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 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 9:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 9:43 AM, 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. 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 56.47   Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  Vial was stored on cooler 1, on 15-Apr-2021, Excursion duration At 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM : 44, 3 PM: 44, 4 PM: 42 and 5 PM : 42.  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 brand 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 on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
A report received from a health care professional on 14OCT2003 concerning a 25 year old female vaccinee who experienced a red, hot, sore injection site the day after receiving Fluvirin vaccine on 10OCT2003. On 11OCT2003, the vaccinee experienced a red, raised, hot to touch, sore area about 1.5 inches in diameter at the site of injection after receiving Fluvirin vaccine on 10OCT2003. The adverse reaction was not yet resolved at the time of reporting but the vaccinee is currently improving. There was insufficient information to determine the reporter's causality assessment. Update 1, 18MAR2004: A follow up report was received from a health care professional indicating that the vaccinee experienced a red raised heated area 24 hours after receiving Fluvirin. The vaccinee recovered from the red, raised heated area in 48 hours. The outcomes of the events reported initially were not reported. No follow up pending, all information received. Reference PJP200300802. PJP20300803
Patient developed localized redness, swelling, and pain. Diagnosed with cellulitis in ER. Took 10 day course of Keflex. Symptoms resolving.
arm swelled up and she had a lump; arm swelled up and she had a lump; This is a spontaneous report from a contactable Pharmacist. A female patient (age: 70s) received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced arm swelled up and she had a lump on an unspecified date with outcome of unknown.  Information about Lot/batch number has been requested.
I went to the hospital due to shortness of breath and extreme pressure and pain in my chest, specifically surrounding my heart, diaphram, and radiating up to my collar bones and shoulders. After blood work and EKG, they found that my EKG was irregular and I had an elevated D-DIMER blood result at 1600. I was taken for a CAT scan of my upper abdomen and they found that I had a large (650ml) pericardial effusion causing cardiac tampenade. I underwent a procedure that inserted a needle into my pericardium, sucked out the fluid, and inserted a drain tube for 48 hours to drain excess fluid. Upon additional testing, it was determined that I had none of the usual causes for a pericardial effusion (no heart attack or trauma, no infection either viral or bacterial, no cancer, no autoimmune conditions.) My inflammation markers were extremely elevated and my lymph nodes in CAT scan were swollen. As a result, I now have constrictive pericarditis, scar like tissue surrounding my heart constricting its function.
Contracted covid between doses of the vaccine, and had AFIB several months later in May (4 months after). Hospitalized, given IV cardizan, prescribed PRN cardizan, have not had to use it since, have not had another episode.
Abnormally heavy menstrual cycle, bleeding through super plus tampons in less than an hour for several hours.
Patient got first dose more than a year ago didn´t get the 2nd; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose more than a year ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. The patient got first dose of Shingrix more than a year ago, the reporter enquired if patient need to restart series get 2 doses now. Till the time of reporting patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
pt recv vax 4MAR97 & had 30sec episode of head shaking, limp 2 days post vax;
I first noticed a red area at the bra line across my chest on the left side. I thought it was irritation from my bra. The area was very sensitive to the touch. April 1, I called my doctor and told her something was wrong and the red area was getting longer from the center of my chest along the bra line to the side. I did a chat with my doctor where I had to hold my phone to show her the rash which was on my chest along my bra line and she said that Shingles and it was blistered and very irritated. I was given a powder and another medication (in pill form) that I can't remember the name of it at the moment. In the next 7-10 days the rash was gone and my skin was back to normal.
Severe migraine; Like cluster headaches; Severe headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Severe migraine), CLUSTER HEADACHE (Like cluster headaches) and HEADACHE (Severe headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Cluster headache (Patient mentioned that she had cluster headaches when she was younger wherein it was debilitating and she couldn't look through light,she has not experienced this for 20 years until she received the vaccine). Concurrent medical conditions included Seasonal allergy and Blood pressure. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for Blood pressure management, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy, MOMETASONE FUROATE (NASONEX) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MIGRAINE (Severe migraine), CLUSTER HEADACHE (Like cluster headaches) and HEADACHE (Severe headache). The patient was treated with SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Pain, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Severe migraine), CLUSTER HEADACHE (Like cluster headaches) and HEADACHE (Severe headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that as a treatment she had an ice pack on head
Stomach pain 3 days after I got the booster. Got diagnosed with pancreatitis
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with refrigerated improperly stored doses of RECOMBIVAX HB lot number M026309, expiration date 11-NOV-2018 (dose and route not reported) for prophylaxis. The vaccines were exposed to a total time in the range 47°F to 77°F (9° C to 25 °C) (15.8°C actual temperature) for 1 hour 34 minutes. The vaccine doses had previous temperature excursions for a total time in the range 47°F to 77°F (9°C to 25°C ) (17.5° C actual temperature) for 6 hours, 20 minutes. The call was placed because of a Digital data logger. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA011935: US-009507513-1703USA011934: US-009507513-1703USA011932: US-009507513-1703USA006822.
