chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extremely sensitive upper arm since vaccination, fever to 101.7 (usually 97.5) for at least eight hours, headache, body aches, fatigue, nausea
shots got them in left leg pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of leg pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer linked case US2023AMR036695).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced leg pain (Verbatim: shots got them in left leg pain). Rechallenge with Shingles vaccine was positive. The outcome of the leg pain was unknown.   It was unknown if the reporter considered the leg pain to be related to Shingles vaccine.     It was unknown if the company considered the leg pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR036695   Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comments: The reporter reported the case via  interactive digital media. The patient had both shots and got them in the left leg pain. Additional Supportive Information: The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR036695:
Patient developed intense pruritis, nausea and vomiting, flushing and wheezing with hypoxia.  Received oral Benadryl and Albuterol NMT x 2.
Discovered after the vaccine was given that the patient is 17 years of age and should not have received Moderna but rather should have received Pfizer.
bilat knee pain & swelling Narrative:  At covid vaccine appt for dose #2, pt reported the following side  effect from dose#1: (from nurses note dated 3/17/2021) "veteran reports bilateral  knee pain/swelling following first dose of covid 19 vaccine. Veteran reports that  it was difficult to walk the pain was so intense. he reports that pain persisted for  28 days post shot. and that he still has pain today. he denies any other symptoms or side effects. he denies any other preceding event that could have caused this pain. he is oriented and in a good mood during our conversation. agrees to discussing side effects with pcp before proceeding with 2nd dose of vaccine."
Evening after vaccination, ran 101 fever and vomiting. Next day after vaccination 105 fever (mom was giving fever meds and antinausea med - and cool baths etc). Brought to ER Tuesday 8-17-10 - gave IV fluids, antibiotics, blood work. Now taking antibiotic Amoxicillin. Fever broke 5 AM Wednesday. Thursday child developed fine red rash all over body, no itching, hives or trouble breathing (consistent with normal rash after MMR.)
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Information has been received from a physician concerning a female who was vaccinated on an unspecified date with a dose of Gardasil. Subsequently, the patient experienced a bacterial infection. The outcome was not reported. The patient's sister's experience with Gardasil was reported in WAES#0704USA02596. Additional information was been requested.
face is swollen; face turned black, green and blue; spots all over her; feels burning; scratching; over heated; This case was reported by a consumer via patient support programs and described the occurrence of facial swelling in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included brain neoplasm (Brain tumor since 2008).   In May 2018, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced facial swelling, skin discoloration, rash, burning sensation, scratch and hot feeling generalized. On an unknown date, the outcome of the facial swelling, skin discoloration, rash, burning sensation, scratch and hot feeling generalized were not recovered/not resolved.   The reporter considered the facial swelling to be unrelated to Shingrix. It was unknown if the reporter considered the skin discoloration, rash, burning sensation, scratch and hot feeling generalized to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received Shingrix shot and her face turned black, green and blue, had spots all over her, one part of her face was swollen, felt burning, scratching and felt over heated constantly. The patient still had those effects. The patient reported that she only received a letter stating that probably the effects were from something else.
