chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 10-AUG-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10Pk 50U/1 mL) lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 4 times with the following lowest recorded temperatures: 34F (1.111 Celsius degrees) for 88 hours, 32 F (0 Celsius degrees) for 152 hours, 31 F (-0.555 Celsius degrees) for 152 hours and 33 F (0.55 Celsius degrees) for 40 hours. No highest reported temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
1.3ml diluent mixed in 6m - 4yr multidose vial.  Should have been 2.2ml of diluent.  Parent was called by Dr. to report error later on same day.  No adverse reactions per parent.
Patient had Pneumovax and developed hematoma (on Coumadin) at local injection site. Later in week developed a redness below injection site about egg size - now resolved. Slight pinkness there, doesn't look like old blood. She only showed her arm after redness mostly resolved.
ITP (Immune Thrombocytopenia); This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 13Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient had since returned to the clinic with ITP (Immune Thrombocytopenia) with a platelet count of 10/abnormal, which they were treating with steroids. The doctor had already prescribed; Prednisone 20mg, 3 tablets daily, 100 count. The reporter asked it ITP was a reported AE and if there was a protocol for treatment besides the steroids. The provider already directed caller not to get the second dose. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. The company cannot completely exclude a causal relationship between the event immune thrombocytopenia and suspect vaccine BNT162B2. Additional information regarding relevant medical history, underlying conditions, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. 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 Regulatory Authorities, Ethics committees and Investigators, as appropriate.
15 Hours after receiving the booster, I started having terrible chills, a splitting headache, body aches, and fatigue. For the following 24 hours, I slept about 18 of those 24 hours and went back and forth between sweating profusely and shivering uncontrollably. Headache and chills subsided Sunday (approximately 48 hours after receiving the vaccine). Minor body aches and fatigue continue through Monday along with a golf ball sized lump (red and warm to touch) at the site of injection (approximately 60 hours post-vaccination).
Arm soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 23-years-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Mar2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date in Mar2021, the patient experienced arm soreness. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm soreness was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1/31- Left arm muscle hurt beginning the night of the first injection. Muscle sore and tender to touch for 3 days. All pain went away.  2/7- In the late afternoon, the muscles in my left arm started with a burning and itching sensation. Became more painful to the touch as the hours passed. No redness but firmness under the skin. Continued itching and painful to touch on 2/8. Itching has subsided but painful to touch and still firmness at the site of the injection as I report this at 7:45pm on 2/9/21.  Discomfort but am able to continue to work and do regular activities.
Fever (100.3), joint and muscle pain and HA.  Treatment: Tylenol with moderate improvement . Outcome: Does not interfere with ADLs.
After my first Covid vaccine, I had pain in the muscle I received the shot in and in that axilla. After the second Covid vaccine, I experienced extreme pain in the muscle I received the shot in and in that axilla. I was not able to palpate my lymph node under the affected arm either time.  I also experienced headaches and fatigue after the second vaccine, which lasted a few days. Unfortunately, I continue to experience mild pain under both axilla, which tends to come and go, sometimes under one arm and sometimes the other, but it is present most days.
Severe skin all over body on fire - no fever. Had shot after 3pm, took Ethambutol at 8pm, and Rifampin at 10pm. Could be drug interaction as didn't have symptoms after first vaccine.
