chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health care worker concerning a 72 year old male who on 08-OCT-2007 was vaccinated (site and route not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot#658074/0961U). On 09-OCT-2007, post vaccination, the patient developed arm pain, numbness and weakness. There was no redness or swelling at the injection site. The arm pain, numbness and weakness lasted for 5-7 days and then resolved. The patient received unspecified medical attention and recovered. This is one of several reports from the same source. Additional information has been requested.
Right arm swelling, erythema of entire upper arm elbow to shoulder (3 1/2cm difference in diameter from non affected arm) no fever, no tenderness, no itching
head cold; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age (Age: 53; Unit: Unknown) received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: not reported), via an unspecified route of administration on 04Feb2021 as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced head cold on un unspecified date. Patient reported that, she would like to know whether she may receive her 2nd dose of the covid vaccine if she is currently experiencing symptoms of a head cold. Patient said, she received her 1st dose of the Pfizer covid vaccine 04Feb2021 and is due to get the 2nd dose 25Feb2021. She has had symptoms of a head cold which she does not associate to covid. She thought she got it from her boyfriend since he had a head cold 5 days prior to her receiving her vaccine and he did not receive the vaccine. She had energy, had been working and working out. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 08-SEP-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (Lot # J013450 Expiration date: 24-JAN-2015) (dose, route and anatomical location of administration were not reported). No adverse effect was reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
rarely sick in life until she took that flu shot; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non healthcare professional.  This case is linked to case 2020SA294157 and 2020SA294125.  This case involves a female patient (unknown age) who was rarely sick in life until she took that flu shot (Illness), while she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient felt sick (illness) (unknown latency) (non serious) following the administration of INFLUENZA VACCINE.  It was reported that reporter's family (reporter and mother) had good immune systems and never had flu, and rarely sick in life until she took flu shot.   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was Unknown for illness., at the time of reporting.  There will be no information available on the batch number for this case.
Skipped May's normal menstruation date, then started spotting on 5/29/21. On 6/11/21 started a normal menstruation flow which lasted until 6/17/21. Then back to spotting 6/18/21-6/20/21. On 6/21/21 menstrual flow became heavy with a lot of clots and has continued until today on 6/23/21.
Mom called clinic 445 to say pt was inconsolable had given APAP prior to vax; instructed if not better in 1 hr to go to Er; pt was taken to ER;
pt recv vax & passed out & became rigid w/a sz like activity;regained consciousness w/in 1min;
The patient developed a fever of 103 degrees Fahrenheit on the evening of the vaccine administration. He didn't feel well. His arm was sore, although not terribly so.  By the following day, he was improved.
pt recv vax 15OCT97 & 19OCT97 pt devel a moderate rash w/greater than 50 lesions covering the upper trunk, abd & scalp;
Big red circle on her arm, sore and itchy, its like a rash; SWOLLEN ARM; ITCHINESS; SORENESS IN ARM; A spontaneous report was received from a Consumer concerning a 41 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, soreness in the arm, itchiness, big red circle on her arm, sore and itchy, its like a rash, swollen arm. The patient's medical history was not provided. Concomitant medications reported were Dayquil, Nightquil for drug use for unknown indication. On 24 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 042L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 24 Jan 2021, the patient experienced the events, soreness in the arm. itchiness. On 1 Feb 2021, the patient experienced the events, big red circle on her arm. sore and itchy, its like a rash, swollen arm. Treatment details included Antihistamine - Benadryl Action taken with mRNA-1273 in response to the events, soreness in the arm, itchiness, big red circle on her arm, sore and itchy, its like a rash, swollen arm was not reported.   On an unknown date the outcome of events include, soreness in the arm, itchiness, big red circle on her arm, sore and itchy, its like a rash, swollen arm was not reported.
