chrisvoncsefalvay/vaers-outcomes huggingface dataset:
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 27th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There was 13, 11, and 6 different doses given to patient. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to MODERNATX, INC.-MOD-2023-703461 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-703461:Master case
vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 64 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "vertigo".  Additional info: Patient stated, in between her first and second dose of the vaccine she had vertigo. Caller stated after the second vaccine, two and a half weeks later she got vertigo again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (11Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient had a history of splenectomy. The patient's concurrent conditions, concomitant medications and drug reactions or allergies were not specified. On an unknown date, the patient was vaccinated with a properly stored PNEUMOVAX 23 lot # N013521, expiration date 23-JAN-2019, one dose (route of administration not specified) for prophylaxis. On an unknown date, the patient experienced swelling, itchiness and redness migrating down the arm. The patient did not seek any medical attention. The reporter requested checking the lot # B013521 of PNEUMOVAX 23. The outcome of the events was reported as recovered. The relatedness between PNEUMOVAX 23 and the events was not specified. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA005621: Original Case : 1710USA005621 US-009507513-1710USA007749:
1115 Vaccine administered. 1125 c/o mild nausea and dizziness, local reaction at site of injection (warmth to touch, redness), 1140 redness at site decreasing in size, states nausea & dizziness improving. Dizziness is only when standing, 1215 redness & warm to touch continue to decrease as well as nausea per pt. No longer dizzy.
Myalgia x 3 days, Fatigue x 4 days, Shivering x 2 days, Fever x 2 days, Loss of appetite x 3 days.
It was reported that a 48 year old male patient received a Fluzone SV vaccination on 12/05/2000. Reportedly sometime after the vaccination the patient developed a local reaction of redness, hardness and pain at the injection site.
Information has been received from a physician concerning a "12 or 13 years old" female who on an unspecified date was vaccinated with a dose of GARDASIL, 0.5 mL, intramuscularly. The physician reported that on an unspecified date the patient experienced Bell's palsy and  was taken to a children hospital ER. Hospital stay duration was unspecified. The therapy was discontinued. After stopping the therapy, the adverse effect did not improve. At the time of reporting, the patient had not recovered. Bell's palsy was considered to be disabling by the reporter. No further information is available.
Mentally incompetent. No eye contact. Minimal communication. No affection or empathy.  No humor or express of emotions. Confused. Forgetful.  Looks straight ahead,  not at a person when speaking as if it is difficult to find words. Loss appetite. Completely distant and no longer maintains or attempts to maintain a relationship with parents or siblings. Completely different person.
Expired Drug Used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 24th February 2022, unknown after receiving Kinrix and Kinrix 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the administration of an expired dose of Kinrix vaccine to the patient. The reporter consented to follow up.
Redness and swelling of right thigh x 24 hrs. Also with fever on day 2 after vaccination. 3 inch size area of erythema and induration right anterolateral thigh, tender, warm to the touch. Treated with an antibiotic for probable cellulitis
A 2'' area of redness, swelling, and irritation around injection site. The area was painful and itchy. Within  24 hours it more than doubled in sixe. . It began resolving 48 hours later with a decrease in redness.
Readmitted for worsening  respiratory decline (Previously admitted to hospital from 10-24-10/26 for COVID, discharged and readmitted to hospital On 10/29). Resp decline requiring intubation on 10/29.
Vomiting that was treated with Zofran but continued despite G-tube feedings being held. Resident was also very pale, abdomen was distended, and resident's breath sounds were very congested. Resident was sent to the hospital and had a low-grade fever 99.9 F, decreased level of consciousness, and productive cough.
FEELING COLD; SWEAT; BACK PAIN; LEG PAIN AND PAIN IN LEFT ARM; FEVER; Injection site pain; PAIN IN BACK OF HEAD; MUSCLE PAIN BOTH LEGS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 805020,  expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced feeling cold. On MAR-2021, the subject experienced sweat. On MAR-2021, the subject experienced back pain. On MAR-2021, the subject experienced leg pain and pain in left arm. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced injection site pain. On MAR-2021, the subject experienced pain in back of head. On MAR-2021, the subject experienced muscle pain both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, leg pain and pain in left arm, pain in back of head, back pain, sweat, injection site pain, muscle pain both legs and feeling cold was not reported. This report was non-serious.
I am a nurse at the clinic that provided the vaccination.  The adverse event was reported to me by  school nurse at the patient's high school.  The incident was described to me as follows: Pt reported to school's health room at approximately 0930 on 03/05/2020.  He was described as clutching his chest and very anxious, moaning and writhing in pain.  BP 180/100, P 160 and remained elevated during time in health room.  Pt reported pain as "15" on scale of 0 to 10, and said pain was deep in his chest (denied radiation).  He was not pale or diaphoretic.  Pt was asked if he ingested any drugs and stated he did not understand the question.  He remained alert and oriented.  He was taken by ambulance to Medical Center. Treatment and outcome are not known by this writer. The school nurse looked at the student's history and physical.  There was no reported history of chronic health problems with student or family.
