chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sinus infection; This non-serious case was reported by a consumer via call center representative and described the occurrence of sinus infection in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-JUL-2023, the patient received the 2nd dose of Shingrix. On 20-JUL-2023, 8 days after receiving Shingrix, the patient experienced sinus infection (Verbatim: sinus infection). The outcome of the sinus infection was not resolved.   It was unknown if the reporter considered the sinus infection to be related to Shingrix.     It was unknown if the company considered the sinus infection to be related to Shingrix.   Additional Information: GSK receipt date: 20-Jul-2023 The patient received a dose of Shingrix  and was diagnosed with a sinus infection on the day of reporting and was ordered to start prednisone (tomorrow).  The patient would call her primary care practitioner (PCP) and make sure it was ok to start the steroid.  Adverse event was filed with limited information.  Spoken as per package insert and offered package insert.  Referred to health care professional. Did not consent to follow-up.
Warm to touch at injection site; Burning at injection site; Mouth tingling; Facial and neck paresthesia (burning, itching, tingling); Facial and neck paresthesia (burning, itching, tingling), scalp itching; This is a spontaneous report from a non-contactable nurse, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3102) via an unspecified route of administration in the left arm on 24Sep2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Sep2021, the patient experienced warm to touch at injection site, burning at the injection site, mouth tingling, facial and neck paresthesia (burning, itching, tingling) and scalp itching. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department, or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events warm to touch at injection site, burning at injection site, mouth tingling, facial and neck paresthesia (burning, itching, tingling) and scalp itching was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Immediate mild reaction to include shaking, flushing of skin, and dizziness. Vitals monitored for 30 minutes by staff. Symptoms resolved and sent home. 11Jan2021 red, itching rash appeared over entire body. Not responsive to zyrtec or atarax. Saw PCM 12Jan2021 and was prescribed dexamethosone 4mg twice a day for five days. Currently on day two of treatment with no improvement.
Severe and sudden  Crohn?s disease flareup. Excruciating abdominal pain and fatigue after eating for the next two weeks until I was able to buy more AMP floracel and increase my dose for moderate relief. Saw some intestinal bleeding on the 9th day
Second Dose: Miscarriage; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Jan2022 (Lot number: FL3206) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot: 331308A or 331308H), administration date: 22Dec2021, when the patient was 35 years old, for COVID-19 Immunization, reaction(s): "First Dose: A Little Rash and Itchiness", "First Dose: A Little Rash and Itchiness". The following information was reported: ABORTION SPONTANEOUS (non-serious) with onset 24Feb2022, outcome "unknown", described as "Second Dose: Miscarriage". The event "second dose: miscarriage" was evaluated at the physician office visit. The pregnancy resulted in spontaneous abortion (24Feb2022). The patient underwent the following laboratory tests and procedures: pregnancy test: positive, notes: it was the first pregnancy test. Therapeutic measures were taken as a result of abortion spontaneous.  Clinical Course: She was vaccinated with the Pfizer vaccine on 22Dec2021 for her first dose and her second dose was on 31Jan2022. Caller states after the first dose, she had a little rash so she was checking with her PCP and he said it would be okay to move forward with the second one, that was the second one was a little bit later. her husband and her were trying to get pregnant and she got a positive pregnancy test and it was the first pregnancy test. At their first OBGYN appointment the doctor labeled it a miscarriage. She was not sure that the Pfizer vaccine could have interfered with the pregnancy, but she just wanted to let Pfizer know going forward. Rash: She was supposed to go for her second dose on 13Jan2022, but the rash started a few days before that, she felt itchiness also, it started about a week and a half later. That is why she was thinking twice before getting the second one. The doctor gave her a steroid cream. The rash lasted almost 2 weeks. Treatment: Miscarriage: Had to go in last week and take a pill in the office and the next day take 4 more pills and then the miscarriage began, goes for follow up 14Mar2022. Rash: Steroid She Couldn't said that the miscarriage was related or not, but she just wanted to be part of the information and report it. Vaccination Facility Type: Pharmacy/Drug Store. Adverse Event (AE) Details: Provide the time of onset of AE(s): Rash, a week, and a half later. No visit requires for AE(s) to: Emergency Room. They visited to Physician Office: OBGYN Twice. No hospitalization. There was no prior Vaccinations (within 4 weeks). No patient's Medical History (including any illness at time of vaccination). No family Medical History Relevant to AE(s). She does have 2 other daughters 5-year-old and 2-year-old daughter. No other Relevant Tests.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200388405 Same patient and drug, different dose
Information has been received from a physician assistant concerning a male over 60 year old who on an unknown date was vaccinate with an unspecified dose of PNEUMOVAX vaccine. Physician assistant reported that the patient developed hives after receiving PNEUMOVAX vaccine. It is unknown if this was the only PNEUMOVAX vaccine for this patient. The hives have appeared intermittently since PNEUMOVAX vaccine and respond to BENADRYL. The patient has had several episodes of hives separated by varying periods of time (no pattern). Additional information has been requested.
