chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever developed the same day shots were given. Then blister formed on arm and popped, which drained clear fluid. Area is red, swollen, and warm to the touch. Pt is also irritable. Mom doesn't measure fever, just gives ibuprofen & TYLENOL when pt feels warm. Treat with BENADRYL, hot packs and cephalexin 250mg/5mL to 5 mL PO every 8 hrs x 10 days.
Nosebleed on 4/14/2021 (this was the first nosebleed that he has ever experienced. He was cutting onions at the time of the nosebleed). So far no additional treatment has occurred, but I plan to call a healthcare professional today and will likely schedule a visit.
Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2015, at approximately 66 years of age, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. Additional information has been requested.
The patient received the vaccine at approximately 1:30. They were observed for the standard 15 minute wait time at which time they complained of some mild numbness to their arm. The patient felt well enough to return to work after the 15 minute observation time. They returned approximately 20 to 30 minutes later complaining of more numbness and some dizziness. She (the patient) was told to continue to monitor symptoms and alert anyone of worsening side effects or symptoms. The patient returned to the room again and was now complaining of nausea. She was offered Benadryl but patient refused stating " I cant have Benadryl" after multiple times of the pharmacist(s)  offering Benadryl. Patient stated they sometimes take Claritin so they were instructed to take it and lie down in an area where staff could monitor her. At about 3:30 another staff member came into the vaccination room and alerted the pharmacist they were having a hard time keeping to patient awake.  Upon arrival at the patient's side they were coughing and seemed to be in a state of drowsiness. They were linked to a vitals monitor by the staff. BP: 170/110 O2: 96-100% HR between 80 and 90.  Approximately 2 minutes after arrival at patient's side 911 was called. Pharmacist retrieved the Epi-Pen and was on standby if administration was needed.  The patient was moved to a chair and vomited multiple times over the course of a few minutes. The Patient was able to vocalize and stated they felt "aweful" and has some difficulty swallowing, and when asked if they were short of breath they stated "a little." Over the next 5 minutes (approx.) the patient's BP went down to 152/90'S and O2 saturation was holding at 97-100%. Epinephrine was not administered during this time as patient was breathing and did not appear to have hives. Emergency medical services arrived about 5 minutes but within 10 minutes after the call was placed. EMS then took over care  for the patient. EMS was told of condition and that epinephrine was not administered at this time. After patient assessment by EMS they also declined to use epinephrine. At around 3:40 the patient was transferred to a transport bed and was taken away by ambulance.
Received pfizer on 7/7/21 and 7/28. Presented to ER on 1/18/22 and found to be COVID positive. She presented to the emergency department on the  date of admission secondary to chest pain, described in the associated H and  P.  She was found to have an elevated troponin consistent with  non-ST-elevation MI.  Cardiology was consulted.  Workup also was positive for  DVT and pulmonary embolism. She was positive for COVID-19-19, but  basically asymptomatic, was isolated and quarantined as per protocol. Discharged on 1/22/22
12 YO was given Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 3rd March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th October 2022, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 19th October 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 16-Nov-2022 Reporter's comment: The health manager called to ask information on how to proceed after administration of Infanrix to two patients who were given their first dose at an inappropriate age. The vaccine administration facility was the same as primary reporter. The health care professional asked for follow-up from safety via email. The reporter consented to follow-up. This case was for 2 of 2 linked patients, reported by same reporter. Additional supportive information: The patient received a dose of Infanrix at inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2022170377:Same reporter
patient had apparent partial complex seizure 2 days after immunization and a second episode 7 days after immunization.  CT scan and EEG both normal.
Ten minutes after vaccine was injected pt started having elevated heart rate and mild flushing.. She was sent to the emergency department for clinical evaluation and further observation. She refused medication while at the vaccination site.
