chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (18Aug2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including PAXLOVID given from 08Aug2022 to 13Aug2022.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
On Monday, February 18th, around 08:25 in the morning, I noticed an itchy rash broke out around the back of my neck. I attempted to treat the rash with Triamcinolone Acetonide Cream USP, 0.5%. On Tuesday, February 19th, I noticed the rash had spread from the back of my neck to the front and down and across my chest. The rash also began appearing on the sides of my face and above my eyebrows.
Chills, fever, severe headache, arm soreness, fatigue starting about 9 hours after shot. Continued through the night. Woke up with severe headache next day. 4 days later have headache and sore arm returning.
pt recv 1 dose of varivax 10/95 & in 4/98 pt devel a ``full blown care of chickenpox w/approx 500 box on his body''
New onset atrial fibrillation, began at approximately 1:45pm of the 14th of May 2021,  Was first seen by a nurse who called EMTs to transport to emergency hospital.  Was admitted to hospital critical care room at approximately 7pm same day.  Remained in Afib until approximately 3:30am on the 15th.  Treatment included a course of eliquis at 10 mg, along with IV administration of Cardizem (unsure of dosage.)
Pt called call center. Pt c/o on/off dizziness since 04/26/2021 and also feeling slight anxious. Pt also stated she had fever and chills on 04/22/021 after she got covid 19 vaccine Moderna on 04/22 but fever, chills went away and was feeling ok till yesterday. Pt advised to go to urgent care or ED.
12 hours post vaccination the worst headache of my life and severe flu symptoms which calmed down after 24 hours.  At the 24 hour mark a cough developed and has not gone away since. It is a non productive dry cough that has not improved since onset. The headaches have also been consistent since the onset, but have toned down to a moderate headache. Headaches have been consistent for 5-6x per week since vaccination. Broken blood vessels in eyes and pain with eye movements was a symptom from week 1 to last week. Now my eyes are just full of broken blood vessels, but not as much pain with movement.
Patient became flushed, pale, stated her throat felt like it was hard to swallow. Administered 25 mg Benadryl PO, Vitals taken at 11:47 Pulse Ox 85%, BP 128/64, Vital signs at 12:15 BP 128/62, pulse ox 100%, pulse 84, and temp 98.1 Patient given water and ice pack to the back of the neck Patient at 12:17 states feels better, no longer flushed or complaining that throat feels funny.
13 Years old Female with no PMH presenting with numbness/tingling in all extremities generalized weakness x 1 week (since 9/7). Started with bilateral lower extremity paraesthesias ("tingling pins and needles like when my leg falls asleep") from mid-thigh to toes while lying in bed at night. Sensation exacerbated by movement. Has persisted for the past 7 days. The next day, she began to have a similar sensation in her hands bilaterally (all four fingers, wrist to fingertips). Hand paraesthesias also persisted since they began. Also had intermittent abdominal paraesthesias which have since resolved. 24 hours ago developed poor grasp and tremor. Increased fatigue and general weakness. One fever (100.9 orally) on 9/10. Went to pediatrician who sent her to the ED on 9/10. Left before being seen by attending. Felt one skipped beat last night. Frontal bilateral dull headache last night while lying down, self resolved after one hour. Has had about 5 nighttime headaches in the past month. No headaches during the day. No visual changes.  Second dose of Pfizer was done on Aug 31st. No history of known or suspected covid infection. No dizziness, n/v, chest pain, sob, recent unintended weight loss, chills, cough, throat pain, odynophagia, change in appetite, tick bites, dysuria, heavy periods, medication use/ vitamin use, abdominal pain, recent travel, sick contacts, rash, diarrhea, constipation, urinary symptoms, hematochezia, fall, or pain anywhere.  Admitted to Medical Center on 9/13. Treatment with 40g IVIG started 9/15/2021 and second dose 9/16/2021 40 g.  Patient is currently hospitalized at the time of submitting this report.
