chrisvoncsefalvay/vaers-outcomes huggingface dataset:
herpes reactivation; herpes reactivation worsened; this was herpes S1 since it was on her face; broke out on her lower lip and a couple of days later she broke out in the back of her throat next to the uvula; This is a spontaneous report from a contactable consumer reported for herself. A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6208; Expiration date was not reported) via an unspecified route of administration, administered in arm left on 27Mar2021 10:50 (at the age of 62-years old) as dose 1, single and received second dose via an unspecified route of administration, administered in arm left on 17Apr2021 (Lot number: ER8737; at the age of 62-years old) as dose 2, single for COVID-19 immunisation. Medical history included genital herpes that she has had in the past from unknown date and unknown if ongoing. Other medical history or conditions, concomitant products, investigational assessment, test results, history of all previous immunization with the Pfizer vaccine considered as suspect, additional administered vaccines included none. Prior vaccinations (within 4 weeks) were not reported and for adverse events (AE) following prior vaccination, patient stated no not herpes. For family medical history relevant to AE, the patient stated she was not really sure what was relevant to herpes. Patient took COVID 19 vaccine for protection from COVID so she would not have to go to the hospital. No other products taken. On 27Mar2021, the patient experienced herpes reactivation which was reported as worsened, and this was herpes S1 since it was on her face; it broke out on her lower lip and a couple of days later she broke out in the back of her throat next to the uvula. Therapeutic measures were taken because of events. No emergency room visit was done. Clinical course was as follow: The patient calling about the COVID-19 vaccine to report a side effect. The patient saw a nurse practitioner which was an APRN for her side effect. The patient had a herpes reactivation on her face instead of genital herpes that she has had in the past. The patient stated this was herpes S1 since it was on her face. This started the first day that she received the first vaccine, and she broke out on her lower lip and a couple of days later she broke out in the back of her throat next to the uvula. The patient noticed the first day because she knew the symptoms. The patient stated she took ACYCLOVIR, which was recommended, and the herpes reactivation was strong enough it broke out. The patient was treating her symptoms with ACYCLOVIR, 5 times a day which 5 times a day was the maximum. For the second dose of the vaccine, she made sure she had enough to take the extra 5 times a day and she still broke out within hours. She was having to take 5 pills of the ACYCLOVIR to keep her symptoms at bay instead of the normal 2 pills. Relevant tests included none. Clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Shingles; This spontaneous report was received from a lawyer refers to a currently 79-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On an unknown date in 2006, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency, lot number, expiration date, route of administration and anatomical location were not provided) for long-term prevention of shingles and zoster-related conditions.         On an unknown date, the patient experienced shingles and she received treatment for this adverse event.       The outcome of the singles was unknown.  The causality assessment between the event and the suspect therapy was reported as related.
On June 5th, at 7:30 AM was noted to have maculopapular rash on trunk and slightly on back. No other rash noted on arms, face, neck or legs. Complained of slight itching.
swollen face lips; swollen face lips; sob; squeezing of the chest; tingling; chills (hot and cold); This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swollen face lips), LIP SWELLING (swollen face lips), DYSPNOEA (sob), CHEST DISCOMFORT (squeezing of the chest) and PARAESTHESIA (tingling) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information provided by the reporter. and concomitant drugs are provided.  Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE), ATORVASTATIN CALCIUM (LIPITOR), AMLODIPINE, TIOTROPIUM BROMIDE (SPIRIVA) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced SWELLING FACE (swollen face lips), LIP SWELLING (swollen face lips), DYSPNOEA (sob), CHEST DISCOMFORT (squeezing of the chest), PARAESTHESIA (tingling) and CHILLS (chills (hot and cold)). The patient was treated with ACRIVASTINE (BENADRYL ALLERGY RELIEF) ongoing since an unknown date at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SWELLING FACE (swollen face lips), LIP SWELLING (swollen face lips), DYSPNOEA (sob), CHEST DISCOMFORT (squeezing of the chest), PARAESTHESIA (tingling) and CHILLS (chills (hot and cold)) outcome was unknown. Not Provided          Concomitant medication includes Hypertension medications.  Treatment also includes nebulizer.
Rec'd vaccine in (Employee Hlth Dept. at 530PM) started next day around 12N with muscle aches, lethargic, and severe chills. No fever. Slept for 5hrs. Awoke feeling better, but not feeling herself.
Pt arrived with body aches and malaise.  Husband is also COVID positive.  Pt has history of CAD, obesity, and diabetes.  Pt was admitted for hypoxia.
9/10 Received vaccines early afternoon, next day arm was red and warm to the touch, raised and red 2 areas, also feeling. 9/12 Patient came in recommended cetirizine at night and acetaminophen for the pain and aches.
Post 1st dose, vaccinee experienced pain & severe rash @ deltoid (site of inject) which lasted 5 days.
