chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizziness; weakness; Irregular and rapid heartbeat; hasn't been feeling well; extreme fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness), HEART RATE IRREGULAR (Irregular and rapid heartbeat), MALAISE (hasn't been feeling well) and FATIGUE (extreme fatigue) in a 52-year-old female patient who received mRNA-1273 (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness), HEART RATE IRREGULAR (Irregular and rapid heartbeat), MALAISE (hasn't been feeling well) and FATIGUE (extreme fatigue). At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness), HEART RATE IRREGULAR (Irregular and rapid heartbeat), MALAISE (hasn't been feeling well) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Blood pressure measurement: 85/67 (Low) Low.     The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   An electrocardiogram performed on 26-Apr-2021 did not reveal any findings.   No concomitant medications were reported.  No treatment information was provided.
Sore arm at injection site, fever, chills, body aches, fatigue (ongoing)
No observed adverse event. Submitting report because DTaP-IPV and MMRV were given too early. These doses were not due until after the 4th birthday.
Bivalent 5-11 was ordered and bivalent 12 and up was admisitered
On Oct 19 I was diagnosed with slight pneumonia, took antibiotics on Dec 2 went back to urgent care 2nd round of antibiotics. Dec 26 went to E.R. diagnosed with Cardiac failure, cardiomyopathy, heart not beating but15%. Hospitalized for about 7 days, following up with cardiologist and put on a Life Vest
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: Red Splotchy Marks
This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Looks like shingles on her hairline and partially on scalp), VISION BLURRED (Unable to focus in one eye), DECREASED APPETITE (Loss of appetite), SWELLING (Head feels swollen) and ASTHENIA (weak) in a 74-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. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Looks like shingles on her hairline and partially on scalp), VISION BLURRED (Unable to focus in one eye), DECREASED APPETITE (Loss of appetite), SWELLING (Head feels swollen), ASTHENIA (weak), HEAD DISCOMFORT (Head feels filled with Cement) and HEADACHE (occasional pains running up the back of her head). The patient was treated with GABAPENTIN at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Looks like shingles on her hairline and partially on scalp), VISION BLURRED (Unable to focus in one eye), DECREASED APPETITE (Loss of appetite), SWELLING (Head feels swollen), ASTHENIA (weak), HEAD DISCOMFORT (Head feels filled with Cement) and HEADACHE (occasional pains running up the back of her head) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. The treatment reported was eye drops.
Extreme raging headache started about 12 hours after dose, lasting about 36 hours
Heart problems; Diagnosed him with pericarditis that's the inflammation of the heart; This is a spontaneous report from a contactable consumer. A 17-year-old male patient (reporter's brother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0153), via an unspecified route of administration on an unspecified date (at 17-year-old) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history was reported as none and no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number unknown), via an unspecified route of administration on an unspecified date (at an unspecified age) as 1st dose, single for COVID-19 immunisation. On an unspecified date after the second dose of vaccine, the patient had heart problem and doctor diagnosed him with pericarditis that's the inflammation of the heart. Lab test: He went under test after he had the symptoms multiple EKGs, multiple blood test, CT scan, and he also did ultrasound for his heart. Treatment: For the side effects he took some Motrin, for the heart problems the cardiologist told him to take some Motrin, it's Ibuprofen and that's for the side effects. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Coughing; sneezing; runny nose; throat scratchy; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), SNEEZING (sneezing), RHINORRHOEA (runny nose) and THROAT IRRITATION (throat scratchy) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Prophylactic vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE for Flu.    Concurrent medical conditions included Flu.   In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In 2022, the patient experienced COUGH (Coughing), SNEEZING (sneezing), RHINORRHOEA (runny nose) and THROAT IRRITATION (throat scratchy). At the time of the report, COUGH (Coughing), SNEEZING (sneezing), RHINORRHOEA (runny nose) and THROAT IRRITATION (throat scratchy) outcome was unknown.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   Concomitant medication was not reported.  No treatment medication was reported.
Patient received 2nd dose of Moderna Covid Vaccine at 1pm.  At 2:30pm he started to develop chest pain  and left side neck and arm pain.  He was admitted to the hospital for further work-up.  While in the hospital the patient had relief only from sitting up and forward.  The doctor decided to transfer the patient to another facility that had specialist.  At the next hospital it was determined that the patient had Viral Pericarditis, associated with the Covid Vaccine.
erythema, edema entire arm & shoulder-elbow w/extensive erythema to chest & forearm approx 36hr p/vax;
Received ZOSTAVAX on 7/3/13. On 7/5/13 pt awoke with redness, marked swelling, warmth and mild itching around injection site. No systemic symptoms. Pt saw MD on 7/8/13 who confirmed irritant reaction. No sign of allergy.
