chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 102; Body aches; Chills; lump under left arm pit size of a soft ball where he received his 1st shot; Whole left shoulder is swollen; Right leg is sore; Right leg is swollen to groin; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102), MYALGIA (Body aches), CHILLS (Chills), VACCINATION SITE MASS (lump under left arm pit size of a soft ball where he received his 1st shot) and SWELLING (Whole left shoulder is swollen) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced PYREXIA (Fever of 102), MYALGIA (Body aches), CHILLS (Chills), VACCINATION SITE MASS (lump under left arm pit size of a soft ball where he received his 1st shot), SWELLING (Whole left shoulder is swollen), PAIN IN EXTREMITY (Right leg is sore) and PERIPHERAL SWELLING (Right leg is swollen to groin). At the time of the report, PYREXIA (Fever of 102), MYALGIA (Body aches), CHILLS (Chills), VACCINATION SITE MASS (lump under left arm pit size of a soft ball where he received his 1st shot), SWELLING (Whole left shoulder is swollen), PAIN IN EXTREMITY (Right leg is sore) and PERIPHERAL SWELLING (Right leg is swollen to groin) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jun-2021, Pyrexia: 102 (Inconclusive) Fever of 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatments were reported.
pt recvd vax late October but may have had flu-like illness mid Nov; about 16NOV had leg aching but not weakness until several days later & soon thereabouts had paresthesia; paresthesia now in fingertips;
Rash broke out over body; Chills; Pins and needles sensation; shaking; Hand is cold; fever; fatigue; headache; pinched nerve; Achy; pain/tingling and numbness in left arm (injection site).; pain/tingling and numbness in left arm (injection site).; pain/tingling and numbness in left arm (injection site).; This is a spontaneous report from a contactable other health professional (other HCP) (patient) reported for herself. A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6203) via an unspecified route of administration at left arm on 26Feb2021 (at 31-year-old at vaccination) at 01:00 PM for COVID-19 immunisation. Medical history included congenital sucrase-isomaltase deficiency (CSID). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264) via an unspecified route of administration at right arm on 03Feb2021 (at 31-year-old at vaccination) at 01:00 PM for COVID-19 immunization. No known allergies. No other vaccine in four weeks. Other medications in two weeks included topirmirate, levonorgestrel (MIRENA, intrauterine device (IUD)) and low-dose naltrexone (LDN). The patient was not pregnant. Facility type vaccine was at hospital. The patient experienced adverse events included: 12 hours: chills, fever, shaking; 24 hours: achy, fatigue, headache wouldn't go away 6 days: Rash broke out over body (have pictures), pain/tingling and numbness in left arm (injection site). Rash responded to diphenhydramine hydrochloride (BENADRYL) and cetirizine hydrochloride (ZYRTEC), left arm was still tingling and painful on day 7. Almost felt like pinched nerve. Hand was cold. Pins and needles sensation. The adverse event start date was reported as on 04Mar2021 at 06:30 PM. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of events was not resolved. Treatment received for adverse event included OTC treatment with antihistamines; epinephrine (EPIPEN). No covid prior vaccination. No covid tested post vaccination.; Sender's Comments: A contributory role of vaccine BNT162B2 to the reported events rash and chills cannot be excluded based on the plausible temporal relationship and product safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ehics Committees, and Investigators, as appropriate.
TWO BROKEN VIALS; POTENTIAL ADMINISTRATION ERROR FROM ONE CRACKED VIAL; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 04-AUG-2021) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, the subject experienced two broken vials. On 28-JUL-2021, the subject experienced potential administration error from one cracked vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the two broken vials and potential administration error from one cracked vial was not reported. This report was non-serious.