ARM FEELS VERY HEAVY; SORE ARM; MUSCLE QUIVERING; ENLARGED VEINS; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced muscle quivering. On MAY-2021, the subject experienced enlarged veins. On 17-MAY-2021, the subject experienced arm feels very heavy. On 17-MAY-2021, the subject experienced sore arm. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from arm feels very heavy, sore arm, muscle quivering, and enlarged veins. This report was non-serious.
redness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness in injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 211B21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included FLUTICASONE for COPD, DILTIAZEM, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), TAMSULOSIN, IBUPROFEN, FINASTERIDE, MONTELUKAST and LORATADINE for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness in injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness in injection site) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. No treatment was taken by the patient.   This case was linked to US-MODERNATX, INC.-MOD-2021-079246 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079246:Wife case
Pt vaccinated with TD 15-20min after receiving vaccine, started having nausea, throat burning, felt as if ear drums were swelling, eyes itched, swelling of face, macula rash of neck, face & arms. Given Benadryl.
R deltoid red swollen and warm 3x3.5 cm  L deltoid red swollen warm 1.5 x 2
Felt bad; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (Felt bad) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included COVID-19.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt bad). At the time of the report, FEELING ABNORMAL (Felt bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.  Patient was 18 year old had a difficult time with her first dose, and received her second dose,  She is feeling very badly after this dose also, low grade fever, fatigue, cold and hot, lethargic, and pain in the site that radiates to her arm and chest.  Also she did have COVID19 in late December   This case was linked to MOD-2021-186957 (Patient Link).   Reporter did not allow further contact
Severe tinnitus. Developed in right ear only, several weeks after vaccine. No prior history of any tinnitus.
On June 7, 1999 the pt developed about five chickenpox lesions characterized by two liquid filled and one scabbed over itching with fever and runny nose.
p/vax pt woke up w/rash & swollen eye lids;no other sx;skin w/erythematous macular papular rash;exam nl otherwise;
RA, 4 X 5 cm, swelling from elbow to shoulder, Vomiting , Fever
Red, raised, patient describes as, "small welt noticed morning of 10/26 and got bigger as the day passed... arm pain".
Did not report on check in yesterday because I didn't think there was a correlation.   I developed severe persistent heartburn 2.5 weeks after second dose.  I considered this as more coincidence (although I have never had severe heartburn except once related to NSAID use) given the timing (2.5 weeks after vaccine) and that I had not seen this listed as a potential side effect.  It then dawned on me that if no one reported for the same reasons you would never know that there is in fact a correlation so I am deciding to report.   It may be worthless data but it may also be relevant.
Right after my first vaccine I immediatly fainted, since that day and throughout the last two vaccines i have had strange symptoms.  Feeling dizzy occurs all of the time and i have had extreme joint problems including swelling and horrible pain.  The dizzyness is continuous, but the joint pain comes and goes.  The joint pain and swelling mostly occurs where i had been given the vaccines(arm and thigh).  10/10/08 Reviewed rheumatology records of 1/24-3/11/08. FINAL DX: inflammatory polyarthralgia NOS Records reveal patient experienced intermittent right hip, left shoulder & right wrist pain x 3 mos along with myalgia of LEs, dizziness & lightheadedness s/p HPV vaccines 10/07 & 12/07.  Tx w/pain meds initially but no improvement.  3/08 tx w/steroid tx for possible seronegative RA.  No further records available.   10/3/08 Reviewed GYN medical records of 2/28/07-4/25/2008. FINAL DX: none provided Records reveal patient in usual state of good health on day of vaccination w/sexual dysfunction.  Joint pain reported on 4/25/08 & was being seen by rheumatologist.    10/24/08 Reviewed PCP medical records of 10/11/07-1/22/2008. FINAL DX: Records reveal patient experienced right wrist pain 10/11/07 w/x-ray normal.  12/12/07 c/o of dizziness, lightheadedness, feeling faint x 2-3 weeks.  Had fainted w/HPV #1.  Right wrist pain persisted & referred to ortho.  1/16/2008 c/o continued left shoulder joint pain, right wrist pain & right hip pain.  Referred to rheum.
Hours later had pain at injection site and swelling all the way to the elbow that lasted 3-4 days, low fever that lasted 1 day
feet broke out in a hives allergic reaction, from his knees down to his feet; itches bad; This is a spontaneous report from a contactable consumer(patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8735) via an unspecified route of administration on 07May2021 at 15:30 (age at vaccination 42 years-old) as dose 2, single for COVID-19 immunization . The patient's medical history and concomitant medications was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: LEW0151, Expiration date: 31Jul2021) on 14Apr2021 (age at vaccination 42 years-old) between 13:30-14:00 as dose 1, single for COVID-19 immunization. When he woke up Sunday morning on 09May2021 the caller stated his feet broke out in a hives allergic reaction, from his knees down to his feet and it itches bad. No additional vaccines administered on same date of the Pfizer suspect. No emergency room and physician office visit was reported. It was reported as product complaint. The patient took Cortisone 10 cream and Benadryl as a treatment but that didn't help that much. Clarified, after he put it on, for an hour or two it allows him to not itch it but after 4-5 hours it started to itch again. Stated he tried not to itch it or it gets red. The outcome of the events was reported as not recovered. No follow-up attempts are possible. No further information is expected.
