chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Recurrence of hives and HSV-1 lesions both on lips; Recurrence of hives and HSV-1 lesions both on lips; This is a spontaneous report from a non-contactable consumer, the patient. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809), via an unspecified route of administration on an unknown date (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included hives and Herpes Simplex Virus (HSV)-1 lesions both on lips on an unknown date. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient experienced recurrence of hives and HSV-1 lesions both on lips after 25 years being dormant. The recurrences began within 2 weeks of the second dose. The clinical outcome of the events recurrence of hives and HSV-1 lesions both on lips were unknown at the time of this report.    No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course of the events: The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment: No. The patient previously received a COVID-19 Vaccine. Reported Event: Covid symptoms reoccurred  about 5 days after the paxlovid treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Allergies: Hydrochlorothiazide, Pneumococcal Vaccines, Latex and Sulfa Drugs; This is a spontaneous report from two contactable nurses. A 72-year-old female patient received pneumococcal vaccines (manufacturer unknown), via an unspecified route of administration on an unspecified date at single dose for immunization, received hydrochlorothiazide (manufacturer unknown) and unspecified sulfa drugs, via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced allergies: hydrochlorothiazide, pneumococcal vaccines, latex and sulfa drugs on an unspecified date with outcome of unknown. The action taken in response to the event for pneumococcal vaccines was not applicable, for hydrochlorothiazide was unknown.  Pfizer is a marketing authorization holder of [Pneumococcal Conj Vac, 13-Val] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal Conj Vac, 13-Val] has submitted the same report to the regulatory authorities.
Sweating Night Chills Sore Throat Small lesions on back, chest, and head
10SEP & 11SEP c/o lethargy;12SEp t101, lethargy cont;13SEP no fever, hives devel MD called, advised to start DPH;14SEP, 15SEP aching hives recur if no DPH in over 7hr;
Vial was stored at room temperature post puncture; No adverse event; administered vaccine more than 12 hours post puncture of the vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccine more than 12 hours post puncture of the vial), PRODUCT STORAGE ERROR (Vial was stored at room temperature post puncture) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030M20A) for COVID-19 prophylaxis. No Medical History information was reported. On 10-Nov-2022 at 3:25 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Nov-2022 at 3:25 PM, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccine more than 12 hours post puncture of the vial). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored at room temperature post puncture). an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered vaccine more than 12 hours post puncture of the vial), PRODUCT STORAGE ERROR (Vial was stored at room temperature post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered vaccine more than 12 hours post puncture of the vial) and PRODUCT STORAGE ERROR (Vial was stored at room temperature post puncture). No concomitant medications were reported. It was reported that, vaccine vial was first punctured on 09-Nov-2022 at 12 noon and was administer to the patient on 10-Nov-2022 at 15:25. The vial size reported was 2.5 milliliter. The vial was initially stored in the refrigerator on 08-Nov-2022. The vial was stored at room temperature post puncture. The vial did not undergo any temperature excursion. No treatment details were reported This case was linked to MODERNATX, INC.-MOD-2022-670595 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2022-670595: Same reporter case.
Within the first week had bad diarrhea that wouldn't quite and developed severe pain in stomach. Blood pressure started to drop way to low and he started to loss weight no appetite no taste. Dr took him off of everything dealing with his cancer for 2wks to make sure what he was going through was due to the vaccine
At 1036 (approximately 13 minutes post injection), I felt a tingling/burning sensation in my left cheek area.  Over the next hour it spread to the left side of my cheek and bottom lip.  This sensation remained constant until approximately 1900, when it became an intermittent sensation that is on-going at the time of this report.  (Still limited to the left side of my face - cheek/chin/lip area, and occasionally my left ear lobe.)  At approximately 1345 I took asa in hopes of alleviating the headache I developed over the past hour or so.  Also noted I started feeling hotter than normal at this time, but thought it was our office.  (My co-workers didn't comment on the heat, though, and they usually do.)  At 1658 I was so hot I was concerned I developed a fever.  My temperature as only slightly elevated over my normal (~1 degree), but I felt very hot, like I was burning up.  At 1810, while eating dinner, I felt chills and started shivering; this lasted approximately 45 minutes.  I also notice my arm around the injection site had become extremely sore, to the point it hurt to lift it to shoulder height.  At approximately 1900 I began feeling extremely hot, again.  This lasted all night - to the point that I slept outside in my car (car camping) in a tank top without a blanket or other covering in 60 degree weather all night and still woke up a little sweaty.  This finally started letting up a little bit around 1900 on 3-Oct-21 (i.e. 24 hours later), but I'm still feeing warmer than usual.
