chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion); Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant drugs were not reported.  Treatment details were not given.
There was no adverse event reported by patient. Due to the refrigerator temperature excursion on 8//2/16. Manufacture determined the vaccine is not viable and CDC recommend revaccinate.
Janssen COVID-19 Vaccine EUA (Injected IM in Lt Arm on May 4, 2021 at 10:10 am) May 4, 2021 at 6 pm I experienced chills (no fever). During the nights I experienced chills alternating with sweats (no fever). When I awoke at 6 am on May 5 and stood I was very dizzy - enough that I had to brace myself with the wall to walk to the bathroom. Dizziness persisted all day on May 5. I had no further chills nor sweats and continued to be afebrile. On May 6 I was still dizzy but it was not as severe. On May 7 (today) I continue to have dizziness and some nausea but, again, it is not as severe as on May 5.
He did not feel pain to the injection site. On the following day he went to school, he began vomiting with non stop. I gave him medication for the vomiting. I took him to the ER  on 08/27/2022.  He had trouble breathing and like an asthma attack. He had no temperature and began with cough spasms, mucus, nasal sputum. His symptoms worsened and they did diagnostic tests and when they did lung tests they  noticed he had shortness of breath and cough. They gave him therapy with the oxygen and the right lung had some problems with his breathing. They gave him Albuterol and Ondasentron which helped him control his symptoms. Today he is doing alot better and is taking Pedialytie and Pediasure.  Before the vaccine he had no problems with asthma or trouble breathing.
Fever 102.5-103.7 degrees F rectal for at least 10 days started 4 days after immunization
Pt was administered a spoiled dose that had been sitting out about 48 hours. Soreness, itching, upset stomach and tiredness.
ankle swelling; Initial information received on 07-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 23 years old female patient who experienced ankle swelling after receiving vaccine Diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Oct-2022, the patient received dose 0.5 ml Once (1x) (total) Diphtheria-2/tetanus/5 AC pertussis vaccine suspension for injection with strength: Unknown (lot- U7461AA, expiry date- 12-JUL-2024) via intramuscular route in the right deltoid for immunization.  On 31-OCT-2022 the patient developed ankle swelling (joint swelling) latency: 4 days following the administration of Diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (ankle swelling).  Outcome : Not Recovered / Not Resolved.
Case number PHEH2016US023426, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 59 years old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, into left arm on 29 Feb 2016. On 29 Feb 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion was administered to patient. No adverse event was reported following this medication error. The case was assessed as non-serious by the nurse.
PATIENT WAS CALLED BY OUR PHARMACY TO CHECK IF PATIENT WAS OK AFTER ADMINSTERING THE VACCINE. PATIENT REPORTED HE WENT TO THE EMERGENCY ROOM THE EVENING AFTER HE GOT THE SHOT.  HE REPORTED A HEART RATE OF OVER 120.  HE STATED THAT HE FELT HIS HEART RACING AND DECIDED TO GO TO THE EMERGENCYROOM AND WAS OK AFTER THAT.  THE PATIENT DID NOT TELL HIM WHAT HE WAS TREATED WITH.
After he got his 2nd dose of the Covid-19 vaccine and his right axillary lymph nodes were swollen; This is a spontaneous report from a contactable pharmacist (patient). This pharmacist reported similar events for 2 patients. This is the second report out of 2 patients. This case is non-serious. The other case is serious, medically significant.   A male patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. While reporting on another patient, the pharmacist also mentioned that after he got his 2nd dose of the Covid-19 vaccine and his right axillary lymph nodes were swollen. He said that it was not enough to report. He stated that a lot of people have reported it and it it was also reported during the clinical trials. The caller declined to complete a report on himself. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018520 same reporter and drug/similar event/different patients
(over) 2021 Hosp July 14 - Wound Clinic - Adressed the open leaking        20 Wound Clinic sores on my legs and healed        29 and Aug 3 my legs in 4 visits July 19 Care Clinic - Dr. did thorough exam of my eyes and (shot in my eye and IV meds to stop the blood vessel problem) Aug 30 Care Clinic - check up - Dr.: Next Appt Nov 29. Aug 10 Clinic Labs (white count still high 29000) and APNP Sept 20 Dr -Hematology - check for cause of 29,000 white count.  Results pending Recommends: no booster shot.
expired dose of daptacel was administered to a patient with no reported adverse event; Initial information was received on 16-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 1 years old female patient who reported expired dose was administered to a patient with no reported adverse event after receiving diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR).  On 16-May-2023, the patient received a 0.5 ml, total (once) dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (lot:C5893AA, expiry date: 11-May-2023, strength: standard) via intramuscular route in left thigh for Immunization.  On 16-May-2023 the patient had expired dose of daptacel was administered to a patient with no reported adverse event (expired product administered) same day following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the 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.
