chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cellulitis Information has been received from a registered nurse concerning a 62 year old white male teacher with no know drug allergies, who on 14-NOV-2005 at 10:00 was vaccinated IM into the right deltoid with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (Lot #651318/1006P). On 14-NOV-2005, the patient experienced a swollen right arm and "flu symptoms." On 15-NOV-2005 the patient went to the emergency room. His arm was red and edematous from the deltoid to the forearm area was warm and painful to the touch. It was also noted that the patient was running a temperature. It was noted that the patient was diagnosed with cellulitis and received cefazolin sodium (Ancef), 1 gram IV. The redness of the arm remained unchanged and the patient had no other complaints. Laboratory diagnostic tests revealed a complete blood count was within normal limits, a potassium test was low at 2.9 and a glucose test was high at 134. The patient was released from the emergency room on oral antibiotics. The patient stated that he had potassium tablets at home that he was supposed to take daily. He will follow up with his own doctor. On 17-NOV-2005 the patient recovered from cellulitis. An investigation into this lot number was requested. No product quality complaint was involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. In addition, a review of the Quality Control Quarantine/Rejeciton System revealed that there were no open Quarantines registered against this lot/fill. Additional information is not expected.
Very swollen and painful lymph node located directly at the collarbone. Rest. Over the counter pain medication and hot compress. Reporting to doctor tomorrow for further examination. Node is quite swollen.
On the day after my vaccine, I had chills and felt mild malaise.  No definite fever.  Symptoms passed completely by awakening on 1/30/21.
really sick all week; cough for the last 3 days; mucus on his throat; Initial information received on 24-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 63 years old male patient who was really sick all week, cough for the last 3 days and mucus on his throat while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.    On 17-Oct-2022, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as prophylactic vaccination.  In Oct-2022 the patient was really sick all week (illness) had cough for the last 3 days (cough) mucus on his throat (secretion discharge) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization.   Action taken was not applicable.  The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE (DELSYM) for Cough.  At time of reporting, the outcome was Not Recovered / Not Resolved for all.
low-grade fever briefly after injection; itching; urticaria; swollen tongue; swollen hands; This case was reported by a physician via sales rep and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced fever, pruritus, urticaria, swollen tongue and hand swelling. On an unknown date, the outcome of the fever, pruritus, urticaria, swollen tongue and hand swelling were unknown.   It was unknown if the reporter considered the fever, pruritus, urticaria, swollen tongue and hand swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, briefly after vaccination the patient had Additional details were provided as follows: The age at vaccination was not reported. The reporter consented to follow up.
Flu like symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a patient of an unknown age and gender 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 an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment of events was reported. No concomitant medications were reported.   Reporter did not allow further contact
Vomited, choked, resp. distress-cyanosis in evening after injection. Went to ER where she had 2-3 more episodes with vomiting. Pt stabilized and was discharged.
2 day after shot was given had bad joint pain in all of my body Still has not went away.
S/S started  6 hours after receiving second dose. Including headache, confusion, full body aches, chills, nausea, migraine, sore and swollen arm at injection site.  S|S were constant, lasting for about 4 days.  Felt better as of 10-27-2021 morning.
The patient experienced no symptoms.; on 12/8/2019 an improperly stored dose of VARIVAX was administered to a patient; This spontaneous report was received from a pharmacist (also reported as nurse) referring to a patient of unknown age and gender.  Concomitant therapies included sterile diluent.  Information about pertinent medical history, drug reactions or allergies was not provided.           On 08-DEC-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S022758, expiration date 22-JUL-2021, dosage detail and strength was not provided) subcutaneously for prophylaxis. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent.  Administered doses of vaccine experienced temperature excursion of 23 degrees Fahrenheit (F) for 14 hours. There was no previous temperature excursion. Digital data logger was involved. The patient experienced no symptoms.
Tongue burning and enflamed taste buds.  The imflammation moves to different locations on the tongue.  No sense of taste on the front portion of the tongue.  Very sensitive to different spices and salt. Was given prednisone but didn't help.  There doesn't seem to be any improvement.  Tip of tongue looks chopped up.
I got 2 menstrual cycles; This is a spontaneous report from a contactable consumer(patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported she got 2 menstrual cycles. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient was seated in observation chair following vaccinations and fainted within 1-2 minutes of second injection (shingrix).  She was accompanied by male who was able to safely lower her to the ground.  He reported that she was not unconscious for more than a few seconds. She remained laying on the ground but was able to answer questions and carry on conversation shortly after fainting reporting body temperature irregularities only.  EMS was called as precaution since male reported this was not usual for her.  Patient was continuously monitored to ensure no allergic reaction or additional loss of consiousness. EMS arrived and checked vitals and assessed patient. Patient was upright and alert in chair before EMS arrival and their findings were normal. Patient refused EMS transport but remained in pharmacy observation for a few minutes longer and left accompanied at her own discretion with male she arrived with.