cough, tight chest, runny nose, hot flashes starting 1/8/2022
4 am woke up to terrible headache, vomiting,  fevers and chills.    (Sat)   Sun---fever, hives and passing out.    Monday felt ok just very tired.   Hives lasted until Thurs
called pharmacy to report but unable to get the above information - so  self reporting . On 9/30 @ 3:00pm I got the Shingrix shingles vaccine, left arm: part 1. arm was sore, and there was redness at the point of injection, on that day I had no other reaction. On 10/1 at 2:30pm, the redness began to spread. My arm was sore and incrediably itchy. It would continue to spread to almost my entire upper arm - and the itch was horrible. Also on 10/1 starting at 2;30pm - incrediable fatigue, arm soreness and my muscles ached everywhere on my body - head to toe. same on 10/2. 10/3 my fatigue started to end as did the muscle / body aches. the rednes and itcheness - getting worse each day - until 10/6 when it started to disapate.
numbness in hands and feet, cold feeling on face, feeling comes and goes started 10/13/22 continues to present 10/18/22, Treatment-none except to rest, went to doctor, referred me to a neurologist and requested lumbar x ray, PCP said they didn't have enough information on other vaccine recipients to discuss whether Guillain Barre might be the cause.
Information has been received from a Pharm. D. concerning a male with cancer who was vaccinated with hep B vaccine recombinant. Subsequently the pt developed a slightly elevated alpha-fetoprotein (value not reported). The outcome of the pt's elevated serum alpha-fetoprotein was unknown. It was unknown if the pt sought medical attention. Additional info has been requested.
This spontaneous report as received from a pediatric patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB (strength: 5microgram/0.5 milliliter (mcg/ml) at the dose of 5/0.5 mcg/ml (route, lot# and expiry unspecified). The physician reported that a patient might have received 3 pediatric doses of RECOMBIVAX HB and failed to seroconvert; antibodies were low. The doctor stated that she needed to review her records to make sure all 3 doses were administered to the patient. No adverse effects reported. Additional information is not expected.
cold-like symptoms; sneezing; sore throat; eyes were watery; water was coming out of her nose; feels like having the flu; cough; nausea; back aches; dizziness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 26Mar2021 14:00 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Mar2021, by 5-6, patient had cold-like symptoms, she was sneezing, had a sore throat, her eyes were watery and water was coming out of her nose. She feels like having the flu, with cold symptoms, cough, nausea, back aches and dizziness. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Muscle soreness started the evening of the vaccination along with being unusually tired. Being tired has improved the but the muscle soreness still prevails. After about a week after the vaccination my hair started falling out, this is such more than the amount of hair I loose daily.
