chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine leaked out of patient's arm; A spontaneous report was received from a pharmacist concerning an unknown age patient who received Moderna's COVID-19 vaccine (mRNA-1273), some of vaccine leaked out of the patient's arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their second of two planned doses of mRNA-1273 (Batch Number: Unknown), unknown route for prophylaxis of COVID-19 infection. It was reported that some of vaccine leaked out of the patient's arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event some of vaccine leaked out of the patient's arm considered resolved.; Reporter's Comments: This report refers to a case of vaccination site discharge for mRNA-1273 vaccine, batch number unknown, with no associated AEs.
Patient received his 1st dose of AstraZeneca vaccine in another Country and then received his 1st dose ofModerna vaccine here; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received his 1st dose of AstraZeneca vaccine in another country and then received his 1st dose ofModerna vaccine here) 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 June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received his 1st dose of AstraZeneca vaccine in another Country and then received his 1st dose ofModerna vaccine here. In June 2021, INTERCHANGE OF VACCINE PRODUCTS (Patient received his 1st dose of AstraZeneca vaccine in another Country and then received his 1st dose ofModerna vaccine here had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was unknown.  The patient per pharmacist got his 1st dose of AstraZeneca vaccine in another Country and then received his 1st dose of Moderna vaccine here in beginning of June,2021 and was inquiring about getting the 2nd dose of Moderna vaccine.
Patients (R) arm froze up shortly after shot given. Patient went to emergency room. Arm felt paralyzed. Patient discharged 10-17-10. Arm still unable to move.
This spontaneous report as received from a female consumer refers to herself. The patient was vaccinated with ZOSTAVAX (lot# was not reported) on 18-JUL-2012 "wednesday" and she experienced swelling and redness on the arm that she received the injection in July 2012. The patient took an anti-inflammatory medicine, ibuprofen. She also got her pharmacist to look at her arm. No other co-suspects were reported. No concomitant medications were reported. Additional information is not expected.
This spontaneous report has been received from a Certified Medical Assistant concerning an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. The primary reporter stated that ton 13-OCT-2015, when temperature excursion was recorded, an unspecified number of patients were administered on an unspecified dates improperly stored dose of VAQTA, (lot # K012457, exp. date on 04-JUN-2017), (strength, route of administration and dose were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received Johnson & Johnson vaccine for Covid 19.  Have had diarrhea daily since Wednesday 19th, 5 days after I received the shot.  I have a very strong stomach I have not had routine diarrhea ever.  I feel this is definitely related to receiving the vaccine.
The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 19-JAN-2018, the patient was vaccinated with ROTATEQ (strength were unknown, lot# N003984 and expiration date 19-NOV-2018) 1 dose form orally for prophylaxis. No adverse event was reported. The excursion temperature on 08-NOV-2017 and 16-NOV-2017 was 47 degree Celsius for max 15 hours. And on 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
At the time I had redness and swelling on the left arm where I got my injection at. I was also fatigue. My most recent visit to the provider's I was prescribed medication. It is an antibiotic named cefuroxime axetil, nasal spray and generic ADVAIR. I am having symptoms now sinus congestion, pressure and pain. I also have a dry cough and a lot of throats clearing. I am also developing some pain in my ears as well. The provider states I might have a sinus affection and if I am not feeling better in 7-10 days. I will be referred to a ear, throat doctor.
Swelling in the feet; Rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in the feet) and RASH (Rash all over the body) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling in the feet) and RASH (Rash all over the body). At the time of the report, PERIPHERAL SWELLING (Swelling in the feet) and RASH (Rash all over the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient took allergy medication which helped a little by the symptoms are still ongoing.   Reporter did not allow further contact
Vaccine administered  after 10 week BUD date  The BUD date was 01/77/2022
Petechiae to L leg and lower abdomen 1 day after vaccination. 1 week after vaccination pt developed epigastric abdominal pain and CT abdomen with impression of  "1. Right 18 cm small bowel segment of circumferential moderate thickening and inflammatory mesentery with concern for ischemic enteritis.  Additionally, consider possible inflammatory bowel or Crohn's disease.
