chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 23-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six months old male patient who had received D-TAP/ IPOL diluent (lot number: 2030999) but not ACTHIB (lot number: C5456AA, expiry date: 18-Dec-2018), while he received a third dose of PENTACEL in left thigh on 22-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE and PREVNAR 13 for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was unknown if any adverse event was occurred. 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 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. Documents held by sender: none.
After Dose 1, fatigue for 12 hours after dose, 12 hours after Dose had fatigue & listlessness, 24 hours after dose had 101 fever and extreme fatigue that lasted another 24 hours.; After Dose 1, fatigue for 12 hours after dose, 12 hours after Dose had fatigue & listlessness, 24 hours after dose had 101 fever and extreme fatigue that lasted another 24 hours.; After Dose 1, fatigue for 12 hours after dose, 12 hours after Dose had fatigue & listlessness, 24 hours after dose had 101 fever and extreme fatigue that lasted another 24 hours.; After Dose 1, fatigue for 12 hours after dose, 12 hours after Dose had fatigue & listlessness, 24 hours after dose had 101 fever and extreme fatigue that lasted another 24 hours.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTRADIOL; PROGESTERONE. Past drug history included: Lovenox, reaction(s): "Known allergies: Lovenox", notes: Known allergies: Lovenox. The following information was reported: FATIGUE (non-serious), LISTLESS (non-serious), PYREXIA (non-serious), FATIGUE (non-serious) all with onset Oct2021, outcome "recovered" and all described as "After Dose 1, fatigue for 12 hours after dose, 12 hours after Dose had fatigue & listlessness, 24 hours after dose had 101 fever and extreme fatigue that lasted another 24 hours.". The events "after dose 1, fatigue for 12 hours after dose, 12 hours after dose had fatigue & listlessness, 24 hours after dose had 101 fever and extreme fatigue that lasted another 24 hours." required physician office visit. Therapeutic measures were not taken as a result of fatigue, listless, pyrexia,  fatigue.  Additional Information: No Other vaccine in four weeks. After Dose 1, fatigue for 12 hours after dose, 12 hours after Dose had fatigue & listlessness, 24 hours after dose had 101 fever and extreme fatigue that lasted another 24 hours. After Dose 3 had extreme fatigue, 101-102 degree fever for 3 days, muscle aches & extreme fatigue for 6 days including chest pain. CRP measure by doctor was elevated 3x normal.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Eye rolling, absence seizures, eye fluttering, stop in play 3.5 seconds during seizure. Seizures occurred in clusters lasting about 90 seconds each occurrence. Began 3 days post vaccination and even rash 3/18/18 stopped occurring 7 days post vaccination. No fever during this time period (not febrile seizure). Excessive sleeping and lethargy for 2 days. Was referred to neurology.
can not sleep; Bells Palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy) in a male 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. No Medical History information was reported.   In July 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced BELL'S PALSY (Bells Palsy) (seriousness criterion medically significant). On an unknown date, the patient experienced INSOMNIA (can not sleep). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and VALACICLOVIR for Adverse event, at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bells Palsy) and INSOMNIA (can not sleep) outcome was unknown.            No concomitant medications were reported. Patient was also treated with eye ointment, an eye patch at night to keep the eye shut, and some eye drops for daytime.  Reported that Patient went to the ER because they developed facial paralysis affecting the left side and wanted to rule out a stroke.   Reported that There patient were diagnosed with Bell's Palsy and can not eat and can not drink, can not smile, can not sleep, can not close their left eye.  Company comment: This case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected serious event and AESI of Bell's palsy. The event occurred approximately 2 months after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected serious event and AESI of Bell's palsy. The event occurred approximately 2 months after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Woke up at 2am achey, dizzy, headache, nausea, chills, tingling hands
This spontaneous report was received from a pharmacist reporting about her father who is a male patient of unknown age. The patient's pertinent medical history and concurrent condition was unspecified. On an unspecified date, the patient was vaccinated with either PNEUMOVAX 23 or PREVNAR dose 1 in the arm (not specified). Other suspect therapies included unspecified influenza virus vaccine (reported as Flu shot) taken on the same day on a different arm. It was not specified as to which vaccine was taken in which arm. After the administration of both the vaccine the patient's one of the arm (unspecified which arm and unspecified which vaccine) began to swell, he could not lift his arm and developed pain in one arm. The patient went to the emergency room (ER) and was there for 36 hours. The patient received unspecified treatment at ER. The outcome of events and causality assessment was not reported. No further information was provided. The events were considered serious since the patient required to be in emergency room for 36 hours (considered as hospitalization). Additional information has been requested.
rash all over her body; pain at the injection site; rash mostly around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over her body), VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE RASH (rash mostly around the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced RASH (rash all over her body), VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE RASH (rash mostly around the injection site). At the time of the report, RASH (rash all over her body) and VACCINATION SITE RASH (rash mostly around the injection site) had not resolved and VACCINATION SITE PAIN (pain at the injection site) had resolved.            Concomitant included allergy medications Treatment information was not provided.
