chrisvoncsefalvay/vaers-outcomes huggingface dataset:
totally stiff and totally sore; terrible body ache; hardly walk; freezing to the bones; chills; feeling exhausted; pain at right arm; with nightmares; flu like symptoms; sweats; shaking; coldness; This spontaneous case was reported by a health care professional and describes the occurrence of MUSCULOSKELETAL STIFFNESS (totally stiff and totally sore), PAIN (terrible body ache), GAIT DISTURBANCE (hardly walk), FREEZING PHENOMENON (freezing to the bones) and NIGHTMARE (with nightmares) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU VACCINE VII (similar symptoms.). Concurrent medical conditions included Spinal stenosis (undergone operation.), Arthritis, Blood pressure management and Cholesterol. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, AMLODIPINE BESILATE (NORVASC) and IRBESARTAN (AVAPRO) for Blood pressure management, PRAVASTATIN for Cholesterol, METAXALONE for Muscle relaxant, DIAZEPAM (VALIUM) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced NIGHTMARE (with nightmares) and VACCINATION SITE PAIN (pain at right arm). On 10-Apr-2021, the patient experienced FATIGUE (feeling exhausted). On 11-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (totally stiff and totally sore), PAIN (terrible body ache), GAIT DISTURBANCE (hardly walk), FREEZING PHENOMENON (freezing to the bones) and CHILLS (chills). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweats), TREMOR (shaking) and FEELING COLD (coldness). On 09-Apr-2021, VACCINATION SITE PAIN (pain at right arm) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (totally stiff and totally sore), PAIN (terrible body ache), GAIT DISTURBANCE (hardly walk), FREEZING PHENOMENON (freezing to the bones), NIGHTMARE (with nightmares), INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweats), TREMOR (shaking), FEELING COLD (coldness), CHILLS (chills) and FATIGUE (feeling exhausted) outcome was unknown.        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.   Treatment includedm1 Skalexin, tylenol and Vallium before bed and one Tylenol in morning.   This case was linked to MOD21-073300 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Events (Hyperhidrosis, tremor, feeling cold) were added and event pain in extremity updated to vaccination site pain. Patient received second dose on 07 May 2021.; Sender's Comments:  MOD21-073300:Link to Dose 2 MOD-2021-123837
Had Tdap 9-21-07, by 9-23-07 was experiencing headache, localized swelling, erythema, warm, tenderness (B) lower extremity tingling, weakness, came in 9-25-07 and reaction almost gone.
Vaccine reaction, initial encounter +7 more Dx Medication Problem Reason for Visit Progress Notes                    Chief Complaint Patient presents with ? Medication Problem   HPI: patient here for COVID vaccine and received at 0923 He states he started feeling lightheaded and hot within 5 minutes   Patient appears diaphoretic, flush and unsteady   Hx of two COVID infections one in March and second in May 2020, today is first dose of vaccine   BG 191, apical pulse 82, LS clear bilateral Patient able to answer all questions     After 20 minutes patient still reports feeling off, denies SOB, mouth or throat tingling, headache or CP   appointment scheduled two days for PCP Requested patient have his daughter pick up patient and he should avoid driving for today and tomorrow   Patient re-evaluated Patient still nauseated Chest tightness-new symptom Cannot stand, unsteady gait  Facial flushness Daughter here to give father a ride but decision to transport to ED by provider, discussed with patient and daughter-pt verbalized understanding   121/83   (T50.Z95A) Vaccine reaction, initial encounter  (primary encounter diagnosis) Comment: symptomatic treatment discussed Plan:    (R42) Light headed Comment:  Plan: RANDOM GLUCOSE IN HOUSE, RANDOM GLUCOSE IN        HOUSE, OXYGEN 2 LITERS VIA NASAL CANNULA          (R61) Diaphoresis Comment:  Plan:    (R26.81) Unsteady gait Comment:  Plan: daughter to drive patient home     PLAN: Discussed symptoms requiring immediate provider contact or when to call EMS-pt verbalizes understanding   Patient given water, patient able to grasp cup and and drink without difficulty   VS retaken 1032   Possible reaction to antibodies due to two COVID inections     rtc 2 days as discussed             Other Notes All notes  Progress Notes from RN (Family Practice) Additional Documentation  Vitals:   BP 132/89 Pulse 87 Temp 98 °F (36.7 °C) (Non Contact) Resp 12 SpO2 100% Pain Sc 0-None SmartForms:    TIME SPENT FOR ENCOUNTER -2021 PHYSICIAN FEE SCHEDULE  Encounter Info:   Billing Info, History, Allergies, Detailed Report  Communications   Letter sent to patient
Post vax, the pt developed redness and swelling the size of a baseball. I took Benadryl and it went away.
CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch no was not reported ,The company is unable to performed follow up to request batch /Lot numbers. No concomitant medications were reported.  On 11-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) negative, and SARS-CoV-2 rapid POC test (NR: not provided) negative. On 13-APR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Covid Arm rash began 2/28/2021 about 6 pm with slight itching, some tenderness & slight swelling. Using ice, Cortisone 10 cream & will take Benadryl tonight 3/1 at bedtime
This spontaneous report has been received from a licensed practical nurse referring to a 4 year old patient of an unknown gender. There was not information regarding the patient's pertinent medical history, drug reaction, allergies or concomitant therapies. On 11-JAN-2017,  the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, route of administration, and frequency were not provided), lot # M034584 and expiration date 27-JUL-2018, for prophylaxis. The vaccine doses were exposed to a temperature excursion of-7 Celsius (C) degrees for a time frame of 1 hour and 20 minutes, also she stated that there was not previous temperature excursion; this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005479: US-009507513-1701USA011004: US-009507513-1701USA011003:
Red spots started on face and have spread to rest of body.  Slightly elevated temperature.  Loss of appetite.  She still has all of these symptoms.  I have not been treating any of them.
pt recvd vax;following dose 1 exp hives which cont through the next 2 doses;unresolved;
This spontaneous report was received from a physician refers to multiple patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses (temperature excursion: 49.94 F, time frame: 15 minutes, unspecified date in October 2015) ROTATEQ with lot/batch # K016263, expiry date 26-JUN-2016 and lot/batch # L002042, expiry date 28-JUL-2016 (dose, dose number, vaccination site and route of administration not provided. There was no previous temperature excursion. Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from same reporter link. Additional information has been requested.
Cellulitis left thigh at vaccine site, fever 104.5. Seen in ER 5/14/05. 00:00 CBC with differential, blood culture 18:26; Cath/Urine culture. Seen in office 5/16/05. Rx BID to Cafril 250/5mg BID.
vaccination failure; This literature marketed report has been received from the authors of a published article, titled as stated below, and refers to a school-aged child patient of unknown gender, whose HIb isolates were ere analyzed using whole-genome sequencing (WGS) in order to evaluate a Cluster and the Overall Trend of Invasive Haemophilus influenzae Serotype b 20052019. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On unknown dates, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (dose, route of administration and lot # were not provided).The child was fully vaccinated based on guidelines.  On unknown date in September 2019, the patient experienced vaccination failure. They developed epiglottitis (Haemophilus influenzae serotype b (Hib) infection). The reporter considered the event vaccination failure to be related to Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports derived from the same literature article (cross-referenced # 2205USA001507). Sender's Comments:  US-009507513- 2205USA001507:
Woke up at 700 with tenderness and slight pain in left breast. By 1100 I felt like I had brain fog. By 300pm I noticed I had a slight fever (99.4). I took Tylenol and a 3 hour nap. I woke up with terrible joint pain, particularly in my knees, hips, ankles and wrists. All day I continued to have breast pain. I went to bed at midnight still I?m hurting. I woke up this morning still noticing the breast pain, but joint pain is gone.
Vaccine is administered COVID-19, Pfizer BioNTech past its useful life. Shelf life date 11/17/2021 7:00 am.
