chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 06Oct2022 as dose number unknown, single (Lot number: FPH35), in left arm for covid-19 immunisation. The patient's relevant medical history included: "cancer survivor" (unspecified if ongoing), notes: cancer survivor. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Syncope immediately following injection; pt describes closing in of vision, scary dreams, defending, awareness of  inability to make  voluntary body movements as consciousness was being regained.
pt recvd vax; 8 hrs after vax t 104; lethargic, fever continued x 4days; pertusis component initially suspect; but 14jun94 rcvd vax & same rxn again;
diarrhea; fever of 101.5 degrees; nausea; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by an other caregiver and describes the occurrence of DIARRHOEA (diarrhea), PYREXIA (fever of 101.5 degrees), NAUSEA (nausea) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), PYREXIA (fever of 101.5 degrees), NAUSEA (nausea) and CHILLS (chills). At the time of the report, DIARRHOEA (diarrhea), PYREXIA (fever of 101.5 degrees), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.            Concomitant medications and treatment details not reported.
loss of consciousness;febrile Narrative: Patient received his 2nd vaccine at 10am 2/17. That evening he felt subjectively febrile and then suffered a ground level fall at 0400 on 2/18. He did not lose consciousness or injure his head. EMS was contacted and assisted him into bed. At 0600, wife noted increased work of breathing, which prompted another EMS call, who found him hypoxic with fever of 106. He was transported to a community hospital, where he was found to have temp 102.9 and blood pressure in 70s-80s systolic. He was transferred to hospital at 1300 on 2/18/21, requiring norepinephrine for pressure support after fluid resuscitation. He c/o stiffness and soreness all over but presenting ROS was otherwise negative. Patient was treated with 4L IV fluids and vancomycin and piperacillin/tazobactam at the outside ER. Here at the hospital he was treated with vancomycin, piperacillin/tazobactam and levofloxacin along with IV fluids and norepinephrine. Despite this he had several fevers with Tmax 103.5F the night of 2/18-2/19 and he required norepinephrine plus vasopressin overnight to maintain blood pressure. Piperacillin/Tazobactam was discontinued in favor of meropenem. His last fever was at 6am on 2/19. ID consult was obtained 2/19/21 and vancomycin and levofloxacin were weaned off. Ultimately his blood pressure improved and he was weaned off of all vasopressors the morning of 2/20. Notably, he never developed severe hypoxemia at rest while in the ICU, but did require BiPAP non-invasive ventilation at night instead of his usual CPAP to keep his oxygen levels > 90% while sleeping and additionally had desaturations into the low 80% range with exertion from which he was slow to recover. His oxygen saturation was >90% on 30-40% FiO2 via aerosol mask overnight and 3L (his current baseline) NC during the day. He was transferred out of the ICU on 2/21 based on hemodynamic improvement, stable oxygenation, and improved mentation and symptoms. Unfortunately, on the morning of 2/22/21, patient had an abrupt change in status and was found to be unresponsive with hypercarbic respiratory failure and hypotension. ABG during this event was 7.16/121/65. BiPAP was initiated as patient's code status was DNR/DNI. CXR with no significant change from 2/18/21. CT of head without contrast was negative for acute processes. Based on lack of rapid improvement, the decision was made by wife to transition to comfort care. Patient died at 1446 on 2/22/21. **Of note: patient was admitted for 1 week for covid 19 pneumonia November 2020. During this hospitalization he was found to have chronic R sided PE, no acute PE.
Unauthorized age group received Moderna vaccine on 10/22/2021. No known adverse effects.
R arm hot & swollen down to elbow & around.  Painful to both sides of site.  Back aches & spasms, neck pain.  Getting better little less painful.
Information has been received from a physician concerning a 70 year old female patient who "about four years" ago, in approximately 2005, was vaccinated with PNEUMOVAX 23 vaccine. It was reported that "about two weeks ago", on approximately 18-SEP-2009, the patient received a booster 0.5 mL dose of PNEUMOVAX 23 vaccine and experienced increased injection site reactions like swelling, pain and asthenia. The patient sought medical attention by a call to the physician's office. The outcome of the patient was unknown. Additional information has been requested.
Two weeks ago she tested positive for covid/she and her husband had the same scenario; Two weeks ago she tested positive for covid/she and her husband had the same scenario; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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 "Two weeks ago she tested positive for covid/she and her husband had the same scenario". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: She is not sure if she should wait 3 months after their natural immunity because they were both pretty sick,but were not hospitalized. She had monoclonal antibody treatment and her husband had treatment with Paxlovid. She stated they are back to normal now, or as normal as 77 year olds can be.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202201160950 same reporter/drug/event, different patients;
Patient developed initial crop 07/16/2006, on 7/17/2006 several more pustules about 15-25 spots developed as initial crop crusted as characterized. Will observe for more SX. Fever 102 present.
