chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red came back and swelled and started itching; Red came back and swelled and started itching; Red came back and swelled and started itching; injection site swelled a little bit; got red and itched at the injection site; got red and itched at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site swelled a little bit), VACCINATION SITE PRURITUS (got red and itched at the injection site), VACCINATION SITE ERYTHEMA (got red and itched at the injection site), VACCINATION SITE PRURITUS (Red came back and swelled and started itching) and VACCINATION SITE ERYTHEMA (Red came back and swelled and started itching) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M209) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE SWELLING (injection site swelled a little bit), VACCINATION SITE PRURITUS (got red and itched at the injection site) and VACCINATION SITE ERYTHEMA (got red and itched at the injection site). On 12-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Red came back and swelled and started itching), VACCINATION SITE ERYTHEMA (Red came back and swelled and started itching) and VACCINATION SITE SWELLING (Red came back and swelled and started itching). The patient was treated with HYDROCORTISONE (topical) for Adverse event, at a dose of UNK dosage form and DIMETICONE, PARAFFIN (RASH RELIEF CLEAR) for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE SWELLING (injection site swelled a little bit), VACCINATION SITE PRURITUS (got red and itched at the injection site), VACCINATION SITE ERYTHEMA (got red and itched at the injection site) and VACCINATION SITE SWELLING (Red came back and swelled and started itching) had resolved and VACCINATION SITE PRURITUS (Red came back and swelled and started itching) and VACCINATION SITE ERYTHEMA (Red came back and swelled and started itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. The patient stated that  at the time of report it stayed red and did not have a rash, it was just red and itching.
Fever, chills, headache, body aches- Tylenol, Motrin, 12 hours
muscle pain; chills; nausea/vomiting; nausea/vomiting; headache; muscle joint; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea/vomiting), VOMITING (nausea/vomiting) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea/vomiting), VOMITING (nausea/vomiting), HEADACHE (headache) and ARTHRALGIA (muscle joint). At the time of the report, MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea/vomiting), VOMITING (nausea/vomiting), HEADACHE (headache) and ARTHRALGIA (muscle joint) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Patient stated that injection was painful. Stated pain grew worse over next couple days and had limited range of motion of shoulder. Took ibuprofen and used heating pad over weekend to self treat. At time patient informed us of issue (9-14-20) was only able to lift arm approximately 30%.
Came in ER  stated she had her covid booster yesterday to her Left deltoid and c/o shooting pains to bilateral arms associated with episode of vomiting X 1 last night;  shortness of breath and chest pain.
Warm to touch; tender, red and puffy. 5cm wide and 4.5cm down arm. No fever in patient.
Spoke to employee on telephone on 03/11/22 and she reported to me that approximately 2 hours after vaccine administration she began feeling weak, dizzy & general malaise. She reported that she was taken to ATU (Assessment & Triage Unit @ a facility), seen by MD, then transferred to outside facility for further testing & treatment.
Very ill for 5 days, entire illness lasted 8 days. Fatigue, muscle aches,  headache, and  sore throat. I took Tylenol and rested.
Pt vaccinated with Influenza/PNU-IMUNE approx 1 hr following administration of vaccine pt developed nausea, vomiting, fever lasting approx 12 hrs.
I feel absolutely horrible; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling miserable in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 15-MAY-2023, the patient received the 1st dose of Shingles vaccine. On 15-MAY-2023, an unknown time after receiving Shingles vaccine, the patient experienced feeling miserable (Verbatim: I feel absolutely horrible). The outcome of the feeling miserable was not reported.   It was unknown if the reporter considered the feeling miserable to be related to Shingles vaccine.     It was unknown if the company considered the feeling miserable to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-May-2023  The patient had first shingles vaccine on day of reporting and highly doubt he/she would get the second. The reporter felt absolutely horrible.  The reporter thought he/she would take his/her chances with shingles.
sore left injection site arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm.) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A, 030C21A and 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left injection site arm.). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm.) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2022-565868, MOD-2022-566266 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow-up received included no new information.
ABOUT A MINUTE AFTER ADMINISTRATION PATIENT COMPLAINED OF SUDDEN HEADACHE (MIGRAINE) ONSET. BP TAKEN AT 10:45AM = 139/89 WHICH WAS THE SAME RANGE/RESULT TAKEN AT THE DR OFFICE. WIFE NOTIFIED (EMPLOYEE AT RX). 10:55 BP=144/88; 11:05 BP=140/84. PATIENT RELEASED AROUND 11:30AM. STILL HAS THE HA BUT SAID IT'S TOLERABLE. ADVISED TO TAKE PAIN PILL.
