chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SICKNESS; ARTHRITIS AGGRAVATED (WORSENING IN ARTHRITIS); This spontaneous report received from a patient concerned a 46 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included sick all the time with Risankizumab (Skyrizi) since OCT-2021, and concurrent conditions included moderate to severe chronic plaque psoriasis. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, and expiry: unknown) dose was not reported, 1 total administered on MAR-2021 for covid-19 vaccination. Concomitant medications included Risankizumab (Skyrizi) for moderate to severe chronic plaque psoriasis. On an unspecified date, the patient experienced arthritis aggravated (worsening in arthritis). On MAR-2021, the patient experienced sickness, and was hospitalized for an unspecified days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sickness, and had not recovered from arthritis aggravated (worsening in arthritis). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210827085-Covid-19 vaccine ad26.cov2.s-Sickness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
25 days of multiple itchy red bumpy (but not vesicular) skin eruption on bilateral trunk (worst on abdomen), not improving despite moisturizer creams, calamine lotion, oral steroid course
did not get the second shot in 42 day window; Rapid heartbeat; Dry mouth; aches; really bad reaction; unbelievable aches; fever; chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not get the second shot in 42 day window), HEART RATE INCREASED (Rapid heartbeat), DRY MOUTH (Dry mouth), PAIN (aches) and ADVERSE EVENT (really bad reaction) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had a history of covid on early December and  was on oxygen was noted.).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced HEART RATE INCREASED (Rapid heartbeat), DRY MOUTH (Dry mouth), PAIN (aches), ADVERSE EVENT (really bad reaction), PAIN (unbelievable aches), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get the second shot in 42 day window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not get the second shot in 42 day window) had resolved and HEART RATE INCREASED (Rapid heartbeat), DRY MOUTH (Dry mouth), PAIN (aches), ADVERSE EVENT (really bad reaction), PAIN (unbelievable aches), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants were not reported. Treatment was not reported.
BP 122/67 prior to vaccine. 8-24-10 vagal response after receiving immunizations. Pt. passed out for 10 seconds & awakening shaking & crying , water & candy given, cool compresses applied. Fan with cool air directed to pt. Instructed pt. to deep breathe. BP 160/100 while pt. remained shaking & crying. Pt. drank water & ate candy & began to calm down, after several deep breaths BP retaken 116/74, pt. remained on exam table and cont. to drink water. Instructed pt. to continue deep breathing. Shaking resolved. BP 112/72. 8-24-10 Pt. reported feeling fine. Pt. sat up in chair & FP visit continued. Pt. walked to front desk & cont. to report she was fine. Instructed mom to take child to ER if any problem should occur after leaving. 8-25-10 Called mother she reported child did not have any more problems after leaving clinic yesterday. Mom reports child had H/A this am & reported arms sore but felt well enough to go to school. Mom reported H/A's in past when child had vagal response. 08/24/10 continued - fine tremor noted (R) arm; lasting about 15-20 minutes, mom reports this has never occurred with previous vagal responses to vaccines.
The patient took the Johnson and Johnson vaccine on 12/03/2021 around 12/18/2021 the patient was noted with a limp and was assessed by the medical doctor.  A venous doppler was performed and the patient was diagnosed with left leg  acute DVT in the popliteal vein and peroneal vein.
rocky mountain fever; having brain fog; she was feeling very fatigued; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program, a Regulatory Authority. A 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient got her first dose of the vaccine and was scheduled for her second dose of the vaccine on 13Jul2021. She stated she thought she was having a reaction to the first shot because she was feeling very fatigued. She was also having brain fog. However, her mother thought it could be a tick bite. She went to get tested and it came back today that she had rocky mountain fever. She was currently taking an antibiotic, doxycycline hyclate, and her last day of that was on 18Jul2021. Patient asked about getting the second dose on 20Jul2021 or 22Jul2021. She wanted to know if she could still get her second dose of the vaccine with rocky mountain fever while taking the antibiotics (doxycycline hyclate). Patient was diagnosed with mountain fever after she received the first dose of the Pfizer covid vacccine. Outcome of events were unknown.  Information on the lot/batch number has been requested.
