chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site reaction; Initial information regarding an unsolicited valid non-serious case was received from a physician via call center via Agency (Reference number- US-SANOFI-00335573) and transmitted to Sanofi on 28-Oct-2020. This case involves female patient (age unspecified) who experienced injection site reaction (vaccination site reaction), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   In 2015, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number, expiry date not reported)(single use vials and pre-filled pens) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious injection site reaction (vaccination site reaction) unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
syncopal episode immediately following 2nd immun on 3JUN93; regained consciousness w/in 15 seconds; able to ambulate w/assistance of 1 w/in 20 minutes;  sore rt arm;
I had severe pain in my upper body in my arms, my hands, my shoulders. I could not reach in cabinets to get anything. I could not lift milk or even pour a bowl of cereal. I could put no weight on my arms at night in bed. I felt completely disabled. The pain was very painful. I could play the piano and drive the car. Also, my arms hurt to get dressed and reaching behind my shoulder. I have had professional physical therapy for my arms, my chest, and my abdominal muscles.
Pt. was waiting in waiting room - saw pt. sitting on couch. Saw he looked paled - looked like he was fainting, went right over to pt., got him laying down, held feet up and had front get another nurse/Dr. come help - we got pt. in wheelchair, took to room, lay him down on exam table, got cool wash cloth. Pt. felt better. Thought he was going to vomit but did not. We watch pt. They slowly got him up. BP where it was when he came in. Pt. left after Dr said ok. Nurse and Dr. help with situation.
Redness; Itchiness and hotness in the arm; Itchiness and hotness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (Itchiness and hotness in the arm) and FEELING HOT (Itchiness and hotness in the arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20V) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced ERYTHEMA (Redness), PRURITUS (Itchiness and hotness in the arm) and FEELING HOT (Itchiness and hotness in the arm). At the time of the report, ERYTHEMA (Redness), PRURITUS (Itchiness and hotness in the arm) and FEELING HOT (Itchiness and hotness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported Treatment medication were not reported
Convulsive syncope 5min post vaccination. Mother reported child shaking, however, when nurse arrived child was awake and talking to mother. Mother states child hit her head on the floor, however, child never c/o pain in back of head.  no swelling.  Youth received Tdap, Menactra, and Gardasil.
A non-serious event of expired product administered was received from a healthcare professional concerning and adult male. No medical or drug history was provided. FluMist was administered on 14-Jan-2008. The FluMist had expired four days earlier on 10-Jan-2008. The patient opted to be revaccinated with either FluMist or FluZone. No signs or symptoms were present at the time of the report. No additional dosing is indicated. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Shot was painful, pain in arm increased over next 2 weeks, and lost range of motion /flexibility in arm. Pain severe. Saw MD. Pain continues even more now, patient going to physical therapy trying to get range of motion back in arm.
Patient was administed the Pfizer Covid vaccination. She was waiting in the waiting room for 15 minutes. After 7 to 10 minutes she notified staff that her arm was swelling and she did not feel right. Pharmacist went to talk with patient. Her arm was swelling and her head did not feel right. She reported she was dizzy and felt faint. 911 was called immediately. Theyresponded and after examination patient was transported to hospital.
mom reports that 30min to 1hr p/vax became real fussy;then 3hr later leg became swollen & red;reports that just about entire top of leg swollen & red;fever 102;pt cried cont & all noc;didn't sleep @ all & couldn't comfort;
Two nights after had extreme vision change like blacking out (lasted 30 seconds).  Did not black out but have been lightheaded (slightly dizzy) since then.  It comes in waves.  I feel like it could be caused by inner ear and not sure the vaccine has anything to do with it. Visited my doctor on 2/11/21 and she assessed dizziness.  Put me on steroid inhaler, nasal washes, antihistamine.
Disoriented when woke up on 9/17, chills, headache & shaking, incoherent, unable to walk, unable to phone for help. Slept on & off most of day. Unable to speak coherently until mid-afternoon. Felt better next day until late afternoon when shaking started again, lasted prox 1 hr. Went to local after-hours clinic, diagnosed reaction to flu shot. Prescribed 2 325mg Tylenol every 6 hrs. Feeling better after 7 days.
318 patients received dose from vials beyond 30-day use by date; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-364240 (Patient Link).
