chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscular weakness; Swelling; Tenderness; This case was received via VAERS (Reference number: 1358802) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of MUSCULAR WEAKNESS (Muscular weakness), SWELLING (Swelling) and TENDERNESS (Tenderness) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.    On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced MUSCULAR WEAKNESS (Muscular weakness) (seriousness criterion hospitalization), SWELLING (Swelling) (seriousness criterion hospitalization) and TENDERNESS (Tenderness) (seriousness criterion hospitalization). At the time of the report, MUSCULAR WEAKNESS (Muscular weakness), SWELLING (Swelling) and TENDERNESS (Tenderness) 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 drug information was provided.  No treatment information was provided.  Limited information regarding the events has been provided at this time and is insufficient for causality assessment.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment.
Waves of chills; Rapid heart beat; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in left arm on 21Mar2021 at 16:00 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Medical history included coronary artery disease (CAD). The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included clopidogrel (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), ASPIRIN (MANUFACTURER UNKNOWN) and C (as reported); all were taken for unknown indications from unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 24Mar2021, at 09:30, the patient experienced waves of chills, rapid heartbeat, nausea and fatigue all intensely. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. The clinical outcome of the events waves of chills, rapid heartbeat, nausea and fatigue were resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Patient was scheduled for 2nd dose of Pfizer COVID-19 vaccine and inadvertently received the Janssen COVID-19 vaccine. Event is mixed doses of COVID-19 vaccines, none dose of Pfizer and one dose of Janssen. Also the patient does not qualify for Janssen COVID-19 Vaccine due to being under the age of 18. Patient did not report any side effects and went to work after his 15 minute observation.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 17-JAN-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA003078:
pt recvd vax & immed a/receiving vax was found to have elevated AST & ALT values; these values returned to nl by 22SEP93;
devel measles 14 days p/vax;strep throat & mono cont until FEB96 - chronic fatigue synd dx;under MD supervision for fatigue;/excessive fatigue;chronic muscle pain, confusion, impaired memory, anxiety, swollen glands,sleepiness,room spinning
the anitbody test was negative; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A female patient of unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on 23Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was vaccinated with the Pfizer-BioNTech COVID-19 vaccine on 23Dec2020. She was given 1 of 2 shots. She then donated blood on 06Jan2021 but the anitbody test was negative. She was scheduled for 2nd vaccine on 13Jan2021. The patient asked when she would be expected to start building antibodies from the vaccine and how many weeks after the 2nd vaccine. She asked the estimated time span. Outcome of the event was unknown.   Information on batch number has been requested.
My body was not the same as before the shot! I have a strange sensation throughout my body almost constantly. I have chest pain or center back pain. It is hard to tell. My blood pressure and heart rate have been all over the place. I have cold & hot sensations. My throat is sore & feels like it is closing in on me sometimes. I can't seem to sleep  longer than four hours at a time most nights, even with a sleeping pill.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ADULT OBSTRUCTIVE SLEEP APNEA ACUTE NON ST ELEVATION MI CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
My bp went up to 182/101 a couple hours after vaccine., had a bad headache, tired and flushed feeling.  Had to take BP meds again n lay down, seemed to go down after an hour of taking BP meds to 140/89
developed non tender erythematous nodules and plaques, right calf tenderness approximately 24 hours after receiving 2nd dose of COVID vaccine . She is otherwise well without fever nor malaise and is acting normally.
Problems with her lymph glands under her arm; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient experienced problems with her lymph glands under her arm. It was reported that reporter had a medical background and a friend of reporter have received her first dose of the Pfizer vaccine anyway reporter trying to help her make a decision because she went to her oncologist and she is having problems with her lymph glands under her arm and the doctor would not tell her to get the second vaccine, the second dose. And she was wondering if she should or if it was going to cause her more problems. And reporter also stated that will they be able to advise her whether she should take the vaccine or not. The outcome of the event was unknown.   Information on the lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Patient mentioned before administration of shot that she fainted before getting her previous dose of the COVID shot. I positioned patient in upright position told her to take deep steady breaths had a bottle of water and snacks on standby. I administered the shot and right after patient stated she wasnt feeling well so I was monitoring her breathing and then patient's head fell back while being on her chair while shaking. I called 911 with one hand while trying to hold patient's head upright and I used my walkie talkie to page the other pharmacist as well as the nurse practitioner in the minute clinic. Patient regained conciousness after a couple seconds and I gave her water to drink and then a couple minutes later fainted again. Nurse practitioner then took her blood pressure and it dropped to 70/40. Patient kept regaining conciousness and would say she doesnt feel good but then would pass out again. Nurse practitioner, the other RpH and I were monitoring her breathing and holding her upright. Patient stated that she couldnt feel her hands or feet and was having shortness of breath.  Patient also stated that she had blurry vision. The EMS came after roughly 10-15 minutes after and asked for the vial in which I used to admnister the shot and took her blood pressure and took her to the hospital.
