chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Other vaccine same date details/other vaccine same date product; mild visual acuity decrease/slight decrease Visual Acuity and depth perception; Neuromyelitis optica exacerbation; This is a spontaneous report from a contactable Physician. A 68-years-old (non-pregnant) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9265, expiration date was not provided), via intramuscular route of administration at right arm on 09Feb2021 14:00 (at the age of 68-years-old) as single dose for COVID-19 immunization. Medical history included Addisons Ds, hypertension, Post Hysterectomy, Optic Neuritis type symptoms and Minor visual symptom. Concomitant medications included amlodipine for hypertension, estradiol for hysterectomy, fludrocortisone for addisons disease, hydrocortisone for addison's disease, metoprolol hypertension olmesartan hypertension. On 28Feb2021, the patient awoke with slight decrease visual acuity and depth perception and neuromyelitis Optica exacerbation and required visit to physician office. Other vaccine same date details/other vaccine same date product. The patient was treated with solumedrol high dose iv starting Rituxan Infusions for event neuromyelitis Optica exacerbation. The seriousness of the event neuromyelitis Optica exacerbation was considered as medically significant. The patient was not pregnant at the time of vaccination. The patient did not have any known allergies. The patient had no other vaccine within four weeks. 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 provided information to you regarding the reported adverse event(s) with the use of the product as consider the Pfizer product had a casual effect to the adverse event. The outcome of the event was event neuromyelitis Optica exacerbation was recovering on 03Mar2021, and outcome of other events was unknown.  No follow-up attempts are needed. No further Information is expected.; Sender's Comments: Based on medical history and concurrent disease the event neuromylitis optica progression and visual acuity decreased mostly represented intercurrent condition in this patient unrelated 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 RAs, Ethics Committees, and Investigators, as appropriate
Child was given the 3+ vaccine as that is what sibling was receiving. Vaccine that the child should have received was the 6-35 month product. Boxes and syringes similar in appearance just slightly different coloring. It was confusing as well as estimating child's age to be 3.
Whole body rash. Facial swelling and dizziness. Prescribed Zyrtec, xyzol and Oral steroid.
Fatigue before going to bed.  I did not get good sleep that evening of the vaccine due to muscle soreness and joint pain.  I woke up with what felt like a full-blown flu with extreme fatigue, muscle soreness, systemic joint pain, a headache and sore throat.
fever 100-101, n/v; restless throughout noc 31JAN-1FEB p/vax; slept throughout noc; c/o aching all over, h/a; has not eaten since vax;  devel rash;
Called 1/5/19, experiencing redness from the injection site area to elbow and inside arm. On 1/6/19, patient visited urgent care and diagnosed with Cellulitis.
No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-May-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 12-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No concomitant medications were provided. It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 77 Monovalent doses administered after the BUD to patients 12 and up. 26 doses from Lot 065K21A. No treatment medication was provided.   This case was linked to MOD-2022-691046 (Patient Link).
Metallic taste immediately after.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm right on 08Apr2021 at 11:45 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies, CVID immune deficiency and ehlers-danlos syndrome. Concomitant medications 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. On 08Apr2021 at 11:45, the patient experienced metallic taste immediately after. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event metallic taste immediately after was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
vial was first punctured on 17May2022 at 12 PM/stored at room temperature post puncture/ vial was exposed to room temperature for 25hrs; Patient got expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got expired dose) and PRODUCT STORAGE ERROR (vial was first punctured on 17May2022 at 12 PM/stored at room temperature post puncture/ vial was exposed to room temperature for 25hrs) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2022 at 1:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2022 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got expired dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was first punctured on 17May2022 at 12 PM/stored at room temperature post puncture/ vial was exposed to room temperature for 25hrs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got expired dose) and PRODUCT STORAGE ERROR (vial was first punctured on 17May2022 at 12 PM/stored at room temperature post puncture/ vial was exposed to room temperature for 25hrs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  The pharmacist found out that two patients in their hospital got expired Moderna COVID-19 vaccine on 18-May-2022 around 1 PM. The vials should have expired around 00:00 on 18-May-2022. She wanted to make sure the vaccine still maintained potency and the patients did not need to be revaccinated.  Number of doses/vials included 2 doses.   Date the vial was initially stored in the refrigerator - 27-Apr-2022.  The vial did not undergo any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8 to 25 C= 46 to 77 F): 25 hours  No treatment medications were provided.
pt recv vax 17OCT96 & 10DEC96 pt exp flu sx & was seen by MD who prescribed ATB;
Experienced irregular mid-cycle menstrual bleeding 10 days after receiving first vaccine injection. The bleeding is intermittent and has been continuous for going on 4 days. Impending early menstrual period (2 weeks early)  is also of concern.
