chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant on 02-JUL-2015, concerning a patient of an unknown age and gender. On 08-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Started wheezing on or about 3/23/2021; PCP prescribed Albuterol inhaler 3/25; SOB and wheezing worsened daily; 4/4/2021 was unresponsive 911 called and taken to ER with pulse ox of 58 and multiple bilateral PE noted on CT scan.
swollen left arm down though elbow area, swollen underarm area, swollen and pain left side of breast up near under arm,   could not lift left arm, painful down arm, up neck area, still having pain in arm. Pain is subsiding gradually daily, still noticeable.
Ringing in the ears / tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 14:15 (Lot number: ER8737) at the age of 43 years as dose 2, single and administered in arm right, administration date 11Mar2021 14:15 (Lot number: EN6208) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Crohn's Disease" (ongoing); "hypothyroidism" (ongoing); "Seborrhoeic dermatitis" (ongoing). Concomitant medication(s) included: HUMIRA; LEVOTHYROXINE; ALLEGRA. The following information was reported: TINNITUS (non-serious) with onset 03Apr2021, outcome "not recovered", described as "Ringing in the ears / tinnitus". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: Patient did not receive any other vaccine in four weeks. She received Humira, levothyroxine, Allegra, multivitamin medications in two weeks. She did not have covid prior vaccination and did not test covid post vaccination. No Known allergies. She did not have relevant past drug history. She did not required hospitalization Prolonged and did not received treatment. Device Date 17Aug2021.  Follow-up attempts are completed. No further information is expected.
doctors office sent it to her/and/had it laying around for 4 months /took it to the doctors office and had it injected; This case was reported by a consumer via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional case details were reported as follows: The case was reported by the patient. Age at vaccination was not reported. Caller stated that her pharmacy sent the shingrix vaccine for her to the doctor, then the doctors office sent it to her house and the patient just had it laying around for 4 months before she took it to the doctors office and had it injected which led to incorrect storage of drug.  She refused to give any contact information or additional information for herself or the office or pharmacy or the vaccine. The reporter did not consent to follow-up.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 3:29 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 3:29 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 82.58 for dose administered on 07-JAN-2021. No concomitant medications were reported. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
I started getting sick on the 23MAR2023, my asthma kicked in. I was coughing, short of breath and very tired. I went to the doctor he gave me pramasone, he also gave me some cough medicine. The doctor also switched my medication and I have been doing breathing treatment, I feel like this more allergy and asthma related but I am not getting better.
R deltoid where vaccine was given became hard and "goose-egg" size and very tender and painful at 0005 on 6/20/07. Vaccine was given at 1845 on 6/19/07. By 0600 on 6/20/07 R deltoid area of vaccine almost doubled in size and remained hard. Percocet 1 tab and Benadryl 50mg PO was given on 6/20/07at 0005.
Pt received FLUZONE at 1:45 on 9-17-13. Pt began running fever and coughing evening of 9-20-13. Pt had TESSALON and Ibuprofen on hand and took those over weekend. Reported to pharmacy on 9-23-13.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA002453: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA003062.
This spontaneous report was received from a registered nurse refers to a 6 month old patient of unknown gender. No medical history or concurrent conditions were reported. On 04-SEP-2014, the patient was vaccinated with a fourth dose of ROTATEQ, oral (dose, strength and lot number not reported) after patient received a third dose of ROTATEQ on 25-AUG-2014. No adverse effects were reported. Additional information has been requested.
