chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 4:34 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 4:34 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 50.09  No concomitant medications were reported.  Batch number 030B21A administered on 03-Apr-2021 had  temperature 34 at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
After about 10 minutes post-injection, patient started to get really dizzy.  He was helped from chair to the floor.  He never fully passed out but said he has gotten dizzy after traumatic events in the past.  The paramedic was already onsite and monitored him for next 15 minutes until he felt better and was stable.  He left feeling fine.
Having ringing in ear - hissing sound. Never had any issues before. Occurred a few hours after the vacine, still continuing.
pt recvd vax & devel fever x 2 days; 13OCT93 AM adm to hosp t105 had sz, cyanosis, eyes turned up in head, & became frozen & gagging which lasted for minutes; regained consciousness & became limp; adm for febrile szs;
Information has been received from a pharmacist referring to a 63 year old male patient. On 14-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX, (strength was not reported), (lot number was J016325 which was an invalid lot number for ZOSTAVAX, expiry date was reported as 24-DEC-2015), 0.65 ml, subcutaneously. On 14-JAN-2015, the patient experienced swelling at the injection site "as big as a baseball". The patient didn't seek medical attention. There were no lab diagnostics studies performed. On 19-JAN-2015, the swelling resolved without treatment. Additional information has been requested.
Muscle and joint pain, exhaustion, back ache and brain fog for about 10 days after the booster. Developed a UTI three days after the booster. Participated in a telehealth appointment and was prescribed Bactrim. Had an adverse reaction to Bactrim so stopped taking it.
Systemic: Pt was in the observation area, almost fainted, fell out of the chair-Mild, Additional Details: Pt stated he has a needle phobia.  He felt faint and fell out of the chair in the obsearvation area and hit his head on the floor.  Pt did not pass out and was alert. He did not need an epi pen or benadryl.  He was offered water and accepted.  He stayed 20 minuted and left, fine. Manager is calling into the incident line as well.
About 6-7 days after first dose my son developed a rash on chest and back.; Took to dr who said he had pityriasisrosea.; This is a spontaneous report from a contactable consumer (parent). A 13-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: Unknown) via an unspecified route of administration in the left arm on 13May2021 at 16:30 (at the age of 13-year-old) as a dose 1, single for COVID-19 immunisation. Relevant medical history and known allergies included none. Concomitant medications included dexmethylphenidate hydrochloride (FOCALIN XR) and fexofenadine hydrochloride (ALLEGRA) for unspecified indication, start and stop dates were not reported. 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. It was reported that about 6 to 7 days after first dose, the patient developed a rash on chest and back, was taken to doctor who said he had pityriasis rosea on 19May2021 16:00. The reporter asked if it was related to vaccine and the doctor said who knows. The reporter searched online and saw reports even others had rashes on day 7 and wanted to report for the sake of documentation. Not itchy but all over torso and back. And the patient's age was 13 at the time of this report. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events was recovering at the time of this report.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients, names and other demographics unknown, who since MAR-2017 have been administered doses of VAQTA lot # M039202, expiration date 11-MAR-2018, RECOMBIVAX HB lot # M035487, expiration date 23-FEB-2019, ROTATEQ lot # M040270, expiration date 29-APR-2018 and GARDASIL 9 lot # M041212, expiration date 21-JUN-2019 which were improperly stored. The doses were stored at temperatures in the range of 32 degrees Fahrenheit to 35 degrees Fahrenheit (34 Fahrenheit) for a time frame of 4 hours; 36 degrees Fahrenheit to 46 degrees Fahrenheit (35.8 Fahrenheit) for a time frame of 12 hours. Previous temperature excursions was reported as NA. The call was not because of a data logger. No adverse effects were reported. No further information was provided. Additional information has been requested.
Allergic Reaction close to injection site; This case was reported by a physician via call center representative and described the occurrence of allergic reaction in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: In july 2020, after receiving 1st dose of Shingrix, the patient developed some allergic reactions, but not sure what they were. One of them was close to the injection site. The reporter was consented to follow up. No further details were reported.
Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling tired) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included IBUPROFEN and PARACETAMOL (ACETAMINOPHEN) for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced FATIGUE (Feeling tired). At the time of the report, FATIGUE (Feeling tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient received his first dose at left arm shoulder deltoid muscle. The patient received her second Moderna Covid-19 vaccine on 22JAN2021 lot number is unknown expiration date is not known. Patient does not remember which arm that he received the Moderna Covid-19 vaccine in. Patient received the vaccine as an Intramuscular injection. The patient had no adverse Reactions or side effects after the second Moderna Covid-19 vaccine. Treatment information was not provided
The patient received her first dose of the Moderna Covid-19 vaccine. She was asked to wait for 15 minutes seated in her chair.  A few minutes after the vaccine, the patient passed out in the chair and fell to the floor. She woke up as soon as the pharmacist spoke to her. She stayed on the floor until she was no longer dizzy. Then she sat back up in the chair and was given water and orange juice. She stated that she had hit her head. We offered to call an ambulance, but she refused. She refused ice. We offered to call someone to pick her up, but she refused. Once she was feeling better, she stayed another 15 minutes before leaving.
