chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shoulder pain starting 1-2 days after administration and persisting now 6 days,  limited range of movement
Two to three hours after injected, I  bit my inner lip several time while eating.  My wife said left side of face seem swelling.  The next morning has symptoms of Bell's Palsy.  Left side of face seem paralysis.  As days progress, the symptoms was more obvious.  Text doctor on Sunday and Doctor office called on Monday and recommend i go to ER to confirm .
patient received 3rd Moderna vaccine dose in error; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (patient received 3rd Moderna vaccine dose in error) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 016C21A and 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced ACCIDENTAL OVERDOSE (patient received 3rd Moderna vaccine dose in error). At the time of the report, ACCIDENTAL OVERDOSE (patient received 3rd Moderna vaccine dose in error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Action taken in response to mRNA-1273 was considered to be not applicable.
Got the pfizer and then the moderna; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Got the pfizer and then the moderna) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Vaccination: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Got the pfizer and then the moderna). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Got the pfizer and then the moderna) had resolved.            No concomitant drug information was provided.  It was reported that the patient received vaccines from a health authority, but recently moved.
On 2/23/01, 48 hours, post vax, client was found passed out in bathtub by father. Paramedics called. Glucose given. Two days, after this incident, client could not move entire left side for about 5 minutes. Diabetic-AM blood sugar 118. States "paramedic blood sugar was 28, after above episode."
Sore tongue; difficulty chewing; This spontaneous case was reported by a consumer and describes the occurrence of GLOSSODYNIA (Sore tongue) and MASTICATION DISORDER (difficulty chewing) 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.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced GLOSSODYNIA (Sore tongue) and MASTICATION DISORDER (difficulty chewing). At the time of the report, GLOSSODYNIA (Sore tongue) and MASTICATION DISORDER (difficulty chewing) outcome was unknown.            No concomitant medications were provided  Treatment details included Tylenol.
Intermittent right arm twitching, intentional tremor lasting for 3 days, no unresponsiveness or other neurologic signs
BRADYCARDIA; HYPOTENSION; This spontaneous report received from a health care professional concerned a 56 year old female. This report was received from news/social media. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, and iodine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 for prophylactic vaccination. The vaccination site had outdoor temperatures around 78-80 degrees. No concomitant medications were reported.  On 08-APR-2021, at 12:46, the patient experienced lightheadedness, hypotension, bradycardia and nausea and the patient was evaluated by emergency medical services (EMS), the patient was sent to hospital for further observation. The patient was hospitalized for 1 day and discharged in good health. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bradycardia, and hypotension on APR-2021. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210415566.; Sender's Comments: 20210441834-covid-19 vaccine ad26.cov2.s-Bradycardia, Hypotension. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
. I had the flu vaccine on the same day as well .A few hours after the vaccine. muscle aches, fatigue and low grade fever about 2 days. Covid symptoms on 9Jan2022 - Sore throat, fever , cough, runny nose and body aches.  Went to urgent care on 12Jan2022
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfides" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Acute vertigo, otalgia and headache 20 days after Varicella booster Provisional diagnosis - Neuronitis.
Fever of 102.4, chills, soreness at injection site, throwing up, nausea, head ache, uncontrollable shaking, stuffy nose.
Swelling, soreness, hardness, redness and heat at injection site and 3 inches all around, increasing until very severe at 24 hours after injection, and diminishing slowly. At 5 days after injection the skin is still red and slightly sore to touch, but the underlying tissue is no longer hard, and the injection site no longer feels hot. In addition to the injection site reaction, I had a severe headache requiring alternating ibuprofen and acetaminophen for 3 days. Also, fatigue and muscle languor lasting 3 days. These side effects took me by surprise because I has no reactions all to initial dose, not even skin redness.
Patient experienced periorbital swelling, swelling lips and papular pruritic rash face (temporal region) approximately 20 hours after receiving yellow fever in left deltoid.  Patient treated with Benadryl and Pepcid by mouth.
