chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bad headache; Dizzy; just ached all over; is is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 2, single (Lot number: EL9265) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic/ type 2 diabetic" (ongoing), notes: took Rybelsus and Jardiance; "osteoporosis" (ongoing), notes: takes supplements due to her osteoporosis; "Blood pressure abnormal" (ongoing), notes: Takes blood pressure medication; "Knows that she has a lot of sensitivities to medications" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Rybelsus for type 2 diabetic; Jardiance for type 2 diabetic. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: EL3246, Anatomical location: left arm), administration date: 21Jan2021, for COVID-19 immunisation, reaction(s): "Bad headache", "Dizzy", "bone pain". The following information was reported: HEADACHE (non-serious) with onset 11Feb2021, outcome "recovered" (12Feb2021), described as "Bad headache"; DIZZINESS (non-serious) with onset 11Feb2021, outcome "recovered" (12Feb2021), described as "Dizzy"; PAIN (non-serious) with onset 11Feb2021, outcome "recovered" (12Feb2021), described as "just ached all over". Therapeutic measures were taken as a result of headache, dizziness, pain.  Additional information: Additional information: Regarding Covid vaccines, caller states she felt very protected. Knows that she had a lot of sensitivities to mediations. Was pretty worried there would be some reaction. It was pretty strong so, she just blocked out a couple of days each time to get over it. Caller was very pleased with the vaccine. Knew there was going to be side effects. She was so sensitive to medications. Had a lot of allergic reactions, blocks out a couple of days each time for it. She had someone drive her to get it, because of the last reaction. Told them she had reaction and instead of waiting 20 minutes, like usual, they had her wait more, like an hour. Treatment given was just Tylenol. Patient takes medication for diabetes and blood pressure.  Sender's Comments: Linked Report(s) : US-PFIZER INC-202300077890 Same patient/product, different dose/events;
Rash - not urticarial - around mouth, trunk & legs. No other symptoms.
On 2/9/01, around midnight, mom heard baby cry out. She went to check on her and extremities limp, blue lips for approx. 1 minute in duration. She called 911. When they arrived, pt was ok. No follow-up. Reported to us on 3/13/01.
Patient called our pharmacy this morning 9/18, stating that she had received a flu vaccine on 9/16, and that today she noticed the area of the vaccine was red and slightly swollen. Patient did not state any other symptoms, did not have fever or feel otherwise ill, did not have any numbness or tingling in her vaccinated arm. I advised the patient to continue to monitor and if symptoms persisted or got worse to seek medical assistance.
This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient were vaccinated with improperly stored PROQUAD lot # L019995/Expiration Date- 02-DEC-2016, lot # M019232/Expiration Date- 17-OCT-2017, lot # L030589/Expiration Date- 10-FEB-2017. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented for her first COVID-19 vaccine. Approximately a minute after vaccine was given, she was noted to be seated upright in the passenger seat of her car, with head bent forward and eyes open. She was unresponsive, stiff posture, and was placed into a reclined position. She then had some posturing with head turned to the left, no eye deviation or nystagmus, no tonic-clonic movement. Radial pulse was thready, bradycardia was noted, with normal respirations. She was noted to become diaphoretic and pale/ashen color noted to the face and arms. She became responsive within a few minutes, however initially was not able to answer questions clearly. She had no loss of bowel or bladder function. EMS assisted with evaluation.  Initial blood pressure 78/31, HR 54, SpO2 100%.  EMS then transferred her to the stretcher and she was transitioned from her car to the ambulance. She continued to improve spontaneously with BP 94/61 then 103/60 and HR 86 then 74. SpO2 remained stable at 100%.  Skin color improved. She had normal responses to questions, no complaints of headache, dizziness, chest tightness, shortness of breath, numbness or tingling. She had some shaking/voluntary movement of the limbs and body noted, but she could control and stop this voluntarily, no myoclonic or tonic-clonic jerking noted.  After syncopal event occurred, mom reported that the patient has a history of syncope routinely with blood draws and vaccines in the past, however this episode was slightly more prolonged and seizure-like activity was different. She has had some jerking movement previously with syncope which lasts 20-30 seconds, different from today's response. No known history of seizure disorder.