little, sudden bursts of headaches that last 1 to 2 minutes and go away/ (headache) episodes are subsiding slowly; mouth was hot; mouth sores; gum irritation; headaches were more persistent the first couple of weeks; Pain at the injection site; Arm became swollen; Arm quite sore; Dermatitis; malaise; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), PERIPHERAL SWELLING (Arm became swollen), LIMB DISCOMFORT (Arm quite sore), DERMATITIS (Dermatitis) and MALAISE (malaise) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism, Glaucoma, Allergy to grains (Gluten allergy.), Allergy to allopathic drugs (Vicodin and Codeine allergy.) and Lactose intolerant. Concomitant products included Travoprost (Travoprost eye drops) for Glaucoma, LEVOTHYROXINE for Hypothyroidism.    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 VACCINATION SITE PAIN (Pain at the injection site), PERIPHERAL SWELLING (Arm became swollen), LIMB DISCOMFORT (Arm quite sore), DERMATITIS (Dermatitis) and MALAISE (malaise). On 30-Dec-2020, the patient experienced HEADACHE (headaches were more persistent the first couple of weeks). On 03-Jan-2021, the patient experienced STOMATITIS (mouth was hot), MOUTH ULCERATION (mouth sores) and GINGIVAL DISCOMFORT (gum irritation). On 15-Jan-2021, the patient experienced CLUSTER HEADACHE (little, sudden bursts of headaches that last 1 to 2 minutes and go away/ (headache) episodes are subsiding slowly). On 03-Jan-2021, HEADACHE (headaches were more persistent the first couple of weeks), STOMATITIS (mouth was hot), MOUTH ULCERATION (mouth sores) and GINGIVAL DISCOMFORT (gum irritation) had resolved. On 05-Jan-2021, VACCINATION SITE PAIN (Pain at the injection site), PERIPHERAL SWELLING (Arm became swollen), LIMB DISCOMFORT (Arm quite sore) and DERMATITIS (Dermatitis) had resolved. At the time of the report, MALAISE (malaise) had resolved and CLUSTER HEADACHE (little, sudden bursts of headaches that last 1 to 2 minutes and go away/ (headache) episodes are subsiding slowly) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen Citrate free. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   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.  Company comment: This spontaneous case concerns adult female patient of unspecified age, with concurrent condition of Plaque psoriasis treated with ADALIMUMAB (HUMIRA), who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to first dose of mRNA-1273 vaccine. SARS-CoV-2 test was Positives on unspecified day. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was not resolved. The concurrent condition of Plaque psoriasis treated with ADALIMUMAB (HUMIRA) could be the risk factor for the event. Ongoing pandemic remains a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns adult female patient of unspecified age, with concurrent condition of Plaque psoriasis treated with ADALIMUMAB (HUMIRA), who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to first dose of mRNA-1273 vaccine. SARS-CoV-2 test was Positives on unspecified day. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was not resolved. The concurrent condition of Plaque psoriasis treated with ADALIMUMAB (HUMIRA) could be the risk factor for the event. Ongoing pandemic remains a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
10/9/18- L supraclavicular nodes back   1/18/19- Nodes back- no illness or shots 3/31/19- Dizziness- fell 4/1/19- Dx HA- Dizziness- ortostatic hypotension 4/3/19- Dx syncopy 4/11/19 Dx with POTS by Cardiology 5/13/19- Exercise elevated TSH 10/11/19- HPV # 2 given 10/12/19- supraclavicular nodes back 10/22/19- Nodes gone 1/14/20 Cardiology decreased contraction 1/28/20 Neurology- ? Absence seizures
red painful rash growing from injection site to elbow; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red painful rash growing from injection site to elbow) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     The patient's past medical history included Parkinson's disease. Concurrent medical conditions included Allergy to allopathic drugs, Penicillin allergy and Blood pressure high.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter once. On 07-Jul-2021, the patient experienced RASH ERYTHEMATOUS (red painful rash growing from injection site to elbow). At the time of the report, RASH ERYTHEMATOUS (red painful rash growing from injection site to elbow) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Symptoms started 8 minutes after injection. Reported by patient 15 minutes after injection Symptoms noted: light headedness Treatments: vitals taken, water given and patient reclined Outcome: extended monitoring, patient given orders for IVF bolus, taken to hospital floor for monitoring during bolus. Per hospital staff, pt improved. Respirations 16 and Blood Pressure 95/65, BP after another 10 minutes 95/65. Finger stick glucose taken about 30 minutes later at 209.  Pt encouraged to get up and walk a few steps, but was unable. BP taken again 40 minutes post injection up to 162/62. Pt stood and turned in circle then sat back down and BP was 120/65.
