chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness; Itchy; face is swollen; arm is hurting underneath; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), PRURITUS (Itchy), SWELLING FACE (face is swollen) and AXILLARY PAIN (arm is hurting underneath) in a 77-year-old female patient 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) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), PRURITUS (Itchy), SWELLING FACE (face is swollen) and AXILLARY PAIN (arm is hurting underneath). At the time of the report, ERYTHEMA (redness), PRURITUS (Itchy), SWELLING FACE (face is swollen) and AXILLARY PAIN (arm is hurting underneath) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Reporter did not allow further contact there is no information provided. There is no batch number provided.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the reported events has been provided at this time. Based on the current available information, a causal relationship cannot be excluded.
I am not able to function; strong pain on her joints/hip pain/pain in wrist joints; muscle contractions; Lot of pain all over my body; my neck paining; my back paining; my arm paining; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Feb2021 (at the age of 69 year old) as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure and fibromyalgia. Patient had taken unspecified medications for fibromyalgia, but it was suspended. Concomitant medications included amlodipine and meloxicam both taken for an unspecified indication. On 25Feb2021, patient received the vaccine, she did not felt anything for first 2 days. But by the third day, on 28Feb2021, she developed strong pain on her joints, and muscle contractions and a lot of pain all over my body. Pain made her very difficult to get up, she used to stood and bend because of intense pain on her hip, in the middle, wrist joints and also had pain in her back, neck and arm. She also reported that she was not able to function due to pain. At the time of report, it was 6th day, still having the pain. Before she had the vaccine, she was suffering from Fibromyalgia, at that time, she had pain all over but the pain that now she have, was more intense. At the time of report, she felt dragged and forced by the pain. Patient had unspecified medication for the pain. She wanted to go to Physical therapy but she want to make sure that she can do. So she called the doctor's office, the nurse advised her to go ahead and to go to Physical therapy but she was confused whether she would get better or may get worse. The second dose would be on 19Mar2021. The outcome of the events muscle contractions and not able to function due to pain was unknown and  of the other events was not recovered   No follow-up attempts are possible. No further information is expected.
Pt received shot on 2/12/19. Three to four days later, on inside of armpit, opposite side of arm pain and redness radiated to shoulder and face from armpit, skin and shoulder joint. Pt went to Dr. The Dr. diagnosed the redness as a fungal infection and prescribed "a cream", which the pt did not use. Pt reports that the pain and swelling is going down, using only ALEVE. As of today, 3/4/19, the pain is "tolerable" with ALEVE.
Red rash that expended from shoulder to elbow and lasted for one week; Pain; Soreness and pain on site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), INJECTION SITE PAIN (Soreness and pain on site of injection) and INJECTION SITE RASH (Red rash that expended from shoulder to elbow and lasted for one week) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PAIN (Pain) and INJECTION SITE PAIN (Soreness and pain on site of injection). On 17-Mar-2021, the patient experienced INJECTION SITE RASH (Red rash that expended from shoulder to elbow and lasted for one week). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 24-Mar-2021, PAIN (Pain), INJECTION SITE PAIN (Soreness and pain on site of injection) and INJECTION SITE RASH (Red rash that expended from shoulder to elbow and lasted for one week) had resolved.            Concomitant products details not provided.
103 degrees temp - back and neck aches. Vomited. Fever broke 5/15/03.
A bruising of the left upper lateral side of arm with some redness around it. size of a egg some tingling felt when it was given.
Patient reported her vaccine was administered too low. Staff reviewed with provider who determined based on location vaccine was likely administered subcutaneously and not in the muscle. An order to repeat the dose was received by health staff and relayed to clinic staff. Individual received a repeat dose on 1/22/2021
CLIENT STARTED ITCHING ON HER FACE ABOUT AN HOUR AFTER FLUMIST, ONE HIVE NOTED ON HER RIGHT CHEEK. GIVEN DOSE APPROPRIATE TO HER WEIGHT OF BENADRYL TIMES ONE ONLY WITH COMPLETE RELIEF OF HER SYMPTOMS. MOTHER ADVISED TO DISCUSS WITH CLIENTS PEDIATRICIAN PRIOR TO MORE IMMUNIZATIONS.
