chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 24-AUG-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23, 0.5 ml, which had a lot # of L003188 and an expiration date of 06-JUL-2016 (route and anatomical location of administration were not reported). The sum of hours in excursion was 16 hours and the lowest recorded temperature reported as 33 Fahrenheit (F) (0.555555556 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses (incorrect product storage) of injectable VARIVAX (lot# L050956, expiration date 17-DEC-2017; and lot# M017290, expiration date 07-APR-2018), subcutaneously for prophylaxis (strength, dose, frequency, albumin status and anatomical location were not reported). The vaccine doses were exposed to a temperature excursion of 19.4 Fahrenheit degrees in a time frame of 3 hours and 45 minutes; digital data logger was involved and previous temperature excursion was confirmed. No adverse effects were reported. Reportedly, the vaccine doses were reconstituted with properly stored diluent MRK (lot number and expiration date were unknown). There was no product quality complain (PQC) reported. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001051: US-009507513-1704USA002389:
Red and swelling that begins at shoulder and goes all the way to her elbow- warm to the touch - Also when I called her back she had chills.
12 hrs after immunizations pt developed acute fever, body aches, and nausea. Treat Kw/OTC antifebriles and rest. Pt is expected to recover completely.
Sore arm.  Sunday evening (about 9 or 10 hrs after shot), more easily racing heart when doing normal activities like walking around house or climbing flight of stairs; didn't notice issues after getting into bed for evening.  Woke Monday morning with mild headache (ibuprofen took care of the headache) and slightly more tired than normal, although nothing overly noticeable (no nap required).
Stiff neck, body aches, fever and chils, sweats and stiff arm: can't lift it, can barely move the arm, swelling in shot area and redness.
Relates developed some itching and swelling to (L) upper arm. Two days later swelling increased with redness and fever. Went to PCP. Diagnosed with cellulitis and placed on antibiotics.
had a mild, non severe reaction to the first dose of the vaccine/ She was told to go see an allergist; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "had a mild, non severe reaction to the first dose of the vaccine/ She was told to go see an allergist".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, feeling hot or cold. 3 days bed rest, smell and taste diminished, memory, confusion, stress, right side head pains from front of head to back of head down to neck, runny right eye and right face  Bell Palsy. low energy constantly worried.
fainted, hospitalized overnight; nauseated, hospitalized overnight; Drug dose administration interval too long; This case was reported by a consumer via call center representative and described the occurrence of syncope in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included vasovagal attack. Concurrent medical conditions included artificial cardiac pacemaker user.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced syncope (serious criteria hospitalization and GSK medically significant), nausea (serious criteria hospitalization) and drug dose administration interval too long. On an unknown date, the outcome of the syncope and nausea were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the syncope and nausea to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-JUL-2022 Reporter's comments: This case was reported by the patient herself. The reporter stated that she received her first dose of Shingrix about four years prior to the reporting. About 12 hours after the dose, she felt nauseated then fainted. The reporter stated that she was hospitalized overnight for monitoring. The reporter stated that this adverse event was reported in May 2018 through Vaccine Adverse Event Reporting System (VAERS). The reporter stated that her cardiologist felt the syncope may have been due to the nausea. The reporter stated that at the time, her primary physician recommended she would not get the second Shingrix dose, the physician was now recommending her to receive second dose, and she plans to get it. The reporter stated that she had nothing else to report. The reporter consented to follow up and also, may follow up with physician. Additional Supportive Information: Vasovagal episodes was reported as Historical drug as Condition Type however the drug was not reported hence captured currently as Historical Condition. The patient plans to get 2nd dose late, which led to lengthening of vaccination schedule.
Client received AstraZeneca Covid vaccine with no reaction. Previous vaccine unavailable in the Janssen given as an alternative on 9.15.21.
