chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 4:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 4:14 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 39.07 Years.   Concomitant products were not provided.   On 27-Apr-2021, Excursion time was 09:00 AM, temperature was 35, total doses given for the day was 42, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 27-Apr-2021. 8 vials were sent to clinic. Vaccine BUD date was 19-May-2021.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.   Temperature recordings were taken using a traceable temperature monitor at every hour.   After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.   Treatment medications were not reported.
Rash on back of neck Saturday evening 06/01/02. On Sunday afternoon, the patient was scratching both arms and rash was on both arms. On Sunday night, rash was noticed on her abdomen,chest, back and legs. On Monday, her eyes were swollen, Taken to doctor, Doctor  stated probably vaccine reaction and prescribed (?),Referred to HD. Rash on back, abdomen, arms, legs and face, red & raised.
Felt warm, neck aching, shortness of breath, blurred vision. Called family Dr and ordered an Allegra 24 hr. Took BP 137/91 And BS 84. Remained in pharmacy for one hour for observation. I walked her to car and felt good. She reported back to me at 6pm and 8pm no more symptoms.
10/26/10 - Bell's Palsy, temporary paralysis to right side of face, symptoms started 10/25/10
Red rash and blisters on right leg and foot started on 04/17/2021 a couple days after the Moderna vaccine and continued to worsen over the next 5 days.  On 04/22/2021  dermatologist confirmed the condition was shingles.  He prescribed Valacyclovir (Valtrex) for one week.  The condition is starting to clear up now on 04/26/2021.
I started with left arm soreness and swelling around the injection site..  Starting about 3 days after vaccine I started experiencing intermittent headaches and fatigue that lasted 8 days.  Day 8 was the worst with extreme fatigue.   The left arm soreness improved but remained..  After 8 days it all improved except the arm soreness which improved after a massage.
Initial unsolicited misuse report received from a consumer on 26-SEP-2016. This case involves a 47-year-old female patient who was vaccinated with a dose of FLUZONE ID (batch number, expiry date, dose, dose in series were not reported) subcutaneously, in left deltoid on 25-SEP-2015. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications were not reported. On 25-SEP-2015, eight hours following the vaccination, the patient developed flu like symptoms, exhaustion, body aches and temperature of 100.5 Fahrenheit. On 27-OCT-2015, one month following the vaccination, the patient's right eye vision loss occurred. On an unspecified date, the patient was seen by MD and eye specialist and was diagnosed with optic nerve neuritis with permanent vision loss. It was a case of incorrect route of drug administration as as the vaccine FLUZONE ID was administered subcutaneously. It was reported that the patient required emergency room/doctor visit. Lab data and corrective treatment were not reported. On an unspecified date, the outcome of the events flu like symptoms, exhaustion, body aches and temperature of 100.5 Fahrenheit was reported as recovered (Symptoms lasted 4 weeks) whereas the outcome for right eye vision loss, optic nerve neuritis with permanent vision loss was unknown. Upon medical review, the case was considered as serious due to important medical event: optic nerve neuritis with permanent vision loss. List of documents held by sender: none. Sender's Comments: This case concerns 47 year old female patient who received INFLUENZA USP TRIVAL A-B INTRADERMAL ADULT SUBVIRION VACCINE and 8 hour later developed flu like symptoms, exhaustion, body aches, temp of 100.5F. One month after vaccination patient developed optic neuritis and vision loss. Time to onset of events is compatible. However patient's medical history, concomitant medication, concurrent condition, other etiological work up, investigation results will be needed for complete assessment of case. Based on available information role of vaccine cannot be ruled out.
Per review patient's caregiver request for pt to receive pedi dose instead of adult dose.  vaccinator proceeded and administered pedi dose to patient before follow-up with clinical coordinator.  Event was discovered after the fact dose was given.  No side effects reported to the writer at the time of this report.  Pt's guardian was talked to and 2nd dose appt was canceled as pt and pt's guardian were deferred to follow-up with doctor for any special dose requests for future doses.
