chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Pounding headache; Extremely sore body; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Pounding headache) and MYALGIA (Extremely sore body) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN and AMLODIPINE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced CHILLS (Chills), HEADACHE (Pounding headache) and MYALGIA (Extremely sore body). At the time of the report, CHILLS (Chills), HEADACHE (Pounding headache) and MYALGIA (Extremely sore body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is taking high Blood Pressure Medications. Patient said that her symptoms are still ongoing. Treatment was not taking
New patient to our primary care office presenting for symptoms of Tinnitus starting approximately 1 week since receiving Pfizer in November 2021 (exact date of receiving vaccine unknown)
Patient felt faint a few minutes after injection.  Patient fainted in chair, after 15 to 20 seconds he had some jerky movements and regained consciousness with a gasp.  He lay on the ground for a few minutes and drank water I provided when he felt better.  He ate a granola bar and left after 15 minute observation.  Counseled mom on vasovagal syncope and prevention.
chest pain and low fever. chest pain for 5 day (increase day to day). low fever for 1 day.
Pt received HPV, TdaP, Hep A, & varicella. Pt received 4 IM injections, tolerated them well. Approx. 4-5 minutes afterwards pt. became dizzy and almost lost consciousness. Pt was in altered state of consciousness for 20+ minutes before his condition improved.
CHEST RASH AND DIZZINESS LASTING FOR 1 MONTH AFTER SHOT; DID NOT RECEIVE SECOND SHOT IN SERIES BECAUSE OF THIS
The patient broke out into a rash. She came to the pharmacy the day after she received her flu shot, the pharmacist recommend she get seen by a provider soon. she was seen the next day and was prescribed antibiotics. She is doing better now.
Patient received PREVNAR on 3/11/15. Reports next day her whole upper arm swollen (baseball size) and it is red. Her arm feels tight and she can see visible welt.
Rash/rash/hives in different parts of the body, sometimes disappear and appear in other different parts, little itching, no pain. This started 8 days after the first dose of the covid vaccine, I have 4 days like this.
Within 10 minutes of receiving my shot the fingers on my left hand (the same arm I got the shot in) turned white. They weren't painful, just a bit cold.  A doctor came over and asked if I had Raynaud's, but I didn't prior to getting the shot. After about 40 minutes, my hand went back to normal. A few days later, I was on a walk, and one of my fingers on my left hand turned white and painful. It eventually went back to normal, but then a few days after that, both of my hands started frequently changing colors. I went to the doctor, and they diagnosed me with Raynaud's. To this day, whenever my hands get cold, they get painful and change colors.   I had one of the common responses to the second dose of the vaccine - 24 hours of a high fever (103), racing heart, excessive sweating, fatigue. The intense symptoms wore off fairly quickly, but a few weeks later, I started having problems with my heart racing, and started having hot flashes as well. My doctor and I eventually determined that some of these symptoms were being caused by panic attacks (which I had never had before March of 2021), but I wonder if some of the symptoms could've been connected to the vaccine as well. My health was really poor throughout the month following my vaccine.   I had COVID in July of 2020, and have had a variety of Long COVID symptoms ever since. When I got my first dose of the COVID vaccine, I felt ok, but after the second dose it felt like my system had been pushed into overload. In April of 2021 I started having extreme fatigue, and my doctor is unsure if it is being caused by Long COVID, or if I have developed Chronic Fatigue Syndrome. I don't know if the vaccine impacted this at all (although it did start after the vaccine), but I include it in case it might be useful information.
When Student nurse was trying to give the patient  her initial dose of Moderna  COVID vaccine the needle and syringe came apart.  Pt did not receive a full dose of vaccine.  Most of the vaccine sprayed in the air. Patient was then give a second dose in the right  deltoid. Patient's failed initial dose injection was attempted in the left arm.