Received Moderna Covid-19 vaccine at age 17; Patient is Breast feeding received vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna Covid-19 vaccine at age 17) and MATERNAL EXPOSURE DURING BREAST FEEDING (Patient is Breast feeding received vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna Covid-19 vaccine at age 17) and MATERNAL EXPOSURE DURING BREAST FEEDING (Patient is Breast feeding received vaccine). On 24-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna Covid-19 vaccine at age 17) had resolved. At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Patient is Breast feeding received vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.  Company Comment: This case concerns a 17-year-old, female patient with no relevant medical history reported, in which product administered to patient of inappropriate age and maternal exposure during breast feeding were reported with no associated adverse events. The patient received the first dose of Spikevax. The rechallenge was not applicable due to the nature of the events. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-342801 (Parent-Child Link).   See case MOD-2021-342801 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow up received on 08-Oct-2021 contains non new information .; Sender's Comments: This case concerns a 17-year-old, female patient with no relevant medical history reported, in which product administered to patient of inappropriate age and maternal exposure during breast feeding were reported with no associated adverse events. The patient received the first dose of Spikevax. The rechallenge was not applicable due to the nature of the events. The benefit-risk relationship of Spikevax is not affected by this report.
Pt became faint, sweaty, nauseated 10min p/vax; phoned MD 16JUL91 to report slept 2 hrs p/returning home; Was awakened by pain in arm radiating into neck to wrist;slept another 14hrs p/being up 2 hrs;Arm still a little sore 16JUL.
Pt had flu shot (L) deltoid at about 6 AM at 6:30 AM pt had paresthesias down entire arm.
5 minutes p/inject person was standing along wall & last consciousness, skin cool, clammy, BP 100/64;
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-FEB-2018, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N025929 and expiration date on 18-MAR-2019, for prophylaxis (dose, route of administration and anatomical location were not reported). The sterile diluent (MERCK) lot # M017324 and expiration date on 25-SEP-2018, used to reconstitute the vaccine was properly stored. The administered dose of the vaccine experienced a temperature excursion of -14°C to-10°C for 22 minutes as recorded by a data logger, with a previous temperature excursion report in the range between -14°C to -10°C  for 22 minutes. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA011935.
Patient experienced lightheadedness and dizziness  upon rising from the chair.  Advised patient to sit have a seat and gave them a bottle of water. A few minutes later the patient threw up and then lied down on the floor to prevent a fall. Patient was very pale and we retrieved a pillow for the patient to rest their head. The patient never lost consciousness  and began to recover. Paramedics arrived and took over the situation. Patient elected to not take an ambulance to the hospital
After more or less 7 hours of vaccines, patient developed hypotony, floppy, somnolence, 1 episode of vomiting; was brought back to clinic. Found awake, presual but sleepy with decrease muscular tone. We got concerns with hypotonic-hyporesponsive episodes (HHE) describe with pertussis. Patient admitted for observation to the hospital.
was administered an expired dose / expiration date: 7/5/2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 38-year-old male patient who received HAV (Havrix) (batch number D94MK, expiry date 5th July 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th July 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 8th July 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Pharmacist reported that, the patient was administered an expired dose of HAVRIX vaccine, which led to expired vaccine used. No further details were provided at the time of the call. The reporter consented to follow up.
04-02-2021 Left upper arm became more sore and swelling. Also is warm to the touch 04-03-2021 Mid bicep and up on left arm is very hard(swollen) and stiff. Itchy  Just took a 25mg of Bbenadryl
Started out as quarter sized red spot at vaccine spot (Shingles vaccine.). It got bigger and by Friday, 10/28, it was red, swollen, and I could feel a lump. It started itching 10/29. And it's sore to the touch.
Horribly severe headache.  Incredible muscular pain and body aches, severe dehydration, extreme chills , and a high fever. I have never been so ill in my entire life. All of these symptom started out mild, but grew more severe into the night. The duration was  about 8-9 hours.
This spontaneous report as received from a nurse / office manager refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in February 2016, the patient was administered the first dose of GARDASIL 9 intramuscularly (lot # and expiration date were not reported). On an unknown date in May 2016, the patient received the second dose of GARDASIL 9 intramuscularly (lot # and expiration date were not reported) and on 17-AUG-2016, the third dose of GARDASIL 9 intramuscularly (lot # and expiration date were not reported) (coded as inappropriate schedule of vaccine administered). There was no adverse event reported. Additional information is not expected because there was no consent to contact nurse.
No Adverse event. On 11/03/2021 the Vaccine Refrig data logger showed a temperature excursion occurred on 10/29/2021 at 10:48 a.m. of +50.7 (F). The timeframe documented is 13 mins with n 5 min alarm notification totaling 18 min. The vaccine providers were not aware that the vaccine needed to be used within a 24 hour timeframe of the excursion prior to discussion with the health department on 11/3/2021. A clinic was scheduled for Moderna Booster doses at a High School (AIM) for their employees for 11/1/2021. This clinic did occur with the Moderna Vaccine with Lot # 076C21A between the hours of 3:00-5:00 p.m. A total of 16 people received Moderna Booster shots 0.25ml.  The vaccine provider learned on 11/3/2021 in conversations with the health department that due to the excursion, the vaccine should be discarded if not used within 24 hours of the temperature excursion. With the instructional education provided via the health department, all remaining doses of Moderna with Lot# 076C21A was wasted.
pt recv vax OCT96 & pt exp rash;reporter did not know if the rash was dx as chickenpox;@ the time of the report rash had cleared;
PM of 12-9-08 started vomiting; vomited throughout the night.  12-10-08 Temp 102, taken to clinic, given IVs.