The patient came in to receive the 2nd original Pfizer vaccine but was given the Bivalent Pfizer booster dose.
flareup, pain in wrist; lump under left arm; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021177869), license party for etanercept (ENBREL).  This serious solicited report (USASL2021177869) was reported to Amgen on 09/NOV/2021 by a consumer from a commercial program (PSP00086) and involves a 48 year old female patient who had flareup, pain in wrist [PT: rheumatoid arthritis], lump under left arm [PT: limb mass] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were reported. The co-suspect medications included covid-19 vaccine. The patient began Enbrel, Single Dose Prefilled Autoinjector on an unknown date. On an unknown date in 2021, the patient reported flare up, pain in wrist and lump under left arm after receiving second Covid vaccine in JUN/2021. No treatment information was received. The outcome of the events rheumatoid arthritis, limb mass were reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was reported as unknown for the events rheumatoid arthritis and limb mass. The causal relationship between the events rheumatoid arthritis, limb mass and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent to contact. No follow up attempts are possible. No further information is expected. Follow up has been requested for lot number.  The reporter's assessment of the causal relationship of the events with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Amgen comment:This individual case report does not change the safety profile of the product.  Amgen assessment: Amgen assessed the events Rheumatoid arthritis flare up, Upper extremity mass as serious and unrelated to etanercept.  No follow up attempts are possible. Information on the lot/batch number cannot be obtained.; Sender's Comments: Pfizer comment: Based on the information provided by the reporter, it appears unlikely that the suspect drugs contributed to the reported events, that most likely were due to underlying medical conditions.
covid vaccine breakthrough case  dose 1 Moderna 4/21/21 025B21A dose 2 Moderna 5/20/21 041C21A
Pt became flushed, dizzy.  Complained of some mild tongue swelling and a few minutes later started having mild chest pain.
Near immediate onset of nausea and ill feeling which improved over following 4 days. Significant arm soreness: persisting but improving.
02/04/2021 I received my dose 1 about an hour later my heartbeat was out of control. Nothing severe happened but my watch that had recorded all the statistics were indicating that something was wrong. I wasn't aware of it. I thought something was wrong with my watch. I saw the recording after one month later after my second dose my heart started beating again fast. It wasn't normal for me because I am a healthy person. I realize that something was wrong so I decided to contact my doctor to see what was going on. I have low blood pressure, and regular normal heartbeat. My doctor prescribed me blood thinners so I don't get stroke or a heart attack. I was lucky that I was healthy. My PCP referred me to a cardiologist gave me beta blockers to slow down my heart rate. I am still taking medication for this. My blood pressure and heartbeat became irregular because of the vaccine. They did electroshock to my heart at the end of July to bring my heart beat to regular.
After receiving my Covid vaccine this past Saturday (07Oct2023). I had rap arm soreness.; I've now got a lump under my arm, in the armpit area; Started feeling chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 as dose number unknown (booster), 0.3ml single (Lot number: HF9275, Expiration Date: Dec2023) at the age of 54 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUAD), on 07Oct2023 as dose number unknown, 1.5 ml single (Lot number: 944463, Expiration Date: Jun2024) for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma. Vaccination history included: COVID-19 vaccine (primary immunization series complete; unknown manufacturer), for COVID-19 immunization; COVID-19 vaccine (dose number unknown (booster), manufacturer unknown), administration date: Oct2022, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Oct2023, outcome "unknown", described as "After receiving my Covid vaccine this past Saturday (07Oct2023). I had rap arm soreness."; AXILLARY MASS (non-serious) with onset 08Oct2023, outcome "not recovered", described as "I've now got a lump under my arm, in the armpit area"; CHILLS (non-serious) with onset 08Oct2023, outcome "unknown", described as "Started feeling chills". Therapeutic measures were taken as a result of pain in extremity, axillary mass, chills. Additional information: the patient specified that It formed a lump under her arms. It was actually a large lump, it's now going down but it's still there. Consumer stated, "I would be going to go the urgent care clinic, but I am figuring is, the shot because I didn't have it and I put a warm compress on it. I have been taking like Ibuprofen, I took Tylenol earlier and I had to put like."
The day after getting second dose of Pfizer COVID-19 vaccined, started with flu symptoms, body aches, joint aches, headache and nausea and vomiting.  Intermittent diarrhea onset at same time until June, since then is having daily diarrhea (several).  Intermittently feeling feverish.