Started having seizures. One after the other. 3 within 20 minutes.  Became completely unresponsive for 1 1/2 hours. Was taken to the ER to be monitored.
It was reported that a 19 month old male patient received an ActHib vaccination, administered on 12/18/01. The next day, the patient developed a large "baseball size" reddened area at the injection site.
pt recv vax & pt devel a localized rxn in mouth;skin around mouth & nose looked as if it was wind burned & was dried & reddened;reporter had no addtl details concerning the pt's exp
joint pain; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever) in a 67-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 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 ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever). At the time of the report, ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Patient typically has joint pain and took tramadol and meloxicam. Concomitant product use was not provided by the reporter.
CLIENT C/O FEELING FAINT AND SHAKY AND LIKE "MY THROAT IS CLOSING UP."  911 called.  Vital signs stable.  Refused transport to ER.  Husband took her home.  She was called the next day and said that she took a Benadryl, had something to eat, slept, and then felt tine.
2 days of vomiting, trembling  h Arachne chills  2 days , fever , right leg and abdominal muscles felt paralyzed , extreme  Fatigue
chills; hives; headache; extreme fatigue/became very tired/exhausted; Couldn't stay awake; cannot function; This is a spontaneous report from contactable nurse (patient) via medical information team. A 71-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: Unknown) via an unknown route of administration on 12Mar2021 at 11:30 at single dose for COVID-19 immunization in airfield where they build airplanes. Medical history included spleen removed many years ago due to enlargement from the blood disorder. Also had ongoing spherocytosis (States takes B12 and Folic Acid for this condition), ongoing sleep disorder, ongoing narcolepsy, chronic fatigue syndrome. She got pneumonia and respiratory failure after pneumonia vaccine and was hospitalized for 6 weeks. This happened years ago. She was almost died. So she avoids vaccines. Concomitant medications included ongoing methylphenidate hydrochloride (RITALIN) for sleep disorder and narcolepsy (20 years), folic acid for spherocytosis, cyanocobalamin (B12-VITAMIIN) for spherocytosis. No prior vaccinations (within 4 weeks). Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 12Mar2021 at 11:30 (Friday as reported). In the evening she started experiencing some reactions (caller states she got the paper with the side effects and it mentions that they are usually worse after the second dose of the vaccine); chills, hives, headache and extreme fatigue on 12Mar2021. She is still very tired (crippling fatigue) and her headache is not so bad. She felt fine until around 1700 of the same day, when she experienced chills, hives, headache, became very tired, couldn't stay awake and went to bed. The next day she still had a headache, was still tired, hives were gone. At this time, just the extreme fatigue is continuing. States that today she is so tired she cannot function. Also mentions that she did not get a vaccine card from the facility that administered the vaccination. States that she is sorry that she got the product because she has a history of chronic fatigue syndrome and wondered if this would trigger it; but that her doctor said it would not. Caller feels that it has, because she can't function and this is terrible. She was afraid to get the second dose if she felt this crappy after the first one. She had no soreness or anything from the injection. With this amount of fatigue, she is just exhausted. States she has not been seen by her doctor, did not expect her doctor to do anything. A visit to emergency room or physician office was not required for events. Events were reported as medically significant. Specific causality was not provided for each event by the reporter. The outcome of event hives recovered on 13Mar2021; for events headache and fatigue was not recovered; for other events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the events,chills, hives, headache, extreme fatigue ,somnolence and cannot function cannot be completely ruled out.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not provided by the reporter. On an unknown date, the patients were vaccinated with multiple doses of improperly stored PNEUMOVAX 23 (strength, dose, route of administration, lot/batch# and expiration date were not reported) for prophylaxis. The temperature and time frame to which vaccine was exposed was unknown by the reporter. There was no previous temperature excursion. No adverse events were reported. Digital data logger was involved. It was reported that there were multiple lots involved. There was no product quality complaint (PQC) involved. It was requested to send copies of data logger information as opposed to multiple excursion forms. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA003603: US-009507513-1708USA003015: US-009507513-1708USA003604: US-009507513-1708USA003606: US-009507513-1708USA003607.
