chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12:30pm roughly- injection site became itchy and had a few hives. That evening sound 7pm it became very itchy. I removed my sweatshirt and my arm was visibly swollen, red, and warm at the injection site.  I called our nurse advice line and they said I should be seen within 24 but the only thing open on the military base was the ER and I didn?t feel it was ER worthy.  I took some Allegra which helped some. Over the next 2 days, my arm itched but not as bad, swelling went down, but the redness spread to about the size of a tennis ball.
Information has been received from a physician concerning a female patient who was vaccinated IM with Gardasil (Lot # not reported). The patient experienced pain when Gardasil was administered. Additional information is not expected. This is one of several reports received from the same source.
3 inch diameter red area to left deltoid. Edema noted, warm to touch; denies pain or fever. Cold compress applied to site of injection.
Vaccine Leaked out of the Left Deltoid Muscle; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of UNDERDOSE (Vaccine Leaked out of the Left Deltoid Muscle) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced UNDERDOSE (Vaccine Leaked out of the Left Deltoid Muscle). On 11-May-2021, UNDERDOSE (Vaccine Leaked out of the Left Deltoid Muscle) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.  It was reported that a couple of drops leaked or may be half of the vaccine (0.25ml) leaked out of the deltoid muscle of left arm. Concomitant medications were not provided. Treatment information was not provided.
Arm where pneumonia vaccine was given was sore, some swelling and was red for about one week.  It continues to have intermittent pain, tingling, and itching in an area just below the muscle where shot was given.
Mom called and said child's left leg was a little swollen and red. Had no fever but a litter tender. Told mom to use ice packs and Tylenol and also to massage leg throughout the leg.
No additional adverse events; Caller is medical assistant reporting that 2 patients had received second dose of GARDASIL 9  one year after first dose; This spontaneous report was received from a medical assistant, referring to a 16-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not provided.  On 21-JUN-2021, the patient was vaccinated with the first dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, strength, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 22-JUN-2022 the patient was vaccinated with the second dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, strength, route of administration, anatomical location, lot# and expiration date were not provided), which was over 1 year after his initial first dose (inappropriate schedule of product administration). No additional adverse events were reported (no adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA006986:MSD
Information has been received from a health professional concerning a 16 month old male pt with no past medical history or allergies who on 02Jun03 was vaccinated SC into the left arm with a first dose of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). It was noted that the pt had diaper dermatitis at the time of vaccination. On 13Jun03 the mother brought the pt to the office and the pt was seen by the nurse practitioner because of a rash mainly on his trunk which started on 12Jun03. The pt was diagnosed with an MMR related rash. The pt was treated with diphenhydramine hydrochloride elixir (Benadryl). It was noted that the pt did not have a fever and the mother was told to call back in 72 hrs if no improvement. As of 16Jun03, it was reported that the mother had not called back and the pt recovered. It was noted that the pt did not have an adverse event following prior vaccination. Additional information is not expected.
This spontaneous report was received from a female patient of an unknown age, who was also an emergency medical technician reporting on her self. The patient's conditions, medical history and concomitant therapy were not reported. On an unknown date in September 2015, the patient was vaccinated with an unspecified dose of M-M-R II (dose, route of administration and lot# were not reported). On an unspecified date, after the administration of M-M-R II, the patient stated she developed "joint pain in the knuckles on both her right and left hands, as well as in her right wrist and right elbow". The outcome of the event was reported as not recovered. The relatedness between "joint pain in the knuckles on both her right and left hands, as well as in her right wrist and her right elbow" and M-M-R II was not provided. Additional information has been requested.
After Pfizer vaccination patient was being observed for 15 minutes for  adverse reaction. Patient passed out and fell face first to the floor. Patients nose  was bleeding. A rapid response was called. Patient was placed in a wheelchair and taken to  the ER.Patient  normal vitals on presentation. Not acutely toxic appearing.  Exam with mild ecchymoses along the left maxilla and along the left neck  concerning for possible head injury. EKG shows sinus bradycardia. Head CT shows  no evidence of acute intracranial hemorrhage. It does note a posterior left  orbital floor fracture with blood in the left maxillary sinus. He has no evidence  of visual acuity changes or visual complaints. No signs of entrapment. Feel he is  stable for discharge at this time. I spoke with on-call ophthalmology, doctor. He states that the patient walk-in tomorrow for follow-up.
