chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stiff neck; Vaccine caused sore arm for one to two days; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck) and PAIN IN EXTREMITY (Vaccine caused sore arm for one to two days) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck) and PAIN IN EXTREMITY (Vaccine caused sore arm for one to two days). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck) had not resolved and PAIN IN EXTREMITY (Vaccine caused sore arm for one to two days) had resolved.            Concomitant product use was not provided by the reporter.  The reporter's causality for the events of stiff neck and vaccine caused sore arm for one to two days with respect to Humira was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment information was provided.   Reporter did not allow further contact
headache; feeling achey/extreme body aches; Chills; Temperature 99-100F; This is a spontaneous report from a contactable nurse (patient). A 25-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685 and expiry date: unknown), intramuscular on the left arm on 06Jan2021 07:30 at a single dose for COVID-19 immunisation. Medical history included Spinal fusion L4-S1, latex and adhesive allergy. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient previously took BACLOFEN and BACRIM and experienced allergy, and the first dose of BNT162B2 for covid 19 immunization on an unspecified date. The patient started feeling achey 10-12 hours after second dose on 06Jan2021 17:30. By 2300 that night, there were extreme body aches and headache. Patient was still achey throughout following day on 07Jan2021. She was feeling better, but on 11Jan2021 started feeling achey again. She had chills and temperature was 99-100F on Jan2021. Outcome of the events was unknown. No treatment was received for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Tiredness 10 hours after shot lasted 2 1/2 days, Headache 10 hours after shot lasted 2 1/2 days, Muscle pain 10 hours after shot lasted 2 1/2 days, *Ringing in the ears 10 hours after shot and has not stopped.
Pt came to the Pharmacy and informed that she might have had the reaction to PNEUMOVAX 23. Once she got home in couple hours after the shot, she was very down and tired. She could hardly move much. Also the next day she noticed a red rash about 2 inches away from the injection site which went away the following day after 24 hours. She used Vitamin E cream.
Headache, diarrhea ,sick at stomach ,body aches, balance problems,  and low grade fever. Symptoms lasted 36 hours.
pt devel malaise & swollen lymph nodes; lt supraclavicular; pt seen 1 wk later & sx are resolving;
Patient was given undiluted Pediatric Pfizer 0.2ml IM right deltoid. Nurse was unaware of event until after patient left Clinic. Patient was observed for 15 minutes with no reaction. Nurse reported event to Nurse Supervisor @ 2:53pm. Nurse Supervisor reported to Clinical Director @ 2:56 pm, then State Nursing Director @ 3:00pm. Pfizer was called @ 3:05pm and guidance received for patient treatment @ 3:50pm. MD was called  and given/ faxed report from Pfizer. Nurse Supervisor then called patient's father using Language Services. Parent informed of event and possible complications, patient doing well as stated by father. Father verbalized understanding.
This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness, no energy), PAIN (Everything was hurting), GAIT DISTURBANCE (Couldn't walk), CHILLS (Body chills) and FATIGUE (Tired) in a 48-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. A57144B, 012421A, 028A21A and 032821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2022 at 11:00 AM, received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2022, the patient experienced NAUSEA (Little bit of nausea). On 03-Sep-2022 at 4:00 PM, the patient experienced ASTHENIA (Weakness, no energy) and FATIGUE (Tired). On 03-Sep-2022 at 6:00 PM, the patient experienced PAIN (Everything was hurting), GAIT DISTURBANCE (Couldn't walk), CHILLS (Body chills), HEADACHE (Headaches) and PAIN IN EXTREMITY (Arm hurt when lifting it up). At the time of the report, ASTHENIA (Weakness, no energy), PAIN (Everything was hurting), GAIT DISTURBANCE (Couldn't walk), CHILLS (Body chills), FATIGUE (Tired), HEADACHE (Headaches), PAIN IN EXTREMITY (Arm hurt when lifting it up) and NAUSEA (Little bit of nausea) had resolved. No concomitant medications was reported. The patient not had a fever and not received any medications or treatments.
I experienced arm pain, fatigue, fever of 101, nausea, loss of appetite, had trouble walking a few steps to the bathroom and could not control her bladder which lasted until 5/5/22, and the symptoms are beginning to improve with only a low grade temp of 99 degrees Fahrenheit. The symptoms are improving, but they are not yet fully resolved.
throat swelling and difficulty swallowing--treated with meds left eye swelling--resolved spontaneously
mom reported @ next visit to clinic on 7SEP94 that pt had fever of 105.2 & was hospitalized but no tx other than antipyritic & cool baths;
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 30-DEC-2008 and 26-JUN-2009 the patient was vaccinated with pediatric dose of VAQTA (route, lot # not reported) respectively. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
fever at 100.5F; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever at 100.5F) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 020B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PYREXIA (fever at 100.5F) and HEADACHE (headache). At the time of the report, PYREXIA (fever at 100.5F) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Pyrexia: 100.5 Farad (High) 100.5F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
On day six after shots were given pt was seen in our office with a reaction (red bright raised area, bruise like dark area). Did have any pain in area. There wasn't any treatment given-they were just to watch for any changes and report.
