chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited case received from a nurse on 11-Oct-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Fluzone (Batch number, expiry date, route and site of administration: not reported) on an unspecified date (reported as last year). Patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient experienced cellulitis. It was reported that, patient also had vaccinated with Fluzone two year ago and developed cellulitis. Patient's lab data was not reported. Corrective treatment received was antibiotics. The outcome of the events was not reported. Upon internal review, the company decided to consider the event serious because of important medical event cellulitis. List of documents held by sender: none. Sender's Comments: Cellulitis is unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. This is poorly documented case. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case. More over patient received more than one vaccine hence role of a particular vaccine cannot be assessed.
itchy eyes after the first dose; This is a spontaneous report from a contactable consumer (patient herself) a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 13Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Apr2021 the patient experienced itchy eyes after the first dose. The patient is asking how long does the side effects last after getting the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Severe chest pain; difficulty in breathing; EKG changes; elevated troponin level; This is a spontaneous report from a contactable consumer or other non hcp.   A 12-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number was not reported), via an unspecified route of administration, administered in Arm Left at the age of 12-year-old on 30Jun2021 as single dose for covid-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. Patient had no relevant past drug history and known allergies. 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. The patient did not receive any other medications within 2 weeks of vaccination. On 03Jul2021 05:30 the patient experienced severe chest pain, difficulty in breathing, ekg changes, elevated troponin level. The patient was hospitalized for the events. The patient underwent lab tests and procedures which included electrocardiogram: unknown, troponin increased: elevated. The adverse event resulted in Emergency room/department or urgent care. The patient received treatment for the adverse event with Pain medication. The clinical outcome of events was recovering.  Information about batch/Lot number has been requested.
This spontaneous report as received from a doctor of pharmacist concerning a female patient of unknown age who on approximately 1993. More than 20 year ago was vaccinated with M-M-R II, (manufacturer and brand unspecified was also reported) (dose, route and lot number not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced severe arthritis like reaction to rubella containing vaccine. No treatment information was reported. The outcome of severe arthritis like reaction to rubella containing vaccine was reported as recovered/resolved. Severe arthritis like reaction to rubella containing vaccines was related to M-M-R II (manufacturer and brand unspecified was also reported). Additional information has been requested.
First dose of Moderna vaccine on 06-Jan-2021 and second dose on 20-Aug-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna vaccine on 06-Jan-2021 and second dose on 20-Aug-2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Prostatectomy. Concurrent medical conditions included HIV infection and Melanoma. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY), VALACYCLOVIR [VALACICLOVIR], CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), TADALAFIL (CIALIS), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), FAMOTIDINE, VITAMIN C [ASCORBIC ACID], ZINC, CALCIUM;MAGNESIUM, BIFIDOBACTERIUM INFANTIS (ALIGN), ASCORBIC ACID, CALCIUM PHOSPHATE, LACTOBACILLUS NOS, VACCINIUM MACROCARPON (AZO CRANBERRY), VITAMIN B COMPLEX (B-COMPLEX [VITAMIN B COMPLEX]), ACETYLCYSTEINE (NAC [ACETYLCYSTEINE]), LYSINE, ROSUVASTATIN CALCIUM (CRESTOR), UBIDECARENONE (COQ10 [UBIDECARENONE]) and BROMELAINS, QUERCETIN (NOW QUERCETIN WITH BROMELAIN) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna vaccine on 06-Jan-2021 and second dose on 20-Aug-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna vaccine on 06-Jan-2021 and second dose on 20-Aug-2021) outcome was unknown.            No treatment information was provided by the reporter.   This case was linked to MOD-2022-570348 (Patient Link).
Extreme soreness of right arm & spreading red spot on arm as well. Fever, sinus & some lung congestion in the morning
Scattered tiny exudative ulcerative points on an erythematous base on soft palate and tonsils. Brown staining / darkening of the posterior dorsal tongue. Mild tongue discomfort, no pain with swallowing.
Patient woke up from nap screaming inconsolably, shaking and crying. Cried for 30 minutes straight until I took her into the shower with me to calm her down. She calmed fairly quickly there and so we got out, dressed and she got a little upset but calmed down after a little more convincing. She then started to fuss again, and threw up roughly 3-4 oz of formula/fluid. Fussed a little longer after and then when to sleep. Not running a fever currently but have been giving her 2.5 ml of baby Tylenol since 11 a.m. per doctor's suggestion.
