chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; every muscle i was just aching; it was hard to walk; slept most all the day; Flu like symptoms; preety intense; A spontaneous report was received from a Consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events flu-like symptoms, pretty intense, headache, every muscle, i was just aching, it was hard to walk, couldn't eat, slept most, all day, didn't feel hungry.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced the events flu-like symptoms. pretty intense, headache, every muscle, i was just aching, it was hard to walk, couldn't eat. On 23 Jan 2021, the patient experienced the events slept most. all day, didn't feel hungry.  Treatment details included Not provided  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, flu-like symptoms, pretty intense, headache, every muscle, i was just aching, it was hard to walk, couldn't eat, slept most, all day, didn't feel hungry was not reported.
Bone Aches; Little bit Dizzy; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone Aches), DIZZINESS (Little bit Dizzy) and CHILLS (Chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021 at 4:00 PM, the patient experienced BONE PAIN (Bone Aches), DIZZINESS (Little bit Dizzy) and CHILLS (Chills). At the time of the report, BONE PAIN (Bone Aches), DIZZINESS (Little bit Dizzy) and CHILLS (Chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were reported.   This case was linked to MOD21-063332 (E2B Linked Report). This case was linked to MOD-2021-059986 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Non significant information provided (Reporter's address).; Sender's Comments:  MOD21-063332:
has not yet received second dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 15th October 2021, batch number DK23D, expiry date 08th February 2022).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete vaccination schedule but was schedule to be administered on 14th February 2022. Nurse confirmed that, the delay in schedule was due to the patient's compliance and not due to any supply issue.   The reporter consented to follow up.  VAERS details pertained to the 1st dose of Twinrix. The Vaccine Administration Facility is the same as Primary Reporter.
23Jul90 pt vax 3rd dose;  did not seroconvert.  Pt recvd 2 booster doses; Titer 1 mo after booster was 150.
The patient should have been given MMR; A 46-year-old patient was vaccinated with PROQUAD; This spontaneous report has been received from a nurse, concerning to a 46 years-old female patient.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 23-SEP-2020, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 ml subcutaneously (lot#: T015599, expiration date: 02-NOV-2021) for prophylaxis (product administered to patient of inappropriate age). It was reported that the patient should have been given Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR) instead of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (wrong vaccine administered). No further information was provided.
Unclear if patient received Moderna or Pfizer. Patient was originally scheduled for Moderna Vaccine. Documented that patient received Pfizer. Patient came in for 2nd dose of Moderna. Once here medical professional saw documented vaccine as Pfizer. Patient did not know which one she received either. Patient decided not to get 2nd dose.
Administration of expired moderna vaccine that were given as booster shot; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. Pharmacist stated that the vaccines was stored in freezer and taken out one to two vials and placed in fridge each day as needed. The pharmacist reported that expired vaccines were given as booster shot to patient around 490 to 500 people on the last date 20-Oct-2021 to 29-Nov-2021. No treatment given to the patient.
Several hours after vaccine, I started developing fatigue, chills, a low grade fever, and inability to sleep due to severity of chills. I also experienced headaches, arm soreness and dizziness. The next day my left arm hurt more than the night before, and I had a fever off and on from 8am to 12pm. No additional symptoms after 5pm the next day 12/31/2020.
possible to get a sore throat; This case was reported by a consumer via call center representative and described the occurrence of sore throat in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced sore throat. On an unknown date, the outcome of the sore throat was unknown.   It was unknown if the reporter considered the sore throat to be related to Shingrix.  Additional case details were reported as follows: On 28th July 2020 at night, the patient received 2nd dose of Shingrix. The patient asked is it possible to get a sore throat.
Client c/o itchy chin. Hx of Peanut allergy and carries an epi pen.  EMS evaluated.  Itchiness went away in 5 min.  No swollen tongue or face.  No respiratory distress, no hives noted.  Mother came and brought child home.  Mother wanted to know if daughter should have 2nd dose. Instructed to talk to child's allergist for advice.
