chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weird vivid dream with elevated temperature (99 F) after vaccination, who usually don?t have dream when sleeping
No additional AE reported; one year old son was accidently administered an adult dose of hepatitis A vaccine, instead of pediatric dose; This spontaneous report was received from a consumer (patient's father) and refers to an 1-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-MAR-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, dosage, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported). The patient was accidently administered an adult dose instead of pediatric dose (incorrect dose administered). No additional adverse event was reported.
The backside of my COVID-19 Vaccination Record Card was left void when I left the facility. It states in the literature that the date of the next Dose (No 2) was to be filled out by the Shot administrator.  It remains blank and there is no resources to complete my vaccination of  Dose #2.
Started itching and breaking out in rash 45min, felt like her skin was on fire on the inside. Gave bendaryl 25 mg, Did not want to go to Emergency room, said she did not feel like that was necessary. Day two she reported it was somewhat better and was able to work, using bendaryl for itching,  Day 3 reports itching is worse, I suggested she seek medical advice as might need different treatment than bendaryl. No shortness of breath, had headache, chills and body aches also.
Was feeling fine right after and the remainder of evening until I feel asleep then woke up about 3 a.m. itchy under arms and thighs. Not so bad that I couldn?t sleep so I fell back asleep and woke up around 5:30 a.m. and seen that I had a rash in my arm pits and a long the inside of my arms, seemed to be worse on my left arm. I also had this rash on neck, lower part of face and on the upper part of my legs with a few bumps around knees. I had no rash on my torso, breast or bottom.
Last Menstruated 6/2-6/6/2021  At 4:00pm breast tenderness and pelvic cramps began  At 6:30pm spotting started  At 8:30 pm one sanitary napkin of clots presented  ? bleeding persisted, assumed second period has begun.  6/14/2021  Muscle aches throughout body.   Joint pain primarily focused on hips and tailbone  More bleeding than normal period, considerably more clots and blood is bright red; nor normal crimson clot colored like normal period.  Breast tenderness still considerably worse than normal cycle.
Vaccine given was invalid due to exposure to out-of-range temperatures during transport. Manufacturer, CDC, and medical director recommended revaccination.
Day 1 shortness of breath, as soon as the vaccine went on my chest was tight.  I had to use inhaler to breath.  Day 3 body swollen and hip joint painful to the point that I could not walk.  X-rays show no injuries or break.  Day 7 body still swollen after 13 years of no vaginal bleeding as I had ablation surgery, I am spotting, breast swollen, skin itches due to being stretched due to swelling.
Pt states he received his vaccine and a few days later was diagnosed with COVID.  Pt was asymptomatic at time of vaccine.  Pt quarantined for 10 days and continues to feel poorly, Head and sinus congestion, "my head feels like a brick", fatigue, head ache and worsening hearing loss
longer fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FATIGUE (longer fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (longer fatigue). At the time of the report, FATIGUE (longer fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-073528 (Patient Link).
The site was hot to touch; a red circle around injection site; lump in center; This serious case was reported by a consumer and described the occurrence of injection site erythema in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 27-SEP-2023, the patient received Arexvy (unknown arm). On 28-SEP-2023, 1 days after receiving Arexvy, the patient experienced injection site erythema (Verbatim: a red circle around injection site) (serious criteria clinically significant/intervention required) and injection site lump (Verbatim: lump in center) (serious criteria clinically significant/intervention required). On an unknown date, the patient experienced injection site warmth (Verbatim: The site was hot to touch) (serious criteria clinically significant/intervention required). The patient was treated with cefalexin (Keflex) and doxycycline. The outcome of the injection site erythema, injection site lump and injection site warmth were not reported.   It was unknown if the reporter considered the injection site erythema, injection site lump and injection site warmth to be related to Arexvy.     It was unknown if the company considered the injection site erythema, injection site lump and injection site warmth to be related to Arexvy.   Additional Information: GSK Receipt date: 09-NOV-2023 A reporter reported that his sister (patient) received the RSV vaccine. The day after receiving the vaccine her arm had a red circle around injection site with a small lump in center. The site was hot to touch and informed pharmacy of condition, they told her to see her physician.  Made appointment with family doctor and visited family doctor on 6th October 2023, was prescribed Keflex.  Returned to Family physician on 20th October 2023, conditioned worsened.  He prescribed Doxycycline and sent her to wound Specialist and saw wound specialist on 25th October 2023.  The patient had surgery on vaccine site on 3rd November 2023. The reporter provided the patient's email address for any email exchanges. The reporter consent to follow up.