Information was obtained on a request by the Company from the agency via a Public Case Detail (OPR # 320872) concerning a 13 year old female patient. The patient's medical history included allergy to KEFLEX and idiopathic anaphylaxis with shellfish. On 27-MAY-2013, the patient was vaccinated with a second dose of intramuscular GARDASIL (dose and lot number were not provided). On 27-MAY-2013, 30 minutes later the patient felt faint and had a rash on the arm. Lips and throat were hot. The patient self-administered ZYRTEC. Ambulance was called and the patient was transferred to hospital, was observed and discharge. On 27-MAY-2013, the patient recovered from the adverse events. The adverse events were possible related to GARDASIL by the reporter. The original reporting source was State/Territory health department. Additional information is not expected.
Subconjunctival hemorrhage; This case was reported by a pharmacist via call center representative and described the occurrence of subconjunctival hemorrhage in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number HE4P7, expiry date unknown) for prophylaxis.   On 2nd December 2022, the patient received the 2nd dose of Shingrix. On 6th December 2022, 4 days after receiving Shingrix, the patient experienced subconjunctival hemorrhage (serious criteria GSK medically significant). On an unknown date, the outcome of the subconjunctival hemorrhage was unknown.   It was unknown if the reporter considered the subconjunctival hemorrhage to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comment: The patient informed that subconjunctival hemorrhage was experienced after receiving the Shingrix vaccine. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Alopicia, generalized (head and body) Hair started falling out 4 days after administration hep B 1
I have had severe memory and cognitive issues. Mostly memory. It was observed by my family and manager.
no redness, no swelling or puffiness;pt only stated had a deep, aching pain in muscle of amr shot was administered in deltoid;
No adverse effects. Pt received 0.5mL dose of Pfizer bivalent booster instead of 0.3mL. When pt called after mistake was realized, he reported soreness at injection site and increased fatigue
On 11 June 2021, developed zoster on R side of face at V1 distribution. Prior to this time and after his vaccination on 26 March 2021, he reported no adverse reactions. He was treated in June 2021 with valacyclovir and subsequently has been treated with gabapentin for post herpetic neuralgia.
mild-moderate headache that has been persistent 1 week after J & J vaccine x20 days. no other symptoms
On an unknown date after the first injection of the pfizer covid-19 vaccine, the patient got COVID-19 infection.; On an unknown date after the first injection of the pfizer covid-19 vaccine, the patient got COVID-19 infection.; This is a spontaneous report received from a contactable pharmacist via Pfizer Sponsored Program. A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number and Expiration date was not reported), via an unspecified route of administration on 25May2021 as a single dose for covid-19 immunization. On an unspecified date in 2021, after the first injection of the Pfizer covid-19 vaccine, the patient got COVID-19 infection. On 16Jun2021, the patient was treated with monoclonal antibodies for the COVID-19 infection. It was reported that, patient is scheduled to get their second dose of the product today (as per report 12Jul2021). However, the patient took a medication for COVID on 16Jun2021, and reporter wanted to confirm if the patient could safely get the second dose of the vaccine today (12Jul2021). The reporter assessed the event as non serious. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on known safety profile and plausible temporal relationship, a possible causal association between the reported events and the suspect drug BNT162B2 cannot be excluded.
Urticaria rash lasting 2 days. Rx OTC antihistamines.
The first and second day I felt pain in my arm and tired/sluggish. The third day and moving forward I felt unwell with soar throat, mucus, runny nose, mild fever.
body rashes with itching and burning; body rashes with itching and burning; diarrhea; Tired; headeache; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 28Mar2021 at 17:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune disorder, penicillin allergy and sulfonamide allergy. Concomitant medications included thyroid (ARMOUR THYROID), progesterone (MANAFACTURER UNKNOWN) cream, testosterone (MANAFACTURER UNKNOWN) cream all from an unknown date for an unspecified indication. The patient previously took PABA (MANAFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021, the patient experienced tired and some headache for the first two days. On 30Mar2021 the patient experienced diarrhea and it was still happening, kept getting random headaches. On 05Apr2021, the patient experienced random body rashes with itching and burning that went away after taking antihistamines. That lasted three days, then started taking more antihistamine and did not happen for one day, but again a day later. Still had diarrhea and was exhausted. Patient stated that she felt great before getting the vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events random body rashes with itching and burning and included treatment with antihistamin. The clinical outcome of the events tired and some headache, diarrhea, random body rashes with itching and burning was not recovered.  No follow-up attempts are needed. No further information is expected.
