chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 01-14-2021 at about 8:00pm, I began to experience nerve inflammation. I had pain in my right arm, it was a fiery electrical pain that radiated from my right shoulder down to my right hand. The joints in my hands particularly my right index finger, ring finger and thumb felt incredibly painful. I could not pick up or grasp anything. It felt like I had intense rheumatoid arthritis and my symptoms lasted about 5-6 days before they started to go away.
Erythema multiforme, onset 14 days after smallpox and anthrax #1 vaccination.  Involving arms, legs, hands and feet.
Rash all over body, doesn't itch. Headache, since injection. Spanish speaking, difficult to get much information. Referred to PMD for evaluation.
Pt reported prolonged soreness/immobility in arm in weeks follow vaccination pt followed up w/MD.
Unable to walk; Limping; Congestion in the chest; Little redness on the face; Little soreness on the face; Slight Headache; Bad arthritis reaction in hands, neck; Bad arthritis reaction in hands, neck; Bad gout reaction in all joints, big toe, feet, hands, wrist; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (Congestion in the chest), ERYTHEMA (Little redness on the face), FACIAL PAIN (Little soreness on the face), ARTHRITIS (Bad arthritis reaction in hands, neck) and GAIT INABILITY (Unable to walk) in a 57-year-old male 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 Gout. Concurrent medical conditions included Diabetes, Blood pressure high and Cholesterol total abnormal NOS. Concomitant products included METFORMIN for an unknown indication.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced ARTHRITIS (Bad arthritis reaction in hands, neck), SPONDYLITIS (Bad arthritis reaction in hands, neck) and GOUT (Bad gout reaction in all joints, big toe, feet, hands, wrist). On 01-May-2021, the patient experienced CHEST DISCOMFORT (Congestion in the chest), ERYTHEMA (Little redness on the face), FACIAL PAIN (Little soreness on the face) and HEADACHE (Slight Headache). On an unknown date, the patient experienced GAIT INABILITY (Unable to walk) and GAIT DISTURBANCE (Limping). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 03-May-2021, CHEST DISCOMFORT (Congestion in the chest), ERYTHEMA (Little redness on the face), FACIAL PAIN (Little soreness on the face) and HEADACHE (Slight Headache) had resolved. At the time of the report, ARTHRITIS (Bad arthritis reaction in hands, neck), GAIT INABILITY (Unable to walk), GAIT DISTURBANCE (Limping), SPONDYLITIS (Bad arthritis reaction in hands, neck) and GOUT (Bad gout reaction in all joints, big toe, feet, hands, wrist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that he experienced COVID -like symptoms which included slight headache, congestion in chest, little redness and soreness in the face. Patient reported that he soaked in bathtub for 5 hours.  The concomitant medication included 2 unspecified medications for high blood pressure and 1 unspecified medication for cholesterol.
Injection site erythema and tenderness without purulence, left axillary tender lymphadenopathy, myalgia,  fatigue.
developed a facial droop, bell's palsy; A spontaneous report (United States) was received from a nurse concerning a 47-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a facial droop and was diagnosed with Bell's palsy/facial paralysis with seriousness criteria as hospitalization.   The patient's medical history was not provided by the reporter. Concomitant medications reported included humera, high blood pressure medication and arthritis medication.  On 13 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 016M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 13 Feb 2021, after two hours, the patient experienced, a facial droop and was concerned for stroke therefore was hospitalized and recognized this as Bell's palsy.   Lab details were not provided by the reporter.  Treatment for the events included vitamin B12 and was on steroids for 5 days, both for Bell's palsy.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, facial droop and bell's palsy were recovering.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Moderna COVID-19 Vaccine EUA 10pm - administration site soreness 11:15pm - violent chills 12:15am - posterior neck pain 1am - full body ache 4am - frontal & maxillary sinus pain, low grade fever 6am - intense neck and sinus pain 8am - exhaustion, administration site hardness 10am - chills subsiding 12pm - intense pain improves to moderate 1pm - mild fever and fatigue persist 4pm - diffuse muscle & joint pain 6pm - symptoms the same
Patient stated he felt "funny in the head" on 02/19/2021 at 4:00 pm. His wife stated that the patient had seemed confused.  Gave patient 2L of fluids and discontinued trazodone. Patient returned to baseline and was discharged after 24 hours.