Couldn't open her hands/ trouble maneuvering her wheelchair; Hands are very painful; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Couldn't open her hands/ trouble maneuvering her wheelchair) and PAIN IN EXTREMITY (Hands are very painful) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high, High cholesterol, Food allergy and Amputee.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (Couldn't open her hands/ trouble maneuvering her wheelchair) and PAIN IN EXTREMITY (Hands are very painful). At the time of the report, JOINT RANGE OF MOTION DECREASED (Couldn't open her hands/ trouble maneuvering her wheelchair) and PAIN IN EXTREMITY (Hands are very painful) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
hair loss on top of scalp & front of head;the hair started growing back p/2month
I had the second dose of the Pfizer/BioNTech vaccine on June 19, 2021. Everything seemed fine at first just the normal fever, sweats, headache & sore arm for about 48 hours. Then late in the evening on day 5 (6/24/21) the soreness started to come back & there was a tiny knot right at the injection site. By morning of day 6 (6/25/21) the area was swollen, red, hard, very hot to the touch, extremely sore & extremely itchy--anytime I scratched it burned as if it were sunburned. I also began noticing swollen lymph nodes in my armpit area. Everything I had read online about my reaction said although it was rare, it wouldn't harm me & would eventually go away, therefore I did not go to the doctor for treatment.
Pfizer Dose 1 3/9/21 (EN6205) Pfizer Dose 2 4/6/21 (EN6208) COVID Positive 1/21/22  1/21/22: Patient is a 79-year-old male with history of generalized anxiety, COPD, CVA, and HTN.  He also reports chronic alcohol abuse.  Reports he drinks 3 cans of beer daily.  Reports he woke up suddenly at 01:30 today with cough, shortness of breath, and chest congestion.  He denies fever, chills, nausea, vomiting, diarrhea, recent exposure to COVID.  He is fully vaccinated for COVID, but has not gotten his booster.   Patient's vitals have been stable in the ED.  He was placed on supplemental oxygen at 2L for comfort, but has no documented hypoxia.  Labs were fairly unremarkable, aside from a WBC count of 32.23.  CXR showed no acute processes, however, CTA chest showed a persistent right middle lobe infiltrate/consolidation with milder bilateral lower lobe infiltrate or atelectasis.  They recommended follow-up CT in 6-8 weeks and pulmonology follow-up at discharge to ensure resolution of right middle lobe consolidation and to exclude an underlying malignancy or endobronchial obstructing process.  CT of abdomen showed no acute processes.  In the ED, the patient received 125 mg Solu-Medrol, 750 mg Levaquin, and a DuoNeb.  1/24/22: Patient is a 79-year-old male with history of COPD, HTN, CVA, and anxiety disorder who was admitted on 1/21/2022 with acute COPD exacerbation, bilateral COVID pneumonia, likely superimposed bacterial pneumonia, and sepsis.  He was admitted to the medical floor and was started on IV antibiotics, IV steroids, and remdesivir.  On admission, his CT chest showed persistent right middle lobe infiltrate/consolidation, and the radiologist recommended follow-up CT in 6-8 weeks as well as Pulmonary consult to ensure the resolution of the right middle lobe consolidation and to exclude an underlying malignancy or endobronchial obstructing process.  I discussed this with the patient, and he tells me he will follow-up with his PCP.  The patient has slowly improved over the last several days.  His WBCs are trending down, and today are at 13k.  He denies shortness of breath at rest, dyspnea on exertion, chest pain, palpitations.  He is requesting to go home today.  As he is not requiring supplemental oxygen, he will be discharged home on dexamethasone and Levaquin.  I explained to him the importance of finishing both of these medications, even if he feels like he does not need them. He verbalized understanding.
sick to stomack digestive , dizzy , confused, headache, took tylenol and went to bed, feel drained tired today aug 26
Fully vaccinated with moderna vaccine x 3. Tested positive for Covid on 01/24/2022.  Case expired on 01/27/2022.
side effects with the first shot; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a male 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 adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was recovered/resolved.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The reporter is the patient's wife reported on behalf of husband. The age at vaccination was not reported. The patient had some side effects with the first shot. However she provided no additional information. For tolerance to 2nd dose refer linked case US2020AMR138047, reported by the same reporter.
nausea; body aches; headache; fatigue; tingling in both hands (and fingers); crushing depression; This is a spontaneous report from a contactable healthcare professional. A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration at the left arm on 19Jan2021 13:45 at single dose for COVID-19 immunisation. Medical history included osteoarthritis, restless legs syndrome, rubber sensitivity (latex allergies), and COVID-19. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included ropinirole. On 19Jan2021 14:15, the patient experienced nausea, body aches, headache, fatigue, tingling in both hands (and fingers) and crushing depression. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Facial paralysis, this occurred with the booster too; on 03Dec2021 on my right arm. To this day, I am having a hard time lifting it and it still hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, I did have facial paralysis when I received my first and second dose.), for Covid-19 Immunization, reaction(s): "facial paralysis"; Bnt162b2 (DOSE 2, SINGLE, I did have facial paralysis when I received my first and second dose.), for Covid-19 Immunization, reaction(s): "facial paralysis". The following information was reported: FACIAL PARALYSIS (medically significant), outcome "unknown", described as "Facial paralysis, this occurred with the booster too"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "on 03Dec2021 on my right arm. To this day, I am having a hard time lifting it and it still hurts".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Difficulty breathing/wheezing 4 hrs after vaccine - did not see a health provider for it. Rash appears. 24 hrs later - urticarial with itching.
