chrisvoncsefalvay/vaers-outcomes huggingface dataset:
More than 35 days after the first dose without receiving the second dose; More than 35 days after the first dose without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (More than 35 days after the first dose without receiving the second dose) and PRODUCT AVAILABILITY ISSUE (More than 35 days after the first dose without receiving the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (More than 35 days after the first dose without receiving the second dose) and PRODUCT AVAILABILITY ISSUE (More than 35 days after the first dose without receiving the second dose). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (More than 35 days after the first dose without receiving the second dose) and PRODUCT AVAILABILITY ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were not provided by the provider
Conjunctivitis, difficulty in breathing with chest tightness and cough, itching.
After the vaccine she experienced two days of fever, fatigue, generalized myalgias, headache, sweating, leg edema, chest discomfort, SOB (felt it was difficult to take a deep breath), and b/l burning leg pain. Majority of sx have resolved by date of visit 9/3/21 although still experiencing R upper arm pain at injection site, intermittent headache, and leg swelling/pain. The sx have all improved significantly and edema is nearly resolved today. The pain has been circumferential.
Pt reported feeling fuzzy/dizzy and lightheaded. Sat and rested with water and VS check and returned to baseline 40 minutes later.  Pt felt ok to drive after her evaluation from EMT's and left to go to work.
i thought i was going to die; horrible body aches; piled a fast heart rate; i had forty-two hours of severe nausea during which i could not even hold down a drop of water; massive headache; This is a spontaneous report from a non-contactable consumer(patient). A 61-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and expiration date was not reported) via an unspecified route of administration, administered on 21Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and expiration date was not reported) via an unspecified route of administration, administered an unknown date as dose 1, single for COVID-19 immunization. The patient reported that she had forty two hours of severe nausea during which she could not even hold down a drop of water in addition to a massive headache and horrible body aches and piled a fast heart rate, she thought she was going to die. The patient underwent lab tests and procedures which included heart rate and reported as fast on an unknown date. The outcome of the events was reported as unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received regarding a case in litigation on 26-MAY-2017 from a lawyer and a consumer regarding a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 08-DEC-2010 at a health clinic, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-OCT-2011, the patient was treated by health care professionals at a health clinic for a vesicular outbreak that was diagnosed as herpes zoster (shingles.) As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Bell?s Palsy, right side of face, affect eyelid, cheek, lips, tongue
The patient is a male and CERVARIX was given to him instead of GARDASIL. We called the patient to come in to receive a GARDASIL vaccine.
This case was reported by a nurse via call center representative and described the occurrence of vomiting in a 16-year-old male patient who received MENVEO. On 4th August 2016, the patient received MENVEO .5 ml. On 4th August 2016, less than a day after receiving MENVEO, the patient experienced vomiting (serious criteria other: As per reporter) and fever. On an unknown date, the outcome of the vomiting and fever were unknown. It was unknown if the reporter considered the vomiting and fever to be related to MENVEO. Additional details were provided as follows: The sales representative and nurse reported that the patient required emergency room visit with no admission for events. The limited patient details were available.
Patient presented with weakness and AMS. On admission, patient had severe hyponatremia and confusion continued as was also found to have supratherapeutic tacrolimus level. Patient started experiencing respiratory symptoms on day 2 of admission requiring O2 and treatment for COVID.
Donor complained of vomiting/nausea 1 hour after shot and nausea lasted a few hours, also felt a little dizzy. Arm was sore. Donor states she thinks she felt sick from not eating prior to donation that day - feels fine now.
Injection site red, swollen, warm to touch. Lump felt. Patient states she had fever at home.
Administration after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patients received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patients experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-Jan-2023 Reporter's comment: A medical assistant reported that Bexsero vaccines were exposed, in October 2022, to a temperature of 8.7 degree Celsius for 120 hours (temperature excursion determined that vaccines were no longer viable).  The vaccines were administered to an unknown quantity of patients.  The reporter mentioned that once she got the information she would call and provide information about patients who received the vaccine. Additional supportive information: The patients received Bexsero vaccine after temperature excursion, which led to incorrect storage of drug.
Information has been received from a company representative concerning a patient who on 02/19/1997 was vaccinated with varicella virus vaccine live. Subsequently the patient experienced breakthrough chicken pox. It was also reported that 4 children at the patient's daycare had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested.