Became somewhat lethargic and often crying.  Took a long afternoon nap which is unusual for her.  Complained of stomach hurting.  Verified temperature of 101.7 (orally with digital thermometer) at approximately 3:45 PM.  Please note that on 10\23\09, patient was given an IM injection of the Swine Flu Vaccine.  The Doctor's office called one week later stating that the initial vaccine was stored at too low of a temperature and that another "1st" vaccine needed to be given again.  This occurred approximately 1 week later with a nasal injection and is appearing to be correlated to patient's temperature, etc.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: PATIENT REPORTED TO PHARMACY CONSULT AREA SHOWING LEFT UPPER ARM RED AND REPORTING PAIN. CONSULTED TO TAKE BENEDRYL AND WE WOULD FOLLOW UP TO SEE THE PROGRESSION OF THIS REACTION
This case was considered medically important (OMIC). Information regarding Hib-Titer Vaccine was received from a healthcare professional regarding a 4 year old male patient who experienced developmental delay and weakness of all aspects of language based learning. The patient received the fourth dose of Hib-Titer on 6/27/97. Reported stated no medical history or conditions other than developmental delay. Indication for Hib-Titer vaccine was immunization. Product was administered on 6/27/97. Dose regimen was 1 dose. Additional suspect medication included Orimune vaccine, IPOL, Tetramune Vaccine, Acel-Imune vaccine, Infanrix, MMR II, Varivax, Engerix B, and Hepatitis B vaccine. Concomitant medications were not reported. The patient was diagnosed with developmental delay on 2/5/01. On an undisclosed date, the patient additionally was diagnosed with weakness of all aspects of language based learning. No additional information was available at the time of this report. A copy of this report is being forwarded to the manufacturers of the concomitantly administered vaccines.
3 blisters on chest developed on 7/18/18 and then scabbed/resolved after 2 days. Fever for 24-36 hours at that time. Fever resolved. On 7/21/18 she developed fever. Tmax 102. Fever persisted until 7/24/18. Concurrent lip smacking, fussiness, crying out at night. Erythematous macular rash over buttocks started 7/25/18. Mother reports she is complaining of mouth pain. Decreased appetite but drinking ok.
Information has been received from health professional concerning a 71 yr old male, with atrial fibrillation, diabetes, hypertension and cholesterolemia, and no known allergies, who on 21Sep05 was vaccinated with a SC dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P). Concomitant therapy included warfarin sodium (Coumadin). It was reported that on 23Sep05 the pt's entire arm, that had received the injection, had redness, swelling, pain, and was warm to the touch. The swelling was past the elbow into the forearm. The pt was seen in the ER and given diphenhydramine hydrochloride (Benadryl). He was then rechecked in the physician's office on 27Sep05. It was reported that the pt recovered. No other information was provided. Additional information has been requested.
she look it up as tinnitus, I had a buzzing noise in my head; I had a fever; she maybe had an infection inside her ear since the right ear sometimes has drainage; she maybe had an infection inside her ear since the right ear sometimes has drainage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "she look it up as tinnitus, I had a buzzing noise in my head"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "I had a fever"; EAR INFECTION (non-serious), OTORRHOEA (non-serious) all with onset 2021, outcome "unknown" and all described as "she maybe had an infection inside her ear since the right ear sometimes has drainage". The event "she look it up as tinnitus, i had a buzzing noise in my head" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus, ear infection, otorrhoea.  Additional Information: The patient stated that she developed a buzzing noise in her head. She thought it could be fever, or the medicine effect on her body. There was a light buzzing in her head for a while. She refers that at first, in Mar2021, it was very light and she would ignore it. Then she google it, found out it was tinnitus and it was permanent and wanted to take care of it. She bought over the counter ear remedy and more medications. She went to the doctor and had an audiogram. The doctor confirmed it was permanent and prescribed steroid ear drops. She thought she maybe had an infection inside her ear since the right ear sometimes has drainage. She was checking her blood pressure and using ear drops in case there was an infection.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I gave the vaccine 7/31/13 but did not speak to client 8/1/13. She apparently felt a small welt on her face when leaving the building. Later in day felt tongue tingling, got a welt on her Rt. ankle and Rt. upper thigh. Then had fever, dizziness and emesis. Was fine today at p/c.
Dose was given on the 34th day after the vial was thawed; Dose was given on the 34th day after the vial was thawed; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given on the 34th day after the vial was thawed) and PRODUCT STORAGE ERROR (Dose was given on the 34th day after the vial was thawed) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given on the 34th day after the vial was thawed). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose was given on the 34th day after the vial was thawed). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Dose was given on the 34th day after the vial was thawed) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Dose was given on the 34th day after the vial was thawed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Swelling of throat and neck pain, shortness of breath, headache progressed for 1 hour after shot. Went to ER at Hospital.  Took 25 mg Benedryl, declined prednisone, but left ER 2 hrs later with prescription for epipen and prednisone.  Took Zytec at home and slept.  Symptoms were gone next day.
vaccinated with pfizer in April 2021. has hadeache sore throat and cough.
