chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very bad local reaction to the first dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of local reaction in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced local reaction. On an unknown date, the outcome of the local reaction was unknown.   It was unknown if the reporter considered the local reaction to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported.  The patient received 1st dose of shingrix and experienced local bad reaction and afraid of getting 2nd dose. The reporter inquired about the efficacy of 1 dose of shingrix. The reporter just wanted to know the percentage effectiveness of one dose. The information regarding consent to follow was not reported.
Developed hard, warm, red , slightly raised area over my Right deltoid. Obvious injection hole in center of  raised area.
Blurred vision, especially in right eye. Lasting for days. Dull steady headache. Terrible tinnitus in ears. Lethargic and tired for days
Patient's mother reports the patient has a Petechiae rash on the upper lip 1 day post vaccination for 3rd Pfizer vaccine, no difficulty breathing, no other rashes anywhere on the body
sore all over; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date and experienced no adverse event).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovering/resolving.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient took 1st Shingrix shot and stated "it was like nothing at all" compared to the second shot. The reporter stated that after the second Shingrix shot the patient was sore all over. The reporter did not have lot number and did not wish to provide the health care provider's information. The outcome of the event was reported in source document as recovering and resolving, however it was reported as not recovered and not resolved.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Additional Details: LARGE BRUSING AREA IN THE ARM
This spontaneous report was received from a male patient of unknown age regarding himself. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient experienced injection site pain after receiving PNEUMOVAX23. The outcome of injection site pain was unknown. The relatedness for injection site pain was unknown for PNEUMOVAX23. Additional information is not expected.
My daughter began with having seizure type spasms in her arm and leg in late January 2008 (had an mri on 1/30/08) and was diagnosed on February 4, 2008 with Multiple Sclerosis.
Terrible headache; I felt weak for about five hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 96 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Mar2021 (Batch/Lot number: unknown) at the age of 96 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Neuropathy peripheral" (unspecified if ongoing), notes: Verbatim: Neuropathy; "Seizure" (unspecified if ongoing), notes: Verbatim: Seizures; "blood clots" (unspecified if ongoing), notes: Consumer stated, "I have blood clots, I had one may be about nine years ago and there was small one in leg about seven years ago, I take 'Clonidine' (not clarified), I take 2 mg and 3 mg, sometimes I have to take 2 and at certain days I have to take 3 mg, it is a little pill. I take it orally everyday." (medication name not clarified, hence not captured in tab). Concomitant medication(s) included: GABAPENTIN taken for neuropathy peripheral; PHENYTOIN taken for seizure. The following information was reported: HEADACHE (non-serious) with onset 14Mar2021, outcome "recovered" (14Mar2021), described as "Terrible headache"; ASTHENIA (non-serious) with onset 14Mar2021, outcome "recovered" (14Mar2021), described as "I felt weak for about five hours". Therapeutic measures were taken as a result of headache, asthenia.  Additional information: Phenytoin; Dosage text: one in morning and one in night, capsule, orally. Consumer stated, "I have blood clots, I had one may be about nine years ago and there was small one in leg about seven years ago, I take 'Clonidine' (not clarified), I take 2 mg and 3 mg, sometimes I have to take 2 and at certain days I have to take 3 mg, it is a little pill. I take it orally every day." I have Neuropathy and it is in my feet and hands and it was about 5-6 years ago it started and it was very mild otherwise I am okay. I take Gabapentin and I think it is 400 mg (consumer was not sure of the dose)." Treatment: Consumer stated, "They told me to take Tylenol and that is all I took, the extra strong and it is over the counter. I took two and I laid down and then I woke up then it started again, so I took one, so throughput the day I took three, it is 500 mg each and it is capsule. I took two after I got the shot and one was four hours after."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna /Pfizer / BioNTech; Reoccurrence of COVID symptoms and positive test; Reoccurrence of COVID symptoms and positive test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 2, single (Lot number: FF2593), in left arm and on 23Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 09Mar2021 as dose 1, single (Lot number: 030A21A), in left arm and on 05Apr2022 as dose 3 (booster), single (Lot number: 025B21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Reoccurrence of COVID symptoms and positive test"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Moderna /Pfizer / BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19; Positive, notes: Reoccurrence of COVID symptoms and positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No Other medication in 2 weeks, treatment with Paxlovid (Treatment start date: 29Jul2022, Treatment stop date: 02Aug2022) Indication: Treatment of COVID-19, no known allergies.
