chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Contracted coronavirus 2 weeks ago; felt like he fell in big tub of ice/ chills for 5-10 mins/ chills came out of nowhere, went fast away; first dose of the Moderna COVID-19 vaccine second dose patient received Pfizer vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of CORONAVIRUS INFECTION (Contracted coronavirus 2 weeks ago), INTERCHANGE OF VACCINE PRODUCTS (first dose of the Moderna COVID-19 vaccine second dose patient received Pfizer vaccine) and CHILLS (felt like he fell in big tub of ice/ chills for 5-10 mins/ chills came out of nowhere, went fast away) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (first dose of the Moderna COVID-19 vaccine second dose patient received Pfizer vaccine). On an unknown date, the patient experienced CORONAVIRUS INFECTION (Contracted coronavirus 2 weeks ago) and CHILLS (felt like he fell in big tub of ice/ chills for 5-10 mins/ chills came out of nowhere, went fast away). On 30-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (first dose of the Moderna COVID-19 vaccine second dose patient received Pfizer vaccine) had resolved. At the time of the report, CORONAVIRUS INFECTION (Contracted coronavirus 2 weeks ago) outcome was unknown and CHILLS (felt like he fell in big tub of ice/ chills for 5-10 mins/ chills came out of nowhere, went fast away) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: unknown (Positive) Covid-19 Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Significant Follow-up Received on 01-Sept-2021. Co-suspect Pfizer was added. Two Events- Corona Virus infection and Chills were added.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 19-JUL-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # M000996, expiry date 07-JAN-2018, dose, strength, vaccination site, route unspecified). The vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
injection site soreness; little nauseous; getting a headache; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included multiple sclerosis (in remission for ten years). Concurrent medical conditions included immunocompromised (because of the Multiple sclerosis) and gluten sensitivity (eliminated soy, corn, and dairy from diet). Concomitant products included naltrexone.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain, nausea and headache. On an unknown date, the outcome of the injection site pain, nausea and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain, nausea and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The patient felt after the 1st Shingrix, injection site soreness, being a little nauseous and getting a headache. The patient events resolved.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR237558:same patient (2nd dose)
Information has been received from a consumer concerning her current 17 year old female daughter with allergy to red dye and stings and no pertinent medical history who on 08-JUN-2010 was vaccinated IM with a 0.5 ml dose of GARDASIL (Lot# unknown). There was no concomitant medication. The consumer reported that her daughter every month when she got her menstrual period cycle since 25-JUN-2010 after the GARDASIL, she experienced severe adverse reactions. They included lots of pain, cold to the touch, burning up, sweating, diarrhea, abdominal pain, pain in her lower back, lightheaded, weakness, nausea and vomiting. There were no laboratory tests or diagnostic studies performed. On 30-AUG-2010, the patient had recovered. The patient did not seek medical attention. Additional information has been requested.
Suspected vaccination failure; had an extreme case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving both doses of Shingles vaccine, 6 months later, the patient had an extreme case of shingles. At the time of reporting, the patient was in week 8 of shingles and still healing. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation of shingles was not provided.
Day #1 minor pain in left shoulder Day #2 felt fatigued, headache, chills. Day #3 showered at 9:30 pm and noticed significant swelling under my left arm and into my left chest area. I had increase in neck pain on left side.
pt arm was very swollen and very red with unusual soreness. pt ran 101.01 fever for 2 days. pt vomitted same night as vaccine and has been itchy for 4 days
Information has been received from a nurse concerning an 8 week old male who on 12-JUN-2008 was vaccinated po with a dose of ROTATEQ. It was reported that on 12-JUN-2008 that the patient was given the dose of ROTATEQ then had vomiting. The outcome was not reported. A product quality complaint was not involved. Additional information has been requested.
Patient was given a pentacel vaccine that was adminsitered after 30 mins of being drawn up.  Patient has no adverse symptoms.
standard pain; redness; swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number P7HK7, expiry date unknown) or (batch number 275KY, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2020-2021 season. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season, the patient experienced pain, erythema and swelling. On an unknown date, the outcome of the pain, erythema and swelling were unknown.   It was unknown if the reporter considered the pain, erythema and swelling to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received Flulaval and experienced standard pain, redness and swelling. The patient received FluLaval tetra 2020-2021 with batch number either P7HK7 or 275KY. The reporter mentioned that, it was possible that those were administration technique errors and not related to vaccine product quality and were currently evaluating the administration technique and retraining. This case was 1 of the 5 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR189451:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189448:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189418:same reporter US-GLAXOSMITHKLINE-US2020AMR189449:same reporter
Induration, redness, appx. 9cm elevation appx. 1cm. C/o itching, tenderness upon palpation.
