chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jun-2022 at 11:28 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2022 at 11:28 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that patient received half dose. It was reported that no adverse event occurred at time of administration or were reported thereafter. Treatment medications were not reported.
No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report as received from a physician refers to an 12 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 12-JUL-2017, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766:
Pt experienced swelling of entire thigh, red, not to touch, pain, difficulty walking and fever, placed on abx for cellulitis 3 days after receiving shot.
Smelled yeasty; Bright red rash on her neck, under her armpits, under her breasts; Appetite hasn't been the same; Lost 4 pounds; Blood in my urine; White blood cell count was high in urine; Pain when I felt like I needed to urinate/pain at the end of urination; Fever of 101; Body and muscle aches were terrible; Severe pounding headache; Really fatigued; In bed all day; Thigh muscles were killing me; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (In bed all day), MUSCLE DISCOMFORT (Thigh muscles were killing me), SKIN ODOUR ABNORMAL (Smelled yeasty), RASH ERYTHEMATOUS (Bright red rash on her neck, under her armpits, under her breasts) and APPETITE DISORDER (Appetite hasn't been the same) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076DZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced BEDRIDDEN (In bed all day), MUSCLE DISCOMFORT (Thigh muscles were killing me), PYREXIA (Fever of 101), MYALGIA (Body and muscle aches were terrible), HEADACHE (Severe pounding headache) and FATIGUE (Really fatigued). On 29-Oct-2021, the patient experienced DYSURIA (Pain when I felt like I needed to urinate/pain at the end of urination). On an unknown date, the patient experienced SKIN ODOUR ABNORMAL (Smelled yeasty), RASH ERYTHEMATOUS (Bright red rash on her neck, under her armpits, under her breasts), APPETITE DISORDER (Appetite hasn't been the same), WEIGHT DECREASED (Lost 4 pounds), BLOOD URINE PRESENT (Blood in my urine) and WHITE BLOOD CELLS URINE POSITIVE (White blood cell count was high in urine). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) on 30-Oct-2021 for Symptomatic treatment, at a dose of 800 mg and PHENAZOPYRIDINE on 30-Oct-2021 for Symptomatic treatment, at a dose of 200 mg three times a day. At the time of the report, BEDRIDDEN (In bed all day), MUSCLE DISCOMFORT (Thigh muscles were killing me), SKIN ODOUR ABNORMAL (Smelled yeasty), RASH ERYTHEMATOUS (Bright red rash on her neck, under her armpits, under her breasts), APPETITE DISORDER (Appetite hasn't been the same), WEIGHT DECREASED (Lost 4 pounds), DYSURIA (Pain when I felt like I needed to urinate/pain at the end of urination), BLOOD URINE PRESENT (Blood in my urine), WHITE BLOOD CELLS URINE POSITIVE (White blood cell count was high in urine), PYREXIA (Fever of 101), MYALGIA (Body and muscle aches were terrible), HEADACHE (Severe pounding headache) and FATIGUE (Really fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) Fever of 101. On an unknown date, Weight: lost 4 pounds (abnormal) lost 4 pounds.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-370442 (Patient Link).
BACK PAIN; TIRED; FLU LIKE SYMPTOMS; FELT TERRIBLE; This spontaneous report received from a consumer concerned a female 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 not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-SEP-2021, the patient experienced flu like symptoms, felt terrible, and tired. On 11-SEP-2021, the patient experienced back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt terrible on 05-SEP-2021, and the outcome of flu like symptoms, back pain and tired was not reported. This report was non-serious. This case, from the same reporter is linked to 20220200435.
The pt experienced a rash on the abdomen and back. Treated with Zyrtec.
