chrisvoncsefalvay/vaers-outcomes huggingface dataset:
50 patients administered doses from temp excursion vials; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (50 patients administered doses from temp excursion vials) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (50 patients administered doses from temp excursion vials). On 29-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (50 patients administered doses from temp excursion vials) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It mentioned that the patients were not experienced any events.  No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow-up was received on 4-NOV-2021 and Reporters response includes no events were experienced by patients.
No additional AE information provided; MMR II underwent multiple temperature excursions was administered to a patient; This spontaneous report was received from a pharmacist and referring to an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not provided.  On 13-OCT-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (lot #U014656 with an expiration date on 07-MAY-2023), administered for prophylaxis (strength, anatomical location and route of administration were not provided).  The doses of vaccine underwent multiple temperature excursions of 9.13 °C (Celsius degrees) for 1 hour; and -8.45 °C for 37 hours and 15 minutes (incorrect product storage). No additional adverse event information was provided. No previous temperature excursions were reported.
pt recvd flu vax & 1 day later devel a red, raised rash @ inj site; pt also c/o itching, swelling, & tenderness @ inj site;
This case involves a 60 years old female patient (66 kg) who was tested positive for covid while receiving vaccines COVID-19 VACCINE and INFLUENZA VACCINE and while treated with TREPROSTINIL SODIUM [TYVASO].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included SILDENAFIL CITRATE (REVATIO); and MACITENTAN (OPSUMIT).  On 04-Nov-2020, the patient started taking TYVASO (TREPROSTINIL SODIUM, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A) at a dosage of 54 ug QID (four times a day) via inhalational route (with an unknown formulation and batch number) for Pulmonary arterial hypertension.  On 13-Sep-2022, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, dose, route and lot number not reported) and a Booster dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (formulation, strength, dose, route and lot number not reported), both for prophylactic immunization.  On an unknown date in Sep-2022, the patient developed a non-serious event of tested positive for covid (covid-19) (unknown latency) following the first dose intake of TREPROSTINIL SODIUM, and following the administration of INFLUENZA VACCINE and COVID-19 VACCINE.  On 13 Sep 2022, the patient got both a Covid third booster and a flu vaccine and ended up catching Covid (COVID-19) (coronavirus disease) and had to go to urgent care and placed on molnupiravir and medication for Covid. She was using more oxygen than normal while having Covid.  Relevant laboratory test results included: SARS-CoV-2 test - In September 2022: Positive UNK  Action taken with TREPROSTINIL SODIUM (TYVASO) was unknown. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) and COVID-19 VACCINE (COVID-19 VACCINE) was not applicable.  The patient was treated with MOLNUPIRAVIR and medication for Covid for COVID-19.  At time of reporting, the outcome was Unknown for the event tested positive for covid.
Pt vaccinated with Typhoid Vaccine developed increased pulse rate, increased blood pressure, shaking, chills and a temp of 104 degrees F.
I experienced extremely painful body aches for 5 months after taking the 2nd dose. I also had COVID-19 in 02/2022. My symptoms included stuffy nose, body aches, slight coughing, headache, fever, and chills. I had difficulty functioning, remembering things, or organizing tasks.
Pt recv vax on 2/2/99; on 2/2/99 pt exp rt arm sore & warm, felt unwell (feverish), headache, sweating, fatigue, increased sleeping; tx=Ibuprofen
pt recv vax;became cranky&T elev to 104.1;apap given;improved mom call hosp
Within 10 minutes after receiving the vaccination, patient reported headache and blurred vision. He was sweating with shallow wheezing breaths. He reported trouble breathing. While asking him questions, his head rolled back and his arms and legs began convulsing for a couple seconds. Epinephrine from the e-kit was administered and emergency services were called. Patient was moved to prone position on the floor, breathing quickly, with pale lips and complaints of numb fingers. Emergency services arrived, were informed of events, and took over. They determined he was probably having a panic attack, although he did not report nerves regarding the vaccination. Patient had never experienced a reaction to previous vaccinations. Panic or fear of initial headache and blurred vision may have elevated reaction. Patient eventually left with family.
