chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at injection site; Redness at the injection site; Dose 1 of Shingrix on January 20, 2020, and dose 2 in August 2020; Body aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included eczema and arthritis (unspecified). Previously administered products included Shingrix with an associated reaction of pain (1st dose received in Januray 2020 also experienced injection site pain after receiving 1st dose on 20th January 2020 for futher tolerance refer case US2021AMR015150).   In August 2020, the patient received the 2nd dose of Shingrix (intramuscular). In August 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced injection site pain, injection site erythema and general body pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved and the outcome of the general body pain was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Patient had eczema and arthritis unspecified in past. Patient received the dose of Shingrix and experienced body ache which lasted a day and then resolved also experienced injection site redness and injection site pain which was not resolved till the time of reporting. Patient received 2nd dose later than recommended time interval ,which led to lengthening of the schedule. The reporter consented to follow up. This case was linked with US2021AMR015150 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR015150:Same reporter
3 1/4 by 3 inch area at arm. Chills, aching, red and hot to touch.  Was given antibiotic and steroid to treat from ER and PMD.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.), POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.).    Concomitant medications were not reported.   Temperature excursion occurred several days ago in the Freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. Patient did not report any adverse reaction. The patient received the booster dose. The excursion was noticed in audit.   Treatment medications were not reported.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 13-JUL-2016 the patient was inadvertently administered an expired dose of ZOSTAVAX (19400 PFU, lot # L006392, expiration date 25-MAY-2016, route not reported. The concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
It started about a week after getting the vaccine. I had tingling in my feet and my hands, more prominent on my left side. Like pins and needles. Really hard to remain laying on my back. I cannot breathe. A couple of days back I got really dizzy, I have been really bad nauseous. A couple of days ago my middle finger in my left hand was like a little numb. Yesterday with the doctor they tested my sensitivity and I definitely have less sensitivity in my left side. I have more migraines now. They referred me to a neurologist but I have not seen him yet. The day before yesterday I had really bad pain on my left shoulder, I could not move it so I went to urgent care at 9 am yesterday.
woke up with Chill in the middle of the night; being very hot; moderate nausea and fatigue; moderate nausea and fatigue; significant soreness at the injection site; server headache; muscle pain through both legs, particularly through the lower legs; This is a spontaneous report from a non-contactable consumer, the patient. A 38-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration in arm left on 23Feb2021 10:30 as dose 2 single (at the age of 38-years-old) for covid-19 immunization. The medical history reported as none. The patient concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1 single for covid-19 immunization. On 24Feb2021 02:00 AM, the patient woke up with chill in the middle of the night, that was followed by being very hot. Patient experienced moderate nausea and fatigue. There was significant soreness at the injection site and experienced a server headache and muscle pain through both legs, particularly through the lower legs. The patient did not have allergies to medications, food or other products. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications within 2 weeks of vaccination. The patient did not diagnose with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The reporter assessed this case as non-serious. The outcome of the events was recovered.  No follow-up attempts were possible. No further information was expected.
Received injection in Apr2018; reportedly had normal blistering reaction that resolved. In Dec2018, started developing pruritus at the site, eventually became well demarcated erythematous patch w/ raised border and crusting. No vesicles/pustules or blister.
pt recvd vax & told mom stomach hurting began falling; then pt began shaking for a few seconds then became stiff; lost consciousness for few seconds; pale & frighten;
Pt recvd 3 doses of Engerix-B & on 24OCT91 pt exp needlestick & it was determined that pt did not respond to the vax series; 4th doses of Engerix-B & HBIG was given;  4th & 5th dose of Engerix-B given & pt did not respond;
Fever Headache Left arm discomfort Malaise; Fever Headache Left arm discomfort Malaise; Fever Headache Left arm discomfort Malaise; Fever Headache Left arm discomfort Malaise; This is a spontaneous report from a contactable physician.  A 33-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular in the left arm on 16Dec2020 at 10:45 (at the age of 33-years-old) as a single dose for COVID-19 immunization.  Medical history included generalized anxiety disorder, gastrooesophageal reflux disease, vague gallbladder, and lactose allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Dec2020 at 21:00, the patient experienced fever, headache, left arm discomfort, and malaise. Therapeutic measures were taken as a result of fever, headache, left arm discomfort, and malaise and included treatment with paracetamol (ACETAMINOPHEN). The clinical outcomes of the fever, headache, left arm discomfort, and malaise were recovered on an unknown date in Dec2020.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sore arm; Fever; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and MYALGIA (Muscle ache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and MYALGIA (Muscle ache). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and MYALGIA (Muscle ache) had not resolved.            No treatment information was provided.  No relevant concomitant medications were reported.
On 1/13/20, patient received a flu shot.  On 1/17/20,  she complained of having about 10 red splotches near the injection site that were 6 inches long and 3 inches wide.  She said the splotches were not itchy.  She was not having any problems breathing.
