chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a patient of unspecified age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant therapies reported. On 03-JAN-2017, the patient was vaccinated with one dose of PROQUAD lot number: M004893 with expiration date: 26-JUL-2017 (dose and route of administration were not provided), for prophylaxis. The administered dose had been improperly stored at a temperature of 5°F to 14°F for one hour (digital data logger) without any previous temperature excursion. No adverse effects were reported.  There was no product quality complaint involved. Additional information has been requested.
pt. reports that directly after injection felt arm pain, instantly, describes as nerve pain, then progressed to limited mobility, her Pharmacist reports that she may have had gotten the bursa or nerve was hit. her physician has not been consulted for this event. she was reading on the internet and feels this is what happened. reports she is still "jerky" had spasms to multiple places to her body-all parts-reports that it is improving. reports that 5 days later she needed to use her albuterol inhaler she feels this was due to jerky and the muscles around her rib cage were tight and painful to take deep breaths.  reports still very sore to direct injection site as well.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: redness on arm-Mild, Additional Details: redness and swelling of injection arm
heartbeat faster; High fever; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heartbeat faster) and PYREXIA (High fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 ("long COVID" really bad in January 2021.) in January 2021. Concurrent medical conditions included Aneurysm and Kidney failure.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (heartbeat faster) and PYREXIA (High fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (heartbeat faster) and PYREXIA (High fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) High. On an unknown date, Heart rate: high heart beats per minute (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.
11/3/21 presents to EC ED "with cough congestion rhinorrhea and body aches". PMHx " includes hypertension, hyperlipidemia and a remote history of prostate cancer".
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (very sore arm - left arm), myalgia (muscle pain), fatigue (exhaustion) and headache in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 023M20A) for COVID-19 immunization. No medical history reported. On Mar 24, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Mar 24, 2021, patient experienced pain in extremity (very sore arm - left arm), myalgia (muscle pain), fatigue (exhaustion) and headache. At the time of the report, pain in extremity (very sore arm - left arm), myalgia (muscle pain), fatigue (exhaustion) and headache outcome: unknown. No concomitant medication or treatment information reported. Reporter did not allow further contact.
No adverse event; HCP states that 4 patients were administered an expired dose of the Moderna COVID-19 vaccine on 27-Feb-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that 4 patients were administered an expired dose of the Moderna COVID-19 vaccine on 27-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 9-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis. No Medical History information was reported.    On 27-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that 4 patients were administered an expired dose of the Moderna COVID-19 vaccine on 27-Feb-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that 4 patients were administered an expired dose of the Moderna COVID-19 vaccine on 27-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that 4 patients were administered an expired dose of the Moderna COVID-19 vaccine on 27-Feb-2023).    No concomitant medications were provided. The patient in this report did not experience any side effects from the invalid dose that was administered. No treatment medication was provided.  No concomitant medications details were reported.  Moderna was not authorized to communicate with the vaccine recipient's primary healthcare professional regarding this notification. Details of inquiry was there any stability data on Moderna primary series 6 to 11 year old vaccine given within a week of the expiration date passing also, what was the recommendation on revaccination if expired product was given. The Moderna lot number 064A22A expired on 24-Feb-2023. The patient in this report did not experience any side effects from the invalid dose that was administered.  No treatment medications details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713718, US-MODERNATX, INC.-MOD-2023-713858, US-MODERNATX, INC.-MOD-2023-713723 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2023: Follow-up received includes non significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713718:Same reporter US-MODERNATX, INC.-MOD-2023-713858:Same reporter US-MODERNATX, INC.-MOD-2023-713723:Same reporter
Complained of lips burning, flushing, tingling to lips.  50 mg Oral Benadryl given. Symptoms dissipating  Taken home by daughter
Achy body overall; Pain in joints; Temperature 101F; Chills; Pains in muscles; Felt almost like she had kidney infection (no shooting pains); Stomach cramps; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Felt almost like she had kidney infection (no shooting pains)), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea), PAIN (Achy body overall) and ARTHRALGIA (Pain in joints) in a 35-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.     The patient's past medical history included No adverse event (No medical history reported).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DIARRHOEA (Diarrhea). On 03-Apr-2021, the patient experienced UNEVALUABLE EVENT (Felt almost like she had kidney infection (no shooting pains)), ABDOMINAL PAIN UPPER (Stomach cramps), PAIN (Achy body overall), ARTHRALGIA (Pain in joints), PYREXIA (Temperature 101F), CHILLS (Chills) and MYALGIA (Pains in muscles). On 06-Apr-2021, ABDOMINAL PAIN UPPER (Stomach cramps), PYREXIA (Temperature 101F) and CHILLS (Chills) had resolved. At the time of the report, UNEVALUABLE EVENT (Felt almost like she had kidney infection (no shooting pains)), PAIN (Achy body overall), ARTHRALGIA (Pain in joints) and MYALGIA (Pains in muscles) had resolved and DIARRHOEA (Diarrhea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment for the events was fluids only, no medications.
