chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial reactions:  Increased nasal congestion, dizziness, strong wheezing cough.  By 11/01/09: fever (up to 101.7), headache (mild), muscle aches, tiredness, continued strong cough.  Spent the day 11/01/09 resting.  Fever diminished within 24 hours.  Mild cough and sore throat persist 11/02/09.
MENACTRA was scheduled to be delivered on 5/31/19, but they did not get the vaccine until 6/4/19 and when they opened ice packs were in the container but it was not frozen.; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA193300, 2019SA193301, 2019SA193302, 2019SA193307, 2019SA193304, 2019SA193305, 2019SA193306 and 2019SA158240 (same reporter).   This case involves 13 years old female patient with who was vaccinated with 0.5 ml first primary dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6365AA and expiry date was not reported) via intramuscular route in the arm NOS, on 03-Jun-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage. It was reported that MENACTRA was scheduled to be delivered on 31-May-2019. Caller stated they did not get the vaccine until 04-Jun-2019. Caller stated when they opened ice packs were in the container but it was not frozen. It was stored incorrectly from 31-May-2019 to 09-Jun-2019.  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 holder's compliance with the requirements set out in Directive and Module VI of the 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.   List of document held by sender: none.
Mom states pt recvd DTP/OPV/MMR?HIB on 6MAR92 & devel fever 103.6 w/nasal congestion on 16MAR, fever cont 17MAR92; pt seen by MD dx as vax rxn; On 19MAR fever subsided, pt devel light rash-face, chest, back, progessively worse by 20AMR92;
It was reported that a female received vaccines on 11/1/99. On 11/2/99, she experienced "localized erythema and swelling of the left thigh 8cm X 6cm and mild warmth to the area". The pt has recovered.
Awoke with redness, swelling, achiness and slight itching of L arm. Massaged the arm and symptoms worsened, with redness extendng down arm and warm to touch. 10x8cm area of mild erythema and edema. No tenderness or induration with palpation.
Patient received first Pfizer COVID-19 vaccine on 1/20/2021 and second dose on 2/12/2021. Patient had minor symptoms such as body aches with both vaccine doses which resolved. Patient then stated she started to experience headache, nausea, and body aches, decreased oral intake, and chill starting on 2/18/2021. On 2/20/2021 patient had several loss of consciousness episodes. Patient presented to the Emergency Department on 2/21/2021 with a chief complaint of syncope, nausea, and vomiting and subsequently admitted to the hospital for potential sepsis, syncope, hyponatremia, dehydration, lactic acidosis. (Continued on second page)
Severe L leg swelling from hip to knee, inability to bear weight x 3-4 days
annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonresponsive for a few moments/was asked a question and did not respond; sweats; high blood pressure; annoying pain; itching; hives on the arms and chest; Hot flashes; This is a spontaneous report from a contactable consumer (patient)  A 56-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EN5318  at left arm on 16Feb2021 at SINGLE DOSE for covid-19 immunisation . Age at vacciantion 56 years.Vaccination Facility Type: Workplace Clinic.  Medical history included ongoing allergies (5-10 years). She had a flu shot in Oct2020.  There were no concomitant medications.Immediately after the vaccine she became nonresponsive for a few moments, broke out in sweats, had high blood pressure, annoying pain, and has been having itching and hives on the arms and chest.Clincal course was reported as follows:  On 16Feb she had hot flashes,pruritus and blood pressure has not been right .On17Feb she developed annoying feeling in her chest.Then , it was added as follows: she received the first dose of the Covid-19 vaccine on 16Feb2021. She had an allergic reaction. The second dose was due 09Mar2020.  She was under the impression that she has to take the vaccine she was told she needed a cocktail to get the shot.She had hot flashes and was itching. Her blood pressure has not been right. Her pressure was low then normal then high. She has an annoying feeling in her chest. The itching has stopped after she was medicated. She can't take Benadryl and she was given something else. She applied hydrocortisone cream and it helped.  She had a flu shot in Oct2020. She went to the ER on 20Feb2021 because her blood pressure was spiking too high. She had an EKG which was normal. When she went to the ER her blood pressure was 167/100. Yesterday her blood pressure was 167/102. She was nervous about taking the second dose. Her blood pressure usually ranges from 119-120. It was off the charts at 130/80 and 150/99. Pateint was treated for pruritus.She was wondered if she can get the second dose .Events reported as non serious.Lab data  included:EKG on20Feb2021:normal.Blood pressure measurement (16Feb2021): has not been right. Her pressure was low then normal then high , blood pressure measurement: 167/100   on 20Feb2021 , blood pressure measurement: 167/102   on 24Feb2021.Patient's recovered from pruritus while the outcome of the other events was unknown.