Stroke-like symptoms of headache and left-sided facial droop/paralysis began around 3:30pm on 5/21/2021.  Went to Emergency Room.  CT scan ruled out blood clot and stroke.  Diagnosed with Bells Palsy.  15 day  course of treatment of Prednisone is currently underway, starting with 60 mg on days 1-5, followed by 50mg  day 6-7, 40 mg day 8-9, 30 mg  day 10-11, 20 mg day 13-14, and 10 mg day 14-15.  (As of today, 5/28/2021, I am on 50mg day 7).  Paralysis has not yet subsided.
This is a spontaneous report from a contactable pharmacist. A female patient of unknown age and race/ethnicity received PREVNAR 13 (lot T35176, exp. date 31Jan2020, NDC number 0005197105) for immunization on 25Jan2018 at single dose. Relevant medical history included pain, unknown if ongoing. Concomitant medication included tramadol for pain. On 26Jan2018 the patient experienced swelling and redness at the area. The outcome of the events was not recovered. The patient received just the ice packs for the events. An unknown lab works were performed.
This spontaneous report as received from a pharmacist refers to a 75 years old male patient. The patient's medical history and concurrent conditions were not reported. On 16-JUN-2015 the patient was vaccinated with PNEUMOVAX 23 0.5 ml, intramuscular, lot # K010465 expiration date 23-MAR-2016. The patient's concomitant therapies were not reported. On approximately on 16-JUN-2015, reported as after receiving the vaccine the patient experienced redness, mild but visible swelling, down to the elbow and soreness at the injection site. The patient sought medical attention by saw the pharmacist and no treatment was given for the adverse events. The reporter stated that the patient was ambulatory, alert and had no fever or systemic complaints. No laboratory diagnostic test were performed. At the time of the report, the outcome of redness, erythema, peripheral swelling and injection site pain was unknown. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
having pain in hands shoulder and knees; having pain in hands shoulder and knees; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer-sponsored program. A 65-year-old female patient received bnt162b2 (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 11Mar2021 (at the age of 65 years old) as single dose for covid-19 immunization; tofacitinib citrate (XELJANZ, Lot Number: DP7374), orally from an unspecified date to an unspecified date, at 1 Tablet by mouth daily for OTH Rheeumatoid Arthritis w Rheumatoid Fator mult site. Medical history included age-related Osteoporosis without current pathological fracture. Concomitant medications included ascorbic acid/ ferrous fumarate/ folic acid/retinol (PRENATAL), ertugliflozin pidolate (STEGLATRO), lisinopril, levothyroxine sodium (LEVO T), metformin hcl, flucytosine, curcuma longa (TURMERIC CURCUMIN), vitamins and minerals. The patient stated that she stopped taking the medication on 11Mar2021 due to receiving the COVID-19 vaccination, the MD told her to restart the medication 1 week after second vaccination scheduled for 09Apr2021, patient reported due to not being on medication, she was having pain in hands shoulder and knees, all questions and concerns addressed, patient agreed to follow up calls after she restarts the regimen. The action taken of tofacitinib citrate was unknown. The outcome of events was unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
About 3 minutes after Comvax given, entire left leg became red. This lasted 20 minutes. Patient was awake, alert, in no distress throughout whole event. After redness subsided, the leg looked perfectly normal.