Hurting over the left shoulder and down the spine after booster; Hurting over the left shoulder and down the spine after booster; Left arm hurt after booster/Pain on left arm has has not improved after booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT PAIN (Hurting over the left shoulder and down the spine after booster), SPINAL PAIN (Hurting over the left shoulder and down the spine after booster) and VACCINATION SITE PAIN (Left arm hurt after booster/Pain on left arm has has not improved after booster) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE JANSSEN (around 23MAR2021 to 15APR2021). Concurrent medical conditions included Fibroids (Cancerous Fibroids).    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced VACCINATION SITE PAIN (Left arm hurt after booster/Pain on left arm has has not improved after booster). On 28-Dec-2021, the patient experienced VACCINATION SITE JOINT PAIN (Hurting over the left shoulder and down the spine after booster). 28-Dec-2021, the patient experienced SPINAL PAIN (Hurting over the left shoulder and down the spine after booster). At the time of the report, VACCINATION SITE JOINT PAIN (Hurting over the left shoulder and down the spine after booster) and SPINAL PAIN (Hurting over the left shoulder and down the spine after booster) outcome was unknown and VACCINATION SITE PAIN (Left arm hurt after booster/Pain on left arm has has not improved after booster) had not resolved.            No concomitant medication details was reported. No treatment medication details was reported.
Fatigue approx. 6 hours after injection; chills approx. 13 hours after injection, followed by headache and body aches. Symptoms have lasted for approx. 27 hours but are improving. Intermittent nausea.
Muscle pain on my arm; I had a bad day; Runny nose; Headache; Very tired and very weak; Very tired and very weak; This is a spontaneous report from a contactable consumer. A 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 21Jan2021 (Batch/Lot Number: EL3247; Expiration Date: May2021) as dose number unknown, single (at the age of 82-years-old) for covid-19 immunisation. Medical history included that she had pacemaker and breast cancer. Concomitant medications included letrozole once a day and olmesartan medoxomil (BENICAR) 20mg, oral, once a day due to pacemaker and Letrozole. The patient stated that she was 83 years of old, second of all her doctor wants her to take it because she had breast cancer. The patient was very tired and very weak on 22Jan2021. The patient experienced few days of runny nose, headache and she bad day on 25Jan2021. The patient stated that last day she had experienced was 25Jan2021 and since then she had been fine but all of a sudden on Saturday the 06Feb2021, she started having like muscle pain on her arm, the one she got the shot and Saturday, Sunday and today. Last night she put some kind of cream for the muscle pain relief and little bit better this morning. She enquired if that was normal to have pain after almost so many days after the vaccine. The outcome of the event runny nose, I had a bad day, headache, very tired and very weak was recovered while the outcome of Muscle pain on my arm was recovering.  Follow-up attempts completed. No further information expected.  Amendment: This follow-up report is being submitted to amend previously reported Information: To delete the event "Off label use in unapproved indication", added breast cancer in the medical history, removed the indication breast cancer for drug bnt162b2 and added COVID-19 immunisation and deleted At Risk classification.
Pt seen in office 12/27/10, diagnosed with sinusitis et dermatitis. Temp 98.2. Given PENTACEL (#4), PCV (#4) et flu shot after parental consent. Mom gave pt AMOXIL et DIMETAPP (1 tsp) at 9:00 PM. At around 3:00 AM 12/28/10, parents awakened by pt. "shaking all of body, making jaw movements, eyes rolled back". Pt. felt hot. Parents estimate event lasted about 5 min. Afterward, pt. awoke briefly. Mom tried to administer TYLENOL, but pt "let it roll out of his mouth". Then pt. fell asleep, mom called ER, who said they could not give out phone advice. Mom stayed up et observed pt, who slept peacefully the rest of the night et awoke "acting normal" today. She gave pt. TYLENOL this AM, then brought him in for office visit. Temp 99.4. Pt looks and acts normal, except for thick greenish nasal discharge. Family notes history of febrile seizures in 3-4 other relatives, none prior for this child.