Swelling, extreme tenderness to tendons/ligaments (shoulder Joint ), significant decrease in ROM of the right shoulder (unable to abduct arm, move arm behind body, limited and painful to move are Forward and/or straighten arm at the elbow) , right pinky and ring finger numbness,  visible change in color (purple/blue) to both fingers and decrease in temperature to right hand overall especially pinky and ring finger (significantly cooler than the left hand).
MULTISYSTEM SARCOIDOSIS ASSOCIATED WITH THE COVID-19 MRNA VACCINE; This is a literature report.  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (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, SINGLE), for COVID-19 Immunisation, reaction(s): "low grade fever"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunisation, reaction(s): "fatigue", "lethargy", "fever". The following information was reported: SARCOIDOSIS (medically significant), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "MULTISYSTEM SARCOIDOSIS ASSOCIATED WITH THE COVID-19 MRNA VACCINE". The event "multisystem sarcoidosis associated with the covid-19 mrna vaccine" required physician office visit. Therapeutic measures were taken as a result of sarcoidosis.  Clinical course: she received her booster dose (~6 months after the second dose) and 2 weeks later, she noticed a right posterior calf mass that was firm and non-tender on exam. Rest of the exam was unremarkable. Orthopedic surgery was involved, and an excision biopsy was done. Pathology demonstrated non-necrotizing granulomatous inflammation. Her blood counts and metabolic panel were normal. Other labs showed elevated C-reactive protein of 19 mg/L (normal < 5 mg/L), angiotensin-converting enzyme level of 93 U/L (normal is 9-67) and Vitamin D level of 8.4 ng/mL (normal is 20-50 ng/mL). She was referred to pulmonary clinic for further evaluation. Pulmonary function test showed mild restrictive physiology. CT chest revealed enlarged mediastinal and hilar lymph nodes and lung parenchymal involvement. EBUS guided TBNA was performed and showed granulomatous inflammation.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the event Sarcoidosis and the suspect drug  BNT162b2  The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-202201213046 Same article/ drug/ patient and different event for different dose;US-PFIZER INC-PV202200078685 Same article/ drug/ patient and different event for different dose;
Has peculiar large red patchwith blood vessels under the skin from the high dose- she has not had a shot 6x8 inches.
About a minute following the second vaccine, before he was supposed to receive a 3rd (Varivax) he asked for a minute because he wasn't feeling well. Then, he fainted. He was not able to be aroused for approximately 2 minutes by shaking/shouting/placing an alcohol swab under his nose. He was making unusual breathing sounds with slight bradycardia. We called 911 to evaluate. He denied medical treatment/follow-up.
Info has been received from a physician concerning a 7 year old female who was vaccinated with a dose of varicella virus vaccine live. The physician reported that the pt subsequently, developed 50 lesions and a 101 degree fever. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional info has been requested.
left side numbness, tingling, speech slurring, weakness. Went to ER and was given TPA, symptoms resolved prettyquickly. A week later, still experiencing balance problems, headache, overall fatigue and weakness.
Itching, pain in back. Narrative:  #1 dose on 1/15/21 on 1/19/21 diagnosed with shingles, off work 5 days. Hesitant to complete covid 19 series, dose #2 as feels there was a connection between receiving vaccine and developing shingles
unexplained transient but severe anemia & Hgb 1.7 detected 5DEC97-PRBC transfusion required;
Information has been received from a medical assistant concerning a 13 week old male patient who on 12-DEC-2011 was vaccinated with the first dose of ROTATEQ (lot #, dose and route not reported). On 04-JAN-2012 the patient was vaccinated with the second dose of ROTATEQ (lot #, dose and route not reported) too early. She stated that no adverse experience had been observed or reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Health Problems; This is a spontaneous case, initial and follow up versions, received on 03-Jul-2019 (both versions being processed together), concerning a patient of unspecified age (reported as sixties) and gender.  On an unspecified date, the patient was administered INN Flu Vaccine Pandemic (reported as swine flu vaccine) [influenza virus vaccine monovalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported] for an unknown indication.  On an unspecified date after vaccination, the patient developed unspecified health problems (ill-defined disorder). It was reported that the patient was in 60s and ended up dying. It was unknown whether autopsy was performed.  The reporter assessed the case as serious (death).  Significant case amendment (03-Jul-2019): The report type of the case was changed from invalid to valid in the general tab. The determined causality and reported causality in the event assessment tab were amended accordingly. The narrative was amended accordingly.; Reporter's Comments: A patient of unspecified age (reported as sixties) and gender developed unspecified health problems (ill-defined disorder), on an unknown day after administration of INN Flu Vaccine. The case lacks information important for the causality assessment, such as onset latency between the vaccination and reported event, vaccination details, concurrent medical conditions, autopsy report and investigations to provide alternate aetiologies. Hence the causal role of suspect vaccine was assessed as unassessable. The case will be reassessed upon receipt of follow-up information.; Reported Cause(s) of Death: Health problems