chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Friday, 1/21/22, Patient came to a local Covid-19 Vaccination Site for her Covid-19 Pfizer booster vaccine. During assessment questions, client stated she had a medical history that included asthma, allergy to latex and takes Qvar redihaler 80 mcg PRN. Client was to be a 30 minute observation. At 1:00 PM, client got vaccinated with Pfizer (LOT #: FK9729) in her left deltoid. At 1:18 PM, while waiting in Observation Area, client stated to EMT she felt "dizziness, a headache and blurry vision when she looks at her phone." Client denied any pain or shortness of breath. Client was brought over to sit in anti gravity chair by EMT. At 1:18 PM vitals started, BP: 104/70, HR: 77, O2 sat: 99%, RR: 16, skin: pink, warm and dry. At 1:22 PM, client stated she will see a doctor for an eye check and her headache feels like "pressure 9 out of 10 on the sides of her head." She stated she has not drank anything today but did eat breakfast this morning. EMT offered client a water bottle and crackers. Client accepted and consumed water and crackers. At 1:25 PM, BP: 100/68, HR: 72, O2 sat: 99%, RR: 16, skin: warm, pink and dry. Client states the pressure in her head felt like a "7 out of 10" and that she experienced this same sensation after her first Covid-19 dose that was Janssen. Client stated she took an ibuprofen and symptoms improved. At 1:30 PM, client stated her head pressure was "3 out of 10" and her blurry vision was "improving" with no sensation of dizziness. At 1:34 PM, BP: 102/70, HR: 68, O2 sat: 99%, RR: 16, skin: pink, warm and dry. At 1:43 PM, HR: 70, O2 sat: 99%, RR: 16. At 1:48 PM, HR: 77, O2 sat: 99%. Client states she feels tired and wants to sleep. At 1:48 PM, BP: 104/64, HR: 77, O2 sat: 99%, RR: 16. Client states she no longer has a headache and denies dizziness and blurry vision. No further interventions needed. Client was educated by EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. At 1:50 PM, client left vaccination site with a steady gait and her Mother drove her home.
I had a cough and congestion in my lungs. An ongoing cough and an ongoing congestion for a few weeks. I noticed the cough and congestion on 06/07/2021. I still have it now, it's just lingering, and it's not as severe as it was.
Had tightness in her throat after COVID vaccine and patient was give Epinephrine and sent to ED
Chills, fever x2 days. From shot #1. Chills, Fever x2 days, 2nd day swelling size of a quarter developed. 3rd day R arm swelling,  hot to touch, sheering pain size half of a grapefruit.  Tingling in right hand.  Sought medical help.
Irregular MenstruaL cycle. I?m not pregnant. I track my cycle with ?cycles? fertility app. My period was very regular and since my vaccine it has occurred one time and was incredibly heavy.
Muscle aches, wheezes, clear phlegm, nose d/c - clear, weakNess
Rash injection site. Also has Psoriasis on same arm. 20 mg of BENADRYL PO with improvement.
Reports flu-like sxs, dizziness, headaches rated on 8 on scale of 1-10, bodyaches, severe fatigues-laying around house, called out of work x 3 days, awakens in cold sweats at night, chills.  Denies fevers though. Temp now: 99.7  Taken Advil since onset of sxs
Scratchy throat and sustained elevated resting heart rate between 80 and 100 (normal is low to mid 60s)
Swelling and pain at site of injection within hours of injection; Axillary and pectoral lymphadenopathy on ipsilateral side for 3 weeks
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 27-year-old white female patient who experienced hives, fever and sore throat. Medical history: Relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunisation. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant therapy: Concomitant medications were not reported. Event details: On 14-Nov-2003, the patient developed hives (urticaria), a fever (pyrexia) and sore throat (pharyngolaryngeal pain). She was treated with Benadryl. On a unspecified date, the patient recovered. No additional information was available at the time of this report.
9 days after vaccination arm is red, slightly swollen, itching. Red is growing larger. Was about 1 inch in diameter now it is about 3 inches in diameter
A non-serious spontaneous report of patient over the age of 49 was administered FLUMIST has been received from a nurse concerning a male born in 1947. Neither relevant medical history nor concomitant medications have been reported for this patient. 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.