For a few days after the vaccine, my arm was sore but it went away after a few days but then I developed a rash on the arm around the area of the injection site. It is red, warm to touch and slightly puffy and itchy.
Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication history not provided.  Treatment information was unknown.  Patient wants to ask Should take Acetaminophen
BODY ACHES, CHILLS, CONGESTION, RIGHT SIDED RIB PAIN, FATIGUE, PRODUCTIVE COUGH W/ VOMITING, PAIN W/ DEEP BREATHS, HYPOXIA,  FEBRILE
could not breathe; pain in arm; hard to lift arm off pillow; weakness; blurred vision; pain behind eyes; irregular heartbeat; headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (could not breathe), PAIN IN EXTREMITY (pain in arm), MUSCULAR WEAKNESS (hard to lift arm off pillow), ASTHENIA (weakness) and VISION BLURRED (blurred vision) in an 80-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.     The patient's past medical history included Surgery (Patient stated that she has undergone surgery a month before receiving the vaccine.). Concurrent medical conditions included Allergy multiple. Concomitant products included NADOLOL (CORGARD), CANDESARTAN CILEXETIL (ATACAND) and CLONIDINE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced DYSPNOEA (could not breathe), PAIN IN EXTREMITY (pain in arm), MUSCULAR WEAKNESS (hard to lift arm off pillow), ASTHENIA (weakness), VISION BLURRED (blurred vision), EYE PAIN (pain behind eyes), HEART RATE IRREGULAR (irregular heartbeat) and HEADACHE (headache). At the time of the report, DYSPNOEA (could not breathe), PAIN IN EXTREMITY (pain in arm), MUSCULAR WEAKNESS (hard to lift arm off pillow), ASTHENIA (weakness), VISION BLURRED (blurred vision), EYE PAIN (pain behind eyes), HEART RATE IRREGULAR (irregular heartbeat) and HEADACHE (headache) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   Concomitant medications include diabetic medications.  No treatment medications were reported.   This case was linked to MOD-2021-263014 (Patient Link).  Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: NNI On 21-Jul-2021: Updated event outcome. Added second dose events.
Over the course of 10 days following the injection I had fever spikes (up to 102), fatigue, loss of appetite, muscle soreness and joint stiffness (more than normal), chills, sweating, heaviness in chest, diarrhea, I vomitted the day after, but that was just for a period of 4 hours. On the 4th day I woke up with stiffness in my left arm and underarm, and swollen glands. I went to the urgent care on the following morning, but the stiffness and swelling had started to retreat and has since disappeared. Soreness at the injection site for about two weeks after vaccine. It is still a bit tender to the touch, but does not bother me unless rubbed hard. There was also redness and tenderness and some itching at the injection site. I felt poorly enough (the fatigue, mostly), that I was not able to work for 10 days. At about the two week mark I finally had the feeling that I felt good!  I occasionally feel fatigued, but have been able to resume normal activities.
3/12/21 Mild headache Total loss of energy Upset stomach Right arm very painful still today, even though exercising from beginning
No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 12-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.   This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
This spontaneous report as received from a medical assistant refers to a 16 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 10-JUL-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J014584, expiry date: 16-JAN-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. Addtional information has been requested.
Starting the day after vaccination, pt experienced swelling of the vaccinated arm from the injection site to elbow. It was hot, itchy and caused pt severe pain. Pt did not experience any other adverse reaction. At the time of reporting, 8.16.2018 the rxn had not abated. Told pt's husband who reported that she should call dr. I also tried to call dr.
Nausea; Pain at injection; Headache; Chills/ Chills for 24 hours after vaccine; Shakes for 24 hours after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes for 24 hours after vaccine), CHILLS (Chills/ Chills for 24 hours after vaccine), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at injection) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced CHILLS (Chills/ Chills for 24 hours after vaccine) and HEADACHE (Headache). On an unknown date, the patient experienced TREMOR (Shakes for 24 hours after vaccine), NAUSEA (Nausea) and VACCINATION SITE PAIN (Pain at injection). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, TREMOR (Shakes for 24 hours after vaccine) and CHILLS (Chills/ Chills for 24 hours after vaccine) had resolved and NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at injection) outcome was unknown.            No concomitant medications were provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-020063 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 03-JUN-2021 contains significant information: Added new event "Shakes for 24 hours". The outcome of the events (chills and shakes for 24 hours after vaccine) changed from unknown to resolved.
