chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rapid heart rate; Sore arm; Consumer experienced nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA, PAIN IN EXTREMITY, NAUSEA, and HEADACHE in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve prolapse and Anxiety disorder. Concurrent medical conditions included Blood pressure high and Chronic pain. Concomitant products included NORCO and CLONAZEPAM for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced TACHYCARDIA, PAIN IN EXTREMITY, NAUSEA, and HEADACHE. On 03-Apr-2021, PAIN IN EXTREMITY, NAUSEA, and HEADACHE had resolved. At the time of the report, TACHYCARDIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included blood pressure medication.  No treatment information was provided.
5:00pm 2/6 Sore arm and general malaise   10:00pm  Fever and muscle aches  2/8 Fever, pain at injection site, swelling of lymph node in armpit of injection, muscle ache, headache, tiredness   2/9  Fever, pain at injection site, swelling of lymph node in armpit of injection, muscle ache, headache, tiredness
Sore shoulder than progressed into a frozen shoulder. Suspect exacerbation of latent impingement syndrome. Exercises started, no resolution yet.
This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 13Nov2021 at 14:45 (at the age of 63-years-old) as 30 mcg/0.3 ml single dose for COVID-19 immunisation. Medical history included asthma, arthritis, heart murmur and known allergies to latex, sulfa drugs and seasonal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cannabidiol (CBD), gummies (MANUFACTURER UNKNOWN), cyanocobalamin (B12), probiotics (MANUFACTURER UNKNOWN), curcuma longa rhizome (TURMERIC), calcium (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date and unknown if ongoing. The patient received steroid shot (MANUFACTURER UNKNOWN) in the hip on 01Nov2021, within four weeks prior to the COVID-19 vaccine. On 14Nov2021 at 00:00, the patient experienced tired, chills, nausea, weak, (took shot in left arm) pain in right arm and slight wheezing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events tired, chills, nausea, weak, (took shot in left arm) pain in right arm and slight wheezing was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A report has been received from a Health Professional concerning a 16 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST started on 24-Dec-2013. It was reported that the patient had administration of expired dose which started on 24-Dec-2013. The outcome of the event of administration of expired dose is unknown. The report was considered to be non-serious.
This spontaneous report as received from a nurse practitioner refers to a 83 year old female patient. The patient's medical history included hypertension, GERD (Gastroesophageal reflux disease), glaucoma and hypothyroidism. Patient had no known allergies. In November 2013 the patient was vaccinated with ZOSTAVAX (at another unspecified site) (lot number not reported). Concomitant therapies included citalopram, aspirin, folic acid, DIOVAN, EVISTA, fish oil, levothyroxine sodium, vitamins (unspecified) (multivitamin OTC), PRILOSEC and vitamin D (unspecified). On 01-MAR-2014, the patient experienced Bell's Palsy (medically significant). No product quality complaints were involved. Treatment included prednisone and VALTREX. Lyme disease titer and CBC (complete blood count) were performed on an unknown date. The outcome of Bell's Palsy was reported as not recovered. Patient sought medical attention on 03-MAR-2014 by contacting office. The causality of the event was not reported. Additional information has been requested.
This literature marketed report as received from a other health professional refers to a pediatric patient of unknown age. the retrospective study objective was to develop a valid and reliable algorithm to identify ADRs (Adverse drug reactions) in the NICU (neonatal intensive care units). Algorithm development began with a 24-item questionnaire for data collection on 100 previously suspected Adverse Drug Reaction (ADR). Five pediatric pharmacologists independently rated cases as definite, probable, possible, and unlikely ADRs. On an unknown date, the patient was vaccinated with Hib (manufacturer unknown) and also pneumococcal vaccine (unspecified). No concomitant medications were reported. On an unknown date the patient experienced redness, swelling at injection site and redness, swelling at injection site. It was reported that in an adverse drug reactions by drug class for the cases from the neonatal intensive care units. The outcome of redness, swelling at injection site was unknown. The author considered redness, swelling at injection site to be related to Hib vaccine (manufacturer unknown). In conclusion the author stated that, the new algorithm was developed based on actual patient data using a novel mathematical approach. The resulting scoring system appeared to be significantly more valid and reliable compared with the Naranjo algorithm in an inborn NICU population. It was believed that with greater numbers of patients with varied demographics, diseases, and therapies, the validity and reliability of this ADR algorithm developed could be further improved. A similar approach could be used to develop and refine an algorithm for older pediatric patients. This retrospective study had demonstrated the advantage of using real patient data for the development of an ADR assessment algorithm and is an important first step toward eventually obtaining a valid and reliable ADR assessment algorithm for this very vulnerable population. The case is linked to 1306USA007154, 1306USA007153, 1306USA004473, 1306USA007336, 1306USA007337, 1306USA007338, 1306USA007339, 1306USA007340, 1306USA007341, 1306USA007342 via same reporter link. Additional information has been requested.
