chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose August 2019, 2nd dose in June-July 2021; 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received in August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, 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.  Additional details were reported as follows: The age at vaccination was not reported. As patient received 2nd dose of Shingrix either June or July of 2021 later than the recommended interval which led to drug dose administration interval too long. No symptoms reported. The health care professional did not have the patient's date of birth or exact dates of vaccination. The HCP did not have the lot for the 2nd dose as it was not given at that pharmacy. The reporter consented to follow up.
Right hand swelling, mild tenderness to palpation. Had subdural hematoma 2 weeks ago, has been having decline in LOC, sent back to ED, CT showed worsening subdural hematoma. Right arm swelling may not have been related to vaccine.  Arm swelling not the main reason he was sent to the ED.
This case was reported by a healthcare professional (nurse) and described the occurrence of bell's palsy in an adult male subject aged less than 65 years who was vaccinated with FLUARIX (GlaxoSmithKline). On 3 October 2013 the subject received a dose of FLUARIX (unknown details). On 8 October 2013, 5 days after vaccination with FLUARIX, the subject experienced bell's palsy. The subject "was seen by the physician on 8 October 2013 and diagnosed with Bell's palsy." The reporter did not know when the symptoms started or have any subject specific details at the time of reporting. The subject was vaccinated at an off site health fair on 3 October 2013 and the reporter "thinks the patient was less than 65 years old as another group was vaccinating older adults." This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unknown.
Headache; Body aches; Chills; Fatigue; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine and experienced headache, body aches, chills, and fatigue.    The patient's medical history was not reported No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (batch: 011L20A) for prophylaxis of COVID-19 infection.   On 07 Jan 2021, the patient reported body aches, chills, fatigue and headache. Treatment included ibuprofen.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, headache, body aches, chills and fatigue was considered recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. All the events are listed in RA.
Pt states feeling light headed and tightness in upper throat about fives minutes after receiving booster vaccine.
Flu vaccine administered to left deltoid of arm on 9-26-16, on 9-29-16 c/o rt. hand, unable to make fist, denies fever or headaches, progressed to both legs weakness, and c/o on top of both knees feels tightness. Went to Clinic to be evaluated.
PEDIATRIC dose of ENGERIX B was given to an adult; PEDIATRIC dose of ENGERIX B was given to an adult; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 54-year-old female patient who received HBV (Engerix B pediatric) (batch number J7H4d, expiry date 23rd March 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th December 2021, the patient received Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 20th December 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-Apr-2022 Reporter's comment: The adult patient received a pediatric dose of Engerix B in right deltoid. Additional Supportive Information: The adult patient received a pediatric dose of Engerix B, which led to adult use of a child product and underdose.
Over 1 week of nasal congestion and rhinorrhea.  2-3 days of general malaise.  Headache 1 day. Above symptoms treated with over the counter cold remedies including Claritin, and Nyquil.
Moderna COVID-19 Vaccine EUA Sunday, Jan 24 2021  Afternoon - Chills, Achiness Dinnertime - Addition of Nausea Evening - Addition of Joint Pain, Muscle Pain and Fatigue Monday, Jan 25 2021 Basically out of it all day with extreme fatigue, headache similar to a migraine where it hurt to even move my head, stiff neck, chills, nausea, muscle and joint pain.  Did not take temperature as I was sleeping most of the day, made it to the bathroom but that was it. Tuesday, Jan 26, 2021 Less fatigued, headache and stiff neck was there but not nearly as bad.  Still had the chills, nausea, muscle and joint pain. Temp was 99.4 when taken Wednesday & Thursday (Jan 27 & 28, 2021) - Each day felt a bit better but still seemed to tire easily and gradually got back to feeling like eating something. Friday, Jan 29, 2021 - Felt pretty much back to normal but tire easily. Sat Jan 30 - Monday Feb 1, 2021 - Still feel I am tiring easy but each day gets better. Monday Feb 1, 2021 - Afternoon - Have tingling in throat and right ear.  Typical of reaction to IGG Infusion. Have taken Benadryl 25.  If continues will call PCP.
nausea; stomach cramping; chills; slight fever; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in the left arm on an unspecified date in Mar2021 at 12:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to shellfish. The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 24Mar2021 at 05:45 the patient experienced nausea with terrible stomach cramping for 5 hours, chills and slight fever. The patient did not receive any treatment for the adverse events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of nausea, stomach cramping, chills and slight fever was not resolved on an unspecified date in Mar2021.   Information about Lot number has been requested.