Chills, fever began about 8 hours after vaccine shot. Slight headache began about 11 hours after vaccine shot. Acetaminophen taken 15 hours after vaccine shot to aid in sleep. No symptoms starting about 26 hours after vaccine shot.
Pt presented to ER ascending leg weakness, tingling, gait ataxia. Admitted after LP, Labs, CT IV immunoglobulin TRSFR to ICU several days later in increased respiratory distress, (higher lever hospital some where else).  2/13/07 Received medical records from hospital which reveal patient experienced numbness & ascending weakness 1 week s/p flu vax.  Went to outlying hospital ER & had LP & neuro eval & dx w/GBS.  Admitted to outlying hospital & Tx w/IVIG but had progressive worsening of symptoms & transferred to this hospital on 11/20/06.  Admit eval revealed speech difficulty, significant LE weakness, areflexia.  Received additional 5 days of IVIG but continued to worsen.  Was intubated on 11/25.  Plasmapheresis x 3 was done w/o significant improvement.  Trached on 11/20.  Had intermittent fever & atelectasis while hospitalized & was on multiple antibiotics.  Approx 2 weeks prior to d/c on 1/25/07, strength began to return & was able to be weaned off vent though cough was still poor.  Developed decubitus ulcers as complication of immobility.  Transferred to Rehab on 1/25/07. FINAL DX: Guillain Barre Syndrome secondary to flu vax; staph aureus pneumonitis; e. coli, Klebsiella pneumonitis; decubitus ulcer.
rapid heartbeat; tiredness; headache; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 56-year-old female patient received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1), administration date: 25Jan2021, for Covid-19 immunization; BNT162b2 (Dose 2), administration date: 17Feb2021, for Covid-19 immunization; BNT162b2 (Dose 3), administration date: 03Dec2021, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 10Jun2022, outcome "unknown"; FATIGUE (non-serious) with onset 10Jun2022, outcome "unknown", described as "tiredness"; HEART RATE INCREASED (non-serious) with onset 12Jun2022, outcome "unknown", described as "rapid heartbeat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient was tested positive on COVID-19 rapid antigen test today (12Jun2022). Her symptoms were tiredness and headache over the last two days and rapid heartbeat today (12Jun2022). No other respiratory symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Localized itching/ ITCHING TORSO; PSORIASIS SCALY SPOTS COMING; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Localized itching/ ITCHING TORSO) and PSORIASIS (PSORIASIS SCALY SPOTS COMING) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    The patient's past medical history included Alcohol use (ALCOHOL USE (Stopped February 2020)) in February 2020, COVID-19 in November 2020, Tobacco user (TOBACCO USE (Stopped February 2020)) in February 2020 and Colonoscopy. Previously administered products included for Psoriasis: HUMIRA. Past adverse reactions to the above products included No adverse reaction with HUMIRA. Concurrent medical conditions included Itching since 2019. Concomitant products included PREDNISONE for Itching.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. On an unknown date, the patient experienced PRURITUS (Localized itching/ ITCHING TORSO) and PSORIASIS (PSORIASIS SCALY SPOTS COMING). At the time of the report, PRURITUS (Localized itching/ ITCHING TORSO) had resolved and PSORIASIS (PSORIASIS SCALY SPOTS COMING) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2019, Tryptase: HIGH LEVELS OF TRIPTASE. In November 2020, SARS-CoV-2 test: (Positive) Positive.            Patient reports Itching torso and Psoriasis scaly spots coming back with SKYRIZI. The patient had a relevant medical history of Itching torso and Psoriasis scaly spots  The patient stated she got COVID 19 on Thanksgiving 2020.  She had the high levels of Triptaste in her blood and that could be Masto-cytosis, but she stated she had this problem prior to Skyrizi and it had not worsened since starting SkyRizi.  She stated her psoriasis had cleared up and after taking the first round of the Moderna her Psoriasis came back.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment information was reported.
Received two different Covid vaccines, first dose of pfizer and 2nd dose of moderna; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received two different Covid vaccines, first dose of pfizer and 2nd dose of moderna) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044821A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) injection for COVID-19 vaccination.    No Medical History information was reported.   On 13-Mar-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received two different Covid vaccines, first dose of pfizer and 2nd dose of moderna). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received two different Covid vaccines, first dose of pfizer and 2nd dose of moderna) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information provided. No treatment medication information provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up information received on 24-jul-2021 contains non-significant information.Further Consent denied; Sender's Comments: This report refers to a case of interchange of vaccine products for mRNA-1273 (lot number unknown) with no associated AEs reported.