After recieving his shot to enter pre-school, patient became dispondant and lost ALL of his vocabulary. He would cry for no reason after the shots, he had been a very happy child prior to the round of vaccinations he got at 2 yrs old. It wasn't until he was three yrs that his preschool teacher informed me and my husband that he had some "unusal autistic like" behaviors so we took him to the hospital, which was a referral from the pediatrician where he recieved his shots. There he was diagnosed with "High functioning Autism with an obsessive componant". We have been treating his symptoms and he has had an IEP in place in the public school system ever since. Follow up: Vaccine provider listed on the original report states that this child was seen in her office for the first time on 06/01/1998. Therefore they did not provide the immunizations given on 07/19/1996.
Significant Tinnitus, pressure in ears, headache, nausea, sensitivity to noise
Sudden onset vertigo began six days after second pfizer dose. Saw PCP the next morning; suspected vestibular neuritis. A static migraine began about 24 hours after the vertigo began. The vertigo and dizziness lasted two months. The migraine lasted one month, with no relief except briefly when prescription medicine was taken. After the resolution of the migraine and the dizziness, a chronic tension headache was left. I am unable to read without immediately getting a headache. My threshold to migraine is still quite low, and I get about one migraine per week instead of one migraine per year, as I did before taking my second pfizer dose.
Chills, fever, fatigue/malaise, nausea and vomiting; treated with chewable Tylenol but having difficulty keeping it down. Ongoing since about 12:30 am and currently 2:15pm
Pt recvd 3rd dose of Hep B vax (Recomb) on 15JUN91; Approx 3 hrs following 3rd dose, devel achiness, fever, generalized malaise, nausea, & vomiting; Inject site was red, warm & sore; pt unable to work for 3 days;
Constant Headache I have not been able to shake. Not in the back or front of the head but feels like it is in the middle and most noticeable when i am laying down or waking up but I can still feel it in my everyday life.
Swollen hands; Swollen fingers; Metallic taste in the mouth; Headache; Chills; Joint pain; Muscle pain; Fingers and hands swollen, more the left than the right; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 17-Mar-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 17-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen hands), PERIPHERAL SWELLING (Swollen fingers), DYSGEUSIA (Metallic taste in the mouth), HEADACHE (Headache) and CHILLS (Chills) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 PERIPHERAL SWELLING (Swollen hands), PERIPHERAL SWELLING (Swollen fingers), DYSGEUSIA (Metallic taste in the mouth), HEADACHE (Headache), CHILLS (Chills), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and PERIPHERAL SWELLING (Fingers and hands swollen, more the left than the right). At the time of the report, PERIPHERAL SWELLING (Swollen hands), PERIPHERAL SWELLING (Swollen fingers), DYSGEUSIA (Metallic taste in the mouth), HEADACHE (Headache), CHILLS (Chills), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and PERIPHERAL SWELLING (Fingers and hands swollen, more the left than the right) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up received on 06-MAY-2021. The Adverse events updated as Resolved/Recovered
Heartbeat was out of rhythm/ every 5th heart beat was skipping; Heartbeat was out of rhythm/ every 5th heart beat was skipping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ARRHYTHMIA (medically significant), outcome "unknown", EXTRASYSTOLES (non-serious) with onset 2021, outcome "unknown" and all described as "Heartbeat was out of rhythm/ every 5th heart beat was skipping". The event was reported as non-serious. The lot number for bnt162b2 was not provided and will be requested during follow up.
I had dry sinuses, hoarse voice, and cough. I tested positive for COVID-19. I saw a doctor and he prescribed me PAXLOVID 12/21/2022. I still have a cough.
Stuttering in his speech; Difficulty Spelling; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 65 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Apr2021 14:00 (Lot number: ER8733) at the age of 65 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Lot number: EN6202,First dose, Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Lot number: EN6202), administration date: 11Mar2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "Difficulty walking", "Disease recurrence", "Speech impairment NOS", "Stroke".  The following information was reported: DYSPHEMIA (non-serious) with onset Apr2021, outcome "unknown", described as "Stuttering in his speech"; MEMORY IMPAIRMENT (non-serious) with onset Apr2021, outcome "unknown", described as "Difficulty Spelling". The events "stuttering in his speech" and "difficulty spelling" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dysphemia, memory impairment.  Additional Information: Upon 2nd vaccine 01Apr2021 within 24 hours. Has difficulty spelling and stuttering in his speech. Change in Medication was done by (withheld) (Neurologist).  No follow-up attempts are possible. No further information is expected.