Nausea; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and MYALGIA (Body aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No patient history was reported.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced NAUSEA (Nausea) and MYALGIA (Body aches). At the time of the report, NAUSEA (Nausea) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information were not reported.
went to ER; Fever of 100.9; Chills; Tired; Sick; Achy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), PAIN (Achy), ADVERSE EVENT (went to ER), PYREXIA (Fever of 100.9) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ILLNESS (Sick), PAIN (Achy), PYREXIA (Fever of 100.9), CHILLS (Chills) and FATIGUE (Tired). On 05-Mar-2021, the patient experienced ADVERSE EVENT (went to ER). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, ADVERSE EVENT (went to ER) outcome was unknown. At the time of the report, ILLNESS (Sick), PAIN (Achy), PYREXIA (Fever of 100.9), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided
Patient called to report adverse symptoms after receiving Twinrix #2. She complained of leg cramps with pain, tingling and weak muscles two days after receiving the injection. She stated that her symptoms felt like flu-like symptoms in her legs which lasted about 3 days. She had none of these problems after the first injection 11/15/02. 1/10/03 Legs still feel weak when she gets up or stoops. Should she receive dose #3? She will be visiting Russia in May.
I got my shot in the left arm, and having pain in the arm where the shot was put into the muscle area.
Swollen, red, warm area noted 24 hours after FLUZONE given. Remained for 24 hours then seen in clinic. Given BENADRYL 25 mg PO. Redness slightly decreased.
this morning she noted a red blotch on her left eye sclera. her right eye is fine. she denies rubbing her eye, foreign body, or coughing or sneezing or force. instructed not likely related but asked to call back if worsening, vision loss, or blurred vision. wash hands well after touching face. call back prn.Followed up with patient today. She said that the red blotch in her eye is still there but not as red and can tell that it is going away. It doesn't bother her. She did contact her PCP and they told her that it is likely not related. She thanked me for my call. Will close case.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
Seen in ER on 11/25/22 with c/o body aches, ams, cough, sob, runny nose.  Patient was admitted with Dx of hypoxia, pneumonia and altered mental status
It was discovered after the Patient left the building that she was given Pfizer Bivalent 5-11 instead of Pfizer Bivalent 12+.  The medical Director was contacted and VAERS completed. No adverse effects were noted but patient was under-dosed.
i had tetanus boosters in 1975 and 1984, and again once after that of a date unrecalled.  each time i had sever arm pain and was unable to move arm for about a week.  not once was i told that would be a contraindication to further vaccination. in 1990, as a checker at a market, after 3 months i acquired a repetitive strain injury.  it occurred unusually quickly and did not resolve with normal treatment.  i have now been receiving treatment for 30 years, and still impacts me.  I did not realize until recently that the etiology of the injury was from brachial neuritis due to the tetanus shot.  all providers who have treated me said my injury was unusual lu extreme considering the supposed onset.   i have complex involvement of the fascia, and could not work for years.  i need constant graston treatment to break up the scarring.  it mimics chronic tetanus and i am saddened that doctors did not recognize the syndrome sooner.
bell's palsy from covid vaccine; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose on Jan2021 for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  On Jan2021 the patient experienced bell's palsy from COVID-19 vaccine. The event resulted in doctor office/clinic visit, disability or permanent damage. Since the vaccination, the patient has not been tested for COVID-19. At the time of reporting the outcome of the event was not recovered.    Information on the lot/batch number has been requested.
Symptoms: dizziness and "heaviness in head" that began 10 minutes after vaccine administration. Vitals were taken every 5 minutes, client was placed in a zero-gravity chair and given water.  S/s improved with time & subsided completely after 15 minutes.
Started to experience extreme fatigue, joint pain, chills the morning after receiving Dose 1 of Moderna vaccine.  Fever of 101 developed in afternoon and persisted until around 9pm that night when it started to go down.  Rest of symptoms resolved within 24 hours of onset.  Felt a bit tired the next day, but that's it.  I did have a confirmed case of COVID-19 (positive test 12/4/20) prior to receiving this vaccination.
Strong pain during injection (much more than 2nd dose). Severe pain in left shoulder for first two days following injection, could not lift arm. After 48 hours pain in shoulder had lessened slightly, but pain had spread to trapezius muscle and left side of neck. Since injection (1 month ago), daily shoulder, trapezius, and neck pain that has not improved. Cannot lay down flat without severe pain in shoulder. Daily tasks have been interrupted due to pain and discomfort. Waking up throughout the night due to pain.
