chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She started having a low fever and then chills and a headache midday on Thursday, February 17th. Around 3:00am on Friday morning, February 18th, she started having an itchy rash on her legs, bottom and back. After giving her some Benadryl, it was better on those areas, by the morning. But, that morning, around 7:00am, she did have a rash on her neck and a small bit on the side of her face. By 9:00am, the rash was on her back again and then soon after, it had spread all over her face, with swelling in her face and one of her ears. Around 12:00pm, there was rash and swelling on the arm where she had the injection and all over her back and side, as well as her face. She went to the doctor and was prescribed prednisolone. She continued with another dose of Benadryl around 2:00pm. That helped swelling to go down, but it was back by 4:45pm. She took the prescription at dinner time and it helped a little bit. She was up off and on through Friday night with itchy swollen hands and feet, as well as the other swelling and rash over the other parts of her body already mentioned. Today, Saturday, February 19, rash and swelling continue. Benadryl at 7:30am and again at 12:00pm. When Benadryl kicks in, swelling and rash decrease, but once it wears off, it comes back with aggression.
Having difficulty with coordination; Can't grasp objects; Feeling tingling in my mouth; Have extreme joint pain; Have Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COORDINATION ABNORMAL (Having difficulty with coordination), MOTOR DYSFUNCTION (Can't grasp objects), PARAESTHESIA ORAL (Feeling tingling in my mouth), ARTHRALGIA (Have extreme joint pain) and FATIGUE (Have Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to metronidazole (Flagyl)), Drug allergy (allergy to infliximab (Remicade)) and Ankylosing spondylitis (ankylosing spondylitis). Concomitant products included ESTRADIOL (ESTROGEN), GABAPENTIN, BUSPIRONE and PROGESTERONE for an unknown indication.   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 23-Apr-2021, the patient experienced COORDINATION ABNORMAL (Having difficulty with coordination), MOTOR DYSFUNCTION (Can't grasp objects), PARAESTHESIA ORAL (Feeling tingling in my mouth), ARTHRALGIA (Have extreme joint pain) and FATIGUE (Have Fatigue). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, COORDINATION ABNORMAL (Having difficulty with coordination), MOTOR DYSFUNCTION (Can't grasp objects), PARAESTHESIA ORAL (Feeling tingling in my mouth), ARTHRALGIA (Have extreme joint pain) and FATIGUE (Have Fatigue) had not resolved.            As treatment, the patient took acetaminophen but it did not help alleviate any of the symptoms.
Right arm vaccine is given 12/10/09. Patient returned 12/11/09 with redness and swelling to injection site.
Pt reports that had generalized rash on body, multiple tiny red bumps, intermittently itch. Rash remained for about a month.
Normal known side effects of vaccine for first 24 hours: fever, body aches, chills, fatigue. Then at about 48 hours I developed a bad cough, nasal congestion, ear congestion, headache. Then at 56 hours lost taste. Then at 80 hours lost smell. I have tested negative for COVID as of today, 6 days post vaccine and 3.5 days post unusual symptoms so it is not that. Lost of taste and smell continue to persist as well as cough, nasal congestion and horrible ear pain.
NO ADVERSE EVENT; This spontaneous report received from a patient concerned a 73 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced no adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of no adverse event was not reported. This report was non-serious.  This case, from the same reporter is linked to 20210440109.
He noticed some pain in his chest. I was worried he had COVID-19, because of the pain and he had some sinus drainage, and he didn't feel good. He had been around someone with COVID-19 a week before that.  He also had his regular heart doctor on Monday. He said to keep up the regiment of medication he received at ER. They gave him Colchicine and one aspirin 325 mg (the ER doctor had the aspirin dose higher, but his regular doctor reduced it to one). The baby aspirin was taken away from daily regimen.  He's better today than he was, but in the meantime he has been sick. It hurts him and he doesn't have any energy.  He had a flu shot - A week before the COVID-19 booster; He got that at Pharmacy (left arm). Not sure which brand of flu shot it was, or the exact date.
ELEVATED TEMPERATURE OF 101.3 TREATED WITH TYLENOL. ON 3/21/2014 AT 10:30 AM SHE DEVELOPED SEVERE RASH ON BUTTOCKS WITH BLISTERS ON BACK OF LEGS. BLISTERS SPREAD FURTHER. CHICKENPOX DIAGNOSED ON 3/22/2014 AT 12:30 PM. TREATING WITH OTC CALAMINE LOTION. SHE STILL HAS A FEVER OF 100 AS OF 3/23/2014 AT 4:50 PM.