Pt administered PROQUAD 0.5ml SQ x 1 (L) arm.
1 week post vaccination pt had rash itching and redness in the arm. She will continue to monitor.
Pt. received extra dose of MENACTRA. Patient's first dose was 7/18/2012 and second dose was 02/20/2018. Patient received an additional dose on 7/10/2018. No adverse effects.
TDAP given to a 10 yr old.  ADACEL is licensed for 11 yr +.  Spoke with manufacturer representative who states  that dose will count as an adequate booster dose.  No need to repeat dose.
Please see attached. About 2 hrs after vaccinations were administered, pt woke up screaming and was not able to walk. I gave him MOTRIN at 5:00pm, he received the vaccinations at 5:30pm. I carried him to the car, he then fell asleep. At about 7pm, he woke up screaming, I picked him up and tried to stand up so I could look at his legs and his legs would fall out to the sides, both legs were limp. I could touch his legs, even squeeze them and he had no pain/feeling in his legs. He would scream and grasp his groin/hips from what I assume was cramping in that area. His fever stayed about 102 for the entire 4 days. He would grasp the groin area and just scream. This went on for about 4 days, and after the 5th day he could walk, but it appeared his legs were in braces, he walked straight legged, with a swinging motion. It took about 8 days for him to be able to walk normal and not complain of the pain in his groin/hips.
Vaccinated 12/19, had injection site pain for 2 days. Then on 12/25, developed cough, congestion, shortness of breath, fatigue, muscle aches, chills, and headaches. Starting 12/26, managed symptoms with albuterol 6 times/day. By 12/28 symptoms improved.
(R) arm pain postvaccination riadiated to (R) side of neck She took Ibuprofen and she was prescribed Medrol pak She was evaluated by Ortho She had XR (-). Mild - mod tenderness Reduced ROM (Presume tendinitis or bursitis after flu shot) She will follow up with Orthopedic Doctor. - Physical Therapy will be considered.
Flu-like symptoms; This spontaneous case was reported by a dentist and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 04-Jan-2021 to 07-Jan-2021. Concomitant products included PARACETAMOL (TYLENOL) from 04-Jan-2021 to 05-Jan-2021 for COVID-19.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). The patient was treated with PARACETAMOL (TYLENOL) in February 2021 for Flu-like symptoms, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.      Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: TCR Form reported 2nd dose information and AEs from 2nd dose; Sender's Comments: Very limited information regarding this event has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
Light headedness; Feeling of wanting to pass out; Fatigue; Muscle and joint soreness; Muscle and joint soreness; Extreme warm feeling; Hot and cold flashes; Hot and cold flashes; Chills; Some twitching in my left hand; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8732) via an unspecified route of administration on 26Mar2021 at 13:30 (at the age of 64-years-old) as a single dose in the left arm for COVID-19 immunisation. Medical history included high blood pressure from an unspecified date and unspecified if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (received within wo weeks of the vaccination) included lisinopril, rosuvastatin and doxycycline, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN6205) via an unspecified route of administration on 05Mar2021 at 13:30 (at the age of 64-years-old) as a single dose in the left arm for COVID-19 immunisation. On 26Mar2021 at 18:00 the patient experienced lightheadedness, feeling of wanting to pass out, fatigue, muscle and joint soreness, extreme warm feeling, hot and cold flashes, chills, and some twitching in my left hand. The clinical course was reported as follows: "The patient reported that all symptoms occurred between 3 to 5 hours after the second injection. Fatigue, light headedness, muscle and joint soreness, extreme warm feeling over his entire body, hot and cold flashes that lasted several minutes at a time, chills; however, no fever. All the symptoms subsided after three days from the second injection. Several side effects continued for over a month now. Fatigue, muscle and joint soreness as well as the light headedness with the feeling of wanting to pass out.  Some twitching in the left hand intermittently throughout the day skipping days at a time." The adverse events resulted in a doctor or other healthcare professional office/clinic visit. The clinical outcomes of the events lightheadedness, feeling of wanting to pass out, fatigue, muscle and joint soreness, extreme warm feeling, hot and cold flashes, chills, and some twitching in my left hand were recovered/resolved with sequel (recovered with lasting effects). Since the vaccination, the patient had not been tested for COVID-19.   Follow up needed, further information has been requested.