Expired Havrix Administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 85-year-old female patient who received HAV (Havrix) (batch number 7ya99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th November 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 8th November 2022, unknown after receiving Havrix and Havrix 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 Information: GSK receipt date: 8-Nov-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used. This is report for 1 of 2 linked patients reported by same reporter. Suspect was coded as per narrative information.; Sender's Comments:  US-GSK-US2022163638:Same reporter
Body aches, fever, chills, overall malaise. Called pharmacy and they said to treat with Advil or Tylenol.
The day after administration of vaccine, had a swollen red right arm with some blisters. Started on Benadryl, warm compresses and Augmentin. Next day the swelling had reduced significantly. Augmentin was stopped.
Fainted maybe 20-30 seconds post injection; convulsive vasovagal; Fainted maybe 20-30 seconds post injection. Then had what looked like a short seizure.; This is a spontaneous report from a contactable pharmacist (patient's mother). A 12-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 28Jul2021 16:15 (Batch/Lot Number: FA7485), at the age of 12 years old, as dose 2, single for covid-19 immunization in a pharmacy of drug store. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen, cetirizine hydrochloride (ZYRTEC), and mupirocin, all taken for unspecified indications, start and stop date were not reported. No other vaccines were given within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 on 05Jul2021 13:00 (lot no: FA6780), at the age of 12 years old, intramuscular in left arm for COVID-19 immunisation; previously fainted once 2-3 years ago with influenza vaccination. On 28Jul2021 16:15, the patient fainted maybe 20-30 seconds post injection. Then had what looked like a short seizure. He threw himself back in his chair, went totally straight and stiff then threw himself back again. Probably convulsive vasovagal but mom will have him checked out. As treatment, patient was laid on back and was given Gatorade. The events were reported as non-serious. The patient recovered from the events on 28Jul2021.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events syncope and seizure cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report as received from registered nurse refers to a 14 year old unknown gender patient. On 29-JUL-2013 the patient was vaccinated with GARDASIL injection, first dose (lot number and expiry date unspecified) 0.5 ml, intramuscularly. On 30-OCT-2013, second dose of GARDASIL with lot 1745AA expiry date 13-SEP-2014 was administered and no adverse events were reported. The outcome of the event was reported as unknown. This case # 1401USA014551 is linked with case # 1402USA000389 via same reporter link. Additional information has been requested.
Morning after immunization pt woke with itchiness and then right upper arm was swollen, red and warm to the touch. Parents applied ice to arm.
Flushing and redness occurred within 3-5 minutes of vaccination. Pt was uncomfortable and had back pain for about 5-10 minutes. Flushing and back pain subsided in 20-30 minutes (bad back pain was 5-10 minutes). Called Emergency Squad - BP/BS/PO2 all normal. Gave pt H2O. Pt went home but is going to follow up with her doctor.
pt recv vax 17OCT95 & early in the evening pt arm became swollen, warm & sore;arm then became painful w/movement;tx w/APAP & ice;acute pain lasted 3 days & soreness lasted 2 to 3 wk;
Patient stated she experienced nausea (no vomiting), low grade fever (<101 F), and tiredness (felt "wore out").
Swelling of lymph node in armpit and it was very tender for about 6 days, now resolved 1 week out
Dizzy; Weak; Non-stop vomiting for 8 hours; Nausea; Loose stools; Body Aches; Chills, no fever; Too sick to call Pfizer yesterday about symptoms; Has a ton of mucous discharge; This is a spontaneous report from a contactable Nurse. A 62-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: JR8729), via an unspecified route of administration, administered in Deltoid Left on 21Apr2021 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 62 years). The patient's medical history was not reported. There were no concomitant medications. The patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN6207) on 31Mar2021 for covid-19 immunisation and experienced Sore Arm after first vaccine (Age at vaccination: 62 years). The patient also had a historical vaccine of Flu vaccine on 16Oct2020 for immunisation and experienced Local Reaction; Redness at injection site (Age at vaccination: 61 years). The patient experienced non-stop vomiting for 8 hours on 22Apr2021 02:30, nausea, loose stools, body aches, chills, no fever and too sick to call Pfizer yesterday about symptoms on 22Apr2021, dizzy and weak on 23Apr2021. The patient also stated that she has a ton of mucous discharge on Apr2021. The events were considered as medically significant by the reporter. Outcome of the event vomiting was recovered on 22Apr2021, outcome of the events body aches and chills was recovering while outcome of the events mucous discharge and sickness was unknown. Outcome of the remaining events was not recovered.; Sender's Comments: There is a reasonable possibility that the events vomiting, nausea, diarrhea, and chills were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported events with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Large red circle around injection site. Arm pain/tenderness at injection site. Ankle very hot and swollen on injection side all last 3 days then resolved.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had quite a bit of arm pain), MYALGIA (aches for about 24 hrs.) and FATIGUE (tireness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (had quite a bit of arm pain), MYALGIA (aches for about 24 hrs.) and FATIGUE (tireness). At the time of the report, PAIN IN EXTREMITY (had quite a bit of arm pain), MYALGIA (aches for about 24 hrs.) and FATIGUE (tireness) had resolved. It was stated although it was not the official prescribed time for the vaccination we decided to set up the appointment anyway and we had no problem doing so and received the third shot. Mentioned as of today we were both fine and feel a bit more protected. Concomitant medication was not reported.Treatment information was not reported.