Developed URI following Flumist.  Mother given influenza questionnaire and VIS.  Asked if she wanted the shot or the mist and decided to try the mist despite child's history of exercise induced asthma.  The next day the child began with nausea, sore throat, cough.  She was seen twice with URI---no asthma exacerbation.
This case was reported by a nurse and described an adult female subject who was vaccinated with Engerix-B and subsequently tested positive for hepatitis B surface antigen. Medical history included renal failure (cause not specified) requiring lot number not provided). On 10 February 2006 and 17 February 2006, the subject " was negative for hepatitis B surface antigen". On 24 February 2006, 21 days after vaccination with Engerix-B, the subject "was positive for hepatitis B antigen ". The nurse considered the event to possibly be related to vaccination with Engerix-B.
encephalopathy VII cranial nerve complete; paralysis of lt side of face-stabbing pain lt ear; vision blur; bell's palsy;
Local erythema induration and warmth. 7" x 8" oral around site of injection. no fever still increasing in size.
This is a spontaneous report from a contactable consumer (patient). A 43-year-old (non-pregnant) female patient received an unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0150), at the age of 43, via an unspecified route of administration, left arm, on Apr 2, 2021, at 11:15, single dose, for COVID-19 immunisation. The patient has not reported any other health issues. The patient has no known allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 13, 2021, at 12:00, 11 days after vaccine, patient had a constant numbness in her toes and on the top of her feet. Each day the numbness spread a little bit more. The patient had it in the ankles, calves, fingers and tops of hands. The patient was at day 14 from the day of vaccine. Her primary doctor referred her to a neurologist; who she is seeing in 4 days. If symptoms worsened, she was supposed to go to the emergency room. Since the vaccination, patient has not tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures taken as a result of the reported event. The clinical outcome of numbness in toes and on the tops of feet, ankles, calves, fingers and tops of hands: not recovered (at the time of this report). No follow-up attempts needed. No further information expected.
Nausea, vomiting, fevers, dizziness, headaches, fainting, skin reactions
pt recv vax & 15min looked different mom did not bring in until next day;talked to us x 2;shaky dehydrated, BOM-WBC 35,00-dec temp;resuscitated w/fluids;inc temp;adm to hosp; off resp in 24 hr;
In the evening she became restless. Felt hot flashes and extremely restless. Went to shower and felt heat radiating from her arm. There was a red raised patch. Iced it and took a Benadryl and looked on internet and found something about "COVID arm". The next morning it still felt the same and was swollen and achy. Called provider and was seen, was told it was COVID arm. Did not fill prednisone prescription and it took three to four days for it to start clearing up. Was advised to take second dose on the opposite arm. Lymph nodes under arm became swollen. Dr. stated it was as a result of the COVID arm. Swelling resulted on both sides but was worst on the side where she received the vaccine.
Groin pain. Saw pediatrician 6/2/14 - muscle strain.
No Adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No Adverse event) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 014F21A, 030L20A and 025L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case
Developed strong / severe paresthesias - A feeling of tingling / numbess / burning or 'electricity' over whole body, sometimes mild, sometimes more severe, migrating from arms / hands to legs/feet - at night waking up with both arms numb and the numbness feeling extending into chest. Sometimes accompanied by brief, stabbing pains.  Was most severe during the first 3 or so days, then seems to be slowly decreasing but gets worse at night. Has not completely resolved after 7 days. Also developed muscle stiffness / lower back pain around day 4 or so.
