chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US019215 is an initial spontaneous report received from a nurse on 23 SEP 2014 with a follow up report received from the nurse on 31 OCT 2014. This report refers to a 53 year old female patient. Her medical history included hypertension. Her concomitant medications included lisinopril at a dose of 10 mg per oral daily for hypertension, famotidine at a dose of 20 mg per oral daily as necessary for heartburn and Vagifen at a dose of 10 mcg vaginally twice a week for atrophic vaginitis. She had tolerated the vaccination in the past. On 23 SEP 2014, at 04:30 PM, the patient was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412201) intramuscularly into her left deltoid at a dose of 1.0 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).  Follow up report was received from the nurse on 31 OCT 2014. Updated medical history, concomitant medications, time of vaccination, anatomical location of the vaccine administration and vaccination tolerance in the past.
Moderna COVID-19 Vaccine EUA;  Painful swelling in lymph nodes in the axilla of the injection side; localized redness, swelling, and itching of injection site, and full body hives.
This spontaneous report was received from a nurse (also reported as a healthcare worker) refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. Since 04-FEB-2015, an unspecified number of patients were vaccinated with a dose of oral, ROTATEQ, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were incorrect stored. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not consent further follow up.
COVID-19 such as fever, cough, and feeling of tiredness. Rapid antigen test turned positive.; COVID-19 such as fever, cough, and feeling of tiredness. Rapid antigen test turned positive.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old male patient received BNT162b2 (COMIRNATY), in Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 such as fever, cough, and feeling of tiredness. Rapid antigen test turned positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rapid antigen test turned positive.  Clinical information: It was reported that on Friday, 03Jun, the patient reported as having developed symptoms of COVID-19 such as fever, cough, and feeling of tiredness. Rapid antigen test turned positive. He received 1st booster dose back in Dec 2021. Response: Please take note that out of the 4 reports that were submitted yesterday, only the 22 and 12 year old males are the only ones that the reporter was certain of the vaccination status, although the reporter does not know what manufacturer brand of COVID-19 vaccine they received.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient reported they received monoclonal antibody treatment due to past history of COVID-19 on December 14th, 2020. This was noted as a contraindication for receiving the Pfizer covid-19 vaccine. MD was notified and approved patient to receive vaccine. No adverse event reported.
Dehydration     HISTORY OF PRESENT ILLNESS     He a 63 y.o. male with past medical history including: COVID-19 infection on 9/17/21,   Malignancy, secondary metastases to liver, kidney mass, urinary retention, secondary malignancy to the lung, obesity, dysphagia, vocal cord immobility, dysphonia who presents to the emergency department today due to concerns for dehydration.
Vaccine expired on 8/31/22 and dose was given on 9/1/22
Diarrhea, headache, stomachache, bilateral lower leg pain, temp of 103- all symptoms started the following day after vaccine.
Pt exp fever 104 w/1st DTP; 2nd DTP had fever beginning @ 3PM T104 ax; Had one dose of APAP; Threw up subsequent doses; Glassy eyed & rag doll appearance; MD thought poss rxn to pertussis;
SHINGLES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious. This case, from the same reporter is linked to 20221131374.
Generalized urticaria - starting from both injection sites bilaterally. Given injection 10mg Depomedial in ER.
cold; flu; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold) and INFLUENZA (flu) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold) and INFLUENZA (flu). At the time of the report, NASOPHARYNGITIS (cold) and INFLUENZA (flu) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Patient experienced excessive sweating, pain and inflammation in right arm. Inflammation from shoulder to hand. Patient went to Emergency room where she was prescribed cephalexin and acetaminophen for cellulitis and pain. All events happened 10/15/2022
Pt recv vax on 8-15-98; on 8-16-98 pt exp rash to body; urticaria
7/29/15 s/p #1 - Deltoid pain. 10/21/15 - hives/vomit.
