chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine was not properly diluted. Reported to clinical supervisor in Quality. Clinical supervisor contact patient mother and interpreter, conversation held with Supervisor, patient mother, interpretor and told of vaccination administration. Told mother to watch for systemic side effects: pain, fever, fatigue. Patient advised if any questions to call clinic. Patient mother had no questions. Patient's mother was told to not repeat dose per quality. Patient's mother was told that VAERS could possibly contact patient's mother to see how patient is doing. Again asked if any questions. Mother had no questions. Told mother to call clinic if any concerns or questions. Routed to provider.
Reports severe headache, not relieved by medication, low grade fever, and arm soreness. Also notes some nausea without vomiting.
blood clot; Fever; sick feeling; chills; nausea; night sweats; A spontaneous report was received from a healthcare professional concerning a 31-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sick feeling/illness, chills, nausea, night sweats, blood clot/thrombosis, and fever/pyrexia.  The patient's medical history included Cystic Fibrosis and only has half of their liver. No relevant concomitant medications were reported.  On 26-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 26JAN2021, the patient began experiencing symptoms including sick feeing, chills, nausea, and night sweats. The patient had blood clot and fever on 21-FEB-2021. Patient was admitted into the hospital on 22-FEB-2021 and discharged on 26-FEB-2021. He received the following tests while in the hospital: MRI, Bone Density, and LABS.  Treatment of the events included Eliquis.   Action taken with mRNA-1273 in response to the events was not reported.   On 25 Feb 2021 the outcome of event, fever was resolved. The outcome of events, sick feeling, chills, nausea, night sweats, blood clot were unknown.; 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.
Cellulitis; Arm found to be warm; Arm was itchy; Arm was little red; Little headache; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Modena's COVID-19 vaccine and experienced cellulitis, little headache, arm was itchy and red and arm found it to be a warm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 04 Mar 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot number 011A21A) intramuscularly in the left non dominant arm for prophylaxis of COVID-19 infection.   On 04 Mar 2021, the patient had little headache for a day and arm was itchy and little red. 6-7 days later, the patient found it to be warm and very red. On 13 Mar she went to ER (emergency room), doctor said that it could be medically significant event of cellulitis. Treatment for the event included cephalexin.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event little headache was not reported. The outcome of the events cellulitis and arm was itchy and red and arm found it to be a warm was not reported.; Reporter's Comments: This case concerns a 74 Y/O F with a serious unexpected event of Cellulitis and nonserious unexpected vaccination site warmth, and expected vaccination site erythema, vaccination site pruritus, and headache.  Event onset 10 days after first dose mRNA-1273. Treated with cephalexin. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
been given two doses of Shingrix on 21Nov2021; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 21st November 2021, the patient received the 1st dose of Shingrix (unknown) 3. On 21st November 2021, unknown after receiving Shingrix and Shingrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.  Additional details were reported as follows: At the time of reporting, the patient was in her 70s (specific age not provided since pharmacist did not had information at hand). The age at vaccination was not reported. The pharmacist reported that the patient had been given two doses of Shingrix on the same day, which led to overdose. The reporter did not agree nor declined follow-up since they wanted to consult with patient first.
This is a spontaneous case, initially received from a pharmacist on 07-Nov-2018, concerning a 12-year-old, adolescent, male patient. The patient had no medical history and did not receive any concomitant medications. On 07-Nov-2018, the patient was administered partial dose of FLUCELVAX QIVc [dose: less than 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252667 and expiry date: 30-Jun-2019]. It was reported that during vaccination, he tried to push down the plunger, it didn't go forward. So, he pulled out and then pulled a bit more. When he finished administering all the liquid, he removed the needle from the patient's arm then the liquid came out and ran down the patient's arm. A bubble of clear liquid came out which went 2/3 inches down and then cleaned with cotton swab. It was hard to determine the volume of the liquid that came out which was more than a couple of drops. The pharmacist stated that, the patient had only a partial administration but not the full dose and he was not looking at the patient's arm but when he looked the liquid was coming out at the place where it was injected. The outcome of the event (injection site leaking) was not reported. The reporter assessed the case as non-serious.
Resident passed away this morning.  No signs or symptoms prior to his death of an issue with the vaccine.  He was an end stage dementia resident at the nursing home.
