chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 61-year-old female patient who received Influenza vaccine Quadrivalent. Previously administered products included Influenza vaccine (no adverse events). Concurrent medical conditions included spleen disorder (the patient does not have spleen). In October 2017, the patient received Influenza vaccine Quadrivalent. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved. The reporter considered the tiredness to be related to Influenza vaccine Quadrivalent. Additional information was reported as follows: The consumer reported that she got vaccinated in the fall season of 2017, with quadrivalent flu vaccine where the manufacturer is unknown. She stated that, she had received the flu vaccine before also but had not experienced tiredness earlier. She also stated her doctor stated that the tired feeling was because of her body making antibodies. The reporter's healthcare professional was not asked. The caller might call back with identification of the manufacturer.
BLURRED VISION; BURNING IN CHEST; JAW PAIN; BACK PAIN; LOSS OF APPETITE; FELT FATIGUE; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient had no known drug allergies, no known medical conditions and was not taking any medications at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in JUL-2021, the patient experienced blurred vision, burning in chest, jaw pain, back pain, loss of appetite, and felt fatigue. On an unspecified date in JUL-2021, the patient was hospitalized for one night in one hospital and 3-4 nights in another hospital. Patient had been hospitalized twice within the past week of report. Physician stated that, they couldn't figure out what was wrong with patient and also stated that, there was not an issue with patient's heart, lungs and any of organs. On an unspecified date patient was discharged. Patient was hospitalized for 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt fatigue, blurred vision, burning in chest, jaw pain, back pain, and loss of appetite. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210811280-COVID-19 VACCINE AD26.COV2.S-blurred vision, burning in chest, jaw pain, back pain, loss of appetite. 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). 20210811280-COVID-19 VACCINE AD26.COV2.S-felt fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.
1/23/2021 - had cold sensation which lasted a few seconds, then on 1/24/2021 - felt fatigued, left arm soreness, headache - thought it was related to day, so continued on, then noticed a temperature around  11:45 AM  - took tylenol, still having fatigue and headache on 1/26/2021, also has raw feeling on top of roof of mouth
Mother came in with her two kids to get them vaccinated along with their translator. Translator filled out the form and advised us that the boy was five years old. Child got vaccinated and pharmacist had walked by and realized the birthdate didn't match the age.
The patient was given an adult dose of the Pfizer vaccine. This was discovered within minutes of the patient leaving the pharmacy.  I called the parent and reported it to him.
erythema of face, cervical region; tightness on throat as per pollant; lungs: bilateral resp & wheezes w/rhonchi;
EXTREME PAIN IN LEFT SHOULDER AND UPPER ARM, STILL PAINFUL AS OF 10/14/2013, LOSS OF STRENGTH, MOVEMENT, CANT SLEEP.
This case was reported by a pharmacist via sales rep and described the occurrence of respiratory distress in a infant patient who received PEDIARIX. On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced respiratory distress (serious criteria GSK medically significant). On an unknown date, the outcome of the respiratory distress was unknown. The reporter considered the respiratory distress to be possibly related to PEDIARIX. Additional details were provided as follows: The neonatologist (name unknown) informed the reporter that two patients (babies) experienced respiratory distress after vaccination with PEDIARIX. The event occurred in the previous couple of months but specific dates were unknown. The sales representative connected the reporter with agency and agency might also report additional adverse events details. This case has been linked to case US2016041905, reported by the same reporter. No further details were provided.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 24-SEP-2014, patient was vaccinated with RECOMBIVAX HB dose 1, 1 ml intramuscular (lot # was not reported). On 24-MAR-2014, the patient was vaccinated with RECOMBIVAX HB dose 2 (route and lot # were not reported). No adverse effects reported. Therapy with RECOMBIVAX HB was continued. Additional information is not expected.
Cough started 50 hours after the vaccine; Chills; Fatigue; Low-grade fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150) via an unspecified route of administration on 07Apr2021 at 13:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 15:45, 50 hours after the vaccination, the patient experienced chills, fatigue, low-grade fever, cough and headache. The patient reported that the symptoms "pasting" over 24 hours so far at the time of reporting. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, fatigue, low-grade fever, cough and headache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Marked erythema of the injection site with confluent erythema of the upper chest and neck and upper extremities, moderate warmth, elevated BP; intense itching all over.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 08Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 11Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "heart disease" (unspecified if ongoing), notes: heart disease; "obesity" (unspecified if ongoing); "known allergies Penicillin" (unspecified if ongoing), notes: known allergies Penicillin; "history of p.e" (unspecified if ongoing). Concomitant medication(s) included: XARELTO, start date: 05Feb2020, stop date: 16Dec2022.  The following information was reported: VACCINATION FAILURE (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: Negative, notes: Tested negative then tested positive and symptoms returned sick again; Positive, notes: Tested negative then tested positive and symptoms returned sick again. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 16Dec2022 to 21Dec2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received
She recieved the Seasonal Flu vaccine in the left deltoid and the H1N1 vaccine in the right deltoid.  Within a few minutes, she had a rash on her left hand.  She was sent to health.  During transport, she developed SOB and went directly to the ER.  At the ER she was given epinephrine 1:1000, iv Solu-Medrol, iv Zantac, iv Ativan, and NS.  She was discharged with a Medrol Dose Pak. 12/7/2009 ED visit for 11/23/2009 and 11/25/2009, initial visit for c/o's hives, SOB, nausea and tingling in the hands, tx'd with steroids, return visit on 11/25 with c/o's dizziness  and nausea/vomiting, tx'd with IV Zofran and Ativan, cardiac monitoring noted no abnormalities
increased the heart rate; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE ABNORMAL (increased the heart rate) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0081321A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced HEART RATE ABNORMAL (increased the heart rate). On 26-Mar-2021, HEART RATE ABNORMAL (increased the heart rate) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication. Treatment includes medication for something to heart but she can't know what medicines gave to reporters daughter.
