chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe cold/flu symptoms including stiff/sore joints, sore throat, migraine, and lost appetite
patient reported that she had a red circular spot that was a little bigger than a size of a quarter at; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (patient reported that she had a red circular spot that was a little bigger than a size of a quarter at) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (patient reported that she had a red circular spot that was a little bigger than a size of a quarter at). At the time of the report, VACCINATION SITE ERYTHEMA (patient reported that she had a red circular spot that was a little bigger than a size of a quarter at) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
didn't receive the 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (didn't receive the 2nd 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.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (didn't receive the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (didn't receive the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
My period is not due for 2 more days and I am having heavy bleeding with visible blood clots from my vagina.  I do NOT have blood clots in a typical menstrual cycle.  I noticed the bleeding when I woke up this morning and it is still going.
SORE ARM; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
no adverse event; on 19/02/2020, the patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported.  On 17-OCT-2019, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). On 19-FEB-2020, the patient received subsequent dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) lot # 1660112 and expiry date 18-OCT-2020, 1 dosage form for prophylaxis (strength, anatomical location, route not reported). No additional adverse events reported. Doses of suspect vaccines experienced multiple temperature excursions below 2 degrees Celsius (°C) (1.28C) for 2 hours and 30 minutes. It was reported that there was no previous temperature excursion. Data logger was involved. No product quality compliant was involved in the report.
pt recvd vax 12NOV93 & lab eval revealed an elevated SGOT level; no further details were provided;
Narrative: Patient came to facility to wound care. While being seen would care provider, patient stated he was feeling chills and feverish (temp yesterday = 101). Pt was sent to ER for triage. Pt was COVID positive and admitted to hospital 6/14/2022.
Next morning, bruising (1.5 inches long) on one side of injection site; This is a spontaneous report from a contactable consumer. A 71-years-old female 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 Arm Left on 06Feb2021 16:00 as single dose for covid-19 immunisation. Medical history included none. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]), vitamin d nos (VITAMIN D NOS), ascorbic acid (VIT C) from unspecified date to unspecified date for unknown indication. On 07Feb2021 08:00, The patient experienced next morning, bruising (1.5 inches long) on one side of injection site. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was recovering.   Information on the Lot/Batch Number has been requested.
SEVERE HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-JUL-2021, the subject experienced severe headaches. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headaches. This report was non-serious.
Pt received TRUMENBA vaccine at 10:00 AM approximately 11:00 AM pt complained of headache lasting several hours. Headache resolved with in 24 hours.
Within minutes of DTaP & IPV injections he developed an anaphylactic reactions with coughing/ wheezing/ stridor, hives, swollen lips and swollen palms of hands. Treated with BENEDRYL, EPINEPHRINE, ALBUTEROL, PREDNISONE. Improved. Observed over night at hospital.
Fever, not felt well.  Temp elevated each hour.  Went to urgent care.  9-18-2021  Admitted to hospital,  Perforated appendix, appendectomy   09-18-2021
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 18-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K016425, expiration date 26-MAR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Pt recv vax on 8/11/98; on same day pt exp left shoulder pain, stiff muscles in neck & shoulders, neck pain, vertigo;Annual follow-up dated 10/4/00 states that the pt now suffers from severe body pains throughout entire body. She has been diagnosed with fibromyalgia.
HIVES, COULD NOT BREATHE, BLOOD SHOT EYES. TREATMENT- TOOK VITALS, GAVE IV (1 LITER), WAS ON OXYGEN FOR ABOUT 40 MINUTES, BENADRYL SHOT 50MG AROUND 12:45PM
wrong dose for age; wrong dose for age; This non-serious case was reported by a other health professional via sales rep and described the occurrence of overdose in a 19-year-old patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received Engerix B adult 20 ug. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: wrong dose for age) and inappropriate age at vaccine administration (Verbatim: wrong dose for age). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 18-JUL-2023 A 19-year-old patient received Engerix B Adult 20 mcg which was not indicated until w-years, which led to overdose and inappropriate age at vaccine administration. The reporter consented to follow up.