Sever Pain in the armpit with swollen lymph node; Sever Pain in the arm pit with swollen lymph node; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 13Mar2021 12:00 (Batch/Lot number: unknown) at the age of 50 years as dose 2,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 (Product=COVID 19, Brand=Pfizer, Lot unknown=false, Administration date=20Feb2021, Administration time=12:00 PM, Administrator route=Intramuscular, Vaccine location=Left arm), administration date: 20Feb2021, when the patient was 50 years old, for covid-19 immunisation.  The following information was reported: AXILLARY PAIN (non-serious) with onset 13Mar2021 16:00, outcome "not recovered", described as "Sever Pain in the armpit with swollen lymph node"; LYMPHADENOPATHY (non-serious) with onset 13Mar2021 16:00, outcome "not recovered", described as "Sever Pain in the arm pit with swollen lymph node". The events "sever pain in the armpit with swollen lymph node" and "sever pain in the arm pit with swollen lymph node" were evaluated at the physician office visit. Therapeutic measures were taken as a result of axillary pain, lymphadenopathy.  Additional information: The patient did not receive other vaccine in four weeks. The patient had no allergies. The patient has not had covid prior vaccination. The patient did not tested covid post vaccination. The patient receive treatment with Advil for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a medical assistant referring to a currently 17 years old patient of unknown gender. The patient's medical history, current condition and concomitant therapy were not provided. On an unknown date, the patient received dose of improperly stored PROQUAD (lot number R017628 with expiration date 18-DEC-2019) subcutaneously for prophylaxis or VARIVAX (route was unknown, lot number R018931 with expiration date 02-JUL-2020; lot number R018777 with expiration date 01-JUL-2020) for prophylaxis(product storage error). The administered doses experienced a temperature excursion ranged from -14 degree Celsius to -10 degree Celsius for 1 hour and 30 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effects were reported in the patient. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1812USA000015: US-009507513-1811USA012273.
PATIENT EXPERIENCED INTENSE PAIN AT THE INJECTION SITE AT THE TIME OF INJECTION.  PAIN HAS NOT BEEN RELIEVED BY COLD THERAPY (ICE), IBUPROFEN, TIME, OR ACUPUNCTURE.
Loss of taste; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration on an unspecified date (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient was allergic to pork, diary, beef and gluten. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested for COVID-19. On 20Mar2021, the patient experienced loss of taste. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test on 22Mar2021 which included COVID-19 virus test and the test result was negative. The patient did not receive any treatment for the event loss of taste. The clinical outcome of the event loss of taste was recovering at the time of the report.   No follow-up attempts are possible. No further information is expected.
Caller returning call with patient information regarding improperly stored vaccine; This spontaneous report was received from an unspecified reporter, referring to a  currently 4 years old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD), administered at a dose of 0.5 milliliters (ml) (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T005406, expiration date 12-AUG-2021) given as prophylaxis. The vaccine administered experienced a temperature excursion of -9.5 degrees Celsius (C) for 8 hours and 53 minutes; and -10.1C for 6 hours and 40 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse event details were available.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA008353: US-009507513-2009USA008377: US-009507513-2009USA008397: US-009507513-2009USA008398: US-009507513-2009USA008475: US-009507513-2009USA008486: US-009507513-2009USA008520: US-009507513-2009USA008533: US-009507513-2009USA008553: US-009507513-2009USA008675: US-009507513-2009USA008746: US-009507513-2009USA008761: US-009507513-2009USA008780: US-009507513-2009USA008804: US-009507513-2009USA008870:
Menstrual Cycle, which  is on time to almost the hour, was 3 days late and started in the middle of the night.  Woke up covered in blood (through clothes and covered bed) with significant clots.  Cycle lasted 3 days longer than usual and was significantly heavier than average.
Swelling of left side of face/eye swollen shut; left cheek skin dry and flaking off. Rash on upper torso.
From initial information received on 07/26/04 from the patient's bother regarding an adverse event occurring in the USA, it was reported that an 18 year old male patient received a dose of Menomune A/C/Y/W-135, lot number UE123AA and a dose of TD ADS adult, lot number U1281AA, administered at 11:00 AM on 07/26/04. Approximately 2.5 hours post vaccination, the patient developed blurred vision and a headache. The patient took Advil, but the headache persisted. At the time of this repot, the patient was going to go to the emergency room. His recovery status is unknown. From additional information received on 08/30/04 from the responsible physician, this case has been medically confirmed. It was reported that this was the patient's first dose of Menomune and it was administered in the left deltoid. This was the patient's second dose of TD ADS Adult, and it was administered in the left deltoid. The reporter stated that the case was reviewed and that there was not additional information at the time of this report. The recovery status of the patient was not provided. From additional information received on 10/06/04, from the reporting physician, it was reported that "My last contact with this patient was 07/26/04. I have no knowledge of his present situation. I presume he is in college and doing well since neither he nor his parents have contacted me." No further information is anticipated, this case is considered closed.
PT STATED ALTHOUGH SHE HAS A LONG HISTORY OF RECURRENT SHINGLES THAT THE PATIENT GOT SHINGLES 2 TO 3 WEEKS AFTER HER INJECTION. SHE ENDED UP CALLING THE 24HOUR NURSING HOTLINE PROVIDED BY HER HEALTHPLAN. THE SHINGLES IS UNDER THE SKIN (NO RASH) ON THE FACE WHERE SHE NORMALLY GETS HER SHINGLES. SHE STATED SHE FELT "ILL" FOR 2-3 DAYS AFTER RECEIVING HER INJECTION.