Patient stated she had headache, especially eye pain, muscle pain, fever and discolored skin after receiving her flu shot and for almost 2 weeks after.
Right ear felt full, next day decreased hearing at 3000 Hertz noted and placed on Prednisone with complete resolution within two days.
Case number PHEH2016US027765, is an initial spontaneous report received from a pharmacist on 24 Oct 2016. This report refers to a 72 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUAD (batch number: 166002) at an unknown dose intramuscularly on 21 Oct 2016. The pharmacist stated that, a female patient received a partial dose of FLUAD. No adverse event reported following this administration error (underdose).
been itching really bad all over; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (been itching really bad all over) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced PRURITUS (been itching really bad all over). At the time of the report, PRURITUS (been itching really bad all over) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
PATIENT IS 61 AND GOT ADMINISTERED FLUAD HIGH DOSE WHICH IS ELEIGIBLE FOR PATIENTS 65 YARS AND OLDER, DUE TO MISCOMMUNICATION ABOUT AGE IN FLU TENT BEFORE BILING INSURANCE
He was given the vaccine at 315pm. We noticed hives at 3:27pm during the Observation Period. We gave him benadryl oral tablet 25 mg. Hives and a little bit of swelling. No shortness of breath. Had itch. 911 was called. Security informed. Ambulance arrived. Patient observed and discharged as per EMS. Discharged. around 4pm.
Narrative: Pt received an expired COVID-19 Pfizer vaccine on 4/6/22. Pt is unclear of the exact date and time of expiration as the syringe was unable to be visualized well since it was already in the sharps container. However, pt is very certain the vaccine was not made on 4/6/22.
Kloe received the FluMist 9/26/09. On 9/27, she has a fever 0f 104 F. I gave her Tylenol to treat this fever.
Information has been received from a physician concerning a 15 year old female who on 06-MAY-2009 was intramuscular vaccinated with her 05ml dose of GARDASIL. Suspect therapy given on the same day included VAQTA (manufacturer unknown). Concomitant therapy included DTAP and MENACTRA. Subsequently the patient fainted and fell on the ground, when the patient came to, she had a migraine. She had a panic attack which included shaking and breathing fast. The patient had sought medical attention. The patient had recovered by the report time. Additional information has been requested.
chronic and persistent joint pain in knees and legs; Excruciating pain in both hands (mostly right hand)/This pain at times radiates to my upper arm; Tingling; Burning Sensation; Preventing a restful sleep at Night; chronic fatigue; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm (at the age of 52-year-old) on 16Jul2021 15:00 (Batch/Lot Number: FA6780) as dose 1, single for covid-19 immunisation. Medical history included penicillin allergy and sulfonamide allergy. Concomitant medications were not reported. On 18Jul2021, the patient experienced chronic and persistent joint pain in knees and legs; excruciating pain in both hands (mostly right hand), tingling, burning sensations, indescribably painful to the point of tears preventing a restful sleep at night this pain at times radiates to my upper arm; chronic fatigue. The patient had clinic visit on 23Jul2021 and received treatment for the events. The outcome of the events was not recovered.
Fever to 101, crying intermittently noc p/DTP; URI sx w/croupy cough second noc, loss of appetite;
Patient developed fever on the day of vaccines administration. On evaluation patient was also found with right arm deltoid area erythema and mild swelling, non tender and without limitation of range of motion. Tx: Cold compresses in right arm, acetaminophen every 4 hours as needed for fever.
Fever 101.5, BP 99/50, HR 112, headache, nausea, myalgia, chills, abdominal pain.  It has now been 2 days and I expect I will have to miss work tomorrow.  If I had realized how severe the side effects would be I would not have had the vaccination.  I will not be having the second dose.  As a physician I will encourage patients to consider whether the benefits justify tolerating the potential side effects.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On an unknown date in JAN-2016, the patient was vaccinated with first dose of GARDASIL (strength, dosing details, anatomical location, lot# and expiration date were unknown). On 12-JUL-2016 (also reported as today), the patient received the second dose of GARDASIL (strength, dosing details, anatomical location, lot# and expiration date were unknown). No adverse symptoms reported. No product quality complaint was involved. Additional information has been requested.