No symptoms or adverse effects reported; 3 patients received unspecified dose of ROTATEQ that was improperly stored.; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 20-MAY-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1660958, expiration date 23-MAR-2021 (strength, dose and route of administration not provided) for prophylaxis. Administered dose of vaccine was stored in a temperature of 46.9 degrees Fahrenheit (F) for 1 hour. Data logger was involved. There were no previous excursions reported. No symptoms or adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA003740: US-009507513-2005USA008179:
Narrative:  70 y/o male presented to ER  on 1/18/22 with cough and SOB. Presented with leukocytopenia and thrombocytopenia. Elevated inflammatory markers with CT noting pneumonia. Neutropenic fever and sepsis possibly secondary to bilateral COVID-19 pneumonia-oxygen saturation decreased to 89% on ambulation on admission, Treated with dexamethasone. Discharged 1/24/2022. PMH of HTN, myelodysplastic syndrome, CML, RA, AND CKD.
Redness at site of vaccine with warmth and tenderness of (L) thigh Treated with Keflex.
Information has been received from a physician concerning his 65 year old wife who was recently diagnosed with diverticulitis and was vaccinated with pneumococcal vaccine 23 polyvalent. On approximately 11/28/01, the physician's wife had developed pain at the injection site and a mild fever. Unspecified medical attention was sought. Additional information has been requested.
Pt recvd 1st dose of Engerix-B vax 20OCT91 & the following day 21OCT91 exp arthritic sx; swollen joints in both hands & arms w/an ache up to shoulders; Reporter later states date of therapy for 1st dose of vax approx NOV & w/in 1 wk event
The vial was initially stored 30-MAR-2023 and adminstred on 03-MAY-2023; No adverse event; They had a vial of Moderna that had been unpunctured, but it was used after the BUD date/It was administered within 5 days of the expiration of the beyond-use-date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They had a vial of Moderna that had been unpunctured, but it was used after the BUD date/It was administered within 5 days of the expiration of the beyond-use-date), PRODUCT STORAGE ERROR (The vial was initially stored 30-MAR-2023 and administered on 03-MAY-2023) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis. No Medical History information was reported. On 03-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-May-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (They had a vial of Moderna that had been unpunctured, but it was used after the BUD date/It was administered within 5 days of the expiration of the beyond-use-date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored 30-MAR-2023 and administered on 03-MAY-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They had a vial of Moderna that had been unpunctured, but it was used after the BUD date/It was administered within 5 days of the expiration of the beyond-use-date), PRODUCT STORAGE ERROR (The vial was initially stored 30-MAR-2023 and administered on 03-MAY-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (They had a vial of Moderna that had been unpunctured, but it was used after the BUD date/It was administered within 5 days of the expiration of the beyond-use-date) and PRODUCT STORAGE ERROR (The vial was initially stored 30-MAR-2023 and adminstred on 03-MAY-2023).    No concomitant medication was reported.  The vial was initially stored in the refrigerator on 30-MAR-2023. It was administered within 5 days of the expiration of the beyond-use-date, which was 29-Apr-2023. The vial did not undergo any temperature excursions. No treatment information was reported.
High Fever, Diarrhea, Dizziness, Fatigue. Took Tylenol and took until 12/18/2009 in the morning before all symptoms disapeared.
Systemic: Patient requested tdap and meningitis vaccine for college. His mom on speaker phone also states he needs tdap and meningitis. Vaccines given per patient and parent request. After administration, NP clicked on chart review to review immunization report-Mild, Additional Details: vaccine historical administration report pulled up and noticed that patietn received tdap in 2016 and meningitis vaccine in 2021. Provider notified patient of findings and made aware he already had both these vaccines and printed the vaccine history for patient. patient states he was not aware and could not find his vaccine records and his school had trouble locating his records. No adverse effect from vaccine administration, patient tolerated well.
Near syncopal episode after vaccine (about 5-10 seconds). Blood pressure normal. Responded to all questions and able to converse with MD. Pulse initially 60/minute up to 80/minute. T 97.9. Received epinephrine SC 0.3ml.
