chrisvoncsefalvay/vaers-outcomes huggingface dataset:
side effects of headache; achiness; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced headache and pain. On an unknown date, the outcome of the headache and pain were not recovered/not resolved.   It was unknown if the reporter considered the headache and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 05 Nov 2022 Reporter comment: This case was reported by a patient via interactive digital media. The patient was experiencing side effects of headache and achiness. Additional supportive information:  No follow up attempts possible as no contact information available.
This spontaneous report received from a registered nurse referred to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-MAR-2017, the patient was vaccinated with PROQUAD (dose, frequency not reported, lot:M034692, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
On 03/05/2021 approximately 5 hours after vaccination: headache, aches, chills, possible low-grade fever. Symptoms lasted until mid-day 03/06/2021. Acetaminophen was taken after first symptoms appeared and approximately every 6-8 hours until symptoms passed.  Arm soreness lasted several days after vaccination.  On 03/20/2021: felt 2 large swollen (probably) lymph nodes above collarbone on left side. Lymph nodes are visibly raised under the skin. The one closer to the left arm is larger than the one next to it which is closer to the neck. They are barely sore, if at all. Lymph nodes are still swollen at the time of this writing.
Patient said that she felt that the shot was given too high and caused nerve damage to her arm.  She lost some feeling but is now doing better and regaining her feeling back.  She felt that we should know.
Symptoms:  Approximately 5 min. after injection, patient complained of headache, dizziness, and loss of consciousness.   Signs:  Temporary loss of onscioiusness for a few seconds.  Headache. Treatment: O2 administered.  Time course approximately 10 mins.
C/o red rash at injection sits extending to upper chest and neck.  Denies itching.  1:13pm  evaluated by EMS.  BP 171/113.  Recheck improved.  Discharged home with significant improvement in rash.
Shingles; Body aches; Dizziness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), FATIGUE (Fatigue), MYALGIA (Body aches) and HERPES ZOSTER (Shingles) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.    Co-suspect product included non-company product Flu vaccine for an unknown indication.    Concurrent medical conditions included Diabetic and Blood pressure.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started Flu vaccine (unknown route) at an unspecified dose. On 28-Jan-2021, the patient experienced DIZZINESS (Dizziness) and FATIGUE (Fatigue). On 30-Jan-2021, the patient experienced MYALGIA (Body aches). On 22-Feb-2021, the patient experienced HERPES ZOSTER (Shingles). On 31-Jan-2021, DIZZINESS (Dizziness), FATIGUE (Fatigue) and MYALGIA (Body aches) had resolved. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Headaches 5 days after getting the Moderna COVID-19 Vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of HEADACHE (Headaches 5 days after getting the Moderna COVID-19 Vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced HEADACHE (Headaches 5 days after getting the Moderna COVID-19 Vaccine). At the time of the report, HEADACHE (Headaches 5 days after getting the Moderna COVID-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case concerns a female of unknown age a nonserious expected event of headache. Event onset 6 days after first dose mRNA-1273.  Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: This case concerns a female of unknown age a nonserious expected event of headache. Event onset 6 days after first dose mRNA-1273.  Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I started feeling bad the Sunday afternoon after the Friday afternoon injection.  Slight fatigue.  By Monday afternoon, I was feeling very light headed, very tired and very spaced out. I took my blood pressure at home.  It registered 205/105.  I immediately went to the ER near my home.  There the doctor tried to reduce my blood pressure with oral medication.   The doctor was not successful in reducing my blood pressure. After 6 hours in the ER I was transported and admitted to Hospital, for observation.  I was given an IV blood pressure medication prior to the  ride over to the hospital and it did come down with the top line at 150.  I was observed until 6 pm the next day.  Two hours before release my blood pressure was hovering around 180/95.  I had a number of test in the hospital.  Full blood workup, CT Scan, MRI of my brain and an Echo Cardiogram with a Saline IV solution.  All the test came back with a good result.  I have continued to have problems with balance, memory loss and concentration up to this day, 06/10/2021.  I have made a conscious decision not to take the second due to what I perceive as a dangerous reaction to the first vaccination.