pt recv vax & inj site swollen, erythema w/indurated, warmth;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 08Nov2021 at 19:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm 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 included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: a day after testing negative I now test positive; Positive, notes: a day after testing negative I now test positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Menstrual issues-heavy, long term flow; Shortness of breath; This is a spontaneous report from a contactable consumer (Patient). A 44-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 09:30 as (At the age of 44-years) DOSE 1, SINGLE for covid-19 immunization. Medical history included meniere's disease, hashimoto's; all from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; azelastine hydrochloride, fluticasone propionate (DYMISTA) taken for an unspecified indication, start and stop date were not reported. The patient previously took milk and seafood and experienced hypersensitivity. Patient was not pregnant at the time of vaccination. The patient experienced menstrual issues-heavy, long term flow (heavy menstrual bleeding), and shortness of breath (dyspnoea) on 29Mar2021 09:30. Patient was visited Doctor or other healthcare professional office/clinic visit for events. Patient was received treatment as Birth control, inhaler for events. The patient underwent lab tests and procedures which included sars-cov-2 antibody test negative: negative on 06May2021. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
started with red and swollen right arm at injection site and symptoms went away; and then redness came back. Pt describes rash as red area without swelling, has improve pain since shot at injection site Rash is located on the; right arm
Initial unsolicited report received from a consumer (sister of patient) via social media on 10 Oct 2016. This case involves a female patient (age unknown) who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, dose, route and site of administration were not reported) on unspecified date. Medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient had got flu. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. The reporter assessed the events as minor. List of documents held by sender: none.
Nauseous; throwing up; little bit of diarrhea; I am going on a week of feeling awful.; really run down/ tired; This is a spontaneous report from a contactable consumer (patient). A 26-year-old-female (patient) reported herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 04Aug2021 (Batch/Lot number was not reported) as dose 1, single for (at the age of 26-year-old) covid-19 immunisation. The patient medical history and was not reported. The patient was on other medication (Birth control). Consumer stated, she got her first shot a week ago last Wednesday (04Aug2021) and she felt pretty good on Wednesday just like tired and 'out a bit' which was excepted. She woke up last Thursday morning (05Aug2021), super nauseous and throwing up and little bit of diarrhea and then and she have been nauseous ever since last Thursday. So, she was going on a week of feeling awful. Therapeutic measures were taken as a result of nauseous, she had taken over the counter nausea medicine Zofran. The clinical outcome of events nauseous and feeling awful were not recovered, events really run down/ tired, throwing up and little bit of diarrhea were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Adverse reactions: muscle aches, fatigue. Treatment: rest. Time course: 36 hours.
Member had vasovagal response and completely blacked out. episode lasted appx 3 seconds. member was disoriented and slightly confused upon coming to. member was treated by laying him on his back on the exam table, bending his knees, and placing a cold pack behind his neck. member stated after about 5 minutes that he felt back to normal and like himself again.
pt recvd vax & approx 24 hrs after vax, pt devel rash & swollen & painful jts; pt has occasional episodes of cracked skin & swollen jts;
01/02/2021 COVID positive,  headache, terrible sore, PCR negative 12/31/2021, 01/02/2021 positive COVID positive urgent care for instant test. Decongestion and help recover from the vaccination. Never ran a temperature.  Congestion and resolved. Quarintine for 10 days.
I had bad chill without fever. For 48 hrs Swollen lymph node under my left arm side of a ping pong ball. It was extremely sore painful to touch and I couldn't move it. I went to the Dr a week after when it wasn't going away. They sent me to do an ultrasound.  Just confirm swollen lymph node. It can last six week and it was normal side affect. I went sent home afterward. Recommended to take Tylenol. It resolve on its own after 3 weeks.
Received Pfizer vaccines on 4/15/21, 5/6/21 tested positive for COVID by PCR on 10/30/21 admitted to Hospital on 10/30/21 w/ cough, SOB, diagnosed w/ COVID pneumonia.
Sore arm; Could not sleep all night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and INSOMNIA (Could not sleep all night) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported) since an unknown date. Concomitant products included ALPRAZOLAM.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and INSOMNIA (Could not sleep all night). On 19-Feb-2021, INSOMNIA (Could not sleep all night) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided.
Client's mother called the health department on the morning of 8-4-2020 and said that her son started feeling hot, had chills, started vomiting, and had a headache approximately 3-3.5 hours after he received the vaccine on 8-3-2020 at 1:30pm. She said that he started to feel better by night time, and as of today 8-4-2020, he feels completely fine except for a sore arm.
