chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menveo non-approved diluent/sterile water was used to reconstitute Menveo; Menveo non-approved diluent/sterile water was used to reconstitute Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo non-approved diluent/sterile water was used to reconstitute Menveo) and inappropriate dose of vaccine administered (Verbatim: Menveo non-approved diluent/sterile water was used to reconstitute Menveo). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-JUN-2023 The healthcare professional declined providing any information about the patient and vaccine. No consent to follow up because healthcare professional declined information to be stored and requested to be anonymous. The reporter did not consent to follow-up. The reporter reported that sterile water was used to reconstitute Menveo and it was administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Case number PHEH2014US015752, is an initial spontaneous report received from a nurse on 06 Aug 2014, with the follow-up received from a physician on 12 Sep 2014. This report refers to a 13-year-old male patient. Past medical history and concomitant medication were not provided. The patient received only Men CWY-135 liquid conjugate component of MENVEO (batch number: M13051) intramuscularly on 01 Aug 2014. Upon the follow-up, it was reported that, the patient did not receive the entire vaccine and no adverse events were reported following this medication error (inappropriate preparation of medication). Follow-up received from a physician on 12 Sep 2014: Updated reporter comments.
Hot, red, hard below injection site. 8? across & 4? vertical. Fatigue. Chills on day two, with tender skin all day.
tiredness,headache,joint pain, nausea, during 12 - 24 hrs after booster shot.   Just bed rest, plenty of water
I have been getting dizzy spells daily since getting the vaccine. I feel like I am going to fall down sometimes. I have no prior hx of dizziness.; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8734) via an unspecified route of administration in the left arm on 07Apr2021 at 16:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any medication within two weeks of vaccination. The patient previously took metoclopramide (REGLAN) and experienced drug allergy. The patient previously took ciprofloxacin (CIPRO) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. From 07Apr2021 at 19:30, the patient had been getting dizzy spells daily since getting the vaccine. The patient felt like she was going to fall down sometimes. The patient has had no prior history of dizziness. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event had been getting dizzy spells daily since getting the vaccine, felt like she was going to fall down sometimes was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Immense shoulder pain becoming a frozen shoulder. Deep depression suicidal thoughts.  A major flare up of diverticulitis. Had surgery in 2004 with very little problems since. After vaccination had 6 serious flare ups in 12 months.  Now will need surgery.  PSA jumped to 6.8
Full rash on upper arm. Large, somewhat circular, blotchy.  Lasted approximately 5 days.
My daughter tested positive on December 7th, 2022.  The first part of week we were in close proximity.  I then started having symptoms on the December 17th, 2022.  I had a sore throat and minor body aches.  On December 19th, 2022 my throat was really scratchy and fatigued and I tested positive on December 19, 2022. I lost a little taste and smell.  My doctor prescribed Proxlovid on December 20th, 2022.  I had a runny nose that lasted a few days.  I had a slight fever the night of December 19th, 2022.  My temperature was 99.3 degrees.
Extreme soreness at site and up and left down arm, chills and fever, muscle soreness entire body, headache, fatigue. Symptoms began within several hours of vaccine administration. Shingles vaccine was given in the left arm, flu vaccine in right arm. Shingles vaccine symptoms, except for soreness, lasted around 18 hours. Soreness lasted for 2 1/2 days. Soreness from flu vaccine was minimal.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning VARIVAX temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot# J009990 exp. Date: 12-AUG-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
When asked, patient states he did not eat or drink anything today. He noticed a tiny spot of blood at injection site, while his band-aid was being applied, he asked "Is this bad?". Shortly after after her complained of not feeling well. He complained of having blurry vision and the chills while his skin was warm and moist. Patient was laid down on the chaise lounge, and instructed to do isometrics with legs. Ice bags applied to back of neck and forehead. Vitals at 1152 were B/P - 108/58, SPO2: 99%, pulse: 66 bpm. Vitals at 1157 were B/P - 102/60, SPO2: 98%, pulse: 82 bpm. Patient was given water to drink and encouraged to drink lots of fluids today. Color was pink, skin was warm and dry when stood up to leave with mom and brother. Encouraged to eat and drink before second vaccination three weeks from now.
Patient experienced swelling and redness of (L) arm beginning about 12 hours after vaccination; she also experienced some lip and tongue swelling within a few days.
