chrisvoncsefalvay/vaers-outcomes huggingface dataset:
your typical flu; sore arm; stutter; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (your typical flu), PAIN IN EXTREMITY (sore arm) and DYSPHEMIA (stutter) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031L20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE, POTASSIUM, MAGNESIUM, GABAPENTIN, FAMOTIDINE, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS), MIRABEGRON (MYRBETRIQ) and ESTRADIOL for an unknown indication.   On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (your typical flu), PAIN IN EXTREMITY (sore arm) and DYSPHEMIA (stutter). At the time of the report, INFLUENZA (your typical flu), PAIN IN EXTREMITY (sore arm) and DYSPHEMIA (stutter) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 09-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 lot # J004080, expiration date 22-AUG-2014, 0.5 ml, intramuscular. Secondary and concomitant therapies were not reported. The pharmacist reported that a patient received an expired dose of PNEUMOVAX 23 on 09-SEP-2014. No adverse effect reported. Additional information has been requested.
Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration; Doses were administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigrator on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigrator on same day of administration) outcome was unknown. Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. Patient weight has been reported as 185. HCP stated they administered expired doses of the Moderna COVID-19 Vaccine to 27 patients. Dose administered after 30-day Use By Date or after manufacturer date of expiry. Date the vial was initially stored in the refrigerator, was the same day vials were thawed. The vial didn't undergo any temperature excursions No treatment information were provided.
her left arm had become swollen, hard, turned red and got very hot; her left arm had become swollen, hard, turned red and got very hot; her left arm had become swollen, hard, turned red and got very hot; her left arm had become swollen, hard, turned red and got very hot; This is a spontaneous report received from Merck, form a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), first dose via an unspecified route of administration on 26Jan2018 as single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient mentioned that after receiving her first dose on 26Jan2018, she experienced an adverse event. It was reported that her left arm (injection site) had become swollen, hard, turned red, and got "very hot". She was taken to emergency clinic. She was advised not to receive the 2nd dose and had not received it. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Information has been received from a nurse practitioner concerning a 20 year old female with no medical history and no known drug reactions or allergies who in April 2008, was vaccinated with the second dose of GARDASIL vaccine (yeast). The day after the second dose of GARDASIL vaccine (yeast) the patient developed bilateral leg pain, headache, nausea, diarrhea, vomiting and felt faint. On an unspecified date the patient recovered from bilateral leg pain, headache, nausea, diarrhea, vomiting and felt faint. Unknown medical attention was sought in the office. Additional information has been requested.  10/08/2008 This is in follow-up to report(s) previously submitted on 7/15/2008. Initial and follow-up information has been received from a nurse practitioner concerning a 20 year old female with bipolar disorder, no medical history and no known drug reactions or allergies, who on 28-April 2008, was vaccinated intramuscularly with 0.5 ml of the second dose of GARDASIL (lot# 0210U). Concomitant therapy included DESOGEN (dose unspecified), and 150 mg LAMICTAL (therapy started on 09-Apr-2008) for the treatment of bipolar disorder. It was reported that on 28-Apr-2008, the patient developed bilateral leg "restlessness" and pain, worse with walking, then headache, nausea (dry heaves), diarrhea, vomiting, felt faint and her liquid stools by 3 times. Unspecified medical attention was sought in the office. It was reported that on 29-Apr-2008 (next day) the patient recovered from her experience with no recurrence. It was reported that there was no such a problems with the first dose of GARDASIL. The date and lot# of the first dose of GARDASIL was unspecified. It was also reported that the patient opted against receiving the third dose of GARDASIL. Additional information is not expected.
Suspected vaccination failure; Mild Shingles symptoms / after my first Covid vaccine on 4/16/21; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, TOZINAMERAN (COVID-19 VACCINE PFIZER) (batch number ER2613, expiry date unknown) for prophylaxis, estradiol vaginal for drug use for unknown indication and estradiol + norethisterone acetate (Combipatch) for drug use for unapproved indication.   The patient's past medical history included esophageal acid reflux and shingles (experienced one severe case and one mild case of shingles 10 years ago before the date of reporting, when patient was at her mid 50's). Previously administered products included Zostavax (received on 9th January 2015). Concurrent medical conditions included food allergy (Raw shrimp allergy), allergy to antibiotic (Sulfamethoxazole TMP DS 800-160 mg Tablet), drug allergy (vioxx) and fruit allergy (fresh pineapple).   On 1st December 2018, the patient received the 2nd dose of Shingrix. On 2nd July 2018, the patient received the 1st dose of Shingrix. On 16th April 2021, the patient received the 1st dose of COVID-19 VACCINE PFIZER. On an unknown date, the patient started estradiol vaginal at an unknown dose and frequency and Combipatch .05 mg at an unknown frequency. On 16th April 2021, 867 days after receiving Shingrix and 1019 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with estradiol vaginal was unknown. The action taken with Combipatch was unknown. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The ethnicity information and race information was available but not provide. The patient received the two doses of Shingrix,one dose of Covid-19 vaccine on left arm and within 2 weeks of Vaccination patient received estradiol (Vaginal Tabs 10 mcg,) and combipatch (0.05-0.14mg) and later patient experienced mild Shingles symptoms on left side of abdomen and left side of back. The patient had no Shingles side effects until 8 hours after her first Covid vaccine The patient did not received any treatment. The patient was not tested or diagnosed with COVID-19. It was unknown if the reporter considered the shingles to be related to Cocid-19 vaccine, estradiol vaginal tablet and combipatch. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Left frontal lobe focal headache all day, at 7:30pm, feeling of overwhelming doom, followed by sudden onset uncontrollable crying, culminating in a seizure without loss of consciousness. Legs, arms, abdomen jerking in contraction and release.  Extreme fatigue following event.