stroke; R sided weakness; expressive aphagia; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 05Feb2021 (at age of 68 years old, no pregnant, Lot Number: EN5318) as single dose for covid-19 immunization. Medical history included type 1 diabetes, hypertension (HTN). The patient not had COVID prior vaccination also not had COVID tested post vaccination. No known allergies. Concomitant medication included insulin, lisinopril and Multi vitamin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 15Jan2021 at 03:00 P.M. (at age of 68 years old, Batch/Lot number unknown) as single dose for covid-19 immunization. The patient received 2nd Covid shot on 05Feb2021. Had a stroke on 14Feb2021 at 08:00 AM with R sided weakness and expressive aphagia. Stroke noted on MRI in L hemisphere, speech area. The patient had no idea if this was related to the Pfizer Covid vaccine. AE resulted in: Emergency room/department or urgent care, Hospitalization (1 day), Life threatening illness (immediate risk of death from the event). Treatment received for events included observation, Lovenox. The outcome of the events was recovered.; 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 Stroke, Weakness left or right side, and Expressive aphasia cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to  Committees and Investigators, as appropriate.
Pt received pneumonia shot at 1300hrs at her PCP office. Pt was otherwise healthy and well. By 1600 she began having pain, swelling and itching in left deltoid and 1-2 hours later began having chills, myalgias, headaches, and fever. Pt was seen at 2244 with 15cmx15cm. Red, hot, very painful left deltoid T=101.2 with same sx's as above.
Pt reported to mother to having a raised 6cm rash that was hot to touch at injection site. It remained unchanged on 11/10/2013. Pt was offered Benadryl by her mother, but she declined. Rash was noted to have improved by 11/11/2013. Sh called the office on 11/11/2013 to report this and was advised to monitor and call office if rash did not continue to improve.
headache; pain at the injection site; redness and swelling at injection site; redness and swelling at injection site; had pain from waist all the way down both legs; had pain from waist all the way down both legs; fever; chills; nausea; red rash all over body; This case was reported by a consumer via call center representative and described the occurrence of headache in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2022, the patient received the 1st dose of Shingrix. On 1st June 2022, less than an hour after receiving Shingrix, the patient experienced headache, injection site pain, injection site erythema, injection site swelling, pain localized and leg pain. In June 2022, the patient experienced fever, chills, nausea and red rash. The patient was treated with steroids nos (Steroids) and paracetamol (Tylenol). On an unknown date, the outcome of the headache and pain localized were not recovered/not resolved and the outcome of the injection site pain, injection site erythema, injection site swelling, leg pain, fever, chills and nausea were recovered/resolved and the outcome of the red rash was unknown.   It was unknown if the reporter considered the headache, injection site pain, injection site erythema, injection site swelling, pain localized, leg pain, fever, chills, nausea and red rash to be related to Shingrix.     Additional Information: GSK receipt date: 13-JUN-2022 Reporter's comment: The patient reports that she received dose 1 of Shingrix in left arm on 1st June 2022. She stated that within minutes she had a headache pain, redness and swelling at injection site. Hours later she had pain from waist all the way down both legs. In the middle of the night, less than a day after receiving Shigrix she woke up with fever, chills and nausea. She mentioned that less than 2 weeks after vaccination, she had a red rash all over body. She stated that she had to go to the emergency room where they did a Computerised tomogram scan and gave her steroids and Tylenol. The patient was still experiencing headaches without relief for the past 12 days. The patient would not get second dose of Shingrix within 2-6 months. The reporter did not consent to follow up.
cough; congestion; head cold; type A Flu; Initial information was received on 27-Nov-2020 regarding an unsolicited valid non-serious case from a non-health care professional (patient) via social media.  This case involves a patient with an unknown demography details who had diagnosed with type A Flu (influenza) with symptoms of cough, congestion (nasal congestion) and head cold (nasopharyngitis), while being received influenza vaccine.  Medical history, medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date of October-2020, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date of 2020, the patient woke up sick and had dinner with family and Covid test was performed. Covid test result was negative and they checked for flu and strep.   On 25-Nov-2020, (latency: unknown) after starting the suspect vaccine therapy,  the patient was diagnosed with type A Flu (influenza). The patient had symptoms of cough and congestion (nasal congestion), head cold (nasopharyngitis) with intensity very mild.   It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the events were unknown.  There will be no information available regarding batch number in this case.
Felt worse than the flu; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date, which was fine).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad were unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient got the shots, first one was fine but after the second shot, the patient experienced every side effect.  The patient further stated that that was not fun at all and felt worse than the flu. Follow-up would not be possible as no contact details available. The case was reported by case US2021AMR190831, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR190831:Same reporter
Severe arthralgia - paid in 1 wrist left, 1 elbow right and both knees.  Pain was localized in one location in each joint that could be pointed to.  Pain was slightly minimized with ibuprofen.  Wrist and Elbow pain resolved in 1 week, knee pain resolved in approx. 21 days.  Knee pain limited mobility (it was that bad).
