chrisvoncsefalvay/vaers-outcomes huggingface dataset:
OFF LABEL DOSING FREQUENCY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Novavax) concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 1) (form of admin, route of administration, batch number was not reported, expiry: unknown) dose, start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient had allergic reaction after first dose of pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported 1 total administered for covid-19 prophylaxis which was off label dosing frequency and revaccination with different covid-19 vaccine (dose number in series 3). The product was associated with Off label use. The batch number was not reported and has been requested. No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label dosing frequency and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
5 cm red warm area on (L) arm at injection site, site feeling itchy. No fever, no hives, SOB. Ice pack, BENADRYL, azithromycin as site tender and warm, TYLENOL. If no improvement - patient to go to emergency room.
Patient complains of bruise and arm swelling two days after vaccination received AFLURIA 2016-14/PNEUMOVAX 23.
Pt complained of  redness and swelling to injection site. area affected was upper right  arm to below the elbow pt advised to see primary care provider. PT referred to his Primary Care Provider. PT treated with ICD code of 682.8 PT given cipro 500Mg bid x 10 days w/ followup in 24 hrs.
Patient was given second havrix today, however was within 6 month minimum dosing window as last vaccine at 1y3mo
3 days post vax pt devel flu-like sx;17FEB97 pt dx w/strep throat & had skin  rash @ that time;24FEB97 pt cont low-grade temp, devel ear & throat pain & observed a dark discharge from nose;pt also exp sharp pain in lower back;
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient experience rash near injection site and on chest above breast area. Patient already had a mild rash near shoulder before vaccine. Event mostly anxiety driven rash. Patient was given 50 mg of benadryl and rash cleared up within 5-10 min.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Medium, Systemic: Joint Pain-Medium
Pt was given 0.4 mL of pentacel vaccine instead of 0.5 mL. Pt did not have any adverse reactions or symptoms.
After the vaccine I had pain in the injection site, chilis, headache, and high temperature at 99.0.
dizzy, progressing to high heart rate, high than baseline BP, about 1 hour to return to baseline
The day after COVID vaccination on 3/24/2021, patient received a feraheme infusion for anemia. This was her 1st dose in 1.5 years. Reports as soon as it started to flow in her arm started burning, face turned red, heart rate went up, heart pounding, was short of breathe.  At that time was given oxygen, 25mg benedryl, and prednisone. The next day on 3/25/2021- heart rate back down. "Wiped out, nauseated, and wants to sleep"
Moderna COVID-19 vaccine has been administered to patients post excursion.; Poor quality vaccine administered; Pediatric dose was given to adults mistakenly; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine has been administered to patients post excursion.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine has been administered to patients post excursion.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine has been administered to patients post excursion.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine has been administered to patients post excursion.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly).    Concomitant Medication use information was not provided by reporter.  It was reported that there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to Department of Public Health, VAERS, Immunization Registry and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  Treatment Medication use information was not provided by reporter.  This case contains information for the 69th of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
She reports that on 1/7/21 (8 days following vaccination) the injection site became red and itchy and she had a hive like rash at the site x 48 hr. She reports no treatment was necessary and all symptoms have resolved.
On and off  heart palpitations for 2-3 weeks leading up 14-16 hours of heart palpitations on 8/17/2021-8/17/2021.  No previous history of heart palpitations prior to vaccine.
2 days post vaccination developed blisters on backside (site of previous infection) similar to shingles eruptions in past. Itching, but no pain, advised to go to urgent care for exam. Diagnosed with mild shingles, treated with famciclovir. Reports she has had shingles 4 times in past.
Fever; chills; muscle pain; This is a spontaneous report from a contactable physician, the patient. A 44-years-old adult non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 31Mar2021 at 10:30 (at the age of 44-years-old) as a dose number unknown, single for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medications were not reported. On 01Apr2021, at 01:00, the patient experienced fever, chills and muscle pain. The patient did not receive any treatment for the event. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event Fever, chills and muscle pain was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country added UNITED STATES. Narrative "The patient did not receive any medication within two weeks of vaccination." and "The patient did not receive any other vaccines within four weeks prior to the vaccination." removed.
right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer or other non hcp reported that a female patient (reporter's sister) of an unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced right ear itching and burning and then the skin started to crack, her other ear was burning, red, felt hot and started cracking again. The outcomes of events were unknown.  Information about lot/batch number has been requested.
First dose was administered on 29-Jul-2021 and second dose was administered on 10-Nov-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 29-Jul-2021 and second dose was administered on 10-Nov-2021) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A and 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 29-Jul-2021 and second dose was administered on 10-Nov-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 29-Jul-2021 and second dose was administered on 10-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The patient had no known allergies. It was unknown whether the patient had been diagnosed with/ tested positive for COVID 19. Acute and Chronic illness at the time of vaccination was reported as none.  No treatment medication were reported.   This case was linked to MOD-2022-593388 (Patient Link).
07/24/2022 I had just come back from traveling and I was feeling a sore throat, congestion, fatigue, and body aches. I went ahead and gave myself an at home test for COVID-19 and it did come out positive. On Monday I called my doctor's office and after discussing I was given PAXLOVID. I started that the 25th of July and I took that for 3.5 out of 5 days. I was having metallic taste and stomach issues. I slept as much as I needed to from there and I had a very runny nose, congestion, and coughing. I was starting to feel better after a week and then I started to feel worse at the end of the week and began testing positive still. The doctor's believed that I did have a rebound of COVID-19 and instructed me to continue self-medication and finally started to feel better a week after. Today I am feeling much better and the only symptom still is fatigue.