Two days after the vaccine I got hives. They were on my both of my elbows. There were more on the left elbow but the ones on the right appeared the day after the vaccine. They were itchy big welts. The next day my upper lip was swollen and the day after that my lower lip was swollen. My doctor advised I take Allegra. It took a few days for the hives and the swollen lips were I got the second shot and I took two Allegra two hours before the shot. I did not have any hives or swelling after that one.  That shot was 02/25/2021.
This spontaneous report was received from a non-healthcare professional via social media concerning a female patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, unit, route, lot # and expiration unknown) for prophylaxis. On an unknown date, the patient had tumor growth and serious injuries. On an unknown date, the patient died (cause of death was not reported). It was unknown if autopsy performed. The outcome of the events neoplasm progression and injury was unknown. The reporter did not provide the causality assessment for the events. The reporter considered the event injury to be medically significant. Reported Cause(s) of Death: Unknown cause of death.
Pt reports getting dental work 1 week after getting her second Shingrix dose and getting shingles in her mouth as a result. Symptoms of intense pain in the mouth existed for about 2-3 weeks before resolution.
Gold ball size to back of arm on (L) -Redness/warm to touch . She has put a cold compress & shape  went down.
Pt. began to wobble while walking and slowly crumpled to the floor off to her right, leg came in contact with scale and shoulder came in contact with room divider, head did not hit floor. Pts. eyes were open. RN picked child up, placed on exam table, assessed resp/pulse/BP every 5 minutes, lying, sitting, standing, cold compresses to forehead and back of neck. Sips of water. Occurred at about 0933/0935. Left at 0950. Pt. recovered well.
My baby was diagnosed with laryngomalacia and central and obstructive apnea, conditions common for premature babies, but she was born full term at 39 weeks  3 days (by measurement at 6 wk scan and 39 weeks 6 days by what?s actually possible given the date of positive pregnancy test).  She weighed 7lbs 8oz at birth. No pregnancy complications . Traumatic birth (left bruising and broken blood vessel in eye) but no recorded birth injury. Baby was seemingly born stunned but had normal APGAR score by 1 minute. Note, I started to fill out the TDap vaccine but the date was after the COVID vaccine and the form doesn?t let me change it to no vaccines within a month of first Pfizer dose. The TDAP was administered to me at 30 weeks pregnant to ensure 2 weeks after second Pfizer dose. I received TDap on 5/14/21, but I put 03/01/2021 on this form as the date just so I could finish and submit the form.  It won?t let me delete the entry.
patient jerked she didn't get all of the dose but she doesn't know how much with no reported adverse event; Initial information received on 09-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age female patient who jerked while getting INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] she didn't get all of the dose but she doesn't know how much with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength, dose, lot number: unknown) via unknown route in unknown administration site for Immunization.  While receiving vaccine patient jerked she didn't get all of the dose but she doesn't know how much with no reported adverse event (incorrect dose administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient states that she was not feeling right, stated could have been blood pressure, blood pressure was with in normal limits, patient stated that she was having shortness of breath and chest tightness, offered to call ems client refused stated that she had family here with her and that she would have them take her to the ER advised against  offered to call ems again client still refused and left with family in private vehicle .
Vomiting occurred approximately 12 hours post vaccine and lasted approximately 10 hours.  Several rounds of vomiting, chills, restless legs.
STIFF PAIN SHOOTING DOWN ARM INTO FINGER TIPS A FEW SECONDS AFTER SHOT.
Pfizer on 3/10 and 4/7. Positive on 8/22 ADMITTED 9/2 TO CURRENT
Loss of balance, dizziness, numbing and tingling to left side of tongue, face, gums and left lower lip
Administer shot (Zostavax) to 2 patients on 8-12-07 and one patient following week. On 8-23-07 started with breakout that looks like shingles on scalp and forehead. Very mild case too.
Slight headache; nose issues; cough; chest hurting; feels heavy a little; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2022, the patient received Shingrix 50 ug. In September 2022, less than a week after receiving Shingrix, the patient experienced headache, nasal discomfort, cough, chest pain and sensation of heaviness. On an unknown date, the outcome of the headache, nasal discomfort, cough, chest pain and sensation of heaviness were not recovered/not resolved.   It was unknown if the reporter considered the headache, nasal discomfort, cough, chest pain and sensation of heaviness to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-SEP-2022  Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had Shingrix shot yesterday (before reporting). The patient was experiencing slight headache, nose issues, cough and chest hurting, feels heavy a little. The patient asked was this common or could it be side effects. Additional Supportive Information: The follow up would not possible as no contact details were available.
Moderna arm; itching began 5 days after 2nd dose. Large red rash on left (injection) arm starting 2 days after that. Arm throbs and skin is pink, hot, and stings.  Severe headache in the back of my head and neck began 2 days after injection. Tylenol helped a little, but it persisted for 2 more days.
This spontaneous report was received from healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with doses of VARIVAX (Merck), (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Mom states the patient developed a cough and congestion that started Sat night.  Spoke to her on Tues 5/24 and it had not gotten better.  He tested negative for covid.  Spoke to her again 5/26 and she states his cough is better but still has the congestion.  Patient did not seek medical treatment.
