chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Product temperature excursion issue; patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Dose1) on 22-May-2021 and COVID-19 Vaccine (Dose 2) on 20-Jun-2021. Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine and COVID-19 Vaccine.    On 04-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. Vial was stored in refrigerator at the time of excursion. Vial was thawed on 28-Jan-2022. Patient had received booster dose of Moderna vaccine. Storage condition at the time of the excursion: frozen storage / refrigerated storage / ambient room temperature: refrigerator Temperature excursions involving 4 Moderna Covid-19 vaccines inside the refrigerator on 28Jan-30Jan2022, 31Jan2022 and 04Feb2022. On 28 Jan 2022 Maximum or minimum temperatures reached range was positive 34.7F to positive 41.2F, on 30 Jan 2022 temperature range was positive 34.7F to positive 41.2F which occurred approximately for 48 hours, on 31 Jan 2022 temperature range was positive 34.7F to positive 41.2F for 12 hours and on 04 Feb 2022 temperature range was positive 35.2F to positive 41.7F for 12 hours. No patient had reported any adverse events. The reporter wants to know if the patients need to be re-vaccinated. No treatment drug information was provided.
massive stroke; coded six times at the hospital; a pacemaker lead possibly dislodged during vigorous CPR; This is a spontaneous report from a contactable nurse (patient's son) communicated to a Pfizer sales representative. An 81-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on 18Feb2021 as single dose for COVID-19 immunization. Medical history included diffuse atherosclerotic disease including single vessel coronary artery disease, two prior carotid endarterectomy surgeries, an abdominal aortic aneurysm and iliac disease, and cardiac pacemaker insertion. The patient's concomitant medications were not reported. On 20Feb2021, the patient experienced massive stroke less than 48 hours after receiving his second dose of vaccine. On 20Feb2021, the patient coded six times at the hospital and one his pacemaker leads appeared to not be working properly, possibly dislodged during vigorous CPR (Cardiopulmonary resuscitation). The patient's son, a RN (registered nurse) in a cardiology practice for more than 20 years was the reporter. The clinical course was as follows: The stroke happened on 20Feb2021. The patient was taken to Hospital. The patient coded six times at the hospital. One his pacemaker leads appeared to not be working properly, possibly dislodged during vigorous CPR. The clinical outcomes of the events massive stroke, coded six times at the hospital, and a pacemaker lead possibly dislodged during vigorous CPR were not reported.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the preexisting complicated cardiovascular conditions including diffuse atherosclerotic disease, two carotid endarterectomy surgeries, abdominal aortic aneurysm and cardiac pacemaker user, the events massive stoke, coded six times (cardiac arrest transient) and pacemaker dislocation in this 81 years old elderly patient are considered most likely intercurrent medical conditions and not related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Client had been in observation area 21 mins when she reported to EMTs feeling itchiness on face at 1453. PHN  joined at 1455. Upon arrival client sitting upright in chair, alert and oriented x4, flushing noted in face. Client denied shortness of breath, chest pain, blurry vision, or headache. No tongue swelling, no rash noted. EMT took first vitals at 1457: blood pressure 153/103, pulse 88, oxygen sat 99%. Per new onset of itchiness on upper right back and warmth feeling throughout body. Per client 8 weeks pregnant, only takes prenatal vitamins and no known allergies. This is client's second pregnancy. With 1st Moderna Covid vaccine client reported swelling, redness, itching at site that resolved on its own. PHN offered client Benadryl and client accepted. Bendaryl 50mg orally given at 1500. Client contacted family member to pick her up. Vitals at 1504: blood pressure 130/88, pulse 82, oxygen sat 99%. Client reported itchiness to face and upper right back same, face flushed. Vitals at 1509: blood pressure 118/80, pulse 88, oxygen sat 98%. Per client itchiness on upper right back improving. Vitals at 1515: blood pressure 116/74, pulse 81, oxygen sat 98%. Per client itchiness on face improving, upper back itchiness almost resolved. Face color improving, redness in cheeks area. Vitals at 1520: blood pressure 114/82, pulse 85, oxygen sat 98%. Client reported itchiness improving, warm feeling resolved. 1524 client reports upper right back itchiness resolved, face itchiness greatly improved. Client cheeks pink color. Last vitals at 1530: blood pressure 110/86, pulse 83, oxygen sat 99%. Client reports feeling better. Client's cheeks with slight pink color. Per client itchiness resolved. PHN advised client to follow up with provider. ER precautions given. Client left facility at 1532 with steady gait.
