chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderate to severe pain all around the shoulder area, and down to finger tips; Moderate to severe pain all around the shoulder area, and down to finger tips; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 13:00 (Lot number: Er2613) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies Sulfa antibiotics" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "GERD" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRONE; FUROSEMIDE; LAMOTRIGINE; LEVOTHYROXINE. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 26Mar2021, outcome "not recovered" and all described as "Moderate to severe pain all around the shoulder area, and down to finger tips". Therapeutic measures were not taken as a result of arthralgia, pain in extremity. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
I received the COVID19 vaccine on 9/7/2021 approximately at 715am. Around 10am that same day I started to feel nauseated and a bit lightheaded with some dizziness. These symptoms progressed to the next day on 9/8/2021. Additionla symptoms started to become apparent in conjunction with the nausea, dizziness and lightheadedness which were: headaches, loss of appetite, cough, sweat outbreaks, low grade fever. These symptoms lasted and stayed the same until the night of 9/9/2021 when I started to experience chest pressure. I woke up on 9/10/2021 with  two additional episodes of chest pressure and bilateral leg weakness. My left left was worse by far with my left calf muscle having me concerned a blood clot might be present. It was at this point that I went to seek treatment at the Emergency Room. I was told I was having a "Significant  Reaction" to the COVID19 vaccine. I was given Zoloft for my nausea and told to follow up with my regular physician. On 9/11/2021 and 9/12/2021 I tried to go for a walk amidst my bilateral leg weakness and was unable to complete my small walks without difficulty. This was witnessed by my husband and my daughter, On 9/13/2021 I saw my PCP and he prescribed me steroids to help with the muscle weakness and advised that I do not take the second COVID19 vaccine considering my reaction to the first vaccine.
She is having an on and off pain on the left side of her chest and left arm; She is having an on and off pain on the left side of her chest and left arm; This is a spontaneous report from a Pfizer sponsored program. A contactable Other-HCP female patient (girlfriend) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on unknown date at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient was having an on and off pain on the left side of her chest and left arm, it subsided then came back. The outcome was unknown.   Information on Lot/Batch has been requested.
Fever with 101 F/started a 101 fever this PM but now down to 99 now after a couple of Tylenol; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (Fever with 101 F/started a 101 fever this PM but now down to 99 now after a couple of Tylenol) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E22A, 022M20A and 027620A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation (A-fib about a week before the last Moderna Covid shot) in 2021 and Defibrillator/pacemaker insertion (Serous heart with pacemaker & defibrilator) on 01-Jan-2013.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced CHILLS (chills). On 01-Sep-2021, the patient experienced PYREXIA (Fever with 101 F/started a 101 fever this PM but now down to 99 now after a couple of Tylenol). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 01-Sep-2021, CHILLS (chills) and PYREXIA (Fever with 101 F/started a 101 fever this PM but now down to 99 now after a couple of Tylenol) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, Body temperature: 101 (High) High. On an unknown date, Body temperature: 99 (normal) normal.         concomitant medication were not reported The patient had taken 2 Tylenol tablets   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received and the temperature after taking the Tylenol is updated in lab data, also it get updated with the initial event, and all data are corrected from the initial version includes reporter details, lab data, product tab, event tab On 06-Sep-2021: Follow up received on 6-SEP-2021 contains Updated patient demographics and Medical history added.
after more than 12 hours at room temperature and after puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (after more than 12 hours at room temperature and after puncture) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066F21A, 039A21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (after more than 12 hours at room temperature and after puncture). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (after more than 12 hours at room temperature and after puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided. Patient received a booster dose which had been administered more than 12 hours after the initial vial puncture. Reporter stated that there are no known symptoms, though the patient left before monitoring time had elapsed.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml injection, lot # L007495 with expiration date 24-FEB-2017 (route and dose were not reported). This specified lot number vaccine was exposed to temperature excursion three times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) were as following: the first excursion was 24, 33 and R; the second excursion was 272, 31 and R; the third excursion was 120, 29 and R. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
patient was given vaccine after it had been left at room temperature for longer than recommended (4 hours).