Rash; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number Z4359, expiry date 19th September 2021) for prophylaxis.   On 18th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2019, less than a week after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient was experiencing a rash about size of 3 inches by 6 inches between the injection site and the elbow. The reporter briefly mentioned, he had seen rash with other patients whom he had vaccinated Shingrix in the past, refer case US2019AMR117476.  No further details were provided.
body aches; chilling; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (On an unknown date patient received the 1st dose of shingles vaccine refer case.US2022AMR125278).   In August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than 3 weeks after receiving Shingles vaccine, the patient experienced general body pain and chills. On an unknown date, the outcome of the general body pain and chills were not recovered/not resolved.   It was unknown if the reporter considered the general body pain and chills to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient was sucked with both shingles shots but it was better than getting the shingles. The patient just had body aches and chilling. The patient stated that, he/she would get it if others could. Additional Supportive Information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR125278:same patient, other dose US-GSK-US2022AMR117863:tag at post
Pt. received Influenza vaccine L deltoid 11/6/07 and immediately had pain at injection site and L shoulder pain.
Rec'd GARDASIL #2 10/14; on 10/16 had onset of papular, itchy rash on belly and chest; spread to back and arms. Papules are nonpustular, 1-2mm, no erythema. Pt has prior allergy to uncoated tablets taken orally, no other h/o vaccine rxns.
pt had pfizer doses 1 & 2 previously -- 2nd pfizer dose given 4/9/2021 -- patient at clinic today to receive Moderna booster (half dose) -- dose given at 10:56, around 11:02 am she started experiencing itching on her chest, dry throat/cough -- 25mg po benadryl given -- medical response team called for assistance -- Dr. listened to her lungs which were clear at the time - BP 158/80  P:79 --- within 2 mins, her throat was becoming tight -- 0.30 epinephrine auto-injector administered --911 called for transport to ER for observation --  immediately symptoms  (itching/throat tightness) resolved -- BP: 134/80 P:109 --  EMS arrived and transported to local ER --
This spontaneous report was received from a nurse prescriber and refers to an unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with doses of improperly stored M-M-R II, lot # N023024 with expiration date : 23-AUG-2019 and lot # N014485 with expiration date: 10-MAY-2019, RECOMBIVAX HB, lot # R004185 with expiration date: 06-NOV-2020, VAQTA, lot # R002086 and expiration date: 22-APR-2019 (route of administration was not specified for all the vaccines), and the patients were administered doses of improperly stored ROTATEQ orally, lot # N030965 with expiration date: 25-AUG-2019 (exact doses and frequency were not reported for all the vaccines). The vaccines were stored in temperature frame between 9 Celsius degrees (C) and 25 for 2 hours and 30 minutes and between 2 C and 8 C for 30 minutes. There was no previous temperature excursion. The temperature excursion was detected because of Digital Data Logger. No adverse effects were reported.
Red area approx baseball size. Swollen, hot to touch consistent with cellulitis. Painful around tetanus injection site from 9/17/03 on right deltoid. Tx: Keflex 500mg once or twice a day for 7 days. Warm compress for comfort. FU with PCP if any changes. Reported to clinic on 9/27/03.
