chrisvoncsefalvay/vaers-outcomes huggingface dataset:
one of vaccines was not reconstituted, the child received only diluent with no reported adverse event; Initial information received on 15-Jun-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 4 years old male patient who experienced one of Yellow Fever Vaccine [YF-VAX] was not reconstituted, the child received only diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Jun-2023, it was reported that 0.5ml dose of suspect Yellow Fever Vaccine Solution for injection (lot number and expiry: not reported) was not reconstituted and the patient received only diluent via intramuscular route in unknown administration site for immunization, with no reported adverse event (product preparation error) (latency: same day). Information on the batch number was requested.  Reportedly, Pharmacist stated that yesterday, a family came in to have their children receive the YF-Vax prior to travel. But due to HCP error, one child received the YF-VAX, the other child received only diluent. The administering pharmacist does not know which child got the reconstituted vaccine and which received diluent only.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event one of vaccines was not reconstituted, the child received only diluent with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 18-OCT-2012 17:40, 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.
Client informed vaccinator of  itching on back 3 hrs after receiving vaccine that has been intermittent until today. Client denied any shortness of breath or hives. Per client has been using Hydrocortisone cream as needed.
Patient received rabies vaccines 11/20/20. The next day developed nausea, vomiting,  diarrhea and headache.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and 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. Clinical course: The patient received Paxlovid from 21Mar2023 to 26Mar2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300143739 same patient, different product/event;
Severe nausea and diarrhea, so severe I was dehydrated within two hours of onset.  I passed out 3 times and taken to the ER.  At the ER I got IV fluids and 3 doses of nausea meds It was at the ER I tested positive for covid.
Couple of red spots on left arm 1 to 2 inches in diameter in one of the spots has a hard knot. I recommended using ice, TYLENOL/ibuprofen and BENADRYL and to contact dr. Pt went to ER 9/29/17. Pt received cephalexin for cellulitis.
Patient received this dose of Moderna vaccine at Pharmacy on 12/7/21, but came to the Health Department (12/9/21) as they are her Primary Care Provider. Vaccine was given in the left arm and appeared to have been given in the middle of her upper arm instead of the deltoid area. There was a round, red area approximately 2 inches in diameter that was warm to touch and sore. She also had an area under her arm that was sore. She reported having a slight headache yesterday and some mild pain in her chest on that side. She had to leave to take her mother to the hospital for an appointment, but agreed to return to be evaluated by the MD today. She no longer has a headache or chest pain today.
One day p/vax pt devel painful, swollen red inject site; Swelling & pain progressed to involve superior half of upper extremity; resolved slowly over next wk;
Acute onset of fever and joint/body aches as of 7:00AM (upon awakening) the next morning. Fever worsened throughout the day peaking at a measurement of 102.6F. Fever decreased to 101F at bedtime, broke overnight and then recurred at around 101F the following evening. By Monday morning (10/24/22) the fever and body/joint aches were both resolved. Joint and body aches persisted for nearly 48 hours total after vaccination. No local reaction until Tuesday 10/25/22. Local reaction of slight redness and itchiness at injection site. Has not completely resolved at the time of report, but has significantly decreased.
Local expanding redness noted 1 d after vaccination w/ DTaP and IPV immunizations. 9 cm well demarcated redness and 7 cm induration at mid (R) thigh.
Faint feeling, near black out when standing. Nausea and very loud ringing in ears. Chills and fatigue. Had to miss work.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) GARDASIL injection (lot # L014415, exp. date: 25-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
First dose of Pfizer COVID-19 administered to patient who was less than 12 years of age. No adverse effects have been reported at this time. Patient will be 12 on 9/19/2021.
Received Fluzone vaccine 0.5 IM RD. Within 30 minutes of receiving vaccine, experienced facial swelling, became real tired and went to sleep. Also has had mid back pain. Swelling decreased this AM. This person presented to this clinic at 0815 10/27/06. Positive orbital swelling. Given Benadryl  PO. BP 104/80, AP 76. No acute distress at this time.