Fever; light headedness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and DIZZINESS (light headedness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Passive smoking, Bronchitis and Chronic cough.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DIZZINESS (light headedness). On 07-Mar-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) was resolving and DIZZINESS (light headedness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.She reported that within an hour she felt so light. Patient's mucus was cleared up from chest which patient  had from  chronic smoking and bronchitis. patient's chronic cough had also completely gone since the day of getting vaccine.  Treatment information was not provided.
PATIENT WAS VISIBILY PALE, WEAK, AND NAUSEOUS AFTER VACCINE ADMINISTRATION.
Got chicken pox; This spontaneous case was reported by a consumer and describes the occurrence of VARICELLA (Got chicken pox) in a 48-year-old patient of an unknown gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VARICELLA (Got chicken pox). At the time of the report, VARICELLA (Got chicken pox) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
A child age 8 years and 2 weeks of age was given a DTaP instead of a Tdap as the 5th dose in the series.
Information has been received from a nurse referring to multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of VARIVAX (lot # L048467, expiry date 17-FEB-2017) that were improperly stored. No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient fainted after receiving GARDASIL #2.  Patient complained of tingling & numbness of both legs below the knees ~1 day after GARDASIL #2. 8/4/08-records received -7/2/07-C/O chronic shoulder pain. 4/9/08-C/O tingling in legs from knees down. Exercising with 16 pound weight loss, possible reduced potassium intake. 4/30/08-continues with C/O tingling in both legs. 6/25/08-neurology consult-C/O pins and needles in bilateral lower extremities. Swims and runs competitively. C/O developed in March 2008. PE WNL except for minimally decreased pinprick sensation in lateral aspect of both feet.
She notes that she developed a rash about an inch below injection site the day she received, it worked it's way down to elbow crook. Initially raised slightly almost like hives. On Monday 8/12/19 she was going to request and appointment however it had almost completely resolved
First dose was given on  4/25/19 with similar, but not as severe a reaction as the  does given on 10/22/19.  The reactions from the dose given on 10/22/19 included sever chills and shakes from about 8 pm until around 5 am when the shakes started to  reduce.  I felt very cold, but never felt as if I had a fever.  I   continued to sleep until around noon on 10/23 when I woke up with a bad headache & no energy.  I felt as if I was getting better for the next 3-4 hours.  At around 4 pm the chills and shaking came back, but not as sever.  I went to bed after these started and ended up getting sleep easier than the previous night.  I woke in the early morning with my shirt wet , changed clothes and went back to bed.  On 10/24 I felt good enough to visit my doctors office to review my reaction symptoms.  I continued to improve, but was weak and felt like I had a cold for the next few days.  On Monday 10/28 I felt normal again.
At about 12:30 p.m. I received the 1st SHINGRIX shot in the series. The shot hurt like the dickens, and I bled quite a bit (I believe it is because my shirt sleeve was so tight, but it's better to be safe than sorry when providing the details). I went on with my day and about 10 p.m. is when the symptoms began. It started with the feeling I could not get warm and immediately turned into when I laid down to go to sleep my hands and feet were freezing, but my body was on fire. I did not sleep at all that night. The symptoms began getting progressively worse by the minute. At the height of the reaction, I felt like I was on fire, yet freezing and every nerve ending, and I mean every single nerve ending hurt. I began by taking a single 500 mg acetaminophen to attempt to curb the fever and the pain. There was also a feeling of nausea, but I never became physically ill. I grabbed a heating pad to try to rid myself of the back pain, and while it did provide relief, I believe it wasn't until I was finally able to sleep from about 2 p.m. - 4 p.m. that I noticed the symptoms beginning to diminish. I took ibuprofen at 4 p.m. (600 mg) just to try to get rid of the body aches. I went to bed at 8 p.m. that night and woke up the next morning symptom free.