For approx 36 hours I was disoriented, panicked and in emotional distress.  I cried often and felt my heart racing.  My arm was in significant pain and I felt sick to my stomach.     My  cognitive ability was diminished, and I struggled to understand situations.  For example, my husband had placed a glass of water on the floor beside him and I couldn?t figure out how to move around it.   The cognitive/emotional symptoms passed in about 36 hours.  However, 3 weeks later my arm is still tender if I touch the injection site.
Insomnia.  I also had insomnia after my first dose. I felt very sleepy right after I took my first and second dose for a few hours- and then I had bursts of energy.
This spontaneous report was received from a pharmacist refers to a 56-year-old female patient. The patient's pertinent medical history and concomitant medications were not reported. The patient's concurrent conditions included allergy to penicillin and azithromycin. On 09-AUG-2018 the patient was vaccinated with PNEUMOVAX 23 lot # R002354, expiration date 17-DEC-2019 (dose not provided), intramuscularly for vaccination. On 10-AUG-2018, the patient experienced dizziness, nausea and fever. The patient did take paracetamol (TYLENOL). The patient did not seek medical attention and diagnostic laboratories were not performed. As of 16-AUG-2018, the patient was recovered from the events. The pharmacist requested a Lot check and stated it was time sensitive. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1808USA007518: US-009507513-1808USA007466:
Mother stated child had shots 08/19/2003 and no reactions were noticed.  08/20/2003 in the morning before sending her to school no sign of reaction had occurred.  Mother stated she picked child up after school at 12:30 and noticed red raised area where the tetanus shot was given.  Was given Keflex 250/5 for 5 days and Pediapred.
Hives on medial side of forearms, right greater than left.  Patient reported minimal itching. No hives on trunk, head/neck, or lower extremities.
This spontaneous report was received from a female consumer of an unknown age, via company representative referring on herself. The patient reported that last week, on 13-JAN-2014 approximately, she was vaccinated with a dose of ZOSTAVAX (series, route of administration and lot # not reported). The patient told to the company representative that last week, on 13-JAN-2014, approximately, that she didn't feel any worse for wear except she had an egg at the injection site that continues to be very tender and itchy. The outcome of I have an egg at the injection site that continues to be very tender and itchy was unknown. The reporter considered I have an egg at the injection site that continues to be very tender and itchy to be related to ZOSTAVAX. Additional information is not expected.
When I woke up the arm that received the shot was sore, and I had a slight fever. I took Dayquil throughout the day. That night, once the Dayquil wore off, I had a fever of 100.5. I took some Nyquil and went to bed. The fever was gone when I woke up the next day, but my arm is still slightly sore 2 days later.
Arm tingling and numb in injection arm, tongue swelling, hot and sweaty.  Gave 50mg liquid benadryl and observed her for an hour.  Checked on her later in the day and she was feeling fine.
Infection from the nose; This is a spontaneous report received from a contactable consumer (patient husband) via medical information team. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter requested to reschedule the second dose of the patient which would be on 07Mar2021 as she was having the infection from the nose on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a RN concerning a 3rd grade male student in an elementary school who on 01/13/99 was vaccinated with a dose of varicella virus vaccine live. In mid December 2004 he developed chickenpox. According to the school nurse that there were 58 other elementary scholl students involved. 38 of them have been vaccinated with varicela virus vaccine. No product quality compalint was involvd, Addtionala information has been requested.
nausea; pain in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (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: NAUSEA (non-serious) with onset Mar2021, outcome "not recovered", described as "nausea"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "pain in the arm".  Additional information: It was reported that nausea was experienced 12 hours after vaccination and that she was still experiencing the event over 2 weeks now (day of report). Patient stated that pain in the arm went away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was to receive moderna vaccine, instead received afluria. No signs of adverse reaction at this time.