had the breakthrough infections had had two doses of the Pfizer vaccine; had the breakthrough infections had had two doses of the Pfizer vaccine; This is a spontaneous report from a contactable physician reporting same events under the same suspect product for 10 total number patients. This is one of 10 reports.  A patient of unspecified age and gender received two doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported ten patients had breakthrough infections. Local pharmacies in their area giving booster dose and the patients that had had the breakthrough infections had had two doses of the Pfizer vaccine on an unspecified date with outcome of unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID  infections  based on the known safety profile.,Linked Report(s) : US-PFIZER INC-202101100913 same reporter/SD/AE, different patient;US-PFIZER INC-202101100917 same reporter/SD/AE, different patient;US-PFIZER INC-202101100916 same reporter/SD/AE, different patient;US-PFIZER INC-202101100920 same reporter/SD/AE, different patient;US-PFIZER INC-202101100915 same reporter/SD/AE, different patient;US-PFIZER INC-202101100918 same reporter/SD/AE, different patient;US-PFIZER INC-202101100122 same reporter/SD/AE, different patient;US-PFIZER INC-202101100914 same reporter/SD/AE, different patient;US-PFIZER INC-202101100919 same reporter/SD/AE, different patient
mild back spasm in morning and severe back spasm by evening; sudden stabbing pain; spasm in her left calf; spasm in her left calf; difficult to walk; unusual aches in legs/feet; severe pain in her right knee; This is a spontaneous report from a contactable consumer (patient).   A 62-year-old (non-pregnant) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0183), via an unspecified route of administration, administered in right arm on 16May2021 at 13:00 as dose 2, single for COVID-19 immunisation (age at vaccination was 62 years). The patient was not pregnant at time of vaccination. The patient medical history included ACL repair on left knee, hypothyroidism from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing, has not bothered her. She had no known allergies. She was not diagnosed with COVID-19 prior to vaccination, and not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccine in four weeks prior COVID vaccine. Concomitant medications included levothyroxine taken for an unspecified indication, start and stop date were not reported, cobamamide (VITAMIN B12 (COBAMAMIDE)) taken for an unspecified indication, start and stop date were not reported and Beta vulgaris, Brassica spp., Cyanocobalamin, Folic acid, Pyridoxine hydrochloride, Saccharomyces cerevisiae (VEGAN B12) taken for an unspecified indication, start and stop date were not reported. The patient's concomitant medication included Levothyroxine, vitamin B12, Vegan (in two weeks). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0176), via an unspecified route of administration, administered in right arm on 25Apr2021 13:00 (age at vaccination was 62 years) as dose 1, single for COVID-19 immunization. On 17May2021 at 19:00, the patient experienced mild back spasm on waking the morning of the vaccine, she had a severe back spasm by the evening. It made her scream when she walked as it was a very sudden stabbing pain. The next day or 2 it disappeared. The patient developed a spasm in her left calf so that it was difficult to walk. That went on for about a week. For the past 3 months, she had unusual aches in legs/feet and severe pain in her right knee. The patient underwent lab tests and procedures which included X-ray: X-ray showed no arthritis on an unspecified date. No therapeutic measures were taken as a result of events. The patient visited to doctor or other healthcare professional office/clinic as a result of events. The outcome of the events mild back spasm in morning severe back spasm by evening, sudden stabbing pain, spasm in her left calf and difficult to walk was recovered on an unspecified date in May2021. The outcome of the events she had unusual aches in legs/feet and severe pain in her right knee was not recovered.    Follow-up attempts are completed. No further information is expected.
pt recv vax 27AUG97 & pt exp a sudden (rapidly resolving) loss of equilibrium when standing, a sort of vertigo & loss of equilibrium (almost ataxic & also rapidly disappearing) when walking;tx was required;
Both eyes very bloodshot with redness in skin around eyes and slightly swollen , resolved by next day. I never get bloodshot eyes.
35 mins post shot c/o itching, redness lt upper arm; DPH given; 35 mins later intense rash & itching spread to upper chest & upper back (rash-macular) V.S> stable Epi; inc BP & P sl h/a;
This case was reported by a physician via sales rep and described the occurrence of patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSER, the patient experienced pain and fainting. On an unknown date, the outcome of the pain and fainting were unknown. It was unknown if the reporter considered the pain and fainting to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. Medical liaison reported that she had a "matrix connect call" with a physician and a local representative. The physician said that one of their patient's fainted after receiving BEXSERO because of the pain. The physician did not clarify what the pain was. The medical liaison attempted to collect details and the physician said that they needed permission from the patient to answer additional questions and declined answering questions. The physician said that she did not want to report even through the medical liaison. That the physician would get permission from the patient and then report it. It was possible that the physician would send an additional report about this case.