Pt recvd vax & 2 hrs later exp discomfort @ site of inject;
Menstrual cycle irregularities 2 weeks after 1st dose of vaccine. Occurred at least 4 months after 2nd dose of vaccine.  Symptoms include: - Early period start date - Late period - Intense PMS symptoms (cramping which is uncommon for my cycle)
Menstrual cramps and bleeding following the second shot have become severe, causing loss of sleep, dizziness, pain, and impacting ability to work
Headache, fever, body ache, fatigue the next day after vaccine. Fever, body aches, and fatigue went away the next, headache went away 2 months later.
cc: L upper arm pain 8 days post Moderna vaccine received. with swelling, redness.  Cold compress applied yesterday. Took advil 200 mg po last night and Claritin 10 mg po last night.
Daughter contact store and state that her mom experience some CNS issues 30-45 min after receiving the booster on 3/7/22.  Daughter states that mother was speaking gibberish and non-coherent.  Daughter took mother to the emergency room.
Extreme irritability, redness and swelling of thighs. Mom stated patient woke up screaming and unable to calm down for several hours after shots. Mom had to give several doses of Tylenol.
arm pain/sore arm; small red rash in the upper arm; small patches that feel rough inside the mouth; burst blister that do not hurt; spots in the mouth; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain/sore arm), RASH ERYTHEMATOUS (small red rash in the upper arm), ORAL MUCOSAL ROUGHENING (small patches that feel rough inside the mouth), BLISTER (burst blister that do not hurt) and MOUTH ULCERATION (spots in the mouth) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     Concomitant products included Ritalin for ADHD for ADHD, Eyedrop for glaucoma for Glaucoma, Medication for hypothyroidism for Hypothyroidism.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain/sore arm), RASH ERYTHEMATOUS (small red rash in the upper arm), ORAL MUCOSAL ROUGHENING (small patches that feel rough inside the mouth), BLISTER (burst blister that do not hurt) and MOUTH ULCERATION (spots in the mouth). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (arm pain/sore arm), RASH ERYTHEMATOUS (small red rash in the upper arm), ORAL MUCOSAL ROUGHENING (small patches that feel rough inside the mouth), BLISTER (burst blister that do not hurt) and MOUTH ULCERATION (spots in the mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received first dose of Moderna Covid-19 vaccine on 16May2021. It was administered on the right dominant arm. Patient's arm was sore and developed a small red rash in the upper arm. But was concerned patient was a something never experienced before:  small patches that feel rough inside the mouth (inner part of cheeks). Patient described it as "burst blister that do not hurt" and "spots in the mouth". This last symptom has not subsided. Patient is nervous on getting second dose. Patient took Tylenol.
Patient states 12hours after vaccination her hands started to get hot on both arms. Patient reported problem 12-9-16. At this time she states the problem has improved but her hands still feel hot on a daily basis.
Vaccine administered came from vial that was kept in fridge longer than manufacture recommended storage date. The manufacture informed us via written statement that patients "maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration." Revaccination was not advised. We called the patient to inform them of the situation and the information we received from the manufacture. They did not have any adverse reactions.
The patient came back to the pharmacy 2 days after getting a shingles vaccine and experienced a large red and warm bump at the injection site.  She was counseled to try taking Benadryl and to get checked out with a physician. According to the patient, she went to urgent care and they told her the site was infected and was given a prescription of Biaxin. Two days after starting antibiotic therapy, the patient reported the symptoms have diminished.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: This was a reaction to FLUAD not covid it would not let me leave that area blank
patient reports normal pain no different from any other immunization, however the pain never subsided, even after several days. It has now been almost a full 30 days, and patient states "dull pain when using arm, hurts to pick anything up, hurts to lift arm high."
On 10/4/13 - was screened and had (L) shoulder pain with ROM. Pain worsened on next day 3-4 out 10 with extend shoulder (L) ROM. Returns 2/27/14 for shoulder pain.
CHILLS, FREQUENT URINATION, SLEEPLESSNESS: 1 TO 4 AM; THEN EXTREME SWEATING (WITHOUT FEVER) AND DIZZINESS/VERTIGO: 4 TO 6 AM. BOTH TREATED WITH BEDREST. 6 AM TO NOON, HEADACHE, MALAISE AND LOSS OF APPETITE. TYLENOL AND BEDREST.
Pt starting experiencing hives through out the body following 24 hours after vaccination. She had also experience elevated heart rate 140 thereafter.  Pt was seen in clinic and was giving saline and has since been stable.  Prior to that, she had taking benadryl along with ibuprofen/tylenol .
Violent vomiting 14 hours after second dose; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 14:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) and the patient was not taking medication. The patient had no known allergies to medications, food, or other products. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 04:00, the patient experienced violent vomiting 14 hours after second dose. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event violent vomiting 14 hours after second dose was resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist concerning his approximately 17 year old daughter with no known drug reactions or allergies and that smokes cigarettes who on 24-OCT-2007 was intramuscularly vaccinated with the first dose of GARDASIL and on 29-SEP-2009, received her second dose of GARDASIL. Concomitant therapy included unspecified oral contraceptive. The pharmacist reported that in June or July 2009, his daughter had an abnormal PAP test, the result was positive for GARDASIL. It was reported that the abnormal PAP test was before the patient received the second dose of the vaccine. The patient sought medical attention by a physician office visit. At the time of the report, the patient outcome was unspecified. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. This is one of several cases reported by the same source.
