chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced non-stop chest pains on 9/8/2021 that lasted 3 days straight till 9/10/21 and didn't feel relief until 9/11/21. On the pain scale it was about a 3 out of 10, and certain arm movements would increase the pain to a 4.  Experienced elbow pain around Christmas of 2021 with a pain scale of 4 out of 10. The source of pain feels like a tendon/muscle but is within the center of the elbow. Experienced decreased strength when grasping, holding, or lifting objects. Pain also experienced on the brachioradialis muscle on the forearm when lifting objects upwards. Pain is still prevailent today, 3/29/2022, but the intensity of the pain has reduced to 0.5 to 1 after administering Ivermectin 2 tablets a day for the past 10 days and strength has returned significantly.  Experienced stomach pains on 3/4/2022 that lasted 6 hours nonstop. It felt like a stomach ache from unhygienic food, but the severity of the pain is about a 6-7 out of 10. Tried to vomit or use the restroom to expel anything in the stomach, but there was nothing to expel. It's possible it is from food poisoning, but family members unvaccinated experienced very mild side effects from it compared to me.
Left deltoid redness with swelling - 2 by 2 cm area of erythema, not indurated, not fluctuant.
PUI had a moderate to severe illness. She had to be hospitalized. She was diagnosed with COVID 19 pneumonia. PUI is fully vaccinated and believes based on the doctors advice it saved her.
Redness around injection site and on chest. 30 mg BENADRYL-17:13. 17:25-rash subsiding.
myocarditis; fever; ache; lethargy; This is a spontaneous report from a contactable consumer (patient's grandfather). A 13-year-old male patient received bnt162b2 (BNT162B2), first single dose and second single dose, both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for covid-19 immunisation at age of 13-year-old. Medical history concomitant medications were none. Caller stated that he was inquiring for his 13 years old grandson who was very healthy, active, athletic, on no medications, and with no medical problems. He went on to report that when he received the first dose of the vaccine he had a very strong response to it that included; fever, ache, lethargy, and more. When he had the second dose he had a very similar reaction but worse. He stated that the doctors were thinking that his symptoms could be related to possible myocarditis. The caller explained he was encouraged to call by the pediatrician. The caller reported that his grandson just had his second dose of the Pfizer vaccine and with both doses he had, not a terrible one, but a reaction after both doses. His grandson was not on other medications or had any chronic conditions or acute conditions, he was healthy. Outcome of the events was unknown.   Information about batch/ lot number has been requested.
Swelling in upper arm area around injection site and also pain. Stated she has had this for a week.
patient was vaccinated with Fluzone Quadrivalent instead of Fluzone High Dose Quadrivalent/no AE; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 70 year-old male patient who was vaccinated with 0.5 mL INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] via intramuscular route in the left arm instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number and expiry date not reported) on 28-Oct-2020 for prophylactic vaccination (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was also reported that patient had been admitted to the hospital prior to the vaccination.The pharmacist stated that the patient received the Fluzone Quadrivalent injection prior to the HCP recognizing that the patient could have gotten the Fluzone High Dose.   It was a case of overdose and also a actual medication error due to wrong vaccine administered (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
feeling aches; tired; fever; This case was reported by a nurse via other manufacturer and described the occurrence of pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included colecalciferol (Vitamin D3) unknown for product used for unknown indication, vitamin B substances nos (Vitamin B Complex) for product used for unknown indication, lenvatinib mesilate (Lenvima) (batch number 1112974, expiry date 31st August 2023) for product used for unknown indication, naproxen (Aleve) for product used for unknown indication and pembrolizumab (Keytruda) for product used for unknown indication.   Concurrent medical conditions included drug allergy (Cefaclor, cephalosporine, neuromuscular blockers, steroidal, penicillanic, sulfone BL Beta lactamase inhibiters, penicillin).   On an unknown date, the patient received Shingles vaccine, Vitamin D3 at an unknown dose and frequency and Vitamin B Complex at an unknown dose and frequency. On 9th March 2021, the patient started Lenvima 20 mg once daily (20 mg daily). On an unknown date, the patient started Aleve at an unknown dose and frequency and Keytruda at an unknown dose and frequency. On an unknown date, unknown after receiving Shingles vaccine and Vitamin D3, the patient experienced pain, tiredness and fever. The action taken with Vitamin D3 was unknown. The action taken with Vitamin B Complex was unknown. The action taken with Lenvima was unknown. The action taken with Aleve was unknown. The action taken with Keytruda was unknown. On an unknown date, the outcome of the pain, tiredness and fever were unknown.   It was unknown if the reporter considered the pain, tiredness and fever to be related to Shingles vaccine and Vitamin D3.  Additional details were provided as follows: The age at vaccination was not reported. The patient got Shingle shot and was feeling aches, tired and had fever. Wanted to know if it was OK to skip the dose consulted to take continuously and reach out to MD to discuss further information was provided. The patient was taking vitamin b-complex , Vitamin D3, Lenvima, Keytruda and Aleve at or around the time of the event  It was unknown if the reporter considered the pain, tiredness and fever to be related to Vitamin B Complex, Lenvima, Aleve and Keytruda.