Got shingles, nerve pain after 1st dose of Pfizer (May 18, 2021) Got serious rash all over the body after 2nd dose of Pfizer (June 18, 2021)
Diarrhea; Tiredness; Low grade fever; Slight pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FATIGUE (Tiredness), PYREXIA (Low grade fever) and VACCINATION SITE PAIN (Slight pain at injection site) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal).   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Tiredness), PYREXIA (Low grade fever) and VACCINATION SITE PAIN (Slight pain at injection site). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Diarrhea, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) had not resolved and FATIGUE (Tiredness), PYREXIA (Low grade fever) and VACCINATION SITE PAIN (Slight pain at injection site) outcome was unknown.            Concomitant product use included medications for acid reflux.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Achiness at the injection site day after. Flu like symptoms for th following 3 weeks. Nausea for 2 days.
Had not experienced any adverse effects; PEDVAXHIB administered on 16-NOV-2021 and second dose administered; administered expired PEDVAXHIB; PEDVAXHIB/35-year-old; This spontaneous report was received from a pharmacist concerning a 35-years-old female patient. Patient's concurrent condition, medical history and concomitant medications were not provided.  On 16-NOV-2021, the patient was vaccinated with an expired dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot number S000354 with expiration date on 18-OCT-2021 for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided) (expired product administered/product administered to patient of inappropriate age).  On 16-DEC-2021, the patient was vaccinated with a second unaffected dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) batch number reported as U0144484 with expiration date reported as 15-SEP-2023 for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided) (inappropriate schedule of product administration).  It was reported that the patient was fine and had not experienced any adverse effects.
Left eye, Transparent light brown   half-moon shaped visible for approximately 15 minutes. It  disappeared when I went into the cold weather. Both eyes have irritation, burry and itchy.
Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster. No adverse reaction is reported.
skin  redness , irritation and itching. In arms, midsection and groaning areas. Mostly on the  right side. Moderna Vaccine
COVID 19 Moderna dose given beyond use date.  There were no signs or symptoms of side effects.  There was no treatment necessary.
ON WEDNESDAY 12/09/2020 PATIENT REPORTED THE PHARMACY OF HAVING SEVERE HEADACHES AND ELECTRIC SHOCK GOING DOWN HIS NECK. PATIENT REPORTED THAT HE HAS BEEN HAVING THESE SYMPTOMS SINCE A COUPLE DAYS AFTER GETTING THE VACCINE. PATIENT ALSO REPORTED OF HAVING A RASH/BLISTER BEHIND HIS EAR. PATIENT WENT TO HIS PRIMARY CARE PROVIDER AND WAS PRESCRIBED GABAPENTIN TO HELP WITH THE PAIN. ON WEDNESDAY 12/09/2020 WHEN PATIENT REPORTED THE PHARMACY OF HIS SYMPTOMS, PATIENT WAS RECOMMENDED TO GO TO THE ER OR URGENT CARE IF HIS  SYMPTOMS WERE NOT IMPROVING. ON FRIDAY 12/11/2020 PATIENT REPORTED THE PHARMACY THAT HE WAS DIAGNOSED WITH SHINGLES AND WAS BEING TREATED FOR SHINGLES.
shooting pain to elbow about 4 days after administration. Feels most of the pain in the elbow region and when extending the left arm the pain is more severe.
Incident occurred from possible inviable covid-19 pfizer-purple dose (booster) being administered to the patient. Patient's parent reported no adverse events other than typical ones from covid vaccine. Parent will consider the offer to come back for a replacement booster dose.
Fri swelling, redness both sites with pain & itching immediately following vaccines. Mon still red & swollen but improving slowly. Vaccine sites too low (not in deltoids).
