chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Forgot to take Vivotif dose at night and took it the following morning; Spontaneous report received on 15JAN2020.  A nurse reported that a consumer "forgot to take Vivotif dose at night and took it the following morning" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for immunisation. It was reported that one year ago, the consumer took a dose of Vivotif a day late. The dose was scheduled for night but the consumer forgot to take Vivotif dose at night and took it the following morning. The consumer stated that less than 8 hours had past when the missed dose was administered. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer forgot to take Vivotif dose at night and took it the following morning (Inappropriate schedule of product administration). Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer forgot to take Vivotif dose at night and took it the following morning (Inappropriate schedule of product administration). Considering the nature of the event, the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Redness to site 12.5mm x 9 mm, hot to touch, hardening to left mid/lateral thigh
2 days after vaccine developed fiver and fussiness, refusing to eat - brought to walk in and dxd with otitis media.
ARMS RHYTHMICALLY MOVING AND EYES ROLLING BACK; FEVER TO 103
Dizziness, weakness, hot and cold, low grade fever, pressure in back of head, stiff neck. She is being treated with ibuprofen 600mg every 6 hours and butalbital/APAP.
Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; 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 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 1:53 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 1:53 PM, 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 20.09 years. Concomitant products were not provided. On 19-Apr-2021, the vaccine with batch number 007C21A was moved to fridge. On 29-Apr-2021, five vials were moved to the clinic. On the same day, at 10 AM, vials underwent temperature excursion with temperature of 33 degrees Fahrenheit.  The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 19-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  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.
Patient was given his 2nd Moderna vaccine 22 days before the recommended time between the 1st and 2nd dose.
12:08PM LIGHTHEADED AND DIAPHORETIC. BP 80/50. JUICE GIVEN.  'FEELS BETTER NOW'. PLACED ON COT PER WHEEL CHAIR.12:14PM 'FEELS BETTER'. BP 98/60, HR 91, R 16, 02 SAT 95%. 12:19PM SITTING UP BP 104/78. PT STATES '100% BETTER'.  AMBULATORY TO EXIT - GAIT BRISK AND STEADY. A/O, PINK, W/D, RESP REG WITH EASE. 4-7-21 9AM TC: PT STATES HE 'FEELS GREAT'.
4 minutes after administering the moderna covid 19 shot, pt became hot, sweaty and nauseous. we gave him a cold pack for the back of his neck and took his BP, which was 90/52 at 10:20am. pt began to feel better within minutes of using ice pack. BP 5 min later was 124/59. monitored pt for an extra 20 min past his 15 min wait time. he was completely recovered by then.
Rt facial paralysis (Bell's palsy).  Seen in office 1/2/13, started on oral steroids, referred to neurology.
patient stated he received the Johnson and Johnson shot on 5/5/2021, on 5/6/2021  patient stated he is experiencing pain at injection site along with muscle aches and tired
Patient is a 15 year old male with acute febrile illness preceding progressive weakness on bilateral upper extremities and bilateral lower extremities likely due to Guillain Barre Syndrome.  Based on EMG findings and physical exam, this is likely an acute on chronic process, as he has evidence of underlying Charcot Marie Tooth.  He received the vaccines 10 days prior to the onset of neurological symptoms and 2 days after an acute viral illness. Pt was treated in the PICU with IVIG for a total treatment course of five days.
State tightness in throat, rash on upper lip and headache times 2 weeks with generalized achiness.
Pt came in office 6/8/21 with c/o right arm hurting from shoulder down past elbow since 2nd covid vaccine on 4/1/21.
Pt devel inj site rxn of redness & swelling p/vax. Required drainage of site by MD. This is 1 of 15 out of 30 vax to devel inj site rxn p/vax w/lot# 4968253
In the third week, I woke up in the morning and came down with Bells Palsy; After the second shot two week later I became sick with a fever, super tired, and a massive headache at the back of my head behind the ear.; fever; super tired; massive headache at the back of head behind the ear; sick; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 09Apr2021 at 12:30 (Lot Number: er8731) at the age of 55-year-old as single dose for COVID-19 immunization. Medical history included high blood pressure. known allergy included mangos. The patient was not COVID prior vaccination. The patient didn't perform COVID test post vaccination. The patient didn't receive other vaccine in four weeks. The patient didn't receive other medication in two weeks. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm in Mar2021 at 12:30 PM(Lot Number: er2613) as single dose for COVID-19 immunization. On 01May2021 at 07:00 AM , two weeks after the second shot, the patient became sick with a fever, super tired, and a massive headache at the back of head behind the ear. In the third week, the patient woke up in the morning and came down with Bells Palsy. Treatment included predisone. The events resulted in emergency room visit and physician office visit. The outcome of events was recovered with sequel.
