chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient vaccinated 19 hours after vaccine was drawn up and refrigerated; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient vaccinated 19 hours after vaccine was drawn up and refrigerated) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation, Chronic respiratory failure, COPD, Type 2 diabetes mellitus and Liver cirrhosis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient vaccinated 19 hours after vaccine was drawn up and refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient vaccinated 19 hours after vaccine was drawn up and refrigerated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided.
Information has been received from a 22 year old female patient with penicillin allergy who in August 2007, was vaccinated with a first dose of Gardasil. On 24-SEP-2007 she received the second dose of Gardasil. Concomitant therapy included ORTHO-NOVUM. The patient called and reported "experiencing redness and severe pain at the injection site, vomiting, nausea, chills, dehydration and fever after receiving her first and second dose of Gardasil. The adverse experiences were more severe after the second dose". No further information was available. The patient had not recovered as of this report day. Additional information will be requested.
Mixing error occurred, patient may have received only diluent. We have been unable to contact patient.
HOT, itchy, swollen, red around injection site. throughout the day it has continued to swell and she complains she doesn't feel well. Tylenol given.
lost 2 pounds; injection site is red; headache; very lethargic; did not want to eat; craving for salt; blood pressure dropping 116/60mmHg to 86/64mmHg within first 24 hours of receiving; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (very lethargic), EATING DISORDER SYMPTOM (did not want to eat), SALT CRAVING (craving for salt), WEIGHT DECREASED (lost 2 pounds) and HYPOTENSION (blood pressure dropping 116/60mmHg to 86/64mmHg within first 24 hours of receiving) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026a21a and 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure low. Concomitant products included XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II) for Allergy, VITAMIN B6 and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced HYPOTENSION (blood pressure dropping 116/60mmHg to 86/64mmHg within first 24 hours of receiving). On 06-Apr-2021, the patient experienced LETHARGY (very lethargic), EATING DISORDER SYMPTOM (did not want to eat), SALT CRAVING (craving for salt) and HEADACHE (headache). On 07-Apr-2021, the patient experienced WEIGHT DECREASED (lost 2 pounds) and INJECTION SITE ERYTHEMA (injection site is red). On 06-Apr-2021, HYPOTENSION (blood pressure dropping 116/60mmHg to 86/64mmHg within first 24 hours of receiving) had resolved. On 07-Apr-2021, LETHARGY (very lethargic) and EATING DISORDER SYMPTOM (did not want to eat) had resolved. On 16-Apr-2021, HEADACHE (headache) had resolved. At the time of the report, SALT CRAVING (craving for salt), WEIGHT DECREASED (lost 2 pounds) and INJECTION SITE ERYTHEMA (injection site is red) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Blood pressure measurement: 86/64 mmHg (abnormal) low. On 07-Apr-2021, Blood pressure measurement: 97/62 mmHg (abnormal) low and 113/64 mmHg (abnormal) low.         Concomitant product used was nasal spray for allergies, vitamin b6 and vitamin c No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-069816 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: adding MOD21-077549 per MI reconevents and events outcome was updated.concomitant drugs were updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069816:friends case
This is a spontaneous report from a contactable consumer (office practice manager reporting on behalf of the patient). A 80-year-old female patient received PREVNAR 13, (Lot Number: R56671, Expire Date: 01Apr2018), via an unspecified route of administration on 31Oct2017 16:00 at deltoid right at 0.5 ml, single for immunisation. Medical history was none. Concomitant medication included FLUARIX, (Manufacturer: GSK, Lot Number: CX775, Expiry Date: 30 Jun 2018) on 31Oct2017 at left deltoid, route: IM. The patient previously received first dose of FLUARIX in 2014. The patient experienced right arm and shoulder pain and limited range of motion in right arm on 12Dec2017 with outcome of recovering. On 12Dec2017, patient called the office and reported right arm and shoulder pain with no redness or swelling at the injection site. Also reported limited range of motion in the right arm. Scheduled the patient for an office visit three weeks later and the provider offered to send her to the physical therapy and to take Ibuprofen which the patient declined. Another three weeks past and the patient came in for a physical still admits to right arm and shoulder pain with limited range of motion and accepted the physical therapy offer which she did three times. Patient called today because she is still having right arm pain with limited range of motion. It has improved but she has not fully healed. Patient had regular blood work at her appointment on 03Jan2018 having to do with other reasons, but all results were normal.
Headache, severe malaise and low grade fever (99.5 F) started about 20 hrs after vaccine was given.  Fever lasted about 12 hours, headache and malaise lasted 30 hours. Treated with hydration and ibuprofen.