-Presented to ED with complaint of fever onset yesterday. Had the 2nd COVID-19 2 days ago. He has been having fever since yesterday morning running 102.7-103.9F. Called PCP and was advised to present to the ED yesterday but he did not. He fell after losing his balance today. Endorses nausea, confusion. Has extensive medical history. Patient has signs of sepsis with likely bacterial infection acute cystitis/pyelonephritis.  His lactate and procalcitonin are unremarkable and vitals remained stable however he does have an elevated total bilirubin as a possible sign of a more serious systemic response.  The patient does have chronic cirrhosis and persistent fever and tachycardia.  Given these clinical findings he is referred for admission for IV antibiotics and further close monitoring. Unfortunately, urine cultures were not sent.  His blood cultures however did grow 2 of 2 bottles positive for Klebsiella pneumonia.  These are both sensitive to Levaquin.  In the course of his hospitalization, he has improved.  He is now requesting discharge.  Will discharge home on p.o. Levaquin.  Is discharged in improved condition.
Information has been received from a pharmacist referring to a 63 years old female patient. The patient had chickenpox as a child, and had a shingles outbreak, 12 years ago. On an unspecified date employer testing showed no varicella immunity and patient received a first dose of VARIVAX (Merck) (dose, route and lot# were not reported) on an unspecified date. The patient developed a "large red reaction" after being administered. Pharmacist reported a titer, obtained on an unspecified date following the first dose of VARIVAX (Merck), showed immunity. Pharmacist reported it was unknown if patient received a second dose of VARIVAX (Merck). The outcome of the event was unknown. Causality was not reported. Additional information has been requested.
Received Varicella vaccine, now has questionable chicken pox reaction (5 blisters, four on face and one on tongue), as reported by mom, which is starting to scab over. No other serious adverse events. Patient has not seen her pediatrician or other medical provider.
Patient received 0.5 ml of Moderna 6mo- 5 yr vaccine instead of 0.25 ml
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Eczema" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 31Mar2023 to 05Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache & Myalgia dose 1 -day1-3 pain at inj site;redness at inj site day 7-10; day 1-3-ha; fatigue
pt recv vax & cried inconsolably nearly 24hr immed p/vax;family called ER told nl rxn to vaccine;sought no med care;temp to 102, local redness & swelling @ site DTP/HBOC;
Fever Started 3 hours post injection. Localized welts on arm where injection was administered.
This a continuation of worsening symptoms since report on September 30, 2021. My left side paralyzed, couldn't move left leg. I had to go to the hospital and given steroids. I received home health through my health insurance to help with daily activities (showering) and physical therapy. I went back to work on November 23, 2021 and had a seizure. Now, I have to go back to the hospital.
15mo old began having a febrile illness approx 8 days p/receiving his 1st MMR/HIB vax; temp to 102(ax) & febrile convuls; 2 days prior to admission pt began having sx of URI w/rhinitis, cough, congestion & fever worse apneic & cyanotic;
Patient reports swollen red area at injection site. After assessment of medical history, I recommended ibuprofen and asked patient to consult primary care.
1/29/21 - 11 am and beyond - headache and fatigue, sore arm 1/29/21 - 11 pm - fatigue, shaking chills, fever, nausea, headache, joint pain.  Max temp 102.1F overnight. 1/30/21 - all day - fatigue, intermittent fever with chills (max 100.5 F), headache, sore arm 1/31/21 - non-itchy, non-raised rash on torso and under chin, sore arm
Slight fever; Sore injection spot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever) and VACCINATION SITE PAIN (Sore injection spot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced PYREXIA (Slight fever) and VACCINATION SITE PAIN (Sore injection spot). At the time of the report, PYREXIA (Slight fever) and VACCINATION SITE PAIN (Sore injection spot) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided.
On the 5th day patient woke with nausea and extreme exhaustion and weakness in legs. After a few hours nausea subsided but limb weakness persisted. Patient had a hard time walking unassisted. Visited Dr office in early afternoon where neurological assessment occurred. Patient limb strength was normal while seated. All other tests passed. Patient tested negative for covid in pcr exam that day. Symptoms increasingly improved over next few days and symptoms are non existent 1 week following second vaccination on June 5th
15 mins p/adm of vax rt eye began to redden & swell; itchy;
7 days later I have broken out with a rash at or just below injection site.  It is sore, itches, red, and warm.