11/25/2021 symptom onset of Fever, subjective fever, chills, rigors, muscle aches, runny nose, sore throat, new olfactory and taste disorder, headache, fatigue, cough and dizziness.
Patient received their Moderna booster. Upon receipt their arm itched slightly, but no rash. this cleared up and patient was fine for approximately 9 days. On the 10th day the patient developed extreme dizziness and vomiting. Urgent care diagnosed vertigo. The patient took Meclizine and Sudafed with no relief. She worsened and was unable to walk due to the dizziness. She then went to ER. They also thought it was vertigo and gave valium with no relief. They referred her to Neurologist. Today the patient went to neurology apt and the doctor thinks it is Neuritis. They did exercises and red light therapy with patient that gave some relief. They are following up with patient Monday. Patient came in today to get supplements rec by neurologist. Pt in good spirits and I talked to her for a long period. Will follow up closely
Patient was tested for Covidl on 12/15/2021 (positive)  and admitted for a 3 day stay.  Only shortness of breath was posted in records for symptoms.   No other information was charted, no  interview was obtained.  Contact attempted.  Underlying health conditions are unknown as well.
Caller is a M of unknown age reporting he has just called PC. He took the first dose of the Johnson and Johnson COVID-19 vaccine at 1000 on 3/5 and wants to know if he can take ibuprofen or acetaminophen for a headache. Advised caller would need to contact MD or pharmacist for advice.
PATIENT REPORTS PAIN/SWELLING/REDNESS AT INJECTION SITE. STILL HAS FULL RANGE OF MOTION IN ARM AND HANDS.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 63-year-old male patient received BNT162b2 (BNT162B2), on 12Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: Other medical history: HTN; "Hyperlipidemia" (unspecified if ongoing), notes: Other medical history: hyperlipidemia; "elevated PSA" (unspecified if ongoing), notes: Other medical history: elevated PSA. The patient took concomitant medications. Past drug history included: Lisinopril, reaction(s): "known allergies: Lisnopril". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient had started with anti-viral treatment for COVID 19 on 10Jul2022 and stopped treatment on 15Jul2022. The patient had Rebound Symptoms with the anti-viral treatment on 18Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) and COVID-19 cannot be ruled out.
Tightness and mild pain in the left side of the chest; Tightness and mild pain in the left side of the chest; This is a spontaneous report from a contactable consumer (patient). This 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP6955) via an unspecified route of administration in the left arm on 24Mar2021 at 11:45 (at the age of 48-years old, reported as 47-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the 4-weeks prior to the COVID vaccine. On 26Mar2021 at 22:45 the patient experienced tightness and mild pain the left side of the chest. No treatment was received for the events. The clinical outcomes of tightness and mild pain the left side of the chest were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed; no further information is expected.
A week after, started feeling itchy at the injection site.  It is now red and puffy.
She got her vaccine with the flu vaccine, she had high fever and chills that lasted about 12 hours.  Started about 12 hours after getting the vaccine, lasted over night, still slight fever the next day.  By the end of that day was feeling better.   12 hours after it started she had a temp of 102.5, and was higher than that during the night.  She had same reactions with the 1st vaccine with lethargy, not as high fever and could not get up off the sofa.  Then the 2nd vaccine with fevers of 102-103 and bone shaking chills.   She also got her first shingles vaccine between the 1st and 2nd COVID vaccine and had worsening symptoms with that.  Then got the last shingles vaccine in January/February of 2022, and got worse symptoms from the COVID vaccine.    The last Shingrix shot was the worst reaction that she had.  The fever was higher than the previous COVID vaccine.  She also had the feeling of nausea.  At one point she was not able to stand up by herself to go to the bathroom and her husband had to assist her.  With each vaccine the symptoms worsened.    These symptoms started 12 hours after receiving the vaccines, and lasted for about 24-48 hours with progression after each vaccine.   The fevers stopped after 12 hours but the chills continued for about 24 hours, then subsided.