Information has been received from a licensed practical nurse concerning a 50 year old white female with chronic obstructive pulmonary disease, obstructive sleep apnea, mitral valve disorder, cardiomegaly, depression, tobacco addiction, sulfa allergy, amoxicillin allergy, and cefazolin sodium allergy, who on 2/14/05 at 13:30 was vaccinated IM into the right deltoid with a 0.5ml first dose of pneumococcal 23v polysaccharide vaccine (lot # 649912/0529P). Illnesses at the time of vaccination were acute sinusitis, impacted cerumen, and pain in thoracic spine. Concomitant therapy included an IM dose into the left deltoid of influenza virus whole virion 3v vaccine inactivated (batch # U1500AA), azithromycin, pantoprazole sodium, sertraline HCl, estradiol, lisinopril, calcium, levofloxacin, acetaminophen/hydrocodone bitartrate, aspirin/butalbital/caffeine, and Sitrex. On 2/15/05, the patient was seen in the doctor's office with redness, swelling, and pain at the pneumococcal 23v polysaccharide vaccine injection site (right upper arm). She was treated with diphenhydramine hydrochloride, ice packs, and elevation of her arm. The patient's outcome was unknown. No product quality complaint was involved. The LPN considered the patient's adverse experiences to be other important medical events (OMIC). Additional information has been requested.
I usually don't get periods regularly and when I do they are light and short. I experienced a VERY Very heavy and painful period that lasted for 5 days and I would bleed through a pad in less than an hour. The pain was immense. I also had bad brain fog and couldn't think clearly, as if I was using pain medicine for the day of and day after.
had some kidney stones removed; heart rate increased significantly; body pain; joint pain; sore arm; blood pressure increased significantly; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (had some kidney stones removed) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (sore arm), MYALGIA (body pain) and ARTHRALGIA (joint pain). In May 2021, the patient experienced HEART RATE INCREASED (heart rate increased significantly). In 2021, the patient experienced HYPERTENSION (blood pressure increased significantly). On an unknown date, the patient experienced NEPHROLITHIASIS (had some kidney stones removed) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and PARACETAMOL (MINAMOL) at an unspecified dose and frequency. At the time of the report, NEPHROLITHIASIS (had some kidney stones removed), HYPERTENSION (blood pressure increased significantly), PAIN IN EXTREMITY (sore arm), HEART RATE INCREASED (heart rate increased significantly), MYALGIA (body pain) and ARTHRALGIA (joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood pressure measurement: increased (High) increased. In May 2021, Heart rate: increased (High) increased. In June 2021, Blood pressure measurement: increased (High) increased. In June 2021, Heart rate: increased (High) increased.         The patient reported that, they are a high risk patient..  The Patient 1 stated that on 01Nov2021 they will be going to the hospital for a  procedure on their kidneys.  No concomitant medications were provided by the reporter.  Company Comment: This case concerns a 61-year-old, male patient with no relevant medical history, who experienced the serious unexpected event of Nephrolithiasis. The event occurred after unspecified time after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the event occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-055014 (Patient Link).; Sender's Comments: This case concerns a 61-year-old, male patient with no relevant medical history, who experienced the serious unexpected event of Nephrolithiasis. The event occurred after unspecified time after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the event occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Had seizure 24 hours after shots received seen at local hospital, transferred to another hospital. Had two more seizures on next consecutive days, non since.
Father came back to clinic 5 -10 min after leaving and said not breathing. Said child had seizure. Father carried child. Child alert. No seizure activity or incontinence. However didn't recall what had happened. 911 call pt transported to ER. Sent home from ER, but had anther seizure in AM and was sent back to ER.
Tachycardia Narrative: mild elevated heart rate 110-> 100-> 92, resolved after 20 minutes, employee went home. NOrmal HR for emp. is in 80s.