Severe headache, nausea and vomiting >20x the next morning , dizziness, injection site redness, swelling, and tenderness. Stomach cramps Took zofran for vomiting. Nausea, headache, and dizziness lasted x 72 hours after injection Tylenol and Motrin also used which provided no relief
muscle cramps on both legs; having hard time getting up; chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (Fever), MUSCLE SPASMS (muscle cramps on both legs) and MOVEMENT DISORDER (having hard time getting up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (chills) and PYREXIA (Fever). On 10-Feb-2021, the patient experienced MUSCLE SPASMS (muscle cramps on both legs) and MOVEMENT DISORDER (having hard time getting up). At the time of the report, CHILLS (chills), PYREXIA (Fever), MUSCLE SPASMS (muscle cramps on both legs) and MOVEMENT DISORDER (having hard time getting up) outcome was unknown. Not Provided
At first just sore arm at injection site. Within the next 2 hours I started with an irregular heartbeat, slight headache and fatigue, along with pain in my left elbow and right knee. Later that evening the pain in my injection arm increased to the point I could not raise or touch the arm. This morning the pain in the left arm just below the injection site was worse. A headache and fatigue remained with some irregular heartbeats throughout the day. HOWEVER, the WORST is the joint pain. My left elbow is not so bad anymore but the RIGHT elbow is in horrible pain which started around 2pm today and it will not go away. I had Flexeril in my system from 9pm last night, Excedrin this morning, 800mg Ibuprofen at 3pm this afternoon and even tried topical relief such as Biofreeze and Lidocaine. STILL no relief from the left arm pain or the xtreme joint pain in the right elbow. The other joint pain in other areas is more of an ache and more intermittent. I'm still very fatigued as well, but that is manageable.
Information has been received from a consumer who posted her daughter's experience on internet. On unspecified dates, the patient was vaccinated with a first, second, and third dose of GARDASIL. It was reported that her 17 year old had been suffering from the side effects of GARDASIL vaccine since February 2009. She complained of muscle and joint pain after the first shot, and even more after the second one. The reporter did not know it was a side effect. The third shot pushed her little body over the edge. She started having non epileptic seizures, severe muscle spasms in her back; she was totally fatigued all the time still. Her physician says she had a neurological disorder. Sometimes it went into her eyes, causing them to quiver and roll back into her head. This week, on approximately 21-SEP-2009, she lost her vision, could only see images. It was a very scary thing for everyone involved. It seemed like once one thing slows down, something new comes up. She was a SR and cheerleader at school, she was fighting very hard to continue to be an honor student. but it was taking a toll on her. She slept a lot her social life was pretty much nothing was difficult for the reporter to watch her daughter struggle every single day. It was difficult to put a smile on and look her in the eyes and tell her "we will get through this". When she lay in bed, she wondered if we will. His daughter was a healthy active teenager prior to the GARDASIL vaccines. Upon internal review, non epileptic seizures and lost her vision, could only see images were considered to be other important medical events. No further information is available.
Minor itching of face and neck; This is a spontaneous report from a non-contactable healthcare professional (patient).  A 36-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, expiry date EL1284), intramuscular on left arm at 07Jan2020 07:30, intramuscular at a single dose for Covid-19 immunization. The patient has no medical history.  Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient previously took bnt162b2 as first dose for Covid-19 immunization and experienced severe headache and body ache. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 7:45, the patient experienced minor itching of face and neck during the second dose. The patient underwent lab tests and procedures which included nasal swab with negative result on 21Dec2020. There was no treatment received for the adverse events. Outcome of the events was recovered in Jan2021.  No follow-up attempts are possible. No further information is expected.
oral pain inside his mouth/bothersome than painful; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (oral pain inside his mouth/bothersome than painful) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1003B21A) for COVID-19 vaccination.     The patient's past medical history included Oral surgery NOS. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) and LOSARTAN for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced ORAL PAIN (oral pain inside his mouth/bothersome than painful). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ORAL PAIN (oral pain inside his mouth/bothersome than painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had some extensive oral surgery on his right side in his 20's and wondered if that is why he was experiencing this symptom.
14FEB91 had elevated temp of 104 given Tylenol temp down to 101 & 102 range; temp elevated less than 24 hrs.
Patient had seizure (focal) after 2-5 minutes when vaccine given. Patient diagnosed with epilepsy last year. Has not had this with prior vaccines, he says this happens with Dental work. He was able to communicate and was alright. He sat 30 min - 1 hour, had some water, and said he was fully recovered as this happened before, patient not upset.
