chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for covid; tested positive for covid/ she has not experienced any Covid 19 symptoms; Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266) at the age of 32-years-old, via an unspecified route of administration in right arm on 23Feb2021 at 12:00 at single dose for COVID-19 immunization. Medical history was not reported as none. She has no known allergies, was not pregnant, and has no COVID prior to vaccination. Concomitant medications included birth control and allergy medication. The patient has no other vaccine in four weeks. The vaccine was administered in a hospital. The patient experienced Bell's palsy on 13Mar2021 at 18:30 and tested positive for COVID on 14Mar2021. She is scheduled for the second dose on 16Mar2021, but she is not taking it as she was COVID19 positive and had Bell's palsy. She has not experienced any COVID-19 symptoms. The events resulted in doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. Therapeutic measures were taken as a result of Bell's palsy and included treatment with prednisone. The patient underwent lab tests and procedures which included nasal swab PCR which was positive and MRI which was clear, all fine on 14Mar2021.The outcome of the events was recovering.
Rash on the neck area Hives on the body especially under breast and neck (lymph nodes) Itchy skin
Initial report was received 04 November 2010 from a health care professional which involved a cluster of six patients out of 160 vaccinees who all experienced similar events after receiving FLUZONE, lot number U3775CA. One of the six patients also experienced wheezing and has been captured separately in this case. The other five patients have been captured in case number 2010-06367. An unidentified patient (age, sex and date of birth not reported) had received FLUZONE, lot number U3775CA (route, site and date of administration not reported) and an unspecified amount of time later, they developed wheezing, body aches, a fever and chills. Information pertaining to the date of vaccination and event onset, concomitant vaccines, concurrent illness and past medical history were not reported. Outcome was not reported. The reporter for this case is the same as for case number 2010-06367.
Within a few minutes of receiving the COVID 19 vaccination, patient developed lightheadedness, shortness of breath, headache, and some nausea.  She did get some redness to her neck and upper chest.  No recent illness.  Had elevated BPs ranged from 158/103 to 207/126 .  HR ranged from 82-106.  O2 sats always > 96%.  Temp 37.1 C.  Received Tylenol 1000 mg PO, Dexamethasone 10 mg IV, diphenhydramine 50 mg IV, famotidine 20 mg IV, ketorolac 30 mg IV, ondansetron 4 mg IV, and 1 L NS.  Patient prescribed EpiPen and prednisone and discharged.
Necrosis of the skin that is approximately 3 inches around injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site necrosis in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2019, the patient received Shingrix. In November 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site necrosis (serious criteria GSK medically significant). On an unknown date, the outcome of the injection site necrosis was not recovered/not resolved.   It was unknown if the reporter considered the injection site necrosis to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination the patient had necrosis of the skin that was approximately 3 inches around injection site. On 11th November 2019, the patient was seen by doctor's office. On 2nd December 2019, the patient saw a dermatologist. Till the 27th December 2019, the skin necrosis was not recovered. The reporter stated that, the vaccine was administered at the pharmacy that was adjacent to the clinic. The reporter consented to follow up.
The recipient inadvertently received a BOOSTER dose (0.25ml) instead of a FIRST dose (0.5ml). This was recognized by the nurse right away so she gave the recipient a second booster dose of 0.25 ml in the left arm. So the recipient received the FULL FIRST dose of 0.5ml but in 2 separate shots.