Swelling and intense pain in Palm and ankles; Swelling and intense pain in Palm and ankles; Swelling and intense pain in Palm and ankles; Some discoloration; Rashes; Some nodules in the palm that are painful to touch; This is a spontaneous report from a contactable consumer (patient) reported that. A 54-years-old female patient received BNT162B2 (BioNTech/Pfizer vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 (Batch/Lot Number: EW0161) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 54 years). Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient past medical history included diabetes mellitus from an unknown date and unknown if ongoing. There were no allergies reported. Concomitant medication(s) included insulin human, insulin human injection, isophane (INSULIN NOVOLIN) taken for an unspecified indication, start and stop date were not reported; insulin porcine zinc suspension (amorphous), insulin porcine zinc suspension (crystalline) (INSULIN LENTE S) taken for an unspecified indication, start and stop date were not reported and metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (BioNTech/Pfizer vaccine, solution for injection, Batch Number/ Expiration date: EP6955), via intramuscular route of administration on 24Mar2021 as single dose in the ; Right arm for COVID-19 immunization. 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 did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 03May2021, the patient experienced Swelling and intense pain in Palm and ankles and see some discoloration and rashes in both palm and ankles. The swelling has reduced overtime, but the pain has not subsided yet. After the swelling reduced, we notice some nodules in the palm that are painful to touch. The Ae resulted in: [Doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care]. No treatment was received. The event outcome was Not recovered.   Follow-up attempts are completed. No further information is expected.
"I" have been throwing up a mixture of bile and mucous about 12 hours after "my" second shot; This is a spontaneous report from a non-contactable consumer, the patient. A 20-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 06May2021 at 15:30 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to yeast. 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 therapies included unspecified vitamins from an unknown date and indication and unknown whether ongoing at the time of reporting. 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 15Apr2021 at 15:30 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 03:00 (also reported as 12 hours after), the patient experienced throwing up a mixture of bile and mucous. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event throwing up a mixture of bile and mucous was resolving at the time of this report. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported to the pharmacy on 10/13/2019 that he went to the emergency room of the local hospital  because his arm was red and in pain. Patient reported that he was given benadryl and a steroid injection at the hospital.
vaccine was injected directly into her vein/artery; bulging veins; nail beds turned blue; A spontaneous report was received from a consumer concerning a female patient, of unknown age, who developed bulging veins and nail beds turned blue after receiving a first dose of Moderna's  COVID-19 vaccine administered directly into her vein/artery.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 07-JAN-2021 prior to the onset of the events, patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) unknown route of administration. On 03-FEB-2021, patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) unknown route of administration for prophylaxis of COVID-19 infection.    The patient was administered mRNA-1273 vaccine directly into vein/artery, on 07-JAN-2021, and developed bulging veins and nail beds turned blue. Treatment for the event included ice pad. EMTs checked blood pressure and monitor the patient for several minutes.  There was no change planned to the dosing schedule of mRNA-1273 in response to the event.  The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The event, vaccine administered directly into vein/artery was considered resolved.   The outcome for the event bulging veins and nail beds turned blue not provided.    .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. Further information is requested.
Widespread hives on neck, torso; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration on 01Apr2021 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration on 11Mar2021 at 15:00 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, the patient experienced widespread hives on neck, torso. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event widespread hives on neck, torso was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
11:50AM felt hot after receiving FLUMIST then lightheaded and dizzy at 12:10pm fainted when she awoke after about 2-3 minutes felt "out of it" very cold B/P 118/84, P 80. Laid on table did not get up on her own until 2:30pm.
COVID-19; Did not feel well; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well), COVID-19 (COVID-19), HEADACHE (Headache) and FATIGUE (Tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included Overweight. Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Tired). On 05-Apr-2021, the patient experienced MALAISE (Did not feel well). On 06-Apr-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, MALAISE (Did not feel well), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown and COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, SARS-CoV-1 test: positive (Positive) positive.. On an unknown date, SARS-CoV-1 test: negative (Negative) negative..     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 information was not provided.
Got my first vaccine on March 17 around 3 PM I woke up the next morning at 8 AM and was not able to move I had severe back lower pain and leg pain. Had to go to E.R.  Because the pain was to much to handle. I got morphine and other pain Injection but did not help with the pain. You shouldn?t have It?s not getting better I?ve been the same all month. It?s worse in the morning. When I get up in the mornings I can only be up on my feet for like five minutes at a time without having to sit down. I got my second Moderna vaccine yesterday and this morning my pain did get worse but nothing like the first time.  I need help I just want to know if the a possibility that the vaccine is the one causing all my pain and misery. I?ve taken  Norco, ibuprofen or Tylenol and nothing takes the pain away.