Severe fatigue since the day after the vaccine. I can barely keep my eyes open and keep dozing off while working. Slept virtually all weekend long and still fighting to stay awake.
This spontaneous report was received from a male patient (pt) of unknown age who on an unspecified date, received ZOSTAVAX (route and lot number not provided). Medical history and concomitant medications were not provided (pt refused to answer). On an unspecified date, the pt developed shingles. The pt stated he was going to contact his lawyer because "I had ZOSTAVAX and got the shingles anyway". The outcome of the event was not provided. Additional information is not expected as the pt did not provide his contact information.
Site: Swelling at Injection Site-Severe, Additional Details: Pt came for 2nd shot. She told immunizer that her arm was swollen and she had a \"dark spot\" on her elbow for 4 days.  I told her to consult md before getting 2nd dose.
no adverse event; received VARIVAX/that experienced a temperature excursion; This spontaneous report was received from a registered nurse referring to unknown patients of unknown age and gender. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 11-JUL-2022, following vaccines were administered after temperature excursion to 10.8 degree Celsius for 2 hours 27 minutes (product storage error). Names of vaccines involved: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (lot # U011995, expiration date: 15-APR-2023, lot # U009511 expiration date: 25-MAR-2023, lot# U014656 expiration date: 07-MAY-2023, lot # U022318, expiration date: 15-JUL-2023, lot # T025930, expiration date: 30-JUL-2022, lot # U029619, expiration date: 22-SEP-2023) for prophylaxis (strength, dose and route of administration were not provided), measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot #U029319, expiration date: 19-MAR-2023, lot# U024296 expiration date 21-SEP-2023, lot# U039723 expiration date: 15-DEC-2023, lot# U015679 expiration 18-AMY-2023), varicella virus vaccine live (oka/merck) (VARIVAX) (lot #U010396, expiration date: 01-APR-2023, lot# U039723 expiration date: 15-DEC-2023, lot# U015679 expiration date: 18-MAY-2023, U024296 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX) expiration date reported as 21-SEP-2023) for prophylaxis (all vaccines strength, dose, anatomical location and route of administration were not provided). The reported was unsure how many administrations occurred and did not have individual patient information. No additional adverse event was reported (no adverse event).  This case is non-valid due to the number of patients was unspecified and lack of patients' identifiers.  Follow-up information was received from a registered nurse on 09-AUG-2022. This case was previously considered non-valid but per follow-up it was determined to be valid (there were only 3 patients who receive the vaccines). This spontaneous report refers to a 12 month old male patient. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 13-JUL-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # U026207, expiration date 24-AUG-2023, for prophylaxis (dose and route of administration was not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot # U009511, expiration date 25-MAR-2023 (dose and route of administration was not provided) for prophylaxis, both experienced a temperature excursion. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA005428: US-009507513-2208USA004875:
Soreness; Swelling; Redness; inflammation; flu like; ichy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose approximately 2 months ago, refer case US2019154061).   In August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, inflammation, influenza-like symptoms and injection site itching. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, inflammation and influenza-like symptoms were recovered/resolved and the outcome of the injection site swelling was not recovered/not resolved and the outcome of the injection site itching was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, inflammation, influenza-like symptoms and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient experienced inflammation, soreness, swelling, and redness as significantly worse compared to 1st dose. The patient had some sort of flu. The patient reported a bumpy, raised spot at injection site that looks like it contains blisters but it was not. The patient did not consent to follow up.