This spontaneous report was received from a female consumer of unknown age regarding herself. There was no pertinent medical history. On an unknown date in the year 2008, the patient was vaccinated with ZOSTAVAX strength 19400 units reported as PFU (Plaque-forming unit), (dose, units, product Lot#, expiry date, route not reported) for shingles prevention. There was no concomitant therapy. On an unknown date in 2013 (reported as about a year ago), the patient experienced a mild case of shingles after receiving the ZOSTAVAX vaccine. The patient experienced a rash over her body and itchiness. She was seen at the physician's office but no treatment was given. There was no product quality complaint involved. The outcome of event mild case of shingles was unknown and events rash over her body and itchiness was recovered on an unknown date (reported as the symptoms went away after two or three weeks). The causality was unknown. Additional information has been requested.
pt w/temp >104.6R p/APAP given;high pitched cry;inc irritability x 4 days;
Wouldn't eat or drink much since 1:30 pm, he said his body hurt all over, fever, rapid breathing, told me he couldn't breathe a couple times. Temp was at 102.8 and gave him childrens tylenol at 7:39 pm.  Temp was at 103.1 at 10:05pm and gave him Tylenol 11:40pm. This continued throughout the night.  Went to give him another dose of Tylenol at 3:39 AM and his body had cooled down significantly.  Throughout this time had been speaking with advice nurse and she had me count his breathing when he was awake and when he was asleep.
Patient experienced dizziness, headache, fever, muscle/body aches, muscle spasms in the back, and hypertension.  Patient went to primary care provider, was prescribed muscle relaxer, steroid, and narcotic as a result.
Acute coronavirus disease-19 infection, complicated by acute hypoxic respiratory failure + COVID19 test
Child received MMR + dTap immunizations; one in each arm. Not sure what was given in what arm. However, child presented with a mild fever the next day. The area of the injection on the left arm was of a welt, about 2.5 inches in diameter: raised and red, hot to touch. Child did not complain of pain or discomfort and was otherwise in good spirits.  I called the her physician and reported the reaction and have followed the physician's instructions.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021 at 9:48 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 9:48 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 47.29 years. Concomitant products were not provided. On 06-Apr-2021, the vaccine with batch number 044B21A was moved to fridge. On 15-Apr-2021, 18 vials were moved to the clinic. On the same day at 09 AM, vials underwent temperature excursion with temperature of 34 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 09-May-2021. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported. This case was linked to MOD-2022-566976 (Patient Link).
Extreme pain at site. Continued pain with movement of arm - across body or over head. Received testing, 2 courses of prednisone. Pain continues.
Ipsilateral supraclavicular lymphadenopathy starting 1 day after injection, peaking at >1cm diameter on day 3. This also occurred over a similar timeline with injection #2. All injections were taken in left arm. Injection site #3 did not appear to be outside recommended distance from deltoid muscle belly.  Patient also had rigors, diaphoresis, subjective fever, headache, and severe cervical and lumbar muscular pain that mostly resolved by day 3. These symptoms were not present after vaccination 1 or 2.
Patient came in for a flu vaccine. I prepared a Moderna vaccine for a another patient with vaccine card in the basket I use to carry the supplies to the vaccine booth. When I exited the pharmacy, I called out the name. Patient was waiting in waiting area and got up and came into vaccine booth, I should have reviewed with her what vaccine she received and her correct name, and I usually do. It wasn't until I went over side effects of Moderna that I realized I had given her the wrong vaccine.I guess she thought I was calling her name out when I was actually calling for someone else. It was very crowded and loud in Pharmacy area. My mistake for not going over the vaccine I was to give before hand. She received a booster vaccine in August for Pfizer. I explained that I did not feel that any harm was done, but told her that I would be writing up a report and would give her a copy of it. She did not receive a flu vaccine since her insurance was expired. I called her and folowed up with her late today and will do the same tomorrow.
I have experienced chest discomfort for 8 days now. I have what I would describe as an ache in my chest or like something is stuck in my chest or ive been lifting weights and sore in my chest.
Adverse Effect: syncope (Per Father, less than a minute) Tx: Assessed by Provider and VS taken  Outcome: Pt in fowler's position x15 additional minutes, with apple juice and H20 provided
SIX DAYS AFTER VAX, PT WAS LISTLESS ALL DAY. SLIGHT FEVER ESCALATED TO 106.5 UPON ARRIVAL @ ER (6:45PM). 6PM, @ 4 EPISODES OF CONVULSIONS.  STOPPED BREATHING ON SEVERAL OCCASIONS, BUT WOULD START WHEN SHAKEN BY MOTHER.  NO TX GIVEN.
-Fever (100.4) - 24 hours -Nausea (8pm Saturday - 11am Sunday) -Body aches (8pm Saturday - 6pm Sunday) -Migraine (8pm Monday - Currently ongoing as of 11/9/2021) -Lymphadenopathy (Sunday - all day)
Information has been received from health professional concerning a female in her mid 60's who on approximately 10-NOV-2005 was vaccinated in the deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 651329/1047P).  Subsequently, the patient experienced fever, and erythema and edema at injection site.  Subsequently, the patient recovered.  No further information is available.