Big lumpy area after injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Big lumpy area after injection) in a 24-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 an unknown indication.    No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 06-Oct-2021, the patient experienced INJECTION SITE MASS (Big lumpy area after injection). At the time of the report, INJECTION SITE MASS (Big lumpy area after injection) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  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.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 21Jun2023 to 25Jun2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
4/1/23 I started with a scratchy sore throat. I then started sneezing a lot, runny nose and all upper respiratory. Then it went from a dry progressive cough to a croupy cough. I took an at home COVID test on 4/5/23 and it was negative. I was diagnosed with bronchitis and started on azithromycin on 4/11/23. It ran its course.
Pt recvd 2nd dose of Hep B vax on 18SEP91 & 2 hrs p/vax pt exp paresthesia which lasted 6 hrs;
Covid19 Bivalent vaccine lot# GP4345 had a 10 week expiry of 04/07/2023. Administered vaccine three days past due BUD on 04/10/2023. We contact Pfizer on 04/18/2023 for Stability assessment: Stability data DOES SUPPORT. No need to re vaccinated
Narrative:  The patient received two doses of Pfizer COVID 19 Vaccine in Dec 2020/Jan 2021. The patent presented to the ED with a dry cough, weakness, and dizziness on 13 Jun 2022. The patient was admitted to the hospital with covid 19, hypoxia, and mild encephalopathy. The patient was treated with remdesivir and dexamethasone. The patient was discharged on 1 July 2022 in stable condition. Reported per EUA.
Case number PHEH2014US024955, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 59-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 28 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Immediate onset of migraine, nausea, tiredness, early period, painful periods, swollen and painful breasts, new intolerance to gluten, new allergy to nuts, labored breathing, shortness of breath, pain when breathing, general chronic tiredness and fatigue
Pt recvd vax pt was jittery & unable to sleep; No further details were provided;
Significant swelling and redness at site of injection.  Diameter 8-9 cm.  PA prescribed Keflex
After receiving my second dose of the pfizer vaccine my period is 17 days late. I'm not experiencing any signs of it starting anytime soon. My period is regular so this is very unusual for me. I don't have any health problems that would trigger this.
Patient with light-headedness one day after receiving Shingles vaccine. Requesting VAERS report to be filed. Still with sporatic light-headedness since vaccine.
7-10 days after shot, face broke out in small "sores" which went away but sprouted elsewhere on face for about 2 months; then got itchy welts on abdomen, carbe: 1-2" wide, 6" to 9" long on 3 occasions but still getting itchy welts on abdomen now.
Information has been received from a RN concerning a 12 month old female with no allergies or medical history who on 07Oct03 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 19Oct2003 the pt's family called the physician's office to report a light body rash on 18Oct2003 that was gone on 19Oct2003, but a nickel size welt was present at the injection site with two white areas that were draining and crusted. The pt was noted to be afebrile and was treated with warm compresses. Unspecified medical attention was sought and a prescription drug was required. A product quality complaint was not involved. Additional information has been requested.
Patient was 17 years of age and given the Moderna Vaccine. Spoke with patient on 04-06-2021 and no adverse side effects were reported.
Ran a 102-4 degree fever for approximately 36 hours, followed by a 101 degree fever currently.; I have large painful lumps in both armpits (golf ball size).; I have large painful lumps in both armpits (golf ball size).; I have had full bodyaches,; joint pain; chills during fevers, especially at night.; I have a very prominent metallic taste in my mouth.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 10:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hypothyroidism and depression. Concomitant medications included bupropion hydrochloride 160 (WELLBUTRIN), levothyroxine .50 (MANUFACTURER UNKNOWN)) and fluticasone propionate; salmeterol xinafoate 250 (ADVAIR); all taken from an unspecified date for an unknown indication. The patient was allergic to latex, kiwi, avocado, banana, pineapple and mango. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 12:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Mar2021 at 20:00, the patient experienced 102 - 4 degree fever for approximately 36 hours, followed by a 101 degree fever currently. The patient had large painful lumps in both armpits (golf ball size); also had full body aches, joint pain, and chills during fevers, especially at night. The patient had very prominent metallic taste in my mouth. The event did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events fever, swelling, armpit pain, general body pain, joint pain, fever chills and taste metallic were not resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 14:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 26 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: GEODON [ZIPRASIDONE HYDROCHLORIDE]; KLONOPIN. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: The patient received Geodon and Klonopin in two weeks. The patient received COVID 19 Treatment from 04Oct2022 to 09Oct2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
No adverse event reported.  Pentacel may have been given instead of Hib.  Lot numbers similar. Caught when entering data so not sure. Pentacel JU382AAA  Act Hib UJ352AA
14days p/vax pt devel 1-2 lesions on his trunk. addl info recv noted pt lesions were macular eruptions.