My second Pfizer Vaccine was given subcutaneously (Sub-Q). It was not given intramuscularly (IM.) The pharmacy tech created a wheal. All the vaccine was injected. The pharmacy tech stated she was trained to give the Covid vaccines this way. The incident was immediately reported to the on-duty pharmacy manager. Manager stated she would research next steps and call me back. Presently the Sub-Q site is stinging and feels warm to touch.
Six days after the booster developed shingles; Two days after receiving booster experienced a brief TIA; This is a spontaneous report from a contactable consumer(patient). A 72-year-old non-pregnant female patient received third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 30Sep2021 11:30, at 72-year-old, as single dose (Lot Number: 301458A) for covid-19 immunisation.  Known allergies was ZPak. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 22Jan2021 at 10:00, at 72-year-old, as single dose (Lot Number: EL9262) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 12Feb2021 at 10:00, at 72-year-old, as single dose (Lot Number: EN6203) for covid-19 immunisation.  Concomitant medications included Losartan Potassium, Levothyroxine, Zaleplon. All concomitant drugs were taken for an unspecified indication. No other vaccine in four weeks. The patient had not got Covid prior vaccination and had not got Covid tested post vaccination. The patient reported two days after receiving booster experienced a brief transient ischaemic attack (TIA) on 02Oct2021 at 08:30 AM. Six days after the booster developed shingles on 06Oct2021. Therapeutic measures were taken as a result of all events included: appointment scheduled for Carotid Artery scan. The patient had a healthcare professional office/clinic visit for all events. The outcome of all events was recovered. The case was serious due to medically significant condition.  Follow-up attempts are completed. No further information is expected.
Patient received Hepatitis A vaccine Havrik 720 for 15 month old at 6 months due to medical assistant error identification of two well child checks at similar times and giving the Hepatitis A .Patient also received DTap and Influenza .25 On October 15th Patient came in for a return visit with symptoms that mother and physician feel were unrelated to Hepatitis A vaccine administration . On Saturday, infant was irritable the entire time he was awake, did not sleep well , had a barking cough and fever. During the Monday visit, infant was afebrile at 97.6. Doctor noted that infant had excessive crying that settled during visit.
Nauseated around midnight, lost sleep, vomiting (x2) around 9AM 10/7/16, slept (2 hours), nauseated and dizziness since.
Fever, chills, lethargy, R arm soreness with erythema, calor, induration, and TTP.
Pt recvd 2nd dose of vax & devel a localized swelling of the arm which began w/in 24 hrs of inject & lasted for a couple of days; rxn was characterized primarily as localized erythema;
8 year old on catch up schedule for vaccines with no adverse event; Initial information received on 31-May-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an 8-year-old on catch up schedule for Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine [Quadracel] vaccines with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the 8 years old patient on catch up schedule received a dose of suspect Quadracel vaccine (formulation, strength, dose, lot number, expiration date, route of administration and administration site: unknown) as prophylactic vaccination (product use issue, latency unknown)   There will be no information available on the batch number for this case.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.    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 the 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.
Got vaccinated and yesterday was tested positive; Got vaccinated and yesterday was tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 16Feb2022, outcome "unknown" and all described as "Got vaccinated and yesterday was tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Feb2022) positive. Additional information: Caller wants to know when the vaccine will be approved. He also mentioned that he has a friend who was a doctor as well and has a lecture. He mentioned that his friend has had the Covid vaccine and the booster but the friend has had a mild case of omicron. He stated that his daughter got vaccinated and yesterday was tested positive. She was trying to find out if it was Omicron or something else. He basically wants to know, when the vaccine will be available (approved). He also stated that he heard that they have started human trials but he was not interested in participating in the Covid trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200295239 same reporter/patient/drug/AE, different patient
devel rash on abd 15MAY;described by MD as scarlet fever rash, covered entire body had burning of skin, no itching;tongue red, enlarged lymph nodes, skin flaking & peeling especially face & hands;dec appetite;burning & pain @ site;
Painful injection but fine for the majority of the day. Started feeling muscle fatigue around 4pm, with upper body aches, stinging eyes, and nausea by 6pm. Fever of 102, and progression to full body aches and headache by 8pm in addition to the aforementioned symptoms that continued throughout the night. Fever lowered to 99 and only minor body aches by mid morning on the 12th. Headache continued throughout the day with low grade fever. I predict that I will feel 100% better within 48 hours.