The shot was given on left arm. My arm became very red and extremely swollen. It hurt badly up to my finger tips. It lasted for 7 days.
Fever 101 degree F; Chills; Bodyaches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 101 degree F), CHILLS (Chills) and MYALGIA (Bodyaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PYREXIA (Fever 101 degree F), CHILLS (Chills) and MYALGIA (Bodyaches). At the time of the report, PYREXIA (Fever 101 degree F), CHILLS (Chills) and MYALGIA (Bodyaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 101 °F (Inconclusive) 101 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (a lump at injection site/injection site is a swollen lump about 3 inches in diameter), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) and VACCINATION SITE RASH (a 3" rash at injection site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis and Hashimoto's disease. On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) 1 dosage form. On 09-Jun-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). On 16-Jun-2021, the patient experienced VACCINATION SITE MASS (a lump at injection site/injection site is a swollen lump about 3 inches in diameter) and VACCINATION SITE RASH (a 3" rash at injection site). On 09-Jun-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. At the time of the report, VACCINATION SITE MASS (a lump at injection site/injection site is a swollen lump about 3 inches in diameter) and VACCINATION SITE RASH (a 3" rash at injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) was unknown. No concomitant medication details was reported. No treatment medication details was reported.
NOT FEELING WELL; DIARRHEA; DRY COUGH; VOMITING TWICE; FEVER; NAUSEA; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergy, no medical history, not taking any routine medications. the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 16:00 for prophylactic vaccination. Concomitant medications included dextromethorphan hydrobromide/ethanol/guaifenesin for dry cough, and paracetamol for headache. On 28-MAY-2021, the subject experienced fever. On 28-MAY-2021, the subject experienced nausea. On 28-MAY-2021, the subject experienced headache. On 28-MAY-2021, the subject experienced fatigue. On 29-MAY-2021, the subject experienced diarrhea. On 29-MAY-2021, the subject experienced dry cough. On 29-MAY-2021, the subject experienced vomiting twice. Laboratory data included: Body temperature (NR: not provided) 103 F. On an unspecified date, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting twice, had not recovered from fever, nausea, headache, diarrhea, and dry cough, and the outcome of fatigue and not feeling well was not reported. This report was non-serious.
Can't move her arm; nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move her arm), NAUSEA (nausea) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move her arm), NAUSEA (nausea) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move her arm), NAUSEA (nausea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
This case was reported by a physician via sales rep and described the occurrence of abscess in a patient who received PEDIARIX. On an unknown date, the patient received PEDIARIX at an unknown dose. On an unknown date, 14 days after receiving PEDIARIX, the patient experienced abscess. On an unknown date, the outcome of the abscess was unknown. It was unknown if the reporter considered the abscess to be related to PEDIARIX. Additional details were reported as follows: The health care professional reported that the patient experienced an abscess 2 to 3 weeks after receiving PEDIARIX. The patient did come back into the office for a follow up visit. At the time of reporting, no further information was available.
On 09/14/2022 I received my Covid-19 vaccine. On 02/15/2023 I started getting head, fever and congestion. After reaching out to the doctor I was prescribed Paxlovid. Symptoms lasted 7 days.
The following symptoms began 1 day after the second dose of the COVID Moderna vaccine: high fever of 104F, tinnitus, dizziness, nausea, headache, body aches, chest pain, shortness of breath and fatigue. The chest pain and shortness of breath increased over the course of 4 days. On day 6, post vaccine, I went to the ER due to the severity of my symptoms. My cardiac work-up came back normal, although no echocardiogram was completed. I was diagnosed with pleural inflammation and treated with IV anti-inflammatory medications. I was released from the ER the same day. My symptoms persisted for several more days. The chest pain and SOB resolved after 10 days, post vaccine, but the fatigue has continued and not yet resolved.
Bone-killing cold; Sore throat; Troubles sleeping; Itchy rash on the back; Difficulty breathing; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Bone-killing cold), OROPHARYNGEAL PAIN (Sore throat), INSOMNIA (Troubles sleeping), RASH PRURITIC (Itchy rash on the back) and DYSPNOEA (Difficulty breathing) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD (No reported medical history.).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced FEELING COLD (Bone-killing cold), OROPHARYNGEAL PAIN (Sore throat), INSOMNIA (Troubles sleeping), RASH PRURITIC (Itchy rash on the back), DYSPNOEA (Difficulty breathing), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with IBUPROFEN at a dose of UNK dosage form and PREDNISONE at an unspecified dose and frequency. At the time of the report, FEELING COLD (Bone-killing cold), OROPHARYNGEAL PAIN (Sore throat), INSOMNIA (Troubles sleeping), RASH PRURITIC (Itchy rash on the back), DYSPNOEA (Difficulty breathing), HEADACHE (Headache) and PYREXIA (Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Body temperature: 103 (Inconclusive) 103°F.     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.   Concomitant product use was not provided by the reporter.    Treatment for the event included Ibuprofen, inhaler, Prednisone and Z pack unspecified.