chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Have myocarditis from Pfizer vaccine; This is a spontaneous report from a contactable consumer.   A patient (friend's children of reporter) of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOW, SINGLE for COVID-19 immunization.  The patient's medical history and concomitant medications was not reported. The patient experienced have myocarditis from pfizer vaccine on an unspecified date with outcome of unknown.    The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Pt has complained of muscle pain at site of injection for 28days. Pt had no ecchymosis,swelling nor induration ever appreciated.  Pain with raising left arm. Patient has long  ddd in neck for 1-2yrs and new  rotator cuff tendinitis in left shoulder on exam and states those were not bothering her until day of injection. Pt referred to physical therapy to help with pain. No evidence of paresthesias,weakness of left arm.
No known adverse event-upon review of immunization record, it was noted that patient received Proquad on 2/1/07- This is not for use in children >12 years old.
Patient DOB 5/16/1959 received 1st dose of Pfizer Lot # ER8730 and was waiting in the 15 minute observation section when she stated that she felt "swelling of her face and tingling of her lips."  Blood pressure was 196/98, HR 85, O2 97%, Temp 98.1.  Patient was alert and oriented x 4.  Patient stated that she was very anxious today and has allergies to dairy and pollen.  Patient confirmed that her husband was on the way to pick her up and drive her home.  EMT administered 25 mg of Benadryl PO at 12:32 pm.  Patient observed for an additional 50 minutes until her husband arrived to pick her up at 1:22 p.m. Patient stated that she was feeling better and was able to walk unassisted with her husband.  informed patient to go to ER or call 911 if symptoms worsen.
Pediatric patient was given Pfizer Booster vaccine at school site. Patient was on a list of patients previously consented by parents to recieve vaccines at site visit. Patient was kept for observation after recieving vaccine, denied c/o adverse effects. Patient was educated on importance of encouraging fluids. Patient returned to class in no signs of distress.
On or about 09/01/2015 went to pharmacy and received the senior flu immunization. On the second day after, at exactly at the same time we both began to feel slightly ill at ease which quickly became worse over the next several days to dizziness, weakness and other hand to describe symptoms that really have not fully left completely to this day, some 3 months later. This 4x vaccine should not be given to seniors of advanced age without prior warning.
Started period morning after I had the first shot, and had more clotting; Was not due to have period for another week; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 14Apr2021 at 18:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN) and calcium (MANUFACTURER UNKNOWN); both taken for unknown indications from an unknown date and unknown if ongoing. On 15Apr2021, the patient started period morning after she had the first shot, and had more clotting. She was not due to have period for another week. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started period morning after the patient had the first shot, and had more clotting and was not due to have period for another week was resolved on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Arm, pain, Fever 10.3-101, chills, body aches, shakes fatique, peristent nausea and one episode of vomiting
11 x 3 cm erythema and itchiness at the injection site, noticed last night, improving at the time of the visit per mom, after ice application.
ITCHING & REDNESS AROUND SITE OF VACCINATION STARTING DAY OF ADMINISTRATION 10/14/2005. PT STATED SHE HAD THE SAME REACTION LAST YEAR.  STATES EGGS MAKE HER "SICK".
This spontaneous report was received from a pharmacist via Pfizer (MFR control# 2017487097) regarding a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy was not reported. The patient's historical vaccine included PREVNAR 13. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, strength, anatomical location, route, lot/batch and expiration date were not reported) and high dose flu vaccine influenza virus vaccine (unspecified) for prophylaxis. On an unknown date, the patient had heat (vaccination site warmth), swelling (vaccination site swelling) and rash (vaccination site erythema) after receiving PNEUMOVAX 23. The outcome of vaccination site warmth, vaccination site swelling, and vaccination site erythema were considered to be recovered as the patient called on 30-OCT-2017 (reported as two days back) and informed that everything were back to normal. Causality assessment was not provided by the reporter.
No adverse event noted. Found out post administration that pt is actively taking weekly Copaxone 200mg injection for M.S. and shouldn't be taking any live virus vaccination. Pt followed up via phone call and states doing well and will f/u with his neurologist this coming week.
Patient was seen by provider today with symptoms of low oxygenation, malaise, shortness of breath, cough, congestion, left arm pain where vaccination was received and jaw pain.  Patient received Covid vaccine (Moderna) on Tuesday, Jan. 26, 2021.  Seen by provider on Friday, Jan. 29, 2021 with symptoms. He was evaluated and it was decided that he be taken to the emergency room for further evaluation and monitoring.
