chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Since vaccine premenstrual symptoms are more severe; I had never previously experienced sore breasts and now four months in a row I am dealing with pain; I had never previously experienced sore breasts and now four months in a row I am dealing with pain; abdominal crapping; flow and duration have both lessened noticeably; flow and duration have both lessened noticeably; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jun2021 (Lot number: ew0202) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: ALLEGRA; SINGULAIR; DIVALPROEX SODIUM. Vaccination history included: Bnt162b2 (Prev dose lot number: ew0168, Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 24May2021, when the patient was 30 years old, for Covid-19 immunization. The following information was reported: PREMENSTRUAL SYNDROME (non-serious) with onset 10Jul2021, outcome "unknown", described as "Since vaccine premenstrual symptoms are more severe"; BREAST PAIN (non-serious), PAIN (non-serious) all with onset 10Jul2021, outcome "unknown" and all described as "I had never previously experienced sore breasts and now four months in a row I am dealing with pain"; ABDOMINAL PAIN (non-serious) with onset 10Jul2021, outcome "unknown", described as "abdominal crapping"; MENSTRUAL DISORDER (non-serious), POLYMENORRHOEA (non-serious) all with onset 10Jul2021, outcome "unknown" and all described as "flow and duration have both lessened noticeably". Therapeutic measures were not taken as a result of premenstrual syndrome, breast pain, pain, abdominal pain, menstrual disorder, polymenorrhoea.  Additional Information: Facility type vaccine: Pharmacy or Drug Store. It was reported that patient abdominal crapping has become only manageable with medication. Prior to vaccination, patient was diagnosed with Covid-19. Since the vaccination, patient has not been tested for Covid-19. No known allergies. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine.  No Follow-up attempts are possible. No further information is expected.
hives started 30 minutes after vaccine administered,  then she started feeling  wheezy and tongue thickness.  Rapid response team notified.  Epinephrine given and patient transported to ER
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for CKD stage 3b, anxiety, Pulmonary HTN, chronic diastolic heart failure, obstructive sleep apnea, coronary arteriosclerosis, systemic arterial hypertension, Atrial fibrillation, morbid obesity, gout, dyslipidemia, t2dm. Received both doses of Moderna at a outside entity vaccination site. Was admitted in mid April at outside entity facility for abdominal pain. Was scheduled to see outside Primary care on 4/27/21. No notes regarding recent issues or illnesses. Patient deceased 5/10/2021.
DT administered on 4/30/01 in left upper extremity. On 5/2/01, had moderate left upper extremity erythema, induration and tenderness. Treated with elevation, ice, analgesics and cephalexin with good resolution of symptoms.
From walking unassited and pain free to now needing crutches gain; Puffy eyes; Scratchy throat; Constant runny nose; Sneezing; Sore arm; Very painful weight bearing on my new hip/weight bering pain on hip on new hip has gotten worse; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of WALKING DISABILITY (From walking unassited and pain free to now needing crutches gain), PERIORBITAL SWELLING (Puffy eyes), THROAT IRRITATION (Scratchy throat), RHINORRHOEA (Constant runny nose) and SNEEZING (Sneezing) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21a and 038b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthroplasty of hip (Total Arthroplasty of Left Hip) on 13-Apr-2021.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WALKING DISABILITY (From walking unassited and pain free to now needing crutches gain), PERIORBITAL SWELLING (Puffy eyes), THROAT IRRITATION (Scratchy throat), RHINORRHOEA (Constant runny nose), SNEEZING (Sneezing), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (Very painful weight bearing on my new hip/weight bering pain on hip on new hip has gotten worse), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, WALKING DISABILITY (From walking unassited and pain free to now needing crutches gain), PERIORBITAL SWELLING (Puffy eyes), THROAT IRRITATION (Scratchy throat), RHINORRHOEA (Constant runny nose), SNEEZING (Sneezing), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (Very painful weight bearing on my new hip/weight bering pain on hip on new hip has gotten worse), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported  No treatment medications were reported  Patient received first dose of Moderna vaccine experienced no side effects.  It was reported that the patient experienced adverse effects started approximately 16 hours after the second dose. Patient reported that the 'seasonal allergy symptoms' were constant for approximately 16 days and became intermittent.  It was reported that the patient has never suffered a single allergy symptom of any kind in the last 53 years. Patient states that the weight bearing pain on the new hip has gotten progressively worse. Patient also states that the two events are related.