Moderna vaccine was administered to a patient under 18 years of age. No reported side effects or adverse reactions at this time.
Patient received vaccine on Friday, September 1 at 353pm. The morning of Tuesday, September 5, at approximately 930am, the patient contacted the pharmacy discuss her vaccine related adverse event. The patient states she has red, circular swelling, about the size of a golf ball, at the injection site location. It is warm, itchy and somewhat painful to touch. The patient was advised to alternate heat and ice on the injection site. Also, if able, it was recommended she take some otc ibuprofen and acetaminophen to help with the pain and swelling. If the swelling continues, or worsens, over the next 24-48 hours, she should contact her PCP.
Due to inaccurate records, patient was given the Booster dose (0.25ml) instead of the 3rd primary dose which was also not given as the 3rd vaccine.  Patient is immunocompromised.   1st dose 0.5 ml Moderna (100 mcg) 2nd dose 0.5 ml Moderna (100mcg) 3rd dose 0.25 ml Moderna (50 mcg) 4th dose 0.25 ml Moderna (50 mcg)
2018SA202309 Initial information received on 20-Jul-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves patient (age and gender not reported) who experienced reaction with a sore arm, while received vaccine Tetanus Toxoid. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number, expiry date, dosing details not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious reaction with a sore arm (pain in extremity) (unknown latency) following the administration of TETANUS TOXOID. Reaction description: A nurse was calling on behalf of an another nurse to find out if the ADACEL contains horse serum. She reported that a patient was refusing this injection because of this concern. She also reported that the nurse caring for the patient told her that in the past, this patient reported a reaction with a sore arm from a past Tentanus shot but the caller was not sure if this true or if this was for a product we make as Sanofi. She was not sure if this reaction was from a past Tdap or not. She did not know the patient information, date of reported past event, or any details for the template regarding this. The information was asked and the caller did not have this information to provide. Other relevant tests included no lab data. Final diagnosis was reaction with a sore arm. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for reaction with a sore arm.
Baby ran low temperature. 99.8. Began randomly contacting followed by blank staring, fatigue,  lethargy,  and no appetite. Continued and got worse for 36 hours and then took baby to ER.
TINGLING IN HIS LEGS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced tingling in his legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tingling in his legs was not reported. This report was non-serious. This case, from the same reporter is linked to 20210920710.
Savvier pain, on whole arm especially at night.  Flu like symptoms and Temperature of 102 with blurry vision and.
About one minute after the vaccine was given, he got pale, diaphoretic, blurred vision, difficulty speaking for about one minute. Ice pack applied to his neck. He stated that he felt a bit shaky and sweaty for another 5 minutes, at which point he started feeling "normal". We watched him for another 30 min, with no further symptoms.
Left upper arm red and painful, starting about 6 hours after injection with difficulty raising the arm which lasted about 1 day.  She was also nauseated and chills which lasted about 10 hours the first night.  Had frequent voiding during the 1st night.  No treatment.
approximately 24 hours after the second vaccine, I noticed 3 swollen lymph nodes in left neck, same side as vaccine administered.   at approximately 30 hours after the vaccine, pain became about a 4-5 on a scale of 10.  not unbearable but too uncomfortable to sleep.  by 4/4, approximately 6 days after the vaccine, one of the lymph nodes became large and very firm requiring a Dr. visit.   My primary care physician immediately referred me  who performed a needle biopsy on the reactive lymph node on 4/6.   Test results show no cancer cells and determined it was most likely a benign  reactive node. It is not known if this is a direct result of the vaccine.
Left arm shoulder area where shot was administered hurts everyday. Was waking me up in the middle of the night from pain, I have never had pain in my arm prior. Still hurts everyday.