Four days after the first dose, I woke with a pain on the right side of my back, near the hip area. It wasn't terribly painful so I thought it would pass, but everyday it got just a little bit worse. In March, I went to the dr and she said, perhaps a muscle. As the weeks progressed, it got worse and spasms to the umbilical area started to happen. Long story short, I had xrays, an ultrasound, and 3 CT scans! Nothing showed up on those images. Still no diagnosis. I am on Gabapentin 1-2 Tablets every six hours for the pain and cyclobenzaprine for muscle spasms. Here we are in July and the pain and spasms are still there. I can't sleep in our bed. It is July 11, and I am still on the painkillers. Dr says, very strange.
4am woke up with fever alternating with chills for an hour.  Had a headache most of next day and had a lot of fatigue.  Slept for 10 hours overnight and was ok.  Day 2 arm pit sore on injection site side (possibly lymph node swelings) but pain resolved after another couple days
Had some underarm tenderness on the right side. The underarm soreness was much worse on the left side; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E19261) via an unspecified route of administration in the right arm on 24Feb2021 at 14:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included surgery, chemo and radiation treatments, breast cancer from 2006 and unknown if ongoing and lymph nodes removed in 2006. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included flax seed and calcium (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 25Feb2021, the patient experienced some underarm tenderness on the right side. The underarm soreness was much worse on the left side where the patient have had lymph nodes removed in 2006 and took longer to resolve (about 4 days). The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events some underarm tenderness on the right side. The underarm soreness was much worse on the left side was resolved on an unknown date in 2021.    No follow-up attempts are needed. No further information is expected.
potential symptom of being tired; potential symptom of spent a day in bed having fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (potential symptom of being tired) and PYREXIA (potential symptom of spent a day in bed having fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (potential symptom of being tired) and PYREXIA (potential symptom of spent a day in bed having fever). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, FATIGUE (potential symptom of being tired) and PYREXIA (potential symptom of spent a day in bed having fever) outcome was unknown.            No concomitant medications were provided.  Action taken in response to mRNA-1273 was considered to be not  applicable.   This case was linked to MOD-2021-187207 (Patient Link).
Dose 2-next morning  about 3 am-red itchy rash the size of baseball,  around injection site, very swollen., fever. That evening around 6 pm I still had fever, with symptoms continuing and had chills all through the night and very little sleep, continues now
Rash on left thigh only (fine, red, sl). Fluzone given left thigh, 7 days prior. Child was not ill.
1 of 4 pts vax from the same DTP lot#; pt recvd vax & exp a fever of 103.5 & an inject site react consisting of swelling & local rash; pt was not seen by MD; pt recovered;
Left arm with erythema and edema from shoulder to elbow. Circumf 2cm > L compared to Rt. Blanching/pruritic.
Patient left the facility not feeling well - lightheaded, dizzy.  Within 10 minutes, she was having difficulty breathing with dry mouth, heavy chest and swelling throat.  Other symptoms were nausea, extremely white/pale with clammy skin, jello arms and legs.  I spoke with the doctor's office and a family friend who is a nurse.  We had patient drink a sugar drink and rest with cold compresses.  Her symptoms improved over the next 3 hours, and we are continuing to monitor her.
Moderna COVID-19 Vaccine EUA Rash at injection site on the morning of Day 6, no pain or itching, and rash went away by 7pm that night. Rash returned at injection site with itching on day 8 (today). The itching is intermittent so far today.
Was released on 9/6/2022 stating ? Original monovalent mRNA vaccines are no longer able to be used as booster doses in persons 12 years of age or older.?  Original monovalent vaccine was administered 9/9/2022
ocular migraines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, 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: OPHTHALMIC MIGRAINE (non-serious), outcome "not recovered", described as "ocular migraines". Additional information: Patient has been suffering from ocular migraines for almost two years. He took his first Pfizer COVID-19 mRNA immunization in Apr2021, and things haven't been the same since. Strangely, some doctors find the ocular adverse events reported on vaccine have less "test book presentation".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd vax;exp itchiness at inject site; pt exp also uncontrollable v, d & inc t on 21oct94;adm to hosp from 23oct94-28oct94; pt has recovered;
Given Influenza vaccination on 12/12 0.5 cc. client has had no previous flu shots. Mom gave 1 tsps. Children's Motrin after injection. Client had no fever that night or at all. on 12/13 pm rash began on face and chest; red, itchy bumps appearing as "chill bumps". Injection site red , swollen "like a ball", no fever. Seen in ER on 12/14/2002, Sat night0 was given po Benadryl, injection of unknown med and Rx for pills, mom did not meds available at this time. 12/17/2002 rash almost gone.
Muscle pain initially then nerve pain to her left arm which feels like pins and needles that keeps her up at night.
JJ was administered 03/29/21 and 1 dose of Moderna was administered on 07/02/21.  NO ADVERSE EVENTS OR SYMPTOMS WERE REPORTED AS A RESULT OF THE VACCINE RECEIVED.
