chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported.  On 12-JUN-2017, the patient was vaccinated with improperly stored VARIVAX injection, lot #N000683, expiry date: 06-JAN-2019 (dosing details not reported) which was reconstituted with properly stored sterile diluent(MERCK STERILE DILUENT) (lot#, expiry date unknown) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 6 F to 14 F for a duration of 180 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints This is one of several reports received from the same reporter.  Additional information has been requested; Sender's Comments:  US-009507513-1706USA007776:
runny nose; nausea; sore arm; seeing tinted green; chemical taste in mouth; brain not working; Face turned red; Trouble speaking; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (Face turned red), VACCINATION COMPLICATION (Trouble speaking), PAIN IN EXTREMITY (sore arm), RHINORRHOEA (runny nose) and DYSGEUSIA (chemical taste in mouth) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 11-Feb-2021, the patient experienced ERYTHEMA (Face turned red), VACCINATION COMPLICATION (Trouble speaking), DYSGEUSIA (chemical taste in mouth) and COLD-STIMULUS HEADACHE (brain not working). On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (seeing tinted green). On 14-Feb-2021, the patient experienced RHINORRHOEA (runny nose) and NAUSEA (nausea). On 11-Feb-2021, ERYTHEMA (Face turned red) had resolved. On 12-Feb-2021, VACCINATION COMPLICATION (Trouble speaking), PAIN IN EXTREMITY (sore arm), COLD-STIMULUS HEADACHE (brain not working) and FEELING ABNORMAL (seeing tinted green) had resolved. On 14-Feb-2021, RHINORRHOEA (runny nose) and NAUSEA (nausea) had resolved. On 17-Feb-2021, DYSGEUSIA (chemical taste in mouth) had resolved.        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.   Concomitant information were not provided by the reporter. Treatment information were not provided by the reporter.   This case was linked to MOD-2021-034937 (Patient Link).
fever 99.7; swollen lymph node in right armpit; headache; chills
It has been three days. Severe swelling and pain persist at injection site, and a rash at the injection site that appeared yesterday has begun to itch. Severe dizziness this morning.
Red area at right thigh, then 2 papules formed, which almost vesiculated and are now drying up.  These vesicles were at the sight of the varicella injection.  Clinically the child is fine.
Chills; Headache; Muscle Aches; Fatigue; Fever; This is a spontaneous report from a contactable physician reported for himself.   This 65-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EL0142), via an unspecified route of administration at single dose in the right arm on 08Jan2021 10:00 for covid-19 immunisation. Medical history included hypertension. Concomitant medication included lisinopril, chlorthalidone, ascorbic acid;vitamin d nos;zinc. Previously the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EK5730), in the left arm on 19Dec2020 for covid-19 immunisation. On 09Jan2021 02:30, the patient experienced fatigue, fever, chills, headache, muscle aches, all with outcome of recovering. No treatment required. The vaccine was administered at Hospital Facility. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022.  Vial was placed into fridge on 12/28/2021.  Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered.  Manufacturer's expiry date is March 25, 2022.  Provider informed.  Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (covid 19) virus at time of administration'.   Patient called but unable to speak with patient to assess adverse effects, if any.
Pain in extremity; Vomiting; A spontaneous report was received from a Reporter like Consumer concerning a unknown  Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, vomiting are listed.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 17-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On 25-JAN-2021, The patient experienced the event sore arm and vomiting.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events sore arm and vomiting were unknown.  The reporter assessed the events, sore arm and vomiting as related to study drug.
Patient fully vaccinated with Pfizer on dates 4/11/21, 5/2/21, and 9/14/21. Patient admitted to the hospital on 6/18/21 with sepsis, COVID +, diffusely wheezing in afib with RVR.  His BP has remained low and amiodarone gtt was started to control the arrhythmia, he converted out of afib in NSR in the 60-70 and cardiology consulted and recommended after two additional doses of amiodarone, switching him back onto his fleicanide and metoprolol at discharge and stopping amiodarone, given the likely impetus for the event was COVID-19. He still has some wheezing and coughing, minor, suspect chronic given ongoing tobacco abuse. We will dc home on decadron 6mg daily x 5 more days, longer if he has persistent wheezing, given the COVID dose up to 10 days. He will use his albuterol INH 2-3x/day and his atrovent bid at home.
Administered with vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 73-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but  discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273, lot # 025J20-2A. There were no reported AEs associated with this case of Product storage error.