Developed fever up to 102; On the next day after my second shot I started to feel weakness; However I still have some sleeping problems; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0182, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 21May2021 at 10:45 AM (vaccinated at the age of 42 years) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19, prior to vaccination. The most recent COVID-19 vaccine was administered at hospital. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date (vaccinated at the age of 42 years) as DOSE 1, SINGLE for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 22May2021, next day after the shot patient felt weakness, developed fever up to 102 but the day after that, she came to normal (however she still had some sleeping problems). The case was reported as non-serious. The outcome of all events was recovering.  Device Date : 31May2021  Follow-up attempts are completed. No further information is expected.
After getting the shot, my left arm was in pain for 3 days. On the 3rd day I got a swollen an painful left axillary lymph node. On the 7th day of getting the shot I started with fever, chills, body ache, flu like symptoms. Is January  the 3rd and I still have flu like symptoms, no more fever dough.
Mild Pain And Itching At Injection Site; Mild Pain And Itching At Injection Site; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 30Jan2021 17:30 (at the age of 66-year-old) as dose 1, single for covid-19 immunisation. Medical history included high blood pressure, Pre diabetes, High cholesterol. Patient did not have any known allergies. Concomitant medication(s) included amlodipine besilate, olmesartan medoxomil (AMLODIPINE AND OLMESARTAN MEDOXOMIL) taken for an unspecified indication, start and stop date were not reported; metformin 500 mg taken for an unspecified indication, start and stop date were not reported; famotidine taken for an unspecified indication, start and stop date were not reported. Patient did not have covid prior vaccination and covid was not tested post vaccination. The patient experienced mild pain and itching at injection site on 31Jan2021 21:00. Patient did not receive treatment for adverse events. The outcome of mild pain and itching at injection site was recovered on an unspecified date of 2021.  Follow-up attempts completed. No further information expected.
MODERNA BOOSTER VACCINE/SWOLLEN ARM; INJURY/KNEE CAP HURT; This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (INJURY/KNEE CAP HURT) and VACCINATION SITE SWELLING (MODERNA BOOSTER VACCINE/SWOLLEN ARM) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In September 2021, the patient experienced JOINT INJURY (INJURY/KNEE CAP HURT). On an unknown date, the patient experienced VACCINATION SITE SWELLING (MODERNA BOOSTER VACCINE/SWOLLEN ARM). At the time of the report, JOINT INJURY (INJURY/KNEE CAP HURT) had not resolved and VACCINATION SITE SWELLING (MODERNA BOOSTER VACCINE/SWOLLEN ARM) had resolved.      This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Reporter causality for Knee injury was related and vaccination site swelling was not related with Humira
ITCHY, SWOLLEN, RED EYES, HEADACHE, BODY ACHES, COUGH, FEVER, FATIGUE, NAUSEA
Severe muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient asked if side effect of the Shingrix vaccine was severe muscle pain. Additional Supportive Information: The follow up would not possible as no contact details were available.
10/14/2013 Received Tdap and Typhoid Vi (IM (L) deltoid on 10/14/13. 11/4/13 Called c/o (L) arm pain. Recommended Ibuprofen prn reassurance given and advised to follow up with PCP if symptoms continue.
Developed red papular rash on thighs that spread to the calves.  Developed painful firm papular rash on fingers, elbows and palm of hands and soles of feet.  Painful rash around wrists that are now looking like blisters.  These lesions have continued to enlarge.
Within 1 day of receiving Varicella inj site became slightly inflamed. Mom estimates approx 1.5" x 1.5 ". No fever or malaise reported.
This spontaneous report as received from a nurse refers to unknown number of patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the patients were vaccinated with VAQTA lot # L002717, expiration date 02-JUN-2017 (dose strength, route unspecified) post temperature excursion with no adverse effects. No product quality complaint was involved. This case is linked to the case via 1509USA001396 same reporter link. Additional information has been requested.
UNABLE TO MOVE ARM; SORE ARM GETTING WORSE AND WORSE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety, alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included fluoxetine for anxiety.  On 13-MAR-2021, the subject experienced sore arm getting worse and worse. On an unspecified date, the subject experienced unable to move arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm getting worse and worse, and the outcome of unable to move arm was not reported. This report was non-serious.