chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of bronchitis (Refer case US2018107612). Concomitant products included vitamin D and hydrochlorothiazide. On 14th June 2018, the patient received the 2nd dose of SHINGRIX. On 14th June 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain, headache, pain in hand, fever, feeling bad, influenza-like symptoms and swelling of fingers. On an unknown date, the outcome of the muscle pain was recovered/resolved and the outcome of the headache, pain in hand and swelling of fingers were unknown and the outcome of the fever, feeling bad and influenza-like symptoms were not recovered/not resolved. The reporter considered the muscle pain, headache, pain in hand, fever, influenza-like symptoms and swelling of fingers to be related to SHINGRIX. It was unknown if the reporter considered the feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient did not want to get the 2nd dose, but upon instructions by her health care professional she received it on 14th June 2018. That evening she started experiencing muscle pain, a violent headache, a 99 F temperature, pain in her hands, and swelling in her fingers. The symptoms got worse over in the night and at the time of reporting she felt terrible like she had the flu. She had put in a call to her health care professional. The patient had denied permission to contact their physician. This case has been linked to case US2018107612 reported by the same reporter for the same patient.
I took COVID Vaccine; I took Pfizer; tested positive today; I took COVID Vaccine; I took Pfizer; tested positive today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10May2023, outcome "unknown" and all described as "I took COVID Vaccine; I took Pfizer; tested positive today". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Unknown results; Blood thyroid stimulating hormone: (unspecified date) Unknown results; SARS-CoV-2 test: (10May2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient's last dose was, he didn't know but hardly 8 months ago now probably 7 to 8 months ago. Now, he tested positive today, just he tested like 3 hours ago, it came positive. For COVID-19, he took Tylenol, one Tylenol about for 5 to 6 hours ago.  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-202300187320 Same product, patient, different AEs, different dose;
I woke up in the middle of the night (4/2-4/3) approx. 14 hours after receiving Vaccine with noticeable ringing/hissing in ears.  This had never happened prior.I did not think much of it at the time and went back to sleep. On Saturday had intermittent ringing/hissing. By Sunday  it was constant all day with no breaks. Seemed to get slightly worse each day from Monday through Wednesday. Thursday( Today) was the first morning were I woke up and the ringing/hissing was slightly less terrible than the day prior. As of writing this  I have seen my primary care physician  an ENT and an Audiologist. PCP and ENT both noted no visible issues in ear. Audiologist reported no damage to hearing. All three agreed it was Tinnitus.
chronic fatigue, swollen joints shortly after 2nd dose. Then Sept 18, 2022 lost vision in left eye went to ER was admitted due to a stroke. Further testing showed a previous stroke along with a Brain and Carotid Artery Aneurysm
"10 minutes after first pfizer vaccine shot (11:32), pt started having blurry vision, dizziness, and per staff, pt was pale. Per witnesses, pt had a near syncope. Never fully passed out. Helped to the ground.  Initial vitals BP 102/74, HR 64-174, RR 18.  911 called @ 11:35. In the ED: Pt feels better now upon arrival to ED. No seizure-like activity or convulsions.  Patient has no complaints at this time, states he feels back to normal.  He denies injury or pain. POC Glucose - 90 12 lead EKG Normal @12:47. Vitals BP 112/61, HR 67, RR 22, SpO2 100%, Temp 98.4. ED MD concludes that the episode was likely vasovagal syndrome."
Did not return within recommended time frame  to receive the second dose; Injection site reaction; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 9th September 2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the injection site reaction was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced injection site reaction, which resolved on its own however did not return within the recommended time frame to receive the second dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
11/6/03 this 2 month was given flu vaccine in error. Immunization coord. was informed of this error manufacturer and immunization hotline was contacted and they advised there should be no ill effects from this but the infant would not develop antibodies from the vaccine. They advised that mom should contact such as soreness at the site of immunziation and see MD if any adverse reactions occur. She had been instructed on this and given after the vaccine literature. 11/7/03 1105am received phone call from infant's mother who states infant won't take formula. Last bottle was about 3am and she took 2oz. then she states infant had fever last night of 102.4, she gave Tylenol and fever broke. I called kidsmed and explained the vaccine error and infant's symptoms. Talked with PA, she recommended mom bring infant in to be checked. PA said infant could be getting sick with something else but needs to be checked anyway, due to vaccine error, if she was having problems. Appt. was obtained for 2pm today. Infant's mother was contacted and informed of appt. time. I explained to her that I had given pt flu vaccine in error. She stated that pt seemed "okay but she just won't take her milk." Imm. coord., informed of these developments. 3pm received phone call from kidsmed requesting copy of imm. record. This was faxed to them. 305pm received phone call from Dr who saw infant. He said he was going to admit her because she needs fluids til she started eating again. He said that he didn't know whether her symptoms (not eating, decreased urine output) were from the flu vaccine of other vaccines but he was admitting her to give her fluids. Dr also stated that he didn't feel she would have any permanent damage. 11/8/03 at my request imm. coord., called medical center and talked with charge nurse on pt's floor. Charge nurse said infant was taking formula and keeping it down. She was doing well and would probably be discharged that afternoon. 11/10/03 phone call to mother of infant. Mom states baby was discharged 11/8/03 from hospital. Has a return appt with Dr. states infant is doing fine. The medical recoreds state irritable.
tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine; first dose administered to patient under 18 years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose administered to patient under 18 years of age) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose administered to patient under 18 years of age). On 28-Mar-2021, the patient experienced COVID-19 (tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine). At the time of the report, COVID-19 (tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose administered to patient under 18 years of age) 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.   No concomitant medication were provided.  Treatment medication were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Event added.
Pt was getting fist dose of Monkeypox 0.1ml via ID. Vaccinator was unable to get a bubble on Pt's left arm.
Patient developed truncal rash anterior and posterior sparing face and extremities. Rash became more extensive and itchy.
normal symptoms of thrush/yeast thrush infection in mouth; irritation down in crotch area/thrush down in crotch area; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ORAL CANDIDIASIS (normal symptoms of thrush/yeast thrush infection in mouth), GENITAL INFECTION FUNGAL (irritation down in crotch area/thrush down in crotch area), NAUSEA (Nausea) and PYREXIA (Fever) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Fungal infection.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced ORAL CANDIDIASIS (normal symptoms of thrush/yeast thrush infection in mouth), GENITAL INFECTION FUNGAL (irritation down in crotch area/thrush down in crotch area), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with FLUCONAZOLE for Adverse event, at a dose of tablet once a day for 10 days qd and FAMOTIDINE for Throat irritation and Thrush oral, at a dose of 1 tablet once a day for 10 days. At the time of the report, ORAL CANDIDIASIS (normal symptoms of thrush/yeast thrush infection in mouth), GENITAL INFECTION FUNGAL (irritation down in crotch area/thrush down in crotch area), NAUSEA (Nausea) and PYREXIA (Fever) had not resolved.        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.   Concomitant medication included antifungal medication for months, on and off for fungal infection.   This case was linked to MOD-2021-369207 (Patient Link).
left arm was a little sore for about 1-2 days; received first dose of Moderna COVID-19 vaccine at 16 years of age; second dose might be administered after 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was a little sore for about 1-2 days), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose of Moderna COVID-19 vaccine at 16 years of age) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose might be administered after 42 days) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (NIKKI) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm was a little sore for about 1-2 days), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose of Moderna COVID-19 vaccine at 16 years of age) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose might be administered after 42 days). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 08-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose might be administered after 42 days) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm was a little sore for about 1-2 days) outcome was unknown and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose of Moderna COVID-19 vaccine at 16 years of age) had resolved. Not Provided          Concomitant product include birth control.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up was received on 29-APR-2021 and included reporter details and demographic details. Concomitant drug was reported. Treatment drug was reported.
Felt bad as he had COVID again; Was sleepy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Felt bad as he had COVID again) and SOMNOLENCE (Was sleepy) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002-1321A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was exposed by COVID in January 2021 and it was two hard weeks but he was fully recovered in February 2020.) from January 2021 to February 2021. Concomitant products included LISINOPRIL for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced COVID-19 (Felt bad as he had COVID again) and SOMNOLENCE (Was sleepy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 24-Mar-2021, COVID-19 (Felt bad as he had COVID again) and SOMNOLENCE (Was sleepy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Stomach ache, head ache, vomiting, fever, overall body ache, tired, disoriented
Strong hives reaction started on June 9 and still hasn?t resolved.  Tried Prednisone, Hydroxyzine and Zyrtec with no results even today 6/27/2021
Patient reported welt (redness and swelling) a few hours after vaccination. She came in to report adverse reaction and presented with 3-4 in. diameter welt. Patient advised to take diphenhydramine and ibuprofen. Patient went to ER & given shots of BENADRYL and TORADOL. Patient is slowly recovering. Pain has subsided.