71-year-old female with a PMH significant for HTN, HLD, osteoarthritis, vaccination x2 Pfizer who presented to the ER for complaints cough, chest discomfort and loss of sense of taste or smell. She reports symptoms began on 10/31 and became progressive reason for which she went to the pharmacy,  testing positive for covid-19 on 11/03. Her PCP sent her to JSUMC on 11/06 for monoclonal antibody infusion. However, her symptoms worsened reason for which she presented to the ER today. As a side note, she did not check her O2 saturation nor temperature at home. In the ER, she received Rocephin and azithromycin, initial troponin negative, EKG without ST wave abnormalities. D-dimer 498 reason for which she underwent a CTA chest negative for pulmonary emboli but with multiple focal areas of consolidation and large hiatal hernia. O2 sat>97%. She is being admitted to medical for further evaluation
Shingles.  Valtrex 21  pills  Rash, swelling , severe pain  for 2 weeks
o Parent/Guardian attested multiple times that the patient?s date of birth was Wednesday 09/26/2016. Also, confirmed that patient was at least 5 years old. o I tried to correct DOB but data entry system wouldn?t allow it. Guardian did not want to provide birth certificate to submit for change o Patient received the Pfizer 5-11 year old vaccine
Stomach cramping and spasming below naval; Diarrhea all day; vomiting bile x3 in morning; Chills but no fever; headache; very sore body; I woke up feeling like I had pinkeye; No crust but a little redness; Eyes felt dry and tired by the end of the day.; Day 1 - No problem. Arm got sore.; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6201 and Expiration date not reported), (at the age of 56-Year-old) via an unspecified route of administration on 13Feb2021 at 14:30 on left arm as single dose for COVID-19 immunisation. The patient's medical history was not reported. He was allergic to dust, grass, english plantain and iodine dye. Concomitant medications were Losartan potassium 25 mg and Rosuvastatin calcium 10 mg. No other vaccine received in four weeks. On 15Feb2021 at 07:00, the patient experienced "Day 1 - No problem. Arm got sore". On 16Feb2021, he noticed eyes felt dry and tired by the end of the day and arm still very sore. On 17Feb2021, he woke up feeling like he had pinkeye and no crust but a little redness. It annoyed him all day. On 18Feb2021, he had lubricating eye drops so that helped. Stay developed on lower left lid. He used the drops in the morning. Otherwise, ok. On 20Feb2021, He informed that eyes still dry. Stomach cramping and spasming below naval. Diarrhea all day and vomiting bile x3 in morning. Chills but no fever. Headache and very sore body. Slept on and off all day. On 21Feb2021, he started with diarrhea x3 at 4am. Slept until 10:30. More diarrhea x3. Still fatigued but feeling better. Took Imodium to slow things down. Lost 4 pounds. He was thinking he would be 100% by Sunday. Not looking forward to second shot. The patient treated himself for adverse event. The patient tested COVID neither prior vaccination nor post vaccination. The outcome of the events was not recovered.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Fever, headache,  body aches,  fatigue,  injection site soreness Took ibuprofen, hydrated, rested
Within an hour started feeling feverish. Felt nauseous for a week. Headache still. Face turned red, splotchy and swollen. Generally felt bad.  Itchiness throughout my body. On the skin and also internally where scratching would not ease the itch.
1. The left eye was red for a couple of days.   2. Many red spots on the body like rashes. Still going on.
Sudden Hearing Loss and balance problems 5 days after injection. MRI and MRA normal. ETN doctors (started week folowing SHL) put me on steriods, antibotics, diaretics, B vitamins, and ear infusion of steriods. After 5 weeks I still have profound-severe hearing loss. Dr. should provide manufacturing vaccination details.  7/2/09 Consultant records received DOS 5/22/09 6/2/09. Assessment: Nystagmus, hearing loss.  Follow-up: Loss of hearing right side - severe loss, profound.
Low grade fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04421a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Thyroid disorder NOS.   On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced PYREXIA (Low grade fever). At the time of the report, PYREXIA (Low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood corticotrophin increased: 497 (High) results was extremely high with hormone level of 497..         Patient received second of moderna vaccine on 05Jul2021. patient experienced low grade fever. patient was a lab data ATCH test and the result was extremely high with hormone level of 497. patient was received IV for steroids. Patient asked can the Moderna vaccine cause a false lab report. Patient asked will anyone reach out to her. Consent to Safety.Concomitant medication includes steroids, thyroid meds, blood pressure meds. treatment includes IV for steroids.Action taken with mRNA-1273 in response to the events were not applicable. Upon internal review on 05-Aug-2021, the age was confirmed to be unknown. Source document appears to contain erroneous data. Linked case for same patient captured date of birth as 21-May-1956.    This case was linked to MOD-2021-079067 (Patient Link).