Information has been received from a registered nurse concerning her grandson who on unknown date was vaccinated with VARIVAX (Merck) (Lot number was not reported). The patient developed transverse myelitis that had him restricted to a power chair after vaccination. It was unspecified if the patient sought medical attention. At the time of the report, the outcome of the events was unknown. Upon internal review, transverse myelitis was considered to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Mild, Systemic: Weakness-Medium
First dose Moderna/Second dose pfizer; I already had the virus way back in February; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (First dose Moderna/Second dose pfizer) and COVID-19 (I already had the virus way back in February) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In February 2021, the patient experienced COVID-19 (I already had the virus way back in February). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (First dose Moderna/Second dose pfizer). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (First dose Moderna/Second dose pfizer) and COVID-19 (I already had the virus way back in February) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow up was received. Reporter contact information and event- COVID-19 were added
Lymph nodes swollen little bit; Something on my thyroid is growing; This thyroid scare me; I cannot eat, little eating is bothering me because like I said, it is on my thyroid and its very hard; It is like swollen something, it is on my thyroid; Little bit headache; Little bit rash; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Lot number: F36369) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for Covid-19 Immunization; Bnt162b2 (Dose number: 2), for Covid-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Lymph nodes swollen little bit"; THYROID MASS (non-serious), outcome "unknown", described as "Something on my thyroid is growing; This thyroid scare me"; FEEDING DISORDER (non-serious), outcome "unknown", described as "I cannot eat, little eating is bothering me because like I said, it is on my thyroid and it's very hard; It is like swollen something, it is on my thyroid"; HEADACHE (non-serious), outcome "unknown", described as "Little bit headache"; RASH (non-serious), outcome "unknown", described as "Little bit rash".  Additional information: It was reported, the patient had just lymph nodes swollen little bit and something on thyroid was growing. Patient couldn't eat, little eating was bothering because it was on thyroid and it's very hard. Patient didn't know it was like swollen something, it was on thyroid. Patient had like little bit headache and a little bit rash and 'stuff like this'.  No follow up attempts are possible. No further information is expected.
Information has been received on 27-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2010, a healthcare provider at a physician's office administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 04-MAR-2014, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Vaccination site rash; rash little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE PAIN (rash little sore) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L209) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALOGLIPTIN, AMLODIPINE, CHOLECALCIFEROL, CLOTRIMAZOLE, DUPILUMAB (DUPIXENT), LOSARTAN, METFORMIN, MULTVITAMIN & MINERAL, OMEPRAZOLE, ROSUVASTATIN and INSULIN for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE PAIN (rash little sore). At the time of the report, VACCINATION SITE RASH (Vaccination site rash) was resolving and VACCINATION SITE PAIN (rash little sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Lips swelled.  Difficulty swallowing.  Inside of mouth burned.  Gums were red.  Took Benadryl and symptoms subsided.
The patient developed chest pain and some shortness of breath on 10/13/2021. He was seen in the  and discharge with instructions to follow up with Cardiology, Dr. Appointment with Dr.  on 10/15 diagnosed with pericarditis. Dr. recommended Motrin for treatment.
This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On 20-JAN-2015, 30-JUN-2015 and 21-JUL-2015 the patient was vaccinated with 2 doses of GARDASIL inj. No adverse symptoms reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a three unspecified patients of unknown gender and age. In September 2014 (reported as since the temperature event), the patients were vaccinated with a doses of GARDASIL (dose, dose number, route, lot/batch number, expiration date were not reported) that were improperly stored on 08-SEP-2014. No adverse effects were reported. No product quality complaint (PQC) involved. Follow-up information has been received from the reporting medical assistant, who provided patients' identifiers (age and gender), dates of vaccinations and lot numbers. This report concerns a 67 year old female patient. No information on her medical history, concurrent conditions or concomitant drugs was provided. It was reported that the PNEUMOVAX23 underwent the temperature excursion on 08-AUG-2014. On 21-AUG-2014, the patient received a dose of PNEUMOVAX23 which underwent temperature excursion (dose, site and route of administration unknown; lot# J008799, expiration date 16-APR-2014). This is one of several reports from the same reporter. Additional information has been requested.