Progressed to symptoms of angioedema.; Systemic " itching "- head, arms, upper anterior  thighs bilaterally, vaguely within about 20-30 minutes.; Facial swelling; red face; blotchy red patches arms, back, legs face; severe itchy (10) inside of ears (deep), eyes; severe itchy (10) inside of ears (deep), eyes; scratchy throat; Next morning, allergic reaction covered by medication; This is a spontaneous report from a contactable Nurse (patient). A 58-year-old female patient not pregnant received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 16Aug2021 19:00 (Lot Number: fc3181) as single dose (at age of 58-year-old) for covid-19 immunisation. Medical history included migraine headache (h/a), hypothyroid, latex allergy, penicillin (PCN) allergy. Concomitant medications included methylphenidate hydrochloride (CONCERTA); duloxetine hydrochloride (CYMBALTA); thyroid (ARMOUR THYROID). Facility type vaccine: Pharmacy or Drug Store. It was unknown if patient had COVID prior vaccination and was not tested for COVID post vaccination. On 16Aug2021 patient experienced progressed to symptoms of angioedema, systemic " itching "- head, arms, upper anterior  thighs bilaterally, vaguely within about 20-30 minutes, facial swelling, red face, blotchy red patches arms, back, legs face, severe itchy (10) inside of ears (deep), eyes, scratchy throat, next morning, allergic reaction covered by medication. Events resulted in Doctor or other healthcare professional office/clinic visit. Clinical course was reported as follows: Systemic "itching "- head, arms, upper anterior thighs bilaterally, vaguely within about 20-30 minutes. Progressed to symptoms of angioedema. Facial swelling, red face, blotchy red patches arms, back, legs face, although much more severe itchy (10) inside of ears (deep), eyes, and scratchy throat. Patient had no food or anything else but water after the vaccination. These symptoms evolved over two hours, increasing in intensity. Patient had Benadryl and prednisone in her medicine box and took 75 mg Benadryl, (liquid) 50 ng prednisone at 10:00 pm. Was up until 12:00 midnight; symptoms quelled 80% by 12:30 am. Next morning, allergic reaction covered by medication. General practitioner (GP), notified and was documented. Patient was treated for the events. Patient was recovering from all the events, at the time of the report.
Patient developed spots on torso and felt a bit warm per mom on 11/29/16.
Covid positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid positive) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced COVID-19 (Covid positive). At the time of the report, COVID-19 (Covid positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Got the shot got the flu twice, Now wasn't that sweet; Initial information received on 13-Feb-2022 regarding an unsolicited valid non-serious social media case received from a Patient.  This case involves an unknown age and unknown gender patient who Got the shot got the flu twice, Now wasn't that sweet while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine on unknown administration site.(strength, dosage,route of administration, batch number and expiry date: Unknown) for immunization.   On an unknown date the patient developed a non-serious event "Got the shot got the flu twice, Now wasn't that sweet" (Influenza) (unknown latency) following the administration of influenza vaccine.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event
Exhaustion, headache, fever, muscle aches, joint paint, chills, vomiting, diarrhea, dizziness
Immediate onset of headache. By the next day, experienced fever, arm ache and itching mostly on arms. Headache and fever were gone about 24 hours post shot. Rash has continued and is measle-like. Intense itching and welts/hives (mostly on arms, chest, LEFT side of face, and back).
Redness; Flu-like Symptoms; Low-grade Fever; Wrong Route of Administration; This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date 19th September 2021) for prophylaxis.   On 3rd June 2019, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 3rd June 2019, less than a day after receiving Shingrix, the patient experienced erythema, influenza-like symptoms, low grade fever and intramuscular formulation administered by other route. On 4th June 2019, the outcome of the influenza-like symptoms and low grade fever were resolved with sequelae. On an unknown date, the outcome of the erythema was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the erythema, influenza-like symptoms and low grade fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix subcutaneously rather than intramuscularly on the right arm, which led to intramuscular formulation administered by other route. Flu-like symptoms and low-grade fever were lasted for approximately 1 day. This case has been linked with US2019103301 and US2019102448, reported by the same reporter.
Patient received a pediatric dose when she should have received an adult dose. Parent contacted and made aware.
Late menstrual cycle.  Should have gotten it around 09/06/21 and it is 2 weeks later and still no menstrual cycle.; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 03Sep2021 at 14:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 06Sep2021, the patient experienced late menstrual cycle. The patient should have gotten it around 06Sep2021 and it was 2 weeks later and still no menstrual cycle. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event late menstrual cycle was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Patient's entire upper right arm  became bruised 1 week after receiving the vaccine. Patient did not have any pain or itchiness.