No adverse event; Given vaccine which was beyond the 30 day use by date; Given vaccine which underwent temperture excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No adverse event) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion). On 19-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion) and EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date).    No concomitant medicine were reported. No treatment medicine were reported.
Contracted COVID-19.  Symptoms on 5/15/2022 with positive rapid test on 5/17/2022.
Patient was given a dose that was in a syringe that was in a syringe for 24 hours instead of less than the recommended 12 hours.  Facility staff was educated that the dose does not count and the patient will need revaccinated.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 10-SEP-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Had slightly raised red rash from neck down, covering most of body. Dad fist noticed when he awoke at 8am.
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Started with flu-like symptoms, especially sore throat and slight fever. Continued the rest of the week with coughing, shortness of breath, bloody greenish sputum, and higher fever (On Saturday 11/06/2010, fever got to 103 degrees F). Thus, symptoms became pneumonia-like by Friday 11/05/2010. Went to ER on Monday 11/08/2010 and was diagnosed with incipient pneumonia and was prescribed antibiotics. Currently in treatment.
Syncope - hydration + rest; BP 123/57; HR 70; RR 18
fatigue; chills; joint pain; low fever; nausea; loose stool; swollen lymph nodes; insomnia; head ache; scratchy throat; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 04Mar2021 11:00 (Batch/Lot Number: EN6199) (at the age of 67-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. It was unknown if patient had covid prior vaccination. The patient has not been tested for covid post vaccination. Medical history included high blood pressure, hypothyroidism, gout, and known allergies to medications with bromine salts. There were no concomitant medications. On 06Mar2021 16:00, the patient experienced fatigue, chills, joint pain, low fever, nausea, loose stool, swollen lymph nodes, scratchy throat, insomnia, and head ache. No treatment was received for the events. The patient had not yet recovered from the events.  No follow-up attempts are possible. No further information is expected.
By night at 10pm, patient had upset stomach, bad nausea and a bit of diarrhea. The problems lasted for about 1 month. During this month took Coca Cola and cranberry juice to help settle stomach. Eventually patient was able to tolerate eggs. Patient called doctor after 3 weeks of symptoms--by then it was getting better. Patient was weak and mostly in bed.
Information has been received from a physician concerning an 8 year old Arabic female pt who on 4/23/99 was vaccinated with MMR, SC in the arm. On 4/29/99, the pt was dx'd with measles "accompanied by fever, bloodshot eye, and markings on the face, neck, and chest". Follow-up information from a physician reported that subsequently, the pt recoveered.
Information has been received from a licensed practical nurse concerning a 7 year old male caucasian child with NKDA and no past medical history who on 10/27/96 was vaccinated SC with the first dose of varicella virus vaccine live. There were no concomitant therapies or illness at the time of vaccination. On 07/07/2001, the child experienced a rash over his stomach, chest, back, arms, legs, feet, groin and face. He was afebrile and had more than 50 (but less than 100) lesions. He was seen in the office on 07/09/2001 and was treated with hydroxyzine hydrochloride (Atarax) as needed and aluminum acetate solution (domeboro solution) twice a day. Follow-up information received indicated that no additional events occurred. It was noted that the child recovered from the experiences. No further information is available.
Pt admitted to medical center 10/24/2006 for SOB and resp distress. No documented fever. Long standing H/O COPD. Pt expired 11/2/06 no autopsy done.
Full body rash. Hives present as wheals, lumps, red inflamed lines. Presents intermittently over entire body. Hives are hot, swollen, and itchy.
fever 100.2 F; sore arm; This case was reported by a nurse via call center representative and described the occurrence of fever in a 3-year-old female patient who received Rabies NVS (RabAvert) (batch number ARBA51YA, expiry date 31st March 2023) for prophylaxis.   On 17th January 2020, the patient received the 1st dose of RabAvert. In January 2020, less than a week after receiving RabAvert, the patient experienced fever and pain in arm. On an unknown date, the outcome of the fever and pain in arm were unknown.   It was unknown if the reporter considered the fever and pain in arm to be related to RabAvert.  Additional details were provided as follows: The patient developed a fever of 100.2 degree fahrenheit and a sore arm.  It was unknown if the events were ongoing at the time of this report. The reporter consented to follow up.
