chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A spontaneous report was received from a consumer, concerning a 50 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273), and who experienced swelling at the site (vaccination site swelling), redness it got hard, spread almost until elbow, and hot to the touch. The medical history of patient was not provided. Products known to have been used by the patient, within two weeks prior to the event, included multivitamins. On 13 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 19 Jan 2021, the patient experienced swelling at the site and redness. In the three days following, it got hard, spread almost to the elbow, and hot to the touch. Treatment for the event included diphenhydramine and icing it. Action taken with mRNA-1273 in response to the events was not provided. The events, swelling at the site and redness, were considered recovering. The outcome of the events, it got hard, spread almost until elbow, and hot to the touch, were considered unknown.; Reporter's Comments: Based on the current available information, a strong temporal association with onset of the reported events and the use of the product and the known safety profile of mRNA-1273 VACCINE, a causal association cannot be excluded.
Child not hungry at lunch time, very tired. After nap is unusually cranky all afternoon. Very tired/sleeping late afternoon, wants to nurse but not eat solids. Has a rectal temperature of 102.9 F. around 6pm. (I administered child Tylenol). Goes to bed early and sleeps through the night as usual. In the morning he was lethargic and cranky and had a rectal temperature of 103.5 F mid morning. He ate a little and we gave him Tylenol again. He had a nap as usual and the fever was gone in the afternoon. He was acting back to normal after two days.
Patient began experiencing headaches the day after the vaccine. The headaches have continued on and off for the past 4 days and increased in severity. Second dose of the vaccine was administered Monday. Headaches began Tuesday, and have continued as of this reporting (Friday)
gastrointestinal; stomach aches for 3-4 days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "gastrointestinal"; ABDOMINAL PAIN UPPER (non-serious), outcome "recovered", described as "stomach aches for 3-4 days".  Additional information: The patient stated he took the first dose of the Pfizer covid vaccine and experienced minor symptoms, gastrointestinal, stomach aches for 3-4 days. Patient was concerned about getting the second dose and stated that he might not get it due to flu like symptoms after it. patient wanted to know how long the protection may last. The patient wanted to know the efficacy after the first dose and also who should not get the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse via a company representative referring to a 11-12 year old female patient. On 15-JUL-2017, the patient was vaccinated with GARDASIL 9 for prophylaxis. On 15-JUL-2017, the patient experienced dizziness. After she felt fainted, she returned to the office, sat down and water was given her. The outcome of dizziness was reported as recovered/resolved.
Below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number cm7ck, expiry date 29th July 2023) for prophylaxis.   On 17th July 2021, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details provided were as follows: Physician reported that the patient was administered with Boostrix after a below freezing temperature excursion which led to incorrect storage of drug. No adverse event were reported. Reporter consented to follow-up. This case was 1 of 28 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter
Pain at site for 3 days.  Mild fever for two days highest 100.6F.  severe body aches, chills, headache, exhaustion.
Headache, Myalgia, Fever, Tired, Temperature 100.1 with pulse 110
Black floaters in left eye; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 12:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT), trazodone (MANUFACTURER UNKNOWN), levothyroxine sodium (LEVOXYL) and amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL), all for unknown indications from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine.  On 04Apr2021 at 00:30, the patient experienced black floaters in left eye. It got worse, than better, worse better and it was stable with some threads. The patient did not receive any treatment for the event black floaters in left eye. The clinical outcome of the event black floaters in left eye was not resolved at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a female (age not reported) who in May 2007 "7 weeks ago", was vaccinated with a first dose of Gardasil (lot number unknown) 0.5 mL injection and immediately broke out into a rash. Medical attention was sought. The physician prescribed CLARITIN and the rash cleared. On an unspecified date the patient reported to the physician that the rash reappears every time she stops the CLARITIN. The mother of the patient wishes to discontinue the series of Gardasil. No additional information was provided. Additional information has been requested.
Starting 9/12/2021 (1 day later), I had night sweats (fever and chills) and difficulty sleeping. There was also moderate to severe joint pain. This lasted exactly 4 days. After I recovered from that, I had persistent, moderate dull chest pain under my sternum, which lasted for around 4 weeks and I was somewhat concerned about it. The chest pain was most noticeable when standing/walking. As of this report on 12/19/2021, I don't have noticeable or lingering symptoms.
Body aches, congestion, cough, headache and fever starting 12/20/2021.
Patient called reporting sharp pain in head two hours after Johnson and Johnson COVID vaccine. Piercing pain in frontal area of head and  Stomach pain that feels like  "hands inside my stomach and twisting." Constant diarrhea, nausea, and polyuria. Insomnia due to pain. Patient also reports weakness, that prevents her from doing anything. Bone pain reported as severe with body tightness. SOB while speaking and performing daily routine confirmed, Patient denies distress and declines to call 911 or have 911 called on her behalf. Instructed to go to UC/ED for evaluation and COVID testing. Patient was receptive to education, verbalized ability to be able to get to UC/ED on her own.