Dizzy/ Could not stand up; Had to crawl from apartment to another to get help; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/ Could not stand up) and GAIT DISTURBANCE (Had to crawl from apartment to another to get help) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced DIZZINESS (Dizzy/ Could not stand up) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Had to crawl from apartment to another to get help) (seriousness criterion hospitalization). The patient was hospitalized on 04-Nov-2021 due to DIZZINESS and GAIT DISTURBANCE. At the time of the report, DIZZINESS (Dizzy/ Could not stand up) and GAIT DISTURBANCE (Had to crawl from apartment to another to get help) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.  Since 04-Nov-2021, the patient was hospitalized. Patient was dizzy, could not stand up and had to crawl from apartment to another to get help.  Company comment: This is a spontaneous case concerning a female patient of an unknown age with no relevant medical history reported, who experienced serious, unexpected events of Dizziness and Gait disturbance. The events occurred the same day after receiving a dose of mRNA-1273 vaccine. It was not specified whether the events occurred after the first or second dose. It was reported that patient received a dose on 4Nov2021, and has been in the hospital since then. Patient was dizzy and couldn't stand up. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with no relevant medical history reported, who experienced serious, unexpected events of Dizziness and Gait disturbance. The events occurred the same day after receiving a dose of mRNA-1273 vaccine. It was not specified whether the events occurred after the first or second dose. It was reported that patient received a dose on 4Nov2021, and has been in the hospital since then. Patient was dizzy and couldn't stand up. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient stated she noticed some pain in shoulder where vaccine was administrated on 2nd day of administration. 3rd day morning she noticed a red spot on her arm but patient not sure if it is a result of vaccine or a bite as she went to a concert the night before. Patient stated on 3rd day she noticed the pain feeling decreasing. I advised the patient to keep an eye on any changes she might observe and report it if she noticed any change. Meanwhile I advised her to use BENADRYL cream for the red spot on her arm.
Approximately 2 days inflammation at site of injection, difficulty raising arms, L side pain from head to knee; sharp stabbing pains in L top thigh 2 days then moved to muscles in back above waist, and R leg. Still present in back and from under ribs.
Parent brought patient back after 20 minutes post vaccine. Patient had pinpoint non-raised red dots on mid-back and upper left shoulder. No urticaria, swelling, pain or warmth noted to site. Patient was held and assessed for 50 minutes with no signs of worsening symptoms or distress. Vitals: BP 110/68, HR 127, temp 98.1 and RR 26. Parent recommended to contact PCP for further instructions/evaluation. No medications given. Upon re-assessment patient was stable and sent home.
Elevated glucose numbers around 210; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPERGLYCAEMIA (Elevated glucose numbers around 210) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced HYPERGLYCAEMIA (Elevated glucose numbers around 210). At the time of the report, HYPERGLYCAEMIA (Elevated glucose numbers around 210) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Blood glucose increased: 210 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
EXTREMELY SICK FOR 10 HOURS; PAIN; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced extremely sick for 10 hours. On MAR-2021, the subject experienced pain. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain on 08-MAR-2021, was recovering from extremely sick for 10 hours, and had not recovered from fatigue. This report was non-serious.
large red circle that is swollen & irritating.  Also a mark where neddle inserted.Put cool compress on & took tylenol
Pain; get a little stiff for 1 day; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (get a little stiff for 1 day) and PAIN (Pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (get a little stiff for 1 day) and PAIN (Pain). At the time of the report, MUSCULOSKELETAL STIFFNESS (get a little stiff for 1 day) had resolved and PAIN (Pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has a chronic condition.  No concomitant medications were provided.  No treatment information provided  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: TCR received on 28-May-2021, Added new event Pain.
Flu vaccine given IM in (L) deltoid at 2:28pm. At 5:15p or 5:30p developed a feeling of something stuck in throat. Then developed upper lip swelling and itching of tongue, mouth and hands. Pt did not take anything for symptoms. This am resolved except hand itching. Gone later am.
Client presented to clinic and requested to receive his second dose of the COVID vaccine. The client had previously received his first dose of Moderna on 02/08/21. It was explained that Moderna was not available at todays vaccine clinic and programmatic staff tried to assist the individual in exploring options to receive his second dose. The client verbalized that it was unlikely that he would follow through in exploring any of the available options and therefore was unlikely to get his second dose of Moderna. Staff explained the potential risks and benefits of mixing vaccines and the client opted to proceed with getting Pfizer as his second dose.  Client was monitored for 15 minutes with no adverse reactions.
