chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 4:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 4:07 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 80.05.  No concomitant medications were reported.  Batch number 025L20A administered on 07-Jan-2021 with temperature 34 from 09:00 AM to 10:00 AM. This vial was moved to fridge on 05-Jan-2021 and beyond use date for the vial was reported as 27-Jan-2021. Product moved to clinic on 07-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
This spontaneous report as received from a nurse refers to a 20-year-old patient of unknown age. No concurrent conditions or medical history were provided. On 28-JUL-2016, the patient was vaccinated with a pediatric 0.5 ml dose of VAQTA subcutaneously (strength, lot# and expiry date were unspecified). No concomitant medications were reported. Additional information has been requested.
still a little tired; feeling really weak; it was hard for her to walk; She stayed asleep from 1:15 PM until the next morning; really dizzy, like she had no control over her body; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (feeling really weak), GAIT INABILITY (it was hard for her to walk), HYPERSOMNIA (She stayed asleep from 1:15 PM until the next morning), DIZZINESS (really dizzy, like she had no control over her body) and FATIGUE (still a little tired) in an 89-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030371) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza vaccine (flu shot) on 22-Sep-2023. Past adverse reactions to the above products included No adverse event with Influenza vaccine.    On 26-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 27-Sep-2023, the patient experienced ASTHENIA (feeling really weak), GAIT INABILITY (it was hard for her to walk), HYPERSOMNIA (She stayed asleep from 1:15 PM until the next morning) and DIZZINESS (really dizzy, like she had no control over her body). On 28-Sep-2023, the patient experienced FATIGUE (still a little tired). At the time of the report, ASTHENIA (feeling really weak), GAIT INABILITY (it was hard for her to walk), HYPERSOMNIA (She stayed asleep from 1:15 PM until the next morning) and DIZZINESS (really dizzy, like she had no control over her body) was resolving and FATIGUE (still a little tired) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient stated that, she had received many Moderna COVID-19 vaccines and boosters (details unspecified).  On 27-Sep-2023, around 1, patient started feeling really week, really dizzy, like she had no control over her body, and it was hard for her to walk. She made her way to her bedroom and fell asleep. She stayed asleep from 1:15 PM until the next morning. On the reportind day, she was feeling fine, but was still a little tired. She never had an issue with any previous doses.  No treatment information was provided.
Pain in the abdomen and upper left shoulder.  I was put in the hospital for observation on 4/30/22 and released on 5/1/22.  According to the surgeon my spleen was bruised and had an internal bleed.  Fluid was around my spleen.  It has not resolved and they are hoping for it to heal.  Follow up with my primary on 5/11/22 and the area is still sore when pushed on.  Pain in general has improved at least 90% .  No one has been able to figure out why this happened or when it will resolve.  A follow up CT with contrast will be done in early June.  Told to take it easy and stop taking low dose aspirin until checking CT.
Both top and bottom lip swelled immensely the next day after the vaccine. Once again a week later the top lip swelled very large.
Chest tightening; moist non productive cough; tightening of the throat; facial flushing; hot flashes; This is a spontaneous report from a contactable nurse. A 56-year-old female patient received second dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: EL3302) via intramuscular, on right arm on 02Feb2021, 10.30 at single dose for COVID-19 immunization. The medical history included allergies to bees and nickel, GERD (Gastro-oesophageal reflux disease). The concomitant medication included diphenhydramine hydrochloride, paracetamol (TYLENOL PM) on an unknown date in 2021. The patient previously received historical vaccine, first dose of bnt162b2 (Brand: Pfizer, Lot number: EL0140) via intramuscularly on left arm at 9.30 on 12Jan2021 for COVID-19 immunization. It was reported that at 10.45 on 02Feb2021, the patient experienced chest tightening, moist non-productive cough, tightening of the throat, facial flushing, hot flashes. The patient was not pregnant at the time of vaccination. The patient received most recent COVID-19 vaccine at nursing home/senior living facility. The patient didn't receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient received Tylenol Pm within 2 weeks of vaccination. The patient visited emergency room for the events. Therapeutic measures were taken because of events via oral and subcutaneous. The patient had not diagnosed with COVID-19 prior to the vaccination and since the vaccination. The outcome of the events was recovered on an unknown date in 2021.; Sender's Comments: The association between the events chest tightening, moist non-productive cough, tightening of the throat, facial flushing, hot flashes with BNT162B2 use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Patient reported sharp pain from elbow down to wrist since 36-48 hours post vaccine. Pain unchanged by Motrin/Tylenol use. I suggested a topical lidocaine-containing OTC product with continued Motrin/Tylenol use. If still unchanged, I suggested to visit PCP.