ER nurse called pharmacy with adverse event of cellulitis at injection site. patient was prescribed antibiotic for cellulitis on 08/17/2021.
This spontaneous report as received from an other health professional refers to a patient of unknown age who on an unspecified date, one year ago in 2011, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL and on 19-JUL-2012, was vaccinated with the second 0.5 ml dose of GARDASIL (lot number not reported). No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. On an unknown date, the patient experienced pain in a dermatome other than the dermatome that ZOSTAVAX was administered, 12 hours following ZOSTAVAX administration. The outcome of adverse event was unknown. The relatedness between adverse event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
administered the vaccine to the pt and w/in the 15min observation period, the pt told employee she experienced tingling of the ?hands, feet, and head.? The team took a set of vitals [BP 183/95, HR 69, O2 98%, T 98.4]. conducted a THV visit with the pt and the pt?s family member. During the THV, I observed new onset redness of bilateral hands & pt verbally expressed difficulty breathing. Pt was able to respond to my questions without difficulty and I did not observe labored breathing. Denied feelings of itchiness, swelling of face or throat. I assessed & observed no neurological deficits. Pt shared she is not on bp meds and does not have a PCP. I recommended the pt take a dose of Benadryl in the clinic and go to the nearest ER for evaluation to be safe. We offered to call an ambulance for transport, but the pt opted to be driven to the ER by her family member. Employee assisted the pt while she was in person during the THV and administered the Benadryl. We have not had contact with the pt since the incident. Sharing this information so the healthcare team can add it to the incident report log. Please let us know if you have any questions or concerns. The patient reported on 4/30/2021 that she is now feeling better.
Breakthrough case admission after three vaccines Pfizer 3/3/21 Lot# NONE;  3/24/21 Pfizer NO LOT #;  11/18/21PFIZER  NO LOT NUMBER DO NOT SEND REQUEST FOR LOT#'S; THEY ARE NOT IN OUR DATABASE
Pharmacist confirms no symptomatic events or side effects reported. No additional AE/No PQC. / No adverse event known; Pharmacist called to report a VARIVAX Temperature Excursion. Improperly stored VARIVAX was potentially administered on unknown dates to multiple patients (unknown demographics and number of patients involved unknown at time of call, therefore multipl; This spontaneous report was received from a pharmacist concerning a 19-year-old male patient.  The patient's concurrent conditions were not reported. His concomitant therapies included coronavirus disease 2019 (COVID 19) vaccine. Pre-existing physician-diagnosed allergies, birth defects or medical conditions were none known.  On 03-JUL-2023, the patient received an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot #W012165 and expiration date on 12-APR-2024, administered subcutaneously (SC) in the right arm for prophylaxis (dose number was not provided). The vaccine was administered by the healthcare professional at a pharmacy, and it was purchased with private funds. It was unknown if there was illness at the time of vaccination.  On unspecified dates, three separate temperature excursions occurred: one up to 12.092 degrees Fahrenheit (F) for 6 hours and 15 minutes, the second up to 13.6 F for 2 hours and 30 minutes, and the third up to 12.1 F for 1 hour, 45 minutes and 5 seconds. The temperature excursions occurred as a result of a reading from a Digital Data logger.    No adverse events were known.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA000909: US-009507513-2307USA011964: US-009507513-2307USA011965:
coughing; throat started closing; couldn't breath; my heart rate was going down; shakes; could not swallow; This is a spontaneous report received from a contactable consumer (patient) from Medical Information Team. A female consumer of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot: unknown), via an unspecified route of administration on 12May2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received the 1st dose of the Pfizer COVID 19 vaccine on 12May2021, and she kept on coughing and her throat started closing, she couldn't breath, her heart rate was going down, she had the shakes. The patient could not swallow. They called the ambulance and took her to the Hospital. The patient received an Epi-pen and Benadryl. She had an IV. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
I experienced "frozen muscles" was unable to move without assistance for about 30 mins. Over time, the heaviness and brain fogginess subsided. After about 3 hours, was feeling almost normal again
One day after injection- Right arm with large-Approximately 3" in length, red area- warm to touch- slightly swollen. Remained red, warm to touch for 3 days. Ibuprofen and cool compress to site.