Moderna Lot Number 045J21A was inadvertently used one day beyond the expiration date of May 2, 2022.  Per FDA guidance, Moderna was contacted on May 3, 2022 about the vaccine storage error.  Moderna conducted research on the same lot number and simulated the same conditions noted by Public Health.  Moderna found that the vaccine met the required activity to produce the needed immune response.  This is Moderna Case Number CEA-2351.  Although Moderna noted this vaccine was sufficient to produce the needed immune response, patient was encouraged to speak with their provider to determine the next steps appropriate for them.  Patient has experienced no know adverse events.
devel fever & chills 22OCT95 became disoriented; hospitalized w/inc WBC, ATB given;
10 hours post injection - fatigue 12 hours fever - 100° Held for 48 hours Fatigue, aches, headache for 72 hours Lymph node on injection arm swollen and painful 72 hours later
Pt recvd MMR vax on 12MAR87 & on 11FEB91 the pt devel temp; on 14FEB91 seen by MD for temp, stomach ache, diarrhea & earache; dx rt OM, cough, appetite dec; eyes hurt dx measles, erythematous maculopapular rash;
17APR96 mom reports: 7APR96 low grade temp started in evening;11APR96 t103 ax APAP given;temp low grade on friday & subsided on Saturday;13APR96 devel hives -maculopapular & dyspnea;taken to urgent care-sent by amb to ER-tx & returned home;
Feel like I have a fever (but I don't); headache; fatigue; Arm is also sore, feels like someone punched me.; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced fever, headache, fatigue and pain in arm. On an unknown date, the outcome of the fever, headache, fatigue and pain in arm were unknown.   It was unknown if the reporter considered the fever, headache, fatigue and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had fever, headache, fatigue and pain in arm felt like someone punched after vaccination. The patient did not care much about an achy arm.
Presented with SOB, hypoxia; + Covid 4 days PTA; Admit with Covid PNA to tele; tx with maxipime, rocephin, steroids, remdesivir, zithromax, singulair, zinc, minimal supplemental O2 Patient is instructed to self-isolate for 24 hours after temperature returning to normal, symptoms continuing to improve AND 14 days from the onset of symptoms. Disposition: He will be discharged today to home.
received the first dose 20 months ago and has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019, 20 months prior from the reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The reporter was a pharmacy intern. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Information has been received from a physician concerning a 25 year old female who on 29-JUL-2010 was vaccinated in the buttocks with the first dose of GARDASIL (Lot # unknown). On 30-JUL-2010 the patient developed hives in the face and hand. At the time of the report the patient's outcome was not reported. The patient sought medical attention by seen the physician in the office. Additional information has been requested.
Her husband experienced a little weakness; One night of diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Her husband experienced a little weakness"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "One night of diarrhea".  Additional information: It was reported that, the patient was due to get the second vaccine on 17May2021. Second vaccine scheduled 25 days after the first vaccine. Her husband experienced a little weakness and one night of diarrhea. She was not sure the diarrhea was from the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left side face drooping ,  worsening numbness in hands (lasted from afternoon of vaccine until next morning)
congestion; head fog; not sleeping well; cough on and off; not walking well; sore arm for three or four days, it started hurting a couple days after the shot; cold chills; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congestion), FEELING ABNORMAL (head fog), POOR QUALITY SLEEP (not sleeping well), COUGH (cough on and off) and GAIT DISTURBANCE (not walking well) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (congestion), FEELING ABNORMAL (head fog), POOR QUALITY SLEEP (not sleeping well), COUGH (cough on and off), GAIT DISTURBANCE (not walking well), MYALGIA (sore arm for three or four days, it started hurting a couple days after the shot) and CHILLS (cold chills). At the time of the report, NASAL CONGESTION (congestion), FEELING ABNORMAL (head fog), POOR QUALITY SLEEP (not sleeping well), COUGH (cough on and off), GAIT DISTURBANCE (not walking well), MYALGIA (sore arm for three or four days, it started hurting a couple days after the shot) and CHILLS (cold chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Patient says she thinks she might be in the early stages of dementia and that she might be a long hauler.  Concomitant medication was not provided.  Treatment information was not provided.