After chemo was left with RA; Systemic reactions as fever; Malaise; Myalgia; 2nd dose had not been administered; This case was reported by a physician via call center representative and described the occurrence of rheumatoid arthritis in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (diagnosed with breast cancer in mid September 2019), breast cancer (had surgery on 27th September 2019) and chemotherapy (started immunocompromising chemotherapy after first dose).   On 29th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant), fever, malaise, myalgia and incomplete course of vaccination. The patient was treated with methotrexate and hydroxychloroquine. On an unknown date, the outcome of the rheumatoid arthritis, fever, malaise, myalgia and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the rheumatoid arthritis, fever, malaise and myalgia to be related to Shingrix.  Additional details provided were as follows: The case was reported by pediatrician for himself/herself. The age at vaccination was not applicable for 2nd dose. This patient received a dose of Shingrix and started immunocompromising chemotherapy after that. It was mentioned that after the first dose the patient experienced systemic reactions described as fever, malaise and myalgia.  The reporter mentioned that after chemotherapy, patient was left with rheumatoid arthritis and as a measure was treated with methotrexate and hydroxychloroquine. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow-up.
Information has been received from a physician concerning her mother with a history of shingles who was vaccinated with a dose of Zostavax. Subsequently approximately one week after vaccination, she developed a mild case of shingles. The patient did not develop vesicles and the shingles only lasted for 3 days and she fully recovered. Unspecified medical attention was sought. Additional information has been requested.
Patient got flu shot on 9-13-17. That evening rash, swollen where shot given. No itching to report.
Rash around my upper body; Itchy; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 08Jun2021 (Lot Number: EW0186; Expiration Date: Unknown) at the age of 27-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were none. Prior Vaccinations (within 4 weeks), the patient stated none. Investigation assessment was none.  On 24Jun2021, after 16 days after the first shot, the patient experienced rash around upper body and it was not just around the vaccine site, the patient became itchy and was just wondering if anybody else has these side effects and wanted to check if anybody else had something similar to that. And both event serious as medically significant. The patient took a Claritin, and an allergy medication, antihistamine Claritin pill as treatment for events. The patient stated that it could be totally unrelated to the vaccine. The scheduled date for second dose will on 30Jun2021. The outcome of events was not recovered.
Diarrhea, vomiting, unable to breathe. I was sick for almost 2 weeks. As of today 6/8/06 I'm still coughing.
Couldn't speak anymore, mumbled but couldn't say what I wanted to stay; This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M2CA) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced SPEECH DISORDER (Couldn't speak anymore, mumbled but couldn't say what I wanted to stay). On 10-Feb-2021, SPEECH DISORDER had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Headache Body aches Severe coughing Fever 100.6 Started 3 hours after vaccine. In bed for next 38 hours. Fever finally broke.  Felt decent day 2.  Still achy and coughing. Day 4 very congested, achy headache , sunlight bothered my eyes. Voice gone, pale but no fever.
PATIENT REPORTED FEELING LIGHT HEADED AFTER GIVING BOTH SHOTS, HE WAS SWEATING ABOUT A MINUTE AFTER THE VARIVAX SHOT. PT FAINTED FOR AROUND 30 SECONDS AND WOKE BACK UP. 911 WAS CALLED AND PT WAS TAKEN TO HOSPITAL. PT DID NOT EAT THE MORNING OF SHOTS AND WALKED 6 MILES BEFOREHAND.
8/20 - Pt reports having nausea, HA, body aches, et diarrhea starting on 8/18 till 8/20. Denies needing doctor's care at this time. Pt says rest at home has helped.
