chrisvoncsefalvay/vaers-outcomes huggingface dataset:
palpitation; fast heart beat; little short of breath; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitation), HEART RATE INCREASED (fast heart beat), DYSPNOEA (little short of breath) and DIZZINESS (dizziness) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PALPITATIONS (palpitation), HEART RATE INCREASED (fast heart beat), DYSPNOEA (little short of breath) and DIZZINESS (dizziness). At the time of the report, PALPITATIONS (palpitation), HEART RATE INCREASED (fast heart beat), DYSPNOEA (little short of breath) and DIZZINESS (dizziness) 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.   Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Extreme pain in right shoulder and injection site.  Limited mobility in shoulder.  No strength, cannot lift arm up.  This situation still exists 6 month later.  Saw family doctor in May of 2021 and again in August.  Referred to Orthopedic surgeon.
Patient is fully vaccinated and was hospitalized due to Covid. Patient stated before she knew that her symptoms were related to COVID she visited her son in a nursing home, where her son and two others became positive but she stated that was the only positives and it was mild. She stated she had spent the last 6 days in the hospital and had only gotten out yesterday on 07/08/2021. She stated that the doctors confirmed her isolation guidance of 20 days and she was continuing to isolate until 08/09/2021.
overwhelmingly tired exhausted sever fatigue left arm hurts extremely bad by shoulder severe dryness in mouth, almost hard to swallow severe nausea headache
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a Office Staff. This case involves a patient (age and gender not reported), who experienced allergic reaction, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported (expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a non-serious allergic reaction (hypersensitivity), following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was also a case of actual medication error due to inappropriate age at vaccine administration because patient under 65 years old was vaccinated. No Lab data was reported. Final diagnosis was allergic reaction. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. 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.
BlurredVision, Dizziness, Headache, Diarrhea, chills Narrative:
Pfizer-BioNTech COVID-19 Vaccine EUA Swollen lymph nodes
Symptoms showed on Jan. 23 2021 at 0500am, consisting of a painless red rash below injection site around 5 inches wide and 6 inches long. No allergy medications needed due to the rash not itching or burning, only hot to the touch. Upon waking today, Jan. 24 2021 rash has grown in size, but still no pain or itching, just hot to the touch. I am concerned as this was only my first dose, and not sure what to do from here.
This medically confirmed spontaneous report (initial receipt 18-Jun-2013) concerns a female patient approximately 2 years old. Some time in January or February of 2013, the patient developed sepsis and subsequently passed away. The patient had received a flu shot (influenza vaccine, batch and manufacturer unspecified) prior to developing sepsis. The patient had been hospitalised (hospital information and duration unspecified) and CPR (cardiopulmonary resuscitation) had been conducted. The event outcome was fatal. Reporter's comments: The reporter considered events serious due to hospitalisation, intervention to prevent serious criteria (CPR conducted), life threatening events (patient passed away) and death.
After I took vaccine, within 2 hours, I had a very sore arm - very painful. I took Tylenol - extra strength - two every two hours. Two days it faded away and went away. Monday, following vaccine - armpit pain. Tuesday - swollen lymph node - very painful under arm; Wednesday  I woke up and my injection site was very red, big rash (bigger than the size of my palm) and I couldn't move my arm from swollenness and it was very itchy. Dr on Thursday or Friday he Gave me steroid cream - triamcinolone and he told me to take Benadryl and Tylenol. It lasted about five days after my doctor visit.
12/24/2021  That afternoon I fell, lost my balance and passed out.  For the next couple of days, I began feeling bad. My stomach hurt and felt warm like I had a temperature. I became really tired and slept a lot. I started having diarrhea and my temperature went up to 102. I took Tylenol and the fever did not go away. I had no appetite and felt really not myself. I was unable to keep food in. I started passing out, I was unable to keep my balance. Then I began having trouble breathing, which happened fast. My inhaler did not help. I went to the Urgent Care and tested positive for COVID a few days later.  I was told to quarantine for 5 days.  My symptoms got worse. I felt like I was not getting enough air, since I have asthma, I used my inhaler. Tylenol was not keeping my fever down.  I could not keep food down. I had an appointment with my doctor on 1/10/2022.  When I checked in, they saw I could not breathe. They put me on oxygen and called 911. The ambulance took me to the hospital. I stayed in the hospital from 1/10/2022 to 1/14/2022.  I was told I was in respiratory distress and that I had COVID pneumonia. On 1/14/2022 I still had all my symptoms, but they sent me home. After getting home, I continued to pass out, so I went back to the emergency room on 1/16/2022 and they kept me in the hospital until 1/21/2022.  I am still on oxygen. It took a while for the pneumonia to clear up.  This all flared up my asthma and I have been home since.
