chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2021-395985.
This spontaneous case reported by a consumer, describes the occurrence of lymphadenopathy (swollen lymph node on neck) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included hypertension. Concomitant products included Bystolic (nebivolol hydrochloride) for hypertension. On Mar 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 20, 2021, patient experienced  lymphadenopathy (swollen lymph node on neck). The patient treated with Tylenol (paracetamol) for adverse event, at an unspecified dose and frequency. At the time of the report, lymphadenopathy (swollen lymph node on neck) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
More than 35 days in between Moderna Covid-19 vaccinations.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between Moderna Covid-19 vaccinations.) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between Moderna Covid-19 vaccinations.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between Moderna Covid-19 vaccinations.) had resolved.            No concomitant medications were provided by reporter. No treatment details were provided by reporter.   Reporter did not allow further contact
Patient reported feeling bad such as real hot and shivering in the middle of the night on 12/30/02. She woke up with the chicken pox; she reported it is a mild case and was verified by a physician. She should be able to return to work next week per patient.
Swelling and pain at injection site lasting at least 36 hrs, severe fatigue and headaches.  Treated with 600mg of motrin every 6 hrs.
Pt recv vax on 11/9/98; 4 hr later pt exp high pitched cry, arched back, difficulty breathing, purple color
tingling in hands and feet, headache, tired, bilateral bells palsy.  Pain in arms and legs and weakness with extreme fatigue.  Went to the ER, twice and was admitted.  .  Diagnosed with guillain-barré syndrome.  Still sick.
4/10/03 at 3am woke up with chills, fever, nausea, vomiting, diarrhea, lymphangitis from the site to regional nodes considerable local edema at the site with intense erythema, muscle spasms, chest pain.  Also had headache, neck, and back pain.  Treated with Demerol per BCA pump, vancomycin, and clinla.
I63.9 - Cerebral infarction, unspecified N17.9 - Acute kidney failure, unspecified
Case number PHEH2015US021396 is an initial spontaneous report received from a consumer on 19 Oct 2015. This report refers to a 70 year old male patient. Past medical history and concomitant medications were not reported. There was a bat in patient's house and hence the doctor recommended vaccination for protection in the event the patient was bitten. His vaccination history was reported as follows: he had administration of three doses of RABAVERT (batch numbers: 556011A (for first and second doses) and 559011A (for third dose) on 12 Jun 2015, 15 Jun 2015 and 19 Jun 2015 following which he was very sleepy (see related case numbers: PHEH2015US021782, PHEH2015US021783 and PHEH2015US021784 respectively). He was vaccinated with fourth dose of RABAVERT (batch number: 559011A) on 26 Jun 2015. He had arthritis flare up in his back and neck and the flare up lasted from 26 Jun 2015 until the first 2 weeks of Jul 2015. On 10 Jul 2015, about 2 weeks after the injection, he was sleepy and experienced joint pain and a stabbing pain like needles in both feet. In addition, the reporter stated that he had pain on the top of his legs between his knees and hips on 10 Jun 2015 which lasted for a week or so. He had an emergency room visit in Aug 2015. At the hospital, he was given codeine for pain and was told that he had an allergic reaction to the vaccine. The reporter stated that the symptoms just started to settle in Oct 2015. The outcome of sleepiness was reported as complete recovery and that of joint pain, arthritis flare up and feet pain was reported as condition improving. The outcome of allergic reaction to vaccine was not reported. The events were reported as disabling. The causality of the events was not reported.
tenderness of the gums on his teeth at the left lower quadrant of the mouth; tenderness in the teeth on his left lower quadrant, the teeth, gums; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 12:00 (Lot number: ER8727, Expiration Date: 31Jul2021) at the age of 75 years as 2nd dose,single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing), notes: Patient history: high blood pressure (From: Unspecified To: Ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Caller states he received the first dose on 08 MAR 2021, LOT: EN6206, Expiry Date: 30Jun2021), administration date: 08Mar2021, when the patient was 75 years old, for Covid-19 immunization. The following information was reported: GINGIVAL PAIN (non-serious) with onset 05Apr2021, outcome "not recovered", described as "tenderness of the gums on his teeth at the left lower quadrant of the mouth"; TENDERNESS (non-serious) with onset 05Apr2021, outcome "not recovered", described as "tenderness in the teeth on his left lower quadrant, the teeth, gums".  Additional information: Caller states he's not sure if its a side effect or what. Caller states he received the first shot on 08Mar2021 and his second shot 29Mar2021 and he got it in his left arm and abut a week or so after his second shot, he kind of experienced a tenderness in the teeth on his left lower quadrant, the teeth, gums. Caller states the pain of 0-10, its 1 or less, its noticeable but it's not preventing his eating or anything, it is just there and he's never experienced that before. tenderness in the teeth on his left lower quadrant and it started about a week after the second shot. Prior Vaccinations within 4 weeks was reported as no.  No follow-up attempts are possible. No further information is expected.