102 fever with accompanying muscle ache. Took two tylenol. Fever and ache gone by morning
61 y/o with past medical history of Diabetes who presents with shortness of breath, nervousness and possibly elevated glucose. Patient states that she did not take any of her prescribed medications this am or check her glucose. Patient states that she had Cuban coffee, café con leche and pastelitos (Cuban pastries) prior to arrival. Patient states that this is the first dose in the two-dose series (Pfizer). Patient states that she received the vaccination to the left arm. Patient denies previous reaction to vaccinations in the past. Patient denies sore throat, difficulty swallowing, chest pain or rash. NP and Paramedics at patient side. Patient vitals within normal limits (156/81, 127/85, 132/79, 146/82, 133/85 BP, O2 Sats 96-99% RA, 86-98 HR). Patient glucose markedly elevated (202). Patient placed on 2 L O2 by nasal cannula. Within 5 mins of observation patient states that she is feeling better. Patient states that prescribed medication is on her person. NP instructed patient to take prescribed Metformin. Patient states was nervous to get the vaccination and didn?t want to take medications. Patient states also didn?t want to check sugar in case it was high. Glucose rechecked 25 mins post medication administration. Patient glucose decreased to 194. Advise patient needs to seek further medical evaluation/Fire Rescue. Patient denies need for transport and states that she wants to go home. Patient signed Against Medical Advice form. Patient walked off site with husband at side.
This spontaneous report as received from a registered nurse via company representative refers to a 14 year old patient. On 23-OCT-2014, the patient received a dose of PROQUAD (Merck) (batch/lot#, dose and route were not reported) instead of receiving a dose of M-M-R II and a dose of VARIVAX (Merck). No adverse effect was reported. Additional information has been requested.
mild headache, sore arm at injection site, mild nausea, mild weakness. sore arm immediately after injection lasting 2 days.  Headache, nausea and weakness day after vaccination lasting 24 hours.
broke out in rash near the injection site. rash spread out near upper arm. still present today after a week. pt states it is getting better. has not complained of anything further.
Fatigue; muscle soreness at site; muscle ache; mild joint pain; fever 100.1; This is a spontaneous report from a contactable nurse (patient). A 23-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 28Dec2020 12:00 at single dose at left arm for COVID-19 immunization. Medical history included known allergies: Penicillin, erythromycin. Concomitant medication received in two weeks included melatonin. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 15:00 (03:00 PM), the patient experienced fatigue, muscle soreness at site, muscle ache, mild joint pain, fever 100.1. Treatment received for the adverse events included Acetaminophen. The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Patient came to pharmacy on 7/24/2018 reporting severe bruising in the right arm, no current pain, swelling, tingling or other sensation reported at this time. He stated that after 24 hours of receiving the vaccine he experienced pain and redness at the injection site. The redness then began to spread from the injection site and ran to the inner part of the arm, he reported to have swelling in the upper arm and there was a bruise that began to appear in the area where the redness was present. The bruise from observation was located on most of the upper inner arm and it had spread. I noticed the patient was on a blood thinner and this could have been a sign of his medication. I suggested he call and see his provider immediately to ensure there was not a blood clot present and to ensure that there was no excessive thinning of the blood due to the size of the bruise. The bruise did seem to be healing at the time patient presented his reaction to the pharmacy. However, the above was advised as a precaution.
Fever tmax 101.8 from 6/26/15-6/29/15 (present). Treated with Tylenol. Vomited twice on 6/28/15-6/29/15.
Resident found unresponsive, CPR initiated and EMS called. EMS called time of death after arrival.
t100 R screamed x 4 hrs & couldn't comfort would not nurse; had loud shrill cry;
no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 48-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No relevant concomitant medications were reported.  No treatment information was provided.
Patient called with complaint of painful rash on back. After going to MD office patient was given Rx for VALTREX 1g 1 tid for 7 days.
Patient presented with enlarged right inguinal lymph nodes 72 hours after vaccine administration. Patient's mother spoke with nurse at the pediatrician's office and was instructed to call to have patient seen patient exhibited fever, increased irritability, increase in size of lymph nodes, or pain at lymph nodes. Patient had fever of 103 on Saturday, May 16th and increased lymph node size was noted by patient's mother. Patient's mother scheduled follow-up with pediatrician on Monday, May 18th. Pediatrician stated that lymph node size was not "clinically significant," but prescribed augmentin and requested that patient's mother follow-up via phone call in about 48 hours.
This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 26-OCT-2012 at 12:03, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Pt received Menactra and was sent to lab for testing glucose and lipids. suffered from syncope, bradycardia; hypoxia and was given O2 at 5L/min and sent to ER via Rescue (9-11). Pt. was dehydrated, had racing heart, palpitations and nausea. Pt. improved and discharged to home. Dx: syncope due to vasovagal 14:00. No blood drawn.