Left shoulder pain, persistent -rates 4/10 at rest and 8/10 with movement.
patient does not get the second dose in the scheduled time frame; This case was reported by a consumer via Shingrix GSK and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not get the 2nd dose of Shingrix in the scheduled time frame which led to incomplete course of vaccination. The reporter asked that do they just administer the dose and call it good or they need a 3rd catchup dose. The follow-up would not possible as no contact details were available
Nasty taste in mouth , Headache, started 25 min. after shot. Nausea and stomach pain started at 10 PMon the 6 Feb. 2021. body aches. On 7th the same. Nausea went away on 8th. arm sore. went away on 9th. the nasty taste still have it on 10th. No headche stopped on 9th. Just feel week. going away on 9th of Feb.
On approximately 8/17/21, after exposure to ill family members, the patient began to experience cold/flu symptoms including headache, congestion, and cough. Patient also experienced loss of taste and smell. On 8/23/21, the patient started to feel short of breath. On presentation to ED, the patient has an O2 sat of 90% and was started on 2L nasal canula with improvement to 95%. Patient BMI is 78.9. Patient was started on dexamethasone and a heparin drip (for subtherapeutic INR on 1.3). Patient will be admitted to the hospital.
Patient's parents potentially lied about age stating it is 6/17/2009 instead of 9/17/2009 as reported by insurance. Therefore patient is age 11 not 12, which made them ineligible for Pfizer. This was known after the injection was provided.
fever / feeling fever symptoms; chills; swelling near the armpit / swelling under her armpits; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced fever, chills and local swelling. On an unknown date, the outcome of the fever, chills and local swelling were unknown.   It was unknown if the reporter considered the fever, chills and local swelling to be related to Shingrix.  Additional case details were reported as follows: The patient received 2nd dose of Shingrix 2 to 3 days before the reporting date and experienced fever, chills and a swelling near the armpit on the left side where the vaccine was injected. The reporter consented to follow up. This case was received from healthcase provider via the assistance program.
Severe arm pain radiating down arm. Swelling, redness, difficulty sleeping due to pain, can't exercise. Dx cellulitis per doctor visit.
Fever (100.4) started around 10pm.  Woke up every hour, starting at 1am, sweating with a fever (101.1). This went on all night until around 9am. Starting at 10am, severe headache and fever up to 102.7. Extreme fatigue and joint pain as well. This went on until fever broke around 5pm. Headache started back up at around 5:15PM.
Within about 5 hours of vaccination, I became extremely chilled and started shaking uncontrollably. By then, the pharmacy was closed. My husband helped me put on extra clothing to include 2 pairs of socks and winter gloves. Sometime around midnight, the shaking began to subside, and it was not until the wee hours that I could sleep. As of now, I am typically sore and have mild fever. However I have NEVER had a reaction like this to flu vaccine. The only time I ever had chills and uncontrollable shaking like this was when I had a transfusion reaction during a hospitalization many years ago. I did call the pharmacy when they opened, but there seemed to be no interest in follow-up or reporting.
hearing difficulties; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (hearing difficulties) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013h21r) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced HYPOACUSIS (hearing difficulties). At the time of the report, HYPOACUSIS (hearing difficulties) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided.
Vaccine Administered at Inappropriate Site; Headache; Nausea; Vomiting; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Rabies NVS (RabAvert) for prophylaxis.   On 30th September 2019, the patient received the 2nd dose of RabAvert. On 30th September 2019, less than a day after receiving RabAvert, the patient experienced headache, nausea and vomiting. On an unknown date, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the headache, nausea and vomiting were recovering/resolving and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the headache, nausea and vomiting to be related to RabAvert.  Additional details were received as follows: The age at vaccination was not reported.  In that night, the patient started experiencing a bad headache and nausea and vomiting. She stated that his symptoms were reported to the doctor and that he was doing better now and is willing to eat. Caller originally called inquiring if the gluteal muscles should be used for administration as the healthcare provider injected the Rabavert into her son's buttocks. The reporter did not consented to follow up.  The reporter have to leave any demographic information.
After 15 minutes i started getting itching and burning on my face . Was given 2 benedryl. I woke with itching on my side thigh and some on my face took benedryl
adult was administered pediatric dose; adult was administered pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a adult female patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced accidental underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental underdose and inappropriate age at vaccine administration were unknown.       Additional Information: GSK Receipt Date: 13th Apr 2022 Reporter's Comments: The reporter was medical assistant. The reporter stated that adult patient was accidentally administered pediatric dose of Engerix B. The patient was unaware of the mix up, but had not reported any reactions. The reporter consented to follow up. Additional Supportive Information: The adult patient was accidentally administered pediatric dose of Engerix B which led to accidental underdose and inappropriate age at vaccination.
Patient was given BOOSTRIX injection. About 10-15 minutes after injection pt was in his car to leave when he "passed out" per wife. Wife ran back into the office to get help. Patient was in car laying back-once staff got to car-he was pale, sweating. Pulse and heart normal as well as blood pressure.
Shortly after vaccination patient started to feel itchy all over. She dosed with 12.5 mg of benadryl (she didn't want to do more because she is very sensitive and can't function on larger dose). After 30 minutes she was much improved and had no other symptoms - no difficulty breathing or shortness of breath, no rash