1/13/21 developed 3 swollen lymph nodes.  2 left neck, 1 left armpit.  Tender to touch and visible.  Moderate discomfort 1/15/21 developed red skin reaction and deltoid muscle inflammation on left arm near vaccination site
no adverse event. pt received pfizer bivalent on 9/11/22 and 9/17/22
tension head aches; fatigue; sore arm; Following second dose - low grade fever 99.9 - 100.2 12 hours after the shot that went away on it's own within 24 hours; This is a spontaneous report from a contactable Other Healthcare Professional (patient herself). A 25-year-old female patient (Non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection,), dose 2 intramuscularly administered in the Left Arm on 09Jan2021 at 09:15 (at the age of 25-years-old) as a 2ND DOSE, SINGLE DOSE for COVID-19 immunization, at Hospital. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/Lot Number: Unknown) dose 1 intramuscularly administered in the Left Arm on 19Dec2020 at 11:30 AM as a 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Patient did not receive any other vaccine in four weeks. Other medications received in two weeks were none. Patient did not have covid prior vaccination. She did not have any known allergies and other medical history. On 09Jan2021 at 21:15 following second dose, patient experienced, low grade fever 99.9 - 100.2 12 hours after the shot that went away on it's own within 24 hours. She experienced, sore arm on 10Jan2021, arm for 3 days after vaccination and fatigue, tension headaches on 16Jan2021, for 7 days after vaccination. The patient underwent lab tests and procedures which included body temperature, 99.9 - 100.2, on 09Jan2021. Patient did not receive any treatment for the events. She had not been tested for covid post vaccination. Outcome of the low-grade fever 99.9 - 100.2 12 hours after the shot was recovered on 10Jan2021 and rest of the events were recovered on an unspecified date.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient was discharged from hospital on Friday and received a Pneumovax injection prior to discharge.  Patient states about 16 hours later developed pain, redness, and swelling at the site of the injection which extended into the entire arm and down through the elbow.  Patient was seen in ED, placed on antibiotics and told to follow up with primary care provider on Monday.
Fever with sweats and chills, migraine. Happened overnight, about 12 hours of intensity and 12 hours lingering.
This spontaneous report was received from a Registered nurse regarding 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Reference two previous VAERS reports: ID 1848747, number 703062; ID 1779447, number 677797. Two previous VAERs reports document my adverse reactions to the COVID J&J shot I got on 20 sept 2021.  I had a plethora of adverse reactions (which I will sum up here).  Over the course of 30 days, those adverse reactions got better but did not fully go away. Then I got the flu shot and all of the adverse reactions came back in full force. Today, 12 Dec 2021, I am still experiencing all of them. They are: 1) pounding heart/pulse; 2) elevated blood pressure; 3) chest pain (mostly subsided); 4) random body spasms, mostly while at rest.  Sometimes only a specific body part (ankle, arm, leg, hand, etc) or sometimes my entire body. Each spasm last for only a fraction of a second; 5) feeling of adrenaline radiating across my body, originating from the heart - it almost ?feels? like my heart stops for a fraction of a second (again almost exclusively while at rest); The fact that all of these started after the COVID J&J vaccine and then got worse with the flu vaccine indicate that this is vaccine related.
chills; headache; sore arm/ arm pain; fatigue; weakness; not having an appetite to eat school lunch; she spiked a high fever of 102 degrees/  fever returned to 100 degrees; severe stomach pains that led to vomiting; severe stomach pains that led to vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 9 year-old female patient received bnt162b2 (BNT162B2), administration date 06Dec2021 (Batch/Lot number: unknown) at the age of 9 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 07Dec2021, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset 07Dec2021, outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021, outcome "unknown", described as "sore arm/ arm pain"; FATIGUE (non-serious) with onset 07Dec2021, outcome "unknown", described as "fatigue"; ASTHENIA (non-serious) with onset 07Dec2021, outcome "unknown", described as "weakness"; DECREASED APPETITE (non-serious) with onset 07Dec2021, outcome "unknown", described as "not having an appetite to eat school lunch"; PYREXIA (non-serious) with onset 07Dec2021, outcome "not recovered", described as "she spiked a high fever of 102 degrees/  fever returned to 100 degrees"; ABDOMINAL PAIN UPPER (non-serious), VOMITING (non-serious) all with onset 07Dec2021, outcome "unknown" and all described as "severe stomach pains that led to vomiting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.