Multiple joints( wrists, elbows, shoulders, and hand fingers)  excruciating pain, swelling  with hand and shoulder movement limitation. Last two days chest discomfort with some difficulty in breathing. Last night first time developed severe skull pain at posterior area. Symptoms mainly during night time and unable to sleep due to the intensity. Treatment: Voltaren Gel 1%, Generic  Mobic 7.5 mg and Sombra Warm Therapy Natural Pain Reliving  Gel, Acetaminophen 500mg.  Most of the symptoms have been for the last three weeks.
This spontaneous report was received from a registered nurse referring to a patient of currently 15 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of (Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Pt. received MCV4 on 6/18/12, she states that she noted some redness and bumps at site of injection. Pt. called clinic on 6/.19/12 with complaint, was advised to use cool compress and take Advil as needed. Telephone call was made to pt. that PM 6/19/12, pt. not in, spoke to foster mom, stated area on pt. small, no overall body fever, was advised to continue care, call if no better in AM. 6/20 12 Pt. came by clinic, stated area getting bigger, at that time was approx. 2 x 2" in diameter, red with bumps, warm to the touch, pt. was referred to a Dr. and list of Dr. names given to her. 6/24/12 Telephone call to pt. spoke with foster mom, pt. at school, states area bigger, pt. has not seen a Dr. 6/22/12 Telephone call to pt., she went to Dr. today at Urgent Care, temp 98 degrees there, placed on steroids, advised BENADRYL and use of ice to area. Was dx as allergic reaction to MCV4, and told not to received it again.
large swollen area that turned red and hot below the injection site.; Right arm got sore and stiff; Right arm got sore and stiff; large swollen area that turned red and hot below the injection site.; large swollen area that turned red and hot below the injection site.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9809) via an unspecified route of administration, administered in Arm Right on 11Feb2021 10:30 (at the age of 69-year-old) as single dose for COVID-19 immunization. The Patient had no relevant medical history and had no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), omeprazole, azelastine taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine within 4 weeks. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL8982) via an unspecified route of administration, administered in Arm Left on 21Jan2021 11:30 AM (at the age of 69-year-old) as single dose for COVID-19 immunization. On 12Feb2021, the patient experienced right arm got sore and stiff and a large swollen area that turned red and hot below the injection site. The patient did not receive any treatment for the events. The patient had not been tested for covid-19 post vaccination. Outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old patient of an unspecified gender received BNT162B2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jan2021 10:30 as SINGLE DOSE for COVID-19 immunization. Medical history included continuous positive airway pressure use a cpap machine, seasonal allergy have hay fever during spring summer, arthropathy the normal joint issues of someone my age nothing major they are controlled by exercise, drug hypersensitivity Allergies: Sulfa drugs. On 21Jan2021, the patient experienced gas, soft strange stools when pooping, sore arm. Gas and Soft strange stools when pooping started the evening after the injection and lasted until the morning of 9/27 Other than that the only problem was a sore arm that started 5 hours after injection and lasted about 24 hours- since it wasn't on the normal adverse effects list. I figured I would report it. The action taken in response to the event for BNT162B2 was not applicable. The outcome of the event was recovered. Follow-up attempts are completed. No further information is expected.
Information has been received from a consumer concerning his 8 week old daughter with no allergies or medical history who on 10-JAN-2006 was vaccinated inadvertently with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. It was noted that the patient was taken for her shots that she was supposed to be given at two months and she was given measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live by mistake. The reporter noted that the patient "is acting kind of fussy, but she is not having any reaction." Unspecified medical attention was sought. No diagnostic laboratory tests were performed. A product quality complaint was not involved. No further information is available.
Swollen lip and rash around mouth that developed on the evening that 2nd dose of Covid vaccine was given (i.e on evening of 07/01/2021). Rash and swelling of lips and mouth initially seemed to improve, then worsened again by 07/06/21, at which time medical provider (this writer) was contacted. Rash was itchy. Other symptoms included chills, body ache, headache, and soreness at the injection site. Treated with oral Cetirizine with full resolution of symptoms. These symptoms were reported by parent via online messaging system to patient's pediatrician (this writer).
Patient received expired dose of ACtHIB that expired on 3/5/2023. Patient has had no known adverse events until this point.
urticarial lesions that started shortley after injection, improved with Benadryl, recurred/persisted for few days
Bilateral Otitis; This spontaneous case was reported by an other health care professional and describes the occurrence of EAR INFECTION (Bilateral Otitis) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AR9237B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 30-May-2022.   On 06-Jul-2022 at 11:07 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Aug-2022 at 10:11 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-Feb-2023, the patient experienced EAR INFECTION (Bilateral Otitis). On 13-Feb-2023, EAR INFECTION (Bilateral Otitis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient did not had any chronic or long standing health conditions. It was reported that the patient did not had any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or of the adverse event.  Treatment information was not provided.   This case was linked to MOD-2023-713297 (Patient Link).