This spontaneous report as received from a registered nurse, refers to 35 patients of unknown age and gender, who on an unknown dates, were vaccinated with a doses of GARDASIL (doses, routes and lot numbers not reported), that were exposed to 23F for 268 hours. The product was unsupported by in-house stability data for this temperature excursion. No adverse symptoms reported. This is one of several reports received from the same source (related MARRS # 1305USA016227, # 1305USA013465). Additional information has been requested.
right hand fingers were a bit deformed; Tiredness; Cold sores; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sores), FINGER DEFORMITY (right hand fingers were a bit deformed) and FATIGUE (Tiredness) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis, Plaque psoriasis and Ulcerative colitis.    No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced ORAL HERPES (Cold sores). On an unknown date, the patient experienced FINGER DEFORMITY (right hand fingers were a bit deformed) and FATIGUE (Tiredness). At the time of the report, ORAL HERPES (Cold sores) outcome was unknown and FINGER DEFORMITY (right hand fingers were a bit deformed) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if the patient was enrolled in covid-19 vaccine trials.  No concomitant product reported by reporter.  As of 18-Jan-2022, patient was concerned about his finger deformity.  No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.    Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2022: Live significant follow-up included updated patient age, action taken with the suspect product and event outcome.
Cellulitis with induration right outer arm at the site.  History of polysaccharide continued immune dificiency on ganglobulin.
Extreme soreness with a lump under left arm pit started about one day after injection.   Day  three a lump appeared on the crease of my left arm.   Lump on armpit and crease of arm on  the arm the injection was done.
Redness at site day 1. By next day. Increased redness (3" X 2""). Warm to touch.
Initial solicited report received on 05 October 2015 from a consumer in the below mentioned study. The subject (gender and age were not reported) received a dose of INFLUENZA VACCINE (date of vaccination, site and route of administration and batch number were not reported). Medical history and concomitant therapies details were not reported. The subject reported that on an unspecified date the side effects were very mild compared to other medicines. The lab data and corrective treatment details were not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Severe Diarrhea - OTC meds dont seem to help the issue as much as they should or ever used too.
Strong pain at the injection place. Fever. One sleepless night. Subsided in a day and a half.
4/6/21: 1:30PM - Sweating profusely 1 hour after shot, fatigue/fogginess lasting 48 hours. 8:30PM - 99.8°F fever + chills lasting through the night, preventing me from sleeping until 4:30AM. 4/7/21: 6:45AM - fever & chills subside upon waking up. Headache, fatigue, fogginess, and lightheadedness last the entire day. Fell into deep sleep @ 10:30PM. 4/8/21: 9:15AM - woke up sweating but otherwise fine. 11AM - sweating, chills, and shaking returned for 1 hour and have since subsided.  Now - I think I?m back to normal.
pt slept 20hr p/the vax & has cont to be lethargic-can sleep 12hr if not awakened & only stays awake 1 1/2hr p/being awakened;
Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. On unspecified dates in February 2016 (reported as between 15-FEB-2016 and 23-FEB-2016), the patients were vaccinated with doses of improperly stored doses of VARIVAX (dose, route, lot# and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Abdominal pain/cramping/diarrhea 2-3 days Some joint achiness off & on for several weeks.   Severe right groin pain around May 12.    Saw PCP.   Xray showed chondrocalcinosis which I've never had before.    Aleve, Volteran.   Still achy but not severe. Muscle weakness, fatigue, double vision waxed & waned for several weeks & then just got worse.   Saw neurologist May 21. (Doing so well I hadn't seen him for 3 years)   Blood tests & brain MRI.    Only abnormal was a seropositive AchR which I've always been seronegative.     Doubled MTX & wants to do IVIg but insurance is denying at this time.
Vaccine was administered on 11/14/2022 which is after the beyond use date of 11/2/2022Patient did not report adverse event nor symptoms.
Approximately 48 hours after the injection the Occipital lymph nodes on the left side of my head became very swollen and inflamed, and caused great pain and discomfort for about 7 days.  The swelling finally started to go down on Saturday November 6th 2021, as well as the pain began to subside. Still recovering at this time.
HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report was received from a medical assistant and refers to a unspecified age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 08-NOV-2022, the patient was vaccinated with an improper storage dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA(M-M-R II) subcutaneous injection, lot number U039910, expiration date: 16-DEC-2023 who had been verified to be a valid number, administered for prophylaxis (strength,dose and anatomical site of injection were not provided). The vaccine was storage at temperature of 47.83 degree Fahrenheit, with a time frame of 0 hours 10 minutes and 0 seconds. There was no information about previous temperature excursion.
