chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccinated with DTaP in 08/03/04 left arm IM. Family reports "redness and itching" on child arm (left).  08/04/04: Family took child to ER instructed to follow up with PMD, give Tylenol and Benadryl, apply ice to left arm. Brought to health unit 08/05/04-cellulitis noted 70x62mm, red, hardened area warm to touch, child alert, behavior appropriate for age. Caretaker denies child feeling ill or having fever. Instructed to continue to observe area-apply warm moist compresses 203 times a day. Keep follow up with PMD. Return to ER/PMD if area progressively worsens (area marked with into to note margins) also instructed caretaker to take no more (DTaP). Received flagged for this. Pt caretaker verbalizes understanding. Instructed to call if any questions or concerns.
W/i minutes dizziness, lightheadedness lasting 8 hours > flushed, aches fatigue headache for last 24 hours.
Patient immediately got lightheaded after receiving the vaccine. About 5-10 minutes after she fainted but regained consciousness. Patient was nauseous, her ears were ringing, and felt extremely hot. 911 was called and patient was taken to the hospital.
Rash 12 days after injection around injection site.  Severe back ache chills.  Inflammation of whole body.  Rash spread to neck and left side of face.  Then I started having worse back pain, pelvic pain, incontenance, painful to pee, urge to pee all the time.  Abdominal swelling.  Tests came back all negative for infection but steroids and antibiotics are helping.
This case was reported by a pharmacist via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX. Less than one day after vaccination with FLUARIX, the subject experienced injection site pain. The next day, the area was hard (hardness injection site) and a blister formed (injection site blisters). It was reported that it took a week for the events (issue) to resolve. The reporter indicated that this event occurred with seven patients that received FLUARIX. Linked cases include A0950536A, A0950542A, A0950543A, A0950544A, A0950545A and A0950546A.
Given the  booster at a double dose (0.5); This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Given the  booster at a double dose (0.5)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 04-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Given the  booster at a double dose (0.5)). On 04-Nov-2021, ACCIDENTAL OVERDOSE (Given the  booster at a double dose (0.5)) had resolved.      No concomitant medications were reported.  No treatment information was provided.
Pregnant patient received the first dose of Moderna covid-19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of Moderna covid-19 vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-Jun-2020 and the estimated date of delivery was 28-Mar-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of Moderna covid-19 vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 16-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of Moderna covid-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported. On unknown date in Jul 2020, the pregnancy test was positive.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
For two months : inability to work or get out of bed due to severe symptoms including headaches, muscle, joint, nerve pain, fatigue, malaise, cognitive disturbances aka brain fog
mom reports child spiked T 103.6(R), lasting up to 72 hrs-mom states pt had X1 mucus emesis last noc. Mom gave child Tylenol /q 4hrs except @ noc. Mom enc to see family MD today.
Patient reports she developed left chest Herpes Zoster 11 days after second shot and wanted it reported as adverse reaction.; This is a spontaneous report from a contactable physician. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810), intramuscular, administered in Arm Left on 11Feb2021 (at the age of 74-year-old) as dose 2, single for covid-19 immunisation. Medical history included hyperlipidaemia and peripheral neuropathy. Concomitant medication(s) included Gabapentin, Atorvastatin, prasterone (INTRAROSA), vitamin b12, ubidecarenone (CoQ10), calcium, multivitamin. Patient did not receive any other vaccine in four weeks. The patient previously took statins and experienced drug intolerance. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: 3249(Obscured by other product labelling)), intramuscular, administered in Arm Left on 21Jan2021 (at the age of 74-year-old) as dose 1, single for covid-19 immunisation. The patient reported she developed left chest herpes zoster 11 days after second shot and wanted it reported as adverse reaction on 22Feb2021. Patient received treatment for adverse event as Valacyclovir. Patient did not have covid prior vaccination and covid was not tested post vaccination. The outcome of event was recovered on an unspecified date of 2021.  Follow-up attempts are completed. No further information is expected.
Urine color changed.  Similar to the color of ice tea with some red . It has been 3 days since last vaccine.  Is this a side effect of the vaccine?  What do you advise.  I have had all symptoms headaches, muscle aches, nausea, fever and chills. Physically (3rd day after vaccine) I feel fine.  no burning when urinating.  Concerned about urine color
Dizziness, fainting and chest pain within few minutes after vaccination. Transferred to ER by EMS in stable condition.
Pt recvd 3 doses of Engerix-B on 07MAR90, 13APR90, & 09SEP90 & it was determined that pt failed to seroconvert;
10 mins after administration of influenza and Shingrix vaccine patient experienced facial swelling, scratchy throat, and tachycardia.  Patient self treated with Benadryl 50 mg PO and Pepcid 20 mg PO.  Outcome: adverse reaction symptoms resolved.
Severe vomiting started approximately 13 hours after shot and lasted for about 10 hours.