This spontaneous report was received on 27-APR-2017 from a nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. The nurse reported that several doses of improperly stored vaccines were administered to unspecified patients on unspecified dates. No adverse effects were reported. The vaccines were VAQTA (Lot number M039202, expiration date 11-MAR-2018), PEDVAXHIB (Lot number M036056, expiration date 18-MAY-2019), and GARDASIL 9 (Lot number M037770, expiration date 01-JUN-2019). The vaccines dose, site of administration and route of administration were not reported. These three vaccines were exposed to the following temperature of 32 degrees Fahrenheit (F) to 35 degrees Fahrenheit (lowest temperature was 35 degrees Fahrenheit) for a time frame of 72 hours. The call was not due to a data logger. There were no previous temperature excursions. No additional information available at the time of the report. Additional information has been requested.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patiuent was unresponsive for couple of seconds after 1st shot
(Vaccine record says vaccine administered in right arm, but on exam patient has findings on left arm and states that is where vaccine was given) Patient received vaccine at outside clinic on 1/8. She was seen today in my clinic on 1/19 with a four day history of increasing redness of left arm at vaccine site. No improvement with Benadryl.  On exam with large warm patch of skin, well-circumscribed, consistent with either cellulitis or delayed vaccine reaction.
Information was received on 28-JUN-2017 from a physician via a company representative regarding a 60 year old female. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in MAY 2017, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, site of administration and lot number not reported). The physician saw the patient last Friday (23-JUN-2017) and she still had pain at the injection site. No further information was available. The outcome of the event was not recovered at the time of this report.  The causal relationship between the event and the vaccination with ZOSTAVAX was not provided. Additional information has been requested.
U07.1 - COVID-19, E87.1 - Hypo-osmolality and hyponatremia
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with GARDASIL lot # K006124 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well/ There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported to pharmacist on duty she had a localized, red bump approximately 2 inches in diameter.  Took Benadryl.
This spontaneous report as received from a Licensed Practical nurse refers to a patient of unknown age and gender. On an unspecified date, the patient was vaccinated with GARDASIL (lot number, expiry date, route and dose were not reported) that was exposed to 25 degree  Fahrenheit for an unknown period of time. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter (MARRS#1212USA000913, 1212USA000914, 1212USA003709, 1212USA003710, 1212USA003711, 1212USA003712, 1212USA003713, 1212USA003714). Additional information has been requested.
On 10/7/09 patient received her flu vaccine. On 10/9/09 patient c/o not feeling well - nauseous, fever sweating profusely and then blacked out. Taken to ER via ambulance. Treated and released. Patient under stress @ time vaccine received/reaction after many attempts Patient spoken to on 10/23/2009.
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 1:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 1:55 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 74.29   Concomitant products were not provided.  On 03-Nov-2021 Excursion time was reported at 10:00 A.M with  temperature as 35 degrees Fahrenheit, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-May-2021 , vial was moved to clinic on 03-Nov-2021. 6 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021.  Vial was stored on cooler 1, on 03-Nov--2021, Excursion duration At 8 AM: 36, 9 AM: 36, 10 AM: 36, 11 AM: 35, 12 AM: 36, 1PM: 37, 2 PM : 36, 3 PM: 36, 4 PM: 37 and 5 PM : 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Got an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Got an expired dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Got an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Got an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment details were provided.
arm soreness; lethargy; achiness; This case was reported by a consumer and described the occurrence of pain in arm in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 16th September 2020 and experienced sore arm and crampning in arm. For the tolerance of 1st dose, refer linked case US2021000471).   On 16th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix, the patient experienced lethargy and pain. On 16th December 2020, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, lethargy and pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, lethargy and pain to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose in left deltoid. After receiving Shingrix, the patient experienced arm soreness, lethargy, and achiness. Soreness began the same day as receiving the second dose and the lethargy and achiness began over the next 2 days.  The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021000471:1st dose
Screaming tantrum (we haven't seen anything like this since she was 3) with crying for over 45 minutes  plus low-grade fever (99.4). Today (one day after first tantrum & day 4 after vaccination), we've had two screaming tantrums in the same day - no fever.
Reporting medical error. PHN administered typhoid-IM instead. Medical error was not discovered until after vaccine had been administered. Mom was notified over the phone. Sanofi Pasteur was called regarding safety in children under 2 years old. Per medical staff, typhimVi is not approved for children under 2 due to poor immunogenic response. Per medical staff, adverse events from clinical trials (including children 1-12 years old) showed no severe or unusual side effects. Mom was given safety information and what the typical side effects are. Primary care provider was also notified of mistake in case family had to call their medical provider regarding the medical error. VERP report was submitted.