Lots of Pain in arm where shot was received, Itching & Hives for @3 days and on 3rd day after Moderna Vaccine had a slight headache.
Severe headache, chills (97.8 temp), muscle and joint aches, sensitive skin, exhaustion commencing 8 hours post vaccination and continuing for approximately 30 hours.  Despite exhaustion, unable to sleep due an anxious feeling.  Headache and muscle and joint pain subsided but an inability to control body temperature continued but still never a fever.  Developed a scratchy throat and dry cough.  Continued lack of energy.  Unable to work or do physical exercise.  A feeling of coming down with a bad cold, but no cold.  The dry cough lasting 8 days to date (3/26/7/21).    Went to GP, no sign of infection or upper respiratory infection.  Suspects that all symptoms are a result of vaccine #2.  Did have slight rash on left upper arm at vaccine sight that started approximately 48 hours following shot and lasting approximately 3 days.  On day 15, still feeling quite ill.  Not much relief from Tylenol.
The same night for the vaccination, she began to have a high fever, and the next day it was continuing to be very high and completely unrelenting despite using ibuprofen and Tylenol. The fever did not break until the evening of the 6th of July or the 7th of July. I took her to her pediatrician who was not worried and also urgent care. The fever was over 103-104 the entire time. She has had allergies and post nasal drip including a cough however no returned fever. She was also extremely fatigued and she also had no appetite during the week of the fever. Family history of vaccine reaction to D-Tap mother had anaphylactic reaction to it.
Information has been received from a nurse concerning unspecified patients of unknown age and gender.  The patients' concomitant medications, pertinent medical history, and drug reactions and allergies were not provided. On unspecified dates, improperly stored doses of VARIVAX (dose, strength, frequency and route were unknown, lot # M010484 with expiration date 01-MAR-2018, Lot # L045955 with 17-NOV-2017, lot# L048467 with expiration date 02-DEC-2017) were administered to the unspecified patients for prophylaxis. The VARIVAX was exposed 7 Fahrenheit for a time frame of 7 days. No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected since there is no consent for follow up.; Sender's Comments: US-009507513-1612USA006700:
patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 61 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Severe arm pain, with lump currently very hot and tender to touch. Body aches, slight headache, diaherra, nausa, very tired.
few drops leaked out during administration; few drops leaked out during administration; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (few drops leaked out during administration), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (few drops leaked out during administration) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: COVID-19 VACCINE (Do you have information about previous COVID-19 vaccination doses?Answer:2 previous doses) and COVID-19 VACCINE (Do you have information about previous COVID-19 vaccination doses?Answer:2 previous doses). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and COVID-19 VACCINE.    On 19-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Dec-2022, the patient experienced ACCIDENTAL UNDERDOSE (few drops leaked out during administration), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (few drops leaked out during administration) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (few drops leaked out during administration), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (few drops leaked out during administration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for ACCIDENTAL UNDERDOSE (few drops leaked out during administration) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (few drops leaked out during administration).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.
After getting vaccinated I experienced the following symptoms: Palpitations and have to monitor my heart rate every now and then. I had Shingles as well. I took my prescriptions for Shingles (Valtrex, Gabapentin, Vicodin).
Patient was given Covid (Purple Cap) 50 minutes after expired reconstitution time of 6 hours.
body cramps/leg cramps; he is hurting; Body aches; leg cramps; sick from the stomach; soreness in the area of the shot; redness in the area of the shot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (body cramps/leg cramps), PAIN (he is hurting), ABDOMINAL DISCOMFORT (sick from the stomach), VACCINATION SITE PAIN (soreness in the area of the shot) and VACCINATION SITE ERYTHEMA (redness in the area of the shot) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hernia (Patient had several hernia surgeries in the past.) and Surgery (Patient had several hernia surgeries in the past.). Concurrent medical conditions included Cramps (Patient suffers from cramps for several years now.). Concomitant products included CARISOPRODOL (SOMA [CARISOPRODOL]) for Cramp.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced VACCINATION SITE PAIN (soreness in the area of the shot) and VACCINATION SITE ERYTHEMA (redness in the area of the shot). On 28-Jul-2021, the patient experienced ABDOMINAL DISCOMFORT (sick from the stomach). On an unknown date, the patient experienced MUSCLE SPASMS (body cramps/leg cramps), PAIN (he is hurting), MYALGIA (Body aches) and MUSCLE SPASMS (leg cramps). At the time of the report, MUSCLE SPASMS (body cramps/leg cramps), PAIN (he is hurting), ABDOMINAL DISCOMFORT (sick from the stomach), VACCINATION SITE PAIN (soreness in the area of the shot), VACCINATION SITE ERYTHEMA (redness in the area of the shot), MYALGIA (Body aches) and MUSCLE SPASMS (leg cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
sore arm; lower back pain; stiff lower back; pain that interferes with her daily activities; pain that interferes with her daily activities; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), BACK PAIN (lower back pain), MUSCULOSKELETAL STIFFNESS (stiff lower back), PAIN (pain that interferes with her daily activities) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (pain that interferes with her daily activities) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included Viral meningitis. Concurrent medical conditions included Penicillin allergy and Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, MAGNESIUM and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), BACK PAIN (lower back pain), MUSCULOSKELETAL STIFFNESS (stiff lower back), PAIN (pain that interferes with her daily activities) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (pain that interferes with her daily activities). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), BACK PAIN (lower back pain), MUSCULOSKELETAL STIFFNESS (stiff lower back), PAIN (pain that interferes with her daily activities) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (pain that interferes with her daily activities) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took 2 doses of Tylenol extra strength (2 tabs per administration - a total of 4 tabs) a a corrective treatment. She thought she might be taking naproxen later. The patient stated she is sure that what she is feeling right now is viral.