Chills; Fatigue; Nausea; Headache; Swelling of left arm; redness and soreness at injection site; soreness at injection site; Swelling extending to neck and left collar bone; swelling warm to touch; soreness sensitivity heat in upper arm and chest area and neck area; sensitivity heat in upper arm and chest area and neck area; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and PERIPHERAL SWELLING (Swelling of left arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache), PERIPHERAL SWELLING (Swelling of left arm), ERYTHEMA (redness and soreness at injection site), VACCINATION SITE PAIN (soreness at injection site), JOINT SWELLING (Swelling extending to neck and left collar bone), SKIN WARM (swelling warm to touch), MYALGIA (soreness sensitivity heat in upper arm and chest area and neck area) and TEMPERATURE INTOLERANCE (sensitivity heat in upper arm and chest area and neck area). At the time of the report, CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache), PERIPHERAL SWELLING (Swelling of left arm), ERYTHEMA (redness and soreness at injection site), VACCINATION SITE PAIN (soreness at injection site), JOINT SWELLING (Swelling extending to neck and left collar bone), SKIN WARM (swelling warm to touch), MYALGIA (soreness sensitivity heat in upper arm and chest area and neck area) and TEMPERATURE INTOLERANCE (sensitivity heat in upper arm and chest area and neck area) outcome was unknown. Not Provided
numbness in the left arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in the left arm) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness in the left arm). At the time of the report, HYPOAESTHESIA (numbness in the left arm) outcome was unknown.            No Concomitants included.  No treatment was reported by the reporter.
My face started swelling, itching, red; My face started swelling, itching, red; My face started swelling, itching, red; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old female patient receivedfirst dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL8982), via intramuscular route of administration, in the left arm on 27Jan2021 (at the age of 69-years-old) as single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive concomitant medications. The patient did not underwent any lab investigation. Consumer stated, "I am just reporting that I did had a reaction slight reaction to the Shot, Pfizer Shot that I received two days ago. It came about approximately 8 hours after I had the shot my face started swelling, itching, red, so I took couple Benadryl at night, got up the next morning and it was still really swollen, itchy, red. So, I have been on the Benadryl for the last two days. When I got up this morning it is considerably better but I just wanted to let you know that there was a reaction, I am assuming that's probably but easiest way to handle it just take Benadryl until it goes away. Is that correct?". When paraphrased the above concern, consumer stated, "I have already taken Benadryl and it helped and I am just kind of wondering how this will probably last?". Consumer stated, "Well it is getting better, I mean I don't need to go to the doctor. I just want to make a report because I know you are trying to get all the information you can on vaccination." Consumer stated, "Just when I took it or they gave it to me, is that what you want? 27Jan2021, that is when I received the shot." Consumer added, "I haven't received the second one yet. It's due in February." Outcome of the events were recovering.
On 3/1/01, had pain and rash at injection site, left deltoid; red area approx. 1.5cm wide and 3cm long. Denies SOB or hives or itching. Apply ice to area. If not relieved, try warm packs to area.
Feeling faint and light headed; Number of episodes on his sleep apnea machine increased from 1 episode per hour to 28; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling faint and light headed) and SLEEP APNOEA SYNDROME (Number of episodes on his sleep apnea machine increased from 1 episode per hour to 28) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012MZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and High cholesterol. Concomitant products included ATENOLOL, HYDROCHLOROTHIAZIDE, ALOPURINOL and ROSUVASTATIN for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (Feeling faint and light headed) and SLEEP APNOEA SYNDROME (Number of episodes on his sleep apnea machine increased from 1 episode per hour to 28). On 02-Feb-2021, DIZZINESS (Feeling faint and light headed) had resolved. At the time of the report, SLEEP APNOEA SYNDROME (Number of episodes on his sleep apnea machine increased from 1 episode per hour to 28) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Not provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: On 19-Apr-2021: Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Onset of severe headache followed by 1 episode of vomiting. Treated with PO fluids, Ibuprofen and rest.
PATIENT RECIEVED A SECOND DOSE OF J&J AS A BOOSTER ( 3RD DOSE OVERALL)
Pt left arm from the shoulder to the elbow has become swollen, red, and hot to touch.
Pt received Pentacel vaccine instead of HIB vaccine, which meant he got 2 doses of Dtap at this same visit
Patient is fully vaccinated.  COVID + 1/13/2022 on admission to hospital.65-year-old female patient with no past medical history, reports to the ED secondary to dizziness that she states lasted for about 3 minutes yesterday while she was picking up crumbs off the floor.  She states after she sat up, after 2 minutes, dizziness subsided, though she started having some blurry vision.  The patient denies any weakness or changes in speech or headaches at this time. No nausea, vomiting, diarrhea, fevers, or chills.  Patient presents with dizziness and blurred vision. Stroke protocol workup negative.Does not have any respiratory symptoms at this time. CT head: No evidence of acute intracranial hemorrhage, mass effect, or midline shift. Asymptomatic COVID-19 infection. no treatment. No current indication for remdesivir, Decadron, or baricitinib. Discharged.