Information had been received from a physician concerning a 14 year old female who on 26-NOV-2007 was vaccinated SC with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck). On 27-NOV-2007, the patient experienced swelling of hands and feet as well as widespread hives. On 28-NOV-2007, the patient was examined in the office. There were no lab diagnostics studies performed. Unspecified medical attention was sought. The outcome was reported as recovering. No further information was available. There was no product quality complaint. Additional information has been requested.
Myopericarditis. Pt had chest pain was seen at the hospital. Had echocardiogram which showed normal EF,  Myopericarditis. Was sent home with Colchicine and Ibuprofen but had not picked it 5 days later when he came for follow-up. Pt was feeling well at follow-up. Was told to pick up meds and also was referred to Cardiologist.
Erythrodermic rash of the torso and extremities.  Not responsive to prednisone and hydroxyzine after a week of high dose burst.
seizure; POTS; Information has been received from a lawyer referring to a 15-year-old female patient regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (strength, dose, lot# and route unknown) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS) and seizure. Reported date of injury was unspecified date in 2006. The outcome of the events was not reported. The causality assessment was considered as related by the lawyer.  Upon internal review, seizure was determined to be medically significant.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Patient is a lovely 54 year old- year old male initially seen 4/5/2021, kindly referred by Dr. History of COVID pneumonia in 4/2020 which was complicated by ARF and shingles, Ramsay Hunt Syndrome, with subsequent post-herpetic pain on right side of scalp.He recently received his COVID-19 Pfizer vaccine 3/20/2021 11 days prior to presentation to the hospital with shortness of breath, worsening dypnea on exertion which started 2 days after vaccine. Before this he was biking twice a week, and swimming nearly daily. He did report any medical problems before COVID, was on no meds.    3/31/2021-CT PE protocol showed multiple bilateral PEs without right heart strain. Pulmonary Vasculature: Bilateral filling defects consistent with pulmonary emboli are visualized involving the following: Distal right main pulmonary artery extending to the right lower lobar, segmental, and subsegmental branches, right middle lobar, segmental, and subsegmental branches and proximal right upper lobe artery.  Left lower lobar, segmental, and subsegmental arteries.  The right heart is not dilated.COVID/flu swab neg, trop x2 neg, BNP wnl. - Started on therapeutic lovenox then plan to transition on discharge to PO xarelto 15 mg bid x21 days then continue with xarelto 20 mg daily.   He was seen by Dr. and referred to me for follow up. He had US 4/5/2021- which showed Right Lower Extremity: There is acute thrombus of the femoral proximal vein.Right Lower Extremity: There is no evidence of deep or superficial venous thrombosis in the  common femoral, popliteal, posterior tibial, peroneal, GSV and SSV veins. Left Lower Extremity: There is no evidence of deep or superficial venous thrombosis.'   4/5/2021: Initial hematology visit  Currently does not have any pain in legs, swelling. Reports that he still is not back to 100%, he got on peloton yesterday and was only able to go 5-6 miles at a slower pace. Denies fevers, chills, sweats. He has some intermittent pain where his previous zoster scalp lesions were. He has been undergoing facial PT. Thrombophilia workup sent which was grossly negative.
-Red and imflammed starting 1 day after continuing x 1 week, warm to touch; -Flu like symptoms 1 day after x 2 days (cold sweats, aching, fever, stomach cramps) -Extremely sore x 1 week -No MD visit, spoke with md on phone.
Two weeks after my vaccine, my legs started feeling really tired and sluggish. It got progressively worse as time went by. Now, 1 year later, it's gotten so bad that I can barely walk. I saw my Neurologist on 5/23/2022 and am getting referrals for some testing that's going to start on 06/13/2022. I'm getting a Brain MRI, Myasthenia Gravis, NCS test, and getting testing for Guillain-Barre Syndrome. And then I'm getting a referral to start Physical Therapy.
Started feeling sick 10/17/2022, didn't officially test positive for COVID-19, because his wife tested positive for COVID-19 and they were feeling same symptoms of a  fever and sore throat; Had a telehealth appointment with Doctor and is waiting for a prescription, not sure what it is yet.
It was reported on 1/23/02 that a 29-year-old male patient was believed to have received a TD Adult vaccination, lot # U0518AA on 1/16/02 and on 1/17/02 patient reported that he developed body aches, chills, fever recorded of 100F for 24 hours. Patient was advised by the physician to take an acetomenophen, rest and plenty of fluids. Symptoms were resolved by 1/18/02. Patient has received tetanus immunization in the past without incident.
