chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid arm; Itchy at injection site; Swollen at injection site; Flu like symptoms; Nausea; Tired; Headache; Achy; Weakness; Stomachache; This spontaneous case was reported by a health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE REACTION (Covid arm), PAIN (Achy), ASTHENIA (Weakness) and ABDOMINAL PAIN UPPER (Stomachache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Achy), ASTHENIA (Weakness), ABDOMINAL PAIN UPPER (Stomachache), NAUSEA (Nausea), FATIGUE (Tired) and HEADACHE (Headache). On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE SWELLING (Swollen at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Feb-2021, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE SWELLING (Swollen at injection site) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Achy), ASTHENIA (Weakness), ABDOMINAL PAIN UPPER (Stomachache), NAUSEA (Nausea), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Systemic: Tachycardia-Medium, Additional Details: pt states that he is having increased heart rate per his phone wellness app.  At the time of this discussion his heart rate was 72.  Pt states this is high for him.  Advised that he seek medical attention to have a work up done. Pt was not experiencing any other symptoms/issues
Swelling in her neck which doubled in size in 1 week and it was decreasing in size till she received the 2nd dose never went away; Nausea; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in her neck which doubled in size in 1 week and it was decreasing in size till she received the 2nd dose never went away), NAUSEA (Nausea) and HEADACHE (Mild headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011AZ1A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROXYCHLOROQUINE, METFORMIN, ASPIRIN [ACETYLSALICYLIC ACID] and DEXLANSOPRAZOLE (DEXILANT) for an unknown indication.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (Mild headache). On 16-Mar-2021, the patient experienced SWELLING (Swelling in her neck which doubled in size in 1 week and it was decreasing in size till she received the 2nd dose never went away). On 14-Mar-2021, NAUSEA (Nausea) and HEADACHE (Mild headache) had resolved. At the time of the report, SWELLING (Swelling in her neck which doubled in size in 1 week and it was decreasing in size till she received the 2nd dose never went away) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medications were unknown.   This case was linked to MOD-2021-076316 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up information received on 06-MAY-2021 contains non-significant information: Additional information received included information regarding consultation with the physician for the swelling.
Dose #1 3/5/2021 Pfizer EN6205 pt has covid 19 8/9/2021
patient had large bruising at injection site that still existed at time of second dose (May 12) though it looked normal and healing.
Vax adm 26MAR91 24hrs later pt started screaming & cont 5 hrs; MD stated allergic to pertussis; Temp inc 102.4 on 27MAR91;
Fever 105.7F at clinic, referred to hospital. S/P fever and rash for 7 days prior to admission; lethargy, loss of appetite for 2 days prior to admission; rash is micro vesicular that started at face and spread to torso; sepsis syndrome (shock-like) workup.
Generalized nontender nonpruritic rash started at neck spreading down to trunk and extremities.; This is a spontaneous report from a contactable physician. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via intramuscular route of administration in the left arm on 24Apr2021 at 09:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included graves' disease and allergic rhinitis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levocetirizine (MANUFACTURER UNKNOWN) and fluticasone propionate (FLONASE); both from unknown dates for unknown indications and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021 at 07:00, the patient experienced generalized nontender nonpruritic rash started at neck spreading down to trunk and extremities. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event generalized nontender nonpruritic rash started at neck spreading down to trunk and extremities was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 17-NOV-2017, the patient was vaccinated with improperly stored dose of VARIVAX (lot# M048203, expiration date 07-DEC-2018, dose and route of administration were not reported), reconstituted with properly stored sterile diluent (STERILE DILUENT MRK) for prophylaxis.  Reporter stated that the vaccines were stored in 7 degrees Fahrenheit for 2 hours 1 minute. There was previous temperature excursions on 30-OCT-2017, indicated as 17.6 degrees Fahrenheit for 2 hours 15 minutes. Vaccinations occurred after first excursion on 30-OCT-2017. The digital data logger was used. The patient did not experience any adverse events. Product quality complaint was not involved. This is one of three reports from he same reporter.; Sender's Comments:  US-009507513-1712USA009982: US-009507513-1712USA009987:
Ocean sound in her head making her not sleep and not put her head down/ whistling in her head while on the phone.; Ocean sound in her head" making her not sleep and not put her head down.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Ocean sound in her head making her not sleep and not put her head down/ whistling in her head while on the phone."; SLEEP DISORDER (non-serious), outcome "unknown", described as "Ocean sound in her head" making her not sleep and not put her head down.".  Additional information: Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. Female patient called about an "ocean sound in her head" making her not sleep and not put her head down. Patient has consulted with a specialist who didn't see it in her ear and assessed that it was not caused by the Pfizer COVID-19 Vaccine. Caller mentioned that there is still a whistling in her head while on the phone. Caller mentioned that she did not have it before. Caller stated that it came from the Pfizer Vaccine and knows five people off the bat that has the same experience. Caller is asking for recommendations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s): US-PFIZER INC-202101426139 same reporter, different patient and event;
Pt  is a 58 yr old female with past medical hx of copd on oxygen, pulmonary cachexia, previous strokes secondary to trauma as a result of severe spousal abuse resulting in seizure disorder who received her J and J vaccine on 6/5/21 and was admitted to the hospital on June 18th c/o 3-5 days of fatigue, increasing shortness or breath and cough, poor appetite, and was diagnosed with R middle and R low lobe pneumonia, sepsis and acute hypoxic, hypercarbic respiratory failure to the ICU where she remains admitted in critical condition as of June 24th. Prior to this she was in her usual state of health and had not been hospitalized in 19 years. She has persistent lymphopenia on her cbc and differential. She is requiring high flow oxygen and bipap support. She is being treated with antibioitics, a naso gastric feeding tube and physical therapy.