Pfizer covid-19 vaccine was given 32 days after Moderna covid-19 vaccine was given
Day of shot mild discomfort at injection site, mild headache over right eye.  On 3rd day noted sudden  right eye discomfort ( like something was in it) eye unusually dry Over next 24 hours both eyes affected , very dry I then noted slight difficulty with  blowing and sucking which continues to present.  These were subtle symptoms,  no facial droop noted  I tried to report it via the V- Safe site but it wasn't included in any of the symptoms listed so the app did not accept
This spontaneous report as received from a registered nurse refers to an unspecified patient (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# were not reported) which this single dose was exposed to -1C for 22 days. The nurse stated that she was not sure if dose may had been administered to the patient. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Nausea/vomiting. Tempature of 102 oral that night and tempature up and down for 2 days.  Mother took her to PMD's office the day after the shot.  Dx. was gastrointestinal virus with possible reaction to shot.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could hardly lift arm up), RASH ERYTHEMATOUS (Red rash perfect circle for 5 days), SWELLING (Swelling, but it went away), PRURITUS (Itching for 5 days) and PAIN IN EXTREMITY (Very sore arm for a week) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Radiation therapy (Did radiation for Rosai-Dorfman Disease in July and August.).  Concurrent medical conditions included Rosai-Dorfman syndrome (A histiocytosis disease, which is a non malignant blood cancer, but it is not present in the blood stream.) and Diabetic. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, 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 experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could hardly lift arm up), RASH ERYTHEMATOUS (Red rash perfect circle for 5 days), SWELLING (Swelling, but it went away), PRURITUS (Itching for 5 days), PAIN IN EXTREMITY (Very sore arm for a week), PYREXIA (Slight fever) and HEADACHE (Bad headache for a day). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could hardly lift arm up), RASH ERYTHEMATOUS (Red rash perfect circle for 5 days), SWELLING (Swelling, but it went away), PRURITUS (Itching for 5 days), PAIN IN EXTREMITY (Very sore arm for a week) and HEADACHE (Bad headache for a day) had resolved and PYREXIA (Slight fever) outcome was unknown. No concomitant medications were reported. This case was linked to MOD-2021-339411 (Patient Link).
continous crying > 3 hrs; inject area tender to touch, lt leg swollen, reddened-6cm size;
3 days post vaccine, 12/30/2020 in the evening I started with body aches, sore throat, mild cough; overnight I developed fever max 100.5 so far and headache, some chills.  unclear if truly adverse event or I just contracted covid at about the same time I got the vaccine.
Pt not having pain in the right arm from FLUVIRIN. Pt called me on 9-9-10 to let me know her left arm was really hurting her after her PNEUMOVAX shot on 9-8-10. I told her to see Urgent Care. I called to check in with her on 9-10-10 but could not reach her. Called pt on 9-11-10 pt said that she saw doctor on 9-11-10 & that she had bursitis from the shot. She is in a lot of pain. Pt is using LIDODERM patches to manage pain & VOLTAREN Gel & TYLENOL ES.
I contracted COVID-19 after my 4th dose vaccination.  symptoms: cold like symptoms Prescription: no prescription
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 10-OCT-2012, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician at a clinic for the following injury resulting from the patient's ZOSTAVAX use: Post-herpetic neuralgia. The patient claims damages including: injury to herself and economic losses. The outcome of post-herpetic neuralgia was unknown. Post-herpetic neuralgia was reported as related to ZOSTAVAX. Additional information has been requested.
Inflammation in just about every system in my body. I have no insurance or doctor, so I used braces for my hands and elbows, hot compresses and saline for my sinuses, and after a week, aspirin for headache. I took extra Vitamin C and used my waterpik 3x per day to reduce gum inflammation. I removed all piercings as they also became painful.  Ten days later, my hands and feet are still inflamed and painful, and I still have a headache.
had Covid; had Covid; This is a spontaneous report  from a non-contactable consumer (patient herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had Covid last week on Apr2021. She wanted to know if she can still receive the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine even if she had Covid. Outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Red rash at injection site, spread down arm, hives on face and throat, lump in armpit and neck, sore throat, dizziness, disoriented
A report has been received from a Pharmacist concerning a 7 month old, subject of unknown gender, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. It was reported that administered to 7 month old. The outcome of the event of ADMINISTERED TO 7 MONTH OLD is unknown. The report was considered to be non-serious.