Medical Complaint: I got the COVID vaccine yesterday at 335 pm , 12 hours later, HA, body aches, Temp of 101 oral.
Intermittent pain in right ear; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 18Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced intermittent pain in right ear. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event intermittent pain in right ear was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Severe Headache, nausea, vomiting, muscle aches, chills, red face,
Red, swollen tender area to right upper arm.  Hot to the touch.  Immunization reaction  VS cellulitis.  Prescribed Benadryl PRN and Omnicef for 10 days.
From intital information received on 07/20/04 from a NP regarding an adverse event occurring in the USA, it was reported that a six month old male patient received a does of Daptacel, lot number C1383AA, administered in the left thigh and a dose of Prevnar, lot number 492408, administered in the right thigh on 06/27/03. The routes of administration were not reported. An unspecified amount of time later, the patient developed three vesicles measuring two to three millimeters in size at the site of injection. The patient was not seen by a physician. Reportedly, the patient recovered from this event. From additional information received on 08/30/04 from the initial reporter, additional patient and vaccine information was provided. The Daptacel and Prevnar vaccinations were administered intra muscularly. It was reported that the onset date of event was 06/28/03, the day after vaccination and duration of symptoms lasted three to four days. The patient's mother did not call the doctor's office about symptoms. She reported the symptoms at the 19 month exam. No further information is anticipated, this case is considered closed.
A report was received from a healthcare professional on 11Nov02 concerning a 25 year old female vaccinee who experienced an increased WBC count and was 30 weeks pregnant when she received Fluvirin on 08Nov02. On 08Nov02 the vaccinee was 30 weeks pregnant and received 0.5ml Fluvirin IM. On 11Nov02 the reporter ( a nurse) ordered a complete blood count test and noticed that the WBC was increased to 20.8. The clinics protocol specifies 4.0-11.0 as normal. It was reported that the vaccinee did not experience any adverse reaction. The vaccinee had not been vaccinated prior to this event. The reporter has classified the relationship of the event to the vaccine as possible.
This spontaneous report as received from a health department nurse refers to an unknown number of patients of unknown ages and genders. On unknown dates the patients were vaccinated with VARIVAX (Merck) injection which underwent a supported temperature excursion, but was outside the recommended temperature provided in the prescribing information, intramuscular (lot #, expiry date and dose unknown). No adverse effects reported. Additional information has been requested.
Large bruise at injection site started during the night with soreness then next morning had baseball sized bruise. Reduced in size over next few days.
Injection site pain; Fatigue; Headache; Muscle aches; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER 8730) via an unspecified route of administration in the left arm on 01Apr2021 at 14:30 (at the age of 42-years-old) as dose 2, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration, on an unknown date as dose 1, single (age at vaccination: 42 years), for COVID-19 immunization. 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 02Apr2021, the patient experienced injection site pain, fatigue, headache, muscle aches and chills. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events injection site pain, fatigue, headache, muscle aches and chill. The clinical outcome of the events injection site pain, fatigue, headache, muscle aches and chill were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.  Follow up (21Jul2021) via Amendment: This follow-up report is being submitted to amend previously reported information: Other relevant history for dose 1 age and unit updated; Ending sentence update to 'No follow-up attempts are possible. No further information is expected.'
Pt was extremely fussy x 2 days & screamed x 3-4 hrs straight 1st evening;
post herpetic neuralgia; arrhythmia; cardiac issues; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a female patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, subsequently after receiving zoster vaccine live (ZOSTAVAX), the patient was diagnosed herpes zoster, post herpetic neuralgia, an arrhythmia and cardiac issues. As a result of these symptoms, the patient was seen and treated by medical providers. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations were not present prior to using zoster vaccine live (ZOSTAVAX) vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX) vaccine, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered serious, progressive, permanent, and incurable injuries. The outcome of the event of shingles was considered as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).