Sore arm; a little tired; second dose was due 25Jan2021; Tested positive for COVID-19 on 03Jan2021/congestion and cough; Tested positive for COVID-19 on 03Jan2021/congestion and cough; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). This 39-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via intramuscular at left deltoid on 28Dec2020 11am at single dose for COVID-19 immunization. Medical history included non-smoker with no other illness. Concomitant medication was none. The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. Patient reported after receiving her first dose of the COVID-19 vaccine on 28Dec2020, she had sore arm and a little tired, other than that felt fine. She stated second dose was due 25Jan2021. She was tested positive for COVID-19 (Rapid Covid testing) on 03Jan2021. She already decided going to wait the 90-day-period to get the second dose of the vaccine. Since she was quarantined she wanted to what she should do. She stated her having testing positive for Covid did not have anything to do with the vaccine. She still had some lingering symptoms, congestion and cough. Nothing had worsened, but just wouldn't go away. She did not receive any other vaccines the same day or 4 weeks prior. No history of problems with vaccines in past. She had not had antibodies checked yet. It was reported no AE required a visit to emergency room/physician office. The patient was not hospitalized. The patient received no additional therapies for COVID-19. Patient's outcome with COVID-19 was recovering, and the rest of events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported  tested positive for COVID-19 (Rapid Covid testing), which is considered ineffective of BNT162B2, and the administration of BNT162B2.
A report was received from a health professional on 10/16/02, concerning about 20 vaccinees between the ages of 6-35 months who were inadvertently administered Fluvirin in the vastus latralis between 14-16 October 2002. None of the vaccinees have exhibited any signs or symptoms of an adverse event. The vaccinees will be closely monitored. There was insufficient information to determine the reporters causality assessment. Update (1) 12/27/02: A report received from a health care professional indicated that a 20 month old male vaccinee inadvertently received Fluvirin vaccination on 10/15/02. There were no adverse effects noted at the time of the report. See ref.: PJP200200575, PJP200300020, PJP200300021, PJP200320023, PJP200300024, PJP200300025, PJP200300026, PJP200300027, PJP200300028, PJP200300029.
No additional AE; HCP called to report that an expired dose of PROQUAD was inadvertently administered to a patient.; This spontaneous report was received from a nurse referring to a  5-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 14-JUN-2023, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 mL, Albumin status rHA lot # U039258 with expiration date 09-JUN-2023, for prophylaxis (strength and route of administration were not reported). No additional adverse event (AE) was reported. The reporter asked about potency of the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) and need for revaccination.
VARIVAX administered 1/21/2009 Rt arm. Redness and swelling next morning 1/22/09. School nurse measured redness - 9 cm.
Within an hour after receiving the flu vaccination, the patient complained of headache, said "I see the lights."  Also complained of chest pain and shortness of breath. Employee flu clinic was being held at Urgent Care.  Patient was seen by the staff.  EKG was done, B/P-106/68, HR-97, SPO2 98%, temp 97.7.  Aspirin po was given and she was transferred to the ER.  Patient was reached by phone on 9/22.  She was given a nebulizer treatment in the ER which alleviated her SOB.  She reports a history of asthma.  She was told by the staff that she was having a reaction to the flu vaccine.  She was fully recovered on 9/22 without residual symptoms.
Moderna COVID vaccine # 3 given 11/29/2021, lot #027H21B; 1/3/22 pt admitted to hosp with worsening altered mental state and back pain; found to be positive for COVID; treated with dexamethasone, remdesivir, supportive care; no improvements; transitioned to comfort care and pt passed away in the hosp; DC and med records sent.
Reports onset of blurred peripheral vision and intense headache approx 1 1/2 hrs after administration of vaccine. Advised per clinic coordinator to take TYLENOL or ADVIL and lay down. Go to dr. or hosp if no relief. Telephone call to client at 12:30pm Mon 11/4/09 & ask outcome. She said she took a friend's migraine med. (name unknown) and she was now feeling well.
Received KINRIX (DTAP/IPV) MMR #2, Varic #2 on 6/15/10. Later developed (L) arm swelling-shoulder with demarcation at site of KINRIX admin.
I experienced light headedness, mild delirium, nausea & tiredness. The following morning I felt very sore and achy through the day. The second morning after, I woke with a migraine headache. I feel normal again today.
