chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE information provided; an unspecified number of patients were administered an improperly stored dose of VARIVAX since 2/27/2020; This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions and allergies were unknown. Concomitant therapies included sterile diluent.  Since 27-FEB-2020, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S010297, expiration date 03-APR-2021 (dose number, frequency, route of administration, anatomical location were not reported) for prophylaxis (product storage error).  Temperature excursion of this vaccine was minus 14 degrees Celsius to minus 10 degrees Celsius (minus 10.4 degree Celsius) for 6 hours 2 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.  This is a non-valid case due to lack of patient identifiers and unspecified number of patients.  Follow up information has been received on 29-JUL-2020, the medical assistant was not about to talk due to office being busy. Telephone call and fax numbers were provided.  Follow-up information has been received from the medical assistant on 26-AUG-2020.  The case is valid. The identifiers of 8 patients were provided.  The patient was 4 years old. On 17-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of the eight reports from the same reporter.; Sender's Comments:  US-009507513-2008USA013489: US-009507513-2008USA013494: US-009507513-2008USA013491: US-009507513-2008USA013492: US-009507513-2008USA013493: US-009507513-2003USA007542: US-009507513-2008USA013490:
Increasing pain / in the left upper arm; Limited range of motion in the left upper arm; given FluLaval in the bursa instead of the muscle; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 37-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.  On an unknown date, the patient received FluLaval Tetra 2020-2021 season. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received FluLaval Tetra 2020-2021 season in the bursa instead of the muscle, which led to vaccine administered at inappropriate site. The reporter did not have patient or vaccine information at the time of call.   Follow up information received from other health professional on 12th November 2020: The patient received FluLaval Tetra 2020-2021 season intramuscularly in left deltoid. Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. The patient experienced pain in arm and joint range of motion decreased. The VAERS details were updated.
fever of 99.8°F; Face was red; face warm; Rash on torso; A spontaneous report was received from a Consumer concerning a 29 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever of 99.8°F, her face became red and warm and she had a rash on her torso.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 20/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 20/Jan/2021The patient experienced the events fever of 99.8°F, her face became red and warm and she had a rash on her torso. The symptoms are not ongoing.  Laboratory details were not provided. Patient was treated with Benadryl and Tylenol . Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event was resolved. Patient suffered the symptoms and would like to know whether she can take the next dose. Consent for follow-up is given.
I started experiencing itching immediately after the vaccination while in the waiting room. It started with the palms of my hands and arms on both sides. The itchiness went away quickly but now I have itchy spots on my right leg. It is not constant but every other. There are red spots as well and they look like reddish pink bruises. On 7/12/2022 at night, my skin that felt unusually hot. The next morning I felt nauseous and hot. I took my temperature and it was elevated to around 99.3. I went to the ER due to the fever and had tests ran with COVID-19 negative, Flu was negative, blood test, and urinalyses. No major infection was indicated but blood test and urinalyses were higher than normal. My white blood cell count was higher at 11.5. My blood pressure was elevated and the reading was 140/86. My symptoms went away today about an hour ago and I now only have red itchy on my right leg. I have an appointment with my doctor on Monday.
This case was reported by a pharmacist via sales rep and described the occurrence of wrong vaccine administered in a 58-year-old female patient who received INFANRIX (batch number AC14B182BA, expiry date 28th August 2015). On 14th November 2014, the patient received INFANRIX (unknown). On an unknown date, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received on 14 November 2014: INFANRIX was administered to a 58 years old patient instead of tdap. No adverse event was reported.
Patient developed hives starting on the evening of 3/8/06 which worsened and involved facial and lip swelling by the early morning of 3/10 requiring and emergency room visit. He was given IV medications and sent home with a medrol dose pack and continues taking antihistamines in addition to the oral steriods. He reports he continues with some hives but it is greatly improved and continues to improve. Patient reported he went home immediately aftr receiving the vaccine and had no other known exposures.
Information has been received from an office manager (health professional) referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored M-M-R II (lot # was reported as L00458, expiration date 03-APR-2017, strength, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Immediately after receiving the 1st dose, patient did not feel right. Stayed an additional 15min after the initial 15min observation time. Had face tingling, itchy arms. By the time patient got to her car her face had swollen, hives present, trouble walking, dragging her right leg.  Patient did not get better for the next 10 days. She went to the ED were she was admitted for 11 days.