24 hours after receiving the Hep A and Hep B vaccines she developed a petechiae rash on her right eyelid. The next morning, she woke with a petechiae rash on the left eyelid as well.
received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number LE79N, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th September 2021, the patient received Fluarix Quadrivalent 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device. On 17th September 2021, unknown after receiving Fluarix Quadrivalent 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were reported as follows: On 17th September 2021, patient received Fluarix vaccine, which was expired on 30th June 2021. The reporter consented to follow up. This case has been linked with US2019124829, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019124829:same reporter
About 15 minutes after receiving the vaccine, the patient complained about her left arm hurting. She also complained of chest tightness and difficulty swallowing. Patient also had vision changes. We gave the patient 1 tablet of Benadryl 25 mg and called EMS services. EMS checked her out and we advised the patient to go to the ER to be observed and given more Benadryl. Patient was able to walk out of facility herself.
headache; shivering; pain all over; one to one and a half inch blister; Itchy spots like mosquito bites; red spots; swollen spots; Itchy eyes; Burning eyes; itchy, burning eyes (AE: itch, pain; recovered); This case was reported by a consumer via call center representative and described the occurrence of headache in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2021, the patient received the 1st dose of Shingrix (intramuscular). In December 2021, less than a day after receiving Shingrix, the patient experienced headache, shivering, general body pain, blister, itchy rash, red spotty rash, papular rash, eye pruritus, burning in eyes and eye pain. On an unknown date, the outcome of the headache, shivering, general body pain, eye pruritus, burning in eyes and eye pain were recovered/resolved and the outcome of the blister, itchy rash, red spotty rash and papular rash were not recovered/not resolved.   It was unknown if the reporter considered the headache, shivering, general body pain, blister, itchy rash, red spotty rash, papular rash, eye pruritus, burning in eyes and eye pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received his first Shingrix dose about 3 weeks prior to the reporting date.  That evening he had headache, shivering and pain all over that he describes as feeling like he had been hit by a truck. The shivering and pain resolved after a few days. The headache continued more than a few days but was now resolved.  Three or four days after vaccination he developed a one to one and a half inch blister on his hip.  At that time, patient developed itchy, red, swollen spots on his back that look like mosquito bites.  The patient had not been anywhere to had been bitten by mosquitoes.  Also, about three to four days after vaccination patient had itchy, burning eyes.  The patient had consulted a dermatologist friend who recommended he had a biopsy done on the hip blister. The patient had nothing else to report. The reporter consented to follow up.
Severe nausea and lightheadedness; Severe nausea and lightheadedness; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received both 1st and 2nd doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), both via unspecified routes of administration at the right arm on unspecified dates at single doses for immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. There were no concomitant medications. On an unspecified date, the patient experienced severe nausea and lightheadedness. There was no treatment given for the events. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (Nasal swab) on an unspecified date and result was negative. The outcome of the events was recovering.
started with tingling in feet and numbness. travelled up body to arms and chest. now have shooting pains in fingers, wrists, ankles and toes, mostly at night. lots of chest pains. problems holding bladder and bowels. Problems walking up and down stairs without falling or slipping. Blurry vision. Chest pains.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Hypercholesterolaemia (Cholesterol). Concomitant products included MELOXICAM and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 07-Apr-2021, PYREXIA (Fever) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-076474 (Patient Link).
First thing I noticed was sore throat and a runny nose. I had nausea and an upset stomach. I also had a headache but not really a cough. I had body aches a fever and chills. 10 days after I tested positive I was diagnosed with a ear infection. 5 days after starting that I started getting really bad GI symptoms and went to the ER for it. I ended up back in the ER a few days after that for C diff.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient received dose one of RECOMBIVAX HB (dose, lot # and expiration date were not reported) on 03-OCT-2013 and dose two on 18-MAR-2014 (five month interval). No adverse effects reported. The outcome and causality were not provided. Additional information has been requested.
Headaches; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued) and HEADACHE (Headaches) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced FATIGUE (fatigued). On 23-Aug-2021, the patient experienced HEADACHE (Headaches). At the time of the report, FATIGUE (fatigued) was resolving and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by reporter. No treatment medications were provided by reporter.
hives across both my arms and chest; This case was reported by a consumer and described the occurrence of hives in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 7th April 2021, the patient received the 2nd dose of Shingrix. On 10th April 2021, 3 days after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient himself. After the 2nd dose of Shingrix, 3 days after the shot, he woke up and hives across both his arms and chest. The event lasted for 72 hours, gradually fading and then completely disappeared. The reporter consented to follow up.
dizziness, weakness, sharp pain in right arm and right leg, fatique, cold chills.