18 minutes after shot patient reported itchy throat similar to what she gets with bee stings. Gave Benadryl 50mg. BP 115/90 HR 102 Pulse ox 98%. Patients provider was in house and came and assessed her. At 11:28 she recommended a second dose of Benadryl 50mg which was given. Patient much improved. MD will follow up, second shot not recommended by provider at this time.
Approximately 18 hr after admin. pt reported injection site reaction including swelling, pain, warmth, redness at injection site. Pt also reported increased blood pressure, headache, chills, and diarrhea. Pt did not have fever. Pt rec'd hydroxyzine, tramadol & prednisone from MD.
On 12/23 and 12/24 I had body aches and fever. 12/25 I had vomiting. On 12/30 I started developing swelling, redness and pain in my arm. I had to see a doctor on 12/31/2020 and get prescribed antibiotics and an cream for cellulitis.
"Moderna arm" - swollen, red, sore, itchy lump at injection site about a week later. Not serious.
Breakthrough case admission after 2 vaccines Janssen 3/24/21 lot#1802068
Pt recvd vax & the same day devel lightheadedness, shakiness, t100 & palpitations; elevated temp lasted for 24 hrs; swelling of deltoid @ inject site;
eye fatigue after 1st dose; This is a spontaneous report from a contactable consumer reported for herself that. A 68 age and unit: unknown male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient is sensitive to medication like Flu shot. Patient concomitant medications were not reported.  He experienced eye fatigue after first dose eyes started feeling fatigued 2 weeks later and continued until getting 2nd dose. He is very sensitive to medications for example flu shot usually makes me feel yucky for about a week. Patient asking how long symptoms are expected to last. Outcome of the event eye fatigue was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tenderness, swelling, and discomfort in right axillary area of the arm in which the shot was received.; Tenderness, swelling, and discomfort in right axillary area of the arm in which the shot was received.; Tenderness, swelling, and discomfort in right axillary area of the arm in which the shot was received.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Oct2021 10:45 (Lot number: EW0175) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 22Sep2021; WELLBUTRIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Right, Vaccine Administration Time: 08:45 AM), administration date: 21Dec2020, when the patient was 36 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EK9231, Location of injection: Arm Right, Vaccine Administration Time: 08:45 AM), administration date: 11Jan2021, when the patient was 36 years old, for Covid-19 immunization. The following information was reported: TENDERNESS (non-serious), PERIPHERAL SWELLING (non-serious), LIMB DISCOMFORT (non-serious) all with onset 09Oct2021 02:15, outcome "not recovered" and all described as "Tenderness, swelling, and discomfort in right axillary area of the arm in which the shot was received.". Therapeutic measures were not taken as a result of tenderness, peripheral swelling, limb discomfort.  Follow-up attempts are completed. No further information is expected.
Pt complained of pain approximately 12:00 on 5/4/00. Vaccine placed on 5/2/00. Pt only complained of pain and itching.
I Developed a rash on my right arm on the same location I received the injection. This happened yesterday , Monday April 5th at around 6pm. It was very itchy. This morning when I woke up the area where the itch started appeared larger  and red,  but not itchy. It felt very hard and hot. About an hour ago, at around 6pm on tuesday April 6th, the arm started to feel numb and my hand was cold.
Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Mild, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Vomiting-Mild, Systemic: Weakness-Medium, Additional Details: husband interpreted for her, as well "she is numb all over...tingling"
Redness and swelling from shoulder to elbow within 24 hours of immunization; resolved around 72 hours later. Localized rash developed around and below injection site within 24 hours of injection, per parent "looked like a bunch of broken blood vessels" that have since faded.
Patient was supposed to receive adult gray top vaccine but was given child's dose. Unable to document in chart due to safeguards. Incorrect dose given 6/9/2022.   NDC:59267-1055-1 LOT: FL8095   Correct dose (info above) given 6/10/2022- ADULT DOSE, NO REACTION   NO ADVERSE EVENT/REACTION
Unbearable burning  in my left eye. It began as a hot sensation and built to feeling like lave was in my eye. The tissues around my tear duct appear to be where the pain is coming from, is very swollen and causing my eye to run a bit.