This is a spontaneous report from a contactable other HCP via Pfizer sales representative. An adult patient of unspecified age ethnicity and gender received PREVNAR 13 intramuscular at an unspecified dose, INFLUENZA VACCINE via an unspecified route of administration at UNK, both on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fever 102 F, nausea, redness, warmth, had a reaction (influenza and PREVNAR 13), all on an unspecified date with outcome of unknown. The action taken in response to the events was not applicable. HCP stated that patient due to the medical condition had only one arm available for injection of PREVNAR 13 and Flu vaccine, both vaccines were administered in the same arm in separate syringes. The reporter queried whether influenza and PREVNAR 13 be given on the same arm when the alternate arm isn't an option and if not, what is spacing required when using the same arm. The reporter queried about information on administration of those two vaccines in the same arm. Follow-up (18Dec2014): Follow-up attempts completed. No further information expected.
experienced tachycardia, difficulty sleeping and difficulty breathing.  It started within several hours of receiving the vaccination and persisted for more than 24 hours
11/05/2021, 8:30 AM, home.  Unexplained syncope, resulting in loss of consciousness, a forward fall from a chair, hitting floor above left eye. Unconscious for about 60 seconds. 911 called. Paramedics arrived, completed ECG and functionality tests, recommended visit to ED. I had consumed 12 oz of water and 10 oz of black coffee, was about to eat breakfast when I felt faint and sat down. Hospital ED, 9:45 AM. Admitted to ER quickly. Tests: CT scan, chest x-ray, blood work, urinalysis, multiple ECGs. All tests negative. Syncope believed to be caused by dehydration.  Follow-up, Monday, 11/08/2021, personal physician, completed examination, no adverse results, suggested dehydration as cause, recommended I take losartan at night rather than in the morning and to drink 2 liters of water a day.  11/11/2021. Feeling very good, bruising around eye is rapidly getting lighter and less noticeable. No adverse events sense 11/05. I'm not a doctor, but I don't believe the vaccine had anything to do with my syncope.
anaphylaxis reaction; strong intestinal pain; Test result: Positive; This is a spontaneous report received from contactable reporters (Consumer or other non-HCP and Other HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 13:00 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADD" (unspecified if ongoing); "allergies: Milk" (unspecified if ongoing); "allergies: food" (unspecified if ongoing); "allergies: dye" (unspecified if ongoing); "If Covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication included: ADDERALL. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis reaction"; GASTROINTESTINAL PAIN (non-serious), outcome "unknown", described as "strong intestinal pain"; COVID-19 (non-serious) with onset 21Mar2021, outcome "unknown", described as "Test result: Positive". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (21Mar2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of anaphylactic reaction.  When patient received her dose, she should have had an anaphylaxis reaction days later when she had a interaction with her forgot to ask for special instructions on a food ordered for curbside. She then started testing her allergy/ sensitivity. Normally it took several eppi pens to normalize the reaction and following days strong intestinal pain. But absolutely no issues with milk adverse reactions. Patient had her last dose in August and she could tell that her allergy was now coming back.   The lot number for bnt162b2 was not provided and will be requested during follow up.
pt was fainting around 5 mins after the shot; but woke up right away & we're watching him for 30min. checked bp: was 150/84, was ok after 15min, did not have to give any meds. Followed up with him today; pt just had some chills no pain.
2 days after getting the flu shot, patient called my pharmacy where she received the shot and described, pain, swelling, and warmth below the injection site. I called her the next day and she stated that it was getting better.
On Monday 01/31/2022 I had diarrhea. On Wednesday I woke up in the middle of the night with a severe headache and on Thursday I was tested. Fatigue and headache lasted 24 hours. Two weeks later I did have Appendicitis and my Appendix was removed.
About a week after receiving the vaccine I noticed a cramp feeling in my left calf muscle but I thought it might just be a pulled muscle and didn't pay much attention to it.  As the week went on I also noticed that I was very short of breath and any activity was difficult without losing my breath.  I also noticed the the sore calf muscle did not get any better so after about a week of the soreness I decided to see my family doctor but they suggested that I go to the emergency room since I was having trouble breathing.  The hospital doctor informed me that I had a blood clot in my left leg and several in my lungs.  They put me on a blood thinner and the sore calf muscle did get better and my breathing returned to normal.
only had the shot 3 times n got sick 3 times; it takes the patient out; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) and transmitted to Sanofi on 08-Dec-2020.  This case involved a patient of an unknown age who only had the shot 3 times and got sick 3 times (Illness) and it took the patient out (Feeling abnormal), after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications 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 and expiry date not reported) via an unknown route on an unknown administration site for prophylactic vaccination.  On an unknown date, the patient only had the shot 3 times and got sick 3 times (Illness) and it took the patient out (Feeling abnormal).  Relevant laboratory test was not reported.  Final diagnosis was influenza like illness.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) had resolved.        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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Shots given.  Mom walked out with patient thought baby was asleep but was unresponsive.  Mom brought patient to the nurse and called the doctor.  Baby woke up with stimulation.   Walked to the ER by provider.  EKG and glucose checked.  Monitored in the ER for an hour.