My doctor ordered for me to get a shingles vaccination. I received Rx at pharmacy. Less than an hour later, already at home, I started getting dizzy, got chills, and rapid heart beat. I called my allergist and was recommended to take 5 mg Prednisone and BENADRYL. Next day, September 2, my lips got swollen. My BP went up to 187/110. I took another Prednisone (only 5 mg) and BENADRYL x2 for three more days. It took me a week to finally start feeling better. I checked with pharmacy and my doctor and was told that I needed to report my reaction.
Patient is complaining of shoulder pain radiating down her arm. She claims pharmacist had given the shot too high. It's been about 2 months and she thinks it is due to the flu shot. Sore arm.
I had had COVID-19 October 18th. It was only like a cold. Tested negative a week and a half later. Had my first COVID shot on January 20th. Woke up at 5:00 am on 21st with fever of 100.6.  Extreme pain in muscles of both hips into both buttocks. Chills. Fever went as high as 103.9. Got it down with Tylenol. Slept all day. Fever broke during the night. Next morning no fever but still had pain in muscles. No problems after  that.
Was sick/ She got sick; This is a spontaneous report from a contactable consumer or other non HCP reports for herself. A female patient of an unspecified age received bnt162b2 ((PFIZER-BIONTECH COVID -19 VACCINE, Injection for injection, (Batch/Lot Number is not reported expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported she was sick/ she got sick (illness) on an unspecified date. States she got her 1st shot ;no problem but in between, she was supposed to go back in 3 weeks and she got sick so she couldn't make it to her next appointment for her second shot. She said her doctor told the nurse to go get her a shot, well the nurse told the doctor that the shots weren't any good as they had been sitting out for some time and the doctor says they are fine to get it anyway and she got the shot and then she got extremely ill for a long time, over a month.  She had received her first Pfizer covid 19 vaccine, was sick in between the two doses, received her second dose of the vaccine six weeks or more after the first dose. The nurse at her doctor's office told the doctor the doses aren't good because they were out for too long, the nurse didn't want to give it out. She was informed by her doctor to get the vaccine. She said the vaccines were left out for a couple of days. She had the following side effects after the second dose: chills, diarrhea, headache, joint pain, fever, sweating, hot, it was like I was drained of all my energy, the site where I got injected was swollen, red, and hurt for a long time, and had to wear air all the time, loss her sense of smell, didn't eat, and had to drink Gatorade by the gallons because I was lethargic. She did not want to file a safety report because she doesn't want the information to be relayed to her doctor and to make a report. She had asked what does Pfizer recommend, for storage of the vaccine at room temperature. Is it suppose to be refrigerated. States she got the Pfizer shot. She doesn't know, she hasn't been well for a year and a half since this whole stuff started. She was wondering what could happen if that shot was left out. She wants to know why she got sick like that, should she have not been given that shot since it was left out of refrigeration. She was asking if it is supposed to be refrigerated. she does not know how long it was left out, just that nurse said it wasn't good and they weren't giving it out to anybody. The outcome of the event is recovered on an unspecified date.  The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.
Patient reports fever and headache. Pt also reports redness and swelling that was warm to the touch on entire upper arm (shoulder to elbow).
Raised and flat bumps (itchy) on back and at injection site. Then spread to neck, abd and legs. 50 mg BENADRYL P.O. at 06:00 10/14/14. Improved.
A non-serious, spontaneous report of half dose of FLUMIST administered had been received from a nurse practitioner concerning a four-year-old male patient. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not provided. The subject received a half dose of FLUMIST in one nostril on 08-Oct-009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Required follow-up attempts have been performed, requested information unable to be obtained.  22-Feb-2010.