Headache and pain in neck. Intermittent, usually lasting about 3 hours. Had experienced for several days after vaccine administered.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a male patient who received FLUARIX QUADRIVALENT (batch number C242G, expiry date 30th June 2016). On 10th November 2015, the patient received FLUARIX QUADRIVALENT .5 ml. ON 10th November 2015, immediately after receiving FLUARIX QUADRIVALENT, the patient experienced injection site hemorrhage and injection site swelling. On an unknown date, the outcome of the injection site hemorrhage and injection site swelling were unknown. It was unknown if the reporter considered the injection site hemorrhage and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: On 10th November 2015, immediately after receiving a dose of FLUARIX QUADRIVALENT and while the needle was being withdrawn, the patient's arm began to squirt out the blood and a small bump appeared at the injection site of the patient. The healthcare professional initially called to inquire about this being a possible side effect or adverse reaction of the product. The reporter also stated that, she did not feel comfortable providing more information regarding the incident at this time and would just prefer to speak further regarding the possibility of the adverse reaction being caused by the product. No further information was reported regarding the incident.
administered Pentacel and the patient only needed dtap with no reported adverse event; Initial information received on 29-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient who had administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and the patient only needed DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]) for Prophylactic vaccination; and HIB VACCINE CONJ (TET TOX) (ACTHIB) for Prophylactic vaccination.  On 27-Aug-2022 the patient developed a non-serious event of administered pentacle (formulation: unknown, dose: 0.5ml, 1X(once), intramuscular in Left deltoid, Batch number: UJ620AAA and expiry date: 07-Dec-2022, indication: Immunization) and the patient only needed dtap with no reported adverse event (wrong product administered, Latency: same day).   Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I was the CMA who drew up the vaccines while another CMA administered the vaccines into the patient. I noticed the wrong vaccine was given when I went into the patients chart to document. Patient was given a Tdap when the patient was suppose to get a Dtap. I went and let my supervisor know and she informed the parent/guardian what had happened. Outcome for myself was to re-due medication administration training exam, fill out paper work and do online immunization quizzes and to follow up with my supervisor.
9 pm day of second shot weak and diarrhea  Late evening early morning of shot body aches, headaches, unable to walk or move left arm from pain, back pain and hip pain unbearable fever chills sweating through multiple shirts in a hour
This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain and pain in arm. On an unknown date, the outcome of the muscle pain and pain in arm were recovered/resolved. It was unknown if the reporter considered the muscle pain and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The healthcare professional (HCP) reported that the patient developed muscle pain and arm pain for about 2 weeks after receiving the SHINGRIX. The patient received SHINGRIX from a different HCP than the one reporting it. The healthcare professional did not have patient information or vaccine details to share.
On 10/1/14 am pt reported "I don't feel well, I feel funny, my head is bothering me. I'm seeing colors and things." The symptoms subsided on 10/3/14 am. Pt's daughter reports pt has visual hallucinations after taking ADVIL.
chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    The patient's past medical history included Breast cancer in 2012 and Mastectomy bilateral (She had both breast removed.) in 2012.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In April 2021, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) had resolved. No concomitant medications was reported. No treatment medications was reported. 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. This case was linked to MOD-2022-624208 (Patient Link).
At approximately 18:00 I phoned my father to pick me up as I was unable to care for my son per my symptoms of intense headache, lethargy, nausea, full-body aches, fever, and disorientation. I instructed him to take me to the hospital if I should become non-responsive. He caretook for me (ice pack, etc.) and supervised me for the next 72 hours where I was completely stricken to bed. Most of this Friday evening and Saturday I was agonizing in pain and discomfort. I believe the fever held for Friday and the majority of Saturday where it dropped to a low-grade fever. By Sunday, symptoms had begun to subside but did not cease. I had to call out of work on Monday. By Monday evening I had mostly returned to normal save for exhaustion from the experience. There were 3 witnesses to this event and it was the most severely I have been ill in my life that I can remember. I was too disoriented that weekend to navigate reporting system (I did start) but feel it is my responsibility to do so. Though not formally indicated below, I did fear for my life and safety and informally consulted with a physician following the event.
No adverse effects; administered an improperly stored dose of PEDV AXHIB; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 01-OCT-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (lot # S000356, expiration date on: 17-OCT-2021; exact dose, route and site of administration were unknown). No adverse effects were reported. Administered dose of vaccine experienced the temperature 46.5 degrees Fahrenheit for 15 minutes.  Data logger was not involved. There were no previous excursions reported.
low fever. Very sore arm - raised, swollen, very red, hot, hard as well - next day very painful  On 5/3 = 2 days after = looked like cellulitis   went to Dr on 5/4/19.
10/12/18 nausea beginning at 6 p.m. Severe vomiting began at 8:30 p.m. and continued until 1 a.m. on 10/13/18. Cold sweats, overheating throughout the evening. By 6 a.m. on Saturday 10/13/18, severe hip and knee pain in both legs. Unable to leave the bed or eat until Saturday evening. Felt slightly better on Sunday 10/14/18 but still weak. Left home in the late afternoon and experienced cold sweats again. Joint pain nearly gone by Sunday.
