 8/17/22 reporting she has pounding and hearing loss in her ears.  R ear pounding when she covers the L ear.  Ear wax removal offered but hse refused this day.  Returned and seen a provider on 8/22/22 with tinnitus and hearing loss in R ear and was referred back to ENT.  She seen ENT on 9/7/22 and per their note, " Based on today's results, hearing is deemed inadequate for successful communication at this time. Communication difficulties are expected in most listening environments, especially when speech is directed toward the right ear. Patient to follow up with Dr. on this date.  Impression & Plan:   1. Sudden hearing loss AD  Discussed steroid IT injections with risks and benefits vs oral prednisone and its risks and benefits including hip necrosis I answered all questions. The risks and benefits were discussed in great detail and some of the risks included pain, bleeding, infection, partial or total hearing loss, temporary or permanent vertigo/disequilibrium, tinnitus, TM perforation, cholesteatoma,  2. Cerumen impaction AU NOTE: Cannot examine the TM or middle ear due to blockage and need to see to complete the exam for the patients complaint  Under the microscope each ear was done in a similar fashion. Utilizing microscopic instrumentation the ear canals were cleaned of wax and debrie such that the TM could be examined as it could not be visualized prior to the cleaning  3. Tinnitus AD We had a long discussion on the various treatment options for tinnitus. We discussed  Amplification,  Biofeedback with an app such as Diapason Audio Cardio T-Minus Oto My Tinnitus Neuronomics  Acupuncture Over the counter medications that contain ingredients like zinc, magnesium, ginko, lipoflavinoids Some are called (Arches tinnitus formula, Ring Zen, Tinnitivix) We discussed the use of background noise when going to sleep, such as soft soothing music or white noise (fan) We also discussed prescription medications but will avoid for now."  -- S/s warranting sooner evaluation reviewed -- She is in agreement with this plan "  She is currently awaiting an MRI related to hearing loss and a f/u appt with ENT.
This spontaneous report from a contactable physician (allergist). A 5-month-old male patient received on 23Dec2013 first dose of PREVNAR 13 at 0.5 ml single dose in leg intramuscular. On the same date, the patient concomitantly received hepatitis B vaccine, IPV and DTAP. Vaccinations were provided at the pediatrician's office. Medical history was not provided. The patient was referred to allergist on 30Nov2014 and visited on 17Dec2014. Reaction was described as follows: while the patient was in the office, the hives appeared at vaccination site (leg) of PREVANR 13. The following day, on 24Dec2013, the patient developed a red rash on the neck. The patient was treated with BENADRYL on 23Dec2014 together with a steroid. The rash on the patient's neck did not last long and recovered on unspecified date. The reaction (hives) was not systemic and dissipated slowly by the end of the day (23Dec2013). The pediatrician is waiting to give the remaining dose of vaccine. Follow-up (19Feb2013): Follow-up attempts completed. No further information expected.
Had immediate sensation running down upper extremity distal to injection site. Became swollen and hard for distal third of upper arm that encompassed circumference of arm to elbow. Red, warm to touch. Pain and tenderness also extended up to shoulder and into L side of neck. No swelling visible proximal to injection site.
pt reported that on 10-9-22 at 4am she had pain in her right leg & paralysis of the entire right leg. She had a bladder stinulator on and turned that off at 5am, and back on at 7am  that same morning. Today she is still having pain at a level of 5 out of 10. She is using a cane for support & has never used a cane before. Her upper right part of her leg is weak. Her paralysis is better today (10-10-22), but she still has a lot of pain when she walks. She as contacted her primary care dr & is waiting for him to call her back. She did state that her dr knows that she has unusual reactions to things. She thanked us for checking on her & she will call her PCP if any other issues arise.
One week after getting vaccinated with the first dose of Moderna, the site of the shot in my arm left got red, hard, and a bit swollen. It itches but the pain is mild (the area is about an inch all around)
Shaking; Chills, Shivering; Tired; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Shaking), CHILLS (Chills,Shivering) and FATIGUE (Tired) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced TREMOR (Shaking), CHILLS (Chills,Shivering) and FATIGUE (Tired). At the time of the report, TREMOR (Shaking), CHILLS (Chills,Shivering) and FATIGUE (Tired) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-374769 (Patient Link).
Post menopausal bleeding approximately 5 weeks after second dose (started on 3/10/2021 and continued for around 5 days. Occurred again in early June and lasted a few days. During both occurrences bleeding was accompanied by other menstrual symptoms such as breast tenderness and cramping.