Soreness in entire arm. 9/19/02 PM Fever 101 F, redness at injection site and very warm to touch. 09/20 AM Increase in area of inflammation and now hot to touch. Very sore. Took Tylenol. 9/20/02 PM Elevated temperature 101 F. Injection site inflammation up to softball size. 9/21/02 No fever, inflammation continues at injection site. 9/24/02 Feels much better but arm still sore to touch; still slightly warm, beginning to itch and some skin beginning to slough off. Has used ice pack to arm throughout course.
Pt began experiencing chest discomfort approximately 3 months after 1st anthrax shot. The frequency of the discomfort increased to one a month. In Oct 2000 the severity of the chest discomfort increased. In Dec 2000 the episodes began to include dysphagia and odynophagia, now occurring 2-3 X per day. Pt has lost 25 pounds.
Upon receiving influenza vaccine in 2009, previous vaccination site (2008) on opposite arm reappeared. Why?
Tingling in my right arm, going down to right arm and then it was all down to my right side of my body to the bottom of my foot; Had tingling and numbness for entire 9 days after the shot; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809, the consumer stated that, there was no expiration date of Pfizer COVID-19 Vaccine), via an unspecified route of administration on 14Feb2021 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. The patient medical history included diabetes. Concomitant medications included hydrochlorothiazide, dulaglutide (TRULICITY), hydralazine, metoprolol, atorvastatin, insulin detemir (LEVEMIR). The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3248), via an unspecified route of administration on 24Jan2021 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. She called because she knows they said they can put this form online but since she had this problem for about 9 days now. She just wanted to talk to someone. Stated that, she received her second shot on 14Feb2021. Stated that, she was going to say about an hour after her shot she started feeling some tingling in her right arm, going down to right arm and then it was all down to her right side of her body to the bottom of her foot. Stated that, she don't think it was because of the fact that sometimes they said your arm would be a problem where you got your injection, but the patient wanted to say that she had tingling and numbness for entire 9 days after the shot. The patient did not received treatment for the events and stated that, she didn't know what it was. When provided with the number Pfizer Medical Information, consumer stated that, she had been through doctor one time. They don't know very much about it. She had an appointment again for tomorrow. Stated that, she like to provide as much information as possible so she can get over her problem with her right side. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Vax 2 - Normal (flu-type) symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 10:00 (Lot number: ER8736) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE; AMLODIPINE BESILATE. Past drug history included: No. Vaccination history included: Bnt162b2 (dose 1,single, Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 10:00), administration date: 01Apr2021, when the patient was 55 years old, for Covid-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Vax 2 - Normal (flu-type) symptoms".  Additional Information: If Covid prior vaccination was reported as Unknown. If Covid tested post vaccination was reported as No. Known allergies was reported as No. If other vaccine in four weeks was reported as No.  No follow-up attempts are possible. No further information is expected.
Fainted after vaccines given, dizziness, paleness, slow to respond to name, after receiving vaccines. Received 7 vaccines on 1/6/17 and PPD placement. Recovered after 30 min.
Swollen/closing throat; Swollen/closing throat; hives; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 15:00 (Batch/Lot number: unknown) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLUOXETINE. The patient had known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccine.  The following information was reported: THROAT TIGHTNESS (medically significant), PHARYNGEAL SWELLING (non-serious) all with onset 08Jan2022, outcome "recovering" and all described as "Swollen/closing throat"; DIARRHOEA (non-serious) with onset 07Jan2022 17:00, outcome "recovering", described as "diarrhea"; URTICARIA (non-serious) with onset 08Jan2022, outcome "recovering", described as "hives". Therapeutic measures were not taken as a result of throat tightness, pharyngeal swelling, diarrhoea, urticaria. Since the vaccination the patient was not tested for COVID-19. The lot number for bnt162b2 was not provided and will be requested during follow-up.