Pt developed a high fever of 106F X 3 days. Screamed and cried all day and all night long. She developed a rash 2 days later and then was fine. Gave Tylenol and cool bath.
Severe Back and Kidney Pain, Sweating, Chills, Tremors, Shaking.
Patient stated that she had multiple bloody noses in the days following her first Pfizer dose. Bloody noses are not typical for her. She did not require medical intervention for her bloody noses.
This spontaneous report as received from a physician refers to a patient of unknown and gender. Patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with VARIVAX (dose, frequency, route of administration and indication were not reported). Concomitant medications were not reported. On an unknown date, the patient developed a papular rash 3 days after administration of VARIVAX. The physician reported that the rash had no vesicles and the patient experienced no systemic reaction. The outcome of rash papular was unknown. Causality assessment was not reported. Additional information has been requested.
I had swelling on my left arm which is the side I had breast cancer on. I had a lumpectomy and multiple glands removed. The swelling went down to my elbow. It was very large and lasted about 3-4 days after vaccine. I saw the doctor because I was concerned about it being a blood clot, but we decided to let it just go away by itself and it eventually did. I had swelling on my second dose as well but nothing like this.
Pain in posterior legs unrelated to previous leg cramps and knee pain Pain in palmar area of both hands with decreased grip strength
Immunizations administered at 12:40pm, 12:45pm face red, hives noted on face. Benadryl administered. 2:40pm face no longer red, hives gone.
Pt recv vax on 11/18/98; on 11/30/98 pt exp red rash on body x 3 wk, scratchy throat
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-OCT-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 0.65ml, subcutaneously, lot # M013377, expiration date 27-MAY-2017 (also reported as 25-MAY-2017). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20 degrees Fahrenheit for 26 hours and -0.1 degrees Celsius for 70 hours. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
PATIENT STATED TODAY THAT SHE WANTED TO REPORT ADVERSE EVENT TO PHARMACY THAT HER COVID SHOT IN THE LEFT ARM WAS RED PAINFUL AND INFLAMMED AND HER RIGHT ARE WAS SAME REACTION JUST NOT AS SEVERE AS THE LEFT ARM. PT DID NOT CALL THE PHARMACY AND OR CALL HER DOCTOR AND THAT IT FINALLY HEALED UP AFTER ABOUT 3 WEEKS
fell out of bed; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient's daughter).  A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 30Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown.  After getting shot she fell out of bed and had to be hospitalized. Caller said had nothing to do with shot felt nursing home unsafe and moved to another home once released from hospital. New nursing home not scheduled to give 2nd shots until 28 days and wants to know if ok to wait that extra 8 days. Outcome was unknown. Information on the batch/lot number has been requested.
Sharp Chest Pain resulting in Death 2 hours later, 03/13/2021 @ 12:08
high fever, severe body aches (9 on the scale of 1-10) and crying.
This spontaneous report as received from a medical assistant refers to an adolescent male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-APR-2015, the patient who was 16 years old at that time, was vaccinated with his first dose of the GARDASIL series with GARDASIL 9, (dose, route of administratoin, injection site, lot number and expiration date were not reported). The medical assistant reported that on 29-JUL-2015, the patient was administered the second dose of the series with GARDASIL, (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse effects were reported. The outcome of the event of interchange of vaccine products was unknown at the time of the report. The relatedness between the event and suspect therapies was not reported. Additional information has been requested.
sense of smells vastly enhanced; pain at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of   in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Loss of smell in 2019, Hearing loss in 2019 and Taste loss in 2019.    On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications used were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of December-2021, January-2022, and February-2022. They were filling out a temperature excursion assessment with the State currently. Also reported that no adverse reactions were experienced by any patients.