Patient called office on above date stating he had "severe pain in left arm at Td injection site, Motrin not touching pain."  Dr. gave him a Rx for Vicodin for pain.  Patient then called back again a few days later with continued lt. arm pain, was told to take 2 Aleve twice a day.  Patient returned to office 8/24/11 complaining that he still had severe lt. arm pain that he felt was caused by Td vaccine and was unable to do his patio construction job without severe pain.  Dr. examined patient and explained to him that this was a very atypical reaction (no redness, warmth or swelling at injection site and no pain at time of injection).  She prescibed a course of Prednisone and Naprosyn and refilled Vicodin, gave referral to f/u with Dr., Ortho, if pain continued.
I started feeling week and had muscle aches and joint pain about 8hr after the vaccine.  Then had stabbing sharp pains all over my chest like it was pain in my lungs.  Severe aching for 10 hrs. Severe chills and dizzy for several hrs. Better now. Seemed important to report.
MD Physician Specialty:  Cardiology Consults     Signed Date of Service:  07/27/22 0722         Hide copied text  Hover for details  1.  Accelerating angina 2.  Tobacco abuse 3.  Essential hypertension- uncontrolled  4.  Normal troponin 5.  COVID   Pe  cv  rrr no m/g/r  Lung clear to a and p abd soft nontender Ext no c/c/e   Plan --  Start heparin GTT.   Smoking cessation encouraged.   Continue asa, norvasc..   No b blocker due to bradycardia.   Increase lisinopril.   LHC in am  Patient left AMA after heart cath.
Facial tingling; This spontaneous case was reported by a nurse and describes the occurrence of PARAESTHESIA (Facial tingling) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy (Left) in January 2013. Concurrent medical conditions included Breast cancer (9th year after breast cancer) since December 2012. Concomitant products included VITAMIN D [VITAMIN D NOS], FAMOTIDINE, ANASTROZOLE, ALENDRONATE SODIUM (FOSAMAX) and CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PARAESTHESIA (Facial tingling). At the time of the report, PARAESTHESIA (Facial tingling) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had none allergies. Patient was not diagnosed with or tested positive for COVID-19.  The patient had seen several doctors (ENT, dentist, neurologist) and they have not seen what the cause. The patient believes it was from  the Moderna vaccine. The patient ENT gave steroids  (taper for a week ) and it did not help.   This case was linked to MOD-2022-600654 (Patient Link).
DIZZINESS, THROAT TIGHTNESS, COUGH, ORAL AIRWAY SWELLING. PT WAS GIVEN EPI PEN IM AND BENADRYL 50MG  IM. SHE WS SENT TO THE HOSPITAL EMERGENCY DEPARTMENT FOR EVALUATION BY AMBULANCE
This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot# M049127 with expiration date 15-DEC-2018, lot# N012487 with expiration date 20-APR-2017, and lot#  N017396 with expiration date 07-JUN-2019, for prophylaxis.  Concomitant therapies included sterile diluent (STERILE MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F during a time frame of 1 hour and 50 minutes and 15°F to 46°F for 6 hours and 15 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported.
Pt claims that next day arm turned red and warm around injection site area with some pain. Pt went to emergency room later that evening, said that doctor told her it was cellulitis. Brought in prescriptions for cephalexin and prednisone around 8:30 pm on 8/16/17.