09/17/2011 noticed reddened area on arm about 5 IN" in diameter at site of vaccination (right arm). Suggested take BENADRYL and contact her physician.
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2, dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received his first dose of the vaccine last 25Mar2021. However, he tested positive for Covid-19 on an unspecified date and will finish his isolation on Friday. The patient called in to ask if he can still get his second dose due on 17Apr2021. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Swelling face ,  I gave her benadryl  around 11:00 am  and Tylenol  11:30 am
Initial misuse report received from health care professional on 27 Sep 2013. A dose of FLUZONE ID was administered to a 12 year old patient on an unspecified date. No adverse event was reported. List of documents held by sender: none.
This is a pleasant 64yo male that presents to Hospital with acute SOB. He states that yesterday morning he received his covid-19 vaccine and then went home. Later in the afternoon he developed acute SOB, not made worse by exertion or lying down. He has chronic COPD and checks his pulse ox multiple times per day. He typically runs 85-92% and states that he was running around 87%. Due to his SOB he sought medical care and was found to be hypoxic with an O2 saturation of 78% in the ER. He had a CTA of the chest which showed a chronic left lobe PE and an acute PE to the left subsegmental branch of the inferior lingula artery, small bilateral pleural effusions and cardiomegaly. There was no evidence of right heart strain on the CT readout. His first two troponins are WNL. He admits to being sedentary at home over the last year since he lost his job. He was also found to be in a-fib with RVR and intermittent a-flutter, both of which are new per patient report. He has been started on Cardizem and Heparin drips. Currently, he is up ad lib and comfortable. He denies overt shortness of breath and is able to carry on a full conversation. He denies chest pain, abdominal pain, m/s pain, bowel/bladder issues, n/v/d or diaphoresis. He is alert and oriented. He has a PMH of copd, chroinc hypoxia, tobacco use, ble pitting edema, htn, and hld.
This spontaneous report as received from a nurse via company representative refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The nurse reported that the patient received GARDASIL on a variation of the recommended dosing schedule, as the first dose was administered on an unknown date in February 2015, the second dose was administered on an unknown date in August 2015, and the third dose was administered on an unknown date in November 2015 (doses, routes, lot # and expiry dates were not reported). No adverse effect was reported. The patient did not seek medical attention. Additional information has been requested.
still feeling a little flu-ish; mass in the right portion of her neck; really really sick; severe weakness and aching; severe weakness and aching; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on Jul2021, as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for covid-19 immunisation. On Jul2021, patient had been really really sick and flu-ish and it had been 12 days since her second shot. Patient asked that does it take that long to cause the problem. Patient also had severe weakness, aching and mass in the right portion of her neck. She feels too sick and weak to be on the phone for long. The outcome of all the events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 11-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 24 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Administered ZOSTAVAX 4/13/11 - called pt to check 4/14/11. Came to pharmacy 4/17/11 at 2:20 pm. Area of injection red, swollen, warm & moving down towards elbow. Merck closed. RPh on duty will call Merck.
Covid arm; delayed hypo allergic reaction; It was red and elevated with 7 or 8cm of diameter at the injection site; It was red and elevated with 7 or 8cm of diameter at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), HYPERSENSITIVITY (delayed hypo allergic reaction), VACCINATION SITE SWELLING (It was red and elevated with 7 or 8cm of diameter at the injection site) and VACCINATION SITE ERYTHEMA (It was red and elevated with 7 or 8cm of diameter at the injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), HYPERSENSITIVITY (delayed hypo allergic reaction), VACCINATION SITE SWELLING (It was red and elevated with 7 or 8cm of diameter at the injection site) and VACCINATION SITE ERYTHEMA (It was red and elevated with 7 or 8cm of diameter at the injection site). On 16-May-2021, VACCINATION SITE REACTION (Covid arm), HYPERSENSITIVITY (delayed hypo allergic reaction), VACCINATION SITE SWELLING (It was red and elevated with 7 or 8cm of diameter at the injection site) and VACCINATION SITE ERYTHEMA (It was red and elevated with 7 or 8cm of diameter at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Patient brought into the ED on 9/9 by EMS for weakness and fatigue. A week prior to this, she began to have a cough and tested positive for COVID on 9/8. When EMS arrived to the scene, the patient was hypoxic in the 70's and febrile, so was placed on oxygen.  She was admitted 9/9-9/11. Discharge diagnoses include severe COVID-19, COVID pneumonia, bilateral lung bacterial pneumonia with sepsis, and acute hypoxemic respiratory failure. During admission, patient was able to be weaned off supplemental oxygen. Patient has received COVID vaccine and one booster. This meets criteria for vaccine breakthrough case review.