Hard at top of the arm; Round welch; Swollen top of the arm; itching really bad at the site/Slight itchy after day 1; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Hard at top of the arm), ABSCESS (Round welch), PERIPHERAL SWELLING (Swollen top of the arm), VACCINATION SITE PRURITUS (itching really bad at the site/Slight itchy after day 1) and PYREXIA (Fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Inflammation, Drug allergy (Septra), Allergy to antibiotic (Erythromycin), Drug allergy (Vicodin) and Drug allergy (Clindamycin). Concomitant products included FISH OIL, CURCUMA LONGA RHIZOME (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]) and CHONDROITIN SULFATE, GLUCOSAMINE SULFATE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE SULFATE]) for Inflammation, VITAMIN D NOS, VITAMIN C [ASCORBIC ACID] and BIOTIN for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced INDURATION (Hard at top of the arm), ABSCESS (Round welch), PERIPHERAL SWELLING (Swollen top of the arm), VACCINATION SITE PRURITUS (itching really bad at the site/Slight itchy after day 1) and PYREXIA (Fever). The patient was treated with CEPHALEXIN [CEFALEXIN] at a dose of 500 mg. In June 2021, INDURATION (Hard at top of the arm), ABSCESS (Round welch), PERIPHERAL SWELLING (Swollen top of the arm), VACCINATION SITE PRURITUS (itching really bad at the site/Slight itchy after day 1) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information included Anti-itch cream.   This case was linked to MOD-2021-259228 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Outcome of event ,treatment detail, Vaccine information, Concomitant medication and Patient allergies  updated
Pt. states that after receiving the 1st dose of Jansen J&J dose 09/21/2021, started experiencing symptoms 10/03/2021 of fatigue, dizziness, rapid heart beat, tingling in fingertips, fingertips turning white (10 days/30mins at a time), rash on the left leg, and small bruising on both legs. 11/24/2021 Appendix "attack", Blood Work (Blood Platelet count Low found Bone Marow disorder) MDS treated with B12, 1000mg Vitamin C, Folic Acid Daily. 2 weeks of IV Fluids/Antibiotics at first facility and transferred to second facility.
Fever; aches; headache; This is a spontaneous report from a contactable consumer (patient. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 11Mar2021 12:30 (lot number and expiry date: unknown) at the age of 76-years-old, as dose 1, single, for Covid-19 immunisation. Medical history included Covid-19 (prior vaccination) high blood pressure and allergies: penicillin, some foods. Concomitant medications included losartan, cimetidine (TAGAMET); cetirizine hydrochloride (ZYRTEC) taken for unspecified indications, start and stop dates were not reported. The vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with Covid-19 prior vaccination. On 12Mar2021, the patient experienced fever, aches, and headache for 24 hours. The patient did not receive treatment for the events. The patient recovered from the events on unspecified date. The patient has not been tested for COVID-19 since vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Nausea, vomiting, diarrhea, Headache 12 degrees after shot. Pt given PHENERGAN 25g/1cc - IM, increased fluids, rest.
SHINGLES; This spontaneous report was received from a pharmacist and refers to a 35-year-old female non-pregnant patient. She had no pertinent medical history and drug reactions or allergies. Concomitant therapies were not provided.  On 17-JUL-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, subcutaneously in arm (lot # R035226 and expiry date 04-DEC-2020; exact dose was not reported) for vaccination. The vaccine was reconstituted with sterile diluent. After receiving varicella virus vaccine live (Oka/Merck) (VARIVAX), the patient was given an unspecified "allergy shot" in different arm. On an unknown date in July 2019, she developed rash at the injection site, described as reddened area with small bumps. There was no itching but a small amount of pain while touching. On an unknown date in July 2019, the patient was examined by her physician and diagnosed with shingles. At the time of this report, she was treated with valacyclovir hydrochloride (VALTREX) (also described as antiviral therapy). The pharmacist stated that the rash was healed in 90 %. No laboratory diagnostics were performed. The outcome of the event of shingles was reported as not recovered.  The causality assessment was not provided.
About 12 hours later after 1st dose, she started with really bad ringing in her ears; She felt like she was confused; Light headed; Pain; Aches; She had fever; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (About 12 hours later after 1st dose, she started with really bad ringing in her ears), CONFUSIONAL STATE (She felt like she was confused), DIZZINESS (Light headed), PAIN (Pain) and MYALGIA (Aches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03A21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced TINNITUS (About 12 hours later after 1st dose, she started with really bad ringing in her ears), CONFUSIONAL STATE (She felt like she was confused), DIZZINESS (Light headed), PAIN (Pain), MYALGIA (Aches) and PYREXIA (She had fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, TINNITUS (About 12 hours later after 1st dose, she started with really bad ringing in her ears), CONFUSIONAL STATE (She felt like she was confused), DIZZINESS (Light headed), PAIN (Pain), MYALGIA (Aches) and PYREXIA (She had fever) outcome was unknown.            No concomitant medicines were reported. Treatment medication included acetaminophen.   This case was linked to MOD-2021-082890 (E2B Linked Report).; Sender's Comments:  MOD-2021-082890:
Started having what I thought was a sinus infection, took COVID-19 test and it was positive. Called doctor and given prednisone and doxycycline. Started feeling better a week later.
I experienced chronic insidious cough. I went to see the cardiologist thinking it was my medication, we switched it but that didn't work. Went to the Allergist and gave me meds and didn't work. Went to the Pulmonologist and he tested me and I came up with asthma which I've never had. There is possibility of it being a false positive, we are still working through it to figure it out. I start coughing when talking, after water, in the middle of the night. I've had this chronic cough since the 1st COVID-19 vaccine shot but it's gotten progressively worse, and I didn't connect it until now.
Numbness in thighs for months..as of Sept 10th..felt like something shredding my muscle calf..then joint pain..couldnt walk for 3 days..the joint pain in elbow on same side..pins needles in arms legs, headache..numbness in arms and legs
I feel inclined to file this report in hopes that someone could study how receiving this vaccine affected my endometriosis. Please understand that I?m a proponent of vaccination and building herd immunity; however, women?s health is important and we have a right to be AWARE of ALL side effects. I?ve done my best to research this topic and was able to find very few sources on how COVID-19 vaccines impact menstruation. Aside from the lack of statistics, I found forums on social media platforms with women explaining how their menstrual cycles became irregular some way or another. I did experience the common side effects of fever, nausea, vomiting, diarrhea, soreness, and fatigue. In addition, I experienced severe cramps, back pain, thigh pain, groin pain, and nerve pain associated with the sciatic and obturator. I?m happy to be vaccinated because my immune system is far from the best, but if I were to have known that I would be unable to walk from the pain radiating from my back, pelvis, and thigh I would?ve opted for Moderna or Pfizer. At this point in time, I would NOT recommend the Janssen vaccine to someone with endometriosis. At that, this vaccine should be nowhere near as political as it is! My healthcare providers should be more willing to validate my symptoms, rather than saving face with the validity of the vaccine. I was told since my menstrual cycle is irregular I must coincidentally be getting my period, BUT I have not experienced any bleeding nor even spotting. I have no idea what the vaccine did to my body, I have no clue why it would induce such severe pain. I?m glad that the ?normal? symptoms have subsided by the second day, but the nerve pain complicates walking long distance or carrying heavy objects. I think I?ll eventually make a full recovery in the upcoming days, but this experience was so frightening. I laid on the floor for hours crying after I vomited up everything I had eaten. I couldn?t sleep because I couldn?t bear to lay down for long durations of time- and by that I mean more than ten minutes. It genuinely felt like I was getting my period, but whatever it was led to no external bleeding. Again, I?m grateful for the scientists who dedicate their lives to such integral work. I just wish I would?ve known about what was internally happening to my body beforehand, I would?ve chosen a different vaccine.
its swelling up and that it was getting worse; its swelling up and that it was getting worse; it got harder and more painful and now its itchy; it got harder and more painful and now its itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 21Nov2022 as dose number unknown, single (Lot number: FJ2602) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 2022, outcome "unknown" and all described as "it got harder and more painful and now its itchy"; VACCINATION SITE SWELLING (non-serious) with onset 2022, outcome "not recovered", CONDITION AGGRAVATED (non-serious) with onset 2022, outcome "unknown" and all described as "its swelling up and that it was getting worse".  Additional information: Reporter stated that a patient received her vaccine, the Prevnar 20 vaccine on 21Nov2022 (Monday). She called in the morning of an unknown date and reported that it swelled up and that it was getting worse and she said that was about a centimeter to an inch below where the injection site was and over the last week it got harder and more painful and later it was itchy. She reported that it was like getting worse. Reporter stated that she wanted to report it and then she asked what she should do and they were not 100 percent sure on what to direct her.  No follow-up attempts are possible. No further information is expected.
Seizure following the DTaP #2 (04/29/04), but in retrospect occurred following the DTaP #1. Required hospitalization and has been treated with phenobarbital which is going to be changed soon my pediatric neurologist. Follow up received on 02/03/2005:  Patient is still having seizures and is still on anti-siezure medication.  Nurse follow up on 09/29/04 states: "Hospital d/c summary confirms final diagnosis of seizure."  No seizures since 3/05. Pt. now receives Pediatrics DT instead of DTAP
Mother noticed a dime size red lump about 1" away from the injection site as soon as she returned home. It felt like a marble. Redness and swelling continued to spread to entire thigh over next 2 days. Patient was crying inconsolably during most of night Saturday, was more restless and cranky than usual. Patient also recovered. Had some gas, diarrhea and green stools (baby is being breast fed). Vaccines were administered on a Friday afternoon. Mother called on Monday, 11/20/06 to report his reaction. Today redness is decreasing, but swelling is increasing. Patient's temp. Patient was taken to pediatrician. 11/29/06 Mother states that doctor recommended that optional vaccinations should be avoided for the near future. Patient may outgrow her allergies eventually.
VIAL WAS WASTED 6 HOURS AFTER THE PUNCTURE; VIAL WASTED FOR 6 HOURS AFTER THE PUNCTURE WAS ADMINISTERED; FEVER 103 DEGREES; This spontaneous report received from a pharmacist concerned a 19 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 07-AUG-2021) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination.  No concomitant medications were reported.  On AUG-2021, the patient experienced fever 103 degrees. Laboratory data included: Body temperature (NR: not provided) 103 DEGREES. On 05-AUG-2021, the patient experienced vial was wasted 6 hours after the puncture. On 05-AUG-2021, the patient experienced vial wasted for 6 hours after the puncture was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 103 degrees, vial was wasted 6 hours after the puncture and vial wasted for 6 hours after the puncture was administered was not reported. This report was non-serious.