Mom called day after vaccination, stated pt. had HPV and flu shot yesterday.  Went to schoool today, school nurse called mom to get him, had rash all over.  When she saw him, he had hives all over his body, looked beet red.  No lip swelling, or shortness of breath.  She gave him 25mg. of Benadryl. Nurse advised to give another 25mg, pt improved, but had flare ups of hives all over body for next two to three days requiring hydroxyzine, before resolving. Did not require any other therapy or physician visits. Parents and physician agreed he will not get the HPV again.
following day had muscle aches. Then day after with muscle aches and loose stools for multiple days
Information has been received from a physician concerning a female with papilloma viral infection who was vaccinated with a 0.5 ml dose of Gardasil (lot # unknown). Subsequently the patient "came back" and seemed to have a worst condition then before of the papilloma virus. Unspecified medical attention was sought. At the time of the report, the outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a licensed practice nurse refers to a multiple unspecified patients of unknown age and gender. No information regarding concurrent condition and medical history was reported. On an unknown date the multiple unspecified patients were vaccinated with M-M-R II (strength, dose, unit, lot number, expiry date and route were unknown) which was stored improperly. No concomitant therapy was reported. No adverse event was reported. The outcome of event was unknown. No further informaiton was provided. This is one of several reports received from the same source. Additional information is not expected.
hives on stomach and upper thigh (left). injection on 07/18/2019 and noticed hives around 7pm. still present today 07/21/2019
Sore Arm; Pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and PAIN IN EXTREMITY (Sore Arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Hepatitis A (Hepatitis A treated in 2007.) on 31-Jul-2007. Concurrent medical conditions included Asthma since 14-Nov-1990 and Placenta previa. Concomitant products included FAMOTIDINE from 01-Jan-2021 to an unknown date for Heartburn, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 20-Oct-2020 to an unknown date for an unknown indication.    On 14-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Sep-2020 and the estimated date of delivery was 22-Jun-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 14-Jan-2021 at 1:00 PM, the patient experienced PAIN IN EXTREMITY (Sore Arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  On 14-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. On 15-Jan-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2020, Pregnancy test: positive (Positive) positive. On 11-Nov-2020, Ultrasound foetal: 1 fetus 1 fetus. On 17-Dec-2020, Ultrasound foetal: placenta previa Placenta previa. On 26-Jan-2021, Ultrasound foetal: low line placenta (Low) low line placenta. On 28-Mar-2021, Glucose tolerance impaired: passed- 1 hour test Passed- 1 hour test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (Sore Arm) to be possibly related. No further causality assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy).    On 14jan2021, post vaccination, the patient reported that she experienced symptoms of pain in extremity and exposure during pregnancy.  No treatment information was provided   Follow-up information on 16 APR 2021, included concomitant medications and event for second dose.   This case was linked to MOD-2021-086690 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Internal review on 20jul2021 resulted in updates to pregnancy information On 16-Apr-2021: No specific follow-up information recorded.
c/o subjective fever, N/V, h/a, chills, and generalized body aches after receiving 2nd dose of Moderna COVID vaccine yesterday AM.  HPI: 32yo M presenting to ED for generalized malaise and HA. He received MODERNA COVID #2 vaccine yesterday. HA is not first/worst/max at onset, no chest pain or dyspnea, no focal neuro deficits. Pt has no acute neuro findings- unlikely CVA. Not likely PE/DVT, no evidence of dysrhythmias, unlikely anaphylaxis. F/u and return precautions discussed.
Second dose of the vaccine to be scheduled more than 36 days after the first dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the vaccine to be scheduled more than 36 days after the first dose) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the vaccine to be scheduled more than 36 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the vaccine to be scheduled more than 36 days after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment drug information provided. No concomitant drug information provided.   Reporter did not allow further contact
To ED 1/28/2021- 17:06 complaints of racing heart, and increased blood pressure. ED - B/P 200/107- very anxious. Administered 0.1mg oral Clonidine and B/P significantly improved - at discharge B/P 177/76.