RUNNY NOSE; SNEEZING; ITCHY THROAT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, 1 total, administered on 14-MAR-2021 16:00 for prophylactic vaccination. Batch Number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced runny nose, sneezing, and itchy throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the runny nose, sneezing and itchy throat was not reported. This report was non-serious.
Mother states problem began on left arm at injection site and then extended to shoulder and wrist of left arm. Area became red, hot, hard, raised, painful, and itchy over the course of a few days following vaccination. She states that after about 4-5 days post-vaccination these symptoms simply went away and there are no residual symptoms.
7APR93 small inflammed area around inject site; 8APR93 upper arm inflammed w/edeam; cool compresses to area; 9APR93 improving;
New information in product details and event details regarding PREVNAR 13 was received from a nurse regarding an unknown number of patients who experienced PREVNAR 13 hurts worse for everybody then other vaccines. The patients received a dose in 2009. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered in 2009. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patients experienced PREVNAR 13 hurts worse for everybody than other vaccines in 2009. Outcome was unknown. No additional information was available at the time of this report. It has been determined that US WYE H16088719 is a duplicate report of US WYE H17546510. Therefore, the reports are being consolidated into US WYE H17546510, which will remain the official case of record.
sensation of chest tightness; burning sensation; This is a spontaneous report from a contactable Other Health Professional. A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported) via intramuscular route of administration, administered in Left Arm on 16Jan2021 at 14:30 (at the age of 54-years-old) as Dose number unknown, single for COVID-19 immunization at Hospital. The Patient had sulfa allergies. Concomitant medications included levothyroxine sodium (LEVOXYL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.On 16Jan2021,at 14:30,the patient experienced sensation of chest tightness, burning sensation.It was reported that no therapeutic measures were taken for the events experienced.The outcome of events not recovered/not resolved.  Information on the lot/batch number has been requested  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
pt devel fine papular rash on both thighs & lt upper arms; these were the extremities vax were given in;
On exam (routine) 11/27/01 mother reported to MD that child "screamed, fussy for " up to 6 hours within last DtaP injection on 08/24/01, and upon further thought, felt child was extremely fussy with 2nd DtaP on 07/11/01 although did not report to office at those time, I will elect to use Ped DT in future.
Patient experienced redness and itching at the injection site. She did not seek treatment. Patient reported 5 days after vaccination and will give more time for it to go away.
facial edema (left side of lip/ cheek) recommended Benadryl and to report to md asap for further consult. pt pt since sx onset at 4am her saw some improvement
This spontaneous report as received from a healthcare worker (also provided as an administrator) refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 16-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection, lot # L050956, expiration date: 17-DEC-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
been sick; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration on an unspecified date as 1st single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient was sick. It was reported that the patient received the second dose on day 42 as she mentioned been sick as one of the reasons she could not get it on day 21. Patient was told she could receive the second dose of the Pfizer Covid 19 vaccine up to 42 days after the first dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a pharmacist refers to a 70 year old female patient with psoriasis. Medical history was not reported. On 02-DEC-2014 the patient was vaccinated with ZOSTAVAX injection, subcutaneous in the left arm, lot # K003597, expiration date: 12-MAR-2014, dosage was not reported. Concomitant therapy was unknown. On 19-DEC-2014 the patient developed a blistery rash that was painful and burned, located on the left side hip-joint area. It was unknown if there was any relevant laboratory data. The patient reported that was not a psoriasis outbreak. The outcome of the event was not recovered at the time of this report. Additional information has been requested.
pt reported to me today 5/5/2023 that she hasn't been able to walk since a couple days after dec bivalent shot; leg weakness (gives out). Also, she had a small lump in right breast, which is now large. experiences sob. I informed md and asked them both to arrange an appointment asap.
Patient experienced bruising at the injection site, then a rash about an inch or 2 below the injection site. She described it as inflammed and hot to the touch. She also stated that there was inflammation in the arm in general.
Two days after MMR injection, the patient was noted to have a rash from head to toe with spots in her mouth. Mom took the toddler to the ER. At the ER mom states the MD said " this is a common reaction, a mild form of measles". No medication given.
After administration of vaccine, patient was feeling light headed. He was seated upright and began to be unresponsive to my conversation. He then lost consciousness and his face became flush red. Chin was lifted to attempt to open airway, as no chest rise was observed. Pulse was assessed and no signs of pulse. A 0.3mg Epinephrine syringe was administered to the patient and consciousness was regained. Patient was starting to become responsive, but not fully coherent. Emergency response was activated and paramedics came to assess the patient. Patient was wheeled out with paramedics.