her daughter's blood titers were drawn on 12/14/2020 and showed "non-reactive" for V ARIV AX, RECOMBIV AX, and MMR II.; her daughter's blood titers were drawn on 12/14/2020 and showed "non-reactive" for V ARIV AX, RECOMBIV AX, and MMR II.; her daughter's blood titers were drawn on 12/14/2020 and showed "non-reactive" for V ARIV AX, RECOMBIV AX, and MMR II.; her daughter's blood titers were drawn on 12/14/2020 and showed "non-reactive" for V ARIV AX, RECOMBIV AX, and MMR II.; her daughter's blood titers were drawn on 12/14/2020 and showed "non-reactive" for V ARIV AX, RECOMBIV AX, and MMR II.; This spontaneous report was received from a physician and refers to a currently 19-year-old female patient. There was no information about her concurrent conditions, concomitant therapies or medical history provided. On an unspecified date in 2001, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported), hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported), all for immunization. On 14-DEC-2020, the patient's blood titers were drawn and showed "non-reactive" for varicella virus vaccine live (oka/merck)(VARIVAX), hepatitis b vaccine (recombinant)(RECOMBIVAX HB) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). On an unknown date, the patient sought medical attention (she saw a physician). No treatment was given to the patient. The outcome of the events was not provided. The causality assessment between the events and the suspect therapies was not reported.
Pain in hands; Hands Warm; Itchy hands; Pins in hands; This case was reported by a consumer via call center representative and described the occurrence of pain in hand in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced pain in hand, localized feeling of warmth, itching both hands and pins and needles. On an unknown date, the outcome of the pain in hand, localized feeling of warmth, itching both hands and pins and needles were not recovered/not resolved.   It was unknown if the reporter considered the pain in hand, localized feeling of warmth, itching both hands and pins and needles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm. The reporter received the Shingrix vaccine approximately 10 weeks ago before reporting.  A week after the vaccination, she began to experience pain and pins on the top of both hands, and both hands are warm and itchy. The reporter was still experiencing these symptoms. The reporter gave permission for her physician to be contacted. The reporter was unable to obtain additional information.
Smelling roast beef and cotton candy (phantosmia - or olfactory hallucination); Severe headache; Muscle aches; Chills; Fatigue; This is a spontaneous report received from a contactable pharmacist reporting for herself. A 63-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534), via an unspecified route of administration on 23Mar2021 10:00 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medications included calcium carbonate (CALTRATE), ascorbic acid, retinol, tocopherol (OCUVITE). Historical Vaccine included first dose of BNT162B2 (Lot number EN6203) on 23Mar2021 at 10:00 AM for COVID-19 immunization. The patient experienced Smelling roast beef and cotton candy (phantosmia - or olfactory hallucination), Severe headache, Muscle aches, Chills and Fatigue on 23Mar2021 20:00. Treatment received for event headache included Tylenol 1grm at 9:30 am 3/24. The outcome of the events were resolving.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported event parosmia.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous report was received from a medical assistant and refers to a unspecified number of patients of unknown age and genders. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. Approximately in 2016 (reported as "starting 23-AUG-2016 to present, 08-SEP-2016"), the patients were vaccinated with improperly stored doses of GARDASIL which had a lot # of L035105, and an expiration date of 14-MAY-2017 (concentration, route, dose number, dose and anatomical place of vaccination were not provided). Which were exposed to a temperature of 1.5 C for 21 minutes, and a data logger was involved. Nevertheless, no adverse effects were reported and no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Patient experienced numbness in tongue, SOB, and heavy chest following vaccination. Patient given Benadryl. Patient vitals taken all within normal limits. Patients symptoms absent after 1 hour from Benadryl taken.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: coughing-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Given 2 doses of benadryl at 810 pm and at 841 pm. used cold compress on back of neck and provided blanket for chills. Facility's medical team assisted. bp 160/90 spo2 98% hr 90  numbness was in legs have not been able to reach patient to see how she is doing (5/2/21). patient has anxiety disorder that seemed to worsen symptoms\r\n
Diagnosed with Bell's Palsy on 19Feb2021; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration at the right arm on 06Jan2021 at a single dose for COVID-19 immunization. The vaccine was administered to the patient at a hospital. The patient had no COVID prior to vaccination. The patient's medical history was not reported. Concomitant medication included lisinopril and metoprolol. The patient had no other vaccine in four weeks. The patient was diagnosed with Bell's Palsy on 19Feb2021 (start of event was reported as 19Feb2021 at 06:15 AM). The event resulted in doctor or other healthcare professional office/clinic visit. The patient had COVID test post vaccination which was a nasal swab with unknown results on an unspecified date in 2021. Therapeutic measures were taken as a result of event Bell's Palsy which included unspecified medication. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: The possibility that suspect drug may have contributed to the reported event cannot be excluded. 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.