Narrative:  Patient was hospitalized in timely manner with Pfizer mrna vaccine on 2-19-21 and 3-15-21 respectively at a site. Pt presented to ED 11-9-21 with polyuria, weakness and poor appetite. He tested positive for COVID at a provider 11-1. Patient had a positive biofire on 11-9. He remained hospitalized due to weakness--patient never required O2 support of any COVID treatments. He was later transferred to a medical center for rehabilitation due to deconditioning related to COVID weakness and later discharged home. Patient has history of DLBCL but has been in remission since 2018--not likely related to COVID
This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in their mouth), GASTROOESOPHAGEAL REFLUX DISEASE (esophageal reflux) and THROAT IRRITATION (burning in throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced DYSGEUSIA (metallic taste in their mouth), GASTROOESOPHAGEAL REFLUX DISEASE (esophageal reflux) and THROAT IRRITATION (burning in throat). The patient was treated with ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (metallic taste in their mouth), GASTROOESOPHAGEAL REFLUX DISEASE (esophageal reflux) and THROAT IRRITATION (burning in throat) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No Concomitant informations were reported. This case was linked to MOD-2021-404762 (Patient Link).
rash on arm; fever (101); Nausea; I experienced new loss of smell; dizziness; really bad fogginess; unable to woke up in the morning; loss of taste sensation; Headache; chills; severe joint pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (I experienced new loss of smell), DIZZINESS (dizziness), FEELING ABNORMAL (really bad fogginess), SLEEP DISORDER (unable to woke up in the morning) and AGEUSIA (loss of taste sensation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced ANOSMIA (I experienced new loss of smell), DIZZINESS (dizziness), FEELING ABNORMAL (really bad fogginess), SLEEP DISORDER (unable to woke up in the morning), AGEUSIA (loss of taste sensation), HEADACHE (Headache), CHILLS (chills), ARTHRALGIA (severe joint pain), FATIGUE (fatigue), PYREXIA (fever (101)) and NAUSEA (Nausea). On 18-Mar-2021, the patient experienced RASH (rash on arm). The patient was treated with PARACETAMOL (TYLENOL) for Paracetamol, at an unspecified dose and frequency. On 17-Mar-2021, ANOSMIA (I experienced new loss of smell), FEELING ABNORMAL (really bad fogginess), SLEEP DISORDER (unable to woke up in the morning), AGEUSIA (loss of taste sensation), HEADACHE (Headache), CHILLS (chills), ARTHRALGIA (severe joint pain), FATIGUE (fatigue) and PYREXIA (fever (101)) had resolved. At the time of the report, DIZZINESS (dizziness) and NAUSEA (Nausea) had not resolved and RASH (rash on arm) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Treatment included Tylenol
Pt returned to vaccination station 2 minutes after receiving vaccine complaining of light-headedness and nausea. We had pt sit down and asked him the last time he ate, to which he replyed "yesterday".  I immediately applied an ice pack to back of patient's neck and had him eat candy bars and drink 7up.  He sat for 5 minutes and reported feeling "a lot better". He returned to work and reported no other residual effects.
Information has been received from a licensed practical nurse concerning a 32 year old female who on 25-FEB-2010 was vaccinated with the third dose of GARDASIL. The vaccination dates of the first 0.5ml dose and the second dose were not reported. It was reported that the patient experienced diarrhea and vomiting after getting the first and the third dose. The patient did not experience any AE after the second dose. The patient received unspecified medical attention. The outcome was not recovered. Additional information has been requested.
Slight numbness sensation on 1/2 of face; Slight tingling sensation on 1/2 of face; Slight numbness/tingling sensation on 1/2 of body; Slight numbness/tingling sensation on 1/2 of body; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 at 16:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included an allergy to PCN (penicillin). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified prenatal vitamins, vitamin d nos (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN) and calcium (MANUFACTURER UNKNOWN); all taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received oseltamivir phosphate (TAMIFLU), paracetamol; oxycodone hydrochloride (PERCOCET), azithromycin (MANUFACTURER UNKNOWN) and clindamycin (MANUFACTURER UNKNOWN) and experienced drug allergies. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccination. On 08Apr2021 at 16:30, the patient experienced slight numbness/tingling sensation on half of face/body that started immediately after receiving the shot and continued for days. The events resulted in a doctor or other healthcare professional office/clinic visit. 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 events slight numbness/tingling sensation on half of face/body was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Per CDC guidelines, if a patient has an allergy or contraindication to any of the components of the mRNA COVID-19 vaccines,  the Johnson & Johnson COVID-19 vaccine may be given as a 'dose 2', so long as it is at least 28 days from the first dose of the mRNA vaccine.  Vaccine was given before consent form was fully reviewed.  Patient stated she is getting Johnson & Johnson as dose 2 because her first dose of Moderna was administered 2/2021 so her second dose of Moderna was "missed."  This reason is not CDC supported.
Light headed, dizzy, head ache, general malaise, fatigue, stomach ache.