Have had 3 shingles shots; Diagnosed September 5. Have had 3 shots; Diagnosed September 5; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On 5th September 2021, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had 3 shingles shots which led to extra dose administered. The patient was diagnosed with shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 10-APR-2014, the patient was vaccinated with an expired dose of VARIVAX (Merck) injection (lot # H006952, expiration date 16-MAR-2014, route not reported). No adverse effects was reported. Additional information has been requested.
Patient received an expired QUADRACEL with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Care Professional via Medical Information (Reference number- 00730061) and transmitted to Sanofi on 18-Aug-2021.  This case involves a patient with unknown demography who received a dose of expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 16-Aug-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number was not reported and expiry date: 13-Aug-2021) via unknown route at an unknown administration site for prophylactic vaccination (expired product administered).  It was reported that "Medical assistant supervisor asked if patient should be revaccinated or is there a grace period. Medical assistant supervisor does not have the patient's information on hand. She agreed to call us back if she has obtained the patient's information."  It was a case of actual medication error due to expired vaccine used (latency: same day).   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.  There will be no information on the batch number for this case.
Generalized urticaria 3 minutes after vaccine. Treated with Benadryl 125mg/ml, Decadron 4mg/ml. Rx: Predisone 3ml every 12 hours. Zyrtec 2.5ml QD.
Waking up the next morning after my first dose, every muscle and bone in my body has the same pain I had on the injection site/ whole body muscle soreness; Waking up the next morning after my first dose, every muscle and bone in my body has the same pain I had on the injection site/ Achey joints and bone; Waking up the next morning after my first dose, every muscle and bone in my body has the same pain I had on the injection site.; I also have an intense headache,; Achey joint; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the right arm on 26May2021 at 10:00 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included iron deficiency anemia, plantar fasciitis, COVID-19, allergy to animal (cat), pollen allergy and spice (cinnamon). Concomitant medications were not reported. The patient previously received ciprofloxacin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was 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 27May2021, after waking up the next morning after the first dose the patient's every muscle and bone in the body had the same pain which she had on the injection site. The patient also had an intense headache, whole body muscle soreness, achy joints and bones and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events every muscle and bone in her body had the same pain which she had on the injection site, intense headache, whole body muscle soreness, achy joints and bones and nausea were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
chills; tiredness; temperature was 100.8; sore arm with redness; sore arm with redness; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left arm on 12Jan2021 at a single dose for covid-19 immunisation. Medical history included covid-19 in Apr2020. There were no concomitant medications. On 13Jan2021, the patient experienced chills and tiredness and at the end of the day, her temperature was 100.8. The patient also experienced sore arm with redness in Jan2021. The patient stated that every once in a while, she get a shot and get a sore arm. She added that she noticed that her arm was more sore with redness that morning of reporting. The outcome of events chills, tiredness and temperature was 100.8 recovered on 14Jan2021, event sore arm with redness was not recovered.  Information on the lot/batch number has been requested.
COVID-19 TEST POSITIVE; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included guselkumab.  On an unspecified date, the patient experienced covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This case, involving the same patient is linked to 20210844246. This case was associated with product quality complaint: 90000191182; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
fever; chill; tiredness; mild nausea; stomach pain; loss of appetite; feel like hit by train; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chill), FATIGUE (tiredness), NAUSEA (mild nausea) and ABDOMINAL PAIN UPPER (stomach pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (chill), FATIGUE (tiredness), NAUSEA (mild nausea), ABDOMINAL PAIN UPPER (stomach pain), DECREASED APPETITE (loss of appetite) and PAIN (feel like hit by train). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (chill), FATIGUE (tiredness), NAUSEA (mild nausea), ABDOMINAL PAIN UPPER (stomach pain), DECREASED APPETITE (loss of appetite) and PAIN (feel like hit by train) outcome was unknown.        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.
