chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt states that her ears started itching and became red.  She noticed her back, legs, and arms were red and very itchy.  She says her skins is raised like a rash.  Her voice became strange and she lips were swollen.   She went to bed and when she got up her lips were more swollen.  She took Benadryl for her symptoms and went back to bed.  She says she has some itching but feels like she seems to be improving.
Redness noted night of 8/26/08 became increasing red, swollen, painful indurated from upper left deltoid down to elbow. To ER 8/27/08 in PM put on Keflex; Benadryl; Ibuprofen in ER. Saw MD for follow up on 8/28/2008. No increase in symptoms; patient not uncomfortable
Information has been received from a physician concerning a 55 year old female who on 23-OCT-2007 was vaccinated with PNEUMOVAX 23 (lot# 658075/0926U).  There was no concomitant medication.  Subsequently on an unspecified date the patient experienced redness and swelling at the injection site of the upper arm.  It was unknown which arm was vaccinated.  The patient called the office on 25-OCT-2007 and had a follow-up visit the physician in the afternoon.  At the time of reporting the patient had not recovered.  Additional information has been requested.
Pediatric patient was given the Moderna Covid-19 vaccine and should have received Pfizer.   No adverse reaction noted after receiving the vaccine.   Per CDC guidelines patient is scheduled to receive her 2nd vaccine (Pfizer) on 3-15-2022.  Per CDC "If Moderna Covid-19 Vaccine administered: As the first doe, administer the age-appropriate Pfizer-BioNTech Covid-19 Vaccine as the second dose at least 28 days after the Moderna Vaccine dose.  Administer a Pfizer-BioNTech booster dose at least 5 months later."
The patient had severe joint pains especially on wrists and fingers on both hands but it was more severe on right hand; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (The patient had severe joint pains especially on wrists and fingers on both hands but it was more severe on right hand) in an elderly patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:arthritis, on methotrexate low dose.  Concurrent medical conditions included Arthritis. Concomitant products included METHOTREXATE for Arthritis.    On 13-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (The patient had severe joint pains especially on wrists and fingers on both hands but it was more severe on right hand). At the time of the report, ARTHRALGIA (The patient had severe joint pains especially on wrists and fingers on both hands but it was more severe on right hand) outcome was unknown.            Treatment medication was not reported.  The patient's arthritic problem was improving on 10-Oct-2023.  On 13-Oct-2023, the patient had spikevax vaccine and had severe joint pains especially on wrists and fingers on both hands, but more severe in right hand.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2023: Live significant Follow-up information added. Reference number added.
Sharp shooting pain up my arm, upper chest, the shoulder, above my brest; Trouble swallowing, slurred speech, red across the chest and hoarse/raspy voice; A report was received from a consumer concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced sharp shooting pain up my arm, upper chest, the shoulder, above my brest, trouble swallowing - could not swallow my saliva, slurry speech, red across my chest, and hoarse/raspy voice.   The patient's medical history included diphenhydramine hydrochloride allergy, shellfish allergy, and latex allergy. Concomitant medications included salbutamol sulfate.    The patient received their first dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection in their right arm on 26 Dec 2020.  Five minutes following administration of the vaccine, the patient felt sharp shooting pains up her arm, upper chest, the shoulder, above the breast. Five to 10 minutes after, the patient had trouble swallowing and began to have slurred speech. The patient was administered epinephrine in her right thigh. Following this, she began to experience redness across the chest and was administered another dose of epinephrine. She also experienced hoarse/raspy voice. The patient was then transported to the emergency room in an ambulance, where she received intravenous fluids and solumedrol after which she began feeling better. The patient was observed in the hospital for several hours and discharged on the same day.    Action taken with mRNA-1273 in response to the event was not reported.    The outcome of the event, sharp shooting pain up my arm, upper chest, the shoulder, above my brest, was unknown. The event, trouble swallowing - could not swallow my saliva, was considered resolved on 26 Dec 2020. The outcome of the event, slurry speech, was unknown. The outcome of the event, red across my chest, was unknown. The outcome of the event, hoarse/raspy voice, was unknown.  The reporter did not provide an assessment for the events, sharp shooting pain up my arm, upper chest, the shoulder, above my brest, trouble swallowing - could not swallow my saliva, slurry speech, red across my chest, or hoarse/raspy voice.; Reporter's Comments: This case concerns a female patient with a medical history of diphenhydramine hydrochloride allergy, shellfish allergy, and latex allergy who experienced the events of pains up her arm, upper chest, the shoulder, hypersensitivity reaction with symptoms of trouble swallowing, slurred speech, erythema of the chest  and hoarse/raspy voice, occurring between five and ten minutes following administration of the first dose of mRNA-1273 vaccine. The patient was treated with 2 shots of epinephrine, was transported to the hospital and received and IV solumedrol, after which symptoms improved. Based on the information provided and temporal association, the event is assessed as possibly related to mRNA-1273. The patient's medical history of multiple allergies could have contributed to the event. Further information has been requested.
Initially a bad headache which he never had before, then legs hurt, stomach hurt, eyes hurt, then a cough developed and then a high fever of 103.9
Pt vaccinated with DTP/OPV experienced unconsolable crying for 6hrs .