On a trip, I developed severe watery diarrhea persisting for 4-5 days and it became bloody.  I sought Urgent care where I needed an antibiotic and needed Emergency room care to get intravenous fluids.  Several Days after those symptoms resolved, I developed mild upper respiratory symptoms and tested positive on 5/8 on a Rapid Antigen COVID-19 test.  I was taking Paxlovid and consulted with a Doctor who recommended ?wear a mask and have fun.? While on Paxlovid, I became asymptomatic.  When I returned home, my course of Paxlovid ended on 5/12, on 5/15 I experienced a return of symptoms.  The symptoms were runny nose, chills, body aches, fatigue, and a cough lasted until 5/19, with nasal congestion and slight cough lingering to time of reporting.
Vaccine with expiration date of 09/30/22 was administered to patient on 10/7/2022.  Pt did not report any side effects/symptoms.
Per report from family, pt had been feeling unwell for 3-4 weeks prior to event on 4/27 where he collapsed and suffered a cardiac arrest.    No interventions were performed until EMS arrived 10-15 mins later (again, per family report).  Pt was revived following CPR, and suffered a 2nd episode of cardiac arrest (possible in the ED).  Pt was noted to have PEA at that time.   Pt was intubated and vented in ICU.  Pt was cooled x24 hours (unsure of protocol name) and rewarmed over 24 hours more.  Pt was weaned from all paralytics, etc.  Per RN reports, pt failed all neuro tests except R eye went from 3 > 2 mm (4/29 +).  Pt was transitioned to comfort care on 4/30 and passed within 5 minutes.
This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reaction and allergies were unknown. On 24-JAN-2019, the patient was vaccinated with first dose of ROTATEQ (strength, dose, frequency, route were unknown) (lot # R003148 and expiry date: 05-JUN-2019) for prophylaxis. On the same day, the patient was vaccinated with first dose of PEDVAXHIB (strength, dose, frequency, route were unknown) (lot # R014262 and expiry date: 26-MAR-2021) for prophylaxis. It was reported that the patient received one dose each of two different vaccines following a temperature excursion of 61 Fahrenheit for 2 hours' time frame. There was no previous temperature excursion. Data logger was yes. No adverse effect was reported. There was no product quality complaint reported.
runny nose; really bad sinus drainage in the mornings; red marks on inside of thighs; arm started to ache at the injection site; some aches and pains in my legs; felt like there was a battle going on inside me; really uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (some aches and pains in my legs), PAIN (felt like there was a battle going on inside me), DISCOMFORT (really uncomfortable), RHINORRHOEA (runny nose) and SINUS DISORDER (really bad sinus drainage in the mornings) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included VITAMINS NOS and NAPROXEN SODIUM (ALEVE) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (some aches and pains in my legs), PAIN (felt like there was a battle going on inside me), DISCOMFORT (really uncomfortable) and VACCINATION SITE PAIN (arm started to ache at the injection site). On an unknown date, the patient experienced RHINORRHOEA (runny nose), SINUS DISORDER (really bad sinus drainage in the mornings) and ERYTHEMA (red marks on inside of thighs). At the time of the report, PAIN IN EXTREMITY (some aches and pains in my legs), PAIN (felt like there was a battle going on inside me), DISCOMFORT (really uncomfortable), RHINORRHOEA (runny nose), SINUS DISORDER (really bad sinus drainage in the mornings), ERYTHEMA (red marks on inside of thighs) and VACCINATION SITE PAIN (arm started to ache at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
no adverse event; Vaccines were administered after temperature excursion; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions were not reported.   On 18-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, lot # U017140, expiration date: 28-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided).  Concomitant medications included sterile diluent. However no adverse effects reported.   Administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced the temperature excursion above 6 Fahrenheit grades to 14 Fahrenheit grades for 4 hours 0 minutes 0 seconds. There were no previous temperature excursions reported.