Had arm pain; Malaise; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had arm pain), MALAISE (Malaise) and FATIGUE (Fatigue) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (Allergic to scallops and mollusks) and Hashimoto's thyroiditis.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Had arm pain), MALAISE (Malaise) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Had arm pain), MALAISE (Malaise) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported.  On 02 Apr 2021, the patient received second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  As the patient received both scheduled doses of vaccine action taken with the drug in response to the event was not applicable.    Treatment details was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-070029 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070029:
Itchy rash appeared on back and buttocks.  Seemed like little blisters/boils.  Didn't connect it to the shot, but then heard a friend had a similar reaction and he reported it, so I thought I should, too.
This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a consumer and concerns a 33 year old female: Local case ID 95-011. The subject's height, weight and medical history were not reported. The subject received typhoid vaccine oral ty21a (capsule, hard, oral) on an unspecified date as prophylactic vaccination. Concomitant medications were not reported. On 01-AUG-1993, the subject developed a neurological disorder. Action taken with typhoid vaccine oral ty21a was unknown. The subject had not recovered from neurological disorder, at the time of the report. This report was serious (medically significant).
could not taste food very well; nausea; low fever; sore arm; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (could not taste food very well), PAIN IN EXTREMITY (sore arm), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020 and Loss of smell (Symptom of COVID-19.) in December 2020.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and CHILLS (chills). On 17-Mar-2021, the patient experienced AGEUSIA (could not taste food very well), NAUSEA (nausea) and PYREXIA (low fever). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, AGEUSIA (could not taste food very well), PAIN IN EXTREMITY (sore arm), CHILLS (chills), NAUSEA (nausea) and PYREXIA (low fever) outcome was unknown and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.
Patient received primary vaccine dose instead of Pfizer 5-11 booster. Patient and family was informed.
I had Moderna shot and 2 boosters; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (I had Moderna shot and 2 boosters) 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 20-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced EXTRA DOSE ADMINISTERED (I had Moderna shot and 2 boosters). On 20-Sep-2021, EXTRA DOSE ADMINISTERED (I had Moderna shot and 2 boosters) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 34-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. The patient's last menstrual period was on 07-Sep-2020 and the estimated date of delivery was 21-Jun-2021. On 08-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 08-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Internal review on 20JUL2021 resulted in updates to pregnancy details.
had a pretty high fever/ Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (had a pretty high fever/ Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PANCREATIN (CREON) for Cystic fibrosis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and PANCREATIN (CREON) (Oral) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (had a pretty high fever/ Fever). At the time of the report, PYREXIA (had a pretty high fever/ Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  The patient had reported that with the first dose of the Moderna Vaccine patient had a pretty high fever.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  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.
2 1/2 inches long by 1 1/2 inches wide very dark purple bruise that was very swollen & hot same day of injection on Oct. 30, 2012.
On February 7 I noticed a hard red spot at the injection site; also 2 hard, raised spots of rash about 2" below injection site. It had been mildly itchy earlier in the day but didn't see the rash until I took a shower at night.
01/14/22 presents to EC ED for "weakness, fatigue and abdominal pain". PMHx of "DM2, Gerd, Gout, HLD, HTN and Obesity"
This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. On an unknown date (also reported as since 11-MAY-2016) the patient was vaccinated with improperly stored dose of M-M-R II lot #: L039551. No adverse effect reported. The temperature excursion details included exposure to temperature of 47 Fahrenheit for 8 hours. No previous temperature excursions reported. No additional doses have been administered. This is one of several reports received from the same source. Additional information has been requested.
A few minutes (about 5 to 10 minutes) after patient received his shot, he started to feel dizzy and sweating, He momentarily passed out and was laid down on his back on the floor. He regained consciousness a few minutes afterwards (about 3 minutes). He was talking & said that he's ok & asked for some water to drink. (His mom said that patient had same kind of reaction the last time he got a shot at the doctor's office and they laid him on the floor on his back and that was what she asked that we help her do while we called 911). Before the arrival of the 911 dispatch team, patient was already sitting on the chair and told the dispatch team that he's fine. The dispatch team talked with him, making sure that he was fine before they left.