Information has been received from a medical assistant concerning multiple unspecified patients of unknown ages and genders. The patient's pertinent medical history, concomitant therapies and concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of GARDASIL lot # K008621, expiration date 04-MAR-2017, (dosages and therapy routes were not provided), (unknown dosage, lot no. M013638 exp 19-NOV-2018; M017521 exp 12-OCT-2018). Concomitant therapies were not informed. No adverse effects were reported. Temperature: Minimum of 0.09 degrees C from 01-JUL-2016 through 02-OCT-2016. Time frame: multiple excursions from 01-JUL-2016 through 02-OCT-2016 (total time frame not determined at time of call). There was no a previous temperature excursion and it was not because of a data logger issue. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.
little upset stomach; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (little upset stomach), HEADACHE (headache) and FATIGUE (tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot# 022M20A and 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Historical condition not reported.).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (little upset stomach), HEADACHE (headache) and FATIGUE (tired). At the time of the report, ABDOMINAL DISCOMFORT (little upset stomach), HEADACHE (headache) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-073685 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073685:Dose 2
Yesterday injection site became swollen and sore with an itchy rash surrounding it. Same today and just took one Tylenol and one Advil to relieve inflammation and soreness.
Information has been received from a registered nurse concerning a female patient who in 2006 was vaccinated with her first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast).  Subsequently, she was vaccinated with her second dose of HPV rLi 6 11 16 18 VLP vaccine (yeast).  Subsequently, she developed a blister at the injection site. Medical attention was sought.  The patient's outcome was unknown.  Additional information has been requested. Follow-up informatin received 4-11-08, indicated that the patient was being treated with an unspecified vaccine, and not Gardasil as previously reported. Therefore, WAES #0609USA00390 is being deleted from our files on HPV rL1 6 11 16 8 VLP vaccine (yeast). This report was previously sent to PLA V501 on 09/14/06.
This spontaneous report as received from a 76 year old male consumer with no drug reactions or allergies refers to himself. In 2010(3 years ago) the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported). No concomitant medication was reported. The patient reported that he had developed the shingles twice since receiving ZOSTAVAX. The date that the patient experienced each case of the shingles was unspecified. The patient was currently taking valacyclovir hydrochloride 1 gram/ taken 3 times daily to treat his second occurrence of shingles which was still ongoing. None lab diagnostics studies was performed. The patient had sought medical attention. Additional information is not expected.
Positive PCR test 6 months after 2nd dose/ Tested positive for COVID disease 7 days ago; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive PCR test 6 months after 2nd dose/ Tested positive for COVID disease 7 days ago) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, the patient experienced COVID-19 (Positive PCR test 6 months after 2nd dose/ Tested positive for COVID disease 7 days ago). At the time of the report, COVID-19 (Positive PCR test 6 months after 2nd dose/ Tested positive for COVID disease 7 days ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: positive (Positive) PCR positive.         No concomitant drug details were reported. No treatment details were reported.  Patient stated that he never lost sense of taste or smell. Patient had mild COVID symptoms such as cough and being lethergic Patient received the booster dose on 03-Jan-2022 i.e. 7 days after testing positive for COVID-19.  Company comment :This is a spontaneous case concerning a 75-year-old, male patient with no medical history reported who was diagnosed with COVID-19 7 months after receiving the second dose of mRNA1273. Patient refers having mild symptoms. He confirmed receiving the booster dose on 03JAN2022 without any associated AEs. The benefit-risk relationship of mRNA-1273 in not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 75-year-old, male patient with no medical history reported who was diagnosed with COVID-19 7 months after receiving the second dose of mRNA1273. Patient refers having mild symptoms. He confirmed receiving the booster dose on 03JAN2022 without any associated AEs. The benefit-risk relationship of mRNA-1273 in not affected by this report.
Suspected vaccination failure/got shingles on face, 4 months after second shot; shingles on face; Rash; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine and less than 9 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shingles shots this year and got shingles on his/her face 4 months after his/her second shot. The patient went to the physician who put him/her on an anti viral. Less than 9 months after first and second shot, the patient had rash and it  went away after two days and the patient never in any pain or discomfort. The patient was happy that he/she took the vaccine. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.