2 wks after getting booster shot had 6 hrs of atrial fibrillation(am being monitored). The ONLY other time I had this was about 6 hrs. after my first vaccination ( that time it lasted about 2 hrs Both resolved spontaneously. No other symptoms
Rubeola and varicella vaccines given at around 0715. Patient back in office around 0815 feeling overwhelming fatigue, mild shortness of breath and was diaphoretic and was taken to the emergency room.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 09-SEP-2014 the patient was vaccinated with a dose of (Oka/Merck) PROQUAD (lot K006771, expiration date 07-NOV-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Immediately after client received PREVNAR 13 vaccine IM in RVL this nurse observed redness/swelling of (Rt) thigh. Applied ice pack wrapped in several paper towels for 2 to 3 minutes and observed swelling to decrease. Client monitored for 45 minutes. No swelling or redness present to (Rt) thigh when left facility. Follow up phone call to parent x 2 in 48 hours. No swelling/redness to (Rt) thigh. Equal movement of legs per client's mother.
Severe tinnitus 2 days after first injection. Continued and made worse by second injection. Absolutely no improvement.
This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took second booster dose a month early) and NO ADVERSE EVENT (No adverse event) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took second booster dose a month early). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took second booster dose a month early) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took second booster dose a month early). No concomitant medication information was provided. Patient was given a Moderna COVID-19 booster shot today. They had given her second booster thinking this was first. They found out later that this patient has already received their first booster. This in turn meant they gave her Moderna COVID-19 second booster dose a month early. Most patient information and vaccination information was unknown. The patient did not experienced any side effects. There was no allergies. No COVID positive test or diagnosis. Expiration of the first Moderna COVID-19 vaccine was reported as unknown. Lot number of the second Moderna COVID-19 vaccine was reported as unknown. Expiration of the second Moderna COVID-19 vaccine was reported as unknown. Lot number of the first Moderna COVID-19 booster vaccine was reported as unknown. Expiration of the first Moderna COVID-19 booster vaccine was reported as unknown. Lot number of the second Moderna COVID-19 booster vaccine was reported as unknown. Expiration of the second Moderna COVID-19 booster vaccine was reported as unknown. No treatment medication were provided.
excursion involved UnOpened Vaccine Ipol given to a patient, excursion was 50.4 degrees F. x 30 minutes; Initial information received on 06-Dec-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves the patient of unknown demography who she received vaccines HIB (PRP/T) VACCINE [ACT-HIB] and IPV (VERO) [IPOL] and reported that excursion involved unopened vaccine Ipol given to a patient, excursion was 50.4 degrees F. x 30 minutes (product storage error).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 22-Oct-2019, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UJ076AAA and expiry date: 21-Aug-2020 via unknown route in unknown administration site.  On 22-Oct-2019, the patient received a dose of suspect IPV (VERO) lot P1A251M and expiry date: 02-May-2020 via unknown route in unknown administration site.  It was a case of actual medication error due to incorrect product storage.  It was unknown if the patient had any adverse 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 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.
The RN selected the Pfizer primary vaccine vial instead of the Pfizer bivalent vaccine vial and administered 0.3 ml dose to the patient.
Baby developed hives the night that she received first DTaP (DAPTACEL) which was the only vaccine she received that day. The hives lasted for 10 days.
I got the shot and then next day I was achy with pain in my right hip. I am limping.
Systemic: Abdominal Pain-Severe, Systemic: Nausea-Severe, Systemic: Other- High blood pressure and heart rate
Throwing up, very lethargic, pale. Seen in physician's office and transported to hospital by helicopter due to the pt stopped breathing. Child was ok once at the hospital.