This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 30May2021 at 00:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient has no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 02May2021 at 00:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jun2021 at 04:00 the patient experienced fever and also got shingles two days after the second COVID vaccine dose. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. On 06Jun2021, the patient underwent PCR test (nasal swab) and the result was negative. The clinical outcome of the events fever and shingles were not recovered at the time of the report.  The lot number for the vaccine [BNT162b2] was not provided and will be requested during follow up.
4/15/2022-Presents to ED via EMS, Lightheadedness and Hypoglycemic episode. Chest ct : pleural-based airspace infiltrate in the right lower lobe. Covid + on admission. Admit hypoglycemia.  Vitals stable maintaining spo2 on RA. Start Levofloxacin x1.  4/17/2022-Am: B/P 58/43 Midodrine and Levophed given. HR increased to 100-200's. Transfer to ICU. Started vancomycin and ceftraixone.  Also has significant wound on R foot. B/P now 95/52. Hr down to 93.  4/20/2022-Levophed d/c and SBP's WNL. 4/22/2022-eGFR up to 13 from 9. Covis asymptomatic. Continue Midodrine.  4/24/2022-Continues on RA, B/P maintaining around 100/50-60's.  4/26/2022- Downgraded to MS from ICU.
Heaviness in my chest due to asthma.  It was and still is very difficult to breathe.  I went to my doctor on 10/23/2009 and was ran through a battery of tests which included a thorough exam by the doctor listening to me breathe, adminstering an oxygen saturation test, peak flow meter test ,and a chest x-ray.  As of today, 10/29/2009, I am still currently taking an oral steroid as well as two albuterol nebulizer treatments daily.  12/30/2009 Immunization record received for 10/22/2009. Vaccination listing reflects H1N1 received 10/22/09.  12/31/2009 clinic records received for 10/23/2009-10/30/2009. DX Exacerbation of asthma, Bronchitis with underlying asthma.  Patient presented one day post vaccination with complaint of chest tightness, cough, shortness of breath and feeling tired and grumpy. Lung sounds clear bilaterally. Started on prednisone taper. One week later, patient presented with productive cough, shortness of breath, plugged ears. Chest tightness resolved and patient feels like she now has an illness. Rhonchi in right lower lobe. Started on Levaquin.
At injection site - hotness; Skin hardness at injection site; Extreme pain at injection site; Redness at injection site that has spread; This is a spontaneous case, initially received from other health professional via Agency (case ID: SEQ19-04875) on 16-Oct-2019, concerning a female patient of an unknown age.   The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: P100112490, expiration date: 11-Jun-2020, route of administration and anatomical location: not reported] for an influenza prophylaxis.  On an unknown date, after vaccination, the patient experienced hotness, extreme pain, skin hardness at injection site and redness at injection site that had spread.   On 24-Sep-2019, the reporter stated that the patient was doing well.  The outcome of all the events was recovered, on an unspecified date.  The reporter did not provide seriousness and causality assessment.  The case is linked to 201905307, 201905317, 201905319, 201905320, 201950321, 201905322, 201905323, 201905324 and 201905325 due to same reporter.  Follow up received from other health professional via Agency (SEQ19-05499) on 24-Oct-2019: The reporter stated that all vaccine recipients were doing well. The outcome of all events updated to 'Recovered/resolved'. Narrative amended accordingly.  Company Comment: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
Injection was given much higher than previous injection. Severely sore arm and shoulder, limited mobility of shoulder and arm.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 19-SEP-2013 the patient was vaccinated with a only dose of M-M-R II (dose not reproted, lot # 1449AA, expired date: 13-SEP-2013) intramuscularly. No adverse effect reported. Additional information has been requested.
Night sweats, leg cramps, leg twitching, duration several hours, within 24 hrs of vaccine (same day)
30 minutes after injection headache started, nausea. That evening  headache increase, felt like my head would explode. Temples felt swollen.  Eyes burned, 101 fever chills and sweats. Last 2 days. On the second day a developed a deep croupy cough and chest hurt. Every part of my body hurt. Missed another 1/2 day of work due to cough and feeling sick, this was on 9/24/2021. 3 days after receiving the vaccine. Next day 9/25/2021 still coughing, and  headache. Feel tired with body aches.