The Vaccine was given Intramuscular instead of subcutaneous, patient will be contacted by her physician
Developed varicella lesions 5 days after vaccine administration.  No treatment required and no other sxs developed.  By day 9 several were starting to crust over and no new lesions were developing.
Large red, warm area at injection site went to ER sent to children's with cellulitis.
Patient indicates she has had pain at the site of the immunization since the date of the immunization. (times are estimated due to length of time since occurance).
The patient did not have an adverse event. The problem was during administration. The needle became detached from the syringe causing the dose to be low and spill on on the patient's sweater. We did give the patient another dose.
4am the day after my first shot I woke up to swollen, blood shot eyes which were irritated and itchy. After an hour and a half the symptoms were not getting better so I decided to take claritin since it was similar to the allergic reaction I have to mold. An hour later my eyes were better but still sore around them. The next day they were completely better.   Also, since taking the vaccine I seem to forget things easily,  things that I put in the microwave are sitting there the next morning which is very unusual for me to be so forgetful so many times and even at work my focus was scattered and things that were routine were becoming challenging to remember to complete. After 2 weeks it seems to have faded, although once I became aware of what was happening I have made a conscious effort to remember things.  I realize that these may seem like small events,  but I feel that it is something that should be looked into as it was/is rather concerning since this was only my first shot and the second is supposed to react worse.  I am still contemplating whether getting a second shot is wise for me.
ADACEL given on 11/19/2008; developed fever 102 deg F on 11/20/2008 fever 100 deg F 11/21/2008 and 11/22/2008. Developed erythema, pain and swelling at site 11/11/19/2008. Large induration/ hematoma present 11/24/2008. No fever, less pain on 11/24/2008.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, shivering, muscle pain and sweating. On an unknown date, the outcome of the influenza-like symptoms, fever, shivering, muscle pain and sweating were recovered/resolved. The reporter considered the influenza-like symptoms, fever, shivering, muscle pain and sweating to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination could be 62 or 63 years. This case was reported by GlaxoSmithKline employee on behalf of his brother-in-law (patient).  In January or February of 2018, the patient received the SHINGRIX in the arm. After receiving SHINGRIX, the next day, the patient experienced first does flu like symptoms that included muscle aches, sweating, fever and shivering. The patient experienced these symptoms for 3 days. The patient was bedridden during this time. The reporter had limited details regarding this report. This case has been linked with case.
25JUN97 breakout w/chickenpox-tired-no fever slowly inc #of pox to @ least 200-in mouth, head, throat, nose, ears-not too itchy;confirmed by MD;7JUL97 almost all are clustered over;exposed to sister who also had breakthrough chickenpox
Generalized rash, fever 7 days after vaccination. Confluent exanthem coryza, cough, no conjunctivitis.
Feeling limp in feet & hot & itching from the bottom up. Called 911 & taken to E.R given IV & injections, & felt better.
expired yesterday, given today; Vaccines were frozen and allowed to thaw for 45 minutes before; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired yesterday, given today) and PRODUCT STORAGE ERROR (Vaccines were frozen and allowed to thaw for 45 minutes before) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired yesterday, given today) and PRODUCT STORAGE ERROR (Vaccines were frozen and allowed to thaw for 45 minutes before). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired yesterday, given today) and PRODUCT STORAGE ERROR (Vaccines were frozen and allowed to thaw for 45 minutes before) 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.   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Follow up received contains added reporter details, dose number, batch number and new event .