Information has been received from a pharmacist concerning a79 year old male patient. on 19-MAR-2015, the patient was vaccinated with ZOSTAVAX (dose, strength and frequency were not reported) intramuscular and PNEUMOVAX23 (dose, strength, frequency and route were not reported) both in the physician's office (medication error). The pharmacist reported that the ZOSTAVAX was being stored in the refrigerator (also reported as "incorrect storage of the ZOSTAVAX") and was administered via the intramuscular route (incorrect route of administration). The pharmacist was very concerned as to the efficacy of the vaccine considering the incorrect storage of the ZOSTAVAX as well as the incorrect route of administration. No adverse effects were reported. Additional information has been requested.
Fever, chills, body aches, heart pounding - high bp, headache, severe pain in left arm radiating to wrist.  Vaccine was 10/25
I developed a shooting pain down my leg that lasted several weeks . I saw my doctor and was diagnosed with sciatica.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L028276, expiry date 28-JUL-2017, lot # L009205, expiry date 17-MAR-2017, lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of (Oka/Merck) VARIVAX underwent temperature excursions (14.7F for 2 hours and 15 minutes). There were no previous temperature excursions. This is one of several reports from the same reporter. Additional information has been requested.
Patient notes that she has had increased issues with her vision since she had her first dose of Pfizer vaccine on April 7, and she has decided not to pursue the second dose at this time.   She's had some numbness and swelling in her mouth afterwards that took 3 days to resolve.  Also exacerbation of her asthma with SOB, which improved when she arrived home and used her MDI.
Pt is currently hospitalized under my care with new onset thrombocytopenia, with platelets at 19,000. He has abdominal pain, nausea and vomiting, and diaphoresis with chills. No symptomatic bleeding at this time. Did admit to nose bleed a few days prior to admission.
dizzy, SOB, nausea, called ER from house;ER prescribed DPH;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Apr2021 at 11:00 as dose 1, single (Lot number: EW0164), in left arm, on 09May2021 at 17:00 as dose 2, single (Lot number: EW0179), in left arm, on 11Nov2021 at 16:00 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 05Jul2022 at 14:00 as dose 4 (booster), single (Lot number: FP7135), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BIOTIN, start date: Jan2015; PREGNENOLONE, start date: Apr2018. Patient received also as supplements Thyroid Synergy (Designs for Health) and O.N.E. multivitamin (Pure Encapsulations) from Apr2018 to unknown date. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment with Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
SWOLLEN UNDERARM, TENDER  TO TOUCH ON THE SAME ARM AS THE INJECTION.
This spontaneous report was received from a register nurse referring to multiple patients of unknown genders and ages. Patient's medical history and concurrent conditions were not provided. On an unknown date in November 2015, the patients were vaccinated with an improperly stored GARDASIL lot # K007828, expiration date 03-FEB-2017, (route, anatomical location and dose number were not provided). Concomitant therapies were not provided. At the time of the report, no adverse event was reported. This is one of several reports from the same source. Additional information has been requested.
5:00 AM - Soreness at injection site on left arm 4:00 PM - Soreness increased and patient cannot lift elbow above the level of the shoulder; 4cm lump developed; onset of fever 8:00 PM - Fever increased to 102.5 F; reduced mobility of left arm; soreness has spread to entire arms and hand; soreness in muscles and joint of both legs and general muscle fatigue.