This is a spontaneous report received from a non-contactable consumer via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route on an unknown date in Dec2020 as 1st dose, single dose and via unspecified route on an unknown date in Mar2021 as 2nd dose, single dose for COVID-19 immunization. The patient medical history included ongoing COVID-19 from unknown date in 2020. Concomitant medications were not reported. It was reported that on an unknown date in Nov2020, the patient had COVID. The patient received both vaccines, one in Dec2020 and a second in Mar2021 and still contracted COVID. The reporter wanted to know if it was a false positive. The clinical outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
sore arm; fatigue; feeling dizzy; chills; low grade fever around 100 degrees; A spontaneous report was received from a nurse concerning a 51 year old, female patient who received Moderna's COVID-19 vaccine and experienced chills, low-grade fever, dizziness, arm soreness, and fatigue.    The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient started to have chills and a low-grade fever around 100F. The patient stated she felt like she "had COVID again". Patient also reported feeling dizzy. On 30 Dec 2020, patient still had chills and reported arm soreness and fatigue. Treatment for the event included ibuprofen and paracetamol.   Action taken with mRNA-1273 in response to the event(s) was not reported.   The event, arm soreness, was considered recovered/resolved. The outcome of the events, chills, low-grade fever, dizziness, and fatigue were unknown/not reported.; Reporter's Comments: This case concerns a 51-year-old female, with PMH of COVID-19, who had NS unexpected dizziness, and NS expected chills, low-grade fever, arm soreness, and fatigue.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment included ibuprofen and paracetamol. Arm pain resolved, but other event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
14NOV96 pt devel fever & inc to 103;HR ince to 160 which then dec;15NOV96 pt devel h/a (which was migraine);pt screamed 3hr & would hit head w/hands;MD checked pt d/t redness in throat & ears gave ATB pt had drug rxn-broke out w/rash
PROQUAD administered post temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history and drug reactions/allergies was not provided. Concomitant medication included sterile diluent (manufacturer unknown).   On 21-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter (strength and route were not reported; lot # S031881 with expiration date 07-APR-2021) for prophylaxis (product storage error). The administered dose of the vaccine experienced a temperature in the range -9 Celsius degree to 8 Celsius degree (-2.8 Celsius degree) for 5 hours and 2 minutes recorded by a data logger. There was no previous temperature excursion.  This is one of multiple reports sent by the same reporter.; Sender's Comments:  US-009507513-2009USA000677: US-009507513-2009USA001227: US-009507513-2009USA001249: US-009507513-2009USA001303: US-009507513-2009USA001333: US-009507513-2009USA001367: US-009507513-2009USA001381: US-009507513-2009USA001696: US-009507513-2009USA001697: US-009507513-2009USA001715: US-009507513-2009USA001812: US-009507513-2009USA001823: US-009507513-2009USA001827: US-009507513-2009USA001831:
I have Multiple sclerosis but never been this bad pain I don't want to get out of my bed; Itching/problem with itching; Multiple sclerosis but never been this bad pain I don't want to get out of my bed; have been taking Oxycodone for 20 years; this pain is indescribable because I actually feel it; Terrible weakness; itching in a rash/itch this is different very large rash; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: AR8727; Expiration Date: Jul2021), via an unspecified route of administration, administered in arm right on 01Apr2021 (at the age of 66-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included autoimmune thyroiditis (Hashimoto's thyroiditis), fibromyalgia, osteoarthritis and rheumatoid arthritis, all from an unknown date and unknown if ongoing. Concomitant medications included oxycodone taken for pain and levothyroxine sodium (SYNTHROID) taken for autoimmune thyroiditis, both start and stop date were not reported. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: AN762) on 03Mar2021 for COVID-19 immunisation. The patient stated, "I think I am having a reaction. I had my Pfizer first vaccine on 03Mar (not clarified) and second vaccine on 01Apr. The first one was I can't make it out and the second was initially. I don't have much, it started itching in a rash and now having nothing. I have been to the Hospital I told them that I had Pfizer vaccine with that reason now I am not really comfortable. I have multiple sclerosis but never been this bad pain I don't want to get out of my bed and I am taking oxycodone (treatment for pain) approximately 20 years." The outcome of the events was unknown.    No follow-up attempts are needed. No further information is expected.
Multiple episodes of vomiting in conjunction with fever of 103 and redness at injection site within an hour after receiving vaccine.