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: BENZONATATE, start date: 01Jul2022, stop date: 06Jul2022; ALBUTEROL [SALBUTAMOL], start date: 01Jul2022, stop date: 15Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) negative, notes: I tested negative for covid 6Jul; (13Jul2022) positive, notes: 13Jul my covid symptoms were in full effect again and I tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: I tested negative for covid 6Jul, other than a lingering cough I felt recovered.12Jul I started feeling fatigue and 13Jul my covid symptoms were in full effect again and I tested positive. other medication in 2weeks includes Paxlovid (start date=01Jul2022, stop date=05Jul2022), Benzonatate (start date=01Jul2022, stop date=06Jul2022), Albuterol (start date=01Jul2022, stop date=15Jul2022)  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
daughter was not able to finish the immunization series by her 7th birthday due to illness with no adverse event; Initial information received on 02-May-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 7 years old female patient was not able to finish the immunization series by her 7th birthday due to illness with no adverse event while receiving vaccine diphtheria and tetanus toxoids.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient was not able to finish the immunization series of suspect diphtheria and tetanus toxoids produced by unknown manufacturer (dose, form, strength, batch number and expiry date unknown) via unknown route in unknown administration site for immunization by her 7th birthday due to illness with no adverse event (routine immunisation schedule incomplete) (same day latency). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event daughter was not able to finish the immunization series by her 7th birthday due to illness with no 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.
Vaccine expired 08/2022 and was administered to patient on 9/9/2022
Flu like, pain and achiness through out whole body, especially in joints, diarrhea - all lasting for 4 days then tappering off slowly over the next 3 to 4 days.
started with dizziness, nausea, abd pain on 3/29/2021. treated conservatively. seen in office on 3/31/2021. She started improving the morning of 4/1/2021. Developed Left Bells Palsy on the afternoon of 4/1/2021. Seen in office on 4/2/2021
Patient was mistakenly given a combination vaccine MMRV and Varicella vaccine the same day along with the other 1 yr. vaccines. The vaccines were set up by one nurse and given by another. Pt. has had no ASE'S.
False positive on BD Veritor rapid antigen test.  followed by negative result on SARS COV-S RNA RESP QL NAA+ PROBE
Neighbors got COVID-19 last month after being vaccinated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Neighbors got COVID-19 last month after being vaccinated) and DRUG INEFFECTIVE (Drug ineffective) 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.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced COVID-19 (Neighbors got COVID-19 last month after being vaccinated) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, COVID-19 (Neighbors got COVID-19 last month after being vaccinated) and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown.            No Concomitant medication was reported. No treatment medications were reported  Reporter said they (her neighbors) believe they contracted it from their 4year old grandson who also tested positive for COVID-19. She did not have additional information at the time of the call.
Initial report was received 27 December 2008 from an investigator as part of a study for which Sanofi Pasteur is not a sponsor. A neonate male patient received an initial dose of ADACEL (lot number C2456AA) at approximately 24 weeks gestation placentally. The patient's mother was taking LABETALOL and prenatal vitamins concomitantly throughout the pregnancy. The patient's mother had the following prenatal testing completed: On 16/Mar/2006: parvovirus IgG 5.7, parvovirus IgM negative, Rubella- Imm, NBsAg-NR, HIV-NR, antibody negative. On 04/Aug/2006, 08/Aug/2006, 14/Aug/2006, 17/Aug/2006 normal reactive NST (non fetal stress test). On 12/Jan/2006, 04/Jul/2006, 20/Jun/2006, 05/Jul/2006, 10/Aug/2006 all normal ultrasounds. On 02/Aug/2006: bilateral hydroceles and oliohydramnios AF1-7.3. On 27/Apr/2006: the patient's mother was GBS (group B strep) positive. On 20/Aug/2006 the patient was born at 38 5/7 weeks gestation. The patient had an APGAR score of 9 at one minute and 9 at five minutes. The patient did not have any complications during delivery. List of Documents held by Sender: None. Another case was created for the baby's mother which captured in case number 2008-04114. The reporter of this case is same as cases 2008-04101, 2008-04102, 2008-04103, 2008-04104, 2008-04105, 2008-04106, 2008-04107, 2008-04108, 2008-04109, 2008-04110, 2008-04111, 2008-04112, 2008-04113, 2008-04114.
Severe nausea, dizziness, chills, fever, weakness, faint, sleepiness, and inability to function normally.
Pt. had minor swelling and itch and rash developing on face, arm and legs. Gave 2 tablets of diphenhydramine 25mg. Seemed fine after about 30 minutes.
Have had tinnitus in ears ever since getting Covid Bivalent booster and did not have it previous to the booster.