Breaking out in bumpsthat looked like gangling cysts; Hurt; This spontaneous case was reported by a patient and describes the occurrence of MASS (Breaking out in bumpsthat looked like gangling cysts) and PAIN (Hurt) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006b21a and 011a21a) for COVID-19 vaccination.     Patient had no allergies.  Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MASS (Breaking out in bumpsthat looked like gangling cysts) and PAIN (Hurt). At the time of the report, MASS (Breaking out in bumpsthat looked like gangling cysts) and PAIN (Hurt) had not resolved.            Patient never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The patient does not experienced a similar event in the past. The AE caused patient to seek medical care by office visit. The symptoms were getting worse. The patient had refused to receive any booster. No treatment medication was provided.
Lost a little hearing in my left ear; Intracranial hypotension; got humming in my right ear/Started with a swish in my left ear and then it started humming right after that; swish noise in my ear and the humming started; This is a spontaneous report from a contactable consumer (patient)   A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9266) on 15Mar2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included Atrial fibrillation, Hypertension, Blood cholesterol abnormal. The patient received first dose of BNT162B2 (Lot number-EL9269) on 22Feb2021 and experienced feeling abnormal. Concomitant medications included nebivolol hydrochloride (BYSTOLIC) for blood pressure abnormal, losartan potassium, apixaban (ELIQUIS), calcium and rosuvastatin. From an unspecified date the patient started to get weird sensation on the top of her head and lost a little hearing in my left ear. On about 04Mar2021 she also started to get humming in her left ear; She got humming in her right ear; swish noise in her ear and the humming started. Patient reported that the left ear was the high pitch, the right ear that started later after the second vaccine with the low pitch, so now there are times when it is the whole head. When she got that swish noise in my ear and the humming started.  It was informed that patient was seen by a neurologist. On 02Ap2021 patient underwent MRIs of my brain with and without contrast and 09Apr2021 underwent MRI of spine that showed intracranial hypotension. Patient informed that 'the neurologist wanted to put blood patch in cervical part of the spine but he was not sure; neurosurgeon believed that patient don't need that and commented that  the humming was from the Pfizer, numerous patients that received vaccination have humming in the ears' (as such). At the time of the reporting events outcome was unknown.                                                                                              Follow-up attempts are needed. Further information is expected
Lost almost complete sense of taste and smell for about 24-36 hours, then came back.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received a dose 12 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. Last year from the date of reporting, the patient received 2 doses of Shingles vaccine. The patient had shingles at the time of reporting.  The patient stated that, he/she would not say it had been a mild case. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Per mom, began 9/27/12 am with redness, heat, hard (rt) arm. Brought to clinic marked margin & advised monitor & apply cold compress. RR or take if increase size or see new sx. Mom took to regional ER 9/27/12 pm b/c increase size & dev (lt) arm too. Told it poss-allergic rxn or infection given BENADRYL PO also told to monitor and advised if worse or any new sx talk with immed.
Patient said that her arm began to hurt by the next morning and that is has gotten worse each day and that she can hardly raise her arm.
severe fever, chills, body aches, nausea, vomiting, diarrhea, lack of appetite - lasted for 10 days  Lack of appetite, nausea, body aches for over 1 month  congestion and fluid in chest - from 6/11/21 - to present
Day 2 my bones in shins and forearms ached real real bad and was really fatigue day 4 I had a place come up at the injection site about the size of a quarter that was a hard lump and real red and my whole upper arm hurt, day 5 the size was about 2 quarters side by side and sticking up the lump even bigger and can't hardly pick my arm up. It's really red and hot.
pt recv vax 11FEB97 & 12FEB97 4AM pt exp unusual dreams in which pt saw unusual colors & objects like bugs crawling over everything & talked in sleep;dreams mad skin itch;
VERTIGO DIAGNOSED IN ER AS BBPV. HAD NEVER EXPERIENCED BEFORE. RESOLVED WITH EPLEY PROCEDURE. CONTINUED INTERMITTENT LIGHTHEADEDNESS WITH EXTREME FATIGUE AND MUSCLE ACHES  CONTINUING SINCE INCIDENT NOW AT 11 DAYS.
large red blotch appeared where shot had been administered.  some swelling and itchy rash
The patient stated that her throat was scratchy & itchy just minutes after receiving the injection.  After a few more minutes her lips started feeling tingly.  Her tongue then also started feeling tingly shortly thereafter. The patient started feeling better and went to MD.