Pt experienced vomiting, swollen throat, feeling a lump in the throat, malaise, and fever. Pt didn't go to emergency room by informed her PCP.
Pt presented to ED via EMS with hypoxia/resp distress; Intubated PTA; + Covid in ED; daughter decided to withdraw care in ED; pt died in ED
56 adults patients received doses after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and MI agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
Patient missed second dose because of hospitalization; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed second dose because of hospitalization) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed second dose because of hospitalization) had resolved.        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.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Had COVID vaccine 1/5/2021.   On 1/13/2021 developed headache, fatigue, congestion.  COVID +.
Started running fever on March, 29th at 11:00 pm. Fever persisted for 12 hours. Very tired for 12 hours. Redness and soreness at injection site for 4+ days. Muscle pain in back and neck for 4+ days.  Unable to do normal activities for 14 hours.
sciatica; muscle spasms from his lower back to his toes on the right side; This is a spontaneous report from a contactable Consumer (patient's wife). A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose in the left arm for COVID-19 immunisation. The patient's medical history included twinge in his hamstring in Jan2021. Concomitant medications were not reported. The patient experienced a twinge in his hamstring 2 days before the vaccine but continues to play (reporter mentioned her husband is athletic). He received the first dose of the vaccine on 12Jan2021, played on the 13Jan2021 and could not play on 14Jan2021 two days after vaccine he experienced muscle spasms from his lower back to his toes on the right side and could not get out of bed (shot was in the left arm). Husband went to the hospital on 16Jan2021 and they discharged him and he went back on 17Jan2021 and did a magnetic resonance imaging (MRI) and diagnosed with sciatica and gave him oxycodone 10mg 1 mg 1 four times a day as needed, cyclobenzaprine 10 mg 1 every 8 hours, and  gabapentin 100 mg 2 three times a day and a prednisone 6 pack. Reported not getting any better so took him to pain management and could not get comfortable and screamed the whole way over which was 20 minute ride and went in the office in a wheelchair. They gave him a steroid and told him to wait 1/2 hour. When leaving he experienced the worst spasm ever and they gave him Toradol and then additional steroid injections. Husband was able to walk out with a walker. Can only lay down, can not sit up and is bedridden. Spasms have stopped at the time of the phone call but still in pain. Having physical therapy (PT) come for consult. Husband insists on getting second dose. Husband was told at the hospital that another patient his age came in with the same symptoms as his after a dose of the COVID-19 vaccine. The events had not resolved.  Information on the lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021058075 same reporter/drug/event, different patient
Received TD on 20-APR-89 lt deltoid following closed head injury and laceration rt upper lip.  Office visit 25-APR-89 for suture, removal and c/o discomfort lt upper arm which just started today. indurated area.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information has been received from a nurse concerning VARIVAX (Merck) temperature excursion and one patient (patient ID #112300) of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012211, exp date: 28-SEP-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
I was vaccinated on Friday 7/23/21 and on Saturday 7/24/21 I woke up and there was a red knot under my left breast and a raised line from the knot down to my ribcage, which looked like a vein and it was well recognized, and a little sensitive but not painful. The knot was also itchy.
This spontaneous report as received from a nurse via company representative refers to a twins patients of unknown age and gender. On 15-APR-2014, the patients were intramuscularly vaccinated with the first dose of GARDASIL (dose, lot # and expiration date were not reported).On 25-SEP-2014, the patients were intramuscularly vaccinated with the second dose of GARDASIL (dose, lot # and expiration date were not reported). On 15-OCT-2014, the patients were intramuscularly vaccinated with a third dose of GARDASIL (dose, lot # and expiration date were not reported). Patients received the doses of GARDASIL outside of recommended dosing interval. No adverse effects were reported. Additional information has been requested.
On 9/22/00, the pt woke up with severe headaches and backache duration of 1 day. On 9/24/00, the pt woke up with pain and swelling in the right wrist. Later that day  pain and swelling in right knee. On 9/26/00 same symptoms but right ankle. on 9/27/00 same symptoms but left ankle. On 9/28/00 the client states she still has symptoms in above mentioned joints, but has not sought treatment.
Patient, age 11, received Pfizer 6 mo to 4 year old preparation of vaccine. Patient received repeat dose same day per CDC recommendations.