Mayor constipation; Swollen lymph node in his stomach area; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    A spontaneous report was received from a consumer concerning a 76-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Mayor constipation, swollen lymph node in his stomach area.  The patient's medical history was not provided. relevant concomitant products usage were not reported by the reporter.  On 26 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unk) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 23 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unk) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, Mayor constipation, swollen lymph node in his stomach area.  No treatment information was provided.  The patient received both scheduled doses of mRNA 1273 before the events, therefore Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, Mayor constipation, swollen lymph node in his stomach area was unknown.
I did not have an adverse reaction to the vaccine. On 12/20/2022 I started feeling system of feeling sick. Tested positive for 12/21/2022 for COVID-19 with a home test. I was able to get the prescription for PAXLOVID and started taking it that day 12/21/2022. I previously tested positive for COVID-19 in June 2022 and again on 11/01/2022. I got the prescription for PAXLOVID each time too. As of today, I continue to be fatigued.
15 min. post vaccine, reported red blotchy rash ant. abdomen, upper and lower arms bilaterally and mild itchy throat. Benadryl 50mg po and Albuterol inhaler given. Escorted to ED. ED admin. IV Solumedrol, epinephrine, nebulizer Rx, Recovering well.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-OCT-2009, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a healthcare provider for shingles in March 2013 at the hospital. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death - aggravation of preexisting conditions and activation - of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
pt had a positive COVID test on 1/17/22; pt passed away in the nursing home on comfort care; per death certificate, pt's causes of death were COVID 19, Adult Failure to Thrive, Alzheimer's Dementia
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 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 1:17 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 1:17 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 70.64 years old. Concomitant products were not provided. On 27-Oct-2021, Excursion time was 09 AM and 10 AM, temperature was 29 and 32, total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021 and 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 6 vials were sent to clinic. Vaccine BUD date were 29-Oct-2021 and 04-Nov-2021. On 27-Oct-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM: 46, 3 PM: 46, 4 PM: 46 and 5 PM: 45. 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.
received a kinrix / in spite that /it is for / 4-6 years old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a kinrix dose in spite that,  prescribing information said that it was for patients from 4 to 6 years old, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
violent reaction; she had terribly pain it last 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (violent reaction) and PAIN (she had terribly pain it last 24 hours) in an 82-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (violent reaction) and PAIN (she had terribly pain it last 24 hours). At the time of the report, VACCINATION COMPLICATION (violent reaction) outcome was unknown and PAIN (she had terribly pain it last 24 hours) had resolved.            No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-051966, MOD-2021-051966 (Patient Link).
upper respiratory infection; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 12Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced upper respiratory infection on an unspecified date. The patient received treatment with Z-Pak (azithromycin), an antibiotic and prednisone for 3 days. The outcome of the event was unknown. It was reported that, he was scheduled to receive the second dose of the Pfizer COVID vaccine this Friday (02Apr2021) and wanted to know if he can go ahead and take his second dose of the vaccine. Caller stated on Monday his primary care prescribed a Z-pack and prednisone steroids for an upper respiratory infection. Patient wanted to know if it is okay to receive the second dose of the vaccine this Friday. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Immediate pain in left arm, increased pain when scrum injected in. Decreased ROM with pain. Inability to move arm for 2 months. Still in physical therapy.
Nothing serious but I noticed black patches on my right arm. It was probably a subcutaneous clot which went away in about 4 days.
Circular red mark appeared at injection site one week after receiving the vaccination. No pain, itchiness, or warmth to touch. Mark was not present immediately after receiving vaccine or in the few days following. Red mark appears slightly swollen, not raised. As of this report, has been present for approximately 36 hours with no change.