Breakthrough case of COVID  Positive test 05/19/2022. I was in the hospital beginning 05/17/2022 for 32 hours due to epigastric pain and esophageal pain. Internist Dr. and hospital GI. A CAT SCAN fluid surrounding lungs (plural effusions), thickening at the gastroesophageal junctions. I had an upper endoscopy that was normal, no issues from the inside. I was discharge and they asked my PCP to order a PET Scan. Results of Pet Scan were sx of the Covid, and I am waiting to meet with the GI to see if ore testing is needed. D/C from hospital on 05/18/2022. 05/19/2022 lost sense of taste of and smell and I developed mild congestion and fever of 101 at the highest. I took a home Covid test that came back positive. 05/20/2022, I started on Paxlovid due to concerns with the fluid in my lungs. I am 16 days out and I just have some shortness of breath with mild exertion and leftover fatigue, but that is improving as well.
Headache all day; fever over the course of 3 hours reaching 2.7° above my normal temperature subsiding after 3 hours and after taking Advil
Hard red bump, itchy, uncomfortable, appearing around 5 days after the vaccination and seemingly worse 7 days after (today reporting) Itchy & irritated eyes - recent floaters seem worse. Scary!  Will the second dose make these side effects worse?
14 hrs after 2 vaccines in Rt arm I developed elevated fever, asthma, trembling, nausea & excessive urination. Felt weak - had ice pack on arm - 5" below injection a rash developed with itching, erythema & pain. No food in 2 days. Called another pharmacist in PM 11/20/11. Recommended MD on 11/21/11. Now I have 1" band red 5 " below inj. Sat 11AM unable to see MD yet.
extreme pain at injection site; difficulty raising arm and lifting objects; sirva; vaccine was administered too high on the deltoid resulting in symptoms that occur with Sirva; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 47-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number E975Y, expiry date 25th June 2020) for prophylaxis.   On 17th October 2019, the patient received FluLaval Tetra 2019-2020 season. On 17th October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site pain, injected limb mobility decreased, shoulder injury related to vaccine administration and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the shoulder injury related to vaccine administration and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and shoulder injury related to vaccine administration to be related to FluLaval Tetra 2019-2020 season.  Additional case details were reported as follows: The patient had extreme pain at the injection site.  The patient has difficulty raising his arm and lifting objects.  The reporter suspects the vaccine was administered too high on the deltoid, which led to vaccine administered at inappropriate site. This resulted in symptoms that occur with SIRVA (shoulder injury related to vaccine administration). The reporter consented to follow up. This is 1 of 8 cases reported by same reporter.
Swollen lips; Tingly lips; Scratchy throat; Dizzy; Vomiting; Headache; This is a spontaneous report from a contactable consumer (patient). A 14-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiry date: not reported, at the age of 14-year-old), dose 1 via an unspecified route of administration, administered in left arm on 22May2021 17:15 as dose 1, single for covid-19 immunisation. The patient previously took penicillin and experienced penicillin allergy. Concomitant medication was none. The patient did not receive any other mediations in two weeks of vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22May2021 19:00, the patient experienced swollen lips, tingly lips, scratchy throat, dizzy, vomiting, headache. Therapeutic measures were taken as a result of reported events which included treatment with benadryl and other unspecified over the counter medications (OTC) from an unspecified date in May2021 and unknown if ongoing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of events was recovering.  The lot number for BNT162b2, was not provided and will be requested during follow up.  No follow-up attempts are possible. No further information is expected.
Around 6:30 PM client was eating supper at grandmother's.  Grandmother noticed yellowish brown discoloration around mouth, Grandmother said it was "chocolate colored".  She also had swollen lips.  No breathing problems.   On 01/29/2010 lips still puffy along with cheeks.  Grandmother called ER at 7:15 PM and was advised to give child Benadryl.  Child had liquid Benadryl dose appropriate for her age on 01/28/2010 at 8:30PM, another dose on 01/29/2010 AM.  Grandmother was advised to give client 3-4 doses of Benadryl 12 hrs apart.  Client parents are out of town until 02/01/2010.
Approx. 5 mins after the injection of Moderna dose #1; experienced a hot flash-it subsided but then reports a short period-few minutes-of what felt like "my heart racing".  Then her lips began to tingle and progressed to tingling in her tongue and eventually the back of her throat felt scratchy.  By the end of the 30 min. observation signs/symptoms were dissipating except her throat felt dry.  No visible signs of lips swelling noted.
Pt received the first dose of Moderna vaccine at 1:36 pm. At 1:55 pm pt felt dizzy and fell to the ground. Pt was conscious during the event and his blood pressure was 97/80. Per pt pt had no injury and was feeling fine when he left the pharmacy at 2:10 pm. No Epipen was needed and the pharmacy staff did not need to call 911, . Per pt pt has not had any severe reaction to any vaccine before.