Myalgia, Arthralgia, tiredness Narrative:  plans to call PCP regarding pain
we got fell and me and my mom both at emergency room so the vaccine didn't go through,; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (we got fell and me and my mom both at emergency room so the vaccine didn't go through,) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (we got fell and me and my mom both at emergency room so the vaccine didn't go through,). On 24-May-2021, PRODUCT DOSE OMISSION ISSUE (we got fell and me and my mom both at emergency room so the vaccine didn't go through,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  Company comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (we got fell and me and my mom both at emergency room so the vaccine didn't go through,) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (we got fell and me and my mom both at emergency room so the vaccine didn't go through,). On 24-May-2021, PRODUCT DOSE OMISSION ISSUE (we got fell and me and my mom both at emergency room so the vaccine didn't go through,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  Company comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Myalgia, SkinRash, Rash, chills Narrative:  Employee reports body aches and chills which begin the night after receiving the second dose of the vaccine. He also notes a rash on his left leg. He states he also had a reaction after the 1st dose, where he developed a rash that has not fully resolved, though that was on his torso. Now the rash is on his leg as well. Reports is taking ibuprofen (unknown dose/duration/frequency). Reports has recovered from physical symptoms of chills and body aches. Did see PCP for symptoms.
16 year old got the Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the Moderna Covid-19 vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the Moderna Covid-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment drug details was reported.
Pt came in for a flu shot Flucelvax and instead received a second updated Covid booster. Pt woke with fever 102. Dr was contacted and stated pt could take ibuprofen or acetaminophen and to seek her primary dr at school if needed any further care.
Information has been received from a consumer referring to her 87 years old mother with asthma. The patient's drug reactions/allergies and concomitant therapy were not reported. On approximately 13-OCT-2016 (reported as about 11 days ago), the patient received PNEUMOVAX 23 injection (lot #, expiration date, dose and route were unknown). Within a few hours of the administration, the patient developed itching around injection site. There was no swelling or redness around injection site, but it felt like that itching was from inside out. It was also little bit sore around injection site. The patient had been scratching the itchy area a lot and some bleeding of skin occurred. The patient had called physician. Unspecified treatment was given for the events. The outcome of the events was reported as not recovered. The causality assessment was not reported. Additional information is not expected as there is no consent for follow up.
vaccine end up going down the patient arm, not sure how much dose the patient received; syringe needle was not screwed away; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (vaccine end up going down the patient arm, not sure how much dose the patient received) and DEVICE CONNECTION ISSUE (syringe needle was not screwed away) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19  Vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced UNDERDOSE (vaccine end up going down the patient arm, not sure how much dose the patient received) and DEVICE CONNECTION ISSUE (syringe needle was not screwed away). On 01-Jun-2021, UNDERDOSE (vaccine end up going down the patient arm, not sure how much dose the patient received) and DEVICE CONNECTION ISSUE (syringe needle was not screwed away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up information received on 30-JUN-2021 and does not contain No New Information.
Moderna COVID-19 Vaccine EUA  Event Symptoms: Red rash on arms, chest, neck, and trunk (viral in appearance) in addition to headache, muscle pain, fatigue, and injection site pain  Outcome: resolved on its own  Time Course: rash started to fade 48 hours after it was noticed, but skin itched for an additional 48 hours  Treatment: None
This case was reported by a consumer vial call center representative and described the occurrence of dizziness in a 71-year-old male patient who received Flu Seasonal QIV Dresden. The patient's past medical history included concussion (the patient suffered 13 years ago and this caused him to lose his sense of smell). On 7th September 2016, the patient received Influenza vaccine QUADRIVALENT. In September 2016, less than a day after receiving Influenza vaccine QUADRIVALENT, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown. It was unknown if the reporter considered the dizziness to be related to Influenza vaccine QUADRIVALENT. Additional details were provided as follows: The exact age at vaccination was not reported. The reporter's spouse go the 4 way flu shot at his primary care provider the day before reporting. On the date of reporting (less that 24 hours after vaccination), the patient had symptoms of acute dizziness. The patient felt that , the room was spin when he stood up. The patient never had the symptom before.
Mother called in 12/19/07 and stated that her son has developed red spots on his back and belly. States they are "hand" size. Unclear as to how long after shots baby developed the "red spots." Advised to seek emergency care since baby has no PCP.