I had a sore arm and fatigued for about two days after receiving the vaccine. I began not feeling well on 01/31/2023 with sneezing and sore throat. I tested positive for COVID-19 on 02/02/2023. I contacted my doctor and got a prescription for prednisone and an antibiotic. I also had bronchitis too. As of today, I am feeling better but for four months since having COVID-19, I had extreme fatigue and really bad joint pain.
Information has been received from a licensed practical nurse on 18-JUN-2015 concerning an unspecified number of unspecified patients who were administered an unspecified number of improperly stored doses of ROTATEQ, dosage not reported, orally (lot # K004921, expiration date 25-FEB-2016; and lot #K023534, expiration date 22-MAY-2016) on unspecified dates since 28-APR-2015. It was unspecified which unspecified patients received doses from which of the two lots of ROTATEQ. No adverse effects reported. No additional information provided. Additional information has been requested.
I had joint and muscle pain throughout my body, dizziness and weakness three days after my vaccine after giving blood that Saturday at 11 am. The pain was throughout my body so much that I couldn't do my normal functions.  I also developed stomach pain a day after I gave whole blood. These symptoms lasted 5 days, after which I still had some muscle pains and weakness but not that I couldn't continue on in my normal activities. The muscle pain and weakness symptoms lasted another week before I felt more normal, although, the stomach pain went away after about 5 days.   After my second dose on April 7th, 2021 with Pfizer lot number ER8727 in my left arm, I was tired and had a little bit of muscle pain right away but these symptoms only lasted 24 hours after my shot at 9am that Wednesday I received that dose.
Hives have appeared in the evening, once on my wrist (after first shot). After second have had hives in evening appear in hands, bottom, front of thighs and back of thighs. Often extremely itchy and covering entire area of body where located. Have been treating with ice packs, Benadryl, and cortisone cream.
Sore arm; This spontaneous case from was retrieved on 13-May-2021 from other non-health professional (consumer) via Communication (reference number: SEQW21-01316) and concerned unknown age, male patient.  The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with influenza virus vaccines polyvalent (brand not specified; dose, anatomical location, indication and route of administration: not reported). The batch number was not reported.  On an unknown date, unknown amount of time after receiving influenza virus vaccines polyvalent, the patient experienced sore arm, reported as no issues other than a sore arm.  The outcome of the event was not reported.  The reporter did not provide causality assessment.   The case is linked to case 202102436 (the same patient).  Company comment: A male patient of an unspecified age was vaccinated with influenza virus vaccines polyvalent. An unknown amount of time after receiving influenza virus vaccines polyvalent, the patient experienced sore arm. Causal role of the suspect vaccine is assessed as possibly related.; Sender's Comments: A male patient of an unspecified age was vaccinated with influenza virus vaccines polyvalent. An unknown amount of time after receiving influenza virus vaccines polyvalent, the patient experienced sore arm. Causal role of the suspect vaccine is assessed as possibly related.
Started feeling numbness or faint pain on the area of vaccine right after the first vaccine. Its not continous pain, but sometimes after i lift  anythingno matter how heavy or light. The pain is not always there but I i do feel it occassionally around the exact place that i got the vaccine. The pain feels like its in the muscle. I reported to my primary care physician who directed me to report here.
Patient received flu vaccination, stated that it hurt upon injection, he waited while father got vaccination and then passed out 1-2 minutes after father received vaccination. Father stated son was nervous prior to injection, has had flu shot previously without incidence and has passed out once previously (not medication related). Patient felt nauseous when he regained consciousness, sat in chair, applied cold compresses, took blood pressure twice. First reading-117/82, second reading 10 minutes later-122/79. Patient remained seated for 5 more minutes, felt better.