Fever up to 101 16 hrs post-injection. Severe myalgia and fatigue. Improving on day #2
Fever Chills Headache Body Ache Nausea Tiredness Insomnia
9 days after initial dose my arm begin to hurt as if was given an injection not as bad as day of vaccine,  in the evening I developed raised hives in area of vaccine and itchy. Spoke to Dr, advised to use Benadryl and take Zyrtec daily. Had under armpit discomfort, also faed after few days. Hives faded after few days.  My shoulder area where vaccine was given is achy and burning still after 3 weeks. Unsure if getting the 2nd dose is safe. All above did not happen initially but began 9 days after vaccine was given
RASH  ON THE LOWER RIGHT ARM THAT WENT TO THE LEFT ARM AND UPPER PARTS INCLUDING ABDOMEN, BREAST, AND FACE. ( ONLY UPPER EXTREMITIES ) SEVERE ITCHING, SHORTNESS OF BREATH,
Adverse event: High fever (101+) with headache and extreme soreness on right side of body (arm, shoulder, back, leg all the way to foot.) Queasy stomach, no vomiting. Extreme pain at inside of right elbow, causing throbbing in right hand. These symptoms lasted 40 hours before they began to receded. I took 2 pills Excedrin migrane at noon on October 27 (day after vaccination, day one of symptoms) I took 1 low dose asprin on October 28th at 10 am. I drank a LOT of water the entire time.  Currently (November 12, 2021) still experiencing  continuing soreness in right shoulder, limiting rotation motion. Pain seems to come from front side of shoulder at joint.
About 20 lesions, mostly on trunk, few on face. Vesicles, papules and scabbed papules. DX Varicella, TX Acyclovir.
Vial was in the refrigerator for 7 days post puncture; Received expired 2nd booster 7 days post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster 7 days post puncture) and PRODUCT STORAGE ERROR (Vial was in the refrigerator for 7 days post puncture) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster 7 days post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was in the refrigerator for 7 days post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster 7 days post puncture) and PRODUCT STORAGE ERROR (Vial was in the refrigerator for 7 days post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.    It was reported that the expiration date was unknown. The number of doses per vials was 2 doses per 1 vial. On 19-May-2022 the vial was initially stored in refrigerator. The vial was first punctured on 19-May-2022 about 9:30AM. Vial was stored in refrigerator post puncture. It was in the refrigerator for 7 days post puncture. The vail did not undergo any temperature excursions. Vial was exposed to room temperature for more than 24 hours.  No treatment information was reported.   This case was linked to MOD-2022-583040 (Patient Link).
Narrative:  78yo in hospice care with cancer (Primary malignant neoplasm of sigmoid colon ) died at home in home hospice care om 8/14/2021. Pt had received covid vaccines on 2/25/21 & 3/25/21. Death not related to vaccines.
he got covid 3 to 4 days ago; he got covid 3 to 4 days ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.1 (BNT162B2, BNT162B2 OMI BA.1), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Dec2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "he got covid 3 to 4 days ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) he got covid 3 to 4 days ago.  Clinical course: Caller said received all the five shots of the Pfizer covid-19 vaccine and couldn't believe he got covid 3 to 4 days ago.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
on the night after the shot i had diarhea and heart palpitations then on Jan 15,in the afternoon I started having chills,on the 16th I had a fever 2 dgrees above normal, that lasted under an hour. On the 17th,My blood pressure went way up, until by 3am it was 195 over 116. I went to the emergency room and when I got into a room, it had dropped to 144 over 92. It has stayed well within my normal range.
Information regarding PREVNAR was received from a patient's Mother regarding a 5-month-old female patient who experienced growling noises described as hoarse wheezing, suspected chest infection, growling noises described as hoarse wheezing, peribronchial thickening, esophageal ulcers, blood in stools, bronchiolitis, severe reflux and stopped eating. At 5 months of age, the patient received the first dose in Jun-201. The patient also received a dose of Haemophilus Influenza Type B Polysaccharide (manufacturer unknown) in Jun-2010. In Jun-2010 the patient was administered PREVNAR just before 12:00 and at 18:00 experienced growling noises described as hoarse wheezing. Over the next seven days the patient continued to wheeze and stopped eating. She was seen by her physician and was sent for a chest x-ray which showed peribronchial thickening. The patient's Mother was told by the physician that she suspected a chest infection which was not related to the PREVNAR vaccine. In Jul-2010 the patient stopped eating completely, she began to experience severe gastric problems and blood was appearing in her stools. On 11-Jul-2010 the patient was admitted to the hospital because she had not eaten in 11 days. Unspecified testing showed no viral or bacterial infections and no milk or food allergies. The patient was diagnosed with bronchiolitis and it was determined that the gastric problems were severe reflux caused by esophageal ulcers. On 15-Jul-2010 the patient began treatment with unspecified antacids and the blood in her stool resolved. On 16-Jul-2010 the patient was discharged from the hospital. On 18-Jul-2010 the patient was recovering from the esophageal ulcers and was still experiencing gastric problems. On 19-Jul-2010 that patient continued to recover and the current weight was 21 pounds. The outcome of blood in her stools and stopped eating was recovered at the time of this report. The outcome of growling noises described as hoarse wheezing, suspected chest infection, peribronchial thickening, esophageal ulcers, bronchiolitis and severe reflux was recovering at the time of this report. No additional information was available at the time of this report.
BODY HURT TO TOUCH, CHILL, HEADACHE, TIRED AND NAUSEOUS