Severe pain in whole arm, down to fingers; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 4fk7y, expiry date 29th September 2023) for prophylaxis.   On 8th September 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 8th September 2022, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comments:The reporter stated that the patient got her first Shingrix vaccine about 5 weeks ago and she was still having severe pain in her whole arm.   The patient stated the pain goes all the way down to her fingers. The reporter gave consent to follow up.
Red pinpoint dots all over torso and bottom lip. Doesn?t seem to hurt or itch. But are rough to the touch and slightly raised.
Crying non-stop rash on check, ear & neck, spitting up food. No sleeping.
Information has been received from a healthcare worker (certified medical assistant) referring to an unspecified number of patients of unknown ages and genders. Concurrent condition and medical history were not reported. On unspecified dates, the patients received improperly stored doses of VAQTA (lot # K008254, expired date 12-NOV-2015, strength, dose, frequency and route were not provided) (incorrect product storage). No adverse effect was reported. This is one of two reports received from the same source. Additional information has been requested.
Patient had redness and pain at the injection site. The area was the size of a baseball with a red circle around it.  Patient had pain when he lifted his arm up. Also had pain under his armpit.  He was taking Motrin for the pain. A cold compress for the redness and pain applied to  his right arm. Spoke with mom on 6/15/2022 and pt. was much better. The red circle was gone and a little arm  pain per mom. I have instructed the mom to call us back as needed. The mom has verbalized understanding. Thanks
Patient received first dose of the Moderna COVID-19 vaccine on 04JUN2021 and by 22JUL2021 had still not received the second dose.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received first dose of the Moderna COVID-19 vaccine on 04JUN2021 and by 22JUL2021 had still not received the second dose.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received first dose of the Moderna COVID-19 vaccine on 04JUN2021 and by 22JUL2021 had still not received the second dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient received first dose of the Moderna COVID-19 vaccine on 04JUN2021 and by 22JUL2021 had still not received the second dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up was received on 10-AUG-2021 and contain no new information. The outcome was corrected to recovered , causality for (Privacy) and action taken were corrected from the initial version
Came to ED 2/5/22 Patient was attempting to transfer from the toilet to his wheelchair when he fell.  Patient denies dizziness, syncope, headache, nausea or vomiting.  He states that the wheelchair slipped out from under him.  He denies hitting his head.  Patient has a LifeVest in place and states he is waiting an internal defibrillator however he "keeps getting infections. ".  Patient is anticoagulated on Eliquis.  Patient tested positive for COVID prior to hospitalization, wheezing noted bilaterally.  Discharged 2/9/22 - remained on room air and did not require steriods. Previously vacc Moderna 1/7/21, 2/5/21, 9/14/21
pt newly received at facility with out documentation of prior vaccine, after review, pt was not verified to have had vaccine and was placed back on vaccine list, after pt received vaccine, pt made medical aware that pt received vaccine in county and had received a vaccine card in her property. provider made aware, pt educated to  moderna vaccine, pt denies s/s of side effets,  pt monitored in medical, no s/s of distress noted.
Chills; Headache; Body ache; Sore arm; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 11May2021 at 11:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and alcohol allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline 100mg (MANUFACTURER UNKNOWN) and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) 1mg; both for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 20Apr2021 at 11:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. On 12May2021 at 00:45 the patient experienced chills, headache, body ache, sore arm and nausea. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event chills, headache, body ache, sore arm and nausea were recovered on 12May2021.   No follow-up attempts are needed. No further information is expected.
Sore arm/hurt more than any other vaccination; Malaise; This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm and malaise. On an unknown date, the outcome of the pain in arm and malaise were unknown.   It was unknown if the reporter considered the pain in arm and malaise to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had experienced a sore arm following Shingrix that hurted more than any other previous vaccination. The patient also felt malaise, but also had a flu vaccination, so wasn't sure which to attribute it to. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR225520:Same reporter, same patient
12 days out from vaccine . Where I got my vaccine is size of dime in redness.  About 2 cm below injection site is another red hot spot size of a half dollar.  Sites are tender and dire . Both sites have gotten bigger.
Second period approximately 1.5 weeks after initial  period. Initial period 5/11/21, second period 5/21/2021
Patient noticed redness, soreness at injection site about 7 days after injection. Has lasted for 4 days. Patient ask try oral BENADRYL and contact his primary dr. if no improvement or gets worse.