Approximately 2 weeks after the booster, I had a syncope event.  Subsequently I have been diagnosed with an ascending aorta aneurysm.  I have no history of this and no risk factors for this.
stomachache; Headache; fatigue; nausea; This is a spontaneous report from a contactable consumer (patient).  A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 19:30 (Batch/Lot number was not reported) age at vaccination of 53-years-old, as single dose, for covid-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing, colon cancer from 2009 to an unknown date, drug hypersensitivity from an unknown date and unknown if ongoing (allergy to Sulfa drugs), allergy to chemicals from an unknown date and unknown if ongoing allergy to alcoholic beverages, food allergy from an unknown date and unknown if ongoing (clams). The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included aripiprazole (ABILIFY) taken for an unspecified indication, start and stop date were not reported; venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication, start and stop date were not reported; topiramate (TOPIRAMATE) taken for an unspecified indication, start and stop date were not reported; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache, fatigue, nausea, stomachache on 06Mar2021 08:00. No treatments were given. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
the 66 year old patient was administered a dose of PROQUAD; no adverse effect; This spontaneous report was received from a medical assistant and refers to a 66 year old patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.   On 11-DEC-2018, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) for prophylaxis (product administered to patient of inappropriate age) (dose, strength, route of administration, lot# and expiration date were not reported).         No adverse events were reported.
5-6cm round area of erythema & warmth 2 days p/vax; lt arm;
; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Patient received one dose of the Moderna COVID19 vaccine bivalent after its BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-Jan-2023, and administered on 2-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045h22a) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE in August 2022 and COVID-19 VACCINE (Dose 1). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and COVID-19 VACCINE.
felt like pins and needles and painful; felt like pins and needles and painful; numbness/Numbness on the left side of the body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Mar2021 16:30 (Lot number: EN6205) at the age of 29 years as dose 1, single and intramuscular, administered in arm left, administration date 22Mar2021 16:45 (Lot number: EP7534) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PRENATAL [FERROUS SULFATE;FOLIC ACID;ZINC]. The following information was reported: PARAESTHESIA (non-serious), PAIN (non-serious) all with onset 05Oct2021, outcome "not recovered" and all described as "felt like pins and needles and painful"; HYPOAESTHESIA (non-serious) with onset 10Mar2021, outcome "not recovered", described as "numbness/Numbness on the left side of the body". The events "felt like pins and needles and painful", "numbness/numbness on the left side of the body" and "felt like pins and needles and painful" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia. No follow-up attempts are possible. No further information is expected.
No adverse event; Proquad accidentaly administered to a 20 year old patient; This spontaneous report was received from nurse referring to a 20-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 24-OCT-2022, the patient was accidently administered a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age).
This spontaneous report as received from a healthcare worker refers to a 12 year old female patient. Concomitant medication and pertinent medical history were not provided. On 10-JUN-2014 the patient was vaccinated with a dose of GARDASIL (lot number, dose, route and frequency were not provided) by the  healthcare worker, which was improperly stored and exposed to 51 F for 2 hours. No adverse effects were being reported. The outcome of the events was unknown. Additional information has been requested.
No adverse effects reported; received a partial dose of GARDASIL 9 because "she moved when the needle was in her arm."the syringe has about "a quarter of the product leftover."; Information has been received from a medical assistant referring to a 12 year old female patient. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided.  On 02-JUL-2019,the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (batch/lot number reported as N0268814; expiration date 23-JUN-2021; a partial dose; strength and frequency were not provided) intramuscularly in the left arm for prophylaxis. The patient received a partial dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) because she moved when the needle was in her arm (incorrect dose administered). The syringe had about a quarter of the product leftover.  No adverse effects were reported.
Patient had nausea felt tired and was pale she throw up after receiving the vaccine and was not feeling well.
Began to have swelling/redness on vaccination arm same evening as vaccination 10/10/18. 10/11/18 had cont. symptoms and flu-like symptoms. 10/12/18 area spread pt. went to ER received IV antibiotic. 10-14-18 yellow bruise like area.
Patient states that they had a rash appear at the injection site that appeared at day 10 and last for three days