Patient passed out about 10 minutes after receiving the vaccine.  His mother said when his blood sugar gets low he has fainted before.  Patient woke up within a few seconds.  He was lucid and mom wanted him to get his blood sugar raised because he had not eaten since early in the morning.  We gave him some pop and a piece of candy since that was what they requested.  Patient waited around for approximately 30 minutes after fainting and was fine.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 14-FEB-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Right-sided torticollis, reported by mom & dad, who are physicians. They prescribed Clonapen and Tylenol with improvement.
patient vaccinated / with the powder portion / and another diluent; patient vaccinated / with the powder portion / and another diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 9th August 2021, the patient received the 1st dose of Menveo. On 9th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with the powder portion of Menveo and another diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The health care professional did not want to share demographic data of the patient. The reporter consented to follow up.
Vomiting; Fever; Rash on chest (red dots); Small headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), PYREXIA (Fever), RASH (Rash on chest (red dots)) and HEADACHE (Small headache) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VOMITING (Vomiting), PYREXIA (Fever), RASH (Rash on chest (red dots)) and HEADACHE (Small headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VOMITING (Vomiting), PYREXIA (Fever), RASH (Rash on chest (red dots)) and HEADACHE (Small headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
presents toBeaumont Dearborn hospital emergency department for evaluation of confusion and generalized weakness. His caregiver is at bedside and states he has diabetes and multiple sclerosis
Sore arm; Fatigue; Patient also breast feeding; Patient also breast feeding; This is a spontaneous report from a non-contactable nurse. This patient reported information for both herself and her baby. This is a mother report. A 33-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Dec2020 14:30 at single dose for COVID-19 immunization. Medical history included ongoing breast feeding, asthma, Anaphylaxis to tree nuts. Concomitant medication included bifidobacterium lactis (PROBIOTIC) and prenatal multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. For the first dose the patient only had a sore arm and maybe fatigue. No treatment received for the adverse event. She was also breast feeding. Events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021027460 Mother/Baby case
8-19-08 Slurred speech. 8-13-08 Equallibrium off. 3/18/09-records received for DOS 8/21-8/25/08-DC DX: Viral encephalitis. In ED C/O dizziness, slurred speech times 2 weeks and left arm tremor times 1 week. Presented with some initial neurolgoical changes including confusion and broad based gait, severe headache. Confusion was with slurring speech, arm tremors. 4/16/09-neuro letter received for DOS 9/29/08-evaluation of gait-Beginning 8/9/06 after C/O urinary tract infection and receiving tetanus boost and Z-pak C/O feeling dizzy and swaying gait. 3rd dose of Gardasil received on 7/14/08. Week later slurring of speech worse with fatigue, week later follwed with tremor. All symptoms progressed until hospitalization 8/22/08. Continues to fall when feeling thirsty. Coughs and chokes with liquids. Impression: cerebellar ataxia.  Follow-up: The vaccine was not given in this office - The office that gave the injection would never do any paper work on it... As stated - 12-8-08.
Patient reports joint pain in his Knees, hips and ankles that started 2 days after he received his FLUZONE HD and PREVNAR 13 vaccination. At this time he is still having joint pain and it has only slightly improved.
Large red area in the arm below the injection site, warm, painful to the touch started 5/25/2019. Patient reported after treatment on 5/26/2019 the redness has gone down.
I have chemotherapy induced peripheral neuropathy in my hands and feet. The symptoms drastically increased approximately 6 hours after receiving my second dose of the Pfizer COVID19 vaccine. The numbness in my hands and feet has continued off and on for approximately 7 hours after starting.