Information has been received from a lawyer concerning a female patient who was vaccinated with varicella virus vaccine live. The reporter requested information on the use of varicella virus vaccine live and pregnancy. The lawyer also asked if there was any information on scarring in the brain and late onset epilepsy. The reporter indicated that there was a specific patient involved, but was not able to provide any other information. Upon internal review, the patient's late onset epilepsy was considered to be an other important medical event (OMIC). No further information is available.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old patient received BNT162b2 (BNT162B2), on 28Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Known allergies: Grains" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from  22Apr2023 to 01May2023  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-202300187446 Same patient, different drug, different event;
(Rt) shoulder & arm pain came in 1 week after vaccine with continued (Rt) shoulder & arm pain - given Ibuprofen 600mg TID / disc ice packs to shoulder - patient went to ER next day - given Rx Lidocaine patch
a big round red spot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (a big round red spot at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 18-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (a big round red spot at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (a big round red spot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
This spontaneous report has been received from a medical assistant referring to a 18 year old patient of unknown gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On an unknown date, the patient was vaccinated with a fourth dose of GARDASIL 9 for prophylaxis (strength, dose detail, anatomical location, route of administration, batch/lot # and expiration date were not reported). No adverse effects were reported.
Initial alopecia after varicella in May 2009. Continued for months - seen dermatology in 8/2009. Gave HPV - series - #1 8-23-13 - alopecia - restarted by #2 dose 11-21-13 pt losing eyebrows and lashes too 3rd dose - held.
pt recvd vax 8SEP93 called on 14SEP93 to c/o of itching & redness site observed on 15SEP93; area below the inject site slightly reddened & irritated; pt reported much improvement w/heat & DPH cream;
Severe pain in her leg and now she has swelling in that leg; Severe pain in her leg and now she has swelling in that leg; This is a spontaneous report from a contactable consumer. A female patient (reporter's mother-in-law) of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was unknown), via an unspecified route of administration on an unspecified date (Sunday) as UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 16Jun2021, patient had a severe pain in her leg and in Jun2021, now patient had swelling in that leg. The outcome of both the events was unknown.
8 yr old received Infanrix; received Infanrix instead of Tdap.; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th February 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 25th February 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: 8 year old patient received Infanrix vaccine instead of Tdap, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up via postal.
Within days of receiving the shot, and at present (1 year!) I began to have shortness of breath. I CANNOT walk into a store, do any kind of work more than 15 minutes, walk up a flight of stairs or just have a regular life. The breathing is SO bad, I need to sit , or pass out. Any work around the house is done quite sparsely. The difficulty scares me.
PT WENT PALE AND PASSED OUT. WE CALLED 911 AT MOTHER'S REQUEST AND PT WAS EVALAUATED BY EMTS. PT WAS ABLE TO WALK OFF PREMISES UNAIDED AFTER EVALUATION.
Prior to vaccinate I had pain in the left buttocks from arthritis I. The SI joint and lumbar spine.  Appropriately 10 days after my 1st Vaccine I started to experience severe pain in my left leg.   Subsequent medical treatments with primary care, pain management and spine surgeon revealed significant progression in the inflammation in that area leading to compression of the L5 nerve route.  The inflammation is not responding to treatment with drugs and physical therapy and surgery may be required.  No specific doctor links my circumstances specifically to the covid vaccine.  And, it may be coincidental.  However, MRI reports documents the progression and I?ve been told by multiple physicians that they are seeing many patients with inflammation issues post vaccination.  For these reasons I felt it important to report for awareness and future tracking.
Injection site pain and redness, tiredness, splitting headache, muscle ache, chills,  joint pain, intermittent fever, loss of appetite
Right upper arm is edematous-around 6x4 cm.  It is erythematous and hot to touch.  Pt was given Keflex BID for infection, and advised to use Benadryl elixir (12.5/5ml) 2 tsp.  every 6-8 hours as needed for swelling.
Fever 101.4, chills, muscle ache, headache, fatigue. Treated with Acetaminophen.
swollen and lumpy area under his nipples; swollen and lumpy area under his nipples; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NIPPLE SWELLING (non-serious), NIPPLE DISORDER (non-serious), outcome "unknown" and all described as "swollen and lumpy area under his nipples".  Additional Information: Caller, male, aged 72, received first dose of vaccine on 24Feb2021. A few days later developed swollen and lumpy area under his nipples. This has been ongoing issue for 3 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness following vaccine administration, No LOC. BP 116/60, HR 64, RR 16.
Breakthrough case admission after 2 vaccines Moderna 3/26/21 Lot# 017B21A;  Moderna 4/23/21 Lot# 043B21A
Tremors in arms; eye twitching; vomiting; This is a spontaneous report from a non-contactable consumer (the patient, reported for herself). An adult non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry dates were unknown), via unspecified route of administration in the left arm on 04Feb2021 as single dose for COVID-19 immunization. The patient's medical history included Latex allergy. Concomitant medications were not reported. On an 05Feb2021 at 03:00 PM, patient experienced tremors in arms, eye twitching and vomiting. Unknown if the patient received any treatment for the adverse events. Patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reporter assessed the events as non-serious. Outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The Pharmacy administered a Moderna Vaccination after the vial was punctured and at room temperature for longer than 12 hours. The vial was punctured on 4/21/2022 @ 08:37 AM, which means the vial expired on 04/21/2022 @ 08:37 PM. The vial was left out overnight and was used for patients' vaccination on 04/22/2022 @ 10:31 AM. Patient has been called multiple times but has yet to be reached by the pharmacy.