Patient received immunizations for Influenza and Pneumonia at the same time at different sites on 10/14/2007. Shortly after receiving them, "patient" described that she had a headache and then noticed increased numbness/tingling in her hands and feet with difficulty swallowing for a week prior to admission."Patient" was admitted to Medical Center, on 10/21/2007 with headache, gait disorder, weakness, balance problems, facial weakness and ataxia and was diagnosed with Guillain-Barre Syndrome Miller Fisher variant secondary to immunizations. She was transferred to a rehab center on 12/10/2007 but still is experiencing numbness in her hands and feet. 3/27/08-records received for DOS 10/21-10/30-07-DC DX:Miller Fisher Guillain Barre syndrome. Dysphagia. Admitted with C/O fascial numbness, difficulty swallowing, slurred speech, weakness and ataxia. RX with IVIG, transferred to rehab facility, at time of DC continued to have significant issues with dysphagia.
Hep-B and TD were given and both were expired. Pts mom was notified by doctor. Pts dad said the next day after shots pt had a headache and only a low grade fever and temp. He took some ADVIL. There was no pain/redness/or swelling at injection sites and they were to call if any additional concerns and he was to hydrate well.
Heart burn, body aches, chills, coughing, hoarseness, puffy eyes the next morning.
Awakened at 5:00 am, second day after Pfizer injection, with severe vertigo, nausea and vomiting.  In the following days, rapidly developed cascade of difficulties: bilateral, sharp breast pain. Sharp liver pain. Tinnitus, right side to begin, now bilateral.  No feeling in feet; felt like I was walking on blocks of wood.   Saw numerous alternative practitioners with lessening of vertigo.  March 1, 2022, traveled to health center for physician-monitored fasting with clearance of breast and liver pain and recovery of some feeling in both feet.  Tinnitus continues unabated.
Very red, immediate local rxn @ inject site followed by mottled appearance both lower extremities & buttocks area; Upper body very pale in appearance; Pt seen by pvt MD who suggested this was a "vegal response";
Information has been received from a physician concerning a 14 year old female who on 03-FEB-1998 and 15-DEC-1999 was vaccinated with the first and second dose of MMR II (lot # not reported) respectively. On 17-NOV-2009 the patient experienced left parotitis. On 29-NOV-2009, the patient was diagnosed with mumps. On an unspecified date, the patient had a 103 F fever and the left side of her neck was swollen. Parotitis count was 62. At the time of the report, the patient's status was unknown. In follow-up, the physician indicated that on 25-JAN-2010, the patient experienced mumps. On 26-JAN-2010, the patient was diagnosed. The patient had a swelling under right ear. Parotitis was on the right. It was unknown if the patient had orchitis, sequelae or exposure to others with mumps. The first blood work on 26-JAN-2010 revealed serum IgM <1:10, serum IgG 1.33and serum amylase 80. Additional information has been requested.
This spontaneous report was received from a licensed nurse practitioner and refers to a multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 22-SEP-2016 or 23-SEP-2016, the patients were inadvertently vaccinated with an improperly stored dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). The administered doses of vaccines were exposed to a temperature of 1 Celsius degrees, for 1 hour and 46 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
administered with an expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). In October 2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.  The vaccine was administered to an unknown number of patients over the weekend (16-Oct-2021 to 17-Oct-2021).  The vaccine was only moved from  the freezer to the refrigerator 2 weeks ago
Covid Nasal Test: Positive.; Covid Nasal Test: Positive.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 at 15:30 as dose 1, single (Lot number: EE3590), in left arm and on 01Nov2021 at 15:30 as dose 2, single (Lot number: FF2583) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did not have covid prior to vaccination. No known allergy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "unknown" and all described as "Covid Nasal Test: Positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300276548 Same reporter/patient/drug,  different events and time gap.;
On 1/21/00 mom noted the infant had difficulty with breathing, was having periods of Apnea for 10 seconds while lying on abdomen. Pt was admitted to hospital for evaluation to rule out SIDS syndrome. Pt was discharged 1/25/00. Pt being followed with apnea monitor for 4 weeks and will return to MD for evaluation.