Patient received vaccine at approximately 5:20 PM on 6/27/21 with her sister by her side she express shed was nervous and scared about getting the vaccine so her sister held her had upon receiving the vaccine - about 15 minutes later after monitoring her for any adverse reactions she stood and fainted and hit her head on a pillar in front of the pharmacy. She was picked up by both me, the pharmacist and a pharmacy technician. Upon placing her in a chair she began to fill woozy and expressed that her vision was blurry and didn't know how she fell. After sitting in a chair for a few minutes she asked for a trash can. She began to vomit in the trash can for several minutes and complained of a headache until EMT arrived. EMT arrived and went over basic and essential test with her to ensure she was okay before leaving. . She refused medical transportation and wanted to go home with her father instead, who arrived shortly after EMTs.
Onset of feeling "very hot"  about 50 minutes after injection;  was "heat red" in face- passed in a few minutes.  Ate dinner--> woke about 6 hrs later with severe nausea + vomiting X1, awake next day with bilateral shoulder soreness;  no further n/v.  noted rash on upper torso at end of 2nd day, mild headaches.  Still has rash today (day 3).  Taking BENADRYL- generally feeling much better now.  No site reaction.
1/15/03 Spiked fever of 103; 1/16/03 Fever of 103 continued. 1/17/03 Fever 101. 1/18/03 Broke out in rash on face; blotchy by 6PM. Most of trunk covered in tiny bumps and blotchy by 8PM, whole body covered and face; began to well. Taken to ER 10PM and started with hives. Given Prelone and Benadryl. Found to also have strep, pneumonia, and bronchitis per chest x-ray and exam by ER doctor (rash; heat rash like).
THE CLIENT HAS BRUISING AT THE INJECTION SITE.  DENIES ANY OTHER SYMPTOMS.
First after each vaccination I had fever, tired, and body aches for about a day. For the Pfizer Bivalent, I had these symptoms for about two days. I am fine after that and still able to work. In 17DEC2022 I started with lethargy then that evening, I was freezing to death, fever, chills, headache, a little congestion. The next day, I took my temperature and it was around 101.4 degrees so I took COVID-19 at home test positive. I continued with fever, body aches, extreme fatigue, lack of appetite, very mild congestion. I did not take any medicine that day. I like to let my fever burn off by itself. 19DEC2022 my fever got up to over 102 degrees. I was still tired, fatigued, and tired so I called my doctor. He gave me a prescription for PAXLOVID. I took first dose that night. Through the night, I felt my fever break and it didn't come back after that. My symptoms subsided about 85% after that. I believe the vaccine worked for me. 20DEC2022 I continued to improve but had a foggy brain. I went back to work on 21DEC2022. 24DEC2022 I started to get congested again so I retested and it was negative again. I had a funny bitter taste in my mouth after taking PAXLOVID. In the end I believe the PAXLOVID and vaccine helped me.
Moderate right arm swelling (site of injection), with radiation to shoulder and neck.  Some difficulty swallowing.  Symptoms noticed the day following the injection.  Pt called office, advice was given to apply cold/ice compress, take NSAID.  Pt responded well to this and was much improved by the next day and recovered fully within 48 hours.
Pt received Smallpox vaccination on Friday, 1/10/03. On Saturday, she first noticed myalgias without fever. This has continued through today, although severity has decreased. She was sent home from work Monday and Tuesday, 1/13/03 and 1/14/03.