swelling & erythema @ inj site, fever 101, h/a on 18FEB95; given DPH;21FEB95 large area macular erythema; area of inj erythematous, indurate; afeb; treated w/Keflex
This case was reported by a physician via call center representative and described the occurrence of swelling in a patient who received FLULAVAL Quadrivalent. On 15th September 2016, the patient received FLULAVAL Quadrivalent. On 15th September 2016, less than a day after receiving FLULAVAL Quadrivalent, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown. It was unknown if the reporter considered the swelling to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient experienced significant swelling after vaccination with FLULAVAL. This report came in through a live chat and the reporter decided to call into medical information to provide the details related to this. The reporter did not collect any additional information via chat like lot number, expiry date, patient initials, date of birth or gender.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported No treatment medications were provided  The vaccine was stored in the freezer and one to two vials were taken out and placed in the fridge each day as needed.
Fever 103.9 on 10/21 102.3 on 10/22 and WNL 10/24 Returned to school 10/24.
Sharp shooting pains, like electric shock, and constant ache in shoulder, down arm, tingling on fingers, unable to lift arm overhead, reach across chest or behind my back, can't lay on left side, pain never goes away, makes me sick nauseous
Jan 27;  redness at injection site Jan 29:  oval red patch at injection site; soreness under the armpit, unable to complete raise arm Jan 30-Feb 2: forearm swelling from injection site to inner elbow; burning sensation Feb 5; swelling diminished however bumpy rash began to appear with itching; applied hydorcortisone Feb 7 Virtual doctor visit prescribed ydrOXYzine HCl (ATARAX) ; methylPREDNISolone Feb 10-15 ; bumps diminished, but blistery rash developed and spread down left arm, left side and back, up to front of my chest and left side of neck.  Areas were itchy and extremely sore.    Feb 15 Doctor visit.  received steroid shot; prescribed  predniSONE (DELTASONE)  sulfamethoxazole-trimethoprim   Took about a week to notice relief.  Complete recovery by Mar 7.
patient tested positive for COVID-19 > 14 days after vaccine series. patient is due to deliver on 10/07/2021, and tested positive @ routine 39 week prenatal visit, patient is asymptomatic.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient. There was no pertinent medical history and no drug reactions or allergies. On 07-MAR-2014, the patient was vaccinated with ZOSTAVAX lot # J011549 expiry date 19-DEC-2014, subcutaneous (dose not reported). Concomitant medication was not reported. On 09-MAR-2014, the patient called into the pharmacy stating she developed a rash, a "hard area" and swelling at the injection site. The pharmacist instructed the patient to "put ice on it" (also reported as no treatment given for the events). No lab diagnostics performed. On 12-MAR-2014, the patient came in to the pharmacy and "only the rash was still there". (The outcome of a rash at the injection site was reported as not recovered. The outcome of a "hard area" and swelling at the injection site was reported as recovered). Additional information has been requested.
An approximately 53 year old male patient received 6 OncoTICE installations in 1997 for bladder cancer. Reportedly he started getting a tan colored rash in the groin area soon after receiving the treatment. Over the years the rash had progressed also to the upper leg area and became variously red, itchy, crusty and or/ burning. He had been treated with various medications with only temporary relief. A dermatologist had done a biopsy and this had rule out skin cancer. The patient also stated that his pre-existing urinary frequency problem worsened for urinating 7-8 times  a day to approximately 23 times a day. Steroid based creams/ ointments.
Patient was sitting in observation area. c/o a little blurriness in left eye. Alert and oriented. No other complaints. 1840:tates blurriness is fine now and she feels back to normal. States she was dismissed from the hospital 2 days ago. States she ahs chronic kidney problems.