white rash on arms extending to the shoulders; This spontaneous case was reported by a health care professional and describes the occurrence of RASH (white rash on arms extending to the shoulders) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (white rash on arms extending to the shoulders). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH (white rash on arms extending to the shoulders) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.
Patient vaccinated. Shortly after patient complained of itchiness in throat. A focused exam was gone on the patient. No noted swelling in patients oral cavity. Patient able to talk and swallow. Patient given 10mg of cetirizine. Patient states that itchiness resolved during observation period. Patient refused further treatment and decided to return to work.
Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients might have been vaccinated with improperly stored PROQUAD (dose and route were unknown; lot # M018635 with expiration date 11-OCT-2017, lot # M021731 with expiration date 29-OCT-2017, lot # M032496 with expiration date 02-JAN-2018 and lot # M031941 with expiration date 27-DEC-2017). The vaccines were exposed under temperature of 3 degrees centigrade for 13 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
A report has been received from a Health Professional concerning, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced NOSE BLEED. The outcome of the event of NOSE BLEED is unknown. The report was considered to be non-serious.
Patient hasn't received 2nd dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) 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.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) outcome was unknown.            No concomitant medication was reported. Treatment medication was not provided.   Reporter did not allow further contact
Flu like symptoms; body aches; severe vertigo; nausea and fever lasting around 24 hours; nausea and fever lasting around 24 hours; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13May2021 at 13:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, not severe. The patient was allergic to penicillin. Concomitant medications included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN) taken once weekly or less for an unspecified indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 09:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. 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 14May2021 at 08:00, the patient experienced flu like symptoms, body aches and severe vertigo, nausea and fever which lasted around 24 hours, vertigo and nausea lasted 24 hours after. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events flu like symptoms, body aches and fever were resolved on 15May2021, while the clinical outcome of the events severe vertigo and nausea were resolved an unknown date in May2021.  Information about lot/batch number has been requested.
Hazy/blurry vision began approximately 12 hours after vaccination and lasted for about 2-3 days.
Information has been received from a  nurse practitioner (NP) concerning a 2-month-old male who on 31-JUL-2006 was vaccinated by mouth with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#653661/0146F).  The NP reported that in 2006, the patient developed a slight fever and diarrhea.  Unspecified medical attention was sought, the patient recovered from the slight fever and diarrhea.  Additional information has been requested.
Continuing Fatigue two weeks after second dose.; Extreme heavy menstrual period with clotting; Extreme heavy menstrual period with clotting; This is a spontaneous report from a contactable consumer. A 29-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 17:30 as DOSE 2, SINGLE (at the age of 29-year-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received dose 1 on 22Mar2021 at 05:30 PM (Batch/Lot number: Unknown) for covid-19 immunisation. On 21Apr2021 at 04:30 PM, patient continued fatigue two weeks after second dose. Extreme heavy menstrual period with clotting that did not occur with prior periods. AE resulted in Emergency room/department or urgent care. It was unknown if the patient received the treatment or not. The outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. The reporter considered the injection site pain to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient was a pharmacist who mentioned that the shot was painful. She had only received the 1st dose and was awaiting the 2nd dose as it was nearing the end of the 6 month period. No additional information was provided.