Had typical headache, fatigue, achiness for the first couple days after. On the third day after started with worsening headache that continues. Saw PCP on fourth day after as thought was migraine/tension headache. On fifth day after vaccine, sought treatment in ED for headache as it is still lingering and impactful enough that I am unable to work.
FEVER 100.4, BODY ACHES, HEADACHE, LEFT ARM PAIN - INITIALLY AT INJECTION SITE LATER ON FIRST DAY, AND THEN ON 1/3/2021 NOTICED RED SPOT  JUST BELOW INJECTION SITE THAT WAS TENDER  AND WARM TO TOUCH, ROUGHLY 3X3 IN SIZE. ALSO FELT PAIN IN ARMPIT, TENDER TO TOUCH, BUT NO REDNESS. SINCE 1/30/2021 TOOK TYLENOL 5OOMG 1 - 2 TABS EVERY 6-8 HOURS AS NEEDED.  RELIEVED MOST OF PAIN FEVER AND BODY ACHES SUBSIDED BY DAY 2 WHICH WAS 2/1/2021. HEADACHE AND ARM AND ARMPIT PAIN PERSIST
PATIENT STATES HEART IS RACING. VITAL OBTAINED WITH BP OF 120/74, HR 91, O2 OF 100%. PATIENT OBSERVED ADDITIONAL 15 MINS WITH SYMPTOMS RESOLVING.
Diarrhea; Tight neck and shoulders; Splitting headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MUSCLE TIGHTNESS (Tight neck and shoulders) and HEADACHE (Splitting headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), MUSCLE TIGHTNESS (Tight neck and shoulders) and HEADACHE (Splitting headache). At the time of the report, DIARRHOEA (Diarrhea), MUSCLE TIGHTNESS (Tight neck and shoulders) and HEADACHE (Splitting headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided.
Acute Lymphoblastic Leukemia, Ph- Began feeling tired and noticed becoming slightly out of breath within 2-3 weeks of 2nd dose.  First hospitalized on May 21 after blood work drawn on 5/20 showed hemoglobin below 5.  Nurse at BMT clinic on Sunday told him that he was the 2nd patient that day who mentioned getting leukemia after 2nd dose of Covid vaccine, which prompted this report.
The vaccinee had no known concurrent conditions or relevant medical history. On an unknown date in 2001 the vaccinee received Engerix B vaccine. The reporter stated that in the weeks and months following vaccination the vaccinee gradually dveloped problems at a sensory level so that he was unable to tell when he needed to urinate or defecate which led to urinary and fecal incontinence. He also developed erectile dysfunction. The vaccinee was referred to a neurologist who diagnosed post vaccination myeloradioulopathy (myelitis). The vaccinee has been unable to work and the reporting physician considered his condition to be incapacitating. The most recent information received on 29 April 2002 reports the outcome of the vaccinee as unknown. No other details were given. Additional information has been requested. The follow up info received on 8/6/02 states myeloradiculopathy. The reporting GP siad he had received the info third hand from a priviliged source and so could not provide further info.
Patient was not 18 as required when given the first dose of the Moderna COVID-129 vaccine.  Patient has had no known adverse events due to vaccination. Possible language/communication barrier lead to misunderstanding of age.
initially warm to touch and slightly swollen later that day, then a week later area very red, hard to touch, hot and bumps in the area almost like hives, very itchy.
A report was received from a health care professional on 12/30/03 concerning approximately 10 children of unspecified sex and under 4 years of age who inadvertently received Fluvirin on an unspecified date in December 2003. On an unspecified date in December 2003, approximately 10 children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Initial report received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an eight-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; received on 30 November 2011, 25 January 2012 and 28 March 2012 (lot numbers, routes and sites of administration not reported). On 11 June 2012, the subject developed a cough, seventy five days after the last dose. The subject developed a paroxysmal cough with whoop on 21 June 2012. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 25 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 25 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 26 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Rash, ErythemaMultiform, UrticariaPruritus, knot in injection site arm Narrative:
Pt experienced a febrile seizure 9 hours after receiving the Hepatitis B vaccine. Pt was monitored at home. Evaluation at MD office 24 hrs later proved WNL. Neg PMHx re: vaccine reactions or febrile seizures. Pt experienced a single event.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 27-JUN-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB injection, lot # K011239 and expiration date 11-JUN-2016 (dose and route of administration were not reported). No adverse effects reported. Additional information has been requested.