Initial report received from nurse on 01 Dec 2009: This patient, who was a child younger than 4 years, received FLUVIRIN lot number 1009223P, 0.5 ml intramuscular on 24 Nov 2009. No adverse event was reported.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  It was mentioned that the vial was initially refrigerated  on 17 Nov 2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events.
Received vaccine at medical center. 5 minutes after initial vaccination felt dizzy. After a few minutes he was feeling better so left for car at 15 minutes post vaccination. Once getting to car developed lightheadedness, tachycardia, shortness of breath. Brought back into facility given IM epi 0.3 mg with improvement and send via ambulance to our emergency department. No urticarial lesions or angioedema. Observed for approximately 2 hours. No recurrence. Discharged home.  No additional meds after epi given in the field.
I received the vaccine on Mar. 11th.  I had soreness in left arm the 12th and 13th in muscle that was injected.  On March 19th at 6:15am my left arm started itching around the injection site, is red and feels hot to the touch.  My arm itches a couple inches above my elbow on the anterior side as well.
achy arm [after booster dose]; felt tired [after booster dose]; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy arm [after booster dose]) and FATIGUE (felt tired [after booster dose]) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 0251321A and 010A21A) for COVID-19 vaccination.     The patient did not have any allergies and was never tested or diagnosed for Covid-19. The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Myalgic encephalomyelitis (since she was 25 years old. did not flare after the Moderna doses.).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (achy arm [after booster dose]) and FATIGUE (felt tired [after booster dose]). At the time of the report, PAIN IN EXTREMITY (achy arm [after booster dose]) and FATIGUE (felt tired [after booster dose]) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-532806, MOD-2022-532802 (Patient Link).   Reporter did not allow further contact
Left side of neck and throat swelling about 20 minutes after the shot, numbness on left side of face, tongue. Symptoms lasted a full 7 days.
patient had developed persistant cough after COVID vaccine. he progressively got weaker and presented to the ED po2 was 61 patient was admitted to hosp on 08/10/2021   patient discharged on 08/22/2021
Information has been received from a registered nurse concerning a 5 year old healthy male child who on 08/29/1997 was vaccinated with varicella virus vaccine live. On 01/06/2002 the child broke out with a rash, and on 01/07/2002 the child presented to his physician and was diagnosed with varicella. No treatment was ordered, and the child received comfort measures only. At the time of this report, the outcome of the event was unknown. No further info is expected. The nurse also reported that a 6 year old female and a 7 year old male developed varicella following vaccination with varicella virus vaccine live (WAES0201USA01195 and 0201USA02891).
I woke up around 4am at night because my feet were tingly, like pins and needles. At first I thought maybe I was wearing tight socks, so I took them off, but it wouldn't go away, so then I thought maybe it's just how I have been sleeping so I woke up and started to walk around. I noticed that my feet weren't only just tingly, but they also felt heavy to walk around. It felt like someone had put weights on my feet, and I could hardly pick them up to move. This was on going for about 45 min until I panicked, and I called the ER. They told me since there wasn't much information about adverse effects from the vaccine to just monitor it, and if it didn't go away to go to the ER. It did take about 3 to 4 hours for the sensation to leave. It did gradually fade, so it wasn't the same height of sensation the whole 4 hours.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 13-year old male patient, who had no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported) on 20-JAN-2014 at 10:20 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Parent were going to consult physician and declined to repeat vaccination. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
This case was reported by a pharmacist via call center representative and described the occurrence of chest tightness in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 10th September 2018, the patient received the 2nd dose of SHINGRIX. On 11th September 2018, 1 days after receiving SHINGRIX, the patient experienced chest tightness, tiredness and appetite lost. On an unknown date, the outcome of the chest tightness, tiredness and appetite lost were not recovered/not resolved. It was unknown if the reporter considered the chest tightness, tiredness and appetite lost to be related to SHINGRIX. Additional details were provided as follows: The pharmacist called on behalf of a patient. The patient did not get the SHINGRIX vaccine at her pharmacy; however, the patient started having tightness of chest and loss of appetite. The pharmacist said that the patient was also barely getting out of bed, just feeling run down; she then clarified that what she meant by these two events that the patient if feeling tired.
TIA Mini stroke; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA Mini stroke) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 037B21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, LISINOPRIL, HYDROCHLOROTHIAZIDE and SIMVASTATIN for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA Mini stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 27-Mar-2021 to 29-Mar-2021 due to TRANSIENT ISCHAEMIC ATTACK. On 29-Mar-2021, TRANSIENT ISCHAEMIC ATTACK (TIA Mini stroke) had resolved.            Treatment was not reported.  Very limited information regarding this events has been provided at this time.  Based on the 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. Further information has been requested.   This case was linked to MOD-2021-272348 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time.  Based on the 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. Further information has been requested.