This spontaneous report as received from a physician refers to a 84 year old female patient. On 28-DEC-2012, the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) subcutaneously. The physician reported that on 07-JAN-2013, the patient experienced cellulitis. The patient saw the physician. The outcome of cellulitis was reported as recovered/resolved on an unspecified date. Additional information is not expected.
stiff/sore neck; stiff/sore neck; This case was reported by a consumer via interactive digital media and described the occurrence of neck pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced neck pain and stiff neck. On an unknown date, the outcome of the neck pain and stiff neck were unknown.   It was unknown if the reporter considered the neck pain and stiff neck to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: This case was received via interactive digital media. The reporter stated that could one side effect of Shingrix be a stiff/sore neck. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Patient's mom requested COVID-19 vaccine for him. We used language interperter to ask if patient had received the vaccine before. She answered no. Another adult and language speaking person also asked and same answer. Put his information into Immunization Information System no vaccines came up. Gave the COVID vaccine. When the brother went to sign up for his vaccine, his name had 2 vaccines listed as received. The younger brother said they both would need it again. Immunization Information System had patient's 1st vaccine listed under wrong birth date given on 11/10/21, database had 2nd vaccine listed with correct birth date. Database stated it was sent to Immunization Information System but did not show in Immunization Information System system.
Headache, dizziness and nausea right after vaccine and worsen until vomiting 5-10 hours after vaccine. Milk headache and nausea has sustained daily since first time getting vaccine and worsen after 3rd dose.
numbness in left hand; numbness/tingling in face; numbness/tingling in face; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0173) via an unspecified route of administration in the left arm on 01May2021 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0158) via an unspecified route of administration in the left arm on 09Apr2021 at 17:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01May2021 at 10:15, the patient experienced numbness in left hand immediately after shot and numbness/tingling in face for 1 hour after shot. The clinical outcome of the event numbness in left hand was resolved on an unknown date in May2021; while that of numbness/tingling in face was resolved on 01May2021 at 11:15, after the duration of 1 hour.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from Novartis and was assigned manufacturer report # PUS2015US037699 concerning a 6 year old male patient. On an unspecified date in approximately 1985, the patient was vaccinated with a dose of M-M-R II (dose, route and lot # not reported). On an unspecified date in approximately 1985, the patient experienced an allergic reaction (passed out) to the M-M-R II and wanted to get a flu shot now at the age of 36. At the time of the report, the patient's outcome was unknown. This was originally reported by a physician. Additional information is not expected. There is no complete contact information.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Mar2021 12:00 (Lot number: EN6206) at the age of 30 years as dose 1 , single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "sore arm".  Additional information: No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
On Wednesday 11/11 in the morning patient noticed that area around injection was red. On Thursday 11/12 in the morning he noticed that the area was itchy and by that night the area was tender and hot to the touch, that evening he also had nausea, stomach cramps and urgent need to have a bowel movement. On Friday 11/13 he contacted the facility and described symptoms, they advised that he could come in to the office but they believed that he was just having an allergic reaction and advised him to take benadryl and use warm compress. Two hours after taking benadryl area is less red and itchy but still tender and hot to the touch.
pinch nerve; cannot bend down; muscle pain includes neck, shoulder, back, groin, arm, legs/pain in neck, pain in arm, pain in both shoulders; joint pain includes neck, shoulder, back, groin, arm, legs and every joint; feels like he has a bump on arm of injection; left hand is weak; felt ill; fatigue; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of NERVE COMPRESSION (pinch nerve), HYPOKINESIA (cannot bend down), MYALGIA (muscle pain includes neck, shoulder, back, groin, arm, legs/pain in neck, pain in arm, pain in both shoulders), ARTHRALGIA (joint pain includes neck, shoulder, back, groin, arm, legs and every joint) and MALAISE (felt ill) in a 67-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 Arthritis.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 22-Apr-2021, the patient experienced MALAISE (felt ill), FATIGUE (fatigue) and DYSPNOEA (shortness of breath). On an unknown date, the patient experienced NERVE COMPRESSION (pinch nerve), HYPOKINESIA (cannot bend down), MYALGIA (muscle pain includes neck, shoulder, back, groin, arm, legs/pain in neck, pain in arm, pain in both shoulders), ARTHRALGIA (joint pain includes neck, shoulder, back, groin, arm, legs and every joint), VACCINATION SITE SWELLING (feels like he has a bump on arm of injection) and MUSCULAR WEAKNESS (left hand is weak). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NERVE COMPRESSION (pinch nerve), HYPOKINESIA (cannot bend down), MYALGIA (muscle pain includes neck, shoulder, back, groin, arm, legs/pain in neck, pain in arm, pain in both shoulders), ARTHRALGIA (joint pain includes neck, shoulder, back, groin, arm, legs and every joint), MALAISE (felt ill), FATIGUE (fatigue), DYSPNOEA (shortness of breath), VACCINATION SITE SWELLING (feels like he has a bump on arm of injection) and MUSCULAR WEAKNESS (left hand is weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, COVID-19: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   pain management included in the medical history.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Significant Follow-up included new events
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID-19 Treatment from 12Oct2023 to 16Oct2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
04/10/2021-abdominal, low back and legs ached and cramped really bad with headache. This continued on 4/11 and overnight.  4/12--muscle cramping and aching stopped.  4/13--nasal congestion, headache, sinus pressure, no temp. 4/14-continued 4/15-worse today. Thick green sputum.  A little worse. Feel a lil sick. 4/16 & 4/17---Worse today.  Really feel sick.  Still no temp.  Sinus pressure, body aches, sore throat, sinus drainage.