Patient received second dose of Pfizer at 10:16 AM and was waiting in the waiting area.  Reports no issues with the first does.  At 10:39, observer alerted writer that patient stated she wasn't feeling well.   Pt was brought back to close observation room.  Initial BP was elevated, other VSS.  She c/o chest pressure and that she can feel "every vein in my body".  Denies any shortness of breath.   Reports h/o CAD.  Carries nitro with her.   At 10:49 AM, reports that chest pressure is increased and now is feeling "tingling all over".  States that the pressure doesn't feel as though she need Nitro.   Advised that, due to symptoms, would recommend f/u in ED if symptoms continue.   At 10:55 AM, Patient requests to be taken to the ED.  Husband is accompanying her today.   Patient was taken via wheelchair by HCP.
Patient's full arm is red and swollen on the forearm. He has been taking Ibuprofen, He states that he has completely movement in his arm.
Seemed out of it for a little while, drooling out side of mother , then fell asleep, per mother
On left side of neck the lymph nodes were swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (On left side of neck the lymph nodes were swollen) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced LYMPHADENOPATHY (On left side of neck the lymph nodes were swollen). At the time of the report, LYMPHADENOPATHY (On left side of neck the lymph nodes were swollen) outcome was unknown.            No concomitant medications were reported. No treatment information was provided. Action taken with respect to mRNA-1273 was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Warm to touch; Bruises on her arms, 2 inches from her wrist all the way up to her elbows; Arms are painful when touched rating pain as 4 out of 10, 10 being the highest; Major headaches, rated pain as 7 and 1/2; Chills; redness; Feeling of being tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling of being tired), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Major headaches, rated pain as 7 and 1/2) and CONTUSION (Bruises on her arms, 2 inches from her wrist all the way up to her elbows) in a 32-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.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced FATIGUE (Feeling of being tired), PYREXIA (Fever) and ERYTHEMA (redness). On an unknown date, the patient experienced CHILLS (Chills), HEADACHE (Major headaches, rated pain as 7 and 1/2), CONTUSION (Bruises on her arms, 2 inches from her wrist all the way up to her elbows), FEELING HOT (Warm to touch) and PAIN IN EXTREMITY (Arms are painful when touched rating pain as 4 out of 10, 10 being the highest). The patient was treated with CORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, FATIGUE (Feeling of being tired), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Major headaches, rated pain as 7 and 1/2), CONTUSION (Bruises on her arms, 2 inches from her wrist all the way up to her elbows), FEELING HOT (Warm to touch), ERYTHEMA (redness) and PAIN IN EXTREMITY (Arms are painful when touched rating pain as 4 out of 10, 10 being the highest) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.    This case was linked to US-irms-MOD21-107778 (Patient Link).
stayed in bed the whole weekend; diarrhea; stated not feeling well; headaches; extreme fatigue; can not get enough sleep; she experiences chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 29Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "stayed in bed the whole weekend"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "stated not feeling well"; HEADACHE (non-serious), outcome "not recovered", described as "headaches"; FATIGUE (non-serious), outcome "not recovered", described as "extreme fatigue"; INSOMNIA (non-serious), outcome "unknown", described as "can not get enough sleep"; CHILLS (non-serious), outcome "unknown", described as "she experiences chills".  Additional information: Patient stated that she had the first dose of the pfizer covid 19 vaccine on 29Jan2021 and the second dose on 5Mar2021. Patient stated that she was still having the same problems since the first dose of the vaccine. Patient stated that she got the vaccine on a Friday and stayed in bed the whole weekend , had diarrhea and stated not feeling well. Patient stated she told them when she was sitting there that she was having headaches and extreme fatigue. Patient stated she told them it might be the lighting in there. Patient stated she was still suffering headaches and was so fatigued. Patient stated that she was at her breaking point and can not get enough sleep. Patient stated that she got twinges of headaches and sometimes they last and sometimes they go away. Patient stated that the twinges are constant all day and never stop. Patient stated she can not get rid of the headache or fatigue. Patient stated that she experienced chills here and there. Patient stated that it all together felt like she was coming down with something. Caller stated she does not know what to do.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.