started having gastrointestinal issues; stomach pain with indigestion; stomach pain with indigestion; aches and fever; Diarrhea; aches and fever; extreme nausea; severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (started having gastrointestinal issues), ABDOMINAL PAIN UPPER (stomach pain with indigestion), DYSPEPSIA (stomach pain with indigestion), DIARRHOEA (severe diarrhea) and PAIN (aches and fever) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 047B21A) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced DIARRHOEA (severe diarrhea). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (started having gastrointestinal issues), ABDOMINAL PAIN UPPER (stomach pain with indigestion), DYSPEPSIA (stomach pain with indigestion), PAIN (aches and fever), DIARRHOEA (Diarrhea), PYREXIA (aches and fever) and NAUSEA (extreme nausea). At the time of the report, ABDOMINAL DISCOMFORT (started having gastrointestinal issues), ABDOMINAL PAIN UPPER (stomach pain with indigestion), DYSPEPSIA (stomach pain with indigestion), PAIN (aches and fever), DIARRHOEA (Diarrhea), PYREXIA (aches and fever) and NAUSEA (extreme nausea) outcome was unknown and DIARRHOEA (severe diarrhea) had not resolved.            No concomitant medications were reported. Treatment medications include loperamide hydrochloride  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received on 21 April 2021 patient & event details, treatment information added.
Chest pain starting 1 day after vaccine. Chest pain, followed by passing out while driving and awakening with right sided numbness on day 9 post vaccine. Received TPA in emergency room with improvement of symptoms.  Diagnosed with possible TIA.  Heart rate now going up to 160s just upon standing up. Previously healthy 30 year old female
Pt c/o feeling dizzy within 5 min of being vaccinated with MCV4, pt c/o seeing blurry pt stayed on office 30 min
Patient reported flu like symptoms that started approximately 5 hours after receiving the vaccination and lasted approximately 24 hours. Symptoms included muscle aches and pain. No fever was reported.
Injection site reaction - swelling to 4cm wheal, with warmth, tenderness pain with moving left arm no fever.
nausea; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and ARTHRALGIA (joint pain) 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 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced NAUSEA (nausea) and ARTHRALGIA (joint pain). At the time of the report, NAUSEA (nausea) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Subacute thyroiditis; This is a spontaneous report from a non-contactable consumer or other non hcp. A 59-years-old female patient received second 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 2, SINGLE for COVID-19 immunisation. Historical vaccine included 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 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced subacute thyroiditis (SAT). A safety signal of subacute thyroiditis following vaccination with the novel mRNA- and vector-based COVID-19 vaccines was found during a screening of the WHO database of individual case safety reports. The outcome of the event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974883
Hypersensitivity; Axillary Lymph nodes; Slight itchiness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity), LYMPHADENOPATHY (Axillary Lymph nodes) and VACCINATION SITE PRURITUS (Slight itchiness on the injection site) in a 50-year-old female patient 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 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced LYMPHADENOPATHY (Axillary Lymph nodes) and VACCINATION SITE PRURITUS (Slight itchiness on the injection site). On 13-Jan-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity). At the time of the report, HYPERSENSITIVITY (Hypersensitivity), LYMPHADENOPATHY (Axillary Lymph nodes) and VACCINATION SITE PRURITUS (Slight itchiness on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 11-jan-2021,the patient noticed that she have Axillary Lymph nodes and slight Itchiness on the injection site and Hypersensitivity on day 8 (1/13/21). Treatment information included,400 mg of ibuprofen.
pt came in today claiming her arm that got the moderna vaccine is still sore/painful about 3 on pain scale and pt asked if that is normal. Told the patient people do not usually have pain for that long and to see her doctor as soon as she can. She said she has an appointment on 12/2/21 and she is not too worried.   pt has some pain on her arm that got the moderna vaccine and the pt is going to see the doctor on 12/2/21 and she was not concerned just asking for our advice on what to do.
pt recvd vax 225OCT94 & 25 to 26 hrs later exp disorientation which lasted about 5 hrs; pt did not notice any visual or other neuro defects; also been experiencing h/a w/photophobia; pt is afeb; pt attributes sx to meningeal irritation;
Joint pain and red itchy rash started and have continued for over a year. She had nausea directly after the shots for a few weeks.
Patient did not disclose he received a COVID-19 vaccine by another manufacturer, Janssen, before receiving the Pfizer COVID-19 vaccine.