02/02- Shivering chills, 6 hrs.; muscle & joint pain, 4 days; excessive fatigue and cold, 2 1/2 weeks; fatigue continues;  02/10- injection sight red, feverish. appt. at urgent care 02/11. entire back of right arm infected, cellulitis. RX antibiotic.  End of 10 days, cellulitis appears gone.
On Dec 11th 8:30 am. client fainted when she was going down a set of stairs. Client did not feel anything before she fainted. On Dec 22 2009 passed out and started to vomit client was put on steroid (fl) and encouraged to drink more fluids.
patient fainted and after a sip of water she vomited. The paramedics arrived after 3 minutes and checked all vital signs and she was ok
Shortness of breath lasted for 3 weeks  Chest pressure lasted for 2 days   Seen in doctors office and emergency room   Not sure if related but the vaccine is the only thing that was new to me.
Per patient:  Received flu shot.  One week later was having difficulty hearing.  She went to see her Physician who did standard hearing test but gave not definitive diagnosis.  She went to an ENT Physician who also did tests.  Because of her concerns that hearing lost was due to her flu shot she wanted to report it.
testing positive for covid/ they have had a patient have a positive COVID test after vaccine was given; testing positive for covid/ they have had a patient have a positive COVID test after vaccine was given; This is a spontaneous report from a contactable pharmacist via medical information team and a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs).  A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730, expiration date 31Mar2021), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history included ongoing asthma.  The reporter was not aware of any allergies, adverse reactions to previous vaccines, significant medical history or any relevant family medical history of the patients. Concomitant medications were reported as none. It was reported that that they had a patient who had a positive COVID test after vaccine was given. The patient who received the vaccine on 18Dec2020 now testing positive for COVID. The patient received the first vaccine dose on 18Dec2020. She tested positive 30Dec2020. They wanted to give her monoclonal antibodies (Bamlanivimab) but they don't know how that would interact with the vaccine. Also, they didn't know how the product and the positive test would play into her already having the first dose and getting the second dose. The second shot would be due on 08Jan2020. The patient was not at the facility at the point of reporting, they had been talking to her by phone. The type of test done was unknown. No treatments known. The outcome of the event "positive COVID test after vaccine was given" was not recovered. The event was assessed as medically significant, and unrelated to vaccine by reporter. The seriousness assessment option was made due to her history of asthma.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 cannot be completely excluded for reported "positive COVID test after vaccine was given".
Had chest pain ("lung pain") the day after vaccination, then 2 days after the shot, he experienced some dizziness and nausea. Dizziness and nausea lasted for 3 days and 3 nights. Chest pain persisted and seems to be getting worse. Severity 3/10 - 7/10. + pain with movement, none at rest. No dyspnea, shortness of breath or fever.
Vial was stored in refrigerator on 27-May-2022 and administered on 30-Jun-2022; possible administration of vaccine stored beyond the 30 use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (possible administration of vaccine stored beyond the 30 use by date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 27-May-2022 and administered on 30-Jun-2022) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (possible administration of vaccine stored beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 27-May-2022 and administered on 30-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (possible administration of vaccine stored beyond the 30 use by date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 27-May-2022 and administered on 30-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  Route and body site was reported as deltoid. It was unknown if the patient had any COVID-19 test or diagnosis previously. Acute illness or the chronic conditions at the time of vaccination was also unknown.  Product was initially stored in refrigerator on 27-May-2022. Vaccine was stored in fridge longer than 30 days prior to administration. It was confirmed that the vial had not undergone any temperature excursion issue.  No treatment drug information was provided.   This case was linked to MOD-2022-613779, MOD-2022-613779 (Patient Link).
10mins p/vax exp itching @ inject site; to MD w/itching, swelling, warmth & redness @ inject site; later exp tightness in throat-taken to ER given DPH, EPI, Solu-Medrol; also could not catch breath, mouth blue; dx angioneurotic edema;
A report was received from a health care professional 12/11/03 concerning a male vaccine in his 20's who experienced a burning sensation at the edges of his eye and a bad taste in his mouth on the same day as having Fluvirin inadvertently sprayed into his face on 12/11/03. On 12/11/03 a nurse drawing up the dose of Fluvirin accidentally sprayed his face and both eyes with vaccine. The nurse experienced a mild burning sensation at the edges of the eye and a bad taste in the mouth. He immediately flushed his face with copious amounts of water. At the time of the report, there were no residual symptoms other than a slight bad taste in his mouth. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Patient reports she is not able to lift her arm up past shoulder level since receiving the vaccination. Patient reports no pain.
Feeling worse; This is a spontaneous report received from non-contactable reporter (Consumer). The reporter is the patient.  A 61-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, administration date 12Mar2021 (Batch/Lot number: unknown) at the age of 61 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "recovering", described as "Feeling worse".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At hour 12 post vaccination, chills, low grade temp of 99.0, mild headache, body aches, slight fatigue.  By hour 21 post vaccination, mild body aches and mild headache, slight fatigue.  Noticed a red, non raised rash that mildly itched on my abdomen and outer chest just before my armpits at hour 37 and 45min post vaccination.