Pfizer Covid 19 vaccine vial was mixed with 1.4 instead of 1.8 ml of diluent. Spoke to patient's mother 04/11/2021 she stated the patient had some itching the night of her receiving the vaccine and that it went away when she took a Benadryl. Provided counseling
Discharge Provider:  Primary Care Provider:  MD Admission Date: 9/2/2022 Discharge Date: Sep 12, 2022  PRESENTING PROBLEM: Achromobacter pneumonia   HOSPITAL COURSE:  70 y.o. female who presented as a direct admission. She was asked to go to the E.D. from her Pulmonologist Dr. for her sputum culture resulted in Achromobacter Xylosoxidans. She did not have good po options due to allergy history, and resistance patterns so she was asked to come to the hospital for admission for Meropenem.   Patient follows with Pulmonary for severe copd dependent on 4L oxygen continuously. She was recently treated with doxycycline for RLL pneumonia.    In the E.D. she was hemodynamically stable on 3L oxygen. Labs with stable ckd and cr 2.2 (normally 2-2.5). Hgb at baseline 9.9. Covid pcr +. Blood  cultures were obtained. CXR showed improved but persistent patchy opacity medial RLL. Similar scarring left CP anlge. No new changes. Cardiac silhouette borderline enlarged.   On admission, patient hemodynamically stable she is at her baseline 3 L oxygen.  She was started on Meropenem.  Her home inhalers continued.  Pulmonary consulted and following.  She was not given remdesivir for it was contraindicated for her CKD 4. Infectious Disease was also consulted and they recommended at least 10 day course of antibiotics. She also completed 5 day course of prednisone 40 mg on 09/09/2022.     Arranging home antibiotics is complicated therefore she will stay in house until 09/12/2022 to complete the IV meropenem therapy.  However patient was found to have Aspergillus in her BAL infectious diseases wants to get a CT scan before they decide on antifungal therapy.  CT scan  did not show any cavitary pneumonia, showed improvement in previously noted infiltrates.  No antifungal therapy is planned.   Patient complained of chest pain with elevated troponin EKG changes.  He is treated as a type 2 MI secondary to infectious etiology. Cardiology has seen this patient and did an echo found chronic wall motion abnormalities did not deem a new MI. She completed a 48 hour heparin therapy and is continued on aspirin and Coreg.  Coreg dose was slightly increased to 12.5 mg twice daily
PT CALLED STATING 2HRS AFTER HER VACCINE, SHE FELT LIKE SHE WAS "HIT IN THE HEAD WITH A BRICK"; THIS CONTINUED OFF AND ON, THEN AROUND 7PM SHE DEVELOPED SUDDEN, SEVERE FATIGUE, THE AROUND 9PM SHE STATES SHE DIFFICULTY WITH HER THOUGHT PROCESSES AND DIFFICULTY WITH COMMUNICATING WORDS THAT SHE WOULD TRY TO SAY. SHE STATES THE SYMPTOMS HAVE BEEN IMPROVING OVER THE LAST COUPLE DAYS AND IS FEELING BETTER BUT SHE HAS DIFFICULTY CONCENTRATING ON THINGS. DENIES ANY OTHER S/S.
Received pediatric dose of HEP B instead of adult dose. Discovered immediately and she returned to clinic and received adult dose Hepsliva B at 12:30 PM