Continuous upper arms muscle pain when raise arms overhead; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID. Vaccination history included: Bnt162b2 (in left arm as dose 1, single), for COVID-19 immunisation, reaction(s): "Thyroid gland swelling", "upper arms muscle pain when raise arms overhead", "left lateral upper arm (with pain)", "Hard swelling below injection site on left lateral upper arm approximately 3inches long by 1/2-inch-wide". The following information was reported: MYALGIA (non-serious), outcome "recovering", described as "Continuous upper arms muscle pain when raise arms overhead". Therapeutic measures were not taken as a result of myalgia.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. It was reported that continuous upper arms muscle pain when raise arms overhead was experienced day after both shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable office manager, reporting for herself, via a Pfizer sales representative. This 65 year-old female patient received PREVNAR 13 via an unspecified route of administration in the left arm on 01Nov2016 at 0.5 ml single for routine vaccination. The patient medical history and concomitant medications were not reported. No other vaccines were administered the same day. On an unspecified day in Nov2016 the patient felt achy, arm was killing her, she also experienced flu like symptoms, muscle ache, she felt crappy. The patient recovered on an unspecified day in Nov2016.
The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.; No adverse event; doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 18 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case, Patient 1 out of 50 (Lot AS7143C was administered on 5Jun2023)
Pain, swelling in upper arm. Pain, numbness in left 5th finger (1 day after injection. Still persisting on day four.
This spontaneous report as received from a Licensed Practical Nurse refers to a 13 year old son. On 28-JUN-2013, the patient was vaccinated with GARDASIL dose 1 in the left arm for prophylaxis. Concomitant therapies included TUBERCULIN performed on the lower portion of the patient's left arm. This was the patient's first tuberculin skin test. The licensed practical nurse reports that on the evening of 28-JUN-2013, the site where the tuberculin test was administered was "red and swollen". On 29-JUN-2013, the patient developed a headache and recovered from it the same day, 29-JUN-2013. When the patient went to his unspecified physician's office on 01-JUL-2013 the site where the tuberculin skin test was administered on the patient's arm was "a 13 millimeter, raised, red area" and because of that the patient "tested positive for tuberculosis. No treatment has been given at this time for tuberculosis, however the nurse reports that the patient's doctor scheduled him to have a chest x-ray performed and will begin medication therapy to treat tuberculosis soon. On an unknown date, unspecified "blood work" was performed. The outcome of headache was reported as recovered/resolved. The outcome of the site where the tuberculin test was administered was "red and swollen" was unknown. The action taken with GARDASIL was not applicable. The reporter did not assess the relationship between the events and GARDASIL. Additional information has been requested.
Mixing error resulted in anticipated 30-50% excess dose administered to 16 unknown patients before the error was realized and corrected.  No unusual  adverse events occurred, to my knowledge, associated with this error.  Please note that patient age information was entirely fictitious and just entered in order to complete this form.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 10-OCT-2015 the patient was vaccinated with GARDASIL dose 1 (lot number and expiry date unknown) (dosing regimen and frequency unknown) of immunization series. No concomitant medications were reported. On 22-NOV-2015 the patient was vaccinated with GARDASIL dose 2 (lot number and expiry date unknown) (dosing regimen and frequency unknown) and on 13-MAY-2016 was receiving third dose with GARDASIL 9 (inappropriate schedule of drug administration) (interchange of vaccine products). No adverse effects were reported. The action taken with GARDASIL and GARDASIL 9 was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
Patient is 16 yo female. She was given Moderna COVID-19 vaccine during an off-site vaccine POD reserved for First Responders and persons aged 65 and older. She should not have been scheduled for this event and nurse administered vaccine without verifying patient's age. Phone call to patient's mom, to inform of error. Mother states patient has had no side effects or adverse reactions to Moderna COVID-19 vaccine. Informed that patient will not receive second dose in 4 weeks and also is not eligible to receive Pfizer COVID-19 vaccine due to manufacturer's recommendation that vaccie is not interchangeable with other COVID-19 products.
This spontaneous unconfirmed report was received via company representative and refers to three patients of unknown age and gender. On an unknown dates, the patients were vaccinated with PNEUMOVAX23 (dose, route, site of administration and lot # not reported). On an unknown date, the patients experienced injection site swelling in an approximately 2 inch diameter area. Each patient felt the need to contact the office to inquire about the reaction. The outcome of injection site swelling is unknown. Additional information has been requested.
First Covid-19 Vaccine administered much higher  on left arm closer to left shoulder joint than all other vaccinations in my life.  Extreme pain and burning upon injection reported to nurse. She said it was because I did not have enough meat on my bones. I have never had a vaccination hurt like that in my life ? usually I do not even feel them, or feel just a tiny prick.  Extreme pain despite ice and arm exercises afterwards for months. Saw  PCP- at same clinic  on 02/15/21. He ordered shoulder ultrasound looking for abscess-told it was negative. Told to take NSAIDS for relief. Pain and range of motion difficulties has persisted for months. Unable to sleep on left side; cannot reach over my head or behind my back without pain.   Consulted  an orthopedic specialist-on 11/29/21. Preliminary diagnosis-frozen shoulder. MRI scheduled for 12/08/21 to confirm. Given  care instructions and exercises to do at home.  Offered a cortisone shot but declined at this time in favor of physical therapy.