Adverse recation: None; administered on 10/2019 and 10/2020; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 66-year-old female patient (pt). There was no information about the patient's concurrent conditions, allergies, drug reactions or medical history provided. The pt's historical vaccines included unspecified influenza vaccine administered on an unknown date in October 2018. On unknown date, in October 2019 and on unknown date in October 2020, the patient was vaccinated with unspecified pneumococcal vaccine (manufacturer unknown) for prophylaxis (exact dose, lot #, expiration date, route of administration and anatomical location were not reported) (inappropriate schedule of product administration). Concomitant vaccines included unspecified influenza vaccine . The pt had none of adverse reaction. The outcome of inappropriate schedule of product administration was unknown.  This is one of two reports regarding the same patient.
Client complaint of nausea and emesis post Moderna vaccine.  Client reports she had the same reaction with her first dose. Client BP=130/78 P=80 SATS=99% on RA.  Reports feeling better after approximately five minutes.  Colored returned, A&O x3.  No medications given.
constipation; lightheadedness; dizziness; 2 lumps at Eligard injection site; Diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): TMR293837 (RA).  A male patient received COVID-19 Vaccine - Manufacturer Unknown, in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; leuprorelin acetate (ELIGARD), since Feb2022 (Batch/Lot number: unknown) at 30 mg. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Unknown Manufacturer), administration date: Oct2021, for COVID-19 Immunization; Covid-19 vaccine (Dose: 02, Unknown Manufacturer), administration date: 2021, for COVID-19 Immunization. The following information was reported: INJECTION SITE MASS (non-serious) with onset Feb2022, outcome "not recovered", described as "2 lumps at Eligard injection site"; DIARRHOEA (non-serious) with onset Feb2022, outcome "recovered" (2022), described as "Diarrhea"; CONSTIPATION (non-serious) with onset Feb2022, outcome "recovered" (2022); DIZZINESS (non-serious) with onset Feb2022, outcome "not recovered"; DIZZINESS (non-serious) with onset Feb2022, outcome "not recovered", described as "lightheadedness". The action taken for leuprorelin acetate was unknown.  Additional information: The patient received the second dose of the COVID-19 vaccine in Nov2021 or Dec2021. All the events started the day after he received his Eligard injection in Feb2022 (exact date unknown).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
One week after vaccine given, blood pressure elevated.  Increased lisinopril from 2.5 mg to 5 mg for two days.  Blood pressure returned to usual levels.  One week after second vaccine given (lot number EN6204), blood sugar > 300.  No change in diet or activity.  Her Trulicity was increased from 0.75mg weekly to 1.5 mg weekly.  After 2 doses, her blood sugar continues to be > 250
Approx 2 hrs p/pt recvd vax devel an unusual high pitch cry, pt became pale & limp; pt color began to return, mom tried to nurse pt & another episode of being limp/pale occurred; Pt was then taken to ER MD examined pt & p/1hr returned home;
Upon removal of the needle following injection of the Flucelvax vaccine in the right arm, the patient's arm shot out about a centimeter of blood and then and then it formed a very large bump at least a quarter width in diameter.  It was wider than the width of the Band-Aid requiring two Band-Aids in a cross formation.
This spontaneous report as received from two registered nurses reporting together refers to an unspecified number of patients of unknown gender and age. The patients medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of PROQUAD (Merck), 0.5 ml dose, subcutaneous (dose number, lot/batch and expiration date were not reported) that underwent temperature excursions. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient presented this morning to share her vaccine response. Her arm is red along the shoulder area, on the same arm that vaccine was administered. Patient was unsure on what date symptom began.
Large red circle at injection site. After a week it was bumpy under skin. Several large nodules. Itched like crazy.