"2nd dose 150 days after the first dose,still can working; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION ("2nd dose 150 days after the first dose,still can working) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION ("2nd dose 150 days after the first dose,still can working). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION ("2nd dose 150 days after the first dose,still can working) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
Onset Severe headache, fever to 101.9 on 10/22/01. Saw MD , Prescribed Bactrim for possible sinus infection, 2nd dose pre-exposure rabies vaccine 10/26/01, Onset of sharp, intermittent muscle pains; itching, burning skin sensation without rash, "pins and needles", sensation legs. Returned to MD on 10/31, Contacted health department 11/01/01.
says it is spotting like period blood; first dose, there was blood in the urine/second dose, there was blood in her urine again; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Mar2021 (lot number: EN6208), dose 1, single and on 30Mar2021 (lot number: ER8734), dose 2, single; both via an unspecified route of administration at the age of 79-year-old for COVID-19 immunisation. Medical history included menopause. The patient's concomitant medications were not reported. In Mar2021, 3 days later the vaccination, the patient went to pee and there was blood in the urine. The patient went to the doctor and they checked her urine and there was blood and they said they did not know where the blood was coming from. The patient took an anti-biotic cephalexin (Keflex) 500 mg for 10 days. The bleeding stopped 3 days later after she started the treatment medication. The patient stated there was no more bleeding when she peed for 10 days. Then the patient took the second vaccine around 10:00 in the morning and a couple hours later (about 02:00) she went to pee and there was blood in the urine again. It was kind of suspicious she has never bled since menopause at like 40, she has never bled all these years it was kind of strange she just wanted to tell about her experience. The patient stated she called her gynecologist on 31Mar2021 and she was going to go take a test at 01:45 and see what they say at the hospital. She said it was spotting like period blood and she said it was persisting on 31Mar2021 about the same as on 30Mar2021. The patient further stated, when she peed this morning, a lot of blood came out. The outcome of the events was not recovered.  No follow-up attempts are possible; No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366596 Pfizer
Information has been received from an office manager concerning an 18 year old male patient who on 14-JUN-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number unspecified). The office manager reported that after the three doses of RECOMBIVAX HB were given to the patient, all blood work (hepatitis B surface antibody) came back negative, not immune (lab was less than 5); requiring a fourth dose of the vaccine. The patient was vaccinated with lot# 603895/0748V but it was unknown which dose. The hepatitis B surface antibody was repeated a month after the fourth dose was given to the patient. On 15-JUL-2010 the result was 660. The patient did not develop hepatitis B. No other adverse experience was reported. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The office wanted to know if lot# 603895/0748V was associated with failed immunity. Follow up information has been received from the office manager who reported that the patient was vaccinated twice with RECOMBIVAX HB (lot number lot# 603895/0748V) on 30-SEP-1992 (at the age of 24 weeks) and on 02-DEC-1992 (adult dose), as an infant. The office manager could not confirm if the vaccines were stored correctly back in 1992. A lot check has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of RECOMBIVAX HB. Additional information will be provided upon finalization of this manufacturing investigation. Follow up information has been received from a physician via medical records concerning the now 24 year old male who on 30-SEP-1992 was vaccinated with the first dose of RECOMBIVAX HB (Lot number 603895/0748V) in the right leg. On the same day the patient received a second dose of ACEL-IMUNE (Lot number 318-908) in the left leg, ORIMUNE (Lot number 32093206530) orally and HIBTITER (Lot number M125JD) in the right leg. On 02-DEC-2009, the patient received the second dose of RECOMBIVAX HB (Lot number 603895/0748V) in the right leg. On the same day the patient received the third dose of ACEL-IMUNE (Lot number 330910) in the left leg and HIBTITER (Lot number M020JE) in the right leg. On 16-APR-1993, the patient received the third dose of RECOMBIVAX HB (Lot number ENG1108A2). On 05-JUN-2010 the patient underwent an anti-hbs antibody which was <0.5 (did not have immunity to hepatitis B virus) and his varicella zoster virus Ab was 1.75. On 14-JUN-2010, the patient received a booster dose (4th dose) of ENGERIX-B (Lot number AHBVB789AA) and on 13-JUL-2010 his anti-hbs antibody was 660 (Immunity to Hepatitis B virus). This is one of several report received from the same source. Additional information is not expected. The patient had laboratory work (hepatitis B surface antibody quantitative).
Patient received Fluad 65+ instead of pfizer booster. She had just got her flu shot last week so this was a duplicate as well as the wrong dose