chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered, after gone out of range; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-APR-2022 Reporters comment: The patient received Boostrix after it had gone out of range. All information provided was reported.  It was reported that, for additional information, please reach out to the healthcare professional. Additional supportive information: The patient received Boostrix after it had gone out of range, which led to incorrect storage of drug. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070827:Same reporter. US-GLAXOSMITHKLINE-US2022070813:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071809:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071810:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071811:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071812:Same reporter. US-GLAXOSMITHKLINE-US2022070827:Same Reporter
* Fatigue and tiredness for two days from the night of vaccination,  * Redness, swelling at the site of vaccine (left arm),  * Allergy at different parts of the body--knee, wrist, thigh, foot,  == Fatigue went away naturally after two days but allergy remained for a week. ==
This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A 50-year-old female patient received the 4th dose (second booster) of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 3rd dose (first booster) of the COVID-19 vaccine and the COVID-19 vaccine (primary immunization series complete; manufacturer unknown), for immunization. The patient experienced pyrexia/fever, chills and vaccination site pain/injection site pain, with outcome of unknown. Additional information: Fever, chills and injection site pain occurred after second booster (4th dose). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
The vaccine was mixed with a multi-dose vial of diluent. The diluent vial was punctured twice and used to mix 2 vials of vaccine. The dose was administered IM and a 5/8 inch needle may have been used.
abscess SC in the muscle 2 1/2cm x 1 3/4cm;erythema, fir, sl tender s/p vaccination abscess;
08:40 am, injected arm burning and hot. 11:00 am, reported to co-workers, she didn't feel well. 12:17 pm, called and reported to employee health that she had oral edema. 01:00 pm, admitted to the Emergency with shortness of breath and coughing. Soon after was intubated and admitted to Critical Care Unit.
My daughter is experiencing words reaction after 1 month of her second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (My daughter is experiencing words reaction after 1 month of her second vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (My daughter is experiencing words reaction after 1 month of her second vaccine). At the time of the report, HYPERSENSITIVITY (My daughter is experiencing words reaction after 1 month of her second vaccine) outcome was unknown.            NO concomitant and treatment drugs were used
(Newly) Skin red around injection site about 6 inches in diameter. Skin tight and hot. No symptoms prior to today. Some soreness and muscle aches. Arm pit soreness (left arm, same side injection site), similar to swollen or infected glands (which have had in past, unrelated to vaccine.)
Onset 4/29/2021 of severe left greater than right neuropathic pain which resolved on left but persisted on right and was followed by onset of severe weakness and patchy numbness. Neurologic exam and EMG consistent with brachial plexopathy.
Covid 19 Cough Paxlovid Tessalon pearls Albuterol Still coughing.
nausea; chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness; chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness; chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness; chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness; chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness; fever of 100.1°F; couldn't get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), CHILLS (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), HEADACHE (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), MYALGIA (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness) and DIZZINESS (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cellulitis of leg (Cellulitis on the right leg.) in January 2021 and Bypass surgery (Three bypass).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced NAUSEA (nausea), CHILLS (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), HEADACHE (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), MYALGIA (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), DIZZINESS (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), EAR PAIN (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), PYREXIA (fever of 100.1°F) and BEDRIDDEN (couldn't get out of bed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), CHILLS (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), HEADACHE (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), MYALGIA (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), DIZZINESS (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), EAR PAIN (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), PYREXIA (fever of 100.1°F) and BEDRIDDEN (couldn't get out of bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        The Patient outcome of the events not provided.
