chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse referring to a 43 patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On an unknown date, the patients were vaccinated with an improperly stored doses of VARIVAX lot # M037008 with expiration date of 25-AUG-2017 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of >14 degrees Fahrenheit but <46 degrees Fahrenheit for 116 hours. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
Dizzyness at time of injection; numb feet that afternoon; lung pain that Saturday, continued pins and needles ///numbness muscle weakness, and very dizzy from lying down to standing.   Face felt odd, as if muscles were not fully functioning. It is now 4.5 months of continued numbness and pins & needles.
swelling; headache; pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), HEADACHE (headache) and VACCINATION SITE PAIN (pain in the arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke.   On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced SWELLING (swelling), HEADACHE (headache) and VACCINATION SITE PAIN (pain in the arm). On 03-Nov-2021, SWELLING (swelling), HEADACHE (headache) and VACCINATION SITE PAIN (pain in the arm) had resolved.            No concomitants medications was reported. no treatment drugs are provided.   This case was linked to MOD-2021-378301, MOD-2021-378302 (Patient Link).
Pt on 5/9, got DTAP, MMR, IPV and Hep-A immunization. Mom on morning of 5/10 noticed swelling/erythema of rt arm. Swelling/firmness increased over next 24 hours. Pt had pain in area at rt upper arm without any change in ROM.
developed hives 24 hours later, itchy, treated with benadryl seen in Dr's office 48 hours later, still with hives, treat with benadryl, referred to allergist
Pt reported tingling feeling in her lips aprox 10 minutes after her vaccine. She didnt have any other symptoms, BP 130/68, P80, R24. Symptoms got better after another 10 minnutes.
Pt received flu shot in office. 5-10min later had a seizure.  Pt recovered 1min later Has hx of seizure disorder Has received other flu vaccines in past w/o issue
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized for fever and progressive dyspnea. Vaccination took place on 4/14/2008 and hospital admission was on 5/09/2008. According to the physician, relationship to treatment is 'None'. We would be happy  to forward the Study's SAE Report Form upon request.
Feel achy; Have headache; Really really tired; Sweating; Got dizzy; Passed out; Fever in middle of night; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048821A and 047821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), DIZZINESS (Got dizzy) and PYREXIA (Fever in middle of night). On 28-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating) and FATIGUE (Really really tired). On 29-Apr-2021, the patient experienced PAIN (Feel achy) and HEADACHE (Have headache). On 29-Apr-2021, PYREXIA (Fever in middle of night) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), HYPERHIDROSIS (Sweating), DIZZINESS (Got dizzy), PAIN (Feel achy), HEADACHE (Have headache) and FATIGUE (Really really tired) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided. The patient did not experience any side effects after first dose.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This case was forwarded by Crucell with the reference number CVAE-056-2013. Initial spontaneous case received on 12-Sep-2013 from a physician and from the patient and processed together with follow-up information received on 13-Sep2013 from the physician, which concerns a 46-year old male patient who received 3 oral doses of VIVOTIF (batch number 3000421, expiry date not reported). First dose of VIVOTIF was taken on an unspecified date in Aug-2013 (24.Aug.2013 and 25.Aug.2013 were reported), second capsule on 27-Aug-2013 and third capsule on 29-Aug-2013 respectively. The patient did not take the fourth capsule. The patient had no medical pre-existent condition. The physician reported that the patient had a normal physical examination with normal routine chemistries and Complete Blood Count (CBC) before vaccination. Concomitant medication was not provided. On 26-Aug-2013, the patient experience diarrhea. On 27-Aug-2013, he took the second dose and he experienced intense abdominal pain. On 28.Aug.2013, the pain subsided, but not completely. After the intake of the third capsule of VIVOTIF, on 29-Aug-2013, the patient reported the recurrence of intense abdominal pain and diarrhea. Tests and examinations performed showed negative / normal abdominal CT and MRI, and normal blood tests after the patient stopped the vaccine course two weeks before the date of this report. No treatment was taken for the reported events. The reporting physician was considering antibiotic therapy with azithromycin or ciprofloxacin to treat the patient. As per the reporter physician, at the time of the report, the patient is still having persistent burning abdominal pain and diarrhea several weeks after vaccine administration. The events were assessed as serious, medically important by the reporter physician. No further details were provided.