102.5 fever all night long, uncontrollable shakes (like shivering, but greater) for about an hour, then subsided into regular fever symptoms (aches, temperature, discomfort, shivers)
patient stated the area of injection was hot to the touch and hard, with the feeling spreading below and above the area of injection. she also stated her upper arm was swollen and the pain radiated down the arm (left). I asked the patient to come inside so I could examine the area but she was unable to do so. I advised the patient to contact her pcp for additional support. this was her second dose
24 hour fever that reached 102. It would fluctuate; Body chills and body aches; Body chills and body aches; This is a spontaneous report from a contactable other Health Professional reported for herself. A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Formulation: solution for injection, Lot Number: EL9261, Expiration date: Unknown, Brand: Pfizer), via intramuscular route of administration in the left arm on 28Jan2021 06:15, as SINGLE DOSE for COVID-19 immunization in the hospital. Medical history was not reported. There was no special history of allergies to medications, food, or other products allergy. Concomitant medication included topiramate 50 mg and the patient received other medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 28Jan2021 19:30, the patient experienced 24 hour fever that reached 102, it would fluctuate, body chills and body aches. The events were assessed as non-serious by the reporter. The patient has not been tested for COVID-19 since the vaccination, the patient underwent lab tests and procedures which included body temperature: fever that reached 102 on 28Jan2021. Therapeutic measures were not taken as a result of adverse events. The outcome of the events were recovered on an unspecified date in 2021.
MISSED SECOND DOSE; This spontaneous case report (PVX2019-2642) was received from a healthcare professional on 22-Oct-2019. It described a female consumer who "missed second dose" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer started Vivotif on 18-Oct-2019. She missed her second dose, which was due on 20-Oct-2019.   Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "missed second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed second dose" was considered as not applicable.
Information has been received from a physician concerning a 2 month old (gender unknown) patient who was vaccinated with the first dose of ROTATEQ.  Subsequently the patient experienced 10 days of persistent diarrhea.  Subsequently, the patient recovered on the 11th day after vaccination.  Unspecified medical attention was sought.  No product quality complaint.  Additional information has been requested.
Very painful/sore thighs with difficulty squatting that was severe for two days. Soreness lasted for one week.
I have experienced an increased amount of Afib following my Moderna covid-19 vaccinations. I used to be able to expect at least two weeks Afib free between episodes, but on the evening of my first shot on March 12th I had Afib only four days after a typical episode. Then again on March 22nd and 30th.  On April 8th I had my second Moderna dose. On April 11th I had Afib again and didn't think that much of it being related to the shot as I had been fever free for over a day at that time. But with episodes on the 13th, 14th, 17th, 18th, 20th(3 episodes) of April that far surpass the frequency of Afib in my history, I have become quite suspicious of the shots as the trigger. The episodes have thankfully been shorter than in the past, some ending within 15 minutes and some as long as four hours. My historical events had often lasted 12 to 18 hours. The arrhythmia events have significantly subsided with only one  three minute arrythmia (likely flutter) in the last 12 days and less short duration palpitations as well.