itchiness all over her body, including arms, back, legs, shoulder, and scalp; The itchiness is not just in the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of   in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J200/025JZ00) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
I am letting you know that I had the first in the 2 part series of the COVID vaccine (Moderna) yesterday (Jan. 4, 2021 at 1500) afternoon.  I woke this morning with side effects of fatigue, body aches, mild chills, increased cough, and loss of appetite.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 immunisation.     No Medical History information was reported.    On 03-Apr-2021 at 10:14 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:14 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 58.37 for dose administered on 03-Apr-2021.  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
A non-serious spontaneous report of neuralgia of the trigeminal nerve (right side facial numbness), vertigo, dyshidrotic eczema and rosacea has been received from a consumer (registered nurse) concerning a 35-year-old female patient subsequent to FLUMIST. Medical history was included allergies. Concomitant medications were montelukast, prenatal vitamins (patient was not pregnant) and JUICE PLUS tablets. On 21-Sep-2010, the patient received FLUMIST. On 25-Sep-2010, the patient developed vertigo and two days later, 27-Sep-2010, she developed right facial numbness which was diagnosed as "neuralgia of the trigeminal nerve". She was examined by her primary care physician who subsequently sent her to see a dentist, infection disease specialist, neurologist and an ear, nose and throat specialist. An examination by the infectious disease physician revealed a deeply seated subacute vesiculation of the lateral aspects of several digits with "the right thing in our eminence". There was no evidence of secondary infection or volar wrist or dorsal hands involvement. Treatment included SA 5% fluocinonide acetonide 0.05% cream. He also noted that the patient was having none of the lancinating pain more typically associated with trigeminal neuralgia. In addition to eczema, the physician also diagnosed rosacea; she had moderate blanching erythema of the centrofacial areas of the nose, cheeks and chin with several background telangiectasias and a couple of small centrofacial pustules with no papulopustules. No evidence of ocular involvement was seen . Treatment included azelaic acid 15% gel applied to affected areas twice a day. Brain and internal auditory canal magnetic resonance imaging (MRI) scans with and without contrast were normal, multiple sclerosis (MS), Lyme's disease and multiple blood tests were negative. The event of neuralgia of the trigeminal nerve was ongoing. The events, vertigo, dyshidrotic eczema and rosacea have resolved.
Client stated "I feel dizzy", and client became pale, loss consciousness, used amonia inhalant, client eyes rolled back and he became rigid. Lower client to floor, called 911. Client had uncontrolled body movement of arms and legs. Client foamed at the mouth. The episode lasted approx 1-2 minutes. Vss 140/90 respiration 20. client alert and oriented. assisted on seated up. EMS arrived, client stable. Client refused to go with EMS. Vital stable when EMS arrived. Client declined to leave with EMS. Wife arrived, this nurse insisted that client follow up with neuroligist. Wife verbalized an understanding. Client walked out of client stable with wife by his side.
Systemic: Dizziness / Lightheadness-Severe, Systemic: patients feels hot then an hour later feels cold-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Medium, Additional Details: Patient said she felt light headed and feels weak.  Pharmacist had patient lay down with two legs slightly elevated.  Patient was given water to drink since she said she feels hot and need water. pharmacist check vital signs 3 times.
Notified that patient received the MONOVALENT version of the Pfizer COVID-19 booster vaccine rather than the intended BIVALENT version of the Pfizer COVID-19 booster vaccine on 09/15/2022.
Blurred vision, numbness and loss of strength in left arm, difficulty breathing, left side of face droop
pt recv vax 22JAN98 & 30JAN98 pt exp swelling of the eyelids, a rash on chest, back & unilateral on rt side of face, resp sx, fever, arthralgia, noc sweats & insomnia;tx w/DPH;
Pt complained of pain, swelling, difficulty moving left arm administered 11-19-2016 Reported symptoms to pharmacy 11/27/2016.
Pt exhibited signs of a panic attack, sweating, dizziness, coldness. Pt has history of panic attacks symptoms subsided after 20 minutes.
Client reported first COVID vaccine on 02/19/21 and second vaccine on 03/22/21, adverse reaction may have slightly started after first vaccine but noticeable on 03/23/21.  Client having an unstable equilibrium, dizziness more with standing up, blurred vision with glasses on, and spots in eyes (more in left than right).  Client has called PCP, awaiting response.  Client has been treating adverse reaction wth taking his prescribed medications and eating meals.