This is a spontaneous report from a contactable nurse who reported 10 cases for different patients. This is the 4th of 10 cases. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a lot of pain at the injection site. Clinical outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017083713 same reporter/drug/event, different patient.
2 days after the injection, my left arm, hand, and fingers swelled significantly. This continued for another 5-6 days. It became so bad that I had to have my wedding band and engagement ring cut off my fingers because it was cutting off my circulation. I also had a lump under my left armpit
None @ appt for immunizations symptoms developed in the evening Friday with swelling/redness LT & hurts to touch.
Vesicular rash and fever 11 days after varicella vaccine; pt got better, no major complications.
Pt with lip swelling since day after vaccine, currently getting worse. Given oral steroids and epi-pen
3.5 inch wide red strip from shoulder to elbow; It is warm in the red area.; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 10Apr2021 at 16:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 13Mar2021 at 10:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. On 11Apr2021, the patient experienced 3.5-inch-wide red strip from his shoulder to his elbow. It was warm in the red area. It had been 7 days since his shot. His understanding was that side effects should last 2 or 3 days. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events 3.5-inch-wide red strip from shoulder to elbow and warm in the red area was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "79-year-old female with past medical history significant for chronic obstructive pulmonary disease, DVT and AFib.  She presented to the emergency department on 10/10/2022 with a chief complaint of shortness of breath and diarrhea.  On arrival she was found to have some colitis as well as positive for COVID-19 infection.  She was originally admitted to the ICU due to borderline hypotension on arrival.  CT imaging showed evidence of colitis as well as a renal mass.  She was started on antibiotics as well as steroids.  Her symptoms were slow to improve but continued to improve over the course of her stay.  On day of discharge patient was tolerating her home oxygen and occasionally room air.  She will be discharged home on the completion of her antibiotics and steroids.  She will be sent home with home care and was told to follow-up with her PCP as well as she was sent a referral to Urology for the finding of this renal mass.  On day of discharge she was in improved and stable condition, was ready to go home and was given strict return precautions to which she verbalized understanding"
She had a fever, fatigue and sore arm for a few hours for Dose 3. She tested positive for COVID-19 via a home test on May 12. On May 10 her symptoms: stuffy nose, sore throat and we thought it was seasonal allergies. She threw-up after eating her breakfast one morning before school. She has had extreme fatigue since having COVID-19. I contacted the health department to report her having COVID-19. I gave her MUCINEX to help her with her symptoms. Her oxygen level remained within normal range. She had chest pains with Dose 2 that went away within 24 hours.
rt calf / leg pain - seen in urgent care, sent to ER to r/o DVT
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. It was reported that on an unknown date, an improperly stored dose of VARIVAX (Merck) (lot number, expiry date, dose and route unspecified) that was exposed to 6 degree Fahrenheit (F) consistently for 6 months for about 5000 hours may have been administered to the patient (also reported as it was unknown if the VARIVAX was administered or not). No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
A day after receiving the vaccine and a TB skin test (Tubersol), noticed a puffiness to the L side over L clavicle to the neck with a little tenderness touch and some warmth
his fatigue after getting vaccine took much longer; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (his fatigue after getting vaccine took much longer) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis (Autoimmune disease). Concomitant products included CICLOSPORIN (CYCLOSPORINE) for an unknown indication.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (his fatigue after getting vaccine took much longer). At the time of the report, FATIGUE (his fatigue after getting vaccine took much longer) outcome was unknown.            Treatment information was not provided by the reporter.
This case was reported by a nurse via sales rep and described the occurrence of injection site warmth in a 17-year-old female patient who received BEXSERO. Concomitant products included MENACTRA. On 18th July 2016, the patient received BEXSERO. In July 2016, less than a week after receiving BEXSERO, the patient experienced injection site warmth, injection site pain and injection site redness. On an unknown date, the outcome of the injection site warmth, injection site pain and injection site redness were unknown. The reporter considered the injection site warmth, injection site pain and injection site redness to be probably related to BEXSERO. Additional details were provided as follows: On 22nd July 2016, the patient's mother called the physician's office to report that the patient was experiencing warmth, redness, and soreness around the injection site, where the BEXSERO vaccine was administered. The patient had received a dose of MENACTRA in right deltoid. The field representative was unable to provide any further details. It was unknown if the reactions were considered life-threatening or if the patient had to be hospitalized.