Bradycardia, premature ventricular contractions at 21%, LV severely dilated with moderately reduced systolic function, LVEF = 39.8%, right ventricle moderate-severely dilated with normal ejection fraction, RVEF=54.6%,dilated atria (right greater than left), aortic regurgitation, elevated T2 values suggestive of myocardial edema, myocarditis.  Treatment with Lisinopril 5 mg began 5/19/21.
Sore injection site & arm,  fatigue, headache, muscle aches for 4 days.
3 hours after flu shot patient noted pain in arms & legs, & headache that lasted for 1 wk. Along with those she noted a slight loss of hearing in both ears. She says she can hear but not so much of low pitches. An increase in sensitivity of high pitches ~ 2 wks without any resolve. She says it may have been viral but not sure.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 27-FEB-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J008433 and expiry date: 11-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Immediately after injection vaccine patient vomited one time. No respiratory distress no chest pains, no hives rashes, no LOC BP 120/78.  patient was observed for 30 minutes no further episode of vomiting. Instructed care giver to seek medical attention if any difficulty breathing, selling of throat lips face further vomiting. Patient was called following morning and caregiver reported patient had no further episodes of vomiting.
around 11 pm on the day of the vaccine I started to feel body aches throughout my whole body as well as a headache, and joint pains. Took 2 advil every four hours to help sleep and the symptoms are still present at 6 pm the next day
Received 100mcg Moderna COVID-19 booster instead of 50mcg approved dose.
Pain, weakness and decreased range of motion of L arm since 11/3/05 when Pneumovax injection was given in L arm (deltoid).  Affects entire arm from L shoulder to forearm (on of sensation.  Seen in clinic 1/3/05 and 1/19/05 with same symptoms.
100.3 Fever, pain in abdomen, headache, fatigue, severe congestion, severe cough lasting for 3 days or more - today is the third day. Concerning as I am 27 weeks pregnant. Taking Robutussin and Tylenol to treat symptoms
red hives, it grewdiameter of an orange; hotness; redness; itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (red hives, it grewdiameter of an orange), INJECTION SITE WARMTH (hotness), ERYTHEMA (redness) and PRURITUS (itchy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included EPINEPHRINE (EPIPEN) for Allergy, SALBUTAMOL (SALBUTEROL) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced URTICARIA (red hives, it grewdiameter of an orange), INJECTION SITE WARMTH (hotness), ERYTHEMA (redness) and PRURITUS (itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. On 14-Jan-2021, URTICARIA (red hives, it grewdiameter of an orange), INJECTION SITE WARMTH (hotness), ERYTHEMA (redness) and PRURITUS (itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up received on 05 May 2021 included no new information.
Weakness; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 11Apr2021 at 00:45 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and anemia. The patient had no allergies to any medications, food, or other products. Concomitant medications included guaifenesin (MUCINEX) and antibiotics (unspecified) both for unknown indications from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 00:45, the patient experienced weakness and dizziness. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events weakness and dizziness were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
After 12 hours, I had body chills, body aches, slight fever and a massive headache.
Within 48 hours I had chills, muscle aches, and fatigue. This progressed over the next several days to severe muscle aches, muscle weakness & cramping, fatigue, numbness/heaviness in arms and thighs, pain down the spine, headaches and brain fog, night sweats and chills without a fever. My PCP did lots of lab work and I'm currently on my second round of prednisone.
Shingles all over body. Patient reports having shingles on penis and buttocks. Also reports MD stated having shingles on his bowels/intestine.
Patient's Mother states child broke out in hives on 12/16/2009 that have persisted and areincreasing. Mother agreed to administered Benadryl, was advised that child needed to be seen, Mother refused.
Rapid weight loss over 20 lbs within 10 days Loss of memory worsening over time/brain fog  Initial reaction immediately was very intense strong smells  getting less intense over time
Patients were administered doses from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  The vial was initially stored in the refrigerator on 03 Jan 2022. They were kept in freezer since arrival until 03 Jan 2022 before use. The vial did not undergone any temperature excursions.   This case was linked to MOD-2022-438672, MOD-2022-438670, MOD-2022-438673, MOD-2022-438676, MOD-2022-438657, MOD-2022-438669, MOD-2022-438671, MOD-2022-438674, MOD-2022-438677 (Patient Link).
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 19-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # L008660, expiration date 10-NOV-2016. No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 920, 34 and R; 168, 32 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax & devel thrombotic thrombocytopenic purpura;