Chills and fatigue began at 11:45 pm (Feb ) and ended 5:00 am (Feb 2). Mile soreness at the injection site for approximately 24 hours.
Flu-Like SX. Fever-102' Chills Sweats Bodyaches.
Pt had the pfizer Covid shot.  she was sick from the first shot on  Feb 4 2021.  Fever , headache and chills.  She decided to get the second pfizer on  March 4. Immediate chest pains  then 15 min later, syncope , followed by myoclonic  or seizure type activity of both  the RT  upper and lower extremities.  This was seen by me in the emergency room.  She was given ativan and the seizure type movement stoped.   I called her today  on 03-19-2021,  She told me she was sick for five days following the second pfizer,  Had headaches. body aches and fevers. but today was doing well.
This spontaneous report as received from a registered nurse, female of unknown age who reporting on herself. On an unknown date in July 2013, reported as about one and half months ago, after she injected diluent into a vial of ZOSTAVAX (lot number not reported) and removed the needle from the vial, all of the contents of the vial sprayed into her face. The nurse did not reported experiencing any adverse reactions from having the ZOSTAVAX come into contact with her skin. PQC involved. Additional information has been requested.
Approximately 36 hours of fever of 101, chills, shivering, sweats, aches and pain in every joint in my body, back pain, headache, pain at the injection site, fatigue, weakness, dizziness, nausea, difficulty completing my daily work duties and household activities due to pain and not feeling well. This was not much helped by Alleve, therefore I took Tylenol which was mildly helpful. After the first 36 hours, the symptoms lessened in severity and lasted for about another 12 hours. After that, I felt well for several days in a row, then about 1 week later I felt sore, weak, tired and nauseous. This resolved in its own in about 2 hours. I have felt well since then. I am choosing to receive my second dose of moderna vaccine tomorrow, because I would rather experience these side effects then catch COVID ever again. I caught COVID19 in March 2020. With my COVID infection, I was sick for about 21 days with fever of 101 and more, bone pain, body aches, chest pain, back pain, headaches, nausea, shaking chills, sweats, trouble breathing, dyspnea, cough, runny nose, sore throat, pink eye, dizziness, tiredness, ?brain fog? and fatigue. I was not hospitalized. After about 21 days I began to recover, but the first week after my recovery began I was very weak and tired, and spent most of my time sleeping. I was 41 years old at the time, with health problems including well controlled asthma and being overweight. I never wish to experience this again and I am grateful that I am receiving the Modena vaccine. Thank you so much for logging my side effects.
Red rash appeared on that arm; Large red bump under my left eye; Arms are now fully red from elbow to top of hands both arms; Dry skin; Spots on my legs that look like I've been bit; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (Red rash appeared on that arm), PAPULE (Large red bump under my left eye), ERYTHEMA (Arms are now fully red from elbow to top of hands both arms), DRY SKIN (Dry skin) and BITE (Spots on my legs that look like I've been bit) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Dust allergy and Pollen allergy. Concomitant products included RIVAROXABAN (XARELTO), ATORVASTATIN, CARVEDILOL, ESOMEPRAZOLE and HYDROCHLOROTHIAZIDE for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red rash appeared on that arm), PAPULE (Large red bump under my left eye), ERYTHEMA (Arms are now fully red from elbow to top of hands both arms), DRY SKIN (Dry skin) and BITE (Spots on my legs that look like I've been bit). The patient was treated with MACROGOL, PROPYLENE GLYCOL, SIMETICONE, SORBIC ACID, SORBITOL, WHITE SOFT PARAFFIN (VANICREAM) for Dry skin, at a dose of 1 dosage form; ACRIVASTINE (BENADRYL [ACRIVASTINE]) at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form and TRIAMCINOLONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, RASH ERYTHEMATOUS (Red rash appeared on that arm), PAPULE (Large red bump under my left eye) and DRY SKIN (Dry skin) had not resolved and ERYTHEMA (Arms are now fully red from elbow to top of hands both arms) and BITE (Spots on my legs that look like I've been bit) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-039266 (Patient Link).
Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023).    No concomitant medications were reported.  This lot number 060B22A of vaccine was administered to patients with a count of in between 75 and 125.  It was also reported that there was potentially a second lot number of vials that had expired on 28-Feb-2023 and was administered to patients on 03-Mar-2023, but the healthcare provider did not have any details of that event at that time.  The vial size was reported as 10 dose vial.  The vial had not undergone any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
01/22/22 presents to ED for "Melena, abdominal pain". PMHx of "metastatic colon adenocarcinoma in addition to lung adenocarcinoma"