All over body rash. Patient did not call nor come into office to report until followup visit 02/03/2016. She tried OTC Benadryl and hydrocortisone cream. None helped. Still has some rash covering her left knee.
Ulnar neuropathy after AVA #3. Radiation constant arm pain x10 mo, occasionally still has twinges of pain. States he received the vaccine in the triceps regions. Did not have a significant local reaction. Radicular pain
Started seeming like hearing was a bit muffled to ringing in the ear; Started seeming like hearing was a bit muffled from what it should be.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0165) via an unspecified route of administration in the left arm on 26Apr2021 at 02:00 (at the age of 51-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 17May2021 at 14:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and pre-diabetic. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications in two weeks, but it was unspecified. On an unknown date in May2021, the patient started seeming like hearing was a bit muffled from what it should be, then lead to about two weeks later to ringing in the ear that had not gone away. No therapeutic measures were 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 started seeming like hearing was a bit muffled from what it should be, then lead to about two weeks later to ringing in the ear was not recovered at the time of this report.
Left lateral bicep - 15cm X 6 cm red area.  Warm to the touch.  Bilateral shoulder and elbow joint pain.  No treatment needed.  Joint pain began to decrease on 8/6/2003.
pt recvd vax 8JUN93 & on 16JUN93 & 17JUN93 pt devel a low grade fever;
Painful reaction at site of SQ injection. Red circle approx 3" in diameter very pink and fevered.
9.27.2022 PATIENT STARTED FEELING BLOATED AND CONSTIPATED. HE WENT TO AN URGENT CARE WHERE HE WAS PRESCRIBED REGLAN. HE THEN STARTED HAVING DIARRHEA, NAUSEA AND VOMITING. THEN HE CAME TO OUR ER FOR EVALUATION AND WAS FOUND TO HAVE NEW ONSET OF AFIB WITH RVR.
itching and Rash on back of shoulder and upper chest; injection site pain; This is a spontaneous report from a contactable Non health care professional, the patient. A 61 year old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration at left arm on 10Mar2021, as a single dose for COVID-19 immunisation at the age of 61-year-old. The patient's medical history was not reported. The patient was not Allergic to medications, food, or other products. concomitant medications included Lipitor(MANUFACTURER UNKNOWN) for unknown indication, Fosamax(MANUFACTURER UNKNOWN) for unknown indication, calcium supplement (MANUFACTURER UNKNOWN) for unknown indication. Past medication was not reported. The patient did not underwent COVID-19 test. The patient has not had symptoms associated with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 10Mar2021 after 8 hours of vaccination by 18:30 the patient felt entire left hurt and at the same time Itching on the back of shoulder began. The patient had a raised rash on back of shoulder and some on upper chest. Patient took Self medication, 5mg Xyzal (levocetrizine) as treatment for the allergy and by the early next morning (11Mar2021) the entire rash was gone. Post injection site pain was gone in 3 days (13Mar2021) and she was fine ever since. The clinical outcome for event itching and Rash on back of shoulder and upper chest was recovered on 11Mar2021, injection site pain was recovered on 13Mar2021. No follow-up attempts are needed. No further information is expected.
Skin Rash. Treatment: Diphenhydramine 12.5 mg once.
Pain at injection site began at 8pm.  Fever at Midnight, fatigue and body aches on Wednesday the 20th.  Fever lasted approximately 24 hours body aches 48 hours.  Fatigue lasted about 4-5 days.  A high fever started on 1/27/2021.  Lasting about 8 hours.  Along with severe headache and fatigue.
Patient reports arm is still sore from April injection. She says within 12 hours of vaccine had redness and heat at injection site which went away in a few days. She says arm is still sore and if she applies BIOFREEZE it helps. She has not reported to the doctor but will mention at next well visit.