Received influenza vaccine IM. Two hours later she started to itch & then developed hives & lip tingling.
Herpes zoster virus after receiving 2 previous doses of varicella vaccine (varicella - 08/20/12, MMRV - 08/01/14).
21JAN92 pt recvd 1 dose of Engerix-B & 20 minutes post vax devel local pain which radiated to neck & a h/a; 12 hrs post vax devel nausea & vomiting; 19 hrs post vax exp 2nd episode of vomiting also noted general weakness but able to work;
Patient was accidentally given an MMRV and Varicella. So patient received an extra Varicella.
The pt received the vaccine on 12/21/00. On 12/30/00, a red area with a white spot at the injection site was noticed. It was approximately 1 1/2" long.
Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 30-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Pt. felt lightheaded, flushed skin, increased blood pressure, felt warm, and may have blacked out.
I woke up with a sore throat, body aches and it felt like a sinus congestion. On 09/19/2022 I took my temperature, and it was 101.7, my oxygen was in the 90s, and my pulse was at 103 resting. The next day my temperature was 101.3. I tested positive for COVID-19 on 09/20/2022. On 09/21/2022 my temperature was between 100-101. My resting pulse was in the high 90s and normally it is in the 60s. On 09/22/2022 I called my doctor but because I was out of town, they couldn't prescribe me anything. On 09/24/2022 my temperature was down to 96 and pulse in the 70s. On 10/01/2022 I tested negative.
Severe headache lasting 12 days as of now affecting vision and ability to work.  Untreatable with medication. Fatigue  lasted 6 days.
No additional AE information; the patient was administered an improperly stored dose of PROQUAD; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On 05-FEB-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) subcutaneous injection, lot number S009760, expiration date on 27-SEP-2020 (concentration, dose number, and anatomical location were not reported) as prophylaxis, that had been improperly stored in a temperature of -14 Celsius degrees to -10 Celsius degrees -13.5 Celsius degrees for 41 minutes, there was not a previous temperature excursion. It was reported that the sterile diluent lot number S031278, expiration date on 16-JUN-2022; used to reconstitute the measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) was properly stored. No additional adverse event was reported, and the temperature was recorded by a data logger.
I started feeling fatigue and nausea. Hives developed around 4:30 pm, on arms, scalp, neck and hands. The hives lasted about 5 days. I had continued itching and redness for another 5 days. My doctor recommended I medicate with Zyrtec before the next dose. I didn't have any issues with that one.
Do not know. Autopsy Report received which revealed COD as acute bronchopneumonia.
After receiving Menactra vaccine patient developed headache. The following day she developed a low grade fever, backache, neck ache, and malaise. Symptoms disappeared after 48 hours.
Presented with SOB, received vaccine in Feb.  Dx with Covid PNA.  Has a history of being immunocompromised.  Treated with remdesivir and steroids
1st dose facial numbness for 13 hours after vaccination; pain when breathing 8 hours after vaccine; Now have recurrent idiopathic hives since being vaccinated; This is a spontaneous report received from a non-contactable female consumer (patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number was not reported), via an unspecified route of administration, administered in arm left on 21Jan2021 (at the age of 27-year-old) at a 1st dose, single for COVID-19 immunization. The patient's medical history included psoriatic arthritis, idiopathic autoimmune hives, allergies to bactrim, penicillin, peanuts, shellfish, watermelon. Concomitant medications included Humira, prednisone, Zyrtec. On an unspecified date, the patient experienced 1st dose facial numbness for 13 hours after vaccination, pain when breathing 8 hours after vaccine and now have recurrent idiopathic hives since being vaccinated. AE resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of 1st dose facial numbness for 13 hours after vaccination, pain when breathing 8 hours after vaccine and now have recurrent idiopathic hives since being vaccinated. AE treatment allergy medication included epi pen, allergy testing. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had no covid prior vaccination. Patient has not been tested for COVID-19 post the vaccination. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.