Pt did not have a reaction until 7 days post vax, then developed a 5 inch swollen red rash that itched and burned. Pt still has one inch lump at injection site. #2 shot - pt developed an instant 4 inch red rash by the evening it spread from the arm pit to the elbow at least 12 inches. Pt also had unbearable headache, stiff arm and neck for 1 full week. Most recent symptoms are chest pain, and arm spasms, pt still has a 2 inch lump.
lump on her arm; face all flush,arms and chest were red; left side ear is aching/ears were bothering her; feeling really tired/had 2 cups coffee and still tired; light headed,woozy or dizzy feeling; warm to touch; arm was sore; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (light headed,woozy or dizzy feeling), VACCINATION SITE WARMTH (warm to touch), PAIN IN EXTREMITY (arm was sore), VACCINATION SITE MASS (lump on her arm) and ERYTHEMA (face all flush,arms and chest were red) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced DIZZINESS (light headed,woozy or dizzy feeling), VACCINATION SITE WARMTH (warm to touch) and PAIN IN EXTREMITY (arm was sore). On 02-Apr-2021, the patient experienced VACCINATION SITE MASS (lump on her arm), ERYTHEMA (face all flush,arms and chest were red), EAR PAIN (left side ear is aching/ears were bothering her) and FATIGUE (feeling really tired/had 2 cups coffee and still tired). At the time of the report, DIZZINESS (light headed,woozy or dizzy feeling), VACCINATION SITE WARMTH (warm to touch), PAIN IN EXTREMITY (arm was sore), VACCINATION SITE MASS (lump on her arm), ERYTHEMA (face all flush,arms and chest were red), EAR PAIN (left side ear is aching/ears were bothering her) and FATIGUE (feeling really tired/had 2 cups coffee and still tired) outcome was unknown. Not Provided      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.   Other relevant medication history included cymbalta anxiety depression 90 mg every morning. No treatment information was provided.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes, on 25-SEP-2013 for 45 minutes, on 26-SEP-2013 for 2 hours and 30 minutes and on 01-OCT-2013 for 4 hours. No known adverse effects. This case is linked to case: 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008405, 1310USA008406, 1310USA008407 (same reporter link). Additional information has been requested.
Extremely swollen lymph nodes; moderate pain in neck/under chin; severe ear aches in both ears; Minor red rash on face, neck and chest; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 03Apr2021 at 17:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient was allergic to CIPRO/sulfa drugs. Concomitant medication was not reported. Prior to the 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 vaccination. On 03Apr2021 at 22:00 the patient experienced extremely swollen lymph nodes in neck causing moderate pain in neck/under chin. The swollen lymph nodes were causing severe ear aches in both ears. Minor red rash on face, neck and chest was also reported. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported adverse events. The clinical outcome of the events extremely swollen lymph nodes, moderate pain in neck/under chin, aches in both ears, minor red rash on face, neck and chest were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
passed out; Astronomical Headache; I got very dizzy and had dots; She got very dizzy and had dots; I just started spinning and broke out; Iave a bump on her head; scrape on her knee; chills; Nausea; Vomiting; Diarrhea; I was severely cold; I was very sluggish; My chest feels congested; her head feels like it weighs 30 lbs; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 reported PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as first dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that this past Wednesday (30Apr2021), she was getting severe chills, nausea, vomiting, and diarrhea. She took Dayquil because she still had the chills and she was severely cold. Yesterday (30Apr2021), she was very sluggish. She mentioned that her head feels like it weighs 30 lbs. on 30Apr2021. She added that her chest feels congested on 30Apr2021. This morning (01May2021), she was lightheaded and had an astronomical headache. She got very dizzy and had dots. She got up again to turn the tea kettle off and she just started spinning and broke out and went to the bathroom. When she went to the bathroom and went to squat on the toilet, she passed out. She doesn't know how long she was out. She has a bump on her head and a scrape on her knee. When she woke up, she was so cold, so she put on flannel pajamas. She also mentioned that she was scheduled for second one on next Tuesday (11May2021). She inquired if she can still get Covid after getting the vaccine. The outcome of the events was unknown.  Information about lot/batch number has been requested.