Previous Admission-1/3/2022-  Covid+ test on 12/31/2021- Arrive to ER with complaints of  SOB, weakness and lightheadedness.  On 2L via NC 94% o2 sat.  Chest x ray-Mild righ basal atelectasis versus small infiltrate. Admit with acute hypoxemic respiratory failure due to Covid -19. D-Dimer 396. Start doxycycline, baricitinib, heparin and Decadron.  1/4/2022- O2 around 88% on 2L NC, oxygen titrated. Remdesivir held AKI-creatnine 1.7 1/5/2022- AM-O2 RA sat 98% , afebrile. Covid symptoms resolving.  1/5/2022-PM- Creatnine 1.2.Discharged home continue current medications.   Current-1/8/2022-Arrive to ER increased cough. discplacement of nephrostomy tube. Hypoxic at home, O2 applied 3L via NC. Afebrile .
Bilateral ringing in the ears after the 1st dose/Tinnitus after the 1st dose; Patient missed the 2nd dose; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (Bilateral ringing in the ears after the 1st dose/Tinnitus after the 1st dose) and PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALBUTEROL SULFATE, EZETIMIBE (ZETIA), FAMOTIDINE (PEPCID AC), LISINOPRIL, ROSUVASTATIN CALCIUM (CRESTOR), SERTRALINE HYDROCHLORIDE (ZOLOFT), SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Bilateral ringing in the ears after the 1st dose/Tinnitus after the 1st dose) and PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose). At the time of the report, TINNITUS (Bilateral ringing in the ears after the 1st dose/Tinnitus after the 1st dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reportedly, the ringing in the ears were constant and bothering the patient. The patient didn't take any treatment medications.
On Sunday evening late began having shortness of breath and heaviness in chest. Also experienced loss of appetite and fatigue. Monday morning called PCP and made an appointment. Went into clinic and tested negative for COVID-19. PCP instructed me to retest in 24-48 hours. Retested on Tuesday 12/13/2022, and tested positive. Reached out to PCP's office and waiting for them to return my message. PCP said they would prescribe PAXLOVID. Symptoms have remained about the same. I have increased my cortisone dose per my doctors instructions.
3 days after vaccinations, pt had sudden onset of waking with painful cries then sleeping every 30 minutes x 2 hours -> went to urgent care then ER. Ultrasound was negative, but intussusception was suspected.  12/10/2007 MR received for ER visit 10/30/2007 with Final Impression:  Apparent Acute Abdominal Pain.  Child presented with apparent abdominal discomfort (intermittant crying) and larger than normal BMs.  Sent to r/o IS.  Pt has had no blood in stool, no fever, vomiting or diarrhea.  PE WNL. PE and test findings reassuring for no IS.
Pt was given wrong dose of flu vaccine. Should have been given regular flu vaccine and was given peds dose.
Received 2nd dose of Moderna COVID vaccine at approximatly 255pm, placed in 30 minute observation after advice from her primary care provider after having a delayed cutaneous reaction 24 hours after first dose. After approximatly 20 minutes, she voiced complaintes of a silver dollar sized reddened, raised area at site of injectio, left arm,  with itching and seperate area of redness extending down back of arm. She was given 50mg IM Benadryl and monitored an additional 30 minutes which symptoms resolved at that time. She declined EMS/hospital evaluation. Instructed to notify primary care provider and to seek EMS or ER evaluation if symptoms returned. Stated would continue to take oral benadryl/notify PCP
After receiving the vaccine I was tired. Then one day in April 2022 I had symptoms that started as a sore throat. It was mild at first. Then it worsened over a few days. I had some fatigue and a light fever. It felt similar to seasonal allergies in which I thought I had. I took a covid test and it came back positive. I went to the doctor and they prescribed a cough suppressant which I believe may of been benzonatate. After2 or 3 days I was feeling much better.