Approximately 10 minutes after PREVNAR was given, child developed redness and slight swelling at injection site (5-6 cm and warm to touch). Given Benadryl. Redness improved after 20 minutes. Then soon returned to office with a faint generalized macular rash to face and BLE. She was sleeping without distress. Monitored in office. Rash resolved 40 minutes later except for half dollar size urticaria to left buttock.
This spontaneous report as received from a physician refers to a 64 year old male patient. The patient's current conditions or medical history were not reported. On 27-JAN-2014 at 5:25 pm, the patient was vaccinated with the first dose of VARIVAX (merck) subcutaneous (lot number reported as 1718AA) (dose was not reported) instead of ZOSTAVAX. On 15-FEB-2014, the patient experienced herpetic like rash on right lower back like a band. At the time of the report outcome for herpetic like rash was unknown. The patient was treated with VALTREX 1g every 8 hours. The reporter considered herpetic like rash to be medically significant because it required medical/surgical intervention to prevent serious criteria. This is one from two cases from the same source. MARRS 1401USA013877. Lot number 1718AA is an invalid lot number for VARIVAX (merck). That lot is for sterile diluent. Additional information has been requested.
I experienced blisters/ mouth ulcers within 24 hours of being vaccinated and lower back ache + abdomen discomfort (akin to period pain) within 48 hours.
Pt got shot in afternoon at 7/19. Deltoid swelling & swelling & pain under arm spreading to chest. No redness but swelling. Resolved on its own with MOTRIN.
This spontaneous report has been received from a physician referring to an unspecified number of patients of unknown age and gender. On unspecified dates, an unspecified number of patients was vaccinated with GARDASIL (lot # L040459, expiration date 06-APR-2017, dose and route were not reported) which was improperly stored (incorrect product storage). There was no previous temperature excursion and the temperature of storage was 30.2 F, and the time frame was 41 hours. No symptoms reported. Additional information has been requested.
My eyes started matting up very badly. The left eye wants to stay shut; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (My eyes started matting up very badly. The left eye wants to stay shut) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058f21a, 031A21A and 022M20A) for COVID-19 prophylaxis.   Concurrent medical conditions included Blood pressure high, High cholesterol and Drug allergy (Unspecified drug). Concomitant products included AMLODIPINE, PANTOPRAZOLE, LEVOTHYROXINE, COLESEVELAM, METOPROLOL, LOSARTAN and PAROXETINE for an unknown indication, APIXABAN (ELIQUIS).   On 22-Feb-2021 at 1:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021 at 3:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021 at 2:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2022 at 4:45 PM, the patient experienced OCULAR DISCOMFORT (My eyes started matting up very badly. The left eye wants to stay shut). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 16-Apr-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, OCULAR DISCOMFORT (My eyes started matting up very badly. The left eye wants to stay shut) had not resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in .  The patient taking other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 Vaccine.   Device Date: 17-Apr-2022
faint; Sudden dizziness/felt dizzy; Still had slight fever 99F from previous day this morning; Found heart rate high 80+ to 95+ while lying in bed (Fitbit readings and felt heavy heart beat).; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6205), via an unspecified route of administration, administered in left arm on 05Mar2021 at single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient had no known allergies (not to his knowledge). Concomitant medication included atorvastatin calcium taken for high cholesterol. The patient received first dose of bnt162b2 on 09Feb2021 for COVID-19 immunisation. On 07Mar2021, at around 09:15am, the patient experienced sudden dizziness, faint, while sitting drinking coffee on usual Sunday call with family. This was about an hour after rising. Patient still had slight fever 99F from previous day this morning. Dizziness was only relieved by lying down so he got into bed, and tried to get up a few times, but felt dizzy.  Patient found heart rate was high at 80+ to 95+ while lying in bed and felt heavy heart beat. Heart rate finally back to normal 70+ around 3pm. There was no treatment received for the events. The patient had no Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was recovered on an unspecified date.
Soreness in shoulder and soreness in lower back lower back pin radiated to right buttock and to shin of right leg and has remained and gotten worse.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Patient reports being prescribed methylprednisolone do treat swelling and soreness.  Patient reported having arm soreness that lead to a "sore heart muscle."
Patient started to feel dizziness about 3-5 minutes after vaccine was given. Looked really pale, had a headache and felt hot.
Hair loss; This case was reported by a other health professional via call center representative and described the occurrence of hair loss in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number LD3NH, expiry date 11th December 2021) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was unknown.   It was unknown if the reporter considered the hair loss to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced hair loss. The HCP did not give any diagnosis other than hair loss related to administration of shingrix and did not prescribe anything for the patient. The reporter consented to follow up. This case linked with US2020AMR160960, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR160960:same reporter
The day after skin started to peal on both upper arms. The following day started on both upper legs and 3rd day both legs were pealing a lot.