3th dose was not administered yet; Patient receiving 1st dose on 26-jun-2003 and 2nd dose on 08-aug-2003; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 26th June 2003).   On 8th August 2003, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 8th August 2003, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were 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: 13-MAY-2022 Reporters comment: The patient was 45 years old at the time of reporting. The patient received 2nd dose of Twinrix late and 3rd dose was not administered till the time of reporting.  Patient wanted to remain anonymous, only information the pharmacist provided was that was a female and her age. The reporter consented to follow up. Additional supportive information: The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule and till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete vaccination schedule.
Fever began 12 hours after second shot, approximately 6am, and lasted throughout the day.  The fever peaked around 7pm at 100.6 degrees and was responsive to tylenol.  Intense body aches and chills also accompanied the fever followed by intense thirst around bedtime.  All symptoms went away the following morning with lingering aches and general weakness.
This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "History of breast cancer" (unspecified if ongoing), notes: History of breast cancer; "hypertension" (ongoing); "TPF right leg" (unspecified if ongoing), notes: TPF right leg. The patient's concomitant medications were not reported. Past drug history included: Flagyl, reaction(s): "known allergies Flagyl", notes: known allergies Flagyl; Celexa, reaction(s): "known allergies celexa", notes: known allergies celexa. The following information was reported: DRUG INEFFECTIVE (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; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the event and the suspect drug BNT162B2 cannot be excluded.
Information has been received from a registered pharmacist concerning a newborn female who on 24-JUN-2010 was vaccinated with 0.5mL of RECOMBIVAX HB IM (Lot # 666188/1491Y). On approximately 24-JUN-2010 the patient experienced apnea and seizures. On an unknown date, the patient recovered from apnea and seizures. The patient was in the hospital and sought medical attention. The pharmacist wanted to know with the lot check it will be tested if there was overfill or contaminates. Apnea and seizures were considered to be immediately life-threatening. This is one of 4 reports from the same reporter. It was noted that three of the four patients had seizures and one of the four had full arrest. It was unknown what patient had which of the reactions. A lot check has been initiated. Additional information has been requested.
felt mass or nodule near the injection site; felt mass or nodule near the injection site; This spontaneous report was received from a physician concerning a female patient of unknown age. No concurrent condition, medical history, or concomitant therapy was reported.    On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, lot # and expiration date were unknown), intramuscularly for prophylaxis.         On an unknown date, about one or two months after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination, the patient felt mass or nodule near the injection site. The patient came back to the office and was seen by the physician about the AE. The treatment given for the events was unknown. The outcome of the events was unknown. The causality assessment was not provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2111USA001338: US-009507513-2111USA001337: US-009507513-2111USA001339: US-009507513-2111USA001336:
got the 2 shots I got them/Suspected Vaccination Failure; got them in the forehead; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had lasted a year).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown 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 unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 28-FEB-2023 Reporter's comment: The case  was received from the patient via interactive digital media. The patient stated that finally he/she got the 2 Shingles shots and he/she got shingles in the forehead. The patient thought that he/she would lost mind. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
10 minutes post vax, the pt had a sudden onset of headache, dizziness, and nausea. She experienced the nausea and headache for the rest of the day and had the dizziness into the evening.
Induration and swelling with erythremia on majority of inner upper Brachium L. Painful to touch. Advised cold compress, APAP, Antihistamine. Follow up post 8 days. Reduced swelling and erythremia. Resolving  (injection site rxn).
Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, lot number and expiration date unknown) for prophylaxis. Data logger issue was involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA005356: US-009507513-1702USA010273.
Pt presented to ER on 12/11/09 with numb tongue and right eye watering. Pt had no weakness on either side. Daughter stated her mouth was "crooked". Possible right face droop. Pt had difficulty shutting right eye. CT revealed no acute bleeding or abnmormality. Lungs clear, sensation intact, stable gait, speech stable. No obvious mention of issues in subsequent visits.
Myalgia chills; sweats; aches Narrative:  Tylenol as needed   Other Relevant History:
About 10 minutes after receiving the covid vaccine, I developed a red flush on my face which was bright, hot and uncomfortable. The flush appeared nowhere else on my  body so I concluded that the vaccine must have interacted with the tretinoin cream I use nightly. That is the only area of my skin on which i apply the cream. When I got home, I applied soothing skin cream but no relief. I then tried aloe, which grows in the area, and the flush/burning abated somewhat. The next day, my face was still flushed but less red. the skin surface was scaly. I am continuing to treat at home. No MDs involved.