Patient's husband received smallpox inj. on approx 2/1/03 on his left arm. No other information about vaccination is available to obtain. She was with him on 2/14-15 and then again on 2/21. On 2/21 he showered and his drsg fell off and they did not have a replacement. She slept with him. A possible secondary transmission. On 3/8-9 she developed a erythema rash on her right arm bicep area with about 6 bumps. Papule no pustule,or vesicle. This was the arm that was next to her husband while sleeping. She was itching it and it bled. On 3/10 rash has lessened, but one of the bumps has a scab on it, not the one that was bleeding.  3/11 a couple of the bump have disappeared.
vaccine undergone temperature excrusion adminstered to patient with no reported adverse event; Initial information received on 02-Jun-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced vaccine undergone temperature excrusion adminstered to patient with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On 15-MAY-2022 the patient developed a non-serious vaccine undergone temperature excrusion adminstered to patient with no reported adverse event (product storage error) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  It was not reported if the patient received a corrective treatment for the event (vaccine undergone temperature excrusion adminstered to patient with no reported adverse event).  At time of reporting, the outcome was Unknown for the event vaccine undergone temperature excrusion adminstered to patient with no reported adverse event.     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.
Covid 19 like symptoms, discomfort, feeling of flu like symptoms, pain generalized, leg pain
40x40mm area of erythema on left upper arm. Area is hot, hard and painful to the touch. Per mother's report area of erythema was twice as large yesterday (8/22/07). Mother started oral benadry and ibuprofen with good result. Child brought back in to our office today to check and make sure area is not cellulitis. Dr. examined and stated area is a reaction not cellulitis.
Menstrual cycle began 10 days early, 7 days (to the hour) after my 2nd vaccine dose. Period lasted 9 days, when 4-5 is normal.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 04-AUG-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. On an unknown date in August 2016 [reported as "shortly after" receiving ZOSTAVAX], the patient developed a painful rash on his left arm accompanied by redness, burning, and numbness. In response to these complaints, the patient presented to a medical center and was diagnosed as suffering from shingles. Thereafter, on 19-AUG-2016, the patient had a follow-up appointment and was diagnosed as suffering from post-herpetic neuralgia. The outcome of the events is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 72 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
1.  Difficulty swallowing and very thick mucous that burned my throat and mouth, couldn't swallow it and spitting out was very difficult.  Lasted about 25 minutes. 2.  On day 8 after the shot, my left arm developed red splotches the size of a nickel (two of them) on the skin around the injection site.  Lasted about 2 days.   3.  Left armpit gland/lymph node very swollen and very sore for 13 days straight.  Hurt to touch it.
Dizziness, Pallor and pre faint feeling, diaphoresis then syncope for 20-30 seconds with inconstancy.
Narrative: On 9/16/2021 patient reported he had COVID 19 vaccine in March 2021 and had to be in ER for several hours. Required treatment with epinephrine per patient report. No other information about vaccine available.
10 x 10 cm area of erythema, warmth, pruritis.  Treated with Motrin, non-sedating antihistamines.
felt like her elbows were crushed and her elbows hurt so bad that she could barely move them; felt like her elbows were crushed and her elbows hurt so bad that she could barely move them; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. After she got the first vaccine, like two days later (on 12Feb2021), it felt like her elbows were crushed and her elbows hurt so bad that she could barely move them. The patient asked if that was a normal side effect and if it will continue because it was really bothersome. She also reported that she received the Pfizer vaccine on 10Feb2021, and had second appointment to get her second dose on 03Mar2021 and wanted to change it to the 08Mar2021 at a different location; she was wondering if that would be a problem. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse and refers to a 4 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 11-OCT-2016. On 25-OCT-2016, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M023931 with expiration date of 09-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 14 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Additional Details: Patient presented with seizure like symptoms for 15 seconds. The health hub concierge noticed and called myself over. He was out of it for maybe 15-20 seconds. I asked him questions to see if he was coherent. He was able to tell me where he was and his name. Patient stated he has history of vasovagal syncope so no EMS was required. BP taken at 101/59 on right arm. He waited an hour before leaving with his mother.