vision loss; Patient suffered and eye stroke with vision loss; Booster; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Oct2021 (Lot Number: Unknown) (at the age of 72-year-old) as dose 3 (booster), single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient's known allergies was unknown. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. The patient previously took dose 1 and dose 2 of bnt162b2 (Lot Number: unknown) on an unspecified date for COVID-19 immunization. On 04Nov2021, patient suffered eye stroke with vision loss. The seriousness criteria of events was disabling or incapacitating. These event resulted in Doctor or other healthcare professional office/clinic visit and emergency room /department or urgent care. Patient's doctor commented that he was the second person he had seen had an eye stroke about 3 weeks after receiving the booster shot. Treatment was given for events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The outcome of events was resolved with sequelae (Resolved with lasting effects as reported) on an unspecified date in Nov2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
A territory representative reported that a 74 year old male received Pnu-Imune 23 vaccine on 11/27/00. On 11/28/00, he developed "large" cellulitis at the injection site. The reporter noted that the pt received a previous dose of Pnu-Imune 23 on 12/9/99. He was seen in the ER and treated with cephalexin. He recovered.
24 hours after the shot - Hot flashes, under arm gland swollen (left side) and painful. Area is really sore and numb like feeling.  48 hours after the shot - Left neck gland swollen, no pain at the moment. Still feeling extremely tired. Taking Motrin to handle swelling/inflammation
Patient states that she started developing blisters in her mouth about 3 days after receiving the Shingrix vaccine. Advised patient to make a doctors appointment to be seen
Pt recv vax on 12/19/98; on same day pt exp irritable, hives, warm feeling
sx began 4 hrs p/taking 1st capusle; p/3rd dose thinking about going to hosp;
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    60 doses was received to several patient from Lot AS7148B.  Concomitant medications were not reported.  No treatment information was provided
Administered 10-6-11, patient had swelling of lower lip early A.M. on 10-8-11. Then upper lip morning of 10-9-11. Began BENADRYL at onset of swelling & has continued since.
This spontaneous report was received from a nurse, referring to a patient of unspecified age and gender. Information regarding patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 21-DEC-2017, the patient was inadvertently vaccinated with improperly stored doses of GARDASIL 9 lot # N022584, expiration date 15-JUN-2020, for prophylaxis (strength, dose, route and frequency were not reported). The following temperature excursions were reported: temperature below 32°F during 6 hours 9 minutes, 30.8°F during 2 hours 57 minutes and 31.9°F during 3 hours 12 minutes. Temperature excursion was of 32°F to 35°F during 3 hours 4 minutes, multiple excursions were reported. Previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of the multiple reports received from the same reporter.; Sender's Comments: US-009507513-1801USA001528: US-009507513-1712USA013720: US-009507513-1801USA002100: US-009507513-1801USA002098: US-009507513-1801USA002099:
Moderna vaccine received on 12/21 from my workplace. Rash (reddened skin not raised) appeared after vaccine was given (within 24hrs) the size of a quarter and was gone 3 days later.  Now on 1/3 the rash (red bullseye not raised) came back the size of a baseball and is warm to the touch. Went to urgent care and physician called it a delayed adverse reaction to the moderna vaccine 1st dose
Information has been received from a physician concerning a 2 month old male, with no medical history and no allergies, who, 'about a month ago," on approximately 16-APAR-2007, was vaccinated with a dose of Rotateq. There was no concomitant medication. "About one month ago," on approximately 16-APR-2007, the patient developed a bloody stool. The patient's bloody stool lasted overnight and was considered to be recovered by the reporter. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Upon internal review, the patient's bloody stool considered to be an other important medical event. Additional information has been requested.
Patient had fever, swelling, redness at the injection site that made her report to urgent care for evaluation. Upon examination today, the patient also had some bruising on her arm around the inject site.
macular rash of arms - (not at site of inj.) No SOB, trouble swallowing or other complaints.
worsening pain in lower extreme ties; worsening pain in lower extreme ties; elevated CRP; injection pain; swelling; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) (batch number 432T3) for prophylaxis.   On 30-JUN-2023, the patient received Shingrix. On 30-JUN-2023, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection pain) and swelling (Verbatim: swelling). On an unknown date, the patient experienced pain of lower extremities (Verbatim: worsening pain in lower extreme ties), condition aggravated (Verbatim: worsening pain in lower extreme ties) and c-reactive protein increased (Verbatim: elevated CRP). The outcome of the injection site pain, swelling, pain of lower extremities, condition aggravated and c-reactive protein increased were not resolved.   It was unknown if the reporter considered the injection site pain, swelling, pain of lower extremities, condition aggravated and c-reactive protein increased to be related to Shingrix.     It was unknown if the company considered the injection site pain, swelling, pain of lower extremities, condition aggravated and c-reactive protein increased to be related to Shingrix.   Additional Information: GSK Receipt date: 10-AUG-2023 The patient received Shingrix vaccine and onset of symptoms immediately followed with injection pain, swelling and joint.  The patient first reported these symptoms to the office on 17th July 2023 after symptoms were not improving.  At the time of reporting, symptoms persisted and worsening pain in lower extremities.  The patient also experiencing elevated C-reactive protein increased (CRP) in bloodwork. The reporter agreed to follow up from GlaxoSmithKline (GSK).