very cold; Headache; Pain; a little pain in the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NASOPHARYNGITIS (very cold), PAIN (Pain), INJECTION SITE PAIN (a little pain in the injection site) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN (Pain) and INJECTION SITE PAIN (a little pain in the injection site). On 03-Feb-2021, the patient experienced NASOPHARYNGITIS (very cold) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 03-Feb-2021, NASOPHARYNGITIS (very cold) and HEADACHE (Headache) had resolved. At the time of the report, PAIN (Pain) and INJECTION SITE PAIN (a little pain in the injection site) outcome was unknown.
pt had typical 2nd dose symptoms 2-3 days after vaccine (low-grade fever, body aches, fatigue) which resolved, but the joint aches worsened daily.  Seen 9 days after vaccine administration, he has inflammatory polyarthritis, with R hand significantly swollen, L hand mildly so; bilateral shoulder pain with decreased ROM, bilateral hip pain and spine pain.  saying he can feel every joint - difficult to move around (unusual for this 52 yo male).    He increased his ibuprofen to 800 TID and increased his tylenol to 1 g TID without relief.  Pt was given a shot of steroids (SoluMedrol) on 2/27 with some improvement by 3/1, but not completed resolution of swelling, grip strength or pain.
STARTED 9/29/19 NIGHT AROUND MIDNIGHT, WITH HEADACHE & NAUSEA. THEN BODY ACHES & CHILLS, EVERYTHING HURT. WORST AT LATER PART OF DAY ON 9/30/19.  DR VISIT ON 10/1 @ 12:15PM, DR SAID REACTION TO VACCINE, DR SAID SHE'S SEEN THIS REACTION BEFORE. 10/1 STILL CHILLS COME & GO, & SWEAT, AND HEADACHE, NAUSEA & ACHES CONSTANT
This spontaneous case was initially received on 09-Dec-2015. The case report was received from a Health Professional and concerns a 72 years old female patient who had never gotten the flu vaccine until this year. She did not believe she needed the flu shot because she had never gotten the flu. Weight: not provided, Height: not provided. Concurrent medical condition (s), medical and drug history: The patient has a medical history of Latex allergy and Sensitive to a lot of stuff. She had cancer removal surgery last year and there was an incident. The doctor used latex during surgery and the latex was inside her body. It almost killed her. She did not sue her doctor because he saved her life. The doctor misunderstood her latex allergy for latex sensitivity. The doctor had to give her a bolus of epinephrine because she was in anaphylactic shock. She required a cardiac monitor for days before blood pressure and heart rate went back up. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA injection for indication prevention of influenza on 12-Nov-2015 - 12-Nov-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml, prefilled syringe. This was the only injection she received that day. Her job forced her to get the flu vaccine this year. If employees did not comply, they will be asked for a voluntary resignation. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 12-Nov-2015, 5 mins after starting/ treatment with AFLURIA, the patient felt itchy and sick to the stomach. Ten minutes after the injection, she felt sweaty and the pharmacist urged the patient to stay for additional monitoring. Twenty five minutes after the injection, the nurse stated she had blood red hands. The pharmacist wanted to give her an Epipen and the patient declined because it was expensive ($360 with her insurance). The patient argued with the pharmacist. The pharmacist then asked the patient to stay for additional time and the patient agreed and waited 1 hour before she left. The pharmacist advised the patient to take diphenhydramine for the itching. The patient could not take diphenhydramine because she could not be sleepy at work. She had to work the next day on 13-Nov-2015. She felt very itchy and it got hot because she was moving patients. The heat exaggerated the itchiness. He co-workers said that the patient looked like a 'dog scratching fleas'. The patient was upset about this. Her symptoms lasted for 2.5 days and clearly by the evening of 14-Nov-2015 or morning of 15-Nov-2015. For relevant test results see appropriate report section.
About two days after receiving the RSV vaccine, despite no other symptoms whatsoever, I had pain in my right wrist which has been recently diagnosed with arthritis. It lasted for about 2 1/2 days and went away as quickly as it came.  Mentioned to the pharmacist, who said he had heard similar reports even though arthritis pain was not listed in the literature as a possible side effect.
