chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives-looking rash,little larger than it was initially; Scratches during sleep; rash around the injection site; injection site was sore; headache; chills like crazy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives-looking rash,little larger than it was initially), SCRATCH (Scratches during sleep), INJECTION SITE RASH (rash around the injection site), INJECTION SITE PAIN (injection site was sore) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and MONTELUKAST SODIUM (SINGULAIR) for Allergy NOS, AMLODIPINE and OLMESARTAN for Blood pressure high, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, LEVOTHYROXINE for Thyroid activity decreased.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced INJECTION SITE PAIN (injection site was sore), HEADACHE (headache) and CHILLS (chills like crazy). On 01-Mar-2021, the patient experienced URTICARIA (hives-looking rash,little larger than it was initially), SCRATCH (Scratches during sleep) and INJECTION SITE RASH (rash around the injection site). The patient was treated with CORTISONE for Prophylaxis, at an unspecified dose and frequency and DIMETICONE, MENTHOL, PRAMOCAINE HYDROCHLORIDE (GOLD BOND ANTI-ITCH) for Prophylaxis, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives-looking rash,little larger than it was initially), SCRATCH (Scratches during sleep), INJECTION SITE RASH (rash around the injection site), INJECTION SITE PAIN (injection site was sore), HEADACHE (headache) and CHILLS (chills like crazy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included CORTISONE and GOLD BOND ANTI-ITCH
Clot; Swelling and pain in left foot, ankle, and calf; Swelling and pain in left foot, ankle, and calf; This is a spontaneous report received from a contactable consumer (Patient's son). A 81-years-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/Lot number not reported), via an unspecified route of administration, administered in Arm Left on 02Feb2021 (believes in afternoon) at single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Patient previously took history vaccine included shingles shot received on Nov2020 and Flu shot typically gets every year. On 02Jan2021, patient received first dose of COVID vaccine (BNT162B2) for covid-19 immunisation. The patient experienced severe swelling and pain in foot, calf, and ankle on the left side shortly after the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered. She was hospitalized and placed on Xarelto for treatment by her cardiologist and was scheduled to follow-up to have other procedures performed as deemed needed. Doctor advised patient had a clot and was put on Xarelto. An angio and cath was suggested to see if she had something closing up in her. Patient was going back in a few weeks to see about the clot. she never had this clotting concern before, and this was all new right after the second COVID vaccine. Swelling and pain in left foot, ankle, and calf was either 04Feb2021 or 05Feb2021. she first noticed left foot was swollen. she stated her foot was sore. It was unknown if it went to her ankle and then from there. It was stated that the pain and swelling was better. She was informed by the nurse administering the COVID vaccine that second dose would be a little bit stronger. The patient underwent lab tests and procedures which included MRI on 15Feb2021 and diagnosed the clot. The outcome of the event Clot was unknown. For other events was recovered on unspecified date in 2021.  Information about Batch/Lot number has been requested.
4/19/12 - TDAP shot given, allergy to both legs. 4/20/12 - Fever 3 days. 4/21/12 - Pruritic arm. 4/21/12 - Rashes, swollen, red arm/back ache.
On 05/11/2022 I had a sore throat it felt like I was swallowing glass but I was able to go about my normal activities. That Thursday we went to my grandchild's spring concert at their school because I thought it was just a sore throat. That Friday, I was still experiencing the sore throat and other cold like symptoms. My doctor requires a Covid test to be taken before appointments so I took a home Covid test which was positive. At the recommendation of my sister who works in health care, I requested Paxlovid from my doctor's office, but the receptionist claimed that they don't prescribe it. She advised that I pick up Tylenol and Mucinex. I insisted that I speak with an actual doctor. Later that day, I spoke with the doctor over the phone who prescribed me the Paxlovid. He also suggested that I take Mucinex and Sudafed. For the next few days, I was still fatigued with a headache and a slight cough. But as the days progress, I have began to feel much better.
Fever 102 degrees - early in AM - around 3 AM chills & shakes injection site was sore not red patient took OTC MOTRIN & rested.
Sore arm for about 36 hours, night sweats for two nights starting with the first night, elevated temperature below fever threshold in the 99 range on third night.  Symptoms all resolved.
Fever day 2-3; swelling around and sore lymph nodes under arm and in neck on left side, chills, sweats, tiredness
headache, chills, very tired, low-grade fever, aches - 2 days.  Treated with Acetaminophen, fluids and rest.
Vaccinated a year ago, got shingles/Suspected vaccination failure; Shingles/ Got shingles; Small blisters full of water on my right chest; Tremendous, lot of, pain/a lot of pain and it spread to my back until it surrounded me; I couldn't do nothing; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister, pain and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure, shingles, blister, pain and activities of daily living impaired were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, blister, pain and activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK receipt date: 6-Jan-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient got shingles but the good thing was that a year ago, he/she had been vaccinated and it started with some small blisters full of water on his/her right chest and a lot of pain and they spread to his/her back until it surrounded him/her and with small blisters on his/her back. The patient stated that he/she could not did nothing because of the tremendous pain it was horrible. The patient did not wish this to happen to anyone get vaccinated. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Rash started on checks and spread to trunk, abd, extremities. Parents said she felt warm all over but they did not take temperature. Pt was not ill, or scratching. On date pt seen in clinic parents said rash had calmed down a lot. No s/s discomfort, only a rash 10/10 afebrile, well.