Child received vaccines and was crying upset. Calmed slightly but tearful. Carried out to the car and vomited up mucus per mother. Vomited several times after that. Brought Pt back into office. Pale, then cleaned by staff with "wipes". Noted to have more diffuse redness w/o hives or raised areas which included around eyes, cheeks, chin and fairly diffuse on trunk, extremities, sparing palms/soles. Child sleepy, due for nap. No glf/r, normal respirations. Mother took child home.
This case reported by a physician, via GSK representative, that described the occurrence of high fever in a 4-month-old subject of unspecified gender who was vaccinated with PEDIARIX. Concurrent vaccinations given on the same date as PEDIARIX included ACTHIB, ROTATEQ oral; and PREVNAR. On an unspecified date On an unspecified date, the subject received the 2nd dose of PEDIARIX. At an unspecified time after vaccination with PEDIARIX, the subject experienced a high fever, reported to be in the 103 degree Fahrenheit range. At unspecified time after vaccination with PEDIARIX blood was drawn from the subject and the test results showed a white blood count "shift to the left", but no bacteria was detected. The subject was treated with at least one dose of ROCEPHIN. The fever was reported to be resolved within 24 hours, but the outcome of the abnormal white blood cell count was not reported.
TIA on 12/28/2021 I went to a clinic with TIA symptoms. I was transferred to  Hospital on 12/29/2021  in the evening. I exercise weekly, I am not overweight, my lipid profile was non-fasting.  I am very healthy, I have no contributing factors. I followed up with a heart doctor, I checked with a rheumatologist to see if I had any autoimmune issues that could contribute to this happening and that was negative (1/31/22). I also saw my PCP as a follow up from this hospitalization. I have an appointment as a new patient with PA for neurologist on 6/3/2022 to see if they think anything is contributing. This is something that I believe was a reflection of having the vaccine administered. No Doctor can find why this would ever happen. My Blood Pressure is perfect and with in normal limits. I am a nurse so I am fully aware of keeping good health.
Severe body pain causing patient to be bedridden 1 day after 2nd vaccine. Since then has had severe intermittent pain to lower and middle back, neck, and shoulders.
Chest Tightness, wrapping around to back, left arm very sore and difficult to move.
set of twins to receive ACT-HIB 2-days past the expiration date with no reported adverse events; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who experienced set of twins to receive act-hib 2-days past the expiration date with no reported adverse events while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation.  On 08-AUG-2022 , the patient received a  0.5ml dose of suspect HIB (PRP/T) VACCINE once (lot UJ522AA; expiry date: 06-aug-2022) via intramuscular route in the right thigh for immunization.  On 08-AUG-2022 the patient reported set of twins to receive act-hib 2-days past the expiration date with no reported adverse events (expired product administered) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  Action taken: not applicable.   It time of reporting, the outcome was Unknown for the event expired product administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01227624:
On 02/24/21 & 02/25/21,  I had body aches, fever, nasal drainage, and fatigue. On 02/25/21 I visited the pt care and was swabbed for covid - negative.  On 02/26/21 I began to cough and  felt fatigue. I visited an pt care - tested negative for covid again, & was diagnosed with bronchitis - given a Rocephin & steroid shot + oral antibiotics & an inhaler. On 02/28/21 my left eye broke out in hives. I took benadryl. On 03/01/21 I attempted to go back to work and became over heated, short of breath, and coughed, felt extreme fatigue. I left early and slept from 3pm - the next day. On 03/02/21 I visited my primary care dr and was diagnosed with an adverse reaction to the vaccine and lung inflammation. I was given oxygen in office due to it being low and me being short of breath. Still experiencing coughing, shortness of breath, pain in chest, nasal congestion, fatigue - I was given another steroid shot and a 7 day steroid pack. Chest xray was normal. On 03/09/21 I visited a pulmonologist and was started on breathing treatments, high dose steroid pack, antibiotics, and a different inhaler. Today, 03/11/21 I am experiencing chest pain, fatigue, shortness of breath at rest and on exertion, and extreme brain fog, I have been out of work since 02/24/21.
joint pain, myalgia, nausea, vomiting, injection site pain Narrative:
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced pain on an unspecified date. The outcome of the event was unknown. No follow up attempts are possible; information on the batch number cannot be obtained.
Arm pain in upper left arm 5 days post vaccination. LEVAQUIN, Ibuprofen on 10/12 then Propoxyphene/APAP, methylprednisolone on 10/18.
Information has been received on 13-JUL-2017 from a nurse via a company employee regarding 2 unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. The nurse reported that 2 unspecified patients were administered doses of RECOMBIVAX HB(lot numbers and expiration unknown), intramuscular for prophylaxis on unknown dates. The nurse reported that on unknown dates the patients, both now in their 20s, had titers drawn and they were low. The outcome of had titers drawn and they were low was reported as not recovered/not resolved. The causality was not reported. No further information was provided. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to a 11 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 02-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K004541, expiration date: 04-DEC-2016, (dose, strength and route of administration were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.