Hot at the injection site; itching, is red and hot at the injection site; hot at the injection site and little swollen; red and hot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (itching, is red and hot at the injection site), VACCINATION SITE SWELLING (hot at the injection site and little swollen) and VACCINATION SITE ERYTHEMA (red and hot at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 immunisation.     Concurrent medical conditions included COPD, Thyroid disorder, Rheumatoid arthritis and Osteoporosis.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (itching, is red and hot at the injection site), VACCINATION SITE SWELLING (hot at the injection site and little swollen) and VACCINATION SITE ERYTHEMA (red and hot at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (itching, is red and hot at the injection site), VACCINATION SITE SWELLING (hot at the injection site and little swollen) and VACCINATION SITE ERYTHEMA (red and hot at the injection site) outcome was unknown.            Concomitantly the patient was receiving chronic obstructive pulmonary disease pills, thyroid pills, Rheumatoid arthritis pills and osteoporosis pills (all unspecified). Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable
1 day p/vax c/o dizziness w/in 2k chest pains & palpitation;to ER twice 9/26 and 9/28;MD visit 9/29 did EKG showed rt bundle branch block;went to cardio MD p/vax;
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD injection, lot # M006104, expiration date 01-AUG-2017 or lot # reported as M023931, expiration date 09-NOV-2017 (doses, routes and sites of administration were not reported). It was unknown if the patients experienced any adverse events as the call was disconnected prior to providing this information. Product quality complaint was not involved. The administered doses of vaccine were stored in the temperature of 7.3 degrees Fahrenheit for 18 minutes. The data logger was involved. There were no previous excursions reported. No further information was provided. Additional information has been requested.
This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a certified medical assistant concerning a 22 year old female patient with a history of fainting with injections who on 29-MAY-2007, was vaccinated with a first 0.5 ml dose of Gardasil. On 29-MAY-2007, the patient experienced lightheadedness. On 08-AUG-2007 at 12:57, the patient was vaccinated in the right gluteal with received a second dose of GARDASIL. On 08-AUG-2007 at 12:57 the patient fainted and hit her right upper part of her forehead on the counter top. The patient called her boyfriend to pick her up and laid down on the exam table for an hour before leaving the office. It was offered to the patient to call 911 but the patient refused. The patient also refused to go to the emergency room. A few hours after each injection, the patient recovered from lightheadedness and fainting. No product quality complaint was involved. Additional information is not available.
"Baseball" size knot (R) buttock. "Golf ball" size knot bilateral thighs.
sore arm, mild headache, aching bones and muscles, headache fever 102.5. fatigue
pt recvd vax 20JUL95 & 5 mins later exp tingling & numbness from inj site to fingers as well as pain @ inj site;exam revealed good range of motion & equal strength & sensation in arms;arm cont to hurt & diff w/movement
erythema, pruritus at injections site and distal to same, onset next day; benadryl at home provided no relief.  Medrol dosepak prescribed today
Symtoms: dizziness, chills, low-grade fever, fatigue Treatment: telephone call with Dr office; since symptoms were mild, decided to wait for a day before taking any action Outcome: all symptoms resolved completely within 20-24 hours
No adverse effects were reported in the patient; a patient received a vaccine following a temperature excursion; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 25-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (strength and dose were not reported) for prophylaxis. No adverse effects were reported in the patient. Administered dose of vaccine experienced the temperature excursion of below 36 Fahrenheit degrees (F) / 2 Celsius degrees (C) (35 F) for 430 minutes. The digital data logger was not involved in recording the temperature excursion details. There were no previous excursions reported.
I was exposed to COVID-19 on June 25, 2022, I did not have a fever, it felt more like a bad head cold for me. I tested because I had been exposed and my home COIV-19 Test came back positive. Once it came back positive I went to neighborhood COVID-19 testing center and had a PCR COVID-19 Test on July 1, 2022 that came back positive. I stayed in isolation my required amount of time without medication.