On 12/21/2015 patient was given a Tdap vaccine as part of a new hire assessment. She denied contraindications to Tdap. Two days after receiving the vaccine she developed fatigue, irritability, sore throat, denies redness and swelling of arm. She denied having fever or airway reaction. Her dad remembered that she had a rxn as a child to a DTP and was advised to never be vaccinated with DTP/TD vaccine again. She states she was unaware that she had a contraindication until she had the current reaction. Her symptoms progressed to vomiting. She saw her PCP. On 01/13/2016 she came to EH and reported incident. She had vomiting yesterday and now has gland swelling on the L cervical node. She reports she had no airway rxn. Still feeling poorly. Denies fever. She was advised to complete a PSA. She is advised to seek medical care for increase in gland swelling and given information that it could cause airway impingement if swelling increases. If there are in airway symptoms she should seek immediate emergency care including use of ambulance. She demonstrates an understanding of directions. (Created on 1/11/2016 and 8:59).
My heart beat shot up from 72 to 116 within first few minutes of vaccination, I was having chills . It has been 8 days since I received the vaccine , my resting heart beat is still more than 100 BPM.; congested nose; I was having chills; extreme fatigue; This is a spontaneous report from a contactable Other HCP. This 39-year-old male Other HCP (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO140; Expiration date was not reported) on 24Dec2020 14:30 (at the age of 39-years) as single dose, unspecified route into left arm for immunization. Medical history was reported as none.  Allergies were reported as none. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to BNT162B2.  On 24Dec2020 the patient experienced 'My heartbeat shot up from 72 to 116 within first few minutes of vaccination.  It has been 8 days since I received the vaccine, my resting heartbeat is still more than 100 BPM', 'I was having chills', 'congested nose', and 'extreme fatigue'.  No treatment was received as a result of the events.  Lab data included on 24Dec2020 heartbeat 72 to 116 and Jan2021, reported as still more than 100 beats per minute. The outcome of events 'My heartbeat shot up from 72 to 116 within first few minutes of vaccination.  It has been 8 days since I received the vaccine, my resting heartbeat is still more than 100 BPM', 'I was having chills', 'congested nose', and 'extreme fatigue' were not recovered.
Erythema, swelling, pain and induration at injection site 3cm x 5cm.  Advised warm compresses and Tylenol for pain with follow up tomorrow (10/19/12).  Cellulitis not suspected.
I started out thinking it was a cold or upper respiratory infection but I got a call from my boss stating I may need a test. Scheduled a appt. With a lab to do a drive up CoVid test PCR on 1/5. The test came back negative and no other test were done for my issues. Was given Tessalon pearl's and Amoxicillin for the duration. It took about a week and I have recovered.
delayed injection site reaction that continue for a week still; injection site redness; injection site warmth; vaccination site pain; vaccination site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
patient was given the hib portion with saline and it was given solely as a hib vaccine, without the DTaP-IPV component,Hib component was mixed with a sterile diluent from Merck while administrating Pentacel/No AE; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a 15 months old male patient who was given the Hib portion with saline and it was given solely as a hib vaccine, without the dtap-ipv component, hib component was mixed with a sterile diluent from merck while administrating fourth dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot number not reported via intramuscular route in the left thigh dose four on 16-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  It was an actual medication error due to inappropriate reconstitution technique.  Symptoms: None 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.  Information on the batch number was requested.  List of documents held by sender: none.
Soar throat and nasal congestion during night following the vaccine. Symptoms continued into the following day.
awakened at 3am with fever 101 and shaking chills the night after my second SARS Pfizer vaccine. flu-like sx lasted for one day; fever resolved by this am 1/13
High fever up to 104 degrees F. Intense headache. Sore throat and throat glands. Joint pain in fingers.
Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient ever had tested or diagnosed positive for COVID. It was unknown if patient had Acute or Chronic/ long-standing illnesses at the time of vaccination or up to 1 month prior to vaccination. Information about other vaccines given within 1 month prior to Moderna COVID-19 vaccine was unknown.     On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 23 years and 10 months.   No concomitant medication information was provided. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process.  Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. No treatment medication was provided.
Accidental needlestick after administering  to patient. After vaccinating the patient, I went to put the safety clip on and accidentally pricked my thumb.
Urticaria, allergic reaction to COVID-19 vaccine, treatment with famotidine and benadryl, along with prednisone for 5 days.