Left part of face and left arm at sight of injection went numb and tingly after 25 minutes of receiving 2nd dose. Blood pressure and heart rate all fine during this time. Tastebuds / under tongue area went numb and had no taste. Bottom teeth very sensitive to cold. This all lasted for 24 hours, before going away. After 12 hours of getting the shot, I also had fever like symptoms that lasted for 12 hours.
feeling bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 2, after you have your two main shot, its the third booster, correct." (Clarified as Pfizer COVID-19 Vaccine).), for COVID-19 Immunization; Bnt162b2 (Dose: 1, after you have your two main shot, its the third booster, correct." (Clarified as Pfizer COVID-19 Vaccine).), for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset Oct2022, outcome "unknown", described as "feeling bad".  Additional information: Reporter was calling on behalf of a family member, extended family member who got the shot a week ago Saturday meaning not yesterday, a week ago Saturday and she went to develop side effect that was listed on your website like almost a week later she started feeling bad about Wednesday. Reporter stated it is the third booster after you have your two main shot, its the third booster, correct (Clarified as Pfizer COVID-19 Vaccine).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
flat, red, non-itchy rash about 1.5"x3" appearing 9 days following injection. General lethargy presenting, but no other discomfort or illness.
firm, erythematous, warm raised area rt deltoid; 6cm in diameter; painful;
Two days after the injection, I started having leg cramps and dull pain in my lower legs.  On monday the 19th, I went to the acute care because I was having more leg pain. Dr ordered D dimer test that came back elevated. I was asked to go to the hospital for a doppler test of legs that showed no clots in legs.
tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. She was not hospitalized, she stayed at home. She was fully vaccinated and did not know manufacturer.  Company Comment: This case concerns a female patient of an unknown age, with no medical history reported, who experienced the unexpected  event of SARS-CoV-2 test positive. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age, with no medical history reported, who experienced the unexpected  event of SARS-CoV-2 test positive. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
turned blue; This case was reported by a consumer via interactive digital media and described the occurrence of cyanosis in a female child exposed to Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) in utero. The parent received the product for prophylaxis.   On an unknown date, the mother received Influenza vaccine Quadrivalent unspecified season. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The child was exposed to  at an unknown time during the pregnancy. The child was diagnosed with cyanosis. On an unknown date, the outcome of the cyanosis was unknown.   It was unknown if the reporter considered the cyanosis to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The patient turned blue hours after the flu vaccine, head of pediatrics said oops this did happen, they would put it in her medical file to never give it to her again. The reporter consented to follow up. This case is linked with US2020AMR192700, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR192700:same reporter
"redness, swelling, warmth, and pain" at the injection site; "redness, swelling, warmth, and pain" at the injection site; "redness, swelling, warmth, and pain" at the injection site; "redness, swelling, warmth, and pain" at the injection site; This spontaneous report was received from a nurse via company representative and refers to a 74-year-old female patient. No information regarding her pertinent medical history, drug reactions or allergies was provided. Concomitant therapies included: simvastatin (manufacturer unknown), aspirin (reported as baby aspirin) and estrogens, conjugated (PREMARIN). On 08-JAN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, dose number, route of administration, lot number, expiry date were not provided). On 10-JAN-2020, she experienced redness, swelling, warmth, and pain at the injection site. During the same day, the patient was seen at the office by the physician in which he prescribed sulfamethoxazole (+) trimethoprim (BACTRIM).  Outcome of the events was reported as resolving. Causality assessment between the events and the suspect therapy was not provided.
Patient explains had cardiac symptoms on Tuesday after vaccine. Patient awakened with cardiac symptoms and took Nitroglycerin. Patient complains of lethargy beginning Saturday after vaccine. Patients states feels like kidneys are shutting down. Patient complains of feeling tired and weak beginning day after vaccination. Patient states she felt that her kidneys and organs are "shutting down". Patient complains of symptoms of yeast infection, as well. Patient states that she was watching t.v. on Tuesday after vaccination and fell asleep and awoke with cardiac symptoms. Patient states she was having a heart attack. Patient states she took her Nitroglycerin tablets sublingually to relieve symptoms. Patient began using two nitroglycerin patches twice a day. Before vaccination patient was using one patch twice a day. Patient called her cardiologist and was told to continue using two patches twice a day. Patient continues to use two patches twice a day at present time. Patient is in contact with primary care physician and cardiologist by phone.
cold sore; arm is a little sore; This is a spontaneous report from a contactable female consumer (patient). A female patient with unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number/Expiration date: unknown), via unspecified route, on an unknown date as unknown dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced a cold sore and little arm sore (pain). The patient gets cold sore regularly and wanted to know if she can take her anti-bacterial medication she has been prescribed previously by her doctor. The reporter assessed all events as non-serious. The outcome of the events reported was unknown.  No follow-up attempts possible. No further information expected.