Swelling and pain, mild erythema, slight hyperpigmented skin below deltoid area.
pt rcvd vax; pt devel local reaction; pt experienced itching, shortness of breath;she was treated w/ epinephrine,prednisone;diphenhydramine, & albuterol nebulizer;
pt recvd vax 23OCT95 & pt devel a severe inj site rxn characterized by pain & inflammation;pt has recovered;this is one of six patients from this site who exp the above reaction
Several days after receiving the vaccine, I started to have very dry, irritated, painful and red mouth and chapped lips. The inside of my mouth near my lips was somewhat swollen and my mouth was quite painful and uncomfortable. I could not relieve my chapped lips.  The symptoms lasted for about a month.   I saw a family practice physician, an allergist, dermatologist and an ENT who diagnosed me with Burning Mouth Syndrome with no known underlying cause.   I have had the symptoms crop up again 2 more times in a milder fashion since initial onset. Once in December of 2021 and once in March of 2021.   The issue is chronic and ongoing.
Swollen Lips; throat felt strange; Numb Fingers; Massive Headache; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen Lips), OROPHARYNGEAL DISCOMFORT (throat felt strange), HYPOAESTHESIA (Numb Fingers) and HEADACHE (Massive Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A2A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced LIP SWELLING (Swollen Lips), OROPHARYNGEAL DISCOMFORT (throat felt strange), HYPOAESTHESIA (Numb Fingers) and HEADACHE (Massive Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swollen Lips), OROPHARYNGEAL DISCOMFORT (throat felt strange), HYPOAESTHESIA (Numb Fingers) and HEADACHE (Massive Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: No specific follow-up information recorded.
pt recv vax 30APR97 & 1MAY97 pt devel bumpiness @ inj site;
fuzzy headed; arm hurt; little bit of cough; Body ache; real bad headache; swollen at the site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (fuzzy headed), PAIN IN EXTREMITY (arm hurt), COUGH (little bit of cough), MYALGIA (Body ache) and HEADACHE (real bad headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 18-Nov-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 FEELING ABNORMAL (fuzzy headed), PAIN IN EXTREMITY (arm hurt), COUGH (little bit of cough), MYALGIA (Body ache), HEADACHE (real bad headache) and VACCINATION SITE SWELLING (swollen at the site). At the time of the report, FEELING ABNORMAL (fuzzy headed), PAIN IN EXTREMITY (arm hurt), COUGH (little bit of cough), MYALGIA (Body ache), HEADACHE (real bad headache) and VACCINATION SITE SWELLING (swollen at the site) had not resolved. No concomitant medications and treatment medications reported.This case was linked to MOD-2021-395585, MOD-2021-395756 (Patient Link).
Lip got very swollen; Spontaneous report received on 11JAN2021 from P?zer.  A female consumer reported that her "lip got very swollen" (PT: Lip swelling) following the administration of anthrax vaccine. She inquired if it was safe for her to take Pfizer-Biontech coronavirus disease 2019 (COVID-19) vaccine as she had allergies. She reported that when she took other vaccines (smallpox and rubella) when she was at work she had to go to the hospital and get a spinal tap, and was informed that she cannot get those vaccines. She was not given any vaccine but received 2 rounds of anthrax vaccine. Her lip got very swollen the next day and was given Benadryl (diphenhydramine). She was tuberculosis (TB) positive and did not complete her isonicotinic acid hydrazide (INH) treatment due to her joint hurting. When she got a booster for Hep A (hepatitis A vaccine), she had to be given epinephrine. For typhoid her arm got swollen, more than regular, and for meningococcal she had a small reaction. Currently, she had rhabdomyolysis and malignant hyperthermia. She added that it could be due to other vaccines being live vaccines. The outcome of the reported event was unknown at the time of report.  Company Comment: It was reported that a consumer had lip swelling the next day after receiving presumably BioThrax (Anthrax vaccine). In response to the event, she was treated with Benadryl. This consumer developed several reactions (allergies) to various vaccines over the course of many years. Considering the case information and known effects of BioThrax, the causality of lip swelling is assessed as possible.; Sender's Comments: It was reported that a consumer had lip swelling the next day after receiving presumably BioThrax (Anthrax vaccine). In response to the event, she was treated with Benadryl. This consumer developed several reactions (allergies) to various vaccines over the course of many years. Considering the case information and known effects of BioThrax, the causality of lip swelling is assessed as possible.
Hives - arms/legs.  Parents not sure how long after vaccine that hives started.