Swelling, redness, pain, tenderness to (L) upper deltoid persisted for 1 wk after shot. Treated for cellulitis.
This spontaneous report as received from another health professional (healthcare worker) refers to a 12 year old female patient. The patient had no relevant medical history and no concomitant medication. On 21-JUN-2013 at 3 pm, the patient was vaccinated with GARDASIL(dose number not reported) lot # J003727,  0.5 ml, intramuscular. The patient was observed for 15 minutes afterward with no adverse effects. The healthcare worker reported that later that night, the patient had fainted at home, was limp, pale, sweaty and her eyes rolled back in her head. The patient was seen in the ER of unspecified hospital at 12:45 am and complained of sore throat and a headache. The patient was treated with sodium chloride 0.9% IV and ibuprofen. The patient reported to the healthcare worker that today (25-JUN-2013) she began menstruating and that it was heavier than normal and she was experiencing severe abdominal pain. The patient was planned to be seen in the office later today. The outcome of patient fainted at home, headache, sore throat, her eyes rolled back in her head, sweaty, pale and was limb was reported as recovering/resolving. The outcome of menstruation heavier than normal and experiencing severe abdominal pain was unknown. Reporter causality assessment was not provided. Additional information has been requested.
a very itchy rash (hives-like).  developed during the afternoon that I received the injection(Friday) on my face ,neck, arms, hands and legs.....this is sunday evening writing  this note.....the rash and discomport continues. I secured some hydrocortisone 1%cream this  morning which has provided some relief to the itchiness...;the hive-like welts still remain
Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a non-health professional (sales representative). This case involves a 11 years old male patient who received adacel as his primary dtap series, while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a primary dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route. It was a case of actual medication error due to Inappropriate age at vaccine administration. It was unknown if any adverse event occurred. 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 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.
symptoms: redness, itching, inflamed and blistered at deltoid injection site (probably caused by Pneumovax 23) Time: 6 days Treatment: tylenol OTC, hydrocortisone cream, symptoms has not been resolved after 6 days
chest is tight; couldn't breath properly/couldn't get enough air/I woke up and felt like I couldn't breath; chronic cough/the feeling that patient is not getting enough air to the lungs; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest is tight), DYSPNOEA (couldn't breath properly/couldn't get enough air/I woke up and felt like I couldn't breath) and COUGH (chronic cough/the feeling that patient is not getting enough air to the lungs) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concurrent medical conditions included Dust allergy (allergist ran some allergy test. Patient was allergic to a little bit of dust) since June 2021 and Allergy to plants (allergist ran some allergy test. Patient was allergic to some tree) since June 2021.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (chest is tight), DYSPNOEA (couldn't breath properly/couldn't get enough air/I woke up and felt like I couldn't breath) and COUGH (chronic cough/the feeling that patient is not getting enough air to the lungs). The patient was treated with BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Adverse event, at a dose of two pumps in the morning, two pumps at night. At the time of the report, CHEST DISCOMFORT (chest is tight), DYSPNOEA (couldn't breath properly/couldn't get enough air/I woke up and felt like I couldn't breath) and COUGH (chronic cough/the feeling that patient is not getting enough air to the lungs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received Asthma pump Symbicort (two pumps in the morning, two pumps at night) as a treatment but it did not work. Doctors wanted to give depressants but patient didn't want it. No concomitant medication were reported. cardiologist ran a bunch of tests. Patient also saw a pulmonologist. A couple of days later, patient got results, and doctors said there weren't any problems: heart is fine, lungs are fine. Second shot on 02Jul2021, given in left non-dominant arm. Lot number: 051C21A..
FATIGUE AND EXHAUSTION; COOL SENSATION AT INJECTION SITE; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced cool sensation at injection site. On 14-MAR-2021, the subject experienced fatigue and exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cool sensation at injection site on MAR-2021, and fatigue and exhaustion on 21-MAR-2021. This report was non-serious.
Shaking, chills, fever (101), headache, slight nausea, arm pain.   Took Tylenol.   Night sweat the following night.  Event lasted 24 hours. Fine the following day, 2/27/21.
I went to the doctor for a high-pitched ring in my ear. It feels like it is so loud that it comes three inches from my head and arcs over my head. It never goes away, I play music, different kinds of calming music to help drown out the sound, watch television. The sound is the exact same it does change in pitch, sound nothing. The outside sounds only help to distract me because the sounds are inside my head. I have an appointment with an ENT. I do know from research that there isn't anything that they can do about this, but I will still go to the appointment.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was administered after beyond use date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was administered after beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine was administered after beyond use date) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications information was reported. No treatment medications were provided.
Received vaccines 6/21/10 3PM. On morning of 6/22/10 started breaking out in rash that slowly spread all over her body. Denies SOB or swelling around mouth. Denies taking any other meds. Pt c/o itching and rash has blisters and scabs. Pt denies wheezing or fever. Referred MD/ER for evaluation. 6/28/10 Pt seen at Clinic-diagnosed with poison ivy.
vaccine expired July 13, 2022 and was used on July 15,2022 no adverse reaction reported as of July 26, 2022