*THE BELOW IS A LIST OF SYMPTOMS THAT ARE ONGOING SINCE INJECTION DATE: 12/30/2020  0830 HOURS- *FEVER HOLDS AT 100.5 -101.9 * OVER THE COUNTER TYLENOL REDUCES FEVER BY 1-1.5* *CHILLS , FATIGUE, JOINT & MUSCLE  PAIN AND LO GRADE HEADACHE( ALL SEEM TO MARGINALLY LESS TODAY *DRY INTERMITTANT COUGH OVER LAST 12 HOURS  *CHRONIC CONSTIPATION, NO BOWEL MOVEMENT OVER THE PAST THREE DAYS
Swelling, soreness, chills - Wed night 9-11-13 rash, redness on arm between shoulder and elbow - Thurs, Friday 9-12-13 to 9-13-13. Sat - came in and it looked a lot better - he took some BENADRYL. Left arm - Pneumococcal. 9-18-13 patient is doing great!
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 05-APR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA001558:
Patient developed erythema, swelling and increased warmth in right upper arm. She had right upper extremity inflammation with probable cellulitis.
Enlarged lymph node; soreness above left clavicle; This is a spontaneous report from a contactable other health professional (patient). A 50-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 21Jan2021 08:00 at a single dose on left arm for COVID-19 immunization. The patient medical history were not reported. There were no concomitant medications. The patient previously took keflex [cefalexin monohydrate] and experienced allergies. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO142), via an unspecified route of administration on 31Dec2020 13:00 at a single dose on left arm for COVID-19 immunization. The patient experienced enlarged lymph node and soreness above left clavicle on 21Jan2021 20:00. No treatment received for the events. The outcome of the events was not recovered. The events were considered as non-serious. The patient was not pregnant. No other vaccines within 4 weeks prior to the COVID vaccine. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was at the Hospital.  Information on the lot/batch number has been requested.
Days 1-5 Soreness in arm muscle. Evening of day 2: shivering chills/temperature of 99.8 (resolved after OTC advil) Day 5 & 6: itchy and redness/warmth of left arm (3-4 inches)
He received his third anthrax vaccine on April 24, 2001. Immediately, he reports that he felt burning at the injection site, which he expected. Within 48 hours he reports that he had significant redness and swelling from his shoulder down to his elbow. He reports that he had itching which he rates 5/10 involving the area and also burning 5/10. He went to see a physician who said it was due to the anthrax vaccine and stated that she should not receive further anthrax vaccines. The physician gave him Benadryl 50MG that he found to be effective. However, his arm continued to swell and over the next two days he reports that the swelling extended down past the elbow to the mid forearm. The swelling did not affect his range of motion. He reports that the swelling and redness lasted approximately 10 to 12 days. Upon resolution of symptoms, he reports that he has had no residual effects. He is now due to be deployed and there is some concern as to whether he should receive the anthrax vaccine.
It was reported post vaccine pt developed a rash that extended from her head to her toes. Pt also vomited and became irritable. Additional information received from the physician on 03/14/2001 indicated the patient recovered.
Redness and swelling to left arm, no fever. Using arm well. Advised to use cool compresses and Tylenol for discomfort.
Child was given 2nd dose of H1N1 mist-30 mins. later child complained of a scratchy throat-temp 99.2 degrees F. No other symptoms-focs states child had allergies as a child. Foc took child home. F/u call child had no further reaction-was sleeping.
Begin to experience heart palpitations during moderate exercise on a Monday, lasted duration of exercise. Heart palpitations occurred two additional times throughout the week. The next week, on Monday, May 22, I was on a rowing machine, experienced palpitations, tightness in chest, left arm discomfort, and slight numbness in left hand fingers. Went to the ER and went through a EKG, urine, blood test, and x-ray. Nothing found and no blockages noted. Referred to a cardiologist where I was prescribed a heart monitor and CT scan with dye contrast. Heart monitor observed several readings of palpitations and CT scan showed no blockages/stenosis. Continue to experience palpitations to this day and have a follow up with my primary care physican next week.