Patient required hospitalization due to breakthrough infection. He received Pfizer vaccine (2nd dose in series) on 04/04/21. Patient was hospitalized from 08/28/21 - 08/31/21. Below is copied from discharge summary:   Hospital Course: Case of 69 yo male w PMHx of Colon CA, COVID vaccinated admitted for hypoxemic resp failure in thje setting of COVID 19 PNA.     Acute hypoxemic respiratory failure secodary to COVID 19 PNA - Today feling better, stable - Currently on nasal canula 4lts osat 96% - CXR reviewed, bilateral infiltrates - D Dimer 18 K, CTA negative for PE - Patient was vaccinetad - Decadron 6mg PO daily to complete 10 days - PRN albuterol - recieved remdesivir -Home oxygen qualification test done -case maangement consulted for home oxygen. -Oxygen at bedside    Hypercoagulable state - D Dimer in the 18 K - CTA negative for PE   Oral trush: resolved - Keep switch and swallow - received Diflucan 200mg IV x 3 days     Hx of colon CA - S/p colon resection and colostomy bag - Keep PRN analgesia   Vitals and labs personally reviewed.   Dispo: Dc home today with hhc and home oxygen. Recs as above.   Patient is discharged in stable condition with stable vital signs. All questions rearding hospital course and plan of care after discharge have been answered to satisfaction. Prescriptions for medications needed to be taken after discharge have been given to patient. Patient has been instructed to follow up with PCP within the next 7 days after discharge. Patient verbalizes understanding all given instructions and has no further doubts regarding discharge.
runny nose; sinus issues; throat discomfort; weakness in her arms; headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), SINUSITIS (sinus issues), OROPHARYNGEAL DISCOMFORT (throat discomfort), MUSCULAR WEAKNESS (weakness in her arms) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-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 RHINORRHOEA (runny nose), SINUSITIS (sinus issues), OROPHARYNGEAL DISCOMFORT (throat discomfort), MUSCULAR WEAKNESS (weakness in her arms) and HEADACHE (headache). At the time of the report, RHINORRHOEA (runny nose), SINUSITIS (sinus issues), OROPHARYNGEAL DISCOMFORT (throat discomfort), MUSCULAR WEAKNESS (weakness in her arms) and HEADACHE (headache) outcome was unknown.        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 concomitant product was provided by the reporter. No treatment medication was provided.
I got my period the very next day which was 3 weeks early from a period that is always regular for me. It was also different and not an atypical menstruation.
Approximately 5-10 minutes after administration, patient started sweating, feeling faint, lightheaded, tingling, shaky, pressure in the ears and SOB. Ammonia was first administered without any results. Epinephrine was then administered when patient complained that her throat and ears were closing up, followed by BENADRYL. Patient responded immediately to a single epinephrine dose before paramedics arrived.
Patient presented for 2nd moderna vaccine, during her 30 minute wait the patient experienced SOB. EMS responded, patients breath was labored and patient was coughing, she stated she was having an asthma attack. Medical OIC called to area, BS had expiratory wheezing present, pt asked to take her own albuterol, 2 puffs. Pts breathing began to ease, but cough was still present. Pt given 50 mg benadryl. After 10 mins, patient brought outside for cold air, which patient states makes her asthma better. Patient placed in own car after 10 more minutes, with her husband as the driver, with instructions to seek medical help if s/s worsen.
Extreme pain in left arm from shoulder to hand for 18 hours seriously disturbing sleep, left arm sore for another 24 hours, upper arm sore for another 24 hours, currently only sore around injection site. The day following the injection I was feverish, achy, and sleepy and remained in bed all day. The second day the fever had subsided but I was still achy and dizzy and remained in bed. I took one (1) extra strength TYLENOL. The third day I experienced dizziness every time I moved my head, but was otherwise recovering and was able to be up and about part of the day. The fourth day all symptoms had disappeared except for soreness around the injection site and I was able to resume normal activities.
Fever; This case was reported by a consumer via sales rep and described the occurrence of fever in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix. On 17th July 2019, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information received were as follows: The patient had the first injection and developed a fever. The patient asked to the reporter whether they are going to be able to offer some medical advice on the day of reporting.