12 hours after receiving vaccine I started experiencing chills and a low grade fever. The fever continued to spike and reached 101.2 during the night I experienced sweating, chills, nauseous, vomiting, muscle aches (especially lower back and legs) and sharp headache. Now 24 hours after receiving the vaccine I still am experiencing sweating, fever of 99.6 and muscle aches which aren?t allowing me to get out of bed
discoloration at the injection site; little warm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from information team. The reporter is the patient.  A 87 year-old female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 87 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRESTOR. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious) with onset Mar2021, outcome "not recovered", described as "discoloration at the injection site"; VACCINATION SITE WARMTH (non-serious) with onset Mar2021, outcome "not recovered", described as "little warm". Therapeutic measures were not taken as a result of vaccination site discolouration, vaccination site warmth.  Additional Information: The Patient had her Pfizer covid vaccine on 01Mar and now has a discoloration at the injection site that is about 1 inch long, felt a little warm and it's not really bothering her, just discolored like a black and blue discoloration. The Patient wanted to know if this is common or should she be worried. The Patient had a little side effect, didn't know if she had to report that or not. It was Pfizer, it's at the site of the injection. The patient reported start date of the event as maybe the 3rd or 4th Mar 2021. The outcome of the event was reported as the same, maybe improved, the patient was not sure, it's yellow on the outside, like around the circle. The patient did not receive any treatment. The patient reported that she was taking Thyroid medications. The Patient wanted to know if it was normal what she had.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After dose 1. Sore arm & numbness in left arm After dose 2 sore arm & numbness still continues & the next morning 9/14 woke up to notice i developed a blister type rash on left hand fingers that was very sore & itchy.  Went to Dr on 9/15 because more blisters were forming. Dr informed me it was Shingles that I've never had before.
Nine days after receiving the vaccine I developed a rash around the site of the injection.  It is oval in shape, about 5 inches long, inflamed and itching.  It seems to improve and then increase.  I have used over the counter lotions to ease the itching, but I am now in day 6
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 29-JUN-2016, the patient was inadvertently vaccinated with a dose of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, dose not reported) subcutaneously for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005160: US-009507513-1612USA005161: US-009507513-1612USA005162: US-009507513-1612USA005163: US-009507513-1612USA005164: US-009507513-1612USA005165: US-009507513-1612USA005166: US-009507513-1612USA005167: US-009507513-1612USA005168: US-009507513-1612USA005169.
pt had rxn to vax pt reported running a fever & chills the noc of vax & took APAP all noc & day;rt arm red about size of baseball & warm to touch;
Fever; deep inflammation; redness; Swelling hand; headache; muscle pain; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (Fever), INFLAMMATION (deep inflammation), ERYTHEMA (redness), PERIPHERAL SWELLING (Swelling hand) and HEADACHE (headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PYREXIA (Fever), INFLAMMATION (deep inflammation), ERYTHEMA (redness), PERIPHERAL SWELLING (Swelling hand), HEADACHE (headache) and MYALGIA (muscle pain). At the time of the report, PYREXIA (Fever), INFLAMMATION (deep inflammation), ERYTHEMA (redness), PERIPHERAL SWELLING (Swelling hand), HEADACHE (headache) and MYALGIA (muscle pain) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided by reporter.  No treatment was reported.
Scheduled to receive the second dose today but tested positiveon 4th of February; Scheduled to receive the second dose today but tested positiveon 4th of February; This is a spontaneous report from a contactable Pharmacist. A female patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. It was reported that patient is scheduled to receive the second dose today but tested positive on 04Feb. The reporter wanted to know if she can still give the 2nd dose to the patient. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.