Received dose at 2:02 pm.  LVN alerted PHN to pt at 2:08 pm.  Pt very pale, very diaphrotic, c/o lightheadedness and dizziness, very slow responses to verbal stimuli.  Arms and nail beds blanched white.  Called 911 at 2:08 pm.   VS- SpO2- 71% on RA; P- 51; B/P- 80/40.  Given Epi Pen at 2:10 pm.  Repeat VS at 2:14 pm- SpO2- 79%; P-85.  Still very slow response to verbal stimuli.  VS @ 2:18 pm- P-63; SpO2- 97%- taking slightly deeper breaths.  Some response to verbal stimuli, but still delayed.  Ambulance arrived at 2:20 pm- final VS- SpO2- 82%; P-127- B/P 102/60.  Taken to Hospital.
This case involves an unknown age and unknown gender patient who experienced got so sick while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site as prophylactic vaccination. On an unknown date the patient developed a non-serious got so sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "this is a public post on the Sanofi flu shot campaign Flu Shot Fridays we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: I will never get a flu shot again Had one 2 years ago I got so sick & laid on the bathroom floor for 2 days". Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (got so sick). At time of reporting, the outcome was Unknown for the event got so sick.
3/28/23 I was getting ready to go to bed and received a phone call and I could not talk. I called 911 and went to the hospital by ambulance. I was met by a stroke team and was assessed. I was given medication that they give when you are having a stroke. I was in ICU for two days then transferred to a regular room.  I had an MRI, CT a heart test. The tests showed I had a stroke on the left side which affected my right side and my speech. The heart test did not show anything. I went home after five days. My right hand is numb, and my right leg is a little weak.  My speech has returned.  I am wearing a heart monitor now for another 3 days.
SWELLING/REDNESS/ITCHY AT SIT OF INJ AFTER GOING HOME (2"X2" AREA). BY EVENING 4"X4" AREA PLUS DIFFICULTY BREATHING. UPON ADVICE OF HER PMD WENT TO URGENT CARE ON 11/26 OR 11/27 WHERE THEY GAVE HER AN INJ (SHE THINKS BENADRYL OR EPI OR BOTH) AND TOLD HER TO TAKE BENADRYL EVERY 6-8 HRS.PT CALLED US ON 12/1/2010 TO REPORT
Patient had Guillian-Barre Syndrome in March of 2004.  He has recovered completely.
16hours after injection: 101.5 fever. Sore skin. No appetite. Headache 20 hours afterwards. Lasted 10 hours.
Underneath his armpit he is getting 'bumps'; it is swollen and it hurts when he moves it; it is really bad today. It is causing him a lot of pain; Underneath his armpit he is getting 'bumps'; it is swollen and it hurts when he moves it; it is really bad today. It is causing him a lot of pain; Underneath his armpit he is getting 'bumps'; it is swollen and it hurts when he moves it; it is really bad today. It is causing him a lot of pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A male patient received bnt162b2 (BNT162B2), administration date 13Aug2021 (Lot number: Unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunisation. The following information was reported: AXILLARY PAIN (non-serious), SWELLING (non-serious), RASH (non-serious), outcome "unknown" and all described as "Underneath his armpit he is getting 'bumps'; it is swollen, and it hurts when he moves it; it is really bad today. It is causing him a lot of pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe headache. Nausea. Diarrhea. Lasted 6 hours. Better next day. Scared for second dose. Do Zi need a small person dose? I am an older , small woman. Weight 110lbs.
Information has been received from a male patient of unknown age referring to himself. On an unknown date the patient transported a dose of ZOSTAVAX (unspecified lot number and expiration date) from an unspecified pharmacy to his unspecified doctor's office "without an ice pack". Then he was vaccinated with the improperly stored dose of ZOSTAVAX (dose and route unknown). No adverse effects were reported. Additional information is not expected because there was no contact details.
1/14/2021 Rash started on torso and appeared to be tiny red bumps and fever up to 103. Rash lasted appx 5-7 days. 1/27/2021 Fever up to 101 and diarrhea. 1/30/2021 Rash returned for 2 days.
About 6 min after tongue,top of mouthnumb,repoeted Bendryl 25 given per mouth       6 min after tongue,top of mouth numb repoeted and Bendrly 25mg given by mouth later that day above L eyebrow pain, then over next few days up to now blue around eye  now blue around eye r side  DONE
Left arm was sore the first two days, after 10 days left arm became sore again, rash around the injection site, it was hot and very itchy for 3 days.