Thought he had covid-19; Sleeping on and off; Cold sweats in night; Feel terribly weak; Chills, Teeth chattering; sore arm, bodyache; Fever with 101 degree celsius; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Thought he had covid-19), INSOMNIA (Sleeping on and off), COLD SWEAT (Cold sweats in night), ASTHENIA (Feel terribly weak) and CHILLS (Chills, Teeth chattering) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Radical nephrectomy in February 2020 and Colonoscopy (02Apr the patient underwent colonoscopy). Concurrent medical conditions included Kidney cancer since February 2020.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced THINKING ABNORMAL (Thought he had covid-19), INSOMNIA (Sleeping on and off), COLD SWEAT (Cold sweats in night), ASTHENIA (Feel terribly weak), CHILLS (Chills, Teeth chattering), MYALGIA (sore arm, bodyache) and PYREXIA (Fever with 101 degree celsius). At the time of the report, THINKING ABNORMAL (Thought he had covid-19), INSOMNIA (Sleeping on and off), COLD SWEAT (Cold sweats in night), ASTHENIA (Feel terribly weak), CHILLS (Chills, Teeth chattering), MYALGIA (sore arm, bodyache) and PYREXIA (Fever with 101 degree celsius) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, SARS-CoV-2 test: negative (Negative) covid-19 test and tested negative.. On 13-Apr-2021, Body temperature: 101 (Inconclusive) Fever with 101 degree celsius.         Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information was not provided.   On Feb 2020 patient took nine treatments of BCG , stent put in the heart. On 13-Apr-2021 patient took the tenth BCG maintenance treatment and the patient was taking BCG treatment for past one year.     This case was linked to US-MODERNATX, INC.-MOD-2021-077899 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077899:First dose case
Pt. states that after receiving the 1st dose of Phizer 09/03/2021, started experiencing symptoms 20mins of tenderness in the testicles (more so the right) lasting 7-8hrs. No other noted symptoms. No Primary visit noted.
I didn't think I had COVID-19, I thought I had a cold. I went to the hospital because a had a fall and got stuck between a bed and a nightstand and couldn't lift myself up. My wife called an ambulance, and I was taken to the hospital. The doctor administered the COVID-19 test and told me the results. I remained in the emergency room until I was admitted, the administered remdesivir thru and IV and gave me more fluids because I was dehydrated. I remained in the hospital 2 additional days. I had diarrhea which was caused by the antibiotics. I had a 104-degree temperature upon arrival and was shocked about how high it was. I was discharged on the 3rd day and told to isolate for 10 days. After about 4 days, it got better. The sore throat was the worse symptom.
The MMR II TE and administration occurred today, 07/27/2023, and no adverse issues or side effects are reported.; A HBP called to report a TE for MMR II that had also been administered post excursion.  The MMR II TE and administration occurred today, 07/27/2023, and no adverse issues or side effects are reported.; This spontaneous report was received from other health care professional referring to a 4-years-old patient. The patient's medical history, concomitant therapies, and drug reactions or allergies were not reported.  On 27-JUL-2023, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) subcutaneous injection (lot number: W023508 was verified to be a valid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live rHA (M-M-R II), expiration date was provided and upon internal validation was confirmed to be: 25-JUL-2024) 0.5 mL, via injection in the left thigh as prophylaxis (strength and frequency were not reported) administered post excursion (Product storage error) and no adverse issues or side effects were reported (No adverse event). The reporter could not provide the diluent lot number or expiration date and the vaccine was not available for retrieval as it had already been discarded.
I arrived at the ER complaining of tightness in the chest and nausea, having vomited an hour earlier. At triage, the EKG showed a weak heart rate. This was two and a half days after receiving the shot, and having had other symptoms including fever, chills, general soreness, all of which may have obscured an earlier onset of tightness in the chest. Eventually I was diagnosed with acute Pericarditis and prescribed Colchicine by mouth 2 times a day. I'll need to have follow-ups with a cardiologist, continue taking the Colchicine, and go easy on the heart for 6 weeks to 3 months. Long-term, it's expected I'll make a full recovery.
911 was called and patient was taken to ER. Patient came into received flu shot pursuant to appointment. Upon exiting the store she fell. This form is completed to document the incident. However, it is not believed to be due to vaccine, since pt was disoriented and confused in the store patient also was shaking throughout her presence in the store.
Tested positive for COVID-19 on 3-2-2021 and symptomatic
received the 2nd / shot one week ago / developing shingles / right after / dr diagnosed me with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 2nd dose of Shingrix. In December 2020, immediately after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected adult as per vaccine indication. The patient received Shingrix, a week ago of reporting date and right after the shot, the patient developed shingles. The physician stated there was no chance that the patient could develop shingles as the vaccine has dead virus but the physician diagnosed it as shingles.
I had severe nausea, headache, chills and fever for 24 hours.  The fever and chills lasted two more days.  I have a welt on my left arm, from shoulder to almost down to the elbow, swollen, red and itchy x 4 days.
Shingles rash, first episode started with pain 2/4/2022 then rash appeared 2/6/2022. Pt is otherwise health male. No medications. Allergic Rhinitis only. Left low back, Flank and pelvic area. T2 dermatome.
3 days after immunization Left arm posterior distal aspect has red, itchy 5 x 9 cm area.