pt recv vax 25JUL97 & the following day pt exp fever 105, sweating, body aches &  a stiff neck;f/u on 1JUN98 it was reported pt c/o of elevated temp home of up to 105;general aches, sweating & stiffness in neck;
Thrombus of the right axillary vein extending into the proximal aspect of the more superficially positioned brachial vein. Swelling of right upper extremity (primary encounter diagnosis) Note: s/p flu shot 10/31/18. Unusual appearing reaction. Does not appear cellulitic. Check RUE venous ultrasound. She will complete the course of prednisone already prescribed by sister-in-law doctor- day 3/5 of prednisone 40 mg daily. Knows to call and/or go to an ER if she develops any numbness, tingling, paresthesias or weakness in her arm. Friday night (2 days after flu shot) noticed right bicep swollen with swelling extended into the lower arm and hand. Saturday noticed color change in her arm/hand- bluish/red, a/w the swelling No numbness or tingling. RUE feels tight. Hand feels colder to her. Has full strength in arm. The more she uses her arm the more it swells.
pt came in w/ complaints of rubbery legs, bone pain & dinzziness. pt does take mycophenolate.
headache; like my throat was swelling; heart rate accelerated; I felt tight in my chest and throat; I felt tight in my chest and throat; I felt warm; nauseous; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 02:45 (Batch/Lot Number: EN6204) as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included drospirenone, ethinylestradiol (NIKKI) taken for a contraception, LORATADINE taken for an unspecified indication and start and stop date were not reported. The patient previously took sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. The patient experienced headache, like my throat was swelling, heart rate accelerated, i felt tight in my chest and throat, i felt tight in my chest and throat, i felt warm, nauseous on 07Apr2021 03:30. The patient reported that patient was stayed almost 30 minutes on site with the emt and then on the car ride back home patient started feeling like her throat was swelling and she tried to brush it off but then her heart rate accelerated and she felt tight in her chest and throat and then patient felt warm. patient started feeling nauseous and developed a headache so patient drove to the ER. Her throat continued to swell and release for the next few hours. Therapeutic measures were taken as a result of events includes PREDNISONE. The outcome for all events was recovered on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
PASSING OUT; SLIGHTLY DEHYDRATED; LITTLE RED SPOTS ON CHEST, BACK, ARM, TORSO AND BELOW BREAST; WEAK; TERRIBLE HEADACHE; FEVER 103; DOUBLE VISION; DIZZY; THREW UP; STOMACH PAINS; HARD COLD SWEATS; COULD NOT BREATH; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. After vaccination on 20-MAY-2021, the patient waited in the pharmacy for 20 mins. The patient got into car, the patient could not breath, began to sweat, threw up, experienced double vision and stomach pains. On same day, the patient was dizzy and had fever of 103 F. On 24-MAY-2021, the patient went to the emergency room (ER) by ambulance as the patient had passing out and when patient woke up patient was in ambulance on the way to the ER. The patient continued to have terrible headache, double vision, weak, and sweats which started on the day of vaccination. The patient had cold sweats. The patient still had stomach pains. On 24-MAY-2021, at ER the patient had an X-ray of chest, CT of head and neck. In the ER, patient received Dilaudid for terrible headache and some fluids as patient was slightly dehydrated. The patient had tiny red spots to chest, torso, arm, back an below breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from terrible headache, weak, double vision, fever 103, dizzy, little red spots on chest, back, arm, torso and below breast, stomach pains, and hard cold sweats, and the outcome of threw up, could not breath, passing out and slightly dehydrated was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210549340-covid-19 vaccine ad26.cov2.s-Loss of consciousness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
stored at 30.7F x 3 hours 49 minutes, vaccines administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patient who received Men B NVS (Bexsero) (batch number ABXC06AA, expiry date 31st March 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) (batch number H4Y3G, expiry date 12th March 2024) for prophylaxis, DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B) (batch number 3PA37, expiry date 23rd February 2024) for prophylaxis.   In July 2022, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Infanrix, Infanrix Pre-Filled Syringe Device and Engerix B. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Infanrix, Infanrix Pre-Filled Syringe Device and Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-JUL-2022 Reporter's Comments: The reporter stated administration of Bexsero, Boostrix, Infanrix, Engerix-B to unknown number of patients that were stored at 30.7 degree F for 3 hours and 49 minutes on 13 July 2022. Reporter reported that these vaccines was administered to the patients from 13 July 2022 to 19 July 2022. The reporter stated that the temperature excursion was potentially due to thermometer touching metal in refrigerator and not a true temperature excursion. The reporter consented to follow up. Additional supported information: Bexsero, Boostrix, Infanrix and Engerix-B these vaccines was stored at 30.7 degree Fahrenheit for 3 hours and 49 minutes which led to incorrect storage of vaccine.