she was so much pain; head was sore; Joint pain; Slight fever; Feels so weak; This is spontaneous report from contactable consumer. A contactable female consumer (patient) of an unspecified age reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on 18Sep2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and When she took the first dose, she did not experience any of that. Investigation assessment was not provided. Received call from consumer regarding the Pfizer COVID Vaccine. She took the second dose on 18Sep2021 afternoon. She felt ok, but on 19Sep2021 morning, she was so much pain and her head was sore. She had joint pain, a slight fever and felt so weak also. She would like to know if she could take Tylenol for the pain. Her head was hurting her so bad and felt weak and her joints was hurting her, so she did not wish to complete report. She would contact her pharmacy, where she got the vaccine, to see if they could advise her if she could take Tylenol. The outcome of events was unknown.   The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Left arm remains sore, randomly sensitivity/pain at injection site and/or lower in same arm but not reaching elbow.
Information has been received from a pharmacist referring to a 46 year old female patient. There were no known pertinent medical history and drug reactions or allergies for the patient. On 02-FEB-2015 the patient was vaccinated with ZOSTAVAX (lot # K020801, expiration date 31-JAN-2016, 0.65 ml) subcutaneous in the unspecified arm. No other concomitant medication included for the patient. On 03-FEB-2015, the patient experienced injection site swelling, injection site warmth and injection site redness. The patient sought medical attention via office visit. No treatment was given for the events and no lab diagnostics studies were performed. The outcome of injection site swelling, injection site warmth and injection site redness was unknown. The causality of the events was unknown. No PQC involved. This is one of several cases reported by the same reporter. Additional information has been requested.
24 hrs after vaccination. Flu like symptoms, vertigo, dizziness, nausea. Recovered after 72 hrs.
Lennox Gastaut Epilepsy uncontrolled sz since onset; up to hundreds/day;various combinations of 14 different meds & ketogenic diet have been tried;currently sx free for past 6mo but prognosis for lifetime of intractible sz & mental retard
Patient received vaccination and proceeded to waiting area for 15 minutes of observation. Patient was noticeably dropping a few of her belongings while she was seated and our Pharmacy Technician inquired how she was feeling, and she responded was okay. However, 9 minutes after administration, she experienced syncope and slipped from her chair to the ground. A team member dialed 911 and the pharmacist remained with the patient until EMS arrived to continue care for patient. She had recovered consciousness within 1 minute of fainting and was alert and oriented. After EMS evaluation, they determined hospitalization was not required. Individual was released from their care and remained in the pharmacy for another 5 minutes of observation  before leaving.
VACCINE WAS DILUTED WITH STERILE DILUNT FOR LIVE VIRUS VACCINES USE FOR MMR & VZV
Vomiting/could not hold food down; Skin breakout; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), RASH (Skin breakout) and VOMITING (Vomiting/could not hold food down) in a 58-year-old male 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.    There was no reported medical history.    On 25-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, received second 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 2021, the patient experienced ILLNESS (Sickness). In December 2021, the patient experienced RASH (Skin breakout). On an unknown date, the patient experienced VOMITING (Vomiting/could not hold food down). At the time of the report, ILLNESS (Sickness), RASH (Skin breakout) and VOMITING (Vomiting/could not hold food down) outcome was unknown.      No concomitant medication details were provided. No treatment medication details were provided.   Skyrizi did not worked for patient.  The patient felt sick after second Covid vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of illness with SKYRIZI(RISANKIZUMAB) was no reasonable possibility. The reporter's causality for the event of rash with SKYRIZI(RISANKIZUMAB) was a reasonable possibility. The reporter's causality for the events of vomiting and drug ineffective was not provided.  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.
Initial case retrieved from the scientific literature on 18 November 2014. It pertains to issues discussed at a Food and Drug Administration drug and biologic advisory committee meeting. Within the context of evaluating the risk evaluation and mitigation strategy (REMS) for SOLIRIS (Alexion Pharmaceuticals, Inc) it was reported that 16 patients had been vaccinated with Meningococcal vaccine (manufacturers, lot numbers, and dates of administration not reported) and subsequently developed meningococcal infection as of April 2014. All patients had also been administered SOLIRIS for treatment of either paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, or atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Additional information, including treatment, relevant test results, and outcome, were not reported. Documents held by sender: None.