Pt noticed tenderness and pain near collarbone before bedtime night of vaccine. The next morning noticed a bump of soft tissue in place where pt had discomfort. Dx as lymph node swelling and pt received ZPAK and Pred taper pack 5mg 6 day.
After my second COVID vaccine dose, I felt sharp pain in my lower right leg, from the knee down to the ankle and mainly along the shin and occasionally in the calf area. This happened at night of 04/10/202, same day of the administered shot, in which I took some pain killer to reduce the pain and to get some sleep. Pain continued on and off for several days without swollening/redness or any sign of inflammation.  Then I saw my primary care doctor who refferred me to an orthopedic specialisty clinic where more tests were ordered including X-Rays, Ultrasound for the whole leg to check for blood clots and MRI, all of which showed normal results, but pain continued and it is still continuing asI am ffilling out this form.  I also went to  do physical therapy and then used an aircast boot but none of that helped much.  The pain is not preventing me from doing my normal activities such as walking and exercising  but it's there but it's annoying and irritating.   Now I am being referred to a Neurologist for more evaluation as some burning exists. Based on the above, I am nor really sure if I should take the booster shot!  Please advise!
Patient received Moderna bivalent vaccine instead of Fluad - no adverse events reported - vaccine administration error
Accident; This is a spontaneous report from a contactable consumer (reported for herself). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Feb2021 (at the age of 58-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the consumer stated that she was in an accident and needed four stitches and was recommended to receive a tetanus shot. Consumer would like to know if it is okay to receive the tetanus shot after receiving the Pfizer COVID vaccine. The case assessed as serious (medically significant). The consumer stated the event result emergency room visit. Consumer states she is scheduled to receive the second dose of the vaccine on 03Mar2021. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Intramuscular route o vaccine is administered as subcutaneous; Left side clavicle lymph nodes swollen and sore; left arm sore and decrease ROM; Left side clavicle lymph nodes swollen and sore; left arm sore and decrease ROM; Left side clavicle lymph nodes swollen and sore; left arm sore and decrease ROM; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Left side clavicle lymph nodes swollen and sore; left arm sore and decrease ROM), PERIPHERAL SWELLING (Left side clavicle lymph nodes swollen and sore; left arm sore and decrease ROM), LYMPHADENOPATHY (Left side clavicle lymph nodes swollen and sore; left arm sore and decrease ROM) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Intramuscular route o vaccine is administered as subcutaneous) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 024C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to sulpha).   On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 17-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Left side clavicle lymph nodes swollen and sore; left arm sore and decrease ROM), PERIPHERAL SWELLING (Left side clavicle lymph nodes swollen and sore; left arm sore and decrease ROM) and LYMPHADENOPATHY (Left side clavicle lymph nodes swollen and sore; left arm sore and decrease ROM). On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Intramuscular route o vaccine is administered as subcutaneous). On 27-Jun-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (Left side clavicle lymph nodes swollen and sore; left arm sore and decrease ROM), PERIPHERAL SWELLING (Left side clavicle lymph nodes swollen and sore; left arm sore and decrease ROM) and LYMPHADENOPATHY (Left side clavicle lymph nodes swollen and sore; left arm sore and decrease ROM) had resolved. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Intramuscular route o vaccine is administered as subcutaneous) had resolved.            Concomitant medication were not provided. Treatment medication were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Followup received contains outcome of all the events updated as recovered, updated on both vaccine dose details and race information were updated.
Patient developed "warmth" in her neck and a cough 35 minutes after receiving her first dose of the Pfizer COVID-19 vaccine. Transported to ER via ALS.