Client was vaccinated with Moderna vaccines on 3/20 and 4/17/2021 at a pharmacy in .  Symptoms started on 9/28 - runny nose , cough, sore throat.  Tested + with PCR on 10/1.  Reported as a case of breakthrough Covid in a fully vaccinated person
At time of injection patient noted sensation down arm from site of injection. Next day noticed discomfort, swelling and warmth from injection site to elbow. (Lasted about 2 weeks). Still may be a little bit of swelling on 12/27/14.
Generalized itching and "warm" feeling for about 20 minutes approximately 45 minutes after vaccination.
Patient broke out in hives, generalized rashes and sore throat; Patient broke out in hives, generalized rashes and sore throat; Patient broke out in hives, generalized rashes and sore throat; This is a spontaneous case, initially reported by pharmacist to Agency (reference number: SEQ19-05958) on 31-Oct-2019, concerning a 52-year-old, male patient.  The patient's medical history includes hypertension. The patient's concomitant medication included losartan, hydrochlorothiazide and vitamin D (vitamin D NOS), all used for unknown indications.  On 12-Sep-2019, the patient was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported; batch number: P100100577; expiration date: Jun-2020] for influenza prophylaxis.   On 13-Sep-2019, one day after vaccination, the patient broke out in hives, generalized rashes and sore throat. Patient visited physician and was put on steroid dose.   It was also reported that the patient needed second dose of steroid to resolve generalized rashe which lasted for a month.   At the time of follow-up reporting, the patient was recovering from the events of hives and sore throat. The patient stated he was getting better now.  The reporter did not provide seriousness or causality assessment.  Follow-up received from a pharmacist via Agency [reference number: SEQ19-06734] on 18-Nov-2019: Additional reporter added. Start date of the events confirmed as 13-Sep-2019. Additional Agency reference number added. Narrative updated.  Non-significant follow up received from a pharmacist via Med Communications (reference number: SEQ19-07602) on 27-Dec-2019: Additional Med Communications reference number added. No changes in the narrative.  Company comment: Temporal relationship between introduction of Afluria and development of adverse events is plausible. The adverse events are suggestive of possible hypersensitivity reaction. Causality assessment is confounded by use of concomitant drugs. Nevertheless, all events are assessed as related to the suspect vaccine.; Sender's Comments: Temporal relationship between introduction of Afluria and development of adverse events is plausible. The adverse events are suggestive of possible hypersensitivity reaction. Causality assessment is confounded by use of concomitant drugs. Nevertheless, all events are assessed as related to the suspect vaccine.
The tip of my tongue became numb and slightly tingly.; The tip of my tongue became numb and slightly tingly / around my mouth and on my cheeks became slightly tingly; around my mouth and on my cheeks became slightly tingly; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9266), via an unspecified route of administration in the left arm on 24Feb2021 at 09:00 (at the age of 68-years-old) as a single dose for COVID-19 immunization. Medical history included arthritis, anaphylactic reaction to shellfish (patient carried an epinephrine (EPIPEN). The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included omeprazole and calcium carbonate/colecalciferol (VITAMIN D 2000). The patient did not receive any other vaccines within 4 weeks of the vaccination. The patient previously took ibuprofen and had an anaphylactic reaction (possibly) and received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN9581) on 28Jan2021 at 09:00 (at the age of 68-years-old) in the left arm for COVID-19 immunization. On 24Feb2021 at 09:30, the tip of the patient's tongue became numb and sightly tingly. Also, around the patient's mouth and her cheeks became slightly tingly. This lasted about 45 minutes. The patient was not treated for the events. Since the vaccination, the patient was not diagnosed with COVID-19. The clinical outcome of "the tip of my tongue became numb and slightly tingly / around my mouth and on my cheeks became slightly tingly" was resolved on 24Feb2021 at 10:15.
This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 09 out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patient's received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
Tightening of throat that caused pain and difficulty eating. Throat tightened more during physical activity. Treated with Prednisone, cetirizine & nasal spray. Slowly recovered over a three month period.
Headache, Myalgia, NauseaVomiting, Faitgue Narrative:
3 hours later, became "violently ill", "bones ached", arm very sore/ diarrhea/ vomiting on 11-6-2012 until 2pm 11-7-2012. Also reported "hot & cold "feeling.
sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in extremity in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in April 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient wants to receive the second dose, but she was already late according to recommended schedule, which led to incomplete course of vaccination. The reporter consented to follow up. No data available was available.   Follow up information was received from the pharmacist on 28th February 2020: The reporter stated that the 2nd dose was not administered to the patient at her pharmacy even though her safety report states that the 2nd dose was administered.  In April 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in extremity.  Shingrix was discontinued. The reporter elaborated by reporting the patient did not want to receive 2nd dose due to being "under the weather" and having a sore arm after the patient's 1st dose.  No additional information provided regarding 1st dose. The reporter stated that she will not send return correspondence back to GSK since the patient did not receive the 2nd dose.