This is a 41y.o. male with no PMhx, presented to the ER with c/o left-sided chest pressure radiating into the left arm as a tingling sensation ×2 days. Patient states the pain is intermittent, but denies any associated SOB, and/PE, diaphoresis, or jaw pain. Pain is not associated with exertion. Patient was evaluated yesterday and had a complete evaluation including negative CT PE protocol. Patient had troponin 0.06×2 and was advised to be admitted for a stress test but felt improved and declined admission. Patient did set up an outpatient stress test. When he really awoke with the pain this morning he decided to come in for further evaluation. Positive family history of heart disease, father had an MI at the age of 60. No recent fevers worthless chills, cough, urinary symptoms. No travel or sick contacts. No LE edema   covid pos. Hx of PFE covid vaccine and reports booster 3 weeks ago. No prior covid infection.. ??false positive, to retest for needed home quarantine. No family members w covid.   Follows with Dr. Cardio to eval and coordinate possible dc for today.  troponins neg. Reproducible left superior ant chest wall tenderness.   Patient denies cp/sob. No Dyspnea on exertion No reported GI or GU complaints. No sleep issues or new stress issues
Swollen; 2 inch wide, 6 inch long red streak down his arm; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), ERYTHEMA (2 inch wide, 6 inch long red streak down his arm) and PERIPHERAL SWELLING (Swollen) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041220A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 13-Feb-2021, the patient experienced ERYTHEMA (2 inch wide, 6 inch long red streak down his arm) and PERIPHERAL SWELLING (Swollen). At the time of the report, PAIN IN EXTREMITY (Arm soreness) had resolved and ERYTHEMA (2 inch wide, 6 inch long red streak down his arm) and PERIPHERAL SWELLING (Swollen) had not resolved.
Red, raised rash about 4 inches in diameter around the injection site.  Began itching night of 2/17 and today the circle was noticed because itching intensified
Fever, red blotchy rash on Rt thigh started on 09/21/2010 fever subsided on 09/22/2010 but rash continues.
Trouble breathing. Sinus Infections.  Constant pain in my right shoulder. Constant pain in my neck. Bladder problems. Indigestion.  Trouble sleeping. Anxiety, depression. Constant inflammation throughout my body. Weight gain/weight loss. Mostly weight gain.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This was the patient's very first covid vaccine. The patient was suppose to get a pfizer monovalent vaccine first, followed by finishing the series 21 days later, then the bivalent booster 2 months later. Instead, the patient was given a pfizer bivalent vaccine as their first dose instead of a monovalent vaccine. There was no symptoms reported, but was unsure of how to go with completing the patients series. The clinical specialist recommended for us to give a monovalent vaccine 21 days after the bivalent dose was given on 12/13/2022, then to give another bivalent dose 2 months later.
This spontaneous report as received from a office manager refers to a patient of unknown age and gender. On an unknown date, over one year ago, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot number and expiration date were not provided). On 11-NOV-2014 (reported as "now"), the patient was in the office to receive second dose of GARDASIL (dose, route of administration, lot number and expiration date were not provided) which would be late. No symptoms were reported. Additional information has been requested.
Patient drove his mother to center where she was scheduled to get her 2nd dose of Moderna. The patient stated that he hadn't received a call and that he didn't have his card, was due for his second shot and that he had received it the same date that his mother did. When entering vaccine information into Database, it was noted that he had received a 1st Pfizer vaccine on 3/30/21 and not on the same date that he had previously mentioned. Patient received a 2nd dose Moderna on 4/8/21. Upon realization of the medication error, facility attempted to contact patient at listed number but was unavailable and was asked to return phone call as soon as possible, still awaiting returned phone call.   MD notified.
This spontaneous report was received from a certified medical assistant regarding multiple, unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with oral, ROTATEQ, lot # L020859, expiration date- 19-JAN-2017, lot # L006181, expiration date -13-DEC-2016, lot # L020861, expiration date- 25-JAN-2017 and lot number- L035508, expiration date- 12-MAY-2017. No adverse event was reported. No concomitant medication was reported. The outcome of event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Burning rash occurred Wednesday 8/11. Included Arms, chest, back and legs. The rash has  reoccurred every morning since 8/11.  Sometimes it?s mild  and is just on my arms other times it?s severe with burning and itching. It usually lasts about half hour then goes away.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant product were reported Pharmacist stated that the vaccines was stored in freezer and placed out one to two vials and place in fridge each day as needed Pharmacist reported administration of expired vaccine were given as booster shot to patients around 490 to 500 people on the date last 20-Oct-2021 to 29-Nov-2021. No treatment medication was provided
Pt developed rash at site of injection. Pt complaining of dizziness and pain in extremity; pain at site of rash.
Within 4 hours of vaccination my arm swelled up noticeable, became very stiff and sore and made it painful to move my left arm. By 8:00pm I began to feel weak, tired and poorly. By 11:pm I had developed a fever and aches and pains in most joints and muscles which mimicked flu symptons. During the night I became chilled and found it hard to sleep from all of the discomfort. Most of these symptons were almost gone by the next night except for the swelling, which took another 2 days to go down. I have had no other symptons since then.
Patient with area of spreading erythema +pain at site of where pneumococcal conjugate vaccine 13-valent IM was given 3 days prior.
Patient experienced pain & swelling on injection site, mild in severity on his first 2 shots of GARDASIL. There were no accompanying sign & symptoms. Events resolved in a day or two spontaneously. First vaccine given on 01APR2011 while the second vaccine was given on 07JUN2011. This was part of the GARDASIL vaccine study.
Patient experienced mild rash at injection site. Rash seems to be spreading. Site is tender to touch.
Fever, joint pain in hands, fingers, elbow, chills. Lasting few days, with pain subsiding slightly. Muscle weakness. Planning to see MD.