Left bicep, tricep doubled in size/It became swollen; Left elbow doubled in size/It became swollen; It became hot; Arm had a swelling ring that got hard at the injection site; Got hard at the injection site; The vaccine that was given to me was stored in a pre-filled syringe and that's the problem. It was exposed to latex during that time; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left bicep, tricep doubled in size/It became swollen), JOINT SWELLING (Left elbow doubled in size/It became swollen), FEELING HOT (It became hot), VACCINATION SITE SWELLING (Arm had a swelling ring that got hard at the injection site) and VACCINATION SITE INDURATION (Got hard at the injection site) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Silicone allergy), Latex allergy, Insect sting allergy (Hornets allergy) and Smoke sensitivity (Smoke allergy).   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced PERIPHERAL SWELLING (Left bicep, tricep doubled in size/It became swollen), JOINT SWELLING (Left elbow doubled in size/It became swollen), FEELING HOT (It became hot), VACCINATION SITE SWELLING (Arm had a swelling ring that got hard at the injection site), VACCINATION SITE INDURATION (Got hard at the injection site) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (The vaccine that was given to me was stored in a pre-filled syringe and that's the problem. It was exposed to latex during that time). On 22-May-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (The vaccine that was given to me was stored in a pre-filled syringe and that's the problem. It was exposed to latex during that time) had resolved. At the time of the report, PERIPHERAL SWELLING (Left bicep, tricep doubled in size/It became swollen), JOINT SWELLING (Left elbow doubled in size/It became swollen), FEELING HOT (It became hot), VACCINATION SITE SWELLING (Arm had a swelling ring that got hard at the injection site) and VACCINATION SITE INDURATION (Got hard at the injection site) had resolved.            Patient is allergic to a long list of things.  No Concomitant medication were reported.  It was reported that within 1 hour of getting the vaccine his arm had a swelling ring that got hard at the injection site and 8 hours following this his eft bicep, tricep, elbow doubled in size. It became hot and swollen.  It was reported that a doctor prescribed him antibiotics and his arm got better within 10 days.
Little short of breath; tongue burning "felt like bunch of hot peppers"; Face flushing; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOMFORT (tongue burning "felt like bunch of hot peppers"), FLUSHING (Face flushing) and DYSPNOEA (Little short of breath) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy multiple, Asthma and Atrial fibrillation. Concomitant products included RIVAROXABAN (XARELTO), LANSOPRAZOLE, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), VITAMIN D3, CYANOCOBALAMIN (VITAMIN B12 ALKALOID), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), PARACETAMOL (TYLENOL) and VITAMINS NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced TONGUE DISCOMFORT (tongue burning "felt like bunch of hot peppers") and FLUSHING (Face flushing). On 03-Mar-2021, the patient experienced DYSPNOEA (Little short of breath). On 02-Mar-2021, TONGUE DISCOMFORT (tongue burning "felt like bunch of hot peppers") and FLUSHING (Face flushing) was resolving. On 03-Mar-2021, DYSPNOEA (Little short of breath) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Hypertension (high-Unknown): (High) high blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient stated that she received her first dose of Moderna Covid-19 vaccine on 02March2021 on left arm. The patient notes that she has "a lot of allergies and I am also on medicine for a-fib". The patient states that she received her vaccine in her doctor's office where she started experiencing high blood pressure, tongue burning "felt like bunch of hot peppers" face flushing. The patient states that her symptoms are little bit ongoing. The patient also states that on 03March2021 she felt little short of breath and states that my asthma medicine did not help. The patients states that she end up staying at the doctor's office for an hour. The patient is asking if she should get second dose of vaccine. The patient agreed to follow up with safety. No treatment provided
On 9/10, 9 days after vaccination, I developed tightness in my chest mid morning as well as a mild sore throat. I left work. Went home, slept, woke up around 2:00 with persistent tightness in my chest and sore throat. I rested. That evening I woke up in the night, the left side of my mouth was swollen and my left eye was bloodshot. I put an ice pack on my face and went back to sleep. Next morning, I woke up (9/11), still had tightness in my chest and a sore throat and additionally my hands and feet were swollen. It was painful to walk and open and close my hands. I went to immediate care. They ran an EKG, labs, did a chest X-ray. EKG and chest xray came back clear but my labs revealed a d-dimer value of >3,800 (normal <400) which they said was indicative of me possibly having a pulmonary embolism, especially because I had just gotten the J&J vaccine. I was sent to the hospital immediately. They did additional blood work, EKG, and a chest CT which revealed no PE. I was told it was likely just a bad vaccine reaction and sent home. I followed up with my PCPs office on 9/20 who also believed it was an adverse vaccine reaction.