MISSED A DOSE OF VIVOTIF; This spontaneous case (PVX2019-1149) was received from a pharmacist on 08-May-2019. It describes a 22-year-old female consumer who "missed a dose of Vivotif". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer skipped a dose of Vivotif, but she did not know which dose was missed and she started taking the doses.   Action taken with Vivotif was not applicable.  The clinical outcome of the event "missed a dose of Vivotif" was unknown.  Company's Comment: The causality of the event "missed a dose of Vivotif" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "missed a dose of Vivotif" was considered as not applicable.
arm hurt worse than ever; extremely exhausted; headache; controllable chills; fever of 101; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 02Feb2021 10:30, at single dose, for COVID-19 immunization, at a school or student health clinic. Medical history included COVID-19 (prior to vaccination) and arm hurt, both on an unknown date. The patient was not pregnant at the time of vaccination and has no allergy to medications, food, or other products. Concomitant medication included ibuprofen and vitamins. It was reported that on 02Feb2021 at 14:30, about 4 hours after getting the vaccine, the patient's arm hurt worse than ever and she was extremely exhausted. On 02Feb2021, in the middle of the night, the patient experienced headache, controllable chills and had a fever of 101. No treatment was given for the events. The patient was not tested for COVID-19 since the vaccination. The outcome of the events was not resolved. The reporter assessed the events as non-serious.  Information on the lot/batch number has been requested.
Menactra vaccine was given on 6/16 and it expired on 6/9 (7 days expired) with no reported adverse event; Initial information received on 27-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender patient for whom Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] vaccine was given on 6/16 and it expired on 6/9 (7 days expired) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Jun-2022, the patient received a 7 day expired dose of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine solution for injection (dose, strength unknown) (lot: U6952AA, Expiry: 09-Jun-2023)  via unknown route in unknown administration site for prophylactic vaccination (Immunisation) with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
hives on their arm, that lasted 2 days.; it was itchy and annoying; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on their arm, that lasted 2 days.) and PRURITUS (it was itchy and annoying) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa drug) and Penicillin allergy. Concomitant products included ACYCLOVIR [ACICLOVIR] for Herpes infection, LEVOTHYROXINE for Thyroid disorder.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced URTICARIA (hives on their arm, that lasted 2 days.) and PRURITUS (it was itchy and annoying). The patient was treated with HYDROCORTISONE for Hives, at an unspecified dose and frequency. On 12-Feb-2021, URTICARIA (hives on their arm, that lasted 2 days.) had resolved. At the time of the report, PRURITUS (it was itchy and annoying) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Eosinophil count increased (0-6): 10,6 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
patient states localized shoulder pain that started the day of the vaccine, he is fine while at rest but still when he moves the arm he can feel localized pain in the area of the vaccine
muscle aches; fatigue; did not feel well; This case was reported by a consumer and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain, fatigue and feeling unwell. On an unknown date, the outcome of the muscle pain, fatigue and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the muscle pain, fatigue and feeling unwell to be related to Shingrix.  Additional details were provided as follows:    The reporter was patient's brother.   It was reported that the patient did not feel well after the vaccine, for either 3 or 5 days.  The patient experienced fatigue and muscle aches, but there might have been other symptoms as well.  The patient was not sure if she would receive the 2nd dose.  The reporter spoke with patient about this about 2-3 weeks before the date of reporting.  The reporter did not have additional information, but would ask his sister to call to provide more information.
Different virus; slight temperature; what to do if she cannot get the second dose within 6 weeks; This is a spontaneous report from a contactable consumer (Patient) reporting herself. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 05Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reportedly, caller stated she cancelled her second dose appointment today, since she has "a different virus, slight temperature, and is on antibiotic". She enquired how long should wait between the infection and getting the second dose of the COVID-19 vaccine. She also asked for what to do if she cannot get the second dose within 6 weeks. Caller asked: is there a recommended interval to wait between the end of an antibiotic therapy and the Pfizer-BioNTech COVID-19 vaccine vaccination. Therapeutic measures were taken as a result of different virus, slight temperature, was on antibiotics. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
8 days post-first dose of Modern COVID-19 Vaccine EUA, my arm started itching at the injection site. Today, day 9, the itching is stronger and the injection site is warm to the touch. I called  the clinic and was advised to alternate heat and ice and to take Tylenol. Hopefully I can begin doing that soon.