LDL-P was 1219 and her regular cholesterol was 202; This spontaneous case was reported by a consumer and describes the occurrence of LOW DENSITY LIPOPROTEIN INCREASED (LDL-P was 1219 and her regular cholesterol was 202) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesteraemia since 22-Oct-2020. Concomitant products included EVOLOCUMAB (REPATHA) from September 2020 to an unknown date for Hypercholesterolemia.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced LOW DENSITY LIPOPROTEIN INCREASED (LDL-P was 1219 and her regular cholesterol was 202). At the time of the report, LOW DENSITY LIPOPROTEIN INCREASED (LDL-P was 1219 and her regular cholesterol was 202) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Oct-2020, Blood cholesterol: 171 (normal) 171. On 22-Oct-2020, Low density lipoprotein: 528 (abnormal) LDL P was 528. On 28-Sep-2021, Blood cholesterol: 202 (High) 202. On 28-Sep-2021, Low density lipoprotein: 1219 (High) LDL P was 1219.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient states that she started the medication,repatha in September of 2020  and her numbers were good, she had both doses of the vaccine early this year, had her numbers checked again, and they were  way up again.Her NMR lipoprofile blood test on 22 Oct 2020 and her LDL P was 528 and her regular cholesterol was 171. She had another NMR test on 28 Sep 2021 and her LDL P was 1219 and her regular cholesterol was 202.  Treatment information was not provided.
This spontaneous report as received from a physician via field employee refers to a 16 month old male patient. On 07-JUL-2014 the patient was vaccinated with VARIVAX (Merck) (lot #, expiration date, dose unspecified), "injection". During the same clinic visit on 07-JUL-2041, the patient also received M-M-R II (lot #, expiration date, dose unspecified) and VAQTA (lot #, expiration date, dose unspecified). On 22-JUL-2014 (about 15 days later), developed a chickenpox-like rash "about 15 days later". The rash was described to be "all over the patient's body" including on the patient's tongue. The parents of the patient called the physician's office to seek medical attention. No treatment was given. The event outcome was unknown. Additional information has been requested.
While drawing up the vaccine patient, intended to give 1 Varicella and 1 MMR. Instead, she was given 1 Varicella and 1 Proquad. The patient's parent was called after the MA consulted with MD. It was determined that the patient should not have any adverse effects after data was researched.
none covid 19 vaccine expires 2/8/2023 given 2/27/2023
Feeling ache and pains; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Feeling ache and pains) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Feeling ache and pains). At the time of the report, PAIN (Feeling ache and pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment was reported.
Red raised circle with severe swelling in the upper arm, chills in the morning, whole body muscle pain, and nausea starting Thursday afternoon. Started a fever of 100 f  and a headache Thursday night. The headache, nausea, and swelling in the arm lasted until Sunday night.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-APR-2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-DEC-2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as shingles. On or about 28-DEC-2015, the patient sought subsequent treatment by a physician for a persistent and severe vesicular rash, which was diagnosed as ocular herpes zoster and post-herpetic neuralgia. The patient has been prescribed VALTREX for management of her painful symptoms. As a direct and proximate result ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Upon internal review, ocular herpes zoster was determined to be medically significant. Additional information has been requested.
Pt said she felt dizzy and light-headed after getting her 2nd Shingrix shot. The store manager, service center attendant and I had her sit down for several minutes after she said she started feeling light-headed to prevent her from falling. We got her a granola bar and some orange juice. Once she had some food in her system, she said she started feeling better. She also complained of it feeling as though was difficult to breath with her mask on. She said she thought this was just because her mask. She was talking okay and did not appear visibly short of breath. She said that the dizziness and breathing issue wasn't a problem anymore and said she felt okay to go home. I called to check in on her when she got home, and she said she was doing okay. I recommended that if the difficulty in breathing she had mentioned got worse or did not go away, she should go to the ER. I also called her PCP, and they said they would follow up with her today.
No aditional AE; Nurse reporting patient administered dose of VAQTA after labeled expiration date.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On 25-APR-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, strength: 25 U/0.5mL, at a dose of 0.5ml/once, lot #t034003, expiration date reported as 25-MAR-2022, but upon internal validation established as 28-MAR-2022, administered for prophylaxis (route and site of administration were not provided) after labeled expiration date (expired product administered). It was stated that the vaccine did not experience any temperature excursion. No additional adverse event was reported (no adverse event).
Anaphylaxis symptoms (tongue tingling, nausea, eyelid swelling) began 1hr after I received the COVID booster shot. I took 2 tablets of Claratin, which helped with the swelling. I vomited at around 1hr 45min after the shot, after which I took another 2 tablets of Claratin. Two days later, my eyelids began to swell again, so I took another 2 tablets of Claratin.
Patient reported to the pharmacy the day after the vaccination with swelling, redness, and itching to the site of administration. Patient was managing symptoms with appropriate over the counter medications, and believed it would resolve on its own.
Pt given PCV23 in left arm.  In less than 24 hours pt began to experience swelling to left arm, hives, redness, "chills".  States she had a fever but did not take temp.  Pt utilized tylenol and returned today to have arm checked.  pt did not experience loss of cms, positive radial pulse. Advised pt to utilize benadryl prn,  pain .  reported findings to md.
It was reported that a pt (10 of 10) received a TD Adult that was inadvertently administered intradermal. The pt developed a large local red, hard area at the injection site. Further information is being requested.
I started having what felt like needles stuck in me. From head to toe. It doesn't last very long, it only happens every few days. It started after I received the first shot. I can not anticipate when it will come on. It's not anything that would cause me to faint or black out. it is uncomfortable. It doesn't happen at the same time when it doe happen, not at the same place. At this point it is unsettling.