Rash on body that seemed to start following immunizations. Rash comes and goes, no known egg, seasonal or drug allergies. No wheezing or fever. Was seen in ER - they thought it was possibly a ketchup allergy.
her daughter received her first vaccine dose on April 1 and tested positive for Covid on April 6th; This is a spontaneous report from a contactable consumer (parent) via medical information team. A contactable consumer reported for her daughter.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 01Apr2021 at a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her daughter received her first vaccine dose on April 1 and tested positive for covid on 06Apr2021. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
3 apneic episodes two days after receiving first flu vaccine. The first two were apnea only. The third time she was unresponsive for 15 or 20 secs. No pallor or cyanosis.
Patient received this vaccine at age 45 on 01/27/2021. When they came in for the second dose I noticed her age and contacted the manufacture. She was then told to follow up with her provider to see what to do next.
Bronchitis; Occasional cough; Sweaty; Sinus infection; ear infection; Burning pain on left ear; Chest pain; Eyes swelling; Face swelling; Throat swelling; Difficulty breathing; No taste; No smell; Vomiting; Fatigue; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRONCHITIS (Bronchitis), COUGH (Occasional cough), HYPERHIDROSIS (Sweaty), SINUSITIS (Sinus infection) and EAR PAIN (ear infection) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Perianal abscess (Due to Crohn's) and Ileostomy (Ileostomy placed prior to receiving vaccination.) in February 2021. Concurrent medical conditions included Sulfonamide allergy, Allergy to antibiotic (Cipro), Drug allergy (Zofran), Drug allergy (Chlorophyl) and Crohn's disease.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced BRONCHITIS (Bronchitis), COUGH (Occasional cough), HYPERHIDROSIS (Sweaty), SINUSITIS (Sinus infection), EAR PAIN (ear infection), PAIN (Burning pain on left ear), CHEST PAIN (Chest pain), EYE SWELLING (Eyes swelling), SWELLING FACE (Face swelling), PHARYNGEAL SWELLING (Throat swelling), DYSPNOEA (Difficulty breathing), AGEUSIA (No taste), ANOSMIA (No smell), VOMITING (Vomiting), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, BRONCHITIS (Bronchitis), COUGH (Occasional cough), HYPERHIDROSIS (Sweaty), SINUSITIS (Sinus infection), EAR PAIN (ear infection), PAIN (Burning pain on left ear), CHEST PAIN (Chest pain), EYE SWELLING (Eyes swelling), SWELLING FACE (Face swelling), PHARYNGEAL SWELLING (Throat swelling), DYSPNOEA (Difficulty breathing), AGEUSIA (No taste), ANOSMIA (No smell), VOMITING (Vomiting), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that she had been in and out of the hospital due to perianal abscesses and was diagnosed with Crohn's disease. She also mentioned that she currently has an ileostomy bag that was placed in February of 2021 due to her disease.  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.  further information has been requested.; 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.  further information has been requested.
Menstrual bleeding for several days beyond cycle that has been regular for 20 years. First thought to be unrelated until I discovered that many other women had irregular menstrual bleeding after vaccination as well.
Ten days following vaccination with Pediarix the patient had 8 general tonic clonic seizures.  One seizure lasted greated than 30 minutes and he was taken to the hospital and admitted overnight.  MR received from pediatrician which reveals a 12 month old with a PMH of known seizure disorder.  Six minute seizure noted on Oct. 7th, 11 days prior to vax. Office visit of 10/30/06 notes that child had 8 seizures on Oct. 28, 2006 (10 days following Pediarix).  Was seen in ER.  Mood changes have been noted, as well as a "droopy" look to the eyes since that time. Assessment notes "seizure-post vaccination". 11/22/06: separate VAERS form received today for same child for different event(267293).  MR received from admit of 03/01/2006 (8 months prior to AE) for new onset seizures. DX: New onset seizures. Records will be scanned for VAERS 267293.  ER report received for 10/28/2007 documenting an ER visit for c/o serial seizures, one lasting ~ 30 minutes, others shorter in duration.  Admitted for 23 hour observation and treated with Topamax, Pyridoxine, Folic Acid, Clonazapam, and Fosphenytoin. DX: Serial seizures with one prolonged.
Shortly after her 2 month old shots she had a reaction.  Her father describes the reaction as her had paleness over the whole body.  This lasted for about 3 hours and started about 10 hours after the shot.  She was a little fussy and ate poorly during that time.  She was crying a lot at the time.  The episode went away on its own.  She has since received the HIB vaccine and had no problems except for just a little redness at the site of injection.