itching, edema, redness, mild red rash (pinpoint);tx: avoid heat of day (being out in heat) because first sxs appeared when outside in heat;
exhausted the next day and tired and other stuff; 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 FATIGUE (exhausted the next day and tired and other stuff) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (exhausted the next day and tired and other stuff). At the time of the report, FATIGUE (exhausted the next day and tired and other stuff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  No relevant concomitant medications were reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown.       On 21 Feb 2021, the patient experienced the event sore arm at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event, sore arm at the injection site was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt presented to the er on 4/1/21 c/o epigastric chest pain and belching all day long. also c/o feeling achy all over and feeling shaky and lightheaded. it was recommended that pt be admitted for observation but she signed herself out of the er AMA
Administration error. Patient was given 0.25 mL dose of the Moderna 12+ 2023-2024 formula, rather than 0.25 mL of the 6m-4 year 2023-2024 forumla. Patient had no reaction at the time of the injection.
Rash and itching across upper torso, numbness in R lower lip. Continuing more that 12 hours after onset.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5 ml) (lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer) (R/F) for each time were 40, 34 and R; 136, 33 and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date the patients were vaccinated with doses of improperly stored VAQTA (lot # L045713 with expiration date 14-JAN-2017, dose, frequency and route were unknown). The patient's concomitant medication was not reported. No adverse effects reported. This is one of two reports received from the same reporter. Additional information has been requested.
Moderna vaccine administered outside of BUD. BUD was 6/3/23 and vaccine given on 6/6/23.
Two months after receiving my second booster, I tested positive for COVID-19. My symptoms were a very bad sore throat, runny nose, I felt achy and fatigued. The sore throat was the worst. I was prescribed PAXLOVID and I feel that it relieved my symptoms, but I still had clear phlegm. I also tested positive in November. This time my husband, who is a kidney patient, tested positive also. He had 4 vaccines as well. He was not able to take PAXLOVID because of the anti-immune medications he is already taking. He has to tough it out and he is absolutely miserable. I tested negative on 11/11/2022, but my husband is still testing positive.
Flushing and subjective pruritus 1 hour after vaccination.  Some lightheadedness, but stable blood pressure and no dyspnea or LOC.
On January 3, 2022 I received the Moderna booster shot in Left Arm...on April 29, 2021 I also took the J&J at the same facility...SEE REPORT...I filed an adverse effect to the J&J shot on 1/13/22 with the following info VAERS ID: 2031767, E-Report Number: 772828.
Numbness in face, body, hands, feet BELL's Palsy in face. Losing ability to walk. Low blood pressure readings. Kidney (not normal readings). MRI's (5-6). Spinal tap. Plasma phoresis (5). Surgery to insert shunt.  6/22/09 Hospital records DC summary received DOS 12/29/08 to 01/11/09. Assessment: Guillain-Barre versus CIDP Patient presents with unsteady gait and lower back pain. Facial weakness and numbness of all extremities. Sensation impaired for pain and proprioception. Plasmapherisis performed.  ICD-9 Codes: 781.2 Abnormality of Gait, 357.0 Ac Infect Polyneuritis, 357.81 Chr Inflam Polyneuritis, 458.29 Iatrogenic Hypotension, 276.51 Dehydration, 401.9 Hypertension, 720.0 Ankylosing Spondylitis, 721.0 Cervical Spondylosis.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 9 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UI994AB, expiry date: 09-APR-2019 via intramuscular route in the left deltoid on 01-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to Inappropriate age at vaccine administration and overdose. It was reported that yesterday, 3 patients under the age of 65 had been given FLUZONE HD. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
COVID-19; This spontaneous report received from a patient via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine  was not applicable. The outcome of covid-19 was not reported. This report was non-serious.
arm swelling Narrative:  Patient called telephone triage 2 days after Moderna shot #2 to report the following symptoms: severe headaches, nausea, vomiting, arm redness and swelling, along with throat, tongue, and lip swelling AND hurts to swallow. Patient then reported had some minor tongue swelling following shot #1 though did not seek medical care/advice. Patient denied SOB, wheezing, and self reported O2 sats 98%. Patient was advised to call 911 or present to local ER. Patient declined care advice. Agency Medical provider also called patient following the telephone triage call; share the same concern of anaphylaxis/allergic reaction- patient declined medical advice.