This case was reported by a healthcare professional and described the occurrence of erythema in a female subject of unspecified age who was vaccinated with TWINRIX adult (GlaxoSmithKline). Concurrent medical conditions included allergies. Previous and/or concurrent vaccination included poliomyelitis vaccine, unspecified; manufacturer unspecified; unknown; unknown given on 2 September 2010; BOOSTRIX; GlaxoSmithKline; unknown; unknown given on 2 September 2010; typhoid vaccine (non-gsk); manufacturer unspecified; unknown; unknown given on 2 September 2010. On 2 September 2010 the subject received 1st dose of TWINRIX adult (unknown). On 10 September 2010, 8 days after vaccination with TWINRIX adult, the subject experienced erythema and itching inside. The subject described the itching as sensation of itching inside from head to toe and was red. The subject took BENADRYL and went to bed. By the next day on 11 September 2010, the effects were gone. The nurse stated she could not make the determination if the other vaccines the subject received the same day were also suspect. On 11 September 2010, the erythema and itching were resolved. The nurse reported additional cases see A0882391A, A0882437A and previously reported A0797402A.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative, notes: Tested negative at Day 9; (Jul2022) Positive, notes: tested positive again at Day 15. Therapeutic measures were taken as a result of covid-19, drug ineffective. No known allergies reported for the patient.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information , there is reasonable possibility of causal association between the events Drug Ineffective , COVID 19 and the suspect drug BNT162b2.
erythematous papular rash arms/back/legs/face 1 1/2wk p/inj;
within half hr of vax pt exp dizziness, tingling lips, weakness in upper body & nausea.
This spontaneous report received from a consumer (patient's mother) via social media regarding her son of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with unspecified HPV Vaccine (manufacturer unknown), (dose, route, lot# not reported) for prophylaxis. On an unknown date, the patient died. She reported that her son died after vaccination. No PQC has been filed. Causality assessment was not provided. Upon internal review the event of death was determined to be medically significant. Additional information is expected.
Patient presents to  health care clinic for COVID Pfizer booster reaction.  Received booster on 10/18/2021.    Reports she made an appointment on employee health website.  States she received the booster without knowing it was too early.  States she received Dose 1 on July 7, 2021, and dose 2 on July 18, 2021.    Patient  states since receiving the booster she has had severe headaches that come and go, throat burning constantly, light headedness when ambulating, loss of appetite with nausea constantly, chest pressure that comes and goes.  Reports she gets lightheaded when standing for a long period of time.  Patient states she ?gets winded when ambulating for a long time.?  Patient states her boss told you her she received the booster too early.  Patient  states due to continuing to have these symptoms she came to employee health for evaluation.
Have had chronic diarrhea since first injection. Worsened after second injection. Has not resolved.
Left armpit swelling. Swollen lymph node in armpit on left side. Pain in left armpit
This spontaneous report was received from a healthcare worker (medical assistant) refers to an unknown number of patients of unknown age and gender. The healthcare worker reported that (Merck) VARIVAX that had been transported for the past six months to a sister clinic that was about 15 minutes down the road. The healthcare worker was unable to provide the temperature that the VARIVAX were exposed to or exact time frame. Two boxes of (Merck) VARIVAX were transported an unspecified amount of times. She was able to report the lot # and expiration date for one of the (Merck) VARIVAX which was H011417 and expiration: 07-JUN-2014. She reported that the (Merck) VARIVAX had been administered but she was unable to provide the dates of administration for the vaccine. She did not have patient details or the amount of patients that the (Merck) VARIVAX were administered too at the time of the call. She did not have physician demographics at the time of the call either. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Injection site pain with redness and swelling and heat from the shoulder to the elbow of the arm that received the injection.
Developed swelling and redness in left thigh at injection site day after injection. Since then, increased redness and pruritus.
TDap, MMR, and Varicella ordered. TDap, Proquad, and Varicella given. The error was discovered after the patient and his mother left so we are unaware of any adverse reactions but we know he got those vaccines and we are reporting that fact in this submission.  Tried to notify family x5 but cannot reach them on phone number provided. We will discuss when they present for follow up on 8/18/2023.