Hospitalization from 1/3 to 1/6, due to <O2, Fever, Cough, SOB
30 min after injection, left eye twitch that came and went 12 hours after injection, vomiting for 2+ hours, low grade fever and extreme ache (100.3) 24 hours after injection nausea, achy, but no longer vomiting One week after injection, left eye continues to experience "low grade" twitch on and off during the day Had entire series of COVID vaccines and never had this reaction
The pharmacist was not sure if she gave the dose or syringe was empty; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (The pharmacist was not sure if she gave the dose or syringe was empty) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced UNDERDOSE (The pharmacist was not sure if she gave the dose or syringe was empty). On 15-Apr-2021, UNDERDOSE (The pharmacist was not sure if she gave the dose or syringe was empty) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant  medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: updated reporter's address and email details
Lightheadedness; nausea; extreme weakness; difficulty breathing; chest pain; This is a spontaneous report from a contactable consumer. This 18-year-old female consumer (patient) reported for herself that:   Country:  Language: en Report about Covid vaccine: Yes Reporting type: AE Reporter type: Patient  Age group: Adult (18-64 Years) Current age: 18 Current age unit: Years Gender: Female Is pregnant: No Race: (Withheld)  Covid vaccine details: Product=COVID 19 Brand=Pfizer-Biontech Lot number= EW0164 Lot unknown=False Administration date=16Apr2021 Administration time=11:15 AM Vaccine location= Left arm Dose number=1  Facility type Vaccine: Public Health Clinic Administration facility If other vaccine in four weeks: No Other medications in two weeks: Birth Control and Setraline  Adverse event: Lightheadedness and nausea within 5 minutes of injection. Followed by extreme weakness and difficulty breathing with chest pain. Took 45 minutes to be able to sit up. Adverse event start date: 16Apr2021 Adverse event start time: 11:15 AM Adverse event country:  If patient recovered: Recovered If treatment ae: Yes Ae treatment: Ice/cool cloth for head and apple juice  If Covid prior vaccination: No If Covid tested post vaccination: No  Known allergies: No Other medical history: No  Follow-Up (18Aug2021): Follow-up attempts are completed. No further information is expected. This is a spontaneous report from a contactable consumer or other non hcp.   A 18-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 16Apr2021 11:15 (Batch/Lot Number: EW0164) as DOSE 1, SINGLE for covid-19 immunisation  .  Medical history included contraception from an unknown date and unknown if ongoing Other medications in two weeks: Birth Control. Concomitant medication(s) included sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced lightheadedness (dizziness) (non-serious) on 16Apr2021 11:20 with outcome of recovered , nausea (nausea) (non-serious) on 16Apr2021 11:20 with outcome of recovered , extreme weakness (asthenia) (non-serious) on 16Apr2021 with outcome of recovered , difficulty breathing (dyspnoea) (non-serious) on 16Apr2021 with outcome of recovered , chest pain (chest pain) (non-serious) on 16Apr2021 with outcome of recovered.  The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of lightheadedness (dizziness), nausea (nausea), extreme weakness (asthenia), difficulty breathing (dyspnoea), chest pain (chest pain).
Two days after immunziation had 6x9cm warm red tender area R shoulder (cellulitis),  no fever.
Apparent life threatening event (ALTE). Parents awoke and heard noises; not breathing right color changed. Secretions in mouth and nose - EMS. Hospitalized; no treatment. ? event GERD related. Rx'ed with ZANTAC.
Client developed mild cough, weakness, and extreme fatigue on 6/25.  Tested with PCR on 6/25 and was positive for Covid
Extreme fatigue, slept for hours, paralyzed in arm and legs, extreme weakness, couldn't get up to use the bathroom, could hold urine, urine ran down legs. Felt delerious. Couldn't tell where she was. Had to use clothes to soak up the urine. Tried to call doctor. Couldn't reach him. Fortunately, son came by 24 hours and was able to help. Very frightening, very upsetting experience.
Swelling and redness at injection site. Headache started - general malise. Lymph node swelling. Went to Dr to check - no injection issue but classified as allergy.
Reaction at the injection site.  Lumps, welt, & rash at site.
1st dose/10 days ago/his arm is still "extremely sore"/pain almost reaches the elbow.; the pain almost reaches the elbow; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th July 2021, the patient received the 1st dose of Shingrix (intramuscular). In July 2021, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm and pain in elbow. On an unknown date, the outcome of the pain in arm and pain in elbow were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and pain in elbow to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The patient received the dose of Shingrix 10 days ago in left arm and experienced extremely sore arm which had almost reached the elbow. No further information was available. Lot and expiration date were unknown. Patient provided consent to consent to follow up with healthcare professional even though he got vaccinated at a pharmacy.
So we just had a scary 45 minutes. The baby had vaccinations this morning. (VSD/PDA/PFO/PLSVC) 16 months). Came home went down for a nap woke up tremoring. I assumed fever and gave Tylenol. But then he started turning colors. Lethargic looking. Heart rate above 180. No fever on thermometer. Breathing labored. Nostrils flaring . Home health nurse witnessed it too. Purple toes and fingers, lips, mouth, etc. mottled skin. Took him outside to make sure he was actually turning colors. Call the pediatrician. Wait for virtual call takes forever. Pediatrician thinks it?s just a fever spiking that that?s mass by the tunnel I already gave so we?re monitoring him. His Color has returned. He?s shaking has stopped. His breathing is better. His oxygen has risen. He?s asleep now. His heart rate is 169 which is better than it was.
9 Days after vaccines were given my daughter spiked a high fever of 104 degrees Fahrenheit. I gave her TYLENOL and the fever came down. Then she maintained a temperature around 100 for the next 2 days. Then her fever spiked to 104 again and she started to get red bumps all over her chest, back and head. We took her to the Urgent Care and by the time we saw the Dr. the red dots were darker and more prominent. The Dr. said a lot of the bumps had vesicles. He diagnosed her with chicken pox and she also had a double ear infection. She was given Acyclovir 200MG and Amoxicillin 400MG. Her twin sister who had all the same shots on the same days had the same exact reactions. So both of my daughters are suffering from these reactions and they have yet to subside.
1st dose 2 yrs ago, never got 2nd because of COVID; This case was reported by a consumer via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: The patient self reported this case. The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix 2 years ago and never got 2nd dose because of COVID pandemic.