Throat started to swell. Did not affect my breathing, but made it difficult to swallow. The employee health nurse gave me a Benadryl and  monitored me for an additional 30 minutes or so. By the time I left, my throat was starting to feel a bit better. Never got any worse.
Bump on my left arm; Soreness and pain in the injection site; A spontaneous report  was received from a consumer concerning a female patient, who received Moderna's covid-19 vaccine(mRNA-1273) and experienced bump on the left arm, pain and soreness at injection site.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, the patient received their dose of mRNA-1273 (Batch Number: Unknown) in left arm for prophylaxis of COVID-19 infection.  On an unspecified date, a week after vaccination in Dec 2020, the patient developed a bump on the left arm, soreness and pain in the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events a bump on the left arm, soreness and pain in the injection site was not reported.  The outcome of the event a bump on the left arm, soreness and pain in the injection site was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a registered nurse concerning a male patient (age not reported) with delayed motor function and a history of gastrooesophageal reflux disease and premature birth at 32 weeks, who on 02-SEPT-2005 was vaccinated subcutaneously on his thigh with the first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck) (Lot#646548/0393R). The nurse reported that after the patient received the first dose of the vaccine on approximately 02-SEP-2005, he developed swelling at the injection site, which was on his thigh (unspecified if left thigh or right thigh). On 22-FEB-2007, the patient was vaccinated subcutaneously in his left arm with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot#654610/1049F). There was no concomitant medications. On approximately 22-FEB-2007, the patient experienced swelling and warmth at the injection site. He developed cellulitis to the same arm that was approximately 6 cm x 7 cm. On 27-FEB-2007, the patient's arm was still swollen. The patient sought unspecified medical attention. The patient has been treated with sulfamethoxazole (+) trimethoprim (BACTRIM) and he is recovering. No laboratory diagnostic tests were performed. There was no product quality complaint. Additional information has been requested.2/11/10 Additional information was received from the registered nurse stating that "the patient never came into the office for evaluation description of the adverse event was given to her over the phone by the patient's parent."
Pt experienced difficulty swallowing, swollen neck, Trip to ER recommended pt start benadryl to treat symptoms. ER staff felt it was related to Shingrix
The patient complained of diffuse itching on the skin of her upper body and arms and itching on the back of her throat approximately 8 minutes after the vaccine administration. The patient had brought her own cetirizine 10mg from home and took it, I provided a glass of water to the patient.  The patient stated she was feeling better 11 minutes later and went home.  The patient called from home to report she was feeling even better with no more issues 1 hour later, approximately 12:30p.
This spontaneous report as received from a health worker refers to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patients were vaccinated with a dose of RECOMBIVAX HB (lot # and expiration date were not reported) (route and dose were not reported) which was improperly stored. No concomitant medication was reported. No adverse effect was reported at the time of this report. Additional information has been requested. This is one of several reports from the same source.
This spontaneous report as received from a pharmacist referring to a 62 year old female patient. The patient had no pertinent medical history. He took tetracycline before and experienced unknown reaction. Concomitant therapies included acyclovir. On 23-AUG-2017 the patient received ZOSTAVAX, 0.65 ml, subcutaneous  (lot # M042851/ exp. date 18-JAN-2018) and reconstituted with sterile diluent (manufacturer unknown), (lot # M010689/ exp. date 11-MAR-2018) for prevention of shingles. On 23-AUG-2017 in the evening, the patient experienced itching at the injection site, and itching worsened during the night. No treatment was given for the event. No lab performed. Pharmacist was contacted by the patient on 24-AUG-2017. No further information was provided.  The outcome of injection site pruritus was unknown.
Mother noted a rash all over the baby's body. No fever. On 12/30/01, the rash appeared worse. On 12/31/01, the rash is clearing.