Information has been received from a certified medical assistant concerning a 67 yr old white male who at 09:00 on 21Sep05 was vaccinated IM in the right deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0592P). It was reported that the pt had since developed pain, redness, swelling, and warmth at and around the injection site. On 23Sep05, the pt developed an allergic reaction with some erythema around elbow area. The pt saw the physician and was treated with gatifloxacin (Tequin) 400mg for 4 days to rule out cellulitis. On 23Sep05, the pt was considered recovered. No additional information is expected.
After my vaccine I was feeling tired, achy, fatigued, and it lasted for about 48 hours. No fever or chills. About a month later I did come down with COVID-19 from a wedding I attended on June 11th. I began to feel a scratchy throat and on the 13th coming back home I did test positive. The worst day was the 16th where I had coughing, a lack of appetite, no fever, and aches and pain. No trouble breathing as well.  I am coughing less and recovering well. I do still have some congestion and in the morning I seem to have the most energy.
Patient was given expired (shortdated) vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given expired (shortdated) vaccine) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given expired (shortdated) vaccine). On 30-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient was given expired (shortdated) vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product information was provided.  Treatment information was not provided.
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 5 year old female pt who experienced fever 102 deg F..At 5 years of age, the pt received a dose on 12/16/03. The child had no relevant medical history. Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/16/03.  Dose regimen was 0.5mL (IN). Pt was not taking concomitant therapy. The pt experienced fever 102 deg F (pyrexia) on 12/18/03.  The pt was treated with Tylenol (acetaminophen) and recovered after 4 days.  The physician was not notified.  No additional information was available at the time of this report.Follow UP: follow up informaiton received from the physician medically confirmed events.
This spontaneous report as received from a nurse refers to a patient of unknown demographics. The concurrent condition, medial history and concomitant medication was not reported. On 05-MAY-2016 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot # K016294, Expiry: 28-APR-2016). No adverse effects were reported. No product quality issue was involved. Additional information has been requested.
This spontaneous report was received from a physician via a company representative and refers to a 14-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patient was vaccinated with an unidentified Merck Human Papillomavirus (HPV) vaccine (name, lot number, expiration date, dose and route of administration were not provided). It was unknown how many doses of HPV vaccine were received by the patient. On an unknown date, the patient experienced seizure. On an unknown date, the patient was admitted to the health facility and then she was referred to another health facility for a second opinion, for "specialized care". No product quality complaint was involved. The outcome of seizure was unknown. The relatedness between the adverse event and unidentified Merck HPV vaccine was not reported. Upon internal review, the event of seizure was determined to be medically significant. Additional information has been requested.
Patients dad came in with a picture of patients arm on his cell phone. right arm was all red and swollen. warm to touch per dad. told patients dad to put ice on area, give benadryl and call us back in the morning.  Patients mom called the next morning arm was still red and swollen and patient was having a hard time moving it. Patient came in that morning and Dr. did see patient.  patient is allergic to tetnus.
A pt's mother reports her 11 year old daughter developed asthmatic reactions and nasal polyps after receiving intranasal Flumist. On 17Dec03, an 11 year old female received FluMist for immunization against influenza virus. On 31Dec03, the pt went to ER after developing asthmatic reactions where she was treated with salmeterol xinafoate/fluticasone propionate and pirbuterol acetate. The pt also received fluticasone propionate and montelukast sodium for nasal polyps. The pt is still receiving medications and has not yet recovered from the events. The reporter did not provide relationship between events and FluMist vaccination.
Pt with induration and cellulitis at site of injection. No W, no U, no fever/chills.
Sweating; Muscle pain; Fever(100.6); This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), MYALGIA (Muscle pain) and PYREXIA (Fever(100.6)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), MYALGIA (Muscle pain) and PYREXIA (Fever(100.6)). At the time of the report, HYPERHIDROSIS (Sweating), MYALGIA (Muscle pain) and PYREXIA (Fever(100.6)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 100.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I22.0 SUBSEQ ST ELEVATION MI, LEFT ANTERIOR DESCENDING CORONARY ARTERY, WITHIN 4 WKS OF PREVIOUS MI 3/27/2023 ATHEROSCLEROSIS OF AORTA