heart palpitations; it just progressively getting worse; wakes up with chest pain; feels like heart coming out her chest; it just progressively getting worse; wakes up with chest pain; feels like heart coming out her chest; She is not feeling well; she has fatigue; Shortness of breath; having problem sleeping at night; This is a spontaneous report received from a contactable consumer. This 45-year-old female consumer(patient) reported for herself.  A 45-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot number: EN6198), via an unspecified route of administration, administered in Deltoid Left on 04Mar2021 as dose 2, single for covid-19 immunisation. The patient Medical history and concomitant medications were reported as none. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Lot number: EN6201) in Afternoon, via an unspecified route of administration on 12Feb2021 as dose 1, single for covid-19 immunisation and patient was perfectly fine after getting vaccination, she got second one. On an unspecified date on 2021, the patient experienced heart palpitations, it just progressively got worse; wakes up with chest pain; feels like heart coming out her chest, She is not feeling well, she had fatigue, shortness of breath, had problem sleeping at night. The patient stated to through out the course after she received it having heart palpitations, blood pressure her heart was (incomplete sentence), had chest pain and didn't really thought any thing other in beginning and it just progressively got worse. The Secondary Reporter stated, "she has been seeing a cardiologist, she was having a heart monitor and she was placed on several heart medications. (Further clarifications unknown). She was not feeling well and she was very upset. she was little frustrated and little concern it was going. The reporter stated that she had fatigue, she had shortness of breath, she had such things she is having problem sleeping at night she wakes up with chest pain after taking rest it feels like heart coming out her chest. She is on a beta blocker (Treatment), and they put her on the statin (Treatment) as well because of the heart issue. The events heart palpitations, it just progressively getting worse; wakes up with chest pain; feels like heart coming out her chest, Shortness of breath required physician office visit. On an unspecified date on 2021, the patient underwent lab tests and procedures which included blood test: unknown results, cardiac stress test: unknown results, echocardiogram: unknown results, electrocardiogram: unknown results, magnetic resonance imaging heart: unknown result. The outcome of event it just progressively getting worse; wakes up with chest pain; feels like heart coming out her chest was Not recovered and other events were unknown.  Follow-up attempts are completed. No further information is expected.
Adverse event in second dose only. Chills,nausea, fatigue and administration site swollen and red. Two injection sites appeared with second dose.
Delayed second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Delayed second dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Delayed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Delayed second dose) had resolved. Not Provided      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 and treatment medication information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Upon follow-up receipt:contain non-significant information.
patient describes shot as high - felt hit bone (I suspect joint).  Shoulder pain, arm pain, systemic pain, "can barely walk"  This was called in about 4 hours after shot given
I had burning in my right eye and itching for about 24 hours. I had scabs and sores on my right eye brow up  my forehead into my hairline onto my scalp. I saw my doctor and he diagnosed me with Shingles. The scabs by my hairline and eyes are gone, but the scabs by my eyebrow are still there. The nerve shocks are still there, but I do feel better after the treatment. For treatment, I was given Valacyclovir 3 times a day for 7 days and Medrol Dose Pack for 5 to 6 days.
Developed a rash, runny nose, productive, sore throat, full body rash prescribed Benadryl - 50mg as Prednisone pack as needed. Body pain all over, trouble walking, skin sensitive.
Pt has history of mast cell disease and has numerous medication, food and environmental allergies. She also develops histamine related reactions to stress. She has a history of recurrent anaphylaxis  and carries an epipen. She notes that she felt anxious prior to the shot and developed lightheadedness several minutes after injection. Symptoms were mild to moderate but did not resolve. The pt declined EMS services and decided to go home after approximately 40 minutes. She is aware of the risks. BP 140/90, SP02: 98%, HR: 80