Patient did miss taking some of the time medication when was sick post COVID vaccine; This is a spontaneous report form a contactable other HCP and contactable consumer. A 49-year-old female patient received both doses (first and second dose) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunization and co-suspect ongoing tofacitinib citrate (Xeljanz XR, prolonged-release tablet) 11 mg daily via orally from on an unknown date in Jan2021, taken for rheumatoid arthritis. The patient's medical history included ongoing rheumatoid arthritis. Concomitant medications were not reported. Patient took both COVID vaccine doses, and was off Xeljanz for maybe two weeks per MD recommendation. Patient did miss taking some of the time medication when was sick, post COVID vaccine. One time run out Xeljanz for almost a week-issues with delivery. No symptoms reported with missed doses. The benefits of medication outweigh the risk- it did help patient. Denies feeling sad/ discouraged had learn to live with it- before was feeling discouraged. Outcome of the event was unknown.   Information on lot/batch number has been requested.
This is a spontaneous report received from a contactable other health care physician (patient) via physician. A 44-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: not provided) via an unspecified route of administration at left arm on 08Sep2021 (at the age of 44-year-old) as dose 1, single for COVID-19 immunisation. The patient does not have any medical history including any illness at time of vaccination. There were no concomitant medications. Patient did not receive any other vaccinations prior to vaccination within 4 weeks and It was yes Adverse events following prior vaccinations: to flu vaccine. It was mentioned that caller reported that she received her first Covid vaccine dose yesterday and afterwards experienced an allergic reaction on 08Sep2021. Caller reports that she received the shot between 4-4:30 and at 11pm the injection site started to itch on 08Sep2021, it then spread to her arm and neck. She went to Employee health and got Benadryl but states that she got hives and redness on the left arm also on an Sep2021. Now the caller is trying to get an exemption at work but it was declined. She doesn't want to get the second dose due to her reaction to the first, now wondering what she does. Further caller asking "What do I do if I don't want to get the second dose. Referred to HCP for evaluation and guidance. Caller states she went to employee health today. Caller relays it stopped after the Benadryl and today it started again on her arm, today the redness came back. Caller states she was an allergic person and was trying to get an exemption as she usually develops an allergy and itches with hives all over her body. States they didn't accept her exemption and want her to do the 2nd but she doesn't want to do it as she is allergic. Patient did not visit emergency room but visits the physician office for the events. Therapeutic measures were taken for the events. Outcome of the events allergic reaction, got hives and redness on the left arm also not recovered and injection site started to itch, it then spread to her arm and neck was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax;devel redness & induration (7cmx4cm) around inject site; no tx needed;
Headache, Tingling in mouth, swollen lips, heaviness in the chest, throat closing, sore throat, excessive dry mouth, trouble breathing, tired
I Started Having Diarrhea Really Bad That Night And I Had Severe Stomach Pain & Nausea & So It Continued For About A Month & I Was Just Exhausted So My Husband Took Me To An Urgent Care & I Was Given Several Test & Diagnosed With Adverse Reaction To Vaccine.
Erythema with swelling and itching on left deltoid. Area covers approximately 12.7 cm x 12.7 cm.
Involuntary error, vial Pfizer Biotech vaccine was diluted with 0.3ml of 0.9% sodium Chloride instead of diluting with 1.3m. Dose was administered to patient with 0.2ml after dilution.
Eye Swelling that moved to cheeks and throat. Patient went to her personal doctor and was treated with Benadryl.