Case number PHHY2011US64657 is an initial spontaneous report received from a nurse on 14 Jul 2011. This report refers to a patient of unknown age group and gender. The patient was vaccinated with seasonal Influenza vaccine (manufacturer and batch number unknown) on an unspecified date during 1970's. On an unknown date after vaccination, the patient developed respiratory distress. No further information was available.
Patient is having problems controlling her blood sugar levels; Had a lump on her neck; Felt "so tired" she had to lay down all day; Arm hurt where she got the shot; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE FLUCTUATION (Patient is having problems controlling her blood sugar levels), MASS (Had a lump on her neck), FATIGUE (Felt "so tired" she had to lay down all day) and VACCINATION SITE PAIN (Arm hurt where she got the shot) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic (borderline).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced BLOOD GLUCOSE FLUCTUATION (Patient is having problems controlling her blood sugar levels), MASS (Had a lump on her neck), FATIGUE (Felt "so tired" she had to lay down all day) and VACCINATION SITE PAIN (Arm hurt where she got the shot). The patient was treated with METFORMIN for Diabetes mellitus management, at an unspecified dose and frequency. At the time of the report, BLOOD GLUCOSE FLUCTUATION (Patient is having problems controlling her blood sugar levels), MASS (Had a lump on her neck), FATIGUE (Felt "so tired" she had to lay down all day) and VACCINATION SITE PAIN (Arm hurt where she got the shot) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information included metformin for about three weeks then with no success.  Action taken with mRNA-1273 in response to events was not applicable.
10-15 minutes post injection patient complained of nausea.  Normal vitals. Patient's symptoms subsided 45 minutes after injection and patient was able to ambulate without any symptoms.
Bel's palsy (L side); Fever bolsters in her lips; Real sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bel's palsy (L side)) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bell's palsy (Right side, 12 or 15 years ago). Concurrent medical conditions included Overactive bladder. Concomitant products included OXYBUTYNIN for Overactive bladder.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Real sore arm). On 10-Apr-2021, the patient experienced FACIAL PARALYSIS (Bel's palsy (L side)) (seriousness criterion medically significant) and ORAL HERPES (Fever bolsters in her lips). On 11-Mar-2021, PAIN IN EXTREMITY (Real sore arm) had resolved. At the time of the report, FACIAL PARALYSIS (Bel's palsy (L side)) and ORAL HERPES (Fever bolsters in her lips) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient has her second dose scheduled for 16-Apr-2021.  She developed "bel's palsy" on 10-Apr-2021.  She started to notice it on 09-Apr-2021 but received confirmation on 10-Apr-2021.  She reported a real sore arm for two days after the vaccination.  The patient also developed "fever bolsters" in her lips.  She doesn't know if it is side effects from the vaccine.  The patient had a virtual appointment with her physician, and he recommended that she not receive the second vaccine and to visit a neurologist. Treatment medications included steroid and antiviral medications. Valtrex 1 gr table as needed (3 times a day).  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.; Sender'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.
"Palpitations" later dx as Arrythmia by cardiologist.  Difficulty breathing and heart "racing" just getting out of car and began walking at normal pace.  Was initially intermittent.  Increased in frequency at end of October, no pattern of event trigger; e.g., walking from one end of house to other could cause symptoms.  First week in November became multiple events daily. Scheduled appt with GP.  Saw GP on 11/08/2021 said if continued for another 5 days, see a cardiologist.  Saw cardiologist on 11/16/2021.  Rx for low dose of beta blocker and scheduled multiple tests because of anomaly on ECG and family hx of heart issues on maternal side.  All tests completed by 12/15/2021 and heart of "fine". Beta blocker has helped but still have some break through episodes occasionally.  No pattern to onset or time of day.  Cardiologist suggested might be stress reaction.  Lately has seen a relationship b/w possible dehydration and arrhythmia episodes, i.e., if I experience symptoms and drink water, symptoms ease up.   I have no history of heart issues.  Elevated BP has been managed for over 15 years.
12-24 hr after vax, pt devel neck pain, stiffness and "hot rashes" at the inject site. This is 1 of 6 pts at this site to have similar vax rxn
Within 7 minutes of receiving shot, my vision was slightly impaired (darkening ) cold sweating,  heart racing, head pressure and feeling I was going to faint. Emt?s and nurse assisted me. My blood pressure spiked to 176/100 and my legs and hands were shaking uncontrollably. Someone mentioned a hypertensive crisis and I was getting frightened. I requested an anti anxiety pill from my purse, which they let me have.  It didn?t help me at all.  I was taken to an ambulance and waited for a relative to come pick up my disabled daughter who was with me getting her covid shot as well.  I asked if they were taking me to the hospital, and was told ? you don?t want to go there? after an hour, bp came down to 146/90? ..which is still  too high and not typical for me.This was NOT brought on by an anxiety attack.i was not remotely anxious and was simply sitting and speaking with my daughter when I was striken. The next 3 days my heart was racing. I wear a Fitbit to bed and my heart rate recorded spikes  of 116 while I was asleep. Had bouts of bad stomach pain and diarrhea the next two days. Followed up with my GP 4 days later . Still having palpitations and following up with cardiologist.