About 12 hours later I started getting a runny nose but 24 hours later it became more significant. It lasted for about 3 days. I seemed to have developed seasonal allergies since then. With any activity I get sinus congestion and runny nose. I also had a mild headache that lasted 4 hours.
This case was considered medically important (OMIC). Information regarding Prevnar was received regarding a 3 month old male patient who experienced infantile spasms. The patient received a dose on an unspecified date. The patient previously experienced infantile spasms while taking Rabies Vaccine. The indication for Prevnar was immunization. Product was administered on an unspecified date. The dose regimen was 1 dose 1 time per day. Additional suspect medication included Hib-Titer Vaccine, Pediarix, and Rabies vaccine. Concomitant medications were not reported. Within 24 hours of Prevnar, Hib-Titer, and Pediarix administration, the infant experienced a series of infantile spasms. The episodes occurred over a period of 6 to 8 hours. No additional information was available at the time of this report.
lt arm about 2inches below site of inj to elbow very red & sore to touch;this began the evening of 5MAR97 & very noticeable 6MAR97;t99.6 ax;
After 9 days without an adverse reaction, I developed a very itchy, very hot, very red rash at the injection site. It lasted for approximately 24 hours.  After the second dose, the rash came back even worse within 24 hours.
Patient received 2nd dose of vaccination on 03/01/2021 and developed symptoms on 03/03/2021. He presented with bilateral numbness in feet ascending to his mid shins and weakness complicated with multiple falls due to severe ataxia. He did not report any head injury or loss of consciousness. He also reported mild dysphagia, changes in voice and left arm weakness. Neurological examination showed bilateral leg  strength 4/5 and numbness. The patient was admitted to hospital and given IVIG for 7 days before transfer to an acute inpatient rehab facility. The patient was discharged from rehab facility on 04/05/2021 and still has some residual weakness and numbness.
Case is a nurse practitioner who called and spoke to RN on 2/18/2021 around 0926 to report that her vaccine appears to have been administered too high yesterday. Writer called to follow up with case and she states that the vaccine was administered near the acromion, as opposed to her deltoid. She reports that it was nearly on top of her shoulder, and not in her upper deltoid. Case sent picture to writer of band aid placement from yesterday to get an idea of location of injection. Case states she is sore, but does not feel it was injected into bone. She called to report so that the vaccinator can be reeducated and prevent future errors. Advised to give writer a call if she has any  complications and brought forth to clinic manager as well, who collectively decided we will do a brief reeducation on vaccine administration technique and selection of landmarks.
Information has been received from an approx 60 to 65 yr old physician who on an unspecified date was vaccinated IM with a 0.5mL second dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the physician developed a local reaction and flu like symptoms. The physician sought unspecified medical attention, and subsequently recovered. Additional information has been requested.
pt recv vax 19JUL95 & 15MAY96 pt was exposed to varicella;30MAY96 pt exp a mild case of chicken pox w/5-6 lesions & a fever of 100 for 24hr;
Patient was under the authorized age group of 18 years old.  Should have received a Pfizer dose instead of a Moderna dose for patient in this age group.  This was discovered around the time when 2nd dose was due in series for patient.  I discovered that the pharmacy intern,  incorrectly gave a Moderna shot to a 13 year old when only Pfizer is indicated.  The data verified for the intern was done by RPh.  Parent was alerted and wanted Moderna, but pharmacist recommended Pfizer for patient's second dose as recommended by the CDC guidelines.
Swelling, increase at injection site, warmth, redness, pain, headache. Received on 5/26/16. Discomfort at injection site on Sun and increasing. Exam: swollen, indurated, erythema 3cm (L) deltoid at 8 days post vaccination.
Patient reports swelling in arm that injection was received the next day. A progressive body rash has occurred along with a rash on the face started to occur the day following the vaccination and is still ongoing. It is scaling now and has not gone away as of yet.
Start 5/26/2013 and through 5/28/2013 she developed varicella-like rash on left side to: neck, upper arm, bend of elbow, forearm, wrist et top of hand. Total of approx. 13 lesions. No other c/o. Home tx with BENADRYL cream.
Swelling, redness, itchy, warm to touch, hard to touch. Painful when touched.
Excessive and frequent vaginal bleeding; Heavy bleeding almost constantly between cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROGESTERONE in two weeks. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown, Unable to locate or read the details, Location of injection: Arm Left), for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown, Unable to locate or read the details, Location of injection: Arm Left), for Covid-19 immunization.  The following information was reported: VAGINAL HAEMORRHAGE (non-serious) with onset 14Nov2021, outcome "not recovered", described as "Excessive and frequent vaginal bleeding"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 14Nov2021, outcome "not recovered", described as "Heavy bleeding almost constantly between cycle". The events "excessive and frequent vaginal bleeding" and "heavy bleeding almost constantly between cycle" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of vaginal haemorrhage, heavy menstrual bleeding.  Additional information: Excessive and frequent vaginal bleeding. Heavy bleeding almost constantly between cycle. Patient did not receive other vaccine in four weeks. The Patient did not have covid prior vaccination. The Patient tested covid post vaccination. Known allergies: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (11Mar2022): 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 completed. No further information is expected.
Red, irritated, painful at injection site. Pink area spreading about 3-4 inches from site. Dr. diagnosed as cellulitis and prescribed cephalexin and BENADRYL.
within 10 hours, large red raised circle (hot to touch) around injection site and upper arm very sore (normal reaction). Next morning, pain radiating from injection site, up shoulder to neck, down neck to lower back. Lower back pain worse with movement of neck up and down. Neck and back pain strongly persist for 3 days, starting to improve on day 4.
have lost mobility; can't lift the arm over their head; even feel pain when they sneeze; even feel pain when they sneeze; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 10Sep2021 as dose 2, single (Batch/Lot number: unknown), in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose:1), administration date: 19Aug2021, for Covid-19 Immunization, reaction(s): "felt pressure on their feet", "couldn't walk". The following information was reported: MOBILITY DECREASED (non-serious), outcome "not recovered", described as "have lost mobility"; MOVEMENT DISORDER (non-serious), outcome "not recovered", described as "can't lift the arm over their head"; PAIN (non-serious), SNEEZING (non-serious), outcome "not recovered" and all described as "even feel pain when they sneeze".  Additional information: Caller (female 53 years old) and her husband (male 61 years old) received their first dose on 19Aug2021, they felt pressure on their feet. She stated "like someone hit us with a baseball bat", they couldn't walk. After that they received their second dose on Sep, her husband 09Sep2021 and caller 10Sep2021; she stated that now we are on May but since the month of Mar they are still with the same symptoms. They got the injection on their left shoulder and they have lost mobility, they can't lift the arm over their head. She said "it's horrible to say but I can't shave our arm pits." They can not scratch their backs, she stated they have lost mobility and flexibility of their arm totally. At work she has dropped boxes and her husband has dropped tools. And they even feel pain when they sneeze.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200744594 same reporter/product/event different patient
Patient developed COVID pneumonia 5/6/2021 and admitted to ICU via ED.  Patient intubated due to severe respiratory distress.
Dizzy and flushed right after shot, sat for 15minutes. Mom and son got me to car, within 10 minutes had difficulty breathing, speaking, could not hold head up. Lethargic and could not think. Felt that I had no control over body movements. Entered urgent care at 3:22. Tremors, BPM lower than normal resting, felt completely dis-engaged and very scared. Shaking badly, could not control movements. Had to think to breathe. INJ dexamethasone sod phosphate, 1mg, Diphenhydramine HCI 25mg, EKG 12 Lead w interpr rpt Qty(2) Stat
Patient got rash all over body after 3 to 5 days, rash looks like little bump, itch, pain (more at night).
pt recvd flu vax & devel urticaria which migrated over the body sparing the inject site; reaction resolved p/2 to 3 days;
Received TIV vaccine at 11:30 am.Thurs 10/18/07. Achey by mid afternoon. Shaking chills and fever of 102 (orally) by 5 pm. Vomiting by 5:30 pm.(vomited X2)  In bed that evening and all day Friday. Temp of 101 by mouth (with acetaphminophen, 700mg every 4-6 hours) for next 48 hrs. Recovered slowly on Saturday. Well by Sunday.
Date of vaccine given was 3/27/2023. Expiration date of vaccine was 03/24/2023. No adverse effects felt by patient.
awful, very hard on the body; This case was reported by a consumer and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (feels awful- refer caseUS2021AMR215043, US2021AMR215057).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.   Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and felt awful. The patient also stated that be careful of these shots, they were very hard on the body. The follow-up would not possible as no contact details were available. This is one of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR215057:same patient diferent dose US-GLAXOSMITHKLINE-US2021AMR215043:same reporter
Previously immunized with AstraZeneca Covid vaccine in February when out of the country in Mexico.
Diagnosis of herpes zoster secondary to varicella vaccine - pt received vaccine on 11/26. On 11/28 pt started with lesions around (L) eye. Pt saw eye doctor and then pt came to doctor on 12/4/ b/c lesions still present without relief.  7/10/2008 MR recieved for DOS 12/4-6/2007 with D/C DX: Herpes Zoster.  Impetigo. Pt presented with spreading pustular lesions around the L eye. Tx with Zovirax and Omnicef with good response.
On 2/25/04 (when the patient was 3 months old) he received Prevnar, Pediarix and PedvaxHIB. Nine hours later, the patient was admitted to the ICU for shock. He had to be intubated and treated with Dopamine. He was diagnosed with a probable immune deficiency. Prior to 2/25/04 patient was admitted to the same hospital for septic shock and was diagnosed with subdural empyema. Patient was also admitted again on 3/13/04 for shock. Follow up: Fever,Rotavirus, UTI, and adrenal crisis.
Patient reported pain at injection site on same day the shot was administered.  Patient went on vacation and the pain did not subside. The pain persisted on and off . Sometimes the area gets numb. The area affected was localized but not visible at this time and was about the size of 2 quarters as per patient.  Patient has no problems  moving the arm in any direction. The pain did not move down the arm.  Patient did not come in for me to see the injection site. Patient has not seen any doctor. I advised patient to consult with his Doctor.
Employee states after receiving flu shot at 11:30 am 11/15/05 she felt fine until 6pm or 7pm. Then she ached all over and had trouble exhaling. This lasted 1 hr. She took a sleeping pill and when she woke, she was fine.
This case was reported by a pharmacist and described the occurrence of rash-whole body in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (unknown). Immediately after vaccination with FLUARIX, the subject experienced rash-whole body, swelling all over body, swelling-feet and rash neck area. The pharmacist reported that the subject, an employee of the hospital, had immediate systemic reactions after receiving the FLUARIX vaccine. The subject reported a severe reaction with a rash on the neck and body immediately after receiving the vaccine. The subject also reported swelling in the feet and all over the body. At the time of reporting the outcome of the events were unspecified. This is on of three cases reported by this pharmacist, see cases A0809777A and A0809778A for the other reports.
Menstrual period started the day after my vaccination, and it wouldn't stop. I experienced heavy, continuous bleeding for 26 days before I was able to see my OB/GYN and get a prescription to try to stop the bleeding. I had never experienced anything like this previously.
5 months old patient received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 21st September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Nurse reported that a 4 months old patient received vaccination with Kinrix vaccine, indicated for patients 4 to 6 years old, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
This spontaneous report was received from a medical assistant who refers to a patient of unknown age and gender. It was reported that the patient received first dose of GARDASIL on 01-DEC-2011 (dose, route and lot# not reported) and a second dose of GARDASIL (dose, route and lot# not reported) on 20-NOV-2012. No adverse effects reported. Additional information has been requested.
Three vaccines given in the right arm. 24 hours later, patient had pain. Then a egg-sized rash appeared and spread over time. Rash is now from shoulder to elbow and is pink, swollen and sore. Patient saw provider on 10-6-20. Provider ordered ultrasound to rule out possible clot, antibiotics for potential cellulitis, and Benadryl for rash. Patient has had flu vaccine and tetanus vaccine previously with no adverse events.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was  refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by r COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Patient became light headed/ dizzy and requested ambulance.  EMT came and took her to ER.  Did not receive any (EPI PEN) medication etc at pharmacy where she received vaccine as she just seemed dizzy.
R arm very sore after flu shot on 10/13/03. On Motrin x 14 days, Prednisone 10mg 5, 4, 3, 2, 1. Inflammatory response.