some achiness on the left side above and below the scapula; she had some mucus in her throat around the time of the 3rd vaccine; patient had 3 doses of SHINGRIX; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included phenergan with an associated reaction of pain, phenergan with an associated reaction of swelling, phenergan with an associated reaction of nerve injury (nerve damage in the right shoulder that has resolved) and Shingrix with an associated reaction of pain in extremity (For tolerance after 2nd dose refer case US2020AMR015496). Concurrent medical conditions included drug allergy (received in right deltoid). Concomitant products included ascorbic acid (Vitamin C) and zinc.   On 15th January 2020, the patient received the 3rd dose of Shingrix. On 15th January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, mucus discharge and extra dose administered. On 26th January 2020, the patient experienced scapula pain. Rechallenge with Shingrix was positive. In January 2020, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the scapula pain and mucus discharge were recovering/resolving and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the pain in arm, scapula pain and mucus discharge to be related to Shingrix.  Additional details were reported as follows: in 2000, the patient had an allergic reaction to a phenergan injection that was injected in the righ deltoid. It caused soreness and swelling and resulted in nerve damage in the right shoulder that has resolved. The patioent reported that that she had some mucus in her throat around the time of the 3rd vaccine but it was clearing up. The patient received 3rd dose of Shingrix vaccine in left arm and experienced sore arm on the same day which was lasted for 2 to 3 days. Within the last few days she also experienced some achiness on the left side above and below the scapula. The patient received echincea as concomitant. The patient had scheduled regeneten bioinductive implant on the right side in a few weeks from reporting date. The reporter consented to follow up. This is 1 of the 3 cases, reported by same reporter.
ADR: NAUSEA/VOMITING LASTING WEEKS, LARGE WELT AT SITE LASTING 4 DAYS, FEVER OF greater than 101 F. STILL FEELING NAUSEATED. FEVER AND WELT GONE.
Information has been received from a physician concerning a 5 year old male who on approximately 07/11/2002 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  On approximtely 07/11/2002 the patient developed a dime size welt.  The patient was monitored for 30 minutes at the office without any changes and was sent home.  The patient did seek unspecified medical attention.  Additional information has been requested.
arm is very tender up to her shoulder; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (arm is very tender up to her shoulder) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 036A21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 2000 to an unknown date for Thyroid disorder NOS.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced TENDERNESS (arm is very tender up to her shoulder) and HEADACHE (Headache). At the time of the report, TENDERNESS (arm is very tender up to her shoulder) and HEADACHE (Headache) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-072540 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received on 03-JUN-2021 contains Updated patient demographics, second dose start date.Added concomitant medication.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072540:CROSSLINKED WITH DOSE 1
Develop lightheadedness/dizziness, Rapid Respirations, Left arm and neck pain 30 minutes after receiving 2nd dose. Had same but milder sx. After 1st she thought was related to anxiety. Had skipped Baclofen and Gabapentin this A.M.
This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PAIN (body aches), RASH PRURITIC (itchy rash), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unkown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported adverse event). Concomitant products included SIMVASTATIN and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ASTHENIA (weakness), PAIN (body aches), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and FATIGUE (tiredness). On 06-Mar-2021, the patient experienced RASH PRURITIC (itchy rash). At the time of the report, ASTHENIA (weakness), PAIN (body aches), RASH PRURITIC (itchy rash), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
rash devel 5-6 days p/vax given; there was no Gi or resp component to the reaction; DPH was given;
Hormones have changed; Major cramps; Hurting breast; Dizziness; Lumps under arm pits; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 22Oct2021 (Lot number: unknown) at the age of 43 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Sarcoidosis" (unspecified if ongoing) and "Polycystic ovarian syndrome" (unspecified if ongoing), notes: PCOS. Concomitant medications were not reported. The following information was reported: HORMONE LEVEL ABNORMAL (non-serious) with onset 10Nov2021, outcome "not recovered", described as "Hormones have changed"; MUSCLE SPASMS (non-serious) with onset 10Nov2021, outcome "not recovered", described as "Major cramps"; BREAST PAIN (non-serious) with onset 10Nov2021, outcome "not recovered", described as "Hurting breast"; DIZZINESS (non-serious) with onset 10Nov2021, outcome "not recovered", described as "Dizziness"; AXILLARY MASS (non-serious) with onset 10Nov2021, outcome "not recovered", described as "Lumps under arm pits". The events "Hormones have changed", "Major cramps", "Hurting breast", "Dizziness" and "Lumps under arm pits" were evaluated at the physician office visit.  Additional Information: It was unknown whether any therapeutic measures were taken as a result of the events. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Per mom, diarrhea every 30 mins-1 hour x 3 days (so far).
Received FLUVIRIN 10/25/16 stated felt weakness, clear rhinitis, N and V XI symptoms lasted through 10/26/16. 10/27/16 symptoms resolved reported to Employee Health for scheduled 2nd dose Hep B vaccine IM (R) arm. 10/28/16 upon awakening 0700 c/o pain (R) arm and (R) chest pain. C/O nausea denies vomiting, SOB, diaphoresis. Admitted to ER for evaluation. C/O HA, very tender (R) arm and (R) chest wall with light palpitation. DC ER follow up with PCP.
Headache, SkinRash, chills, rash at injection site, fatigue Narrative:  Other Relevant History: