chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist refers to two unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, two doses of improperly stored ZOSTAVAX 19400 PFU, lot # L011529 and expiration 03-JUL-2016, were administered to 2 unspecified patients (dose and route were not provided). No adverse effects reported and no PQC involved. Additional information has been requested.
Patient developed red puffy eyes, which were itchy. No wheezing, no respiratory difficulties.
4/28/2021-Lower left leg hurting; 4/29/2021-can't put weight on leg; ER visit with doppler to confirm blot clot in calf; ER gave Norco 5-325 mg for pain; fever of 101; 4/30/2021-still can't put weight on leg and fever of 101.8; 5/1/2021-woke up with no pain; clot still there; 5/3/2021-saw primary doctor for ER follow-up on clot; primary doctor confirmed there is a small clot in deep vein and could take up to 6 months for it to dissolve on its own.
Disorientation and confusion for several hours, headache, joint pain, loss of appetitite, occasional chest pain and heaviness, severe chills, shortness of breath, continues until 19 Oct.
On 1/30/06, pt had a small red dot like a pimple on his right cheek. Increased in size to 1 cm x 1 1/2 cm hyperpigmented macule in result. Otitis concurrently treated with Amoxicillin and Bactroban. Child had frequent URIs and Otitis Media 10-06 through 1-07.
Sore throat; Nasal congestion; Flu symptoms; Lot of pain in the arm; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Lot of pain in the arm), HYPERHIDROSIS (Sweating), OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Nasal congestion) and INFLUENZA (Flu symptoms) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Thyroid disorder since an unknown date.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Lot of pain in the arm) and HYPERHIDROSIS (Sweating). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Nasal congestion) and INFLUENZA (Flu symptoms). The patient was treated with IBUPROFEN at a dose of 200 mg; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Cold, at an unspecified dose and frequency. On 12-Feb-2021, PAIN IN EXTREMITY (Lot of pain in the arm) had resolved. At the time of the report, HYPERHIDROSIS (Sweating), OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Nasal congestion) and INFLUENZA (Flu symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Right neck & side of body stiff & sore - vomiting x 1 episode, about 4 hours post injection - chills.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL on 02-FEB-2011 and on 11-NOV-2011 the patient was vaccinated with the second dose. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Additional information has been requested.
Muscle pain in shoulder and associated loss of range of motion.  Started with first shot.  Second and third doses (end of March and October 2021) were given in right arm.  Experienced same symptoms in right arm.  I noted that this is a known reaction to the vaccine but generally was short lived.  I still have these symptoms after almost a year.
Arm swollen in large 7 inch circle that stayed swollen and red for 7 weeks.  Was warm and painful to the touch for 6 weeks.
Expired vaccine.  Expired 03/2022 and dilutent Lot: AMXA468A expired 10/2022.  No adverse effect to patient.
Admitted on 6/28/22-7/6/22 for weakness and shortness of breath. Tested positive for covid 6/28/22. Has Hx of COPD, a fib, bladder cancer, CKD, chronic foley catheter. He resides in a nursing home. Infectious disease, social work, urology, and gastroenterology
heart started racing; She took a test and she caught the virus/started getting sick/low-grade fever/Coughing; She took a test and she caught the virus/started getting sick/low-grade fever/Coughing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: ER8729), on 20May2021 as dose 2, single (Lot number: EW0175) and on 17Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "pacemaker", start date: 2012 (ongoing), notes: Comments: pacemaker; "Blood pressure" (unspecified if ongoing), notes: Indication for use in the case: Blood pressure. Concomitant medication(s) included: VALSARTAN taken for blood pressure abnormal, start date: 2012 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "She took a test and she caught the virus/started getting sick/low-grade fever/Coughing"; PALPITATIONS (non-serious), outcome "unknown", described as "heart started racing". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) Low grade fever; SARS-CoV-2 test: (May2022) Positive, notes: She took a test and she caught the virus; Weight: (unspecified date) weight is 140 something. Therapeutic measures were taken as a result of vaccination failure, covid-19, palpitations. Clinical course: She gave a nurse a ride that didn't take vaccine on a Tuesday, and Wednesday morning she started getting sick. Her heart started racing and had a low-grade fever, ran and got water and Gatorade and took Tylenol. She caught the virus from her. She is saying if she didn't take the 1st (as reported), maybe it could have been worse. She was very sick those 24 hours. Coughing. She took a test and she caught the virus. Patient also had a Flu shot on an unknown date - no further details.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300100075 same reporter/patient, different dose/event;
No additional adverse events reported.; Nurse reporting the administration of expired VAQTA and inquiring viability information pertaining to administration of expired dose.; This spontaneous report has been received from a registered nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 04-MAY-2022, the patient was vaccinated with expired hepatitis a vaccine, inactivated(VAQTA) (lot # U003464 with expiration date: 02-MAY-2022, 0.5 milliliter, strength and route were unknown) for prophylaxis (Expired product administered). The reporter inquired viability information pertaining to administration of expired dose. No additional adverse events reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (PFIZER / BIONTECH COVID-19 VACCINE), on 17Sep2022 as dose 5 (booster), single (Lot number: gj532) at the age of 72 years, in right arm for covid-19 immunisation; coviD-19 vaccine, 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 included: "Hypertension" (unspecified if ongoing); "Prediabetes" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid from 13Mar2023 to 18Mar2023.
mouth sores; Nausea; vomiting; stomach cramps; sweats; joint pain; elevated heart rate; This is a spontaneous report from a contactable other HCP (Patient).  A 21-year-old female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot #EL0140, via an unspecified route of administration on 29Dec2020 12:00 at single dose at Left arm for COVID-19 immunisation.  Medical history included Behcets, dysautonomia, Irritable bowel syndrome (IBS), and COVID-19.  The patient's concomitant medications included unspecified products within two weeks of vaccination.  The patient previously took amoxicillin, MELOXICAM (MOBIC) minocycline and all experienced drug hypersensitivity.  On 30Dec2020 12:00 the patient experienced mouth sores, nausea, vomiting, stomach cramps, sweats, joint pain and elevated heart rate. There was no other vaccine in four weeks. The patient was not pregnant. Prior to vaccination, the patient was diagnosed with COVID-19 and  since the vaccination, the patient has not been tested for COVID-19. The reporter considered all the events are non-serious and stated no treatment was received. The events outcome was not resolved.
Red itchy rash at injection site. Large firm welt (silver dollar size.) Redness.
Severe pain left arm, shoulder radiating into left neck. Unable to move arm without severe pain; OTC medications not helpful to address pain.  Had to keep arm in a sling position to avoid additional throbbing pain.
Case number PHEH2012US008936 is an initial spontaneous report received from a consumer on 24 Apr 2012. This report refers to a female patient whose age, medical history, past drugs, current conditions and concomitant medications were unspecified. It was reported that on 24 Apr 2012, she was vaccinated with MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X10062) intramuscularly on to unspecified site and did not receive the MenA lyophilized conjugate. No adverse reaction was reported following the maladministration.
shingles; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding medical history, concurrent conditions and concomitant medications. On or about 28-JAN-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not provided) at the physician office for the long-term prevention of shingles and/or zoster-related conditions. On unspecified dates, the pt experienced shingles and was admitted to the hospital. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) inoculation, the pt suffered and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Swelling upper and lower lip areas, down to about the chin; Hives; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration administered in Left arm on 14May2021 at 12:00 (53-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. Medical history included hives (had episodes in recent months) from an unknown date and unknown if ongoing. The patient had allergies to birch, dust mites, some grasses and Seasonal allergies. Concomitant medications included antihistamines (unspecified) from an unknown date for unknown indication. Historical vaccine included, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration administered in Left arm on 23Apr2021 at 12:00 PM (53-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 16May2021 21:00, the patient experienced swelling upper and lower lip areas, down to about the chin. Some hives reappeared, but the patient had episodes in recent months. No therapeutic measures were taken as a result of the reported events. The outcomes of events were recovered on an unknown date in May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
inflammation ot eye progressing to ma ocular degeneration in left eye. Possible radiated right breast complications
Arm hurts more than like a normal shot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm hurts more than like a normal shot. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Patient received # 1 in L deltoid per staff took papers (Pfizer) check list from patient.  Nursing student came to the car.  Asked him about his paperwork.  Patient was explaining that the staff had taken his paperwork and had already given his first vaccine.  The nursing student gave the patient a second dose of Pfized vaccine in the L Deltoid. Patient observed 30 days without incident.
@ 2:03pm patient c/o dizziness and headache & nausea. He was helped to a cot, placed in a supine position with feet elevated. Patient was diaphoretic. Applied ice pack behind his neck and encouraged slow deep breaths. Offered patient a bottle of water at room temp. BP=142/70, T=98.2, HR=113 at 89%RA. Administered 10L of O2 via a simple mask. At 2:09pm O2 sat was 94% HR=98. Patient A&O x4 through out this episode. At 2:20pm, patient denied having any prior symptoms and was d/c in a stable condition . Patient did not incur any injuries or falls while at the clinic and ambulated with no difficulty out of clinic.
Information has been received from a physician concerning an adult male with no pertinent medical history who on 24-FEB-2006 was vaccinated with a dose of Recombivax HB. Concomitant therapy that day included typhoid vaccine (unspecified). Other concomitant therapy on 17-FEB-2006 included hepatitis A vaccine (inactive) and influenza virus vaccine (unspecified). Since vaccination, the patient has reported drinking heavily twice during March 2006. Both times, the patient developed a red flushing rash on his face and extremities, and a slight swelling of his tongue. Unspecified medical attention was sought. The outcome was reported as recovered. No other information was available. There was no lab diagnostic studies performed. There was no product quality complaint. No additional information is expected.
pt had a positive COVID test on 8/3/22 and went to the hospital with dyspnea and confusion; found to have pleural effusion; pneumonia; placed in ICU; shock requiring vasopressors; AHRF; right sided pleural chest tube placed; CXR showed worsening pulmonary infiltrates; CT of chest showed PE; ECHO showed right ventricular dysfunction with positive sign; pt's condition deteriorated; she declined further tx; dcd to hospice facility (Hospice); transitioned to comfort care; pt passed away in the hospice facility.
Had a single booster dose of the Moderna COVID-19 Vaccine, the following are some of the symptoms experience on the administer site: pain, tenderness, swelling (hardness), redness, fatigue, headache, muscle pain, joint pain, and ichiness.
After 3 shot given, patient got pale and asked for a trash can and started vomiting right after. Patient has not eaten prior to visit. Provider asked that we contact VAERS and recommend patient to be advised to eat prior to receiving vaccines.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 26-AUG-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 14-MAY-2012, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX and lidocaine for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
slept even more; broke out into a deep deep sweat; he felt like he had a fever of 100.6; body aches all over; got really cold; couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (got really cold), INSOMNIA (couldn't sleep), HYPERSOMNIA (slept even more), HYPERHIDROSIS (broke out into a deep deep sweat) and PYREXIA (he felt like he had a fever of 100.6) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 003B21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced FEELING COLD (got really cold), INSOMNIA (couldn't sleep), PYREXIA (he felt like he had a fever of 100.6) and MYALGIA (body aches all over). On 31-Oct-2021, the patient experienced HYPERSOMNIA (slept even more) and HYPERHIDROSIS (broke out into a deep deep sweat). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (got really cold), INSOMNIA (couldn't sleep), HYPERSOMNIA (slept even more), HYPERHIDROSIS (broke out into a deep deep sweat), PYREXIA (he felt like he had a fever of 100.6) and MYALGIA (body aches all over) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter All three doses were given in his deltoid muscle.  Company Comment - This case concerns a 41-year-old male patient, with no relevant medical history, who experienced the non-serious unexpected AESI of HYPERSOMNIA. The event occurred on the day after receiving a third dose of Moderna COVID-19 vaccine. The rechallenge is not applicable since the outcome of the event is unknown and no further dose is expected at this time. The benefit-risk relation of Moderna COVID-19 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up added events, reporter details and updated vaccination information.; Sender's Comments: This case concerns a 41-year-old male patient, with no relevant medical history, who experienced the non-serious unexpected AESI of HYPERSOMNIA. The event occurred on the day after receiving a third dose of Moderna COVID-19 vaccine. The rechallenge is not applicable since the outcome of the event is unknown and no further dose is expected at this time. The benefit-risk relation of Moderna COVID-19 vaccine is not affected by this report.
Pt states she was extremely sick and could not go to work for a week. States she was extremely tired and run down and her arm hurt. Pt says she tried to report herself but she was unable to get through. Pt wished to proceed with 2nd dose due to it being a requirement for her workplace.
Took Tylenol after injection at approximately 9:30 AM on 26 January 2021; approximately 1:30 AM on 27 January 2021 was awakened by severe chills/tremors/ rigors (to the point it was difficult to hold a glass of water); took Tylenol and waited approximately 1.5 hours for chills and 100 deg. temp to subside. Took Advil at approximately 8:00 AM. Worked all day and at approximately 7:30 PM began having chills again and a fever of 101 deg.  temp. Took Tylenol and temperature began lowering and I went to bed. Woke up again at approximately 1:30 AM 28 January 2021 with significant sweating. Took my temp and it was near normal. No further side effects/symptoms following this event.
Fever, unknown temp. Lasted 4 hours, the next day  was very tired headache
she was diagnosed with Hashimoto disease/ monthly periods and hair loss/ damaged thyroid; ovary failure; This spontaneous report was received from a 17-year-old female patient who reported on herself via a company representative. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 14-AUG-2009, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection and subsequently received next doses as follows: 19-OCT-2009 and 15-FEB-2010 (exact dose, route of administration, anatomical location, lot # and expiration date were not reported for any of them); all for prophylaxis. On an unknown date, she experienced damaged thyroid, "no dairy or gluten", estrogen at menopausal levels, no monthly periods and hair loss (reported as the reporter did not know when the adverse signs and symptoms first started). Then, on an unknown date in August 2015, the patient was diagnosed with Hashimoto's disease and ovary failure. It was reported that it took a long time to get to a diagnosis. The outcome of the events was not reported.  Causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of Hashimoto's disease was considered to be medically significant.