patient was administered an expired Typhim VI vaccine/ No AE; Initial information received on 25-May-2021 regarding an unsolicited valid non-serious case received from other healthcare professional via phone via Medical Information (Reference number- 00614877).  This case involves a 22 years old female patient who was administered an expired 0.5 mL dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] [lot R2S262M, expiry date 10-May-2021] via an unknown route and administration site on 24-May-2021 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included JAPANESE ENCEPHALITIS VACCINE (JAPANESE ENCEPHALITIS VACCINE) on 24-May-2021 for prophylactic vaccination same day of visit.  It was an actual medication error case due to expired vaccine used (latency: same day).  Description: Caller has questions about expired (May 10 2021) Typhim VI administered. No orders were written for the vaccination. Product used. Still using product: No.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient reported to clinic on 12/22/09 with 2 days history of right side facial tingling and weakness, eye droop and tearing, right sided tongue numbness. Diagnoses as mild Bell's palsy.  Treated with 10 days prednisone and eye lubricating drops. 1/7/2010 OB records, ED note  patient pregnant,  EDC 4/7/2010 with c/o's rt facial droop and facial numbness, Dx'd as bell's palsy, tx'd with steroids
This spontaneous report as received from a pharmacist via Pfizer, refers to a male patient of unknown age. Concurrent conditions and medical history of the patient were not provided. On an unreported date, the patient was vaccinated with PNEUMOVAX 23 (dose, site of administration, route, dose# and lot# not reported). Concomitant medication was not mentioned by the pharmacist. On an unknown date the patient experienced blurred vision as a reaction to PNEUMOVAX 23. The outcome of vision blurred was unknown. Causality statement was not provided by the reporter. No product quality complaint was filed. Additional information has been requested.
Several hours after receiving vaccine, child had 3 episodes of brief head/upper trunk/arm shaking and staring; fell asleep shortly after episodes, then developed temperature of 103.1 degrees.
Angioedema and hives. Occurred ~50 hr after second dose. Treated with steroid injection at urgent care.
Sore arm and body aches began after two hours.  Chills began at 10 hours and continued until 24 hours.  Periods of sweating within the same timeframe.
Back pain; Did not take thyroid medication morning of first dose of Covid-19 vacc; she has broke out with a rash on the side of her stomach area; Itching; Prickling; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 64-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration in Arm Left on 09Apr2021 09:30 (Lot Number: EL9264; Expiration Date: 20May2021) as single dose for covid-19 immunisation. Medical history included peripheral venous disease from 2018 and ongoing, ongoing unspecified thyroid condition, ongoing Acid reflux disease, ongoing seasonal allergy, ongoing heat rash. Concomitant medications included levothyroxine (LEVOTHYROXINE) 112 mg once daily taken for thyroid disorder, gabapentin (GABAPENTIN) 100 mg three times per day taken for vein nerves from 2018 to an unspecified stop date; pantoprazole (PANTOPRAZOLE) 40 mg once daily as needed taken for acid reflux disease, tizanidine hydrochloride (TIZANIDINE ARROW) 6 mg as needed taken for hypersensitivity, loratadine, pseudoephedrine sulfate (CLARITIN-D) one tablet once daily as needed, 24-hour strength taken for hypersensitivity. Family medical history was none. No vaccinations prior to COVID-19 vaccine within 4 weeks. On 09Apr2021, the patient experienced she has broken out with a rash on the side of her stomach area, itching, prickling and did not take thyroid medication morning of first dose of covid-19 vaccine, on an unspecified date, experienced back pain. Friday, 09Apr2021, following the Covid-19 vaccine she got a rash. She reported that she thought the rash was a heat rash and the rash was on the right side of her body, on her side by her stomach on the right side. Caller inquired how long the rash will last. Patient reported that she was still experiencing the rash at time of call on 12Apr2021. Patient reported that she has been applied baby powder to the rash like she would if she had a heat rash. Caller reported that she has one section on her body where the rash has congregated. Caller reported that other parts of her body like the side of her stomach have 1 or 2 and reported that it felt like prickling on her skin when the rash was coming out on the night of Friday, 09Apr2021. Caller reported that the prickling became itching, and she can tolerate pain a lot and that she is trying not to let the itching bother her. she did not take her thyroid medication and reported that someone had mentioned that she shouldn't take any medications before she got the Covid-19 vaccine, so she avoided taking her thyroid medication. Caller reported that the back pain started Wednesday of last week, 07Apr2021. Caller reported that later in the day on 09Apr2021, she took Tylenol and the next day, 10Apr2021, she started taking her medications like she normally would. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.