No additional AE reported; Patient was administered expired VAQTA on 11/23/2022; This spontaneous report was received from the healthcare business professional (in charge of vaccine storage/stability) and referred to a patient of unknown age and gender. The patient's medical history, concurrent condition, drug reactions/allergies, and concomitant therapy were not reported.  On 23-NOV-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular pre-filled syringe injection (valid lot #U026792 with the expiration date: 28-OCT-2022; strength, dose, and route of administration were not provided) for prophylaxis (Expired product administered). There was no temperature excursion reported. There was no additional adverse event reported (No adverse event).
arm is still sore after 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is still sore after 24 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is still sore after 24 hours). At the time of the report, PAIN IN EXTREMITY (arm is still sore after 24 hours) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Concomitant products used was not  provided.
stomach discomfort; 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 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergic to penicillin" (unspecified if ongoing), notes: allergic to aspirin and penicillin. The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "allergic to aspirin", notes: allergic to aspirin and penicillin. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "stomach discomfort". Therapeutic measures were taken as a result of abdominal discomfort.  Additional information: The patient took Prilosec for stomach discomfort for the past five days now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At the age of 18 years old the patient was accidentally re-vaccinated and given another dose of GARDASIL 9. The patient is now 19 years old and was given yet another GARDASIL 9 shot; no adverse event; This spontaneous report was received from the patient's mother and refers to a 19 year old female patient. The patient's medical history included thyroid disorder.  The patient's concomitant medications and drug reactions or allergies were not 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) dose 5,  via intramuscular, for prophylaxis (dosage schedule, anatomical location, lot number and expiration date were not reported).     On an unknown date, it was reported that at the age of 18 years old the patient was accidentally re-vaccinated and given another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The patient was now19 years old and was given yet another hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) shot (extra dose administered ). The patient did not experience any reaction.
injection site pain; tiredness; headache; fever; nausea; feeling unwell; dizziness; productive cough (yellow-brown); sneezing; weezing (no deep breaths); This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 11:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 the patient experienced injection site pain, tiredness, headache, fever, nausea, feeling unwell, dizziness, productive cough (yellow-brown), sneezing and wheezing (no deep breaths). Therapeutic measures were not taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event injection site pain, tiredness, headache, fever, nausea, feeling unwell, dizziness, productive cough (yellow-brown), sneezing and wheezing (no deep breaths) were recovered with sequelae on Apr2021 at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received a ZOSTAVAX vaccine on 10/6/14 and present to a doctor who diagnosed him with a infection/cellulitis and prescribed Clindamycin for it.
Patient reported having flu like symptoms and slight respiratory distress (in throat closing up) roughly about 6 hours after receiving the immunizations. Advised patient to take 2 of the diphenhydramine 25mg caps every 6 hours if having trouble breathing. Followed up with the patient the next day and he stated that he still felt like having the flu-like symptoms, but no trouble breathing at all.
Arm a bit sore after vaccination, but 7 days after shot,  upper half of left arm developed a pink rash, that turned red.  Arm was sensitive and itchy.  It felt like a big mosquito bite.  Injection site was red and tender.  Still have pale pink rash on upper left arm and injection site is still red and tender.  No other adverse affect.  Did take picture of arm.
Chills, icy hands and feet, aches, swollen armpit and salivary glands on side of injection, swollen injection site, fatigue, weird persistent twitching/muscle spasm in my left upper lip.
Morbilliform rash began on 12.13.2022.  Fever started on 12.12.2022, diarrhea, decreased appetite, diaper rash
Patient reported on 10/29/19 late morning that he experienced afterwards numbness and swelling of his legs, that he didn't have before.  He still currently has some discomfort with it.  Patient has already seen a medical doctor, who didn't think it was from the shot as well, but advise patient to contact manufacturer.
Reflex Sympathetic Dystrophy type findings-cyanosis, edema, lower temperature
PT reports the HM administered smallpox vaccine on the left arm in 3 locations; re-applying vaccine to the needle on each occasion. He was unable to do "take check one week later" and further states that he was unable to do anything for 3 days as a result of fever, general malaise, body aches, headaches; he does not recall that timeframe stating "I was unconscious for 3 days but was unable to go to hospital because my roomate was out of town".
8 days post vaccination, injection site pain/burning and itching started. Site was sore to touch. Pain and itching was intermittent, but still a nuisance. Noticed redness, swelling and hot to touch at site starting last night. I showed my Provider, today. She doesn't think I need antibiotics at this time. Recommended ice, Hydrocortisone cream, and oral antihistamine.