Arm was swelling pretty bad; This spontaneous case was reported by an other health care professional and describes the occurrence of   in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        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 were reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
headache; kind of dizzy; felt really tired; couldn't concentrate super well; hard to breath for 1 minute; A tight chest for 1 minute; his eyes got puffy; his eyes got red; felt like if someone pushed his arm a couple of hours later; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like if someone pushed his arm a couple of hours later), DYSPNOEA (hard to breath for 1 minute), CHEST DISCOMFORT (A tight chest for 1 minute), PERIORBITAL SWELLING (his eyes got puffy) and OCULAR HYPERAEMIA (his eyes got red) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic kidney disease stage 3 (Chronic kidney disease stage 3). Concomitant products included LISINOPRIL, ATORVASTATIN and FISH OIL for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced FEELING ABNORMAL (felt like if someone pushed his arm a couple of hours later). On 11-Apr-2021, the patient experienced DYSPNOEA (hard to breath for 1 minute), CHEST DISCOMFORT (A tight chest for 1 minute), PERIORBITAL SWELLING (his eyes got puffy) and OCULAR HYPERAEMIA (his eyes got red). On 12-Apr-2021, the patient experienced DISTURBANCE IN ATTENTION (couldn't concentrate super well) and FATIGUE (felt really tired). On 13-Apr-2021, the patient experienced DIZZINESS (kind of dizzy). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, FEELING ABNORMAL (felt like if someone pushed his arm a couple of hours later), DYSPNOEA (hard to breath for 1 minute), CHEST DISCOMFORT (A tight chest for 1 minute), PERIORBITAL SWELLING (his eyes got puffy), OCULAR HYPERAEMIA (his eyes got red), DISTURBANCE IN ATTENTION (couldn't concentrate super well), DIZZINESS (kind of dizzy), FATIGUE (felt really tired) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Received booster dose instead of full dose for 3rd dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Received booster dose instead of full dose for 3rd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ACCIDENTAL UNDERDOSE (Received booster dose instead of full dose for 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Received booster dose instead of full dose for 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.  Patient is immunocompromised and accidentally received half of the full dose. However, he was supposed to receive the 3rd full dose as part of the primary dose and then get a booster as per the current information from CDC
This case was reported by a pharmacist via call center representative and described the occurrence of numbness in hand in a 66-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included diabetes, nerve pain, shingles, skin lesion (lesions on his left upper shoulder arm and his left hand) and scar. Concomitant products included Valacyclovir and gabapentin. On 22nd January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced numbness in hand and paresthesia hand. On an unknown date, the outcome of the numbness in hand and paresthesia hand were not recovered/not resolved. It was unknown if the reporter considered the numbness in hand and paresthesia hand to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported the adverse event along with consumer on line. The patient received the SHINGRIX vaccine in the upper left shoulder. The patient denied any previous history of shingles. He completed the valacyclovir of 1 gram three times daily for 7 days. Since the patient got the SHINGRIX vaccine, he experienced numbness and tingling of his left inner palm, thumb and top of left hand. The patient also visited the physician office on 19th January 2019 for lesions on his left upper shoulder arm and his left hand. At that time, he was diagnosed with shingles and given valacyclovir to take. The patient stated that the spots were present not quite a week before he went to the physician. The spots on his left arm were present when he was given the SHINGRIX vaccine also. The numbness and tingling began about a week after the SHINGRIX vaccination. The patient stated that all the symptoms were present and scar areas of the lesions were visible till the time of reporting.
8 hours after injection feeling headache and achy 12 hours after injection feeling fatigue, nausea, fever, and vomited  28 hours after injection feeling fatigue and headache
Received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication use was reported.
I had spotting - like a menstrual cycle. I have been in menopause for 5 years; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 09Mar2021 (Lot number was not reported) as dose 2, single at 52-years-old for covid-19 immunization at a hospital. Medical history included menopause from an unknown date for 5 years. The patient's concomitant medications include unspecified vitamins and thyroid medications. The patient previously receive the first dose of bnt162b2 on Feb2021 at 10:00 am Left arm at 52-years-old for covid-19 immunization. No known allergies. Not diagnosed with covid-19 prior and not tested post vaccination. Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Apr2021 13:00, the patient reported that "I had spotting - like a menstrual cycle. I have been in menopause for 5 years so this was shocking." The event resulted in: doctor or other healthcare professional office/clinic visit. The reporter considered the event as non-serious. The patient underwent lab tests and procedures which included ultrasound scan: result not provided on an unspecified date. The patient received an unspecified treatment. The outcome of the event was recovered on an unspecified date in 2021.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Severe onset of vertigo/dizziness, required me to lay down for 3 hours until episode passed. Vertigo has persisted off and on since injection.
Pt recvd 1 dose of Engerix-B & exp nausea, vomiting, dizziness, fever, h/a & diarrhea 2-6 hrs p/vax;
Red on upper (R) right arm (inner) Flu shot was (L) arm pain to touch (feels like she has been punched in arm).
had sl fever 100-101 from time recvd vax; relieved temporarily by APAP; 1 wk p/recvd vax fever 105 to ER;
No known adverse events were noted, however the patient received a second booster 2 days after they received their 1st booster
Fever, irritability, loss of appetite, redness, swelling (nickel size) right leg for four days.
PATIENT WITH SUBJECTIVE FEVER; DURING A MISSION TYPE IN WHICH HE HAD PREVIOUSLY PARTICIPATED, WELL ACCLIMATIZED AT BASELINE. SUBJECTIVE FEVER LASTED UNTIL EVENING TIME
Pt recvd Engerix-B; 3 days later on 25JUL92 had sharp pains in back; by 5 days later had blood in urine; seen by MD; 8 day later numbness in entire body, nightmares; elevated liver enzymes; feels poopy;