2nd dose given 3 weeks after 1st; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number G3T43, expiry date 07-JUL-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 09-MAR-2023, the patient received the 2nd dose of Shingrix. On 09-MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose given 3 weeks after 1st). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 9-Mar-2023 The pharmacist reported that he realized that the patient received first dose had been given 3 weeks ago. The reporter asked that if the second dose was valid or if the patient had to receive an extra dose. Permission for follow-up was not requested during the call. The patient received second dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Moderate muscle pain/soreness of left arm- started approximately 6 hours post injection and present even after 24 hours
Onset of moderate arthralgia, injection site pain, and mild myalgia within 9.5 hours of receiving vaccine injection. Onset of severe, activity-limiting arthralgia, myalgia, chills, nausea, and fatigue, as well as 102 F oral temperature, within 22 hours of receipt of vaccine. Symptoms progressively worsened to the point patient suspected influenza infection, so sought testing and evaluation at urgent care facility the evening of 12/31/2020.
Swollen lymph nodes/tender neck and lower face; Swollen lymph nodes/tender neck and lower face; Swollen lymph nodes/tender neck and lower face; pressure on left ear; Headache; pain in upper right abdomen; arm pain; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 via an unspecified route of administration administered in left arm on 24Feb2021 10:00 (at 37 years old) as single dose for COVID-19 immunization. Medical history included appendix removed, gallbladder removed, heartburn, and known allergies to adhesive; all from unspecified date and unknown if ongoing. Concomitant medications included unspecified medication for birth control, buspirone, and omeprazole magnesium (PRILOSEC); all from unspecified date for unspecified indication. There were no other vaccines received within 4 weeks. The patient experienced swollen lymph nodes/tender neck and lower face, pressure on left ear, headache, pain in upper right abdomen, and arm pain; all on 24Feb2021 10:30, which were considered non-serious events. No treatment received for the events. No COVID tests done prior and post vaccination. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Rash / red area around where shot was given.  Applying Benadryl cream - seems to be lessening.
My gums were red and swollen and this  lasted for 7 days.  They were tender but did not bleed.  I got the shot on a Saturday and it took until the following Sunday for the swelling to go down.
The patient developed a rash. Patient went to the doctor's office and was issued a prescription for MEDROL.
The patient started experiencing arm pain 2 days after the vaccination and is seeking a follow up exam with her provider on 11/23/2020. She stated the injection was given in the proper location 2 inches below the shoulder and didn't feel pain during the injection or for 2 days after the injection.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (soreness on injection site) and VACCINATION SITE LYMPHADENOPATHY (swelling of lymph glands on same arm of vaccination) 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. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness on injection site) and VACCINATION SITE LYMPHADENOPATHY (swelling of lymph glands on same arm of vaccination). At the time of the report, VACCINATION SITE PAIN (soreness on injection site) outcome was unknown and VACCINATION SITE LYMPHADENOPATHY (swelling of lymph glands on same arm of vaccination) had not resolved. Not Provided  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown (Inconclusive) swelling of the lymph glands was confirmed to be a side effect from the Moderna COVID-19 Vaccine. Treatment details were not reported. Reporter did not allow further contact.
Left mid thigh, circular area of erythema 14 mm diameter with central papule. No edema. Left lateral thigh, 3 x 4 cm of erythema and swelling. Acetaminophen and diphenhydramine recommended for local reaction.
SHINGRIX WAS ADMINISTERED 22 DAYS AFTER THE FIRST DOSE.  THIS IS DOSE IS CONSIDERED INVALID AND HAS TO BE REPEATED.  THE PATIENT HAS REPORTED NO ADVERSE SIDE EFFECTS.
Dizziness, Headache, Myalgia,  fatigue, reduced BP  Narrative:  Other Relevant History:
This spontaneous report was received from a medical assistant and refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX VIAL 19400 PFU (dosing details and route of administration unknown), lot # M037655 with expiry date 29-NOV-2017 for prophylaxis, which reconstituted with sterile water diluent that was not involved in the temperature excursion. The administered doses experienced a temperature excursion of 6 degree Fahrenheit(F) to 14 degree Fahrenheit(F) for a time frame of 20 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality complaint (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001756: US-009507513-1706USA001757: US-009507513-1706USA001758: US-009507513-1706USA001759: US-009507513-1706USA001760: US-009507513-1706USA001761: US-009507513-1706USA001762: US-009507513-1706USA001763: