chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen feet / 2 weeks after the shot, both of her feet started swelling.; Her heels hurt a lot, rated pain as 8 out of 10, 10 being the highest/ sore feet; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen feet / 2 weeks after the shot, both of her feet started swelling.) and PAIN IN EXTREMITY (Her heels hurt a lot, rated pain as 8 out of 10, 10 being the highest/ sore feet) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen feet / 2 weeks after the shot, both of her feet started swelling.) and PAIN IN EXTREMITY (Her heels hurt a lot, rated pain as 8 out of 10, 10 being the highest/ sore feet). At the time of the report, PERIPHERAL SWELLING (Swollen feet / 2 weeks after the shot, both of her feet started swelling.) and PAIN IN EXTREMITY (Her heels hurt a lot, rated pain as 8 out of 10, 10 being the highest/ sore feet) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.    This case was linked to MOD-2021-226507 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: No specific follow-up information recorded. On 18-Jun-2021: Significant follow up appended to AER
Within 15 minutes started to feel soreness in left leg. Got tired. Next morning was feeling elevated heart rate while laying down.  90 bpm and above when normally 50-60 bpm.  Heart rate would go up and down. This happened mostly on the second day, but also seems to have occurred since then. I have not had this issue before.
No adverse reaction occurred - Pt rec'd KINRIX (Dtap and Polio) instead of INFANRIX.
This spontaneous report was received from a pharmacist via company representative. The pharmacist was reporting on himself. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot# and exp. date were not reported) for shingles prevention. No concomitant therapy was reported. On an unknown date, reported as "about two weeks or more ago", the patient experienced post vaccination shingles. The patient had a rash on his temple and leg and stated that it was very painful. The patient did not seek for medical attention, did not visit the physician and indicated that was going to self-treat himself. The patient did not recover from the event. The relatedness between ZOSTAVAX and the event was not reported. Additional information has been requested.
Fatigue, pain around injection side on the day after vaccine during the day. Nothing concerning but right before he went to bed he didn't feel good. My son thought he had to vomit but couldn't. He said his HEARTBEAT WAS SO MUCH FASTER than normal. I got so concerned that I slept next to him which I never did before. He fell asleep after 1 h and woke up the next morning and felt fine. I did not go to the doctor because he was feeling well the next day.
Headache, Myalgia, Fever, Chills, lymph node swelling, injection site tenderness Narrative: One week after first injection had lymph node swelling and site tenderness. With second injection had fever (100.8), chills, myalgias and headache. Symptoms lasted 24 hours. Missed work x 1 day due to symptoms. NO known  prior COVID infection.
Body aches, fever of 100 to 101. Injection site red, hot and swollen.
Twitching started in upper arm and move to legs and finally settled in the feet. Twitching continued for 4 weeks; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 16:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had known allergies to penicillin, erythromycin, levofloxacin, bactrim and milk. Concomitant medications included calcium (MANUFACTURER UNKNOWN) and loratadine, pseudoephedrine sulfate (CLARITIN-D) for unknown indication, from unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to COVID vaccine. On 18Mar2021, the patient reported that she had twitching, started in upper arm and move to legs and finally settled in the feet, twitching continued for 4 weeks. Almost gone before 2nd vaccine. On an unknown date within 4 hours of second dose of vaccination twitching started, this time only below the knee and in the feet. Constant twitching even when feet was elevated. The feet was not numb. No therapeutic measures were taken as a result of reported events. The event resulted in doctor or other healthcare professional office or clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event twitching started in upper arm and move to legs and finally settled in the feet, twitching continued for 4 weeks, Second vaccine was given and twitching started within 4 hours of vaccine was not recovered at the time of this report.  No follow-up attempts are needed; information about lot or batch number cannot be obtained.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE TRANSIENT CEREBRAL ISCHEMIA LEFT FACIAL MUSCLE WEAKNESS
Severe joint stiffness-difficulty in getting out of bed post vaccination Saturday 18ARP2009;feverish;vomiting
intussusception on 4-16-07 seen at hospital. admitted for emesis.  06/04/2007 MR received for o/n hospital stay for c/o decreased po, crying, vomiting and blood in diaper.  Reduced with Barium enema.   DX Intussusception. Repeat ER visit 5/23/07 with c/o diarrhea and decreased appetite.   DX: Enteritis.
Awoken throughout the night with extreme body aches (Eye sockets, neck, hip sockets--worst )and migraine. Around 5:30am I took two extra strength Tylenol to no avail. I proceeded with chills, shakes, fever, cold hands and feet, sweating, exhaustion, and loss of appetite. These expected symptoms subsided/ were manageable at approximately 5:30 pm.   At 7pm, I began having trouble climbing the stairs and had intense pain in the center of my chest. I could breath alright (I was NOT light headed), but couldn't alleviate the chest pain. I went to sleep at 8:30pm in hopes that it would dissipate.  **(Did not go to hospital because we are military, my husband is TDY and I had no one to watch our children. This is not to downgrade the fear or intensity of the pain. I have a very high pain threshold- this was awful.)**  Saturday (Day 3 after vaccine) no chest pain, but began spotting (my period is very regular and tracked diligently-I'm not meant to start for another 8 days),  still had a very sore neck/ migraine, and swollen/painful lymph nodes in my armpit ( on the vaccine side). Sunday (day 3 after vaccine) still spotting heavily, painful lymph nodes, and migraine.
I?ve had frequent pain  in both thighs and calves. It feels like an aching of my muscles or near bones. I?m in good health, but it?s harder to move around.
This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age and gender. On an unknown dates between 05-JAN-2016 and 15-JAN-2016, the patients were orally vaccinated with incorrectly stored doses of oral, ROTATEQ (dose, frequency, route of administration and indication were not reported, lot # L008996, expiration date 01-DEC-2016; L013203, expiration date 28-JAN-2017; L022447, expiration date 16-FEB-2017; reported as L035276, expiration date 09-JUn-2017). This is one of several reports received from the same reporter. Additional information has been requested.
Worse arm  pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date refer case-US2022AMR131928).   On 12th September 2022, the patient received the 2nd dose of Shingrix. On 12th September 2022, less than a day after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR131928   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comments: The patient reported that today on the day of reporting the patient received  second dose of Shingrix vaccine. The patient again had worse arm pain. The reporter did not consent to follow up. The patient does not wish to provide demographic or HCP information.; Sender's Comments:  US-GSK-US2022AMR131928:Same reporter
A little warmer but no fever; Ringing in the ear; Pain on knee; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration on 25Feb2021 as dose 1, single for COVID- 19 Immunisation. Relevant medical history included thyroid, cholesterol, anxiety/depression, and asthma, sciatica, received lumbar injection last Friday on 24Feb2021. Concomitant medications were not reported. The patient received Flu shot in 2021. On an unknown date in Feb2021, the patient was feeling quite not okay, a little warmer but no fever. The patient experienced ringing in the ear and pain on knee and applied Biofreeze on her knee. The patient was also taking Tylenol every 6 hours. The patient was scheduled to get the second dose on 19Mar2021, which was more than 21 days after the first dose. Caller wants to know if it was because of the vaccine or does the vaccine affect her sciatica. Therapeutic measures were taken with Biofreeze and Tylenol as a result of the all adverse events. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Swollen, hot, reddened arm below the injection site- started 1 week post injection. Ice/cold packs, NSAID, and antihistamines administered. Continue to monitor at this time as still symptomatic
Site: Pain at Injection Site-Medium, Additional Details: patients arm still hurts. it might have been given up too high causing bursitis.
Myopericarditis with fatigue, myalgias, joint pains, and dispnea on exertion since his second COVID 19 shot. Pt also found to have a DVT.
When administering Moderna booster vaccination, needle was loose from syringe and patient did not receive full dose due to vaccine spillage.  Per guidelines and with patient consent, booster dose was repeated. Patient was stable and showed no immediate signs or symptoms of reaction.
Known seizure disorder well controlled with levetiracetam had grand mal seizure 3 days after TRUMENBA.
Pt recvd 2 doses of Engerix-B 1st dose 13SEP91 & 2nd vax on 14OCT91 & on 16OCT91 following 2nd dose devel mouth lesion on inner mucosa & t99.3; 3rd dose not been administered;
have pain in my left arm where it was administered the vaccine/the area was red and inflamed; have pain in my left arm where it was administered the vaccine/the area was red and inflamed; pain in my left arm where it was administered the vaccine; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 15Dec2020 at 14:30 on Arm Left at single dose for COVID-19 immunization in hospital. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. No concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, nor any other medications within two weeks of vaccination. The patient previous took acetylsalicylic acid (ASPIRIN) and experienced allergy. The patient experienced started to have pain in her left arm where it was administered the vaccine on 15Dec2020 at 15:00. The next day (16Dec2020) the area was red and inflamed. The redness and the inflammation lasted three days. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events 'redness and the inflammation' was recovered on 19Dec2020, outcome of the other event was unknown. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Moderna Covid-19 Vaccine Lot # 017C21A Expires: 12-19-21. First dose given at 13:15 hours 11/16/21. Patient began to feel overheated and progressed into feeling itchy on her arms and back, and complaints of dizziness. Patient was diaphoretic and flushed. No signs or symptoms of hives or rash. Patient denied breathing difficulties. History of allergic reaction to Penicillin antibiotic will hives and throat swelling presentation.  Vital signs within normal limits. BP=114/72, HR=73, RR=16 and SpO2=98. Benadryl 50 mg administered orally. After 15 minutes (at approximately 13:45 hours) patient reports improvement in symptoms i.e.  itching, dizziness, elevated temperature dissipated. Gave recommendation to patient to take Benedryl 50 mg at 19:30 hours and again in another 6 hours if needed for any symptom returning.
The patient is a 33-year-old, gravida 1, with intrauterine pregnancy at 39 weeks and 1 day, who presented to clinic today to turn in a 24-hour urine, had mildly elevated blood pressures yesterday, which normalized on Labor and Delivery and preeclamptic labs were normal.  Today, initial blood pressure again is slightly elevated at 142/90, other diastolics 88.  In light of her already being 39 weeks as well as having gestational diabetes, although it has been well-controlled with diet.  I have discussed with the patient recommendation to go ahead and proceed with induction of labor.  Her pregnancy has otherwise been without significant complications.  Again, her gestational diabetes has been well controlled with diet.   She is COVID vaccinated and boosted, although she did test positive for COVID recently, but has been cleared.  She has had good prenatal care with me since the first trimester with good followup care.  PT IS CURRENTLY INPATIENT.
Low grade fever on 10/04/06 afternoon, fussy, cold symptoms, freq stools, rash 6 prominent red peppery of entire body,palms and soles.
2cm x 4cm area of redness in left thigh involves skin and subcutaneous tissue, slightly excoriated and raised. Recommend topical CALAMINE lotion and BENADRYL.
Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 72 years old female patient who experienced motion seems to make her feel worse so she has been lying down most of the day, dizzy, nauseous, and vomiting, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Sep-2018, the patient received 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left deltoid, frequency = once (expiry date not reported). On 25-Sep-2018, one-day post-vaccination patient developed a non-serious motion seems to make her feel worse so she has been lying down most of the day, dizzy, nauseous, and vomiting following the administration of FLUZONE HIGH DOSE. Relevant tests were not reported. Final diagnosis was vomiting, nauseous, dizzy and motion seems to make her feel worse so she has been lying down most of the day. It was not reported if the patient received a corrective treatment. The outcome of the event reported as unknown. List of documents held by sender: none.
pt recv vax & devel extreme eosinophilia;this is 1 of 2 pt from this site to have an adverse exp p/vax;
Left upper arm--cellulitis around site of injection. Tx: Cefzil 180 mg BID po x 5 days
Patient called our clinic (where she received the vaccine - she is not a patient of our clinic but is an employee of our main organization and we are a site where employees can receive the J&J vaccine) to report that she has had tingling in both of her feet. This is not affecting her ability to perform her daily activities and she is seeing her PCP to follow up.
pt got very pale, dizzy, light headed, sweaty, talked the whole time , was shakey .....we layed her down , elevated feet, used ice packs, checked BP 106/87 , called paramedics, pt was fine when leaving
Provider provided the vaccine on 4/13/22 for vaccine administration with a beyond use date/time of 12 hours from vial puncture. Staff at the facility did not provide vaccine to the patient until 4/14/22 at 11 AM. Our pharmacist reached out to the company and reported the following: "I called the company and talked to the support team and gave them all the information on what had occurred. Moderna only has efficacy  data to support up to 24hrs post vial puncture and that any administration after 24hrs would be up to the healthcare professionals to determine if re-vaccination is required. They also mentioned to monitor for s/s of infection due to there being no preservative in the vaccine formulation. "   They will report to the medical doctor to see what further action needs to be.
100 degree F - 2 days; Extreme muscle and joint pain - 2 days; Headache/chills - 2 days; Slight nauseas - 3 days; Photosensitivity - 3 days; Widespread redness around injection sight -4 days and continuing.
Information has been received from a health professional concerning a 35 year old female who on 22-MAY-2007 was vaccinated with a dose of Zostavax. It was reported that the patient had never had chicken pox and wishes to become pregnant. The physician ordered varicella virus vaccine live to be given to the patient. The nurse rushed and inadvertently vaccinated the patient with Zostavax. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
I have tinnitus that appeared 6 hours after the second Pfizer shot and decreased slightly over the next 6 months and then came back even worse 6 hours after the Booster. Please provide me with detailed instructions on how to report this side affect to the appropriate governmental body.  Ringing on his  both ears.
broke out w/200 chicken-pox lesions which lasted for 6 days, low grade temp;
I have had both doses of the vaccine over 6 months ago, but recently diagnosed with Covid.; I have had both doses of the vaccine over 6 months ago, but recently diagnosed with Covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single 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), DRUG INEFFECTIVE (medically significant) all with onset 2021, outcome "unknown" and all described as "I have had both doses of the vaccine over 6 months ago, but recently diagnosed with Covid.".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt developed macular, papular, vesicular lesions that were pruritic and located on his trunk, extremities, head and top of feet. Mother doesn't think he had an elevated temperature but didn't take temp. He had > 50 lesions lasting about 5 days in staged breakouts.
BIVALENT BOOSTER WAS ADMINITERED PRIOR TO 8 WEEKS OF THE DUE DATE
Night sweats, fever, body aches, stiffed neck, lightheadedness, HA, extreme fatigue, canker sores - from 2/10/19 night till now 2/13/19.
Hives on both arms and hands, began hours after injection, and progressively worsened the following day, then remained steady, resolved 10/25/2012. Treatment from pharmacist: Benadryl, and calamine lotion.
Subsequent to vax, this pt became sick, developed an injection site reaction characterized by swelling and stiffness.
After 5 hours unable to move my left arm. The pain was severe and much worse than when I got the previous 3 Covid-19 Pfizer shots. This was my 4th shot (2nd booster). Also bad headache behind forehead and eyes. Chills and very weak. Could not get out of bed the next day until 1pm and still had all the symptoms.
ITCHING ALL OVER; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, shell fish allergy, gold allergy, and silver allergy. The patient experienced drug allergy when treated with pethidine hydrochloride for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAY-2021, the subject experienced itching all over. Treatment medications included: cetirizine hydrochloride, and loratadine. On 21-MAY-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching all over. This report was non-serious.
chest tightness Narrative: Per EOH RN email, employee experienced tightness to the chest about 15 minutes after injection. Employee was seen by doctor and was recommended to report to emergency room, however employee "refused and left AMA." On 12/24 (next day), employee denies any problems/issues and was not in any distress. Employee reports albuterol inhaler (1 puff one time) for shortness of breath.
Pt exp fever to 102, spots 3 on face, 4 on chest, 3 on buttocks; raised red areas size of fingertip, broke out all over;  had runny nose;
She had redness/swelling and warmth to localized area after receiving vaccine.  She states after a number of days it then turned hard and itchy.  She states area is still bruised but has gotten better.
Patient received one dose of GARDASIL 9 about one year ago and did not complete any further dose administration.; No adverse events were reported.; This spontaneous report was received from a physician referring to an 18 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.      On an unknown date (reported as "about one year ago"), the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) for prophylaxis. The patient did not complete any further dose administration. No adverse events were reported.  .
Headache, Myalgia, Fever, fever, chills, sweating, back pain, pain