feeling yucky all over; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING ABNORMAL (feeling yucky all over) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling yucky all over). At the time of the report, FEELING ABNORMAL (feeling yucky all over) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
chills, sweats 16AUG96 & 17AUG96;area of erythema & swelling 7 x 5 1/2cm on rt arm measured 19AUG96;
BODY ACHES; FREEZING COLD; NAUSEA; TIREDNESS; DIZZINESS; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included food allergy, anaphylaxis to allergens, metal allergy, environmental allergy, non smoker, and alcohol use, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:45 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, treatment medications included: ibuprofen. On 11-APR-2021 12:45, the subject experienced dizziness. On 11-APR-2021 12:45, the subject experienced nausea. On 11-APR-2021 12:45, the subject experienced tiredness. On 11-APR-2021 22:30, the subject experienced body aches. On 11-APR-2021 22:30, the subject experienced freezing cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, body aches, freezing cold, nausea, and tiredness on 12-APR-2021. This report was non-serious.
This is a spontaneous report from a contactable a retired nurse reporting on herself. An 81-year-old female patient received PREVNAR 13, intramuscular in left arm on 22Jul2016 at single dose for immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced swelling on 22Jul2016 with outcome of not recovered, redness/redness at the same spot, a little lower/redness increased with fever 101°F/ redness was from my shoulder to my elbow and all around on 22Jul2016 with outcome of recovering, redness increased with fever 101 (condition aggravated) on an unspecified date with outcome of unknown, pain/very painful on 22Jul2016 with outcome of not recovered, fever on 22Jul2016 with outcome of recovered, insomnia on 22Jul2016 with outcome of recovering, appetite went away on 23Jul2016 with outcome of recovering, headache on 23Jul2016 with outcome of not recovered, feeling sleepy on 23Jul2016 with outcome of recovering. She uses a cold compress that helps with and sometimes relieves the pain. Follow up (23Sep2016): New information obtained from a contactable nurse includes: event's details. Follow-up attempts completed. No further information expected.
Date place in refrigerator was 04-Nov-2021; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Date place in refrigerator was 04-Nov-2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date place in refrigerator was 04-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Date place in refrigerator was 04-Nov-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The vial was placed in refrigerator on 04-Nov-2021. It was reported that the expired lots were administered due to the confusion with expiry date printed in the carton and the expiration date when the QR code was scanned. The vials did not undergo temperature excursion. The patient did not experience any adverse event.  No treatment information was provided.
Patient has injection site reaction. She said she has had it since Wednesday when the vaccine was given and today is Friday. She said there is redness, pain and swelling at the site. She said it is getting better.
Patient reported tongue going numb and throat scratchy about 5 minutes after vaccine administration. Gave patient 50mg of diphenhydramine by mouth with some water. Patient stayed 15 more minutes and reported no change, of which I made sure patient was okay to drive home. I instructed the patient to call if anything changed and we would check in the next day.
needle spit out blood during the administration; black and blue, at the injection site; raised and bumpy lump which looks like the size of a dime at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INJURY (needle spit out blood during the administration), INJECTION SITE DISCOLOURATION (black and blue, at the injection site) and INJECTION SITE SWELLING (raised and bumpy lump which looks like the size of a dime 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 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE INJURY (needle spit out blood during the administration), INJECTION SITE DISCOLOURATION (black and blue, at the injection site) and INJECTION SITE SWELLING (raised and bumpy lump which looks like the size of a dime at the injection site). At the time of the report, INJECTION SITE INJURY (needle spit out blood during the administration), INJECTION SITE DISCOLOURATION (black and blue, at the injection site) and INJECTION SITE SWELLING (raised and bumpy lump which looks like the size of a dime at the injection site) outcome was unknown.
several fainting spells because of everything going on; elevated HR in the 130's; Uncontrollable chills; fever of 102.8; pain all over my body; intractable vomiting; This is a spontaneous report from a contactable nurse (patient).  A 55-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EL0140, via an unspecified route of administration in left arm on 07Jan2021 10:45 at single dose for covid-19 immunisation. Medical history included covid-19 on an unknown date prior vaccination. There were not known allergies. Covid was not tested post vaccination. Concomitant medication included vitamin D; vitamin E.  On 08Jan2021 at 02:00 the patient experienced several fainting spells because of everything going on, uncontrollable chills, fever of 102.8, pain all over the body, elevated heart rate in the 130's, and intractable vomiting. The patient was not treated for the events. The outcome of the events was resolved in Jan2021.; Sender's Comments: Based on the time association, all events are reasonably related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
3rd day post vaccine, painful and swollen lymph nodes at the left side collar bone area. Painful to touch the lump and surrounding area. Aches  extending down the left arm.
This spontaneous report was received from a healthcare worker referring to a 11 week old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 27-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.