Initial information received on 01-Mar-2019 regarding an unsolicited valid serious case received from a consumer. This case is linked with 2019SA062563 (same reported, patient's brother). This case involves a child male patient (age unknown) who experienced seizures, sensory issues and allergies and autism with developmental regression, while he received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patients past vaccinations, history, concomitant medication were not provided. Family history included patient brother has Autism. Patient's mother reported that her children were normal and then started to regress. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious seizures (seizure) with unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant. On an unknown date, the patient developed a serious autism (Autism spectrum disorder) with started to regress (Developmental regression) unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant. On an unknown date, the patient developed a non-serious sensory issues (sensory disturbance) with unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. On an unknown date, the patient developed a non-serious allergies (hypersensitivity) with unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. Final diagnosis was allergies, sensory issues and seizures and Autism. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for seizures, as Unknown for sensory issues and as Unknown for allergies and not recovered for Autism and developmental regression. According to reporter adverse event is related to vaccine. List of documents held by sender- none.; Sender's Comments: This case concerns a child patient with history of autism who developed seizures, sensory issues and allergies following vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer. The time to onset is unknown. Moreover, medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not provided. Based upon the reported information, the role of the vaccine cannot be assessed.
injection site pain; flu-like symptoms; fev; chills; received her 2nd dose of Shingrix 9 day earlier than the 2 month mark; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix.   On 22nd February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, fev, chills and drug dose administration interval too short. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, fev and chills were recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, fev and chills to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced flu-like symptoms, but they were more intense and that lasted for 24 hours. The patient his 2nd dose of Shingrix 9 day earlier than the 2 month mark which led to drug dose administration interval too short. Reporter did not consent to follow-up.  For tolerance after 2nd dose refer case US2020AMR034881. This case is linked to the case US2020034256 and US2020AMR034880 wife's case.
Systemic: Fainting/Responsive after mild fall, fully recovered after rest-Mild
8 days after vaccine, I started feeling very fatigued.  My arm developed a rash, itching and some soreness at the injection site.  Rash is also hot to the touch.
pt recv vax & devel malaise & an inj site rxn characterized by tenderness, swelling & induration;1wk later inj site was described as a dissected fascial hematoma;15cm by 3cm distal to inj & raised 1.5cm;non-absorbed hematoma still present;
Patient requested vaccine be given in gluteal upper outer quadrant as she can't have any injections in her deltoids because of her history of abscesses in that area from previous injections. Patient received her first dose in this site. States her PCP recommended all injections in this site including vaccines. Vaccine was given in left gluteal upper outer quadrant.
Severe body and joint pain, fever, chills, nausea, at first   Then macrophage activation syndrome which almost killed me  And now I possibly have a chronic inflammatory condition. The doctors are still trying to figure out how to help me
Pt complaining of "burning pain" around neck, jaw and both collar bones. Upset stomach with nausea and vomiting, "heart pounding" and shortness of breath. Pt instructed not to take flu shots in the future.
At first right after vaccine it just felt like an invasion of something, I knew I had something I had that was different.  March17, I got sick - I had a bad stomach ache. Friday, I thought the doctors would be gone. March 21st, I went to the clinic and they sent me right to the hospital for a scan and I had emergency surgery to remove my appendix - but it did get put off from when I went in because of all the emergencies in front of me with the ambulances coming in from accidents. He said it had burst  by the time the surgeon got to me with the surgery and they gave me antibiotics and he said he poked three holes in my belly. Still recovering - I have follow up tomorrow. I am doing real well. My stomach doesn't hurt and I am not taking pain medication any longer.
This spontaneous report was received from a licensed practitioner nurse refers to a patient of unknown age. On 14-JUL-2016, the patient was vaccinated with a dose of PROQUAD lot # M002053. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from physician assistant refers to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (VIAL 19400 PFU) (lot # and expiry date were not reported) for prophylaxis. On an unknown date the patient developed a recurring shingles rash in the area of her lower back and buttocks. The rash clears up but "keeps coming back" and was treated with Acyclovir. The outcome of rash and herpes zoster was unknown. Causality assessment was not provided by reporter.
1 wk post immunization, PT "sniffles" progressively to URI - chronic cough - __ phlym. To ER 3/12/03 or 3/19/03? Rx for Bronchitis with Amoxicillin. No improvement.