DTAP GIVEN INSTEAD OF TDAP. NO ADVERSE ACTION. NO NEED TO REPEAT PER STATE VFC.
mom noted lump on rt leg few days p/vax no redness or fever doesn't seem to bother pt; fully recovered;
Developed rash on abdomen arms and legs; Developed rash on abdomen arms and legs; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Eng202) via an unspecified route of administration in the left arm on 03Mar2021 at 16:15 hours (at the age of 68-years-old) as a single dose for COVID-19 immunisation. The medical history included poison ivy reaction prior to vaccination and allergy to sulfa and statins. The concomitant medications included lisinopril/hydrochlorothiazide (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), SINGULAIR, BENADRYL and m (unspecified medication). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and was not tested for COVID-19 since having the vaccine. On 06Mar2021, the patient developed rash on abdomen, arms and legs. The events resulted in doctor or other healthcare professional office/clinic visit. The therapeutic measures taken as a result of the event included steroid shot. The clinical outcome of the event developed rash on abdomen, arms and legs was recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Received Pfizer- got chills, body ache, had 102 fever, joints hurt.
Vaccine given to patient at 1302.  At 1304 patient began to report being light headed.  Patient became unresponsive at 1306.  At 1307 epipen was used on patient. Patient then moved to the floor from a chair where they became responsive and began asking what was going on.  EMS arrived as patient was moved to the floor and noted that patient had hives on her chest.  Patient was taken to hospital where they were observed and sent home with no further complications.
Rebound COVID symptoms on 7/12/2022; Rebound COVID symptoms on 7/12/2022; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Aug2021 as dose 3, (booster) single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PTG20210 mutation" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Heparin, reaction(s): "known allergies:Heparin"; Topamax, reaction(s): "known allergies:Topamax". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Rebound COVID symptoms on 7/12/2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received treatment as Paxlovid orally from 02Jul2022 to 06Jul2022 for Covid-19. Patient did not received any other medication within 2 weeks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
awakened from sound sleep with intense sharp pain in upper torso that radiated to my back as well. Pain was so intense that my BP was 166/94. Nauseous, lightheaded, couldn't even sit up. Crumbled to a ball on the floor. Cold sweats. Lasted almost over 30 minutes. Within an hour BP was back to normal 122/70.
Headache, Sedation, Fever, Chills, pain @ injection site Narrative:
The area is observed red, edema, little bit hot when you touch it, no pain. Patient was evaluated with the doctor. The doctor prescribed SEPTRA DS.
This spontaneous report was received from a Licensed Practical Nurse referring to a 38 year old female patient. The patient's concurrent conditions and medical history were not provided. On 17-FEB-2016, the patient was vaccinated with an expired dose of M-M-R II lot number reported as: J01623, expiration date on 19-DEC-2015 (route, anatomical location, and dose were not provided). There was no concomitant medication described. No adverse effects were reported. No product quality complaint was involved. J01623 is an invalid lot number for M-M-R II. Additional information has been requested.
Pt received injection 8/15/18 and began to notice redness and warmth at injection site, growing larger. Suggested that patient mark red area (presently 5x3 inches) and try some BENADRYL tonight to see if reaction decreased. Pt will call back tomorrow if appointment is needed for MD evaluation.
felt feverish, chills,  h/a.  out of work x1 day. Took tylenol x1 week
Narrative:  Pt is a 75y.o. male who died on 04/18/2021 w/ h/o CVA w/o residual deficits (2019), HLD, HTN, bradycardia, HTN, asthma, and PTSD. Pt received Modera Covid-19 Vaccination 1/2 on 03/15/2021. Pt presented to ED on 04/07/2021 reporting c/o soa x 3 days, gradually worsening, along with diarrhea x 1 day, and change in taste. He denied changes in smell or sick contacts. COVID test was negative on arrival. He was admitted for acute hypoxic respiratory failure 2/2 COVID variant vs other viral PNA vs bacterial PNA, hypokalemia, asymptomatic bacteriuria, and elevated transaminases. He developed acute anterior MI (too unstable for transfer to another Hospital, cardiac cath 4/13/21 notable for proximal LAD 90% calcified stenotic lesion, mid-LAD 60% stenotic segment), respiratory distress requiring intubation, hypotension (requiring pressor support), and AKI (requiring dialysis). Infectious disease is consulted, and recommended that a specimen be sent for genome sequencing to the state lab. Pt died while inpatient 04/18/2021 with physician reporting "Death was caused by: Combined septic and cardiogenic shock with multi-organ failure from suspected but not confirmed COVID infection". Unlikely that Moderna Covid-19 Vaccine caused/contributed to pt death.