3 weeks post vax, pt is complaining itching and soreness. The pt kept scratching and rubbing it. He felt a whelp on it. Onset was 10 days prior. Pt had a large circle on left arm, red with some induration around edge of one side. No infection or drainage. Temperature of 98.6. Pt didn't experience any adverse events with 1st dose.
12/30/2020- 5 minutes after receiving vaccination pt c/o throat  tingling and tightening. Then 10 minutes later began having headache. Sent to ED- EKG completed, and pt was monitored. Declined Benadryl. Apx 5-7 pm that night when at home pt decided to take a half dose of OTC Benadryl. pt woke in middle of night still with headache-took Advil. When woke in the morning had diarrhea and stomach discomfort- lasted apx 24 hours. Then beginning on 01/04/2021 pt noticed the sensation of having a burned tongue and roof of mouth.- is constant and sensitive to heat. pt reports that intermittently in the evening she is also getting the sensation of tongue and throat swelling- denies any SOB and denies actual swelling just sensation.
I didn't have an adverse reaction to the Moderna vaccine for dose 4. I tested positive for Covid on May 15. I went to the emergency room on May 17 with difficulty in breathing and was hospitalized at the Hospital and discharged on May 19.
Information has been received from a physician referring to an unspecified patient of unknown age and gender. There was no information regarding concomitant medication, medical history or drug reactions/allergies. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA 25/0.5 (unit not provided) injection (lot # M011116 with expiration date 17-JUN-2017; dose unknown; intramuscular). The vaccine was improperly stored at 31 Fahrenheit for 48 hours. There was no previous excursion. Data logger was involved. No adverse effects were reported. Additional information has been requested.
PATIENT WAS ADMITTED WITH INTUSSUSCEPTION NINE DAYS LATER, AND REDUCED SUCCESSFULLY, AT HOSPITAL  4/3/07 Received medical records from hospital which reveal patient experienced emesis for 3 daysw/decreased feeding beginning 3/5/07 & patient became increasingly lethargic.  On exam, palpable mass was felt in abdomen.  Kept over night for observation, did well & was d/c to home on 3/9/07.  No D/c summary available. FINAL DX: ileocolic intussusception, reduced by barium enema.
December 25, 2022, I woke up with a splitting headache and it lasted three days.  I went to urgent care on the following Monday.  The nurse encouraged me to take ibuprofen instead of Tylenol for my low-grade fever.  I had body aches and chills.  My headache turned into a piercing pain behind my right ear.  I have a mild congestion and nausea.  I continue to be fatigued.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 88-year-old female patient who received Influenza vaccine Quadrivalent. Co-suspect products included ANORO ELLIPTA unknown for chronic obstructive pulmonary disease. Concomitant products included Albuterol, metoprolol and Supplement. In November 2017, the patient received Influenza vaccine Quadrivalent. On an unknown date, the patient started ANORO ELLIPTA 1 puff(s) once daily. On an unknown date, the dose was changed to an unknown dose and frequency. On 17th December 2017, less than a year after receiving Influenza vaccine Quadrivalent and not applicable after starting ANORO ELLIPTA, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the patient experienced tremor and weakness. ANORO ELLIPTA was continued with no change. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved and the outcome of the tremor and weakness were not recovered/not resolved. The reporter considered the vaccination failure and influenza to be unrelated to Influenza vaccine Quadrivalent. The reporter considered the tremor to be possibly related to Influenza vaccine Quadrivalent and ANORO ELLIPTA. It was unknown if the reporter considered the weakness to be related to Influenza vaccine Quadrivalent and ANORO ELLIPTA. The reporter considered the influenza to be unrelated to ANORO ELLIPTA. Additional details were provided as follows: The age at vaccination was not reported. In 2017, the patient received the flu vaccine a couple of months ago. She had been also on ANORO for about 2 months. The patient stated she experienced shakiness and weakness before she got the flu, these got worse with the flu, but at time of reporting, the flu had resolved but she had shakiness and weakness were still present at the time of reporting. She believed the shakiness and weakness began when she started ANORO. She also noted when she flew out of town on 17 December 2017, and spent a week in a hotel because that was when she got the flu. She did not know what flu shot she got. She can't recall all her other medications which she took, but noted those listed in this report. The patient had not notified her physician, but was encouraged to do so. She stated she had an appointment on 20th December 2017. She also provided contact details of the physician. This case was considered as suspected vaccination failure, since the exact time to onset of the event and confirmation of lab test was unknown.