Red, inflamed rash on arm of immunization. Was itchy but painless and non-itching.
Complaints of headache at 1405-vital signs taken-temp= 98.6, BP=102/62, HR=86, 300mg. Ibuprofen given-stayed with nurses until 14:30- called mom left a message-feeling better reported at 1505.
Fever 103, lethargic at 1130 AM on 6-11-12 vaccines given at 0930 on 6-11-12 fever from 6-11-12 thru 6-13-12.
89 Y male, covid-vaccinated, with a h/o dementia, Parkinson's disease, HFpEF(6/2021: 60%, moderate valvular regurgitation), atrial fibrillation/flutter (s/p PPM), bladder Ca s/p TURBT, bronchiectasis, recent diagnosis of colon adenocarcinoma w/ ulcerated mass who was brought in by family for worsening behavioral issues (increasingly confused/agitated), found to be COVID+ on admission.     His agitation resolved with a new psychotropic regimen of VPA 125mg/250mg AM/PM and Seroquel 25mg qhs.  From 1/13-1/18 he remained non-agitated, pleasantly confused AOx1 but intermittently conversant, eating most of his meals, making BM, good UOP. However over the last 4 days he became less interactive.    He had previously been on room air throughout hospitalization, however on 1/19 became acutely hypoxic, going from room air to 16L NRB mask over the course of the morning.  On 1/19, patient's daughters discussed with the palliative care team to discuss goals of care.  Given patient's acute clinical decline, which was likely due to a combination of COVID-19 with possible aspiration, advanced cancer, and progressive dementia/Parkinson's, they decided to transition patient to comfort care.  Patient died on 1/22/2022, time of death 2:20AM
Normal/expected side effects occurred during the first 24-36 hours after receiving my COVID-19 booster shot. I opted to get the Pfizer booster because I'd had a previous adverse reaction to the second dose of the Moderna vaccine, and I'd hoped to avoid the same reaction this time.  In the same manner as my previous adverse reaction, the expected side effects went away and then I began to experience nerve pain and tingling, primarily in legs and feet, 5 days after (on 11/15/21) receiving my booster. I was able to sleep through the pain this time. I also took Amitriptyline on 11/15/21 and 11/16/21 in an effort to help me sleep and better manage the nerve pain. By 11/17/21, the nerve pain and tingling seemed to be improving in my lower extremities and it progressed more into my chest, abdomen, and upper extremities. I also experienced constipation and difficulty urinating during this time. This all made it difficult to eat or drink fluids. I didn't experience relief from constipation until 11/19/21 (after two doses of magnesium citrate and senna/colace) and wasn't able to eat a full meal until 11/21/21.  At this time, some slight tingling and chest pain still exist, more so on the left side of my body. I did not seek any medical attention this time given the fact that I went to urgent care and the ER during my previous reaction, and nothing really helped except for time.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient. Patient had no pertinent medical history and no drug reactions or allergies. On 27-MAY-2015, the patient was vaccinated with ZOSTAVAX, subcutaneously. Concomitant therapies included lisinopril (manufacturer unknown). On 02-JUN-2015, the patient experienced a rash on her abdomen (disability), after receiving a dose of ZOSTAVAX. The patient felt the rash was an outbreak of shingles, but this had not been officially diagnosed at the time of report. No treatment was provided for the rash. No laboratory tests were performed. The patient sought medical attention-she called the pharmacist. The pharmacist felt this was a significant disability for the patient since she was "very concerned" about the rash and did not go to work because of it. The outcome of rash was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 02Apr2021 at 13:00 as dose 1, single (Lot number: 1805025), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Oct2021 at 12:00 as dose 2 (booster), single (Lot number: 012F21A), in left arm and on 21May2022 at 12:00 as dose 3 (booster), single (Lot number: 049L2A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Celebrex, reaction: "Known allergies: Celebrex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (09Apr2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Apr2023) Negative; (10Apr2023) Negative; (11Apr2023) Negative; (12Apr2023) Negative; (13Apr2023) Negative; (14Apr2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Unresponsive; A spontaneous report was received from Pfizer concerning a 52-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 08 Jan 2021, approximately 2 hours prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  for prophylaxis of COVID-19 infection.  On 08 Jan 2021, the patient was monitored for the appropriate amount of time by nursing staff, following vaccination. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 08 Jan 2021 at 2:15pm. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: This case concerns a 52-year old, female patient, who experienced a sudden death 1 day after administration of first dose of mRNA-1273. The cause of death was not provided. Plans for an autopsy were unknown. Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Next day body aches, headache, chills started. Almost exactly 24 hours later, a fever began.