Chest discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) reported in response to the Non-HCP letter sent in cross referenced case. The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 08:30 (Lot number: ERC208) at the age of 72 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHEST DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "Chest discomfort". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient age at time of vaccination was 72 years. Patient Medical History (including any illness at time of vaccination) was reported as None. Patient concomitant medications were reported as None. Vaccination Facility Type was reported as Hospital. Vaccine was not administered at a Facility. Patient did not receive any other vaccination within 4 weeks of vaccination. Chest discomfort in Mar2021 and Apr2021. On Blood Thinner now (as reported). On 05Apr2021 08:30 (the day of second vaccination), the patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ERB732) via an unspecified route of administration in left arm as dose 2, single for COVID-19 immunisation. Relevant Tests included CAT Scan on 08Jun2021 with result as 2 Blood clots in Lung.   No follow-up attempts are possible. No further information is expected.  Follow-up (20Oct2021): Follow-up attempts are completed. No further information is expected.
Day after vaccine, I experienced body aches and chills followed by clammy skin and sweating; took 440mg of naproxen and 1000mg of acetaminophen at onset of symptoms, symptoms subsided within four hours.
Swelling  of  face,  took  benadryl.  2nd  day and still have  some  swelling of face.
Information has been received from a registered nurse concerning a 19 month old female patient with a runny nose and congestion at the time of vaccination who on 4/19/99 was vaccinated with a first dose of varicella virus vaccine live SC in the right arm. Concomitant vaccinations that same day included a first dosae of MMR virus vaccine live SC in the left arm and tuberculin
Erythromelalgia in toes worst ever ongoing flare since the first vaccine dose; EM presents in my toes so seems related to COVID toes; Erythromelalgia in toes worst ever ongoing flare since the first vaccine dose; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on 27Mar2021(at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included erythromelalgia and was ongoing. The patient did not have any allergies to food, medications, or other products. 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 COVID vaccine. Concomitant medications were not reported. On 01Apr2021, the patient experienced " have had erythromelalgia for a few years and have had the worst ever ongoing flare since the first vaccine dose". EM presents in the toes so seems to related to "COVID toes". The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events " have had erythromelalgia for a few years and have had the worst ever ongoing flare since the first vaccine dose". EM presents in the toes so seems to related to "COVID toes" were not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9 (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine were exposed to temperature of 4 Centigrade degrees for a time frame of 2 hours and 55 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA003984: US-009507513-1704USA012143: US-009507513-1704USA012141: US-009507513-1704USA012142.
This case was reported by a healthcare professional and described the occurrence of serum sickness in a 3-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  Concurrent medications included multivitamins.  On 30 January 2008 at 15:00 the subject received 1st dose of Engerix B at 0.5 ml in the left thigh.  On 7 February 2008, 8 days after vaccination with Engerix B, the subject experienced serum sickness (systemic reaction).  The healthcare professional considered the events were disabling.  At the time of reporting the events were improved.
herpes simplex every 6 weeks; This case was reported by a consumer via interactive digital media and described the occurrence of herpes simplex 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced herpes simplex. On an unknown date, the outcome of the herpes simplex was not recovered/not resolved.   It was unknown if the reporter considered the herpes simplex to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the 2 shingles shot and stated that he/she still gets herpes simplex on his/her lower back every 6 weeks and wanted to know if he/she should get another shot. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
1st day very sore left arm applied ice and took tylenol. Pain started radiating up my neck and had shooting pain in my shoulder down to my shoulder blade. No one could even touch my arm it hurt so much. 2nd day- Soreness increased around my shoulder joint up my neck and down my shoulder blade. My injection site was still very sore.  Felt like I was in a car accident not given a safe shot. 3rd day- Injection site soreness started to calm down.  Pain increased around my shoulder joint, up my neck and down my shoulder blade. 4th day until now- it hasn't changed, I have to ice my arm several times a day, complete stretches/physical therapy. My doctor increased my celebrex from 200 mb twice a day to 400 mg twice a day.
Erythema area, 75cm x 64cm in (R) deltoid area (24 hr. in duration) Rx: cool compresses & Ibuprofen.
Red, swollen, itchy splotch around vaccination site. About 2 inches in diameter, less than 1 inch raised.
a dose of Adacel was inadvertently administered to a six year old patient/ No AE; Initial information was received on 17-Mar-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a six years old female patient who on 11-Mar-2020 inadvertently received a 0.5 mL dose one of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6638AA and expiry date 12-Apr-2022) via intramuscular route in the left deltoid for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.     It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of reporting no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.