Rash allover her body, upper lip swollen, hands swollen and red, having a lot of itching; Rash allover her body; Upper lip swollen; Hands swollen and red, having a lot of itching; Hands swollen and red, having a lot of itching; Hands are swollen red and hot; She has blisters or hives on her body and everything is red and inflamed and itchy; She has blisters or hives on her body and everything is red and inflamed and itchy; She has blisters or hives on her body and everything is red and inflamed and itchy; She has blisters or hives on her body and everything is red and inflamed and itchy; Both ears are red and swollen and a lot itching; right shoulder, have a lot of pain and can hardly move it; right shoulder, have a lot of pain and can hardly move it; hives, redness and rash in left arm from where I got the shot; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW3344, Expiry date: unknown) (age at the time of vaccination was 58 years), administered in deltoid Left on 11May2021 at 10:00 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. On 11May2021 at 13:00, after the second dose, the patient started experiencing rash all over her body, upper lip swollen, hands swollen and red, having a lot of itching. The patient received the dose on her left shoulder, but her right shoulder have a lot pain and can hardly move it, and a big red hive, and itching too. The patient had hives, redness and rash in left arm where the patient took the shot and my upper lips were swollen. The patient had different form of lips, because they were so swollen. The patient lips become red, in the back of both legs got itching and hives. The outcome of the events was unknown.  No follow-up attempts were needed; information about lot/batch number cannot be obtained.
I have had sore throat on and off (it was regular ongoing for 10 days). Mild fever with it. I didn't feel better taking allergy medicine. Stuffy and congested nose for 3 1/2 weeks. Unstable bowel movements some days very loose stool and some days diarrhea and that has been consistent for 3 1/2 weeks. I just slept a lot and tried to drink more fluids. Tylenol for the fever and body aches. I took a lot of Nyquil so I could sleep. Ever since I got the shot, I have had yucky symptoms, but they have been coming and going. Fever is gone and sore throat is gone but I have the congestion in nose and loose stools still remain. I saw my doctor for a regular checkup about three weeks and he didn't have anything to help.
Chills; Fever; Nauseous; Bad headache in the temples on the top of my head; Cannot even function; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6208), via an unspecified route of administration on 15Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date as dose 2, single for covid-19 immunisation. The patient started to get chills and fever on 15Mar2021 at 22:00 and on 15Mar2021 during the night patient started to feel nauseous and patient had a real bad headache in the temples on the top of my head. Not really, I had got a bad headache and I really want something that I can really take to get rid of this because I cannot even function. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information was expected.
Redness and swelling and severe achiness. Could not lift his arm the next day, fever. Developed cellulitis from injection point down his biceps to his elbow about 4 inches wide. Also received flu shot on the same day in the same arm.
Both shots were given too high on each shoulder.  The flu shot/left arm injection missed the deltoid muscle and went far too high, into the joint. Severe pain moving the arm within hours, leaving patient in tears and unable to perform regular household tasks.  Over time, symptoms improve somewhat then return. One month later, patient still has difficulty bathing and dressing. Anything requiring the shoulder to rotate forward and apply pressure to lift or pull causes severe pain. The arm cannot be lifted all the way overhead.
Patient was given booster dose of COVID-19 vaccine while in the hospital for an impatient mental health stay - behavioral health admission and treatment.
Shingles developed 2 weeks after second vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 16Apr2021 at 08:00 (at the age of 32-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 19Mar2021 at 08:00 (at the age of 32-years-old), as a single dose for COVID-19 immunisation. On 30Apr2021, 2 weeks after second vaccine, the patient developed shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event and which included treatment with unspecified antiviral medication. The clinical outcome of the event shingles developed 2 weeks after second vaccine was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Pulled muscle; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE STRAIN (Pulled muscle) in a male patient of an unknown age 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 MUSCLE STRAIN (Pulled muscle). At the time of the report, MUSCLE STRAIN (Pulled muscle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.  In the follow up patient was reported feeling fine   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up information received  contains non-significant information
Patient complained of hives showing up on the left side of his body, patient came down to clinic to be looked at and was given Benadryl. Patient did not show any symptoms of any other adverse reaction. Patient did say he had pizza that night.
Pfizer-BioNTech COVID-19 Vaccine EUA  Fever, headache, sore arm 24-48 hours after vaccine was administered.