On Day 8, post vaccine, the injection site became very red, hot and itchy.  It was the size of a baseball.  Systemically, I developed an intense headache, stomach ache and generally feeling of being unwell.....  chills, muscle aches, etc.  This lasted for about 12 hrs.
Felt itchy, became short of breath, and had sensory disturbances on left extremities
a few minutes after second covid vaccination pt broke out in whelps and started coughing saying her throat was feeling strange
Left arm where he got his injection is still sore and hurts "like I got a shot". No redness, warmth or knot.
Fever of 104 degrees, Heart rate of 165BPM, febrile seizures lasting minutes at a time intermittently.
Patient about to receive second vaccine 84day after first vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient about to receive second vaccine 84day after first vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient about to receive second vaccine 84day after first vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient about to receive second vaccine 84day after first vaccine) had resolved.        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.   The concomitant medications were not reported. The treatment information was not provided.  The patient consulted pharmacist for second dose of Moderna COVID-19 Vaccine .Pharmacist wanted to confirm if it was possible to give second dose as it was beyond the window period.
Moderate pain in arm where injection was administered beginning soon after administration. Headache beginning a few hours later, which has persisted despite over-the-counter Advil.
Scratchy throat with post nasal drainage lead to aches, fever and general body discomfort with congestions and cough lasting 7 days.
Soreness, slight swelling, and rash at and around injection. Extreme fatigue, muscle aches and cramping, sinus drainage, occasional headache, decreased ability to attend and concentrate. At this date, the symptoms in my left upper extremity have resolved. The other symptoms are still present mildly and occasionally.
Rash appeared on torso and upper and lower extremities. 2 separate doses of prednisone tx taken 11/2/21 40 mg for 5 days, 11/15/21 Medrol pack, 11/19/21 hydroxyzine 50 mg 3 times daily as needed for rash and itching. (Benedryl and zyrtec used over the counter since 11/2/21), all helped reduce the symptoms of the rash but when prednisone completed the rash returned worse than before.
Presented to the ED with sx of weakness to right hand, and numbness, right leg not affected. Day before reports he had dyspraxia.
Information has been received from a 47 year old female, registered nurse with a history of chronic asthma who on 03-NOV-2006 was vaccinated with Pneumovax 23. At the time that the patient received the Pneumovax 23 she was taking BACTRIM for a pre-existent sinusitis. The patient received on the same date influenza virus vaccine (unspecified) at a different site. The patient reported that within 24 hours, she had developed an injection site reaction that included: redness, swelling, local heat, and a fever of 102 degrees Fahrenheit. The patient's injection site redness, swelling, local heat had since improved except the patient's fever. The patient sought unspecified medical attention. Additional information is not expected.
arm began hurting mildly, nauseauted, muscle and joint pain,  severe leg  cramps
Two days after my second Moderna covid shot, my left arm became swollen and red. It does NOT itch, but is painful. The rash is in the area between my shoulder and my elbow. As of this writing, I still have about half of the rash left.
Vaccines given on 6/16/2005 as part of well exam. 6/22/2005 patient presented with rash to body. No fever present
Pt said he  felt shoulder pain after Dose 2 COVID19 Moderna vaccine administration,  so he went to hospital emergency room, where xrays were taken. Pt says that hospital staff told him that shoulder pain was due to improper vaccine administration technique through rotator cuff.
Hospital Course:  This is a 73 year man with hx of cerebral palsy and chronic bilateral lower extremity weakness presented with cough and generalized weakness for 1 day prior to admission. Patient also develop fever, and fell using  toilet prior to admission. He felt too weak to get up, and called EMS.     He was evaluated in the ER, found to have COVID 19 infection and sepsis.  He was given 1L of normal saline.  They discussed returning home vs observation stay for generalized weakness and COVID 19 infection and he preferred to stay overnight as he lives alone.   Of note, he had a stroke 12/7 and discharged on ASA and Plavix but was only taking the Plavix once every other day due to upset stomach.  He also has asymmetric leg swelling, right leg larger and slightly red/warm compared to the left.  Blood cultures were obtained.  Venous duplex was negative for DVT.    Patient was treated for Enterococcus UTI with Macrobid for 3 days. For RLE cellulitis, patient was transitioned from ceftriaxone to Keflex for 5 more days to complete 7 days of treatment. For COVID pneumonia, patient briefly required supplemental oxygen and was placed on dexamethasone. As patient's oxygen needs improved to room air, dexamethasone was not prescribed at discharge.    Patient was discharged to Home with services - Nursing in stable condition.
Patient came back to pharmacy to notify team of adverse reaction on 9/21/23.  States that her arm had pain all day from shingles vaccine received on 9/15/23.  Pain continued and persists until present date.  Unable to lift left arm and hand.  Has itching and swelling also.  Recommended patient to partner with her provider for further assistance to rule out possible infection/cellulitis and treatment of symptoms. Patient has used cold/ice compress plus Tylenol to lessen the pain and swelling.  Patient will try topical hydrocortisone for her itching.