received only the adjuvant portion / without reconstituting the powder with the gE antigen; received only the adjuvant portion / without reconstituting the powder with the gE antigen; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 96-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th May 2021, the patient received Shingrix. On 18th May 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter informed that, a patient received only the adjuvant portion from the shingrix without reconstituting the powder with the gE antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case is linked with the case- US2021114065, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021114065:Same Reporter
Information has been received from a physician concerning a 14 year old female with no pertinent medical history and no known drug allergies (NKDA) who on 04-NOV-2008 was vaccinated with the first dose of GARDASIL (lot# 660518/0572X, dose and route not reported) and a dose of VARIVAX (Merck) (661668/1194X, dose and route not reported). Concomitant vaccination on 04-NOV-2008 included hepatitis A virus vaccine (unspecified) (lot# AHAVB264AA) and FLUMIST (LOT# 500570P). The patient was vaccinated with the second dose of GARDASIL (lot# 660616/0570X, dose and route not reported) on 10-JAN-2009 and the third 0.5ml dose of GARDASIL (lot# 661846/1312X, injection) on 14-MAY-2009. The patient's first seizure was on 04-MAY-2009 (prior to the third dose of GARDASIL). A computed axial tomography (CT) scan done that day was negative. The patient was not admitted. The patient's next seizure (gran mal) was on 19-MAY-2009. An electroencephalography (EEG) done on that day was abnormal, showing spikes in the left anterior region supportive of seizure disorder. The patient was not admitted again. The patient went on to have additional seizures in the latter part of July 2009, for which she was admitted to hospital and was diagnosed as epileptic syndrome. On unspecified day, a magnetic resonance imaging (MRI) was performed but the results came back clear. Length of hospital stay was unknown. At the time of reporting, the patient was recovering. The patient was being treated with DILANTIN and TOPAMAX and being followed by neurology. It was reported that the condition was not considered life threatening. The physician could only say that the patient found it was hard to read regarding disability. Upon internal review, seizure and gran mal seizure were determined to be other important medical events. Additional information has been requested.  8/14/09 PCP and ER records received DOS 3/28/05 to 7/30/09. Assessment: Localization related epilepsy of left frontal origin. Breakthough Seizures. Subtherapeutic antiseizure levels. 5/04/09 - Patient was sitting at computer, fell sideways to the floor, eyes deviated, foam from mouth, shaking,  "blank in face", tired and unsteady afterwards. Patient was seen at ER and diagnosed with seizure disorder. 6/11/09 - Neurology consult, migraine, epilepsy, patient placed on Topamax. Stopped Topamax against medical advice. 7/21/09 - Seizure and seen again at ER. 7/22/09 - Seen at ER for subsequent grand mal seizure, additional seizure at ER, post-ictal state, ataxia, toxicity from Ativan/Fosphenytoin. 7/28/09 - Neurology consult attributes recurrent seizures to stopping Topmax. 7/30/09 - Felt tired, layed on floor. Falther saw patient sitting on edge of bed, slumped over, upper extremities rigid and some twitiching, ER visit for seizure. Unsteadiness on feet. 8/24/09 Received ICD9 codes: 34590; V1581; 7813. 9/9/09 Hospital records received DOS 7/22/09 to 7/23/09. Additional information abstracted. Assessment: Recurrent Seizure, Post-Ictal. Seizure earlier this evening. Patient complains of headache. Vomited. Unsteady while walking.
felt funny in his chest, like a really weird, really warm and heavy feeling; Sore Arm; This is a spontaneous report from a contactable nurse. The nurse reported similar events for herself and her husband. This is the second of two cases.   A 62-year-old male patient (reporter's husband) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 10Mar2021 at 16:00 as a single dose for COVID-19 immunization. Medical history included ongoing high blood pressure. Concomitant medication included lisinopril (manufacturer unknown) taken for high blood pressure, start and stop date were not reported (reported as for over 5 years). The patient did not have prior vaccinations within 4 weeks from the the COVID vaccine. On 10Mar2021, the patient felt funny in his chest, like a really weird, really warm and heavy feeling. The patient did not freak out and didn't want to appear weak. It lasted 5 minutes and then it went away. It was a warm feeling in the chest and not being able to breathe. The patient also had a sore arm on 10Mar2021. The outcome of the event felt funny in his chest, like a really weird, really warm and heavy feeling was recovered on 10Mar2021 and the outcome of the event sore arm was recovered on 11Mar2021. The event felt funny in his chest, like a really weird, really warm and heavy feeling was reported as medically significant. The patient received the second dose of the vaccine on 31Mar2021. Relatedness of the suspect drug with the reaction 'felt funny in his chest, like a really weird, really warm and heavy feeling' from the Primary Source Reporter (method of assessment) is unknown.  Information on the Lot/batch number has been requested.; Sender's Comments: Based on the narrative information provided, a causal association between the reported event Chest discomfort and BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) cannot be totally excluded. 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.  ,Linked Report(s) : US-PFIZER INC-2021408430 same reporter and drug, similar events, different patient
metallic taste to mouth, thickening of saliva, itching on neck.  Benadryl 50 mg PO, transferred to Urgent Care.  Monitored and discharged with no further incident
This case was reported by a healthcare professional and described the occurrence of injection site pain in a 42 year old male subject who was vaccinated with influenza virus vaccine (Flulaval) for prophylaxis. There was no concurrent medications or relevant medical history. The subject had received influenza vaccination previously and had not experienced any adverse events. On an unspecified date between December 2006 and early January 2007, the subject received an unspecified dose of Flulaval (0.5 ml, unknown, right arm). At an unspecified time after vaccination with Flulaval, the subject experienced severe pain at injection site, nausea, fever, aches and pain, and pharmaceutical product complaint. The subject consulted with his healthcare provider as a result of the events. The events lasted for three days. The reporter indicated that there were approximately six other patients who received the same lot of Flulaval who experienced the same adverse events. The reporter requested a credit for the remaining 86 Flulaval vials he had in stock, which were from the same lot. At the time of reporting the outcome of the events were was unspecified.