EE presented to EH with c/o hives to face and racing heart rate at 1445
CHest pain, heart palpitations fatigue - duration 1 month headaches - duration persistent
pt recv vax 22JAN97 & had dry skin & rash p/shot;23JAN97 mom noticed blisters in inguinal area, on legs, back & chest;seen by MD given skin cream;blisters scabbed over x/those in crease of thighs & in diaper area;red, raised pustules;
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
symptoms noted after her 1st Pfizer COVID shot on 30 July 2020.  On 3 Aug 2021, she developed R sided abdominal/flank/back pain in addition to pain of her R arm that involved not just the site of the injection but her whole R upper arm and R axilla. She also noted nausea and chills but no fevers and no rashes. Follow up with heme/onc had noted mild increase in LFTs, Calcium. PET/CT subsequently ordered and notable for mild R axillary adenopathy.  Symptoms worsened and went to the ER at FBCH on 14 Aug 2021 with RUQ US showing mild hepatic steatosis. Has referral and appointment pending in October to the GI liver clinic.
RETURN OF COVID SYMPTOMS AND RETURN OF POSITIVE RAPID COVID HOME TEST AFTER IT TURNED NEGATIVE ON PAXLOVID; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (RETURN OF COVID SYMPTOMS AND RETURN OF POSITIVE RAPID COVID HOME TEST AFTER IT TURNED NEGATIVE ON PAXLOVID) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Name of drug was not reported).    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (RETURN OF COVID SYMPTOMS AND RETURN OF POSITIVE RAPID COVID HOME TEST AFTER IT TURNED NEGATIVE ON PAXLOVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 13-May-2022 to 17-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (RETURN OF COVID SYMPTOMS AND RETURN OF POSITIVE RAPID COVID HOME TEST AFTER IT TURNED NEGATIVE ON PAXLOVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Rapid covid home test. In 2022, SARS-CoV-2 test: negative (Negative) Turned negative On Paxlovid.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Company comment: This spontaneous case concerns a 67-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (RETURN OF COVID SYMPTOMS AND RETURN OF POSITIVE RAPID COVID HOME TEST AFTER IT TURNED NEGATIVE ON PAXLOVID) which occurred approximately 6 months after the third dose of mRNA-1273 vaccine The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 17-May-2022   for COVID-19 treatment SARS-CoV-2 test was positive as on May 2022 however negative turned negative after  Paxlovid.  Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 67-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (RETURN OF COVID SYMPTOMS AND RETURN OF POSITIVE RAPID COVID HOME TEST AFTER IT TURNED NEGATIVE ON PAXLOVID) which occurred approximately 6 months after the third dose of mRNA-1273 vaccine The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 17-May-2022   for COVID-19 treatment SARS-CoV-2 test was positive as on May 2022 however negative turned negative after  Paxlovid.  Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Client reports swelling in left armpit, assuming lymph node swelling, on Friday evening (over 48 hours after COVID-19 Vaccine #2 was administered in left deltoid). At time of reporting (2/9/21 at 1100) client reports progression of swelling from left armpit to left side of stomach. Client reports "it looks like [he's] gained about 15 pounds on the left side of my body" from armpit to stomach. Client reports he is having no pain or discomfort, but feels "a noticeable pressure from fluid buildup on left side of body." Client went to see internal medicine physician 2/9/21. Physician was not concerned at current state but instructed client to monitor and call physician if pain occurs or if swelling noticeably worsens. When asked if swelling was worsening each day, client states it is hard to tell due to the shifting of fluid and "maybe settling due to gravity."
injection site was sore; red area below the injection site; raised area below the injection site; diarrhea; coughing; headache; nausea; vomiting; fever of 101°F; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), COUGH (coughing), HEADACHE (headache), NAUSEA (nausea) and VOMITING (vomiting) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced DIARRHOEA (diarrhea), COUGH (coughing), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever of 101°F) and FATIGUE (fatigue). On 17-Feb-2021, the patient experienced INJECTION SITE PAIN (injection site was sore), VACCINATION SITE ERYTHEMA (red area below the injection site) and VACCINATION SITE SWELLING (raised area below the injection site). The patient was treated with CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PHENYLPROPANOLAMINE BITARTRATE (ALKA-SELTZER PLUS COLD & FLU MEDICINE) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL LOTION N) for Injection site swelling, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (diarrhea), COUGH (coughing), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever of 101°F) and FATIGUE (fatigue) had resolved and INJECTION SITE PAIN (injection site was sore), VACCINATION SITE ERYTHEMA (red area below the injection site) and VACCINATION SITE SWELLING (raised area below the injection site) outcome was unknown.            No concomitant medications were reported. No laboratory details were  provided. Action taken with mRNA-1273 in response to the events was not applicable.
Fatigue, pruritus, redness around the injected area.  Advised the patient to take Claritin and contact PCP.