From initial information received on 5/10/04 from the patient's parent regarding an adverse event occurring in the USA, it was reported that a 17 year old male patient received his first dose of post-exposure IMOVAX RABIES on 3/27/04 and a second dose of IMOVAX RABIES on 3/30/04. Lot numbers, routes and sites of administration were not reported. 24 days after receipt of his second dose, the patient developed symptoms of headache, which progressively worsened to migraine, nausea, vomiting, and diarrhea. Reportedly, the symptoms lasted seven to ten days. Per mother, the patient is to see a physician for assessment, upon which either the physician or the mother will submit a report. Per recall, the patient is to receive three more doses of the vaccine. The patient's recovery status was not reported. From additional information received on 7/9/04, it was reported that the patient received the vaccines following an animal bite. The type of animal was not specified and it was not reported whether it was tested for rabies. He received the IMOVAX RABIES vaccination in an emergency room and was started on Augmentin on 3/30/04 by another physician. The lot numbers were not provided. It was not reported whether the patient continued the series or whether he recovered from these adverse events.
This is a medication error report. The subject should have received Pfizer COVID-19 vaccine on this date instead of Moderna.
pt recvd vax & 24 to 48 hrs later pt devel soreness, swelling & redness @ the inject sit;
Administration past the 30-day Use by Date of the Moderna vaccine. No Symptoms to report as no adverse event was reported.
Fever 102.5 hot stomach and thighs. Fri. nite arm swelled 2x normal size - Red and hot. Lost appetite for food or drink. Fever went down Sat. morning. Arm immobile from pain. Fever started again-went to Em. Rm. Got steroids and antibiotics. Took 5 days to recover.
Hives starting around 6pm on Thursday evening  Saturday evening horrible headache and head started swelling  Sunday morning back started swelling  Monday morning neck and face started swelling Tuesday went to ER was prescribed Prednisone to start taking on Wednesday been taking for 2 of 4 days and swelling is still present, but starting to lessen.
Moderna vaccine was mistakenly administered to him at age 17 years, 11 months. When charting the next day, the error was discovered. Immediately notified his mother of the error, as well as supervisor RN. Mom states there was no problem/side effects with the vaccine.
A red, firm., swollen patch at vaccine site which began to itch two days after.  I also had fever at 102 degrees, severe body aches, and headache which  continued more than 48 hours after injection
Had severe pain in left arm for about 24-36 hours after shot. I don?t know if a change in my thyroid levels are related but since then my doctor has change my thyroid dosage (my levels had been consistent for 20 years prior). I have felt lethargic, depressed, and mood swings.
Bells Palsy/can not eat and can not drink, can not smile, can not sleep, can not close their left eye; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy/can not eat and can not drink, can not smile, can not sleep, can not close their left eye) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In July 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 03-Oct-2021, the patient experienced BELL'S PALSY (Bells Palsy/can not eat and can not drink, can not smile, can not sleep, can not close their left eye) (seriousness criterion medically significant). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and VALACICLOVIR for Adverse event, at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bells Palsy/can not eat and can not drink, can not smile, can not sleep, can not close their left eye) outcome was unknown.            Concomitant medications were not reported. The patient was also prescribed with some eye ointment, an eye patch at night to keep the eye shut and some eye drops for daytime.; Sender's Comments: This case refers to a male patient of unknown age with no relevant medical history who experienced the expected event of Bell's Palsy approximately 3 months after the second dose of Moderna COVID-19 Vaccine. Rechallenge was assessed as not applicable since limited information on the first dose was provided. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Initial report received from a healthcare professional on 14 October 2013. This case is a cluster of 2 patients. 2 patients whose gender, birthdate and age at the time of event, medical history and concomitant medication were not reported, had received a dose of FLUZONE QIV vaccine (lot number: U4767AA, dose number and route of administration were not reported) in the thigh on an unspecified date. It was reported that 0.25 ml prefilled syringe broke leaving needle piece in patient's thigh vaccine squirt out onto patients' leg leads to incorrect technique used for drug administration and vaccine under dose was administered. Laboratory investigations and corrective medications were not reported. Documents held by sender: None.
BP increased from systolic 135 to 170 for 12 hours. very abnormal for patient