He got his vaccine, he got dizzy immediately, faint feeling.  They needed him to stay there for 10 minutes right before he felt dizzy.  Then later on that day his nose started dripping uncontrollably.  He has never had anything like this prior with any cold or flu that he has had in his entire life ever.  He went to an clinic as he had no insurance at that time.  They tried to give him some codeine syrup which he declined and some antibiotics that helped some.  After he took that he was still having the runny nose.  He then had the 2nd vaccine and it continued after that, as well as the third vaccine which he continued with that.  He was fine prior to the vaccine.  He has not been able to taste or smell since then and has a continuous runny nose  nonstop.  He does not use anything up his nose or any nose drops.     He has had allergies in the past, but nothing like this type of drainage.  He was given a promethazine with codeine syrup and it helped in the past, but since the vaccine it does not help anymore.    2nd vaccine on 9/7/21 PFizer, FC3181, 3rd vaccine 2/26/22 Pfizer, FM6098.
Pt recv vax on 10/12/98; 2 hr later pt exp welt on inner right thigh, welt on right outer forearm, welt on right ribcage; pt seen by M.D.
Rash on feet, legs, arms, mid section. Swollen feet, swelling in joints, pain in feet, and joints through out the body.
RECEIVING ONLY 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 19 year old female. 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: 211A21A expiry: 14-DEC-2021) 2.5 ml, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-NOV-2021, the patient experienced receiving 2.5ml of the janssen covid-19 vaccine. On 14-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the receiving 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious.
Very sore, inflamed throat, runny nose, headache, stiff neck, fatigue.
pt recv vax lt deltoid swelling, tenderness, inc warmth, swelling to elbow; lt axillary node 2 1/2cm, very tender to touch; allergic rx to tetanus; early cellulitis;
No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 73-year-old female patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 07-OCT-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
11 yo presented to clinic w/parents to receive 1 dose of pfizer. Within the 15 minute observation pt started to c/o of chest tightness. No other symptoms. Parents stated pt has a history of a heart murmur, but no past reactions to vaccines or allergies to medication. Pt denied headache, nausea, blurred vision, or numbness/tingling. VS @ 1410 HR 100, BP 118/65, RR 20, O2 99, PAIN 2; @ HR 99, BP 122/64, RR 20, O2 98, PAIN 2. Parents were advised to speak with PCM before 2nd vaccine and to go to ER if sx get worse, they will continue to monitor PT  at home. Decided no ER transport at this time.
Chronic severe headache Chronic Upset stomach Chronic Diarrhea Loss of appetite Weight loss Chronic fatigue
Approx 30 minutes post vaccines administered, child became very flushed, c/o stomach ache, feet itching. Mother took child to ER-dx as allergic type reaction. Tx with Epinephrine and Benadryl and released home with instr to adm more Beandryl.
got the shot, hurt like hell; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: This case was reported by patient via interactive digital media. The patient stated that he got the Shingles shot and it hurt like hell but worth it. The reporter stated that his brother had shingles for a year, suffered daily. Additional supportive information: The follow-up would not possible, as no contact, details were available. This case had been linked with case US2022AMR140129, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR140129:Same reporter
Left upper arm redness, pain, swelling, itching within an hour after receiving. Treatment: Warm soaks, Benadryl, Advil
102.4 Fever for 12 hours headache for 20 hours Body aches for 24 hours Tired for 24 hours
sick with covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (sick with covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2022, the patient experienced COVID-19 (sick with covid). At the time of the report, COVID-19 (sick with covid) outcome was unknown.            No concomitant medication information provided.  Reporter reported that patient experienced sore throat. Patient was vaccinated and boosted with Moderna hence patients case was mild.  No treatment medication information provided. Company comment: This spontaneous case concerns a male patient of unspecified age, with no medical history reported, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred in month of Jun- 2022 after a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient experienced sore throat and was vaccinated and boosted with Moderna and condition is with mild severity. No treatment medication information was provided. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   This case was linked to MOD-2022-592449 (Patient Link).; Sender's Comments: This spontaneous case concerns a male patient of unspecified age, with no medical history reported, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred in month of Jun- 2022 after a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient experienced sore throat and was vaccinated and boosted with Moderna and condition is with mild severity. No treatment medication information was provided. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.