7 days after admin quarter size round bump/hives. Took allegra, didnt help. 8 days after, warm to touch and getting worse
Dose #1 ER5730  12/30/2020. From day 1 post injection 2 - repeat symptoms of extreme SOB on ambulation - worse than with #1. RR 36+ O2 sat stayed at 93 or above with ambulation. HR in supine position 70 w/in 10-15 seconds of ambulation greater than 105. On day 6 post injection, with bagging up a bag of garbage (bending over and picking things up with a spilt can) I had to sit down I was that SOB. HR 130 on pulse ox - O2 sat. 94-95.  Day 7 post injection - ER work up for PE - negative, chf evaluation - negative. no pneumonia or cardiomegaly on CTA. CBC all w/in normal limits except on diff - lymph 0.5 above normal range only. CMP ok as well. BMP and trops normal. Day 9 diffuse itchy rash has developed, even worse now on day 10. Raised, blanching, papules - no pustules/vesicles noted. Trunk presentation spreading to extremities.  leg signifiant more populated than arms. Rash now on tops and bottoms of feet.  Minimal spots on dorsal hands and none on palms. Extremely itchy.   + Celiac patient (Dx- genetically 7-8 years ago, symptoms for over 10) and + Hashimotos patient (29 years). No recent gluten exposure resulting in GI response. (I can get bowel incontinence with cross contamination. ) I'm taking Synthroid as prescribed.  Since I'm in the CD8 peak days (9-11)- can this just be some type of autoimmune storm since it was a viral vaccine? No history of any problems with my yearly influenza vaccine.
I had no issue with the first three shots. With the fourth the next day any energy in the body such as walking moving something lifting something caused extreme limiting a breathing capability. If I was sitting I had absolutely no problem at all. And it was random during the day. But it was every day. My doctor found a spot on the lung he put me on additional medication to separate antibiotics and 20 days of prednisone. None of it is has helped.   My immune system is low so I have infusions once a month of IgG.
Post vax, the patient experienced a red rash and welty area on the left thigh which was hot to the touch.
THE FIRST "SEVERE" EPISODE WAS ON THE DATE ABOVE, PATIENT WAS EXTREMELY WEAK AND UNSTEADY ON HER FEET. SHE HAD BEEN FEELING ILL FOR A COUPLE WEEKS PRIOR TO THIS, SHE WAS SORE, HEADACHE AND DIZZY. THE NEXT DAY 12/21/10 SHE COULD NOT WALK AT ALL AND THIS WAS THE FIRST PARALYSIS. SHE WAS ADMITTED TO THE HOSPITAL, A NEUROLOGIST WAS CALLED IN, SHE HAD MRI AND BLOOD WORK.
Swelling around eyes that resolved in 12 hours. Fever of 101-102 F.
Info regarding Prevnar vaccine was received from a healthcare professional regarding a 2 year old male pt who experienced injection site swelling and injection site knot. The pt received a dose on an unspecified date. Relevant medical history was not provided.  Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 Dosage Form 1 time per day, IM. Patient was not taking concomitant therapy. EVENT DETAILS: This is one of two pts from this facility who developed the same reaction following receipt of Prevnar. No additional info was available at the time of this report.
Admission Date: 4/24/2023 Discharge Date: Apr 26, 2023   PRESENTING PROBLEM: Syncope, unspecified syncope type   HOSPITAL COURSE: Patient, female with a past medical history of dementia paroxysmal atrial fibrillation, hypothyroidism, and essential hypertension among other comorbid conditions presented to the Hospital area department on 04/24/2023 after patient experienced an episode of syncope while at home.  The patient was slowly lowered to the ground by her husband, there was no evidence of head trauma.  Evaluation in the emergency department revealed positive orthostatic vitals but otherwise patient was hemodynamically stable.  Laboratory studies are largely unremarkable except for troponin which was 15 initially and recheck decreased to 13. COVID-19 screen was positive.  Evaluation via imaging which included chest x-ray was negative for acute process.  The patient was provided with Tylenol as well as 1 L of isotonic IV fluids in the emergency room and admitted to the hospitalist service for ongoing management and coordination.  Given the episode of syncope without clear etiology the cardiology team was consulted, evaluated the patient on 04/25/2023.  Determined there was no cardiac etiology for the patient's syncopal episode and was more likely related to the patient COVID-19 infection and related to poor oral intake. While hospitalized the patient remained hemodynamically stable, there were no further episodes of syncope and she was able to work with physical therapy. On 04/26/2023 with labs and vitals stable condition, with having been cleared by the Cardiology team, she was discharged to home instructions follow-up with her primary care physician within 7 days intermittent COVID-19 isolation to complete a total of 5 days per CDC recommendations.
Following 2nd Hep-B vax, experienced arthritis type pain in fingers, hands and wrists x 6 weeks. Following 3rd Hep-B vax, noted severe pain at base of coccyx. Pain gradually worsen and has continued when sitting in certain positions.