local rxn lt arm;rash appear-red welts (5) in the deltoid area;tx ice to area for 24hr-children motrin;
sleeping 11-12 hours at night; feeling more tired than usual; glands are swollen; ihaving more fatigue like a short term disability; increased lymph nodes; feeling more exhausted than usual; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (sleeping 11-12 hours at night), FATIGUE (feeling more tired than usual), LYMPHADENOPATHY (glands are swollen), FATIGUE (ihaving more fatigue like a short term disability) and LYMPHADENOPATHY (increased lymph nodes) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Constipation. Concurrent medical conditions included Chronic fatigue syndrome, Hypothyroidism and Irritable bowel syndrome. Concomitant products included LEVOTHYROXINE, DULOXETINE HYDROCHLORIDE (CYMBALTA), TRAZODONE, LINACLOTIDE (LINZESS) and VITAMINS NOS for an unknown indication.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-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 HYPERSOMNIA (sleeping 11-12 hours at night), FATIGUE (feeling more tired than usual), LYMPHADENOPATHY (glands are swollen), FATIGUE (ihaving more fatigue like a short term disability), LYMPHADENOPATHY (increased lymph nodes) and FATIGUE (feeling more exhausted than usual). At the time of the report, HYPERSOMNIA (sleeping 11-12 hours at night), FATIGUE (feeling more tired than usual), LYMPHADENOPATHY (glands are swollen), FATIGUE (ihaving more fatigue like a short term disability), LYMPHADENOPATHY (increased lymph nodes) and FATIGUE (feeling more exhausted than usual) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication reported such as cocktail for IV therapy to boost the immune system.  No treatment information was provided.
Acute onset of excruciating right shoulder and upper arm pain following flu virus immunization. Pain intensity very high (9+/10) and maximal at onset. Pain is sharp and throbbing and constant since injection. Deep aching and muscle weakness and atrophy in upper right arm. Also, sharp/shooting pain affecting eyes and head. Numbness and muscle weakness continuing chronic right upper arm and shoulder pain, significant muscle weakness continuing with physicians for diagnostic work up. 4/3/09-records received-office visit 1/21/09-C/O 3 months of right upper arm lateral aspect being painful with decreased strength. 4/16/09 neurology consult received for DOS 12/16/08-C/O headaches with black spots in front of eyes. Anxiety worsenes tension type headaches.  Impression: chronic daily headaches both migraine and tension type and analgesic rebound headache. Daytime somnolence snoring and gasping respiration and weight gain. Lancinating headaches. 2/2/09-C/O right upper arm pain since receiving flu shot.
erythematous truncal rash - 1-2mm papules without itching, pain, nor drainage. No significant spread or progression in severity after initial presentation. Preceded by tender left axillary lymphadenopathy (ipsilateral to covid vaccine; no right-sided LAD) and arm soreness - both of these sx were within expected severity for covid vaccine.
covid-19 prior to Paxlovid treatment; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19 prior to Paxlovid treatment) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Drug was not specified).    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19 prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 16-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19 prior to Paxlovid treatment) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Patient did not received any treatment for Rebound COVID after paxlovid.  Company Comment: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient was treated with Paxlovid for Covid-19. After the treatment with paxlovid patient experienced rebound symptoms and was tested positive for covid-19 as on 23-May-2022. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient was treated with Paxlovid for Covid-19. After the treatment with paxlovid patient experienced rebound symptoms and was tested positive for covid-19 as on 23-May-2022. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R013565, expiry date 13-MAY-2020 (exact dose and route of administration were not reported) for prophylaxis, reconstituted with properly stored sterile diluent. The doses of vaccine were stored between 6 degrees Fahrenheit (F) to 14F (10.6F) for 96 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA002745.
Information was received on 10-MAY-2017 from an attorney in the form of an initial legal complaint regarding a female patient (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On 28-SEP-2012 the patient was vaccinated with ZOSTAVAX vaccine, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended (considered vaccination failure), but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-MAR-2015 the patient was treated for a painful rash that was diagnosed as a severe case of shingles. On or about 23-MAR-2015 the patient was treated for vesicular outbreaks, which were diagnosed as shingles. On or about 29-AUG-2015 the patient was treated at the emergency room for painful, worsening symptoms which were diagnosed as neuralgia. She was prescribed acyclovir and hydrocodone for management of her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
I want to be really clear. Within 6 hours after the 2nd shot, I developed extreme fatigue. By about 9 pm, I experienced chills, moderate muscle cramps and headache. I expected this might happen based on news reports and articles of same. By about 6 pm the next day, these symptoms completely resolved and I felt perfectly fine. Sometime within the next week (I estimated date/time), I developed a high-pitched ringing in my left ear. On May 30th, I saw my primary care doctor who prescribed Montelukast; and told me to continue my OTC Zyrtec and Flonase Sensimist. In addition, he suggested OTC Sudafed, which I have not started as it makes me anxious and disturbs my sleep. I have never before had tinnitus and the onset was sudden.
Clearly marginated wheal like lesions on palms, dorsum of hand, lateral and dorsum of feet.  no lesions